Ultra Owner's Booklet Blood Glucose Monitoring System Important Safety Information To be sure your meter is working properly, EVERY time you turn it on confirm that: All segments are visible in the display check display check Example The unit of measure is correct (mg/dL) The date and time are correct date unit of measure time Example The code number on the meter display matches the code number on the test strip vial Example OneTouch® Ultra® System Owner's Booklet i Read this first Each time you turn on your meter, the unit of measure will appear on the display with the R symbol. The unit of measure will also appear under every test result. You may misunderstand your blood glucose results if your meter is set to the incorrect unit of measure. Your meter's unit of measure should be set to mg/dL. If your meter is set to the correct unit of measure, "mg/dL" will appear on the display. Your test result will not include a decimal point (Fig. 1). Do Not change this setting ­ this is the correct unit of measure for the United States. Fig. 1: mg/dL milligrams/deciliter no decimal point ii If your meter is set to the other unit of measure, "mmol/L" will appear on the display. The test result will include a decimal point (Fig. 2). Unless your doctor has told you to use this unit of measure, Do Not test your blood glucose. Call LifeScan Customer Service at 1 800 227-8862 immediately for assistance. Fig. 2: mmol/L millimoles/liter decimal point Always confirm that the unit of measure is in mg/dL every time you test your blood glucose level. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment. iii Dear OneTouch® Ultra® System Owner: You have chosen one of the best blood glucose monitoring systems available. This booklet has important information you must know about the OneTouch® Ultra® System. Please read it carefully. Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%.* The results you get with the OneTouch® Ultra® System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes. As the maker of OneTouch® brand blood glucose monitoring systems, LifeScan is dedicated to your health and satisfaction. You can count on: · 24-hour customer service by highly trained professionals who are ready to answer your questions about meter operation, self-monitoring and diabetes in general · LifeScan.com offering online access to information about our products and services as well as diabetes care · Our OneTouch® Gold program to provide members with a monthly e-Newsletter as well as tools, information and special offers to help make living with diabetes easier. Membership is free. For more information, visit www.LifeScan.com. We have included a warranty registration card with your system. Please complete and return it promptly to receive a gift. You may also complete product registration online at www.OneTouchWarranty.com. We care about what you think and want to keep you informed about the latest on better living for people with diabetes. If you have any questions about your new OneTouch® Ultra® System, please call LifeScan Customer Service at 1 800 227-8862 or visit our website at www.LifeScan.com. *American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993). iv Table of Contents About Your New System vi Using the Meter Memory The Complete OneTouch® Ultra® Blood Glucose Monitoring System OneTouch® Ultra® Blood Glucose Meter OneTouch® Ultra® Meter Display OneTouch® Ultra® Test Strips Before Testing 34 4 5 6 8 10 10 10 13 20 21 24 25 28 31 32 Downloading Test Results to a Personal Computer Comparing Meter and Laboratory Results Meter Set-up 36 38 40 Checking the Meter Display Coding the Meter Checking the System with Control Solution Testing Your Blood Caring for Your OneTouch® Ultra® System 46 Preparing the OneTouch® UltraSoft® Adjustable Blood Sampler Fingertip Blood Sampling Forearm Blood Sampling Step-by-Step Test Procedure Discarding Used Test Strips and Lancets Special Messages Meter OneTouch® UltraSoft® Adjustable Blood Sampler Battery Display Messages and Problem-Solving Guide Specifications Guarantee Index 46 46 47 50 60 61 62 v About Your New System The OneTouch® Ultra® System uses the latest blood glucose monitoring technology. It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and measured by the meter. Test results are "plasma-calibrated." This makes it easier for you and your diabetes-care team to compare your meter results with laboratory tests. If you have been using another type of meter­one that provides whole-blood results­you may notice that your test results with the OneTouch® Ultra® System are about 12 % higher. vi The OneTouch® Ultra® Blood Glucose Monitoring System consists of the OneTouch® Ultra® Blood Glucose Meter, OneTouch® Ultra® Test Strips (may be sold separately), and OneTouch® Ultra® Control Solution. These products have been designed, tested, and proven to work together to produce accurate blood glucose results. Use no other test strips or control solution other than OneTouch® Ultra® brand with your meter. CAUTION: If you cannot test due to a problem with your testing supplies, contact your healthcare professional or LifeScan Customer Service at 1 800 227-8862. Failure to test could delay treatment decisions and lead to a serious medical condition. 