® BLOOD GLUCOSE MONITORING SYSTEM a company Owner's Booklet Dear ONE TOUCH® II System Owner: Congratulations! You've chosen a very easy-to-use blood glucose monitoring system for home testing. Your ONE TOUCH II System will give you the accurate test results you need, just by following a few simple steps. Everything you need to know about using the ONE TOUCH II System is included in this booklet. An audiocassette has been included with your meter. It contains the same information in a shorter format, and will help you get to know your blood glucose monitoring system. A free videotape is also available by calling the LifeScan Customer Services Department. Blood glucose monitoring plays an important role in controlling your diabetes. The results you get with the ONE TOUCH II System can help you and your healthcare professional monitor and adjust your treatment plan (diet, exercise, and medication) to help you gain better control of your diabetes. If you have any questions, please feel free to call our toll-free number and speak with our Customer Services Department, 1 800 227-8862. Thank you for choosing the ONE TOUCH II System. Sincerely, Richard P. Thompson President, LifeScan Inc. P.S. Don't forget to complete and mail the warranty registration card. When we receive your warranty card, we'll send you a complimentary gift to show our appreciation. See your warranty card for details. CAUTION: BEFORE USING ANY PRODUCT TO TEST YOUR BLOOD GLUCOSE (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 HEALTH INDUSTRY MANUFACTURERS ASSOCIATION. LIFESCAN CUSTOMER SERVICES 1 800 227-8862 TABLE OF CONTENTS 1. GETTING STARTED 1 Description and Use Getting to Know the Meter Precautions and Limitations 2. BEFORE TESTING 1 2 5 8 Checking the System Coding the Meter 3. GETTING AND TESTING A DROP OF BLOOD 8 14 17 Using the PENLET® II Automatic Blood Sampler Testing Your Blood Checking the Amount of Blood on the Test Strip 4. HELP! (Troubleshooting) 17 22 28 30 Test Procedure Messages Error Messages Special Function/Memory Messages What to Do If You Think Your Test Results Are Wrong 30 33 38 40 5. TAKING CARE OF THE METER 42 Infection Control Information Doing a Daily Check Cleaning the Meter Replacing the Battery 6. SPECIAL FUNCTIONS 42 43 43 47 50 Setting the Clock Setting Special Functions Recalling Tests from the Meter Memory Setting Event Numbers 7. QUESTIONS AND ANSWERS 8. SPECIFICATIONS 50 54 63 65 68 73 Performance Characteristics Guarantee and Warranty 9. GLOSSARY AND INDEX 73 74 76 1. GETTING STARTED Description and Use The ONE TOUCH® II Blood Glucose Monitoring System is intended for in vitro diagnostic use. This statement means that the system should be used only for testing purposes and only outside of the human body. The ONE TOUCH® II Meter and ONE TOUCH® Test Strips are used for monitoring whole blood glucose for people who have been diagnosed with diabetes mellitus by conventional means. This device is not to be used for the diagnosis of diabetes. The ONE TOUCH II Blood Glucose Monitoring System is used to measure the amount of glucose (sugar) in whole blood. When blood is applied to the test strip, compounds on the test strip react with the blood and a blue color is formed. The intensity of the color is then measured and read by the ONE TOUCH II Meter. 1 Getting to Know the Meter Study this diagram and become familiar with all the parts of your ONE TOUCH® II Meter. M Button C Button Battery Compartment (on back) Display Test Strip Holder On/Off Button Data Port Test Area with Protective Coating 2 ON/OFF BUTTON. This button turns the meter on and off. DISPLAY. This is where you read your test results and the simple messages that help guide you through the test. BATTERY COMPARTMENT. Holds one J-size battery. The battery is already installed in your meter. See page 47 for replacement instructions. M (MEMORY) BUTTON. The ONE TOUCH® II Meter automatically stores your test results. Press the M button when you want to recall past results. For information, see page 63. C (CODE) BUTTON. Each vial of ONE TOUCH® Test Strips has a code number on the label. Use the C button to match the meter code with the code number on the test strip vial. For information, see page 14. TEST STRIP HOLDER. The dark gray test strip holder keeps the test strip in place. The meter reads the color of the reacted test strip through the small hole in the test 3 strip holder. Remove the test strip holder from the meter for cleaning. For information, see page 44. TEST AREA. When the test strip holder is removed, the test area is exposed. The test area has a clear, protective coating over the meter optics window that must be kept clean and lint-free for accurate results. Be careful not to scratch or damage this coating. For information, see page 45. DATA PORT. This port lets you access the information stored in the meter's memory with a Data ManagerTM from LifeScan, or other data management systems. For information, see page 55. TEST STRIPS. ONE TOUCH® Test Strips are used to test your blood glucose (sugar) level. They are sensitive to moisture and light, so they come in a moisture-resistant, light-protected vial. Keep the test strips sealed in their original vial until you're ready to use them. Do not carry loose test strips in your meter case. NO ALCOHOL TEST SUMMARY T E S T S R T CODE: R I P OPEN HERE TEST FOR GLUCOSE IN WHOLE BLOOD 10 PAS D'ALCOOL INC. Milpites,CA Made in U.S.A. 51-453B code10 R Carefully read this owner's booklet and all other instructional material provided with your blood glucose monitoring system and test supplies. Refer to the glossary at the back of this booklet for unfamiliar words. For a free copy of the "ONE TOUCH® II VIDEO PROCEDURE GUIDE", call LifeScan Customer Services. 