User manual LIFESCAN ONETOUCH SURESTEP (WITH DATA PORT)

[. . . ] 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. [. . . ] Follow the advice of your Healthcare Professional. 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. See Checking the System for more information. 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%). Severe dehydration (loss of body fluid) may also cause meter results to be different from a laboratory result. Repeated vomiting or diarrhea, both of which can occur when your glucose is very high, can cause this. Your blood may become thick, with not enough liquid to properly wet the test strip. This may cause your meter to give false low blood glucose results. If you test at a very low or high temperature or a low or high relative humidity or some other extreme environmental condition. If you test under these conditions, 39 repeat the meter test in a climate-controlled place as soon as possible. The operating temperature is 50­95°F. [. . . ] 16, 25 Meter settings ­ 14- and 30-day averages . 28-29 INDEX ­ Applying control solution . 4-5 R Result ­ 14-and 30-day averages . 12 ­ Getting results from meter memory . [. . . ]