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OneTouch Ultra® Test Strips - General Information

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OneTouch Ultra® Test Strips - General Information
OneTouch-Ultra-Test-Strips-General-Information
General information such as intended use, test principle and reagent composition, as well as storage and handling for OneTouch Ultra® Test Strips.
Product Guide
USA
OneTouch Ultra® test strips
English
5.0
Article Details

OneTouch Ultra® Test Strips:
 

  • In vitro diagnostic. For self-testing.
  • Important:
    • Please read this information and your OneTouch Ultra® Family of Meters before using OneTouch Ultra® Test Strips.
    • Do Not use your OneTouch Ultra® Test Strips if your vial is open or damaged in any way as this could lead to error messages or inaccurate blood glucose values. Contact OneTouch® Customer Care 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 for quantitatively measuring glucose in fresh capillary whole blood.
  • The OneTouch Ultra® Test Strips and associated meters are intended for use by people with diabetes at home and health care professionals in the clinical setting.
  • OneTouch Ultra® Test Strips and associated meters are for use in fingertip, forearm, and palm testing.
Storage And Handling:
  • Store the test strip vial in a cool dry place below 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 original vial only. To avoid damage or contamination, Do Not transfer test strips to any other container.
  • Do Not open the test strip vial until you are ready to test. Only open vial when removing test strips.
  • After removing a test strip from the vial, immediately close the vial lid 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 (date opened plus 6 months) on the vial label when you first open it.
  • Do Not use test strips beyond the expiration (printed on vial label) or discard date, whichever comes first.
  • 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 the test strip in any way.
  • Test strips are for single use only. Never reuse a test strip that had blood or control solution applied to it.
  • Make sure your meter and test strips are about the same temperature before you test.
  • Apply only control solution or a blood sample to the test strip.
  • After performing a test, Do Not return the used test strip to the vial.
  • Used test strips may be considered biohazardous waste in your area. Be sure to follow your health care professional’s recommendations or your local regulations for proper disposal.
  • 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. Do Not ingest or swallow any items.
Checking The System:
  • Use OneTouch Ultra® Control Solutions.
    • A control solution test is performed to check that the meter and test strips are working together properly and that you are performing the test correctly.
    • For instructions on how and when to check the system by performing a control solution test, refer to the User Guide that came with your system.
Test Principle:
  • The OneTouch Ultra® Family of Meters are 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 Ultra® Family of Meters and displayed as your blood glucose result. The strength of this current changes with the amount of glucose in the blood sample.
Reagent Composition:
  • Each test strip contains: Glucose oxidase (Aspergillus niger) ≥ 0.08 IU; ferricyanide ≥ 22 µg; other ingredients (buffer, etc.). The test strip vial contains a drying agent.
Description Of Symbols:
  • For a complete description of all symbols used, refer to the User Guide that came with your system.
Our Commitment to You:
  • As your partner in diabetes care, we offer valuable diabetes-related knowledge, tools and special offers online.
  • Should you need additional assistance, we welcome you to contact OneTouch® Customer Care.
  • Health Care Professionals:
    • Please contact OneTouch® Customer Care for additional instructions on using OneTouch® Meters in a clinical setting (e.g., long term care facilities and physician offices).
  • Important: 
    • For complete operating instructions and other important technical information, refer to the User Guide that came with your system. If you have questions about the use of any LifeScan product, please contact OneTouch® Customer Care.
AW 06626608 A
Properties
15/07/2021 00:23
Federico Bouchaton
Juan Sebastian Gonzalez Medina
14/06/2024 19:40
US

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