Before You Begin:
- Before using this product to test your blood glucose, carefully read the Owner's Booklet (articles are provided), and the inserts that come with the OneTouch Ultra Plus™ Test Strips, OneTouch Ultra Plus™ Control Solutions.
Important Safety Instructions:
- This meter and lancing device are for single patient use only. Do Not share them with anyone else, including family members! Do Not use on multiple patients!
- After use and exposure to blood, all parts of this kit are considered infectious or potentially infectious. A used kit may potentially transmit infectious diseases even after you have performed cleaning and disinfection.
Intended Use:
- The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
- The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor effectiveness of diabetes control.
- WARNING: This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by the FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. 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.
Limitations:
- 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™ System is not to be used for the diagnosis or screening of diabetes or for neonatal use. The OneTouch Ultra Plus Flex™ System is not for use on critically ill patients, patients in shock, severely dehydrated patients or hyperosmolar patients (with or without ketosis). Do Not use the OneTouch Ultra Plus Flex™ System for alternate site testing (AST). OneTouch Ultra Plus™ Test Strips should not be used at altitudes above 10,000 feet as there may be an adverse effect on test results. Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit may affect test results. Hematocrit levels below 20% may cause false high readings. Hematocrit levels over 60% may cause false low readings. Talk to your healthcare professional if you don't know your hematocrit level. The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System should not be used within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high glucose results with your meter. Do Not use the OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System if you are being treated for organophosphate poisoning with Pralidoxime (PAM) as it may cause inaccurate glucose results with your meter.
- If you have medical conditions that are associated with high uric acid level or hyperuricemia (e.g. Gout), then please check with your doctor before using the OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System. Uric acid at concentrations greater than 8 mg/dL can interfere with glucose measurements.
- If you take drugs containing acetaminophen (e.g. Tylenol etc.) or Dopamine at doses higher than the recommended high therapeutic level, then you may obtain inaccurate readings from the OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System. Please check with your doctor if you are unsure.
Test Principle:
- Glucose in the blood sample mixes with the enzyme FAD-GDH in the test strip and a small electric current is produced. The strength of this current calculates your blood glucose level. It then displays the blood glucose result and stores it in the meter memory.
- Use only OneTouch Ultra Plus™ Control Solutions and Test Strips with the OneTouch Ultra Plus Flex™ Meter. Use of OneTouch Ultra Plus™ Test Strips with meters for which they are not intended may yield inaccurate results.
