OneTouch ULTRA FASTDRAW DESIGN TEST STRIP PACKAGE INSERT Owner's Booklet

Test Strips
For whole blood glucose testing with the OneTouch
Ultra ® Family of Meters and InDuo
OneTouch ® Ultra ® Family of Meters have OneTouch
Ultra ® as part of their brand name (e.g. OneTouch
UltraSmart ® , etc.).
IMPORTANT: Please read this information and your
OneTouch ® Ultra ® Family of Meters and InDuo
Owner's Booklet before using OneTouch
Strips. Do not use your OneTouch
Strips if your vial is open or damaged in any way as this
could lead to error messages or blood glucose values
that read higher than the actual value. Call LifeScan
Customer Service at 1 800 227-8862 immediately if the
test strip vial is open or damaged or if these instruc-
tional materials or your meter results seem unclear.
Intended Use
OneTouch ® Ultra ® Test Strips are used with the OneTouch
Family of Meters and InDuo Systems for quantitatively measuring
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glucose in fresh capillary whole blood. The OneTouch
Strips and the associated meters are intended for use outside the body
(in vitro diagnostic use) by people with diabetes at home and health-
care professionals in the clinical setting, as an aid to monitor the
effectiveness of diabetes control. OneTouch
associated meters are for use on the finger, palm, and forearm.
Storage and Handling
• Store the test strip package in a cool dry place not
above 86° F (30° C). Do not refrigerate. Keep away
from direct sunlight and heat. Exposure to tempera-
tures and/or humidity outside the required storage
conditions may result in inaccurate readings.
• Store your test strips in their original vial only.
To avoid damage or contamination, do not transfer test
strips to any other place.
• After removing a OneTouch ®
vial, immediately replace the vial cap and close it tightly.
• Use each test strip immediately after removing it from the vial.
• Do not use test strips from any vial that is damaged or left open to air.
• Write the discard date (3 months after first opening the vial) on the
vial label when you first open it. Discard remaining OneTouch
Ultra ® Test Strips after the discard date.
• Do not use test strips beyond the expiration (printed on package)
or discard date, whichever comes first, because they may cause
inaccurate results.
• Avoid getting dirt, food or liquids on the test strip. With clean, dry
hands, you may touch the test strip anywhere on its surface.
• Do not bend, cut, or alter a OneTouch
• OneTouch Ultra Test Strips are for single use only. Never reuse a
® ®
test strip that had either blood or control solution applied to it.
• Apply only OneTouch ® Ultra
the test strip.
WARNING: Keep the test strip vial away from children; test strips
are a choking hazard. Do not swallow test strips. The test strip vial
may contain drying agents that are harmful if inhaled or swallowed
and may cause skin or eye irritation.
Precautions to Obtain Accurate Results
• Code the OneTouch Ultra Family of Meters and
® ®
InDuo ® Systems to match the code number printed
on the OneTouch Ultra Test Strip vial.
® ®
CAUTION: Matching the code on the meter
and the code on the test strip vial is essential
to obtain accurate results. Each time you test,
check to make sure the code numbers match.
(Figure A)
• Check that the meter is set to the correct unit of
measure before each test. The unit of measure is either mg/dL or
mmol/L. Refer to the owner's booklet for the correct unit of measure.
If the unit of measure is not correct, call 1 800 227-8862.
• Use only OneTouch ® Ultra ® Test Strips with the OneTouch
Family of Meters and InDuo
• If you are experiencing symptoms that are not consistent with your
blood glucose test results AND you have followed all instructions
described in your OneTouch
Systems Owner's Booklet, call your healthcare professional.
• Never ignore symptoms or make significant changes to your diabetes
control program without speaking to your healthcare professional.
• If your 14- day and 30- day test result averages are not what you
expect, you should not rely on them.
Test Procedure for Blood Glucose Measurement
Materials provided: OneTouch
Materials required but not provided: your meter, owner's booklet,
lancing device, optional clear cap, and a new, sterile lancet.
Blood Sample Collection
To obtain a drop of blood, follow these steps:
Step 1: Select the puncture site. You may obtain a blood drop from
the fingertip, palm, or forearm. If using the forearm, choose a fleshy
area away from bone, visible veins and hair. Sometimes there is less
blood flow to the forearm than to the fingertips. If using the palm,
choose a fleshy area on the palm below your thumb or pinky finger.
Select a spot with no visible veins and away from deep lines, which
may cause your blood sample to smear. Wash your hands and the
puncture site with warm, soapy water. Dry them thoroughly.
