Understanding testing information and result specifics when testing using OneTouch Ultra® Test Strips.
Product Guide
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OneTouch Ultra® test strips
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OneTouch Ultra® Test Strips:
In vitro diagnostic. For self-testing.
Important:
Please read this information and your OneTouch Ultra® Family of Meters User Guide 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.
Blood Glucose Test Procedure:
For instructions on performing a blood test (including blood sample collection), refer to the User Guide that came with your system.
Important: Some OneTouch Ultra® Meters require coding. For meters that require coding, matching the code on the meter to the code on the test strip vial is essential to obtain accurate results. Refer to the User Guide that came with your system to determine if your meter requires coding and get detailed instructions on coding.
Test Results:
Low glucose values:
If your test result is below 20 mg/dL (1.1 mmol/L), a warning message will appear indicating a low glucose level. This may indicate severe hypoglycemia (low blood glucose).
Treat this condition immediately, according to your health care professional’s recommendations.
Although this message could be due to a test error, it is safer to treat first, and then do another test.
High glucose values:
If your test result is above 600 mg/dL (33.3 mmol/L), a warning message will appear indicating a high glucose level. This may indicate severe hyperglycemia (high blood glucose). You should retest your glucose level.
If the message appears again, call your health care professional immediately.
If you get unexpected results:
If your blood glucose result is below 70 mg/dL (3.9 mmol/L), indicating low blood glucose, or above 180 mg/dL (10.0 mmol/L), indicating high blood glucose, you should contact and follow your health care professional’s treatment advice.
If you continue to get unexpected results, check your system with control solution.
If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in your User Guide, call your health care professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your health care professional.
Range Of Expected Values:
Blood glucose management requires the help of a health care professional. Together you can set your own range of expected blood glucose values, arrange your testing times, and discuss the meaning of your blood glucose results.
Expected blood glucose levels for people without diabetes:
Time: Fasting
Range, mg/dL: Less than 100
Range, mmol/L: Less than 5.6
Time: 2 hours after meals
Range, mg/dL: Less than 140
Range, mmol/L: Less than 7.8
Limitations Of Procedure:
OneTouch Ultra® Test Strips give accurate results when the following limitations are observed:
Do Not use for the diagnosis of diabetes or for testing of newborns.
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.
Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit may affect test results. Hematocrit levels below 30% may cause falsely high readings and hematocrit levels over 55% may cause falsely low readings. If you do not know your hematocrit level, consult your health care professional.
OneTouch Ultra® Test Strips may be used at altitudes up to 10,000 feet (3048 meters) without an effect on test results. Accurate results were demonstrated in clinical studies performed at altitudes up to 5,280 feet (1609 meters) and in studies simulating altitudes up to 10,000 feet (3048 meters).
Health care 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 Ultra® Family of Meters.
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.
