More Data, Better Control Owner's Booklet The OneTouch® Profile® Complete Diabetes Tracking System is intended for in vitro diagnostic use for quantitative determination of glucose in whole blood as an aid in monitoring effectiveness of diabetes management in the home and in clinical settings. It is not intended for use in the diagnosis of diabetes or for neonatal testing (newborns 0­4 weeks old). 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. IMPORTANT: The OneTouch® Profile® System contains many small parts: test strip holder, battery door, batteries, lancets, control solution vial, test strips, test strip vial cap, etc. Keep the system out of the reach of small children because these parts may be dangerous if swallowed. TABLE OF CONTENTS INTRODUCTION PRECAUTIONS AND LIMITATIONS Infection Control GETTING STARTED The Complete OneTouch® Profile® Diabetes Tracking System OneTouch® Profile® Blood Glucose Meter OneTouch® Test Strips OneTouch® Normal Control Solution BEFORE TESTING Checking Meter's Display Setting Meter Code Checking the System ­ Checking with the Check Strip ­ Checking with Control Solution 1 3 4 5 5 7 9 11 12 12 13 15 16 20 LifeScan Customer Services: English 1 800 227-8862 Español 1 800 381-7226 SETTING METER OPTIONS Entering and Using the Set-Up Mode Beep Prompts Time and Date Insulin Prompt Event Averaging Insulin Recording Display Language Time Format Date Format Unit of Measure Decimal Separator Exiting the Set-Up Mode TESTING YOUR BLOOD Abbreviated Test Procedure Detailed Test Procedure 27 27 29 29 31 32 33 35 35 36 36 37 37 38 38 39 LifeScan Customer Services: English 1 800 227-8862 Español 1 800 381-7226 ­ Getting a Drop of Blood ­ How to Test Your Blood Special Messages Checking the Amount of Blood on the Test Strip IMMEDIATELY AFTER TESTING Event Labeling Insulin Recording Carbohydrate Counting UNDERSTANDING YOUR RESULTS Long-Term Diabetes Findings What This Means for You Frequency of Testing COMPARING METER AND LABORATORY RESULTS USING THE METER MEMORY Entering the Memory Mode Event Averages 40 46 49 51 54 54 56 58 60 60 60 61 62 65 65 67 LifeScan Customer Services: English 1 800 227-8862 Español 1 800 381-7226 Recalling Test Results Event Labels Changing an Insulin Record Deleting an Insulin Record SOLVING PROBLEMS Test Procedure Messages Error Messages TAKING CARE OF YOUR METER Doing a Daily Check Cleaning the Meter Replacing the Batteries SPECIFICATIONS GUARANTEE AND WARRANTY 30-Day Money-Back Guarantee Three-Year Warranty INDEX 68 69 69 70 71 71 75 82 83 83 88 92 93 93 93 95 LifeScan Customer Services: English 1 800 227-8862 Español 1 800 381-7226 INTRODUCTION INTRODUCTION Congratulations on selecting the OneTouch® Profile® Complete Diabetes Tracking System--the system that takes OneTouch® technology a step further. In addition to providing you with a simple, fast, and accurate means of blood glucose testing, the OneTouch® Profile® System includes features that allow you to record and review important information regarding your test results, insulin dosages, meals, and other significant events in your treatment plan. Blood glucose monitoring plays an important role in controlling your diabetes. The results you get with the OneTouch® Profile® 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. Everything you need to know about using the OneTouch® Profile® System is included in this booklet. A free instructional videotape is also available by calling LifeScan Customer Services at 1 800 227-8862. If you have any questions about your OneTouch® Profile® System, please call LifeScan Customer Services at 1 800 227-8862. Representatives are on hand 1 INTRODUCTION 24 hours a day, 7 days a week to serve you. Thank you for choosing the OneTouch® Profile® Diabetes Tracking System. P.S. Don't forget to complete and mail the warranty service card. When we receive your warranty card, we'll send you a complimentary gift to show our appreciation. See your warranty card for details. Important phone numbers: Meter Serial Number _______________ LifeScan Customer Services (24 hours a day, 7 days a week): U.S.A. English 1 800 227-8862 Español 1 800 381-7226 Healthcare Professional _______________________ Pharmacist _________________________ Diabetes Educator _____________________________ Other ______________________________ 2 PRECAUTIONS AND LIMITATIONS The following information will be useful to you and your healthcare professional when using the OneTouch® Profile® System to monitor your blood glucose level. If you experience symptoms that are not consistent with your blood glucose test results AND you believe you have followed all instructions 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. 3 If your test result is 60 mg/dL or lower, this indicates low blood glucose (hypoglycemia). The meter will display the test result along with the message do you need a snack. You should immediately treat hypoglycemia as recommended by your healthcare professional. If the message hi danger call.dr. appears on the meter display, this indicates severe high blood glucose (hyperglycemia). Contact your doctor immediately. Extremes in hematocrit (the amount of red blood cells in the blood) can affect test results. Very high hematocrits PRECAUTIONS (above 60%) and very low hematocrits (below 25%) can cause false results.1 Abnormally high levels of Vitamin C or other reducing substances will cause false low blood glucose results.2 Normal levels of reducing substances have little effect on blood glucose results. Do not use blood samples with preservatives that contain fluoride (gray-top test tubes). You will get false low results. When testing, removal of the test strip prior to display of the blood glucose result may give you a false result. Infection Control Use universal blood precautions. All patient samples and materials with which they come in contact are considered biohazards and should be handled as if capable of transmitting infection. Follow proper precautions in accordance with federal, state, and local regulations when disposing of all materials. PRECAUTIONS 4 GETTING STARTED The OneTouch® Profile® Complete Diabetes Tracking System consists of three main products: the OneTouch® Profile® Blood Glucose Meter, OneTouch® Test Strips, and OneTouch® Normal Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Only LifeScan manufactures OneTouch® Profile® System products. Attempting to substitute other products may affect the accuracy of your test results and limit the ability of LifeScan to help you solve problems that may arise. 