LifeScan Customer Service toll-free numbers: English 1 800 227-8862 Español 1 800 381-7226 Visit the LifeScan Web site at www.LifeScan.com ©2006 LifeScan,Inc. Milpitas,CA 95035 Rev date: 04/2006 AW 060-788-02A AW 06078802A Meter and Electronic Logbook In One Owner's Booklet ii Dear OneTouch® UltraSmart® 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® UltraSmart® Blood Glucose Monitoring System. 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® UltraSmart® System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes. Your OneTouch® UltraSmart® System requires a small drop of blood, at least 1L (microliter), and five seconds to provide you with an accurate plasma-calibrated test result. The OneTouch® UltraSmart® Meter also has a memory that allows it to function as an "electronic logbook." Now you can store vital everyday information such as insulin and oral medication doses, food intake, amount of exercise, illnesses, and other pertinent data. You can use your OneTouch® UltraSmart® System simply to test or to serve as a complete storehouse of information regarding your diabetes treatment plan. A warranty registration card is included with your system. If you complete it and mail it to us, we will send you a gift. If you prefer to fill out a warranty card online, please visit www.LifeScan.com. *American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993). iii INTENDED USE: The OneTouch® UltraSmart® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® UltraSmart® System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® UltraSmart® System should not be used for the diagnosis of diabetes or testing of newborns. The OneTouch® UltraSmart® Blood Glucose Monitoring System provides the user with electronic logbook functions, which serve to store such data as insulin and oral medication doses, food intake, amount of exercise, health information such as illnesses, and other pertinent data. The meter includes a data port that enables the user to download logbook data to a personal computer. CAUTION: 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 U.S. Food and Drug Administration, and the Advanced Medical Technology Association. WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, battery, test strips, lancets, protective disks on the lancets, stereo jack cover and the control solution vial cap are choking hazards. iv Important Information · Dehydration: Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from dehydration, consult a healthcare professional immediately. · Low glucose results: If your test result is lower than 70 mg/dL or is shown as "LOW GLUCOSE", 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 "HIGH GLUCOSE", 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 page 12. 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. v Table of Contents THE OneTouch® UltraSmart® SYSTEM . . . . . . . . . . . . . . 1 OneTouch® UltraSmart® Meter . . . . . . . . . . . . . . . . . 2 Navigation Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SmartButtons® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 OneTouch® Ultra® Test Strips . . . . . . . . . . . . . . . . . . 7 BEFORE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Checking the Display . . . . . . . . . . . . . . . . . . . . . . . . . 9 Setting the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Checking the System with Control Solution . . . . . 12 TESTING YOUR BLOOD . . . . . . . . . . . . . . . . . . . . . . . . . 19 Preparing the OneTouch® UltraSoft® Adjustable Blood Sampler . . . . . . . . . . . . . . . . . . . .20 Lancing and Sampling from Your Fingertip . . . . . 23 Lancing and Sampling from an Alternate Site . . . 27 Step-by-Step Test Procedure . . . . . . . . . . . . . . . . . .31 Discarding Used Test Strips and Lancets . . . . . . . 37 Special Messages . . . . . . . . . . . . . . . . . . . . . . . . . . 38 COMPARING METER AND LABORATORY RESULTS . . 40 CARING FOR YOUR SYSTEM . . . . . . . . . . . . . . . . . . . . . 42 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Cleaning the OneTouch® UltraSoft® Adjustable Blood Sampler . . . . . . . . . . . . . . . . . . . 42 vi Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 DISPLAY MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 WARNINGS AND ERROR MESSAGES . . . . . . . . . . . . . 51 PROBLEMS AND POSSIBLE CAUSES . . . . . . . . . . . . . .56 METER SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Entering Basic Set-up Mode . . . . . . . . . . . . . . . . . 58 Selecting Display Language . . . . . . . . . . . . . . . . . 59 Setting Date and Time . . . . . . . . . . . . . . . . . . . . . . 60 CUSTOM METER SET-UP SEQUENCE . . . . . . . . . . . . . . 