OneTouch Ultra Plus™ Test Strips - General Information

OneTouch Ultra Plus^™ Test Strips:
 

• In vitro diagnostic. For self-testing.

IMPORTANT:

• Please read this insert and your User Guide or Owner's Booklet before using. The User Guide or Owner's Booklet has full instructions for blood glucose and control solution testing.
  • OneTouch Ultra Plus Flex™ - Product Guide
• Do Not use new test strips if the vial is open or damaged in any way. This could lead to error messages or inaccurate blood glucose results.
• Contact Customer Care right away if you have questions about your test strips, test results or these instructions.
• Refer to your User Guide or Owner's Booklet for important information about cleaning and disinfecting your meter, lancing device, and caps.
  • OneTouch Ultra Plus Flex™ - Product Guide
• The meter and lancing device are for single patient use. Do Not share them with anyone including other family members! Do Not use on multiple patients! All parts of the kit are considered infectious or potentially infectious and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

• WARNING: Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or other bloodborne pathogens.

Intended Use:

• The OneTouch Ultra Plus^™ Test Strips are used with the OneTouch Ultra Plus Flex^™ Blood Glucose Monitoring System for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch Ultra Plus Flex^™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
• The OneTouch Ultra Plus Flex^™ Blood Glucose Monitoring System is not to be used for the diagnosis or screening of diabetes or for neonatal use.
• Refer to the User Guide or Owner's Booklet that came with your meter for the full system intended use.
  • OneTouch Ultra Plus Flex™ - Product Guide

Storage and Handling:

• Store the test strip vial in a cool dry place between 41°F and 86°F and below 65% relative humidity. Keep away from direct sunlight and heat. Do Not store the test strip vial in rooms where the air is humid such as the kitchen, laundry room or bathroom. Exposure to temperatures outside the storage limits, as well as moisture and humidity, may cause inaccurate readings.
• The expiration date is printed on the vial.
• The discard date is 6 months after you first open a test strip vial. When you open a new vial, write the discard date on the label.
• Do Not use after the expiration or discard date, whichever comes first.
• Store your test strips in the vial only. To avoid damage or contamination, Do Not put test strips in any other container.
• Open the vial only when taking out a test strip for use.
• Close the vial lid tightly right away after removing a test strip. Use each test strip as soon as you take it out of the vial.
• Do Not use test strips from a vial that is damaged or left open to air.
• Do Not get dirt, food or liquids on the test strip. You may touch the test strip anywhere on its surface with clean, dry hands.
• Do Not bend, cut or alter test strips in any way.
• Test strips are for single use only.
• Never reuse a test strip that already has blood or control solution on it.
• Make sure your meter and test strips are about the same temperature before you test.
• Apply only OneTouch Ultra Plus^™ Control Solution or a blood sample to the test strip.
• Do Not put the used test strip back in the vial after taking a test.
• Used test strips are considered infectious or potentially infectious waste. Be sure to follow your healthcare professional’s advice or local laws when throwing them away.

• 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 only OneTouch Ultra Plus^™ Control Solution
  • A control solution test is used to check that:
    • The meter and test strips are working together properly.
    • You are doing the test correctly.
• Do a control solution test
  • When you open a new vial of test strips.
  • If you think the meter or test strips are not working properly.
  • If you get repeated unexpected blood glucose results.
  • If you drop or damage the meter.
• Read your system User Guide or Owner's Booklet for instructions on how to run a control solution test.
  • OneTouch Ultra Plus Flex™ - Product Guide

Test Principle:

• The OneTouch Ultra Plus Flex^™ Meter is plasma-calibrated for easy comparison of results with lab methods. Glucose in the blood sample mixes with special chemicals on the test strip to produce an electrical current. The strength of the current changes with the amount of glucose in the blood sample. The OneTouch Ultra Plus Flex^™ Meter measures the current, calculates your blood glucose level and shows your result.

Reagent Composition:

• Each test strip contains: flavin adenine dinucleotide dependent glucose dehydrogenase or FAD-GDH (from Aspergillus sp.) 0.459–0.628 U; potassium ferricyanide 33.13–37.13 μg; and other ingredients (buffer, etc.). The vial contains a drying agent.

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, or if you have questions about the use of any LifeScan product, contact Customer Care.
  • If you cannot reach Customer Care, contact your healthcare professional for advice.

• OneTouch Ultra Plus Flex™ - Product Guide
• OneTouch Ultra Plus™ Test Strips - Performance Characteristics
• OneTouch Ultra Plus™ Test Strips - Testing Information
• OneTouch Ultra Plus™ Control Solution (Level 3 And 4)