OneTouch Ultra® Test Strips

OneTouch Ultra® test strips are used with the OneTouch Ultra® series of glucose meters to quantitatively measure glucose in fresh whole capillary blood. OneTouch Ultra® test strips and their corresponding glucose meters are intended for use by people with diabetes at home
and by healthcare professionals in clinical settings. Finger, palm, and forearm blood samples are suitable for OneTouch Ultra® test strips and their corresponding glucose meters.

Principle of testing

The OneTouch Ultra® series of blood glucose meters are calibrated to plasma glucose levels, which allows them to be compared with laboratory results. The glucose in the blood sample is mixed with special reagents in the test strip to produce a small electric current. The OneTouch Ultra® series glucose meters measure the strength of this current and display the blood glucose reading. The strength of this current varies depending on the level of glucose in the blood sample.

For detailed information on how to use the glucose meter and other important technical information, refer to the user manual that came with the glucose meter. IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCTS, please call the Lifescan Consultation Line at 0 800 500 353 (toll-free within Ukraine), Mon-Fri, 09:00-18:00.

• Store the test strip vial in a dry place at a temperature (t) between 4 °C and 30 °C and a relative humidity of up to 60%. DO NOT store the test strips in the refrigerator. Protect from direct sunlight and heat. Exposure to temperatures and humidity outside the recommended storage limits may result in inaccurate test results.
• The test strip test should be performed at a temperature (t) between 6 °C and 44 °C and a relative humidity between 10% and 90%.
• When opening the vial for the first time, write the date of disposal (date of opening plus 6 months) on the vial label.
• DO NOT use the test strips after the expiration date (printed on the vial label) or the date of disposal, whichever comes first.
• Store test strips only in the original vial. To avoid damage or contamination, DO NOT transfer the test strips to any other packaging.
• DO NOT open the test strip bottle until you are ready to test. Open the bottle only when you need to remove a test strip for further use.- After removing the test strip from the bottle, immediately close the cap tightly. Use the test strip as soon as you remove it from the vial.
• DO NOT use test strips from a vial that has been damaged or opened.
 Avoid contact of the test strips with dirt, food, or liquids. You may only touch any part of the test strip surface with clean, dry hands.
• DO NOT bend, cut, or deform the test strip.
• Test strips are intended for single use only. Never reuse a test strip that has already been coated with blood or control solution.
• Before testing, make sure that the glucose meter and test strips are at approximately the same temperature.
• Only a control solution or blood sample can be applied to the test strip.
• After testing, DO NOT return the used test strip to the bottle.
• In your area, used test strips may be considered biohazardous waste. Follow the advice of your healthcare provider and local regulations for proper disposal of such items.

WARNING! Keep the test strip bottle out of the reach of children. Swallowing a test strip can lead to a risk of airway obstruction or choking. Do not swallow the test strips. The test strip vial may contain a desiccant that is harmful if inhaled or swallowed and may cause skin or eye irritation. Do not swallow any components of the kit.

Please note that to obtain accurate results, it is important to ensure that the code on the glucose meter matches the code on the test strip bottle. You should check that the codes match before each test. For instructions on how to code your glucose meter, see the user manual that came with the device.

• If your blood glucose results are not consistent with your symptoms and you have followed all the instructions in the user guide     
   for your OneTouch Ultra® blood glucose monitor, contact your healthcare provider.
• Never ignore symptoms or make significant changes to your diabetes management program without consulting your healthcare provider.

Limitations of the procedure

Measurement results with OneTouch Ultra® test strips will be accurate if the following limitations are observed.

The OneTouch Ultra® series glucose meters are intended for use by a single patient and should not be shared with others.

• DO NOT use the glucose meter with test strips to diagnose diabetes or to test the blood glucose level of newborns.
• Test strips are intended for single use only. Do NOT use the same test strip twice.
• These test strips are specific for D-glucose and do not react with other sugars that may be present in the blood.
• Use only fresh whole capillary blood. Do NOT use serum or plasma.
• Hematocrit is the percentage of red blood cells in the blood. Deviations from the normal range of hematocrit can affect test results.2 If your hematocrit is less than 30%, your blood glucose results may be falsely high, and if your hematocrit is greater than 55%, your blood glucose results may be falsely low. If you do not know your hematocrit level, consult your healthcare provider.- OneTouch Ultra® test strips can be used at altitudes up to 3048 meters (m) without affecting the accuracy of the test results. The accuracy of the results has been confirmed in clinical trials conducted at an altitude of approximately 1609 m (m) and in trials that simulated altitudes up to 3048 m (m).
• Results may be falsely low in patients receiving oxygen therapy.
• The test results may be falsely low if the patient is severely dehydrated, in shock, or has an increased blood osmolarity (with or without ketosis). Glucose meters should not be used to determine blood glucose levels in patients in serious and critical condition.
• Blood with high lipid content: cholesterol levels up to 18.1 mmol/l and triglycerides up to 33.9 mmol/l do not affect the test results. The glucose meter has not been tested with blood samples from patients with severe lipidemia. It is not recommended to use the OneTouch Ultra® series of glucometers for testing such patients.

1 package —2 vials of 25 test strips each.

Manufactured at the factory:

LifeScan Scotland Limited, United Kingdom.

Service support:

Our goal is to provide you with quality medical devices and professional customer service. If you have any questions about VanTouch products, please contact the Lifescan Consultation Line at: 0 800 500 353 (free of charge in Ukraine), M-F, 09:00-18:00