4 PAS D'ALCOOL NO ALCOHOL PAS D'ALCOOL NO ALCOHOL Precautions and Limitations The following technical information may be useful if you or your healthcare professional have concerns about the precautions or limitations of the ONE TOUCH® II System. If you experience symptoms that are not consistent with your blood glucose results, and you have carefully followed the procedure described in the owner's booklet, contact your healthcare professional immediately. Never make significant changes to your medication program or ignore physical symptoms without consulting your healthcare professional. When the message high appears on the meter display, this indicates severe hyperglycemia (high blood sugar); contact your healthcare professional immediately. Do not use ONE TOUCH® Test Strips beyond the expiration date printed on the vial. Discard the vial and unused test strips four months after first opening the vial. Do not use ONE TOUCH Test Strips that are discolored, wrinkled, torn, cut, or altered in any way (the test spot of a normal test strip is white or ivory-colored). Do not store test strips outside of the vial. 5 ONE TOUCH® Test Strips must be stored in a cool, dry place, below 86°F (30°C). Do not refrigerate test strips or place test strips in heat or direct sunlight. Use only ONE TOUCH Test Strips with the ONE TOUCH® II Meter. Cleaning your meter as described in this booklet is important for accurate results. For information, see page 43. Clinical Information For use in hospitals, institutions, and clinics, refer to the ONE TOUCH® II Blood Glucose Monitoring System Manual and Inservice Guide for Hospitals and Clinics. The ONE TOUCH II Meter is not intended for monitoring neonatal whole blood samples. Do not use ONE TOUCH Test Strips with plasma or serum samples. Results will be inaccurate. ONE TOUCH Test Strips are intended for use with fresh whole blood or ONE TOUCH ® Normal Control Solution. 6 Hematocrit: Extremes in whole blood hematocrits (above 60%) or very low hematocrits (below 25%) can cause inaccurately low results. Reducing substances, such as ascorbic acid, do not significantly affect blood glucose results when occurring in normal blood concentrations. However, abnormally high concentrations of reducing substances in blood will cause inaccurately low blood glucose results. Do not use samples with preservatives that contain fluoride (gray-top test tubes). The results will be inaccurately low. Blood glucose results obtained with the ONE TOUCH® II Meter may be significantly lower than the true concentrations if excessive water loss or dehydration occurs. This has been reported in the medical literature for leading blood glucose monitoring products.1,2 Severe dehydration can lead to many serious complications. One complication which is of particular importance in diabetes management is a hyperglycemichyperosmolar state, with or without ketosis, which may be life-threatening if left untreated. The following factors can lead to severe dehydration: · vomiting and diarrhea · prescription drugs; i.e., diuretics · inability to recognize or respond to "thirst" sensations · sustained uncontrolled diabetes (very high blood glucose over a long period of time) · shock (severe hypertension or high blood pressure)2,10 7 2. BEFORE TESTING Checking the System There are two ways to make sure your ONE TOUCH® II System is working properly. The check strip is used to check that the meter is operating properly. ONE TOUCH® Normal Control Solution is used to check that both the meter and the test strips are working together as a system, and that you are doing the test correctly. It is very important that you do these simple checks routinely to make sure you get accurate results. 1. Checking Your ONE TOUCH ® II System with Control Solution ONE TOUCH® Normal Control Solution should be used to practice the test procedure and to make sure your meter and test strips are working properly. Before you use the meter to test your blood glucose for the first time, practice the procedure using the control solution. When you can do three tests in a row that are within the acceptable range, you are ready to test your blood. ONE TOUCH Normal Control Solution Normal Control Solution 8 Use only ONE TOUCH® Normal Control Solution, available from your drugstore or authorized LifeScan distributor. Check the expiration date on the control solution vial. If it has expired, replace it with new control solution. Shake the control solution well, before using. To do a control solution test, follow the same procedure you would if you were testing your blood. For information, see page 22. Your control solution results will appear on the meter display as follows: c 98 contrl (example) R The acceptable range* for ONE TOUCH Normal Control Solution is printed on the test strip vial. This range is for the control solution only; it is not intended as a recommended range for your blood glucose test results. * The control solution range is shown in two different units of measure-- mg/dL (used in the United States) and mmol/L (used in Canada and some European countries). 9 CAUTION: If your control solution result falls outside the acceptable range, the system is not working properly. Do not use the system to test your blood until you get a reading that falls within the acceptable range. For assistance, call LifeScan Customer Services. You must use the control solution: At least once a week. When you begin using a new package of test strips. Whenever you suspect the meter or test strips are not working properly (for example -- when your results are not consistent with how you feel). 2. Checking the Meter with the Check Strip A purple and white check strip is included with your ONE TOUCH® II Meter. The check strip is used to make sure your meter is working properly. Check Strip 1 2 Front Back Before doing a check strip test, make sure the test strip holder and the test area are clean, dry, and lint-free. For information, see page 42. Make sure both sides of the check strip are clean and dry. 10 Do the check strip test at room temperature (between 64°F and 79°F [18°­26°C] ). How to use the check strip: Step 1: Press on/off button. code 7 (example) code 7 will appear on the display. (The code number does not need to match the code number on the test strip vial to do a check strip test.) 11 insert strip appears. Slide the check strip into the test strip holder with the notched end first, Side 1 (purple) facing up. wait 1 appears for a few moments. Step 2: When apply sample appears, remove the check strip from the test strip holder. Step 3: When insert side 2 appears, turn the check 2 strip over and put it back into the test strip holder, notched end first, Side 2 (white) facing up. The meter counts do ...