5 The Complete OneTouch® Profile® Diabetes Tracking System Your OneTouch® Profile® System includes: OneTouch® Profile® Meter with Two AAA Batteries (Installed) OneTouch® Test Strips OneTouch® Normal Control Solution Owner's Booklet and Quick Reference Guide Check Strip Penlet® Plus Adjustable Blood Sampler Lancets Carrying Case Logbook GETTING STARTED GETTING STARTED 6 OneTouch® Profile® Blood Glucose Meter Study this diagram to become familiar with all the parts of your OneTouch® Profile® Meter. GETTING STARTED 7 On/Off Button. This button turns the meter on and off. Display. The large, easy-to-read display is where you read the simple messages that guide you through testing, setting options, and using the memory. Your test results are displayed here. See the "Before Testing" section for instructions on how to check that your meter's display is functioning properly. M Button. The OneTouch® Profile® Meter automatically stores your test results. The M button is used to recall the information stored in your meter's memory and to review your meter's option settings. C Button. The C button is used to 8 change the code number and the option settings. Test Strip Holder. The test strip holder holds a OneTouch® Test Strip in place when you perform a blood glucose or control solution test. It must be removed to clean the meter. Test Area. The test area is located under the test strip holder. There is a clear, protective coating over the test area that must be kept clean and undamaged for accurate test results. Battery Compartment. The battery compartment holds two AAA batteries. The batteries are already installed in your meter. GETTING STARTED Data Port. The data port allows you to transfer the information stored in the meter's memory to a computer to view, analyze, and print. Please contact the LifeScan Data Management Line at 1 800 382-7226 for more information about data management software products. test strip react with the blood to form a blue color. The OneTouch® Profile® Meter reads the color to determine the blood glucose level. Test Strip OneTouch® Test Strips The OneTouch® Profile® Diabetes Tracking System measures the amount of sugar (glucose) in whole blood. When blood is applied to a OneTouch® Test Strip, certain compounds on the GETTING STARTED 9 IMPORTANT TEST STRIP INFORMATION GETTING STARTED OneTouch® Test Strips can be damaged by heat and light. Keep them sealed in the original vial. Store the vial in a cool, dry place below 86°F (30°C). Do not refrigerate. Do not place in direct heat or sunlight. OneTouch® Test Strips are intended for use with fresh whole blood or OneTouch® Normal Control Solution. Do not use them with plasma or serum samples. Results will not be accurate. Do not use test strips beyond the expiration date on the vial. When you open a new vial of test strips, record the discard date on the vial. The discard date for test strips is four months after first opening the vial. Discard unused test strips after this date. Do not use test strips that are bent, torn, cut, or changed in any way. Use each test strip immediately after removing it from the vial; replace the vial cap and close it tightly. Never transfer test strips to a new vial or any other container. Always carry test strips in their original container. Do not carry loose test strips in your meter case. Do not use bleach (or products containing bleach) near the test strips. For reliable results, use only OneTouch® Test Strips made by LifeScan. 10 OneTouch® Normal Control Solution OneTouch® Normal Control Solution is an important part of the OneTouch® Profile® System. Use it in two ways: 1) to practice the test procedure, and 2) to make sure that the OneTouch® Profile® Meter and OneTouch® Test Strips are working together properly. (Example) GETTING STARTED 11 BEFORE TESTING BEFORE TESTING Note: You do not have to enter the set-up mode to test. However, the OneTouch® Profile® Meter has a number of settings you can change, including the language, time and date, display formats, and the unit of measure. For a description of these options and how to set them, see page 27. sure all "segments" or parts of the display turn on each time you test your blood. Display Test Properly Functioning Display Checking Meter's Display A display test is built into your meter. When you first begin to perform a blood or control solution test, the entire display will briefly turn on when you turn on your meter. Press and hold the "on/off" button down to extend the viewing period. You should carefully observe the display to make 12 All segments are active, the display is working properly. Display with Missing Segments Some parts of the display are not working. Message will be incomplete. BEFORE TESTING Test Result Recognizable Result, but incorrect Setting Meter Code Code numbers are used to enable your meter to provide consistent measurements. For this reason, it is important that the code is set correctly. You must code the meter before using it for the first time and then every time you change to another vial of OneTouch® Test Strips. CAUTION: If the code number on the meter display does not match the code number on the vial of OneTouch® Test Strips, test results may be false. In this example, the 120 result is reallly 420, as indicated by the missing segment shown in light blue. CAUTION: If you believe your OneTouch® Profile® meter's display has a problem, or if you need help determining if your disp ...