User manual LIFESCAN ONETOUCH SURESTEP (WITH DATA PORT)

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Detailed instructions for use are in the User's Guide.

[. . . ] Blood Glucose Monitoring System Owner's Booklet Easy Easy to Handle, Easy to Read Easy Simple Blood Application Confirms Confirms Enough Blood Is Applied Is The OneTouch® SureStep® System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes. i LEARNING CAUTION: Before using any product to test your blood glucose (blood sugar), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes Healthcare Professional. [. . . ] If you have symptoms that match your test results, or if you continue to get results that fall below 60 mg/dL or above 180 mg/dL when you repeat the test, follow the advice of your Healthcare Professional. If the confirmation dot is not completely blue or has white patches or white streaks (see "How To Test Your Blood"), repeat the test with a new test strip. If the problem continues, call LifeScan Customer Services (1-800-227-8862). If the confirmation dot is completely blue, compare the confirmation dot to the sample color dots on the Color Chart of the test strip label on the bottle. If this comparison indicates that your blood glucose is very low 36 (50 mg/dL), conduct a Control Solution Test (see "Checking The System"). If the Control Solution test indicates that your meter and test strips are working together properly, repeat your blood glucose test with a new test strip. If you continue to receive a very low blood glucose test result, the low glucose result is likely to be correct and you should follow your Healthcare Professional's advice for treating low glucose levels. If the Control Solution test is out of range, call LifeScan Customer Services (1-800-227-8862). I MPORTANT: When proper procedures are followed, the meter will display "HI" in virtually all cases when your result is above 500 mg/dL (27. 8 mmol/ L). The confirmation dot color will also be darker than the "350 mg/dL" sample color dot on the test strip bottle label. If you have never experienced blood glucose levels this high or have not been instructed in how to deal with them by your Healthcare Professional, you should contact your Healthcare Professional at once. How to Check if Your Meter is Working Correctly The easiest way to check if your meter and test strip are working together properly is to run a test with OneTouch® SureStep® Glucose Control Solution. According to the American Diabetes Association (ADA) clinical practice recommendations "Comparisons between results from patient self-testing of blood glucose in the clinic and simultaneous laboratory RESULTS testing are useful to assess the accuracy of patient results. " Consult your Healthcare Professional about doing such a comparison. The following sections discuss how to do such a comparison and the precautions to consider in evaluating your results. in that range is considered accurate when testing with the OneTouch® SureStep® Meter. However, results can differ by more than ±20% in some situations. Such results are more likely to occur under the following conditions: Comparing Meter and Laboratory Results The OneTouch SureStep System is plasma calibrated. Because most laboratories measure plasma glucose, you can directly compare your meter test results with the lab results. However, your meter blood glucose test result may differ somewhat from your laboratory result due to normal sources of variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way. Your meter glucose result should agree with a laboratory result within ±20% most of the time under normal conditions. A result with38 RESULTS ® ® If you have recently eaten, exercised, taken medication, or experienced stress. 5 If you have eaten recently, the blood glucose level from a fingerstick can be up to 70 mg/dL higher than that of a venous sample (blood drawn from a vein) used for a lab test. 6 For the most accurate comparison between meter and laboratory results, the meter test must be done within 10 to 15 minutes of the laboratory test. If samples are taken more than 15 minutes apart, the two tests could have very different results because blood glucose levels can change significantly within short periods of time. Factors such as a low or high hematocrit (the percentage volume of red blood cells in your blood). For example, if your hematocrit is too low (below 25%) or too high (above 60%). [. . . ] drop of blood. 2 E F E K R (Example) (Example) 3 Q U . and then the code number is displayed afterward. I 4 Compare the code number on the meter to the code number on the test strip bottle. If the code numbers do not match, press the green C button until the code number on the meter matches the code number on the test strip bottle. C 3 Check confirmation dot Firmly push the test on back of test strip and strip into the test strip make sure it is completely holder, with the tapered-end blue. Do not remove strip until countdown is complete. 4 70 BLOOD APPLIC ATION How you can be sure that you have applied the right amount of blood: Test Strip White Pad Q Enough Blood Not Enough Blood Too Much Blood U I C Pink Test Square K Confirmation Dot R Front Back Front Back Back Front E Pink test square is where you apply a drop of blood. [. . . ]

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