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. 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 (AdvaMed - formerly known as the Health Industry Manufacturers Association). IMPORTANT: If you have followed the tips to ensure accuracy and your blood glucose results are still out of range, call your Healthcare Professional. The OneTouch® SureStep® System kit contains many small parts: strip holder, battery door, batteries, lancets, control solution bottle, etc. Keep the system out of the reach of small children because these parts may be dangerous if swallowed. If using a 10% bleach solution to disinfect the meter, be sure to completely remove any bleach from the meter and test strip holder with a cloth dampened with water. Bleach will react with the test strips and cause inaccurate results. Failure to remove the excess bleach may result in an error message ( , ) or an inaccurately high result. ii Table of Contents Learning Purpose What to Expect from Your System Warnings and Precautions Importance of Following Instructions OneTouch® SureStep® Test Strips Optional Color Chart Display Symbols 2 2 3 4 5 8 9 10 Coding Coding the Meter 13 13 Checking Checking the System Understanding Control Solution Results 15 15 20 Testing Testing Your Blood Testing Tips for Accurate Results Test Procedures 22 22 23 24 www.LifeScan.com iii Results Understanding Your Results How to Check if Your Meter is Working Correctly Comparing Meter and Laboratory Results Health Conditions Which Can Cause Out-of-Range Results 35 35 37 38 40 Maintenance Caring for Your Meter General Care Cleaning the Meter Changing the Batteries Storage Instructions 41 41 41 41 44 47 Troubleshooting Error Messages 48 48 Symbols Symbols 56 56 Settings Changing Meter Settings Entering Set-Up Mode Changing the Date and Time Setting the Time 58 58 59 59 60 www.LifeScan.com iv Setting the Year Setting the Month Setting the Day Display of Last Results Unit of Measurement Beep Signals 14- and 30- Day Averages Time Format Date Format Exiting the Set-Up Mode 60 61 61 61 61 62 63 64 64 64 Memory Background Information on Meter Memory Getting All Results from Meter Memory First Time Turning on Meter Uploading Memory Data 65 65 65 67 67 Specifications Specifications Guarantee and Warranty 68 68 69 Quick Reference Index www.LifeScan.com 70 72 v LEARNING Welcome to LifeScan Congratulations! You've chosen a product made by LifeScan, a leading company in providing products to help you manage your diabetes. OneTouch® SureStep® blood glucose monitoring products are widely available without a prescription. Blood glucose monitoring plays an important role in controlling your diabetes. A long-term study showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 60%. The results you get with the OneTouch® SureStep® System can help you and your Healthcare Professional monitor and adjust your treatment plan to gain better control of your diabetes. Important phone numbers: LifeScan Customer Services (24 hours a day, 7 days a week): U.S.A. English 1 800 227-8862 Español 1 800 381-7226 www.LifeScan.com Everything you need to know about using the OneTouch® SureStep® System is included in this owner's booklet and in the test strip package insert that comes in each box of test strips. It is important that you read both this booklet and the test strip package insert for critical information on how to use this product. A free instructional videotape is also available by calling LifeScan Customer Services. If you have any questions, please feel free to call the toll-free numbers to speak with our Customer Services Department. Remember to complete and mail the Warranty Registration Card. A complimentary gift is sent when we receive your Warranty Registration Card. Meter Serial Number _____________________________________ Healthcare Professional _______________________________________ Pharmacist ________________________________________________ Diabetes Educator ___________________________________________ Other _____________________________________________________ vi LEARNING READ Units of Measure for Meter Readouts mg/dL milligrams/deciliter no decimal point mmol/L millimoles/liter decimal point PLEASE Your OneTouch® SureStep® Meter can display results in two different units of measure. Milligrams per deciliter (mg/dL) is the standard unit in the United States. Because this meter may be purchased by people living in other parts of the world, it may be reset to another unit of measure called Millimoles per liter (mmol/L). This unit is not used in the United States except on your doctor's recommendation. You can easily determine if the meter has been accidentally reset to the wrong unit of measure. Simply turn on the meter. The unit of measure will appear on the display with your last test result. When looking at a test result on the display, either mg/dL or mmol/L will appear with the result. A test result in mmol/L will have a decimal point. For more information, see pages 61-62, "Unit of Measurement" . vii LEARNING Purpose People with diabetes use the OneTouch SureStep® Blood Glucose Monitoring System to measure the level of glucose (sugar) in their blood. The system is intended for testing whole blood samples at the time when the blood sample is obtained. ® study found that you should keep your blood glucose close to the levels of people without diabetes. You can reduce the risk of problems with the eyes, kidneys, and nervous system by about 60%. You should be aware that keeping your blood glucose level close to the levels of people without diabetes increases your risk of hypoglycemic events1 (low blood sugar). How often you need to test your blood glucose depends on many factors. These include your age, if you have type 1 or type 2 diabetes, your medications, and your health. Your Healthcare Professional will guide you. It is important that you make testing part of your daily routine. Why Test Your Blood Glucose Diabetes is a disease where the body has trouble controlling glucose