General information on OneTouch Select® Test Strips including intended use, storage, handling, precautions, checking the system, limitations, test principle, reagent composition, performance characteristics, precision and a description of symbols.
Product Guide
Global
OneTouch Select Simple® meter; OneTouch Select® test strips
Do Not use your OneTouch® Select™ Test Strips if your vial is open or damaged in any way as this could lead to error messages or blood glucose values that read higher than the actual value. Contact LifeScan Customer Care immediately if the test strip vial is open or damaged or if these instructional materials or your meter results seem unclear.
For further information regarding testing and results, see the following article:
OneTouch® Select™ Test Strips are used with the OneTouch® SelectSimple™ Meter for quantitatively measuring glucose in fresh capillary whole blood.
The OneTouch® Select™ Test Strips and meter are intended for self-testing outside the body (in vitrodiagnostic use) by people with diabetes at home and healthcare professionals in the clinical setting, as an aid to monitor the effectiveness of diabetes control. OneTouch® Select™ Test Strips and meter are for use on the finger, palm, and forearm.
Store the test strip package in a cool dry place not above 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 place.
Do Not open test strip vial until you are ready to test.
After removing a OneTouch® Select™ Test Strip from the vial, immediately 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 (6 months after first opening the vial) on the vial label when you first open it.
Do Not use test strips beyond the expiry (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® Select™ Test Strip in any way. OneTouch® Select™ Test Strips are for single use only. Never reuse a test strip that had either blood or control solution applied to it.
Make sure your meter and test strips are about the same temperature before you test.
Apply only OneTouch® Select™ Control Solution or a blood sample to the test strip.
After performing a test, Do Not return the used test strip to the vial.
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.
Check that the meter is showing the correct unit of measure before each test. The unit of measure is either mg/dL or mmol/L. Refer to the Owner’s Guide for the correct unit of measure. If the unit of measure is not correct, contact the Customer Care.
Use only OneTouch® Select™ Test Strips with the OneTouch® SelectSimple™ Meter to obtain accurate results.
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® SelectSimple™ Meter Owner’s Guide, call your healthcare professional.
Never ignore symptoms or make significant changes to your diabetes control programme without speaking to your healthcare professional.
For complete details about checking the system, refer to your Owner’s Guide.
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
If control solution test results fall outside of the range printed on the test strip vial, repeat the test and refer to your Owner’s Guide.
CAUTION: If you continue to get OneTouch® Select™ Control Solution test results 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, contact Customer Care.
OneTouch® Select™ Test Strips give accurate results when the following limitations are observed:
Do Not use for the diagnosis of diabetes or 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 may be present in blood.
Use only fresh capillary whole blood. Do Not use serum or plasma.
Haematocrit is the percentage of red blood cells in the blood. Extremes in haematocrit may affect test results.3 Haematocrit levels less than 30% may cause falsely high readings and haematocrit levels greater than 55% may cause falsely low readings. If you do not know your haematocrit level, consult your healthcare professional.
OneTouch® Select™ Test Strips may be used at altitudes up to 3048 meters (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).
Healthcare professionals—please note these additional limitations of procedure:
Fresh capillary blood may be collected into heparin-containing test tubes if the blood is used within 10 minutes. Do Not use other anticoagulants or preservatives.
Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), 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.
Patients undergoing oxygen therapy may yield falsely low results.
Test results may be falsely low if the patient is severely dehydrated, in shock, or in a hyperosmolar state (with or without ketosis). Critically ill patients should not be tested by blood glucose meters.
Lipemic samples: Cholesterol levels up to 700 mg/dL (18.1 mmol/L) and triglycerides up to 3000 mg/dL (33.9 mmol/L) do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with the OneTouch® SelectSimple™ Meter.
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.
The OneTouch® SelectSimple™ System is plasma-calibrated to allow easy comparison of results with laboratory methods. Glucose in the blood sample mixes with special chemicals in the test strip and a small electrical current is produced. This current is measured by the OneTouch® SelectSimple™ Meter and displayed as your blood glucose result. The strength of this current changes with the amount of glucose in the blood sample.
Each OneTouch® Select™ Test Strip contains: Glucose oxidase (Aspergillus niger) ≥0.08 IU; ferricyanide ≥22 μg; other ingredients (buffer, etc.). The vial contains a drying agent.
The performance of OneTouch® Select™ Test Strips has been evaluated both in laboratory and in clinical tests.3
3 Data on file.
Measurement range: The measurement range of the OneTouch® Select™ System is 20 to 600 mg/dL (1.1–33.3 mmol/L).
Clinical accuracy: The accuracy of the OneTouch® Select™ System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyser, a laboratory instrument. The following results were obtained by 163 diabetic patients at 3 clinical centres:
This study shows that the OneTouch® Select™ Meter compares well with a laboratory method.3
This study shows a variability from test strip to test strip in blood tests of 3.0% or less.
This data was generated using the OneTouch® Select™ Meter. OneTouch® Select™ system performance is representative of the OneTouch® Select™ Family of Meters (OneTouch® Select™ and OneTouch® SelectSimple™).
Please refer to your Owner’s Guide for performance information for your OneTouch® SelectSimple™ Meter.
IMPORTANT: For a complete description of operating instructions and other important technical information, please refer to the Owner’s Guide that came with your system. IF YOU HAVE QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT CUSTOMER CARE.
For a complete description of all symbols used, refer to the Owner’s Booklet or User Guide that came with your system.
Our Commitment To You:
Creating a world without limits for people with diabetes is what OneTouch® is all about. To enjoy the benefits that OneTouch® has to offer, kindly contact Customer Care to enroll on to our OneTouch® Zone programme.
Healthcare Professionals:
Please contact LifeScan Customer Care for additional instructions on using OneTouch® Meters in a clinical setting (e.g., long term care facilities and physician offices).
