OneTouch Ultra Kit (meter, 10 strips, supplies) The OneTouch Ultra meter uses patented FastDraw glucose test strips to quantitatively measure glucose in whole blood. Kit also contains lancet device capable of lancing either your arm or finger

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OneTouch Ultra Test Strips Summary

IMPORTANT: Please read this information and your OneTouch® Ultra or InDuo™ Brand Owner's Booklet before using OneTouch® Ultra Test Strips.

Intended Use
OneTouch® Ultra Test Strips are used with OneTouch® Ultra Brand and InDuo™ Brand Blood Glucose Meters for quantitatively measuring glucose in whole blood. OneTouch® Ultra Brand and InDuo™ Brand Meters read the glucose level of a whole blood sample on a OneTouch® Ultra Test Strip. OneTouch® Ultra Brand and InDuo™  Brand Systems are plasma-calibrated to allow easy comparison of results with laboratory methods. OneTouch® Ultra Test Strips are for testing outside the body (in vitro, diagnostic use).

Storage and Handling

• Store the test strip package in a cool, dry, place not above 30°C (86°). Keep away from direct sunlight and heat. Do not refrigerate.
• Store your test strips in their original vial only; do not transfer them to a new vial or my other container.
• After removing a OneTouch® Ultra 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.
• Write the discard date on the vial label when you first open it. Discard remaining OneTouch® Ultra Test Strips 3 months after first opening the vial.
• Avoid getting dirt or food on the top edge.
• Do not use test strips beyond the expiration date printed on the package since they may cause inaccurate results. Do not bend, cut, or alter a OneTouch® Ultra Test Strip in any way.

Quality Control: Checking the System 
Do a Control Solution Test: 

• When you begin using a new vial of test strips 
• At least once a week 
• Whenever you suspect that the meter or test strips are not working properly 
• When your blood glucose test results are not consistent with how you feel, or when you think your results are not accurate 
• If you drop the meter

When control solution is applied to the top edge of the OneTouch® Ultra Test Strip, you should get results within the expected range printed on the test strip vial. If control solution test results fail outside this range, repeat the test. Results that fall outside the range may be caused by: 

• Error in performing the test 
• Failure to shake the control solution vial well enough (must shake vigorously) 
• Expired or contaminated control solution 
• Improper coding of the meter 
• Test strip deterioration 
• Meter malfunction 
• Control solution that is too warm or too cool 
• Failure to discard the first drop of control solution

LIMITATIONS

OneTouch® Ultra Test Strips give accurate results when the following limitations are observed:

• The test strips should not be used for 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. 
• Extremes in haematocrit may affect test results.˛ 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® Ultra Test Strips may he used at altitudes up to 10,000 feet without an effect on test results. Accurate results were demonstrated in clinical studies performed at altitudes up to 1,640 feet and in studies simulating altitudes up to 10,000 feet. 
• In-Vitro Diagnosticum; 

Healthcare professionals--please note these additional limitations: 

• 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 mid (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 lower 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 15.5 mmol/L (600 mg/dL) and triglycerides up to 4.55 mmol/L (400 g/dL) do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with OneTouch® Ultra Brand and InDuo™ Brand Systems.

TEST PRINCIPLE
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 Brand or InDuo™ Brand Meter and displayed as your blood glucose result. The strength of these currents changes with the amount of glucose in the blood sample.

REAGENT COMPOSITION
Each OneTouch® Ultra Test Strip contains: Glucose oxidase (Aspergillus niger) > 0.8 IU; other ingredients (mediator, buffer, etc.) > 0.05 mg. The vial or vial cap contains approximately 1.4 g silica gel or 2.8 g of molecular sieve.

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