OneTouch ULTRA FASTDRAW DESIGN TEST STRIP PACKAGE INSERT, ULTRA Owner's Manual
Test Strips
For whole blood glucose testing with the OneTouch
Ultra®Family of Meters and InDuo®Systems. The
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®Systems
Owner’s Booklet before using OneTouch®Ultra®Tes t
Strips. Do not use your OneTouch®Ultra®Brand Test
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 instructional materials or your meter results seem unclear.
Intended Use
OneTouch®Ultra®Test Strips are used with the OneTouch®Ultra
Family of Meters and InDuo®Systems for quantitatively measuring
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 healthcare 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 temperatures and/or humidity outside the required storage
conditions may result in inaccurate readings.
• Store your test strips in their
To avoid damage or contamination,
strips to any other place.
• After removing a OneTouch
original vial only.
do not transfer test
®
Ultra®Test Strip from the
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®Ultra®Test Strip in any way.
• 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®Control Solution or a blood sample to
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
®
InDuo
Systems to match the code number printed
on the OneTouch
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
Family of Meters and InDuo®Systems to obtain accurate results.
• 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.
®
Ultra®Family of Meters and
®
Ultra®Test Strip vial.
®
Ultra®Test Strips with the OneTouch®Ultra
®
Ultra®Family of Meters and InDuo
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.
®
Ultra®Test Strips.
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.
®
®
®
®
Ultra®Test
®
Ultra®Test Strips and
Flip Top Vial
(Figure A - Example)
®
(Example)
®
®
®
Test Strips
AW 06018108F
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 forearm or palm for a few seconds, then press the release button. Keep holding the sampler and cap against your skin until a round drop of blood
forms under the cap. Maintain pressure until the drop
of blood is of at
least one microliter ( actual size).
The blood sample must be at least 1 µL in volume ( actual size) or you
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: Use blood sample from your:
Routinely before meals Fingertip, forearm, or palm
Prior to or more than two Fingertip, forearm, or palm
hours after:
• a meal
• a rapid-acting insulin injection
or insulin pump bolus
• exercise
When your blood glucose is Fingertip
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 Fingertip
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 booklet for instructions on coding the meter correctly.
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.
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 ( actual size). When the
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 confirmation 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,
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.
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.
do not add more blood to the test strip; discard the test
WARNING: Check that the unit
Test Results
• The OneTouch®Ultra®Family of Meters and InDuo®Systems display
results between 20 and 600 mg/dL (1.1–33.3 mmol/L). If your test
result is lower than 20 mg/dL (1.1 mmol/L), a warning message will
appear indicating a low glucose level. This may indicate severe
hypoglycemia (low blood glucose).
Treat this condition immediately according to your healthcare
professional’s recommendations.
Although this message could be due
to a test error, it is safer to treat first, then do another test. If your test
result is above 600 mg/dL (33.3 mmol/L), a warning message will appear
indicating a high glucose level. This may indicate severe hyperglycemia
(high blood glucose). You should retest your glucose level and if the
message appears again, call your healthcare professional immediately.
Range of Expected Values
Blood glucose management requires the help of a healthcare professional. Together you can set your own range of expected blood glucose
values, arrange your testing times, and discuss the meaning of your
blood glucose results.
Expected blood glucose levels for people without diabetes:
1
Time Range, mg/dL Range, mmol/L
Before breakfast 70–105 3.9–5.8
Before lunch or dinner 70–110 3.9–6.1
1 hour after meals Less than 160 Less than 8.9
2 hours after meals Less than 120 Less than 6.7
Between 2 and 4 am Greater than 70 Greater than 3.9
If You Get Unexpected Results:
If your blood glucose result is less than 70 mg/dL (3.9 mmol/L)
indicating low blood glucose or higher than 180 mg/dL (10.0
mmol/L) indicating high blood glucose, you should contact your
healthcare professional and follow his or her treatment advice.
2
If you continue to get unexpected results, check your system with
control solution. If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed
all instructions described in your 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.
Checking the System
Use only OneTouch®Ultra®Control Solution
For complete details about checking the system, refer to your owner’s
booklet.
When to do a Control Solution Test:
• At least once a week
• When you begin using a new vial of test strips
• Whenever you suspect that the meter or test strips are not
working properly
• If you have had repeated unexpected blood glucose results
• If you drop the meter
When control solution is applied to the top edge of the OneTouch
®
Ultra
Test Strip, you should get results within the expected range printed on
the test strip vial
. If control solution test results fall outside this range,
repeat the test. Results that fall outside the range may be caused by:
• Incorrect unit of measure
• Error in performing the test
• Failure to shake the control solution vial well (must shake vigorously)
• Expired or contaminated control solution
• Meter, test strip, or control solution that is too warm or too cool
• Failure to discard the first drop of control solution and wipe the dis-
pense tip clean
• Improper coding of the meter
• Test strip deterioration
• Meter malfunction
CAUTION: If you continue to get OneTouch®Ultra®Control Solution test
results that fall outside the range printed on the vial, your meter may
not be functioning properly. DO NOT use the meter to test your blood
until you get a control solution test result that falls within the range. If
you continue to have problems, call 1 800 227-8862.
Limitations of Procedure
OneTouch
limitations are observed:
• The test strips should not be used for the testing of newborns.
• The test strips are for single use only.
• The test strips are specific to D-glucose and do not react to other
• Use only fresh capillary whole blood.
• Hematocrit is the percentage of red blood cells in the blood.
• OneTouch
Healthcare professionals—please note these additional limitations of
procedure:
• Fresh capillary blood may be collected into heparin-containing test
• Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid
• Patients undergoing oxygen therapy may yield falsely low results.
