OneTouch Ultra Test Strips User Manual

Flip Top Vial
Flacon muni d'un
bouchon couronne
(Example/Exemple)
For whole blood glucose testing with the OneTouch
Family of Meters and InDuo Systems. The OneTouch
Family of Meters have OneTouch
name (e.g. OneTouch
IMPORTANT: Please read this information and your OneTouch
Meters and InDuo ® Systems Owner's Booklet before using OneTouch
Strips. Do not use your OneTouch
damaged in any way as this could lead to error messages or blood glucose values
that read higher than the actual value. Call the OneTouch
1 800 663-5521 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
® ®
Meters and InDuo Systems for quantitatively measuring glucose in fresh
®
capillary whole blood. The OneTouch
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.

Storage and Handling

• Store the test strip vial in a cool, dry place not above 30°C (86°F) . Keep
away from direct sunlight and heat. Do not refrigerate.
• 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
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 One Touch
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.
® ®
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
InDuo ® Systems to match the code number printed
on the OneTouch Ultra
®
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 mmol/L or mg/dL. Refer to the owner's
booklet for the correct unit of measure. If the unit of
measure is not correct, call the OneTouch Customer Care Line at
1 800 663-5521.
• Use only OneTouch Ultra
®
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.

Test Procedure for Blood Glucose Measurement

Materials provided: One Touch
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 either a
fingertip or the forearm. If using the forearm, select a soft, fleshy area on the
forearm (away from bone) that is free of visible veins or excess hair. Wash your
hands and the puncture site with warm, soapy water. Dry them thoroughly.
Step 2: Lance the fingertip or forearm. If lancing the fingertip: Hold the
sampler firmly against the side of your finger. Press the release button.
Massage the fingertip to obtain a round drop of blood. Do not squeeze the
puncture site excessively. If lancing the forearm: Replace the regular sampler
cap with the clear cap and set the sampler for a deeper puncture. Massage
the area gently. If necessary, rub the area more vigorously or apply heat
briefly. Press and hold the sampler against the forearm for a few seconds.
Press the release button. Hold the sampler in place until a blood drop of
sufficient size forms (
the test strip. If you massage the area to obtain more blood, do not squeeze
the site excessively.
The blood sample must be at least 1 µL in volume (
get an inaccurate result.
Important Information About Forearm Testing
• Under certain conditions, blood glucose test results obtained using samples taken
from your forearm may differ significantly from fingertip samples.
• The conditions in which these differences are more likely to occur are when your
blood glucose is changing rapidly such as following a meal, an insulin dose, or
associated with physical exercise.
• When blood glucose is changing rapidly, fingertip samples show these changes
more quickly than forearm samples.
• When your blood glucose is falling, testing with a fingertip sample may identify a
hypoglycemic (low blood sugar) level sooner than a test with a forearm sample.
• Use forearm samples only for testing prior to or more than two hours after meals,
insulin doses, or physical exercise.
• Testing performed within two hours after meals, insulin doses, or physical
exercise, or whenever you feel that your glucose levels may be changing rapidly,
should be done from the fingertip.
• You should also use fingertip testing whenever you have a concern about
hypoglycemia (insulin reactions) such as when driving a car, particularly if you
suffer from hypoglycemic unawareness (lack of symptoms to indicate an insulin
reaction), as forearm testing may fail to detect hypoglycemia.
What you should do:
• Use forearm or fingertip samples for testing prior to, or more than two hours
after, meals, insulin dose, or physical exercise.
• Routine testing before meals can be done either at the fingertip or the forearm.
• Consult your healthcare professional before you begin using the forearm 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. (
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 push your finger against the test strip.
• 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, 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 the
OneTouch Customer Care Line at 1 800 663-5521 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 (mmol/L). If the unit of
measure is not correct, call the OneTouch
For detailed information on the blood sample collection and coding your meter,
please refer to the owner's booklet that came with your system.

Test Results

• The OneTouch Ultra Family of Meters and InDuo
® ®
between 1.1–33.3 mmol/L (20-600 mg/dL). If your test result is lower than
1.1 mmol/L (20 mg/dL), 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 33.3 mmol/L
(600 mg/dL), 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.

Test Strips

® Ultra ® as part of their brand
® UltraSmart ® , etc.).
® Ultra
® Ultra ® Brand Test Strips if your vial is open or
® Customer Care Line at
Ultra
®
Ultra Test Strips and the associated
® ®
Ultra Test Strip from the vial, immediately
® ®
® Ultra ® Test Strip in any way.
® Family of Meters and
Test Strip vial.
®
(Figure A - Example)
Test Strips with the OneTouch
®
Ultra Family of Meters and InDuo
® ®
® Ultra ® Test Strips.
actual size) that will fill the confirmation window of
actual size) or you may
actual size) When the flashing
Customer Care Line at 1 800 663-5521.
®
Systems display results
®
® Ultra ®

Range of Expected Values

® Ultra ®
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.
Targets for glycemic control
® Family of
Type 1 or 2 diabetes
® Ultra ® Test
goals*
Target for most patients
Normal range
(if it can safely be achieved)
*Treatment goals and strategies must be tailored to the patient, with consideration given to
individual risk factors. **An A1C of 7.0% corresponds to a laboratory value of 0.070.