62 Set-up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Diabetes Pill Set-up . . . . . . . . . . . . . . . . . . . . . .68 Insulin Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . .70 Insulin Pump Set-up . . . . . . . . . . . . . . . . . . . . . .72 Advanced Feature Set-up . . . . . . . . . . . . . . . . .72 YOUR ELECTRONIC LOGBOOK . . . . . . . . . . . . . . . . . . . 77 Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Rules for Adding Comments . . . . . . . . . . . . . . . . . . 78 How to Add a Comment . . . . . . . . . . . . . . . . . . . . . 78 Logbook Entries . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Using the SmartButtons® . . . . . . . . . . . . . . . . . . . . 82 Rules for Logbook Entries . . . . . . . . . . . . . . . . . . . 84 Entering the Date and Time . . . . . . . . . . . . . . . . . . 85 Exercise Logbook Entries . . . . . . . . . . . . . . . . . . . . .86 Health Logbook Entries . . . . . . . . . . . . . . . . . . . . . .87 vii Table of Contents (continued) Ketones . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89 HbA1c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91 Microalbumin . . . . . . . . . . . . . . . . . . . . . . . .91 Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . .92 Blood Pressure . . . . . . . . . . . . . . . . . . . . . . .92 Eye Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 Foot Exam . . . . . . . . . . . . . . . . . . . . . . . . . . .93 Weight/Height . . . . . . . . . . . . . . . . . . . . . . .94 Doctor Visit . . . . . . . . . . . . . . . . . . . . . . . . . .94 Medication Logbook Entries . . . . . . . . . . . . . . .95 Food Logbook Entries . . . . . . . . . . . . . . . . . . . .101 Adding, Changing, or Deleting Logbook Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 OneTouch® UltraSmart ® FastFacts® FEATURE . . . . . .108 FastFacts® Menu . . . . . . . . . . . . . . . . . . . . . . . . . . 109 Logbook Memory . . . . . . . . . . . . . . . . . . . . . . .110 Glucose by Meals . . . . . . . . . . . . . . . . . . . . . . .110 Glucose Analysis . . . . . . . . . . . . . . . . . . . . . . . .111 Interactive Graph of All Results . . . . . . . . .111 Graph by Time of Day . . . . . . . . . . . . . . . . .112 Average of All Results . . . . . . . . . . . . . . . . .113 Average by Time of Day . . . . . . . . . . . . . . .114 Average by Exercise . . . . . . . . . . . . . . . . . .114 Glucose Range Info . . . . . . . . . . . . . . . . . . .115 Insulin Intake . . . . . . . . . . . . . . . . . . . . . . . . . . .116 viii Hypoglycemia Information . . . . . . . . . . . . . . .120 Food Averages . . . . . . . . . . . . . . . . . . . . . . . . . .121 Health Checks . . . . . . . . . . . . . . . . . . . . . . . . . .121 Data Downloading . . . . . . . . . . . . . . . . . . . . . . . . 122 SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 PRODUCT SAFETY INFORMATION . . . . . . . . . . . . . . . 126 EXPLANATION OF SYMBOLS ON THE METER . . . . . . 127 GUARANTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 ix x THE OneTouch® UltraSmart® SYSTEM The OneTouch® UltraSmart® 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 is 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 meter--one that provides whole-blood results--you may notice that your test results with the OneTouch® UltraSmart® System are about 12% higher. The OneTouch® UltraSmart® Blood Glucose Monitoring System consists of three main products: the OneTouch® UltraSmart® Meter, OneTouch® Ultra® Test Strips, and OneTouch® Ultra® Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use no other test strips or control solution other than the OneTouch® Ultra® brand with your meter. Your system kit includes: · OneTouch® UltraSmart® Meter · OneTouch® Ultra® Control Solution · OneTouch® UltraSoft® Adjustable Blood Sampler · OneTouch® UltraClear® Cap · OneTouch® UltraSoft® Sterile Lancets · Owner's Booklet · Carrying Case · Quick Reference Guide · Quick Start Guide · Warranty Registration Card · Two AAA Alkaline Batteries (Installed) OneTouch® Ultra® Test Strips sold separately 1 OneTouch® UltraSmart® Meter OneTouch® Ultra® Test Strip Test Port The meter turns on when you insert the OneTouch® Ultra® Test Strip here. Data Port Used to download logbook memory to a computer. Display with Backlight Test results, messages, symbols, and other data appear here. SmartButtons® (See pages 4­5 for description and use.) 2 Navigation Buttons Note: Press and release buttons. Do Not hold buttons down for an extended period of time. Back Button (Off Button) Go back to previous display on certain screens. Press and hold for two seconds to turn off the meter. Arrow Button Scroll through menus, code numbers, and logbook. OK Button (Backlight Button) Accept entries and move to next display. Press and hold for two seconds to turn on backlight. 3 SmartButtons® The SmartButtons® are your keys to getting the most out of your OneTouch® UltraSmart® Meter. They allow you to enter informa ...