User manual LIFESCAN VITA CONTROL SOLUTION REV 3-2008

[. . . ] IVD For self-testing. IMPORTANT: Please read this information and your OneTouch® VitaTM User's Handbook before using OneTouch® VitaTM Control Solution. Intended Use For use with the OneTouch® VitaTM Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that you are performing the test correctly. Summary and Explanation OneTouch® VitaTM control solution contains a known amount of glucose that reacts with OneTouch® VitaTM Test Strips. The test result you obtain should fall within the range of results printed on the vial of the test strips you are using. [. . . ] A control solution test that is within the expected range printed on the test strip vial will tell you the meter and test strips are working together and you are doing the test properly. Test Procedure Carefully read the instructions in your User's Handbook on how to perform a control solution test. Composition Control solution consists of glucose in water (0. 11% for OneTouch® VitaTM Control Solution) with buffers and stabilisers, a viscosity adjusting agent, a preservative, and a dye. Each vial contains enough solution for a minimum of 75 tests. Important Safety Information · Use only OneTouch® VitaTM control solution with the OneTouch® VitaTM Meter. Write the use-by date (date opened plus 3 months) in the space provided on the bottle label when you first open it. · Do not use after the expiry date (printed on bottle label) or use-by date, whichever comes first. · Control solution tests must be done at room temperature (20­25 °C). Control Solution m CAUTION: Do not swallow control solution; it is not for human consumption. Do not apply control solution to the skin or eyes, as it may cause irritation. AW 06529201A Storage and Handling Close the vial tightly immediately after use and store at room temperature below 30 °C. Do not refrigerate. Expected Results At room temperature, control solution test results should fall within the expected range printed on the test strip vial label about 95% of the time. If test results fall outside the expected range, read the notes in the bulleted list below and then repeat the control solution test with a new test strip. Results outside the expected range may indicate: · Failure to follow all the instructions for performing a control solution test described in your User's Handbook. · Control solution is contaminated or past its expiry or use-by date. · Test Strip is damaged or past its expiry or use-by date. [. . . ] Distributed by: LifeScan UK/Ireland, A div. of Ortho-Clinical Diagnostics, Johnson & Johnson, 50 - 100 Holmers Farm Way, High Wycombe, Bucks HP12 4DP United Kingdom www. LifeScan. co. uk 0120 0344 LifeScan Regulatory Affairs Europe Division of Ortho-Clinical Diagnostics France 1, rue Camille Desmoulins 92787 Issy-les-Moulineaux, Cedex 09 France Symbols: LOT ©2008 LifeScan, Inc. Rev. [. . . ]