If You Get Unexpected Results:

Family of
®
If your blood glucose result is less than 3.9 mmol/L (70 mg/dL) indicating low
blood glucose or higher than 10.0 mmol/L (180 mg/dL)indicating high blood
glucose, you should contact your healthcare professional and follow his or her
treatment advice.
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
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
Ultra Test • 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
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 dispense tip
clean
• Improper coding of the meter
• Test strip deterioration
• Meter malfunction
CAUTION: If you continue to get One Touch
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 the
OneTouch Customer Care Line at 1 800 663-5521.
®
Limitations of Procedure
One Touch Ultra
®
are observed:
• The test strips should not be used for the testing of newborns.
Ultra Family
® ®
• The test strips are for single use only. Do not reuse.
• The test strips are specific to D-glucose and do not react to other sugars which
may be present in blood.
• Use only fresh capillary whole blood. Do not use serum or plasma.
®
• Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit
may affect test results.
readings and hematocrit levels greater than 55% may cause falsely low readings. If
you do not know your hematocrit level, consult your healthcare professional.
• OneTouch
(10,000 feet) without an effect on test results. Accurate results were
demonstrated in clinical studies performed at altitudes up to 1609 meters
(5,280 feet) and in studies simulating altitudes up to 3048 meters (10,000 feet).
Healthcare professionals—please note these additional limitations of procedure:
• Fresh capillary blood may be collected into heparin-containing test tubes if
the blood is used within 10 minutes. Do not use other anticoagulants or
preservatives.
• Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (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.
• Patients undergoing oxygen therapy may yield falsely low results.
• Test results may be falsely low if the patient is severely dehydrated, 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 18.1 mmol/L (700 mg/dL) and
triglycerides up to 33.9 mmol/L (3000 mg/dL) do not affect the results. Grossly
lipemic patient samples have not been tested and are not recommended for
testing with the OneTouch
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
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
Ultra Family of Meters and InDuo
®
result. The strength of this current changes with the amount of glucose in the
blood sample.
Reagent Composition
Each OneTouch
≥ 0.08 IU; ferricyanide ≥22 µg; other ingredients (buffer, etc.) The vial contains
a drying agent.
Performance Characteristics
The performance of OneTouch
laboratory and in clinical tests.
Measurement range: The measurement range of the OneTouch
1.1-33.3 mmol/L (20-600 mg/dL).
Clinical Accuracy: The accuracy of the OneTouch
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
y-intercept
Correlation coefficient (r)
No. of samples
Range tested
This study shows that the OneTouch
laboratory method. Additional clinical studies were performed using other meters
from the OneTouch
studies have demonstrated that these meters perform equivalently to the
OneTouch ® Ultra
Precision:
Within Run Precision
Total Precision
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 THE ONETOUCH
1 800 663-5521.
References
1. Canadian Diabetes Association 2003 Clinical Practice Guidelines for the
Prevention and Management of Diabetes in Canada. Can J Diabetes. 2003; 27
(Suppl 2)
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, we offer a No-Risk, Money-
Back Guarantee and will refund your purchase within 30 days. Please contact us
regarding a refund or with questions about the use of any OneTouch
assistance, please contact the OneTouch
1
A1C ** FPG/preprandial PG
(%) (mmol/L)
≤7.0
4.0-7.0
≤6.0
4.0-6.0
If you continue to get unexpected results, check your system
2
® Ultra ® Control Solution
Ultra
®
Test Strips give accurate results when the following limitations
®
3 Hematocrit levels less than 30% may cause falsely high
® Ultra ® Test Strips may be used at altitudes up to 3048 meters
® Ultra ® Family of Meters and InDuo
® Ultra ® Family of Meters and InDuo
Systems and displayed as your blood glucose
®
Ultra Test Strip contains: Glucose oxidase (Aspergillus niger)
® ®
Ultra Test Strips has been evaluated both in
® ®
3
0.986
-0.3 mmol/L (-5.5 mg/dL)
0.984
117
2.0–24.1 mmol/L (36.4–434 mg/dL)
® Ultra ® meter compares well with a
® Ultra ® Family of Meters and the InDuo
® meter. 3
Blood av 2.5 mmol/L (45 mg/dL)
Blood av 4.3 mmol/L
(77 mg/dL)
Blood av 7.2 mmol/L
(129 mg/dL)
Blood av 12.2 mmol/L
Blood av 20.2 mmol/L
Control 2.4 mmol/L (44 mg/dL)
Control 9.5 mmol/L
(171 mg/dL)
Control 20.3 mmol/L
® CUSTOMER CARE LINE AT
® Customer Care Line at 1 800 663-5521.
2-hour postprandial PG
(mmol/L)
5.0-10.0
5.0-8.0
Ultra Test
® ®
Control Solution test results
®
® Systems.
® Systems are plasma-
®
Ultra System is
® ®
Ultra System was assessed by
® ®
® System. Laboratory
CV = 3.2%
CV = 2.0%
CV = 2.1%
CV = 1.8%
(220 mg/dL)
(364 mg/dL) CV = 1.6%
CV = 4.4%
CV = 2.6%
CV = 2.4%
(366 mg/dL)
® products. For