levels properly. Glucose levels may change greatly and quickly. Glucose levels that are too high or too low can lead to serious health issues. This test enables a person to know what his or her glucose is at the time it is measured. In 1993 the National Institutes of Health finished the Diabetes Control and Complications Trial (DCCT.) This was a long-term study of people with type 1 diabetes. This 2 When Not to Use Do not use OneTouch® SureStep® blood glucose results to determine whether LEARNING or not you have diabetes. Only your doctor can diagnose this disease. What to Expect from Your System results can differ by more than ±20% in some situations. See Comparing Meter and Laboratory Results for more information. Blood glucose meters are clinically accurate, but not a substitute for a laboratory result. Originating from laboratory methods, glucose meter systems provide a convenient, portable way to test inexpensively and quickly. However, meter results can be affected by factors and conditions that do not affect laboratory results in the same way. Keep in mind that testing conditions for laboratories are tightly controlled and highly automated. Your meter glucose result should agree with a laboratory result to within ±20% under normal conditions. A result within that range is considered clinically accurate when testing with the OneTouch® SureStep® Meter. However, 3 Blood glucose meters increase your ability to frequently check your blood sugar at reasonable cost so you can see the effect different foods, exercise, and medications can make on your glucose level. You can keep your blood glucose in better control with these devices. Make sure that you are familiar with the limitations of the system before testing. See important information in your OneTouch® SureStep® Test Strip Package Insert. Know the factors that can affect the accuracy of your results. Make sure that you understand your results before acting on them, especially if your results do not reflect how you LEARNING feel. See Understanding Your Results on page 35. Warnings and Precautions Read all the instructions, including the test strip package insert, and practice the test with control solution (see Checking the System) before testing your blood glucose. Do all quality control checks as directed, including checking the meter display symbols (see Description of System), and consult your Healthcare Professional before using this product. The system contains small parts such as lancets, bottle caps, etc. Keep your system out of the reach of small children because these parts may be dangerous if swallowed. The test strip packaging contains a drying agent that may be harmful if inhaled or swallowed. It may also cause skin or eye irritation. 4 Do not use the test strips after the expiration date printed on the bottle label or more than 4 months after first opening the bottle, whichever comes first. You may get inaccurate results if you use the test strips after these dates. Do not use strips that are bent, cut, or altered in any way. Do not use the control solution after the expiration date printed on the bottle label or more than 3 months after first opening the bottle, whichever comes first. Control solution results may not be reliable if you use the solution after these dates. Testing at a very high or very low temperature or relative humidity may affect results particularly if both the temperature and humidity are either high or low. If you test under these conditions, repeat LEARNING the test in a climate-controlled location as soon as possible. Excessive water loss (severe dehydration) may cause false low results.2,3 Severe dehydration, if untreated, can lead to lifethreatening medical complications such as diabetic ketoacidosis. Some factors causing dehydration are vomiting, diarrhea, inadequate fluid intake, some drugs (for example, diuretics), sustained uncontrolled diabetes, and shock.4 If you have these symptoms, consult your Healthcare Professional immediately, even if your glucose reading is not unusually high. Because some diseases can be transmitted by blood, use care when disposing of used lancets and test strips. Professional. Work with your Healthcare Professional to set your own target blood glucose values, arrange your testing times, and discuss the meaning of your blood glucose results. Importance of Following Instructions Your OneTouch® SureStep® Blood Glucose Monitoring System will provide accurate glucose results that can help you control your diabetes, if you follow the directions in this Owner's Booklet and the test strip package insert. Be sure to check the test strip package insert each time you open a new box of test strips for important updates. If you do not follow the instructions, you may get inaccurate results, which can lead to improper treatment. N OT E : Blood glucose monitoring requires the help of a Healthcare 5 The Complete OneTouch® SureStep® Blood Glucose Monitoring System OneTouch® SureStep® Meter (Batteries installed) Owner's Booklet Quick Reference Guide OneTouch® SureStep® Control Solution OneTouch® Penlet® Plus Automatic Blood Sampler OneTouch® FinePointTM Lancets Carrying Case Logbook OneTouch® SureStep® Test Strips (May be sold separately) 6 OneTouch® SureStep® Blood Glucose Meter DATA PORT Allows you to transfer the information stored in the meter's memory to a computer to view, analyze, and print. DISPLAY Shows your test results and symbols that guide you through the test. LENS AREA Contains the meter optics that reads the glucose level. Test strip holder covers the lens area. Front C BUTTON (Green) Codes the meter, changes the meter settings, marks control solution test results, and scrolls through the memory. POWER BUTTON (Blue) Turns the meter on and off, accesses the memory, and navigates through the set-up mode. CONTACT POINTS Sense the position and orientation of the OneTouch® SureStep® Test Strip. TEST STRIP HOLDER LEARNING Back L 5037 ZG 00171 BLOOD GLUCOSE METER Toll-free customer ...