®
® Systems. The
®
®
® Systems
® Ultra ® Test
® Ultra ® Brand Test
® Ultra
® Ultra
Ultra Test Strips and
® ®
Flip Top Vial
Ultra ® Test Strip from the
Ultra Test Strip in any way.
® ®
® Control Solution or a blood sample to
(Figure A - Example)
Systems to obtain accurate results.
®
Ultra Family of Meters and InDuo
® ®
Ultra Test Strips.
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Step 2: Lance the puncture site. If lancing the fingertip: Hold the sampler
firmly against the side of your finger. Press the release button. Gently
squeeze and/or massage your fingertip until a round drop of blood forms
on your fingertip. Do not squeeze the puncture site excessively. If lancing
the forearm or palm: Replace the regular sampler cap with the clear cap
and you may have to adjust the sampler to a deeper setting to get a large
enough drop of blood from your forearm or palm. To help you get a large
enough drop of blood, you may gently massage or apply warmth to the
site to increase blood flow. Press and hold the sampler against your fore-
®
arm or palm for a few seconds, then press the release button. Keep hold-
ing the sampler and cap against your skin until a round drop of blood
® Test
forms under the cap. Maintain pressure until the drop of blood is of at
least one microliter (
The blood sample must be at least 1 µL in volume (
may get an inaccurate result.
Choosing the Right Sampling Site at the Right Time
At times, results obtained at the forearm or palm may be different from a
fingertip measurement. Talk to your healthcare professional before you
begin using your forearm or palm for sampling.
If you are testing:
Routinely before meals
Prior to or more than two
hours after:
• a meal
• a rapid-acting insulin injection
or insulin pump bolus
(Example)
• exercise
When your blood glucose is
changing rapidly, such as:
• within two hours after a meal
®
• within two hours after a
rapid-acting insulin injection
or insulin pump bolus, or
• during or within two hours
after exercise
When you are concerned about
the possibility of hypoglycemia
CAUTION: Do not test on forearm or palm when:
• You think your blood glucose is rapidly falling, such as within two
hours of exercise or a rapid-acting insulin injection or insulin pump
bolus. Testing with a fingertip sample may identify a hypoglycemic
(low blood sugar) level sooner than a test with a forearm or palm sample.
• It has been less than two hours after a meal, a rapid-acting insulin
injection or insulin pump bolus, physical exercise, or you think
your glucose level is changing rapidly.
• You are concerned about the possibility of hypoglycemia (insulin
reactions), such as when driving a car. This is especially important
if you suffer from hypoglycemia unawareness (lack of symptoms to
indicate an insulin reaction).
Remember: Consult with your healthcare professional before using
your forearm or palm for testing.
Blood Glucose Testing
Step 1: Insert test strip. Remove a test strip from the vial. Check the
code number on the test strip vial before inserting the strip. Recap the
vial immediately. Insert the test strip, contact bars end first and facing
up, into the test port. Push it in until it will go no further. The meter
will turn on and the display check will appear briefly. Be sure the meter
and test strip codes match. If they do not match, see your owner's book-
let for instructions on coding the meter correctly.
CAUTION: Matching the code on the meter and the code on the test
® Ultra ®
strip vial is essential to obtain accurate results. Each time you test,
check to make sure the code numbers match.
Next, the apply blood symbol will appear.
Step 2: Apply sample. Using the lancing device, obtain a blood sample
®
large enough to fill the confirmation window (
flashing apply blood symbol appears on the display, touch and hold the
drop of blood to the narrow channel in the top edge of the test strip.
• DO NOT apply sample to the front or back of the test strip.
• DO NOT press the test strip too firmly against your puncture site
(fingertip, forearm, or palm).
• DO NOT apply a smeared sample.
Hold the blood drop to the top edge of the test strip until the confirma-
tion window is full before the meter begins to count down. If the
confirmation window does not fill completely before the meter begins
to count down, do not add more blood to the test strip; discard the test
strip and retest. If the confirmation window is not full, you may get an
error message or an inaccurate test result. If you have trouble filling
the test strip, contact LifeScan Customer Service for assistance.
Step 3: Accurate results in just 5 seconds. Your blood glucose test result
will appear after the meter counts down from 5 to 1. Blood glucose
test results are automatically stored in the meter memory. Turn the
meter off by removing the test strip. WARNING: Check that the unit
of measure is set correctly (mg/dL). If the unit of measure is not
correct, call 1 800 227-8862.
For detailed information on the blood sample collection and coding your
meter, please refer to the owner's booklet that came with your system.
actual size).
actual size) or you
Use blood sample from your:
Fingertip, forearm, or palm
Fingertip, forearm, or palm
Fingertip
Fingertip
actual size). When the