OneTouch ultra test strips User Manual

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Do not store test strips outside the vial.

Ne pas conserver les bandelettes de test hors de leur flacon.

Test

AW 06052707D

Flip Top Vial

Flacon muni d’un

bouchon couronne

(Example/Exemple)

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

IMPORTANT: Please read this information and your OneTouch®Ultra®Family of Meters and InDuo 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®Ultra®Family of Meters and InDuo 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

• Code the OneTouch

InDuo 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 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

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.

Materials provided: One Touch®Ultra®Test Strips. 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 ( actual size) that will fill the confirmation window of 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 ( actual size) or you may 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. ( 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 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

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.

• The OneTouch 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.

Ultra®Test Strips are for single use only.

WARNING: Keep the test strip vial away from children; test stripsare a choking hazard. Do not swallow test strips. The teststrip vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation.

Precautions to Obtain Accurate Results

Systems to match the code number printed

Test Procedure for Blood Glucose Measurement

Customer Care Line at 1 800 663-5521 for assistance.

Test Results

UltraSmart®, etc.).

Systems Owner’s Booklet before using OneTouch®Ultra®Test

Systems for quantitatively measuring glucose in fresh

Ultra®Brand Test Strips if your vial is open or

Customer Care Line at

Ultra®Test Strips and the associated

Ultra®Test Strip from the vial, immediately

Ultra®Test Strip in any way.

Ultra®Family of Meters and

Ultra®Test

(Figure A - Example)

Ultra®Test Strips with the OneTouch®Ultra®Family

Systems to obtain accurate results.

Ultra®Family of Meters and InDuo

Customer Care Line at 1 800 663-5521.

Ultra®Family of Meters and InDuo®Systems display results

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.

Targets for glycemic control

Type 1 or 2 diabetes A1C ** FPG/preprandial PG 2-hour postprandial PG

goals* (%) (mmol/L) (mmol/L) Target for most patients ≤7.0 4.0-7.0 5.0-10.0 Normal range

(if it can safely be achieved) ≤6.0 4.0-6.0 5.0-8.0

*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:

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.

If you continue to get unexpected results, check your system

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

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.

Ultra®Control Solution test results

Ultra®Test

Limitations of Procedure

One Touch are observed:

• The test strips should not be used for the testing of newborns.

• 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

• 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

• OneTouch

Healthcare professionals—please note these additional limitations of procedure:

• Fresh capillary blood may be collected into heparin-containing test tubes if

• Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C),

• Patients undergoing oxygen therapy may yield falsely low results.

• Test results may be falsely low if the patient is severely dehydrated, in shock,

• Lipemic samples: Cholesterol levels up to 18.1 mmol/L (700 mg/dL) and

Ultra®Test Strips give accurate results when the following limitations

may be present in blood.

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.

(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).

the blood is used within 10 minutes. Do not use other anticoagulants or preservatives.

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.

or in a hyperosmolar state (with or without ketosis). Critically ill patients should not be tested by blood glucose meters.

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

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®Systems.

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®Systems and displayed as your blood glucose result. The strength of this current changes with the amount of glucose in the blood sample.

Ultra®Family of Meters and InDuo®Systems are plasma-

Reagent Composition

Each OneTouch ≥ 0.08 IU; ferricyanide ≥22 µg; other ingredients (buffer, etc.) The vial contains a drying agent.

Ultra®Test Strip contains: Glucose oxidase (Aspergillus niger)

Performance Characteristics

The performance of OneTouch laboratory and in clinical tests.

Measurement range: The measurement range of the OneTouch®Ultra®System is

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 0.986 y-intercept -0.3 mmol/L (-5.5 mg/dL) Correlation coefficient (r) 0.984 No. of samples 117 Range tested 2.0–24.1 mmol/L (36.4–434 mg/dL)

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®meter.

Ultra®Family of Meters and the InDuo®System. Laboratory

Ultra®Test Strips has been evaluated both in

Ultra®System was assessed by

Ultra®meter compares well with a

Precision:

Within Run Precision Bloodav2.5 mmol/L

Total Precision Control 2.4 mmol/L (44 mg/dL) CV = 4.4%

Bloodav4.3 mmol/L Bloodav7.2 mmol/L Bloodav12.2 mmol/L Bloodav20.2 mmol/L

Control 9.5 mmol/L Control 20.3 mmol/L

(45 mg/dL) CV = 3.2% (77 mg/dL) CV = 2.0% (129 mg/dL) CV = 2.1%

(220 mg/dL) CV = 1.8% (364 mg/dL) CV = 1.6%

(171 mg/dL) CV = 2.6%

(366 mg/dL) CV = 2.4%

This study shows a variability from strip to strip in blood tests of 3.2% or less.

IMPORTANT: For a complete description of operating instructionsand other important technical information, please refer to the owner’s bookletthat came with your system. IF YOU HAVE QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT THE ONETOUCH 1 800 663-5521.

CUSTOMER CARE LINE AT

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 thisproduct, we offer a No-Risk, MoneyBack 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 contactthe OneTouch®Customer Care Line at 1 800 663-5521.

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