1 The OneTouch® Ultra® System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing fresh capillary whole blood samples for glucose (sugar). It should not be used for the diagnosis of diabetes or for testing newborns. Before using any product to test your blood glucose, read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators, the American Diabetes Association, the U.S. Food and Drug Administration, and the Advanced Medical Technology Association. CAUTION: 2 Important Information Dehydration: Severe dehydration resulting from excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately. Low glucose results: If your test result is lower than 70 mg/dL or is shown as LO, it may mean hypoglycemia (low blood glucose). This may require immediate treatment according to your healthcare professional's recommendations. Although this result could be due to a test error, it is safer to treat first, and then repeat the test. High glucose results: If your test result is greater than 180 mg/dL or is shown as HI, it may mean hyperglycemia (high blood glucose). If you do not have symptoms, first repeat the test. Your healthcare professional can work with you to decide what actions, if any, you should take if you continue to get results higher than 180 mg/dL or if you have symptoms. Repeated unexpected results: If you continue to get unexpected results, check your system with control solution. See Checking the System with Control Solution on pages 13­19. If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this booklet, call your healthcare professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your healthcare professional. Hematocrit: A hematocrit (percentage of your blood that is red blood cells) that is either very high (above 55%) or very low (below 30%) can cause false results. WARNING: Keep the meter and testing supplies away from small children. The battery door, test strips, lancets, protective disks, and control solution cap are choking hazards. 3 The Complete OneTouch® Ultra® Blood Glucose Monitoring System OneTouch® Ultra® Meter Owner's Booklet Quick Reference Guide OneTouch® UltraSoft ® Adjustable Blood Sampler Optional OneTouch UltraClear® Cap ® OneTouch® UltraSoft ® Sterile Lancets OneTouch® Ultra® Control Solution OneTouch® Ultra® Test Strips (may be sold separately) Carrying Case Warranty Registration Card Logbook 4 OneTouch® Ultra® Blood Glucose Meter DISPLAY Symbols, simple messages, and test results appear here. TEST PORT The meter turns on when you insert the OneTouch® Ultra® Test Strip here. M BUTTON Used to enter into: set-up mode memory mode DATA PORT Used to download your test results to a computer. C BUTTON Used to: change time, date, and code number mark control solution tests review test results in memory 5 OneTouch® Ultra® Meter Display CTL Indicates a control solution test result. BLOOD DROP SYMBOL Tells you when to apply the sample. CODE Appears with the code number of the test strips. Check your code every time you test. BATTERY SYMBOL Warns when the battery is low or must be replaced. DAY AVG ­ displayed when 14- or 30-day average is shown. 6 Note: mmol/L and . (decimal point) appear in display but are not used in this meter when displaying glucose results. If your meter is set to the correct unit of measure, "mg/dL" will appear on the display. Your test result will not include a decimal point. Do Not change this setting ­ this is the correct unit of measure for the United States. KETONES? Appears when a test result is above 240 mg/dL to suggest ketone testing. MEM Indicates a test result stored in memory. TEST RESULT AREA Test results are displayed here. mg/dL This is the unit of measure. Be sure this appears with the symbol before applying sample to the test strip. WARNING: If mg/dL does not appear with the symbol, call LifeScan Customer Service at 1 800 227-8862. MONTH DAY HOUR MINUTES AM/PM SYMBOL AM/PM Displayed when set to 12-hour time format. 7 OneTouch® Ultra® Test Strips The OneTouch® Ultra® System measures the amount of glucose in whole blood. Blood is applied in the TOP EDGE of the OneTouch® Ultra® Test Strip and is automatically drawn into the reaction cell where the reaction takes place. TOP EDGE Apply a drop of blood to the narrow channel here in the top edge of the test strip. CONFIRMATION WINDOW Check here to confirm if enough blood has been applied. CONTACT BARS Insert this end of the test strip, contact bars facing up, into the meter. Push it all the way in until it will go no further. 8 Important Test Strip Information Store test strip vials in a cool, dry place below 86°F (30°C). Keep away from direct sunlight and heat. Do Not refrigerate. Store test strips in their original vial only. To avoid damage or contamination, Do Not transfer test strips to any other place. After removing a test strip from the vial, replace the vial cap immediately and close it tightly. Use each test strip immediately after removing it from the vial. Do Not use test strips from any vial that is damaged or left open to air. Write the discard date (3 months after first opening the vial) on the vial label when you first open it. Discard remaining OneTouch® Ultra® Test Strips after the discard date. Do Not use test strips beyond the expiration (printed on package) or discard date, whichever comes first, because they may cause inaccurate results. Avoid getting dirt, food or liquids on the test strip. With clean, dry hands, you may touch the test strip anywhere on its surface. Do Not bend, cut, or alter a OneTouch® Ultra® Test Strip in any way. OneTouch® Ultra® Test Strips are for single use only. Never reuse a test strip that has had either blood or control solution applied to it. Apply only OneTouch® Ultra® Control Solution or a blood sample to the test strip. Refer to additional information in the OneTouch® Ultra® Test Strip package. WARNING: Do Not swallow test strips. The test strip vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation. 9 Before Testing Checking the Meter Display Each time you turn on the OneTouch® Ultra® Meter either by inserting a test strip or pressing the button, all segments of the display will appear briefly. This tells you that the system is performing several self-checks to confirm that the meter is working properly. To check that all display segments are working, with the meter off, press the button and immediately hold the button down. Coding the Meter Code numbers are used to calibrate the OneTouch® Ultra® Meter with OneTouch® Ultra® Test Strips for accurate results. You must code the meter before using it for the first time and th ...