Polymer Technology Systems A1CNow SELF CHECK User manual

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INTENDED USE
The A1CNow®SELFCHECK test provides
quantitative measurement of the percent
of glycated hemoglobin (%A1C) levels in
capillary (ngerstick) 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 ofce 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%.2Your
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 condently 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 signicant 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 uids or
food to perform this test. Use ONLY your
ngerstick 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, ush with
water.
• Leave the Cartridge Pouch sealed until
ready for use.
• DO NOT add your blood directly to the
cartridge. Your blood must rst 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-H OM E A1C SY STEM
91076 B 3/2014

10 13 1611 14 1712 15 18
TROUBLESHOOTING
See the table below for a description of
A1CNow SELFCHECK operating and error
codes (“OR”= Out of Range, “QC”= Quality
Control, “E”= Monitor Error).
MESSAGE DESCRIPTION AND RESOLUTION
OR 1 The blood sample may have too little
hemoglobin for the test to work properly,
or you added too little blood.
Call customer service.
OR 2 The blood sample may have too much
hemoglobin for the test to work properly,
or you added to much blood.
Call customer service.
OR 3 The blood sample may have too little
hemoglobin A1C for the test to work
properly, or you added too little blood.
Call customer service.
OR 4 The blood sample may have too much
hemoglobin A1C for the test to work
properly, or you added too much blood.
Call customer service.
OR 5 The monitor temperature is below
64° F / 18° C. The test must be
repeated with a new cartridge at room
temperature (18-25° C).
MESSAGE DESCRIPTION AND RESOLUTION
OR 6 The monitor temperature is above
77° F / 25° C. The test must be
repeated with a new cartridge at room
temperature (18-25° C).
<4.0 The %A1C is less than 4%.
Call customer service.
>13.0 The %A1C is greater than 13%.
Call your health care professional.
QC 2 Occurs when you insert a Cartridge that
already has sample added to it.
Do not remove and reinsert a Cartridge
after adding sample.
QC 6 Sample was added to Cartridge before
“SMPL” display. This counts down one
test on the Monitor. Remove and discard
Cartridge. To avoid this error, do not add
sample until the “WAIT” prompt clears
and “SMPL” appears.
QC 7 The Cartridge remained in the Monitor
without sample addition for 2 minutes
after “SMPL” prompt. This counts down
one test on the Monitor. Discard the Test
Cartridge and insert a fresh one when
you are ready to dispense the Shaker.
MESSAGE DESCRIPTION AND RESOLUTION
All other QC
Codes
The quality control checks inside the
Monitor did not pass. The test will need
to be repeated with another kit.
Call customer service.
E Codes The Monitor is not working.
Call customer service.
Customer Service: 1-877-870-5610
DISPOSAL OF MATERIALS
Keep the Monitor to run the second test and
dispose of it after the second test has been
performed. Throw away all of the other used
components (except the Lancet) in your
household waste. The Lancet, Shaker, Blood
Collector and Cartridge can be used only
once.
Since the Lancet has a sharp point, it should
be disposed of in an appropriate sharps
container in the same way you dispose of
your blood sugar testing lancets.
FREQUENTLY ASKED QUESTIONS
When should I do the A1CNow
SELFCHECK test?
The A1CNow SELFCHECK test can be
performed at any time of day. No fasting is
required. You may wish to run the test at the
same time you do your blood sugar test.
Sometimes I have trouble getting a blood
drop that is large enough. What can I do?
Try washing your hands in warm water. Warm
water will help increase blood ow for a
better ngerstick. You may also massage the
nger before the ngerstick.
What is the best way to ll the Blood
Collector?
Hold the Blood Collector horizontally or at a
45° angle relative to the blood drop. Touch
the tip gently to the drop of blood and allow
the tube to ll. It will stop automatically when
it is lled completely.
My Blood Collector is not lled
completely. What should I do?
Apply pressure to your nger to get more
blood. Again, touch the tip gently to the
drop of blood and allow the tube to ll. You
may have to re-stick your nger to get the
necessary blood. If the Blood Collector does
not ll, call customer service.
There is extra blood on the tip of the
Blood Collector. What should I do?
Carefully wipe the tip of the Blood Collector
with a piece of gauze or tissue. If some of
the blood comes out while doing this, touch
the tip gently to the blood drop to re-ll the
Blood Collector.
The Shaker seemed to leak when I pushed
the Blood Collector into it. What should I
do?
Call customer service.
The Cartridge will not insert into the
Monitor. What should I do?
Make sure you are inserting the Cartridge
facing correctly. The Code should be on top
as you insert the Cartridge into the Monitor.
I accidentally opened the Cartridge pouch
too early. What should I do?
Throw away the Cartridge that has been
opened for more than 2 minutes. Inaccurate
results can be obtained. Use the second
Cartridge in the kit instead.
The Codes on the Cartridge and the
Monitor are not the same.
Do not use the Cartridge. Save the
packaging materials and call customer
service.
The Monitor did not turn on after I
inserted the Cartridge. What should I do?
Take the Cartridge out. Re-insert in until it
‘clicks’. If the Monitor still does not turn on,
this means that it may have a problem and
can’t be used. Call customer service.
I did not see ‘RUN’ and a countdown after
I added the sample using the Shaker.
What should I do?
Call customer service.
My result says ‘QCOK’ and a number.
What should I do?
‘QCOK’ means the Monitor is working
correctly. The number you see is your A1C
result. Write your result down in the Result
Log in the Quick Reference Guide. Monitor
will show result for 60 minutes and will turn
off automatically.
Review your result with your health care
professional.
My result is not ‘QCOK’ and a number.
What should I do?
Refer to the troubleshooting section. You can
also call customer service.
What should I do with the test after I am
done with it?
After you write down your result, you can
throw away the used Blood Collector, Shaker
and Cartridge in your household trash. These
items can be used only once. Note that the
Lancet is also a single-use item.
Save the Monitor for your second test.
Monitor will display “01TL” showing that
there is one test left. When Monitor is
displaying “00TL” it indicates that you have
used both tests. Once you have used the
second test, you can throw away the Monitor
in your household trash.
QUESTIONS OR COMMENTS
Call customer service at 1-877-870-5610.
1. Burtis, C.A., Ashwood, E.R., Tietz Textbook of Clinical Chemistry,
3rd Edition, W.B. Saunders Co., 1999.
2. American Diabetes Association. Standards of medical care in
diabetes-2011. Diabetes Care, 34 (S1) 2011, pp. S11-S61.
AT-H OM E A1C SY STEM
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, IN 46268 USA
1-877-870-5610