• Test results may be falsely low if the patient is severely dehydrated,
®
Ultra®Test Strips give accurate results when the following
Do not reuse.
sugars which may be present in blood.
Do not use serum or plasma.
Extremes in hematocrit may affect test results.
3
Hematocrit levels
less than 30% may cause falsely high readings and hematocrit levels
greater than 55% may cause falsely low readings. If you do not
know your hematocrit level, consult your healthcare professional.
®
Ultra®Test Strips may be used at altitudes up to 10,000
feet (3048 meters) without an effect on test results. Accurate results
were demonstrated in clinical studies performed at altitudes up to
5,280 feet (1609 meters) and in studies simulating altitudes up to
10,000 feet (3048 meters).
tubes if the blood is used within 10 minutes.
Do not use other anti-
coagulants or preservatives.
(vitamin C), and other reducing substances (when occurring in normal blood or normal therapeutic concentrations) do not significantly
affect results. However, abnormally high concentrations in blood
may cause inaccurately high results.
in shock, or in a hyperosmolar state (with or without ketosis).
Critically ill patients should not be tested by blood glucose meters.
• Lipemic samples: Cholesterol levels up to 700 mg/dL (18.1 mmol/L)
and triglycerides up to 3000 mg/dL (33.9 mmol/L) do not affect the
results. Grossly lipemic patient samples have not been tested and
are not recommended for testing with the OneTouch
of Meters and InDuo
®
Systems.
®
Ultra®Family
Infection Control
Use universal blood precautions when handling, and disposing of,
blood glucose monitoring materials. All patient samples and materials
with which they come in contact are considered biohazards and
should be handled as if capable of transmitting infection. Follow
proper precautions in accordance with local regulations when
disposing of all materials.
CAUTION: To reduce the chance of infection:
Never share a lancet or the lancing device with anyone. Always use
a new, sterile lancet. Lancets are for single use only. Keep your meter
and lancing device clean. Make sure to wash the puncture site with
soap and water before testing.
Test Principle
The OneTouch
plasma-calibrated to allow easy comparison of results with laboratory
methods. Glucose in the blood sample mixes with special chemicals
on the test strip and a small electrical current is produced. This
current is measured by the OneTouch
InDuo
strength of this current changes with the amount of glucose in the
blood sample.
®
Ultra®Family of Meters and InDuo®Systems are
®
®
Systems and displayed as your blood glucose result. The
Ultra®Family of Meters and
Reagent Composition
Each OneTouch
(
Aspergillus niger) ≥ 0.08 IU; ferricyanide ≥ 22 µg; other ingredients
(buffer, etc.). The vial contains a drying agent.
®
Ultra®Test Strip contains: Glucose oxidase
Performance Characteristics
The performance of OneTouch
both in laboratory and in clinical tests.
Measurement range: The measurement range of the OneTouch®Ultra
System is 20 to 600 mg/dL (1.1–33.3 mmol/L).
Clinical Accuracy: The accuracy of the OneTouch®Ultra®System was
assessed by comparing blood glucose results obtained by patients with
those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory
instrument. The following results were obtained by 117 diabetic
patients at 3 clinical centers:
Slope 0.986
y-intercept -5.5 mg/dL (-0.3 mmol/L)
®
Correlation coefficient (r) 0.984
No. of samples 117
Range tested 36.4–434 mg/dL (2.0 - 24.1 mmol/L)
This study shows that the OneTouch®Ultra®Meter compares well with
a laboratory method. Additional clinical studies were performed using
other meters from the OneTouch
®
InDuo
System.
Laboratory studies have demonstrated that these meters perform
equivalently to the OneTouch
Precision:
Within Run Precision Blood
Total Precision Control 44 mg/dL (2.4 mmol/L) CV = 4.4%
This study shows a variability from strip to strip in blood tests of 3.2%
or less.
IMPORTANT: For a complete description of operating instructions
and other important technical information, please refer to the owner’s
booklet that came with your system. IF YOU HAVE QUESTIONS ABOUT
THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT LIFESCAN
CUSTOMER SERVICE AT 1 800 227-8862.
®
Ultra®Test Strips has been evaluated
3
®
Ultra®Family of Meters and the
®
Ultra®Meter.
45 mg/dL (2.5 mmol/L) CV = 3.2%
av
Bloodav77 mg/dL (4.3 mmol/L) CV = 2.0%
3
Bloodav129 mg/dL (7.2 mmol/L) CV = 2.1%
Bloodav220 mg/dL (12.2 mmol/L) CV = 1.8%
Bloodav364 mg/dL (20.2 mmol/L) CV = 1.6%
Control 171 mg/dL (9.5 mmol/L) CV = 2.6%
Control 366 mg/dL (20.3 mmol/L) CV = 2.4%
References
1. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia:
Lea and Febiger (1989), p. 138.
2. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York:
Simon and Schuster (1995), p. 158.
3. Data on file.
OUR COMMITMENT TO YOU:
Our goal is to provide you with quality healthcare products and dedicated
customer service. If you are not fully satisfied with this product, contact
your authorized LifeScan representative at 1 800 227-8862.
Covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, and 6,284,125.
Use of these test strips and associated monitoring device is protected under the following U.S. patents:
6,413,410, 6,733,655. Purchase of the associated monitoring device does not act to grant a use license
under these patents. Such a license is granted only when the associated monitoring device is used with
®
Ultra®Test Strips. No test strip supplier other than LifeScan, Inc. is authorized to grant such
OneTouch
a license. The accuracy of results generated with LifeScan meters using test strips manufactured by
anyone other than LifeScan has not been evaluated by LifeScan.
Distributed by:
LifeScan, Inc.
AW 060-181-08F
Milpitas, CA 95035
© 2006 LifeScan, Inc.
Rev. date: 05/2006
®
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