Blood Glucose Monitoring System Link the Effects of Food to Glucose Results Owner's Booklet Welcome to the OneTouch® family! We know diabetes can be difficult to understand and manage. The right products and services can help make life with diabetes just a little bit easier. We hope the OneTouch® Ultra® 2 System works well for you. We designed this product to make testing easy and to help you manage your diabetes. You can use the meter for fast and simple tests. You can also use it to record information to go with your results. This owner's booklet is designed to provide the information that you are looking for, when you need it. We hope you keep it handy. Of course, you may still have questions. If you do, our Customer Service representatives would be happy to answer your call. You can reach them at 1 800 227-8862, anytime--24 hours a day. You can also obtain information at www.LifeScan.com. i Table of contents Starting the test process Insert a test strip Check the code on the test strip vial before inserting the strip. Make sure the three contact bars are facing you. Push the strip in as far as it will go. Do not bend the strip. pg. 10 Match the code displayed on the meter with the code on the test strip vial If the code on the meter does not match the code on the vial, press or to change the code. If the display changes to the APPLY BLOOD screen before you are ready, remove the strip and re-start the test process. Setting up your system pg. 2 · Getting to know your OneTouch® Ultra® 2 Blood Glucose Meter and Test Strips · Turning your meter on and off · Using the meter display backlight · Setting up your meter NOTE: Before testing, read this owner's booklet carefully. The meter will turn on, show a black start-up screen and then a code number. The first time you use the meter, the CAL CODE screen will display "­­" instead of a number. Press match. when the numbers The meter is ready for testing when the APPLY BLOOD screen appears. ii Getting a blood sample Prepare the OneTouch® UltraSoft® Blood Sampler Remove the blue cap and put a new lancet in the sampler. Twist off the protective disk. Replace the cap and cock the sampler. pg. 14 Get a drop of blood Hold the OneTouch® UltraSoft® Blood Sampler firmly against your finger. Press the release button. Applying blood pg. 25 and reading results Touch and hold the drop of blood to the narrow channel in the top edge of the test strip Blood will be drawn into the strip. Keep holding the drop of blood to the top edge of the strip until the confirmation window is full. The meter will begin to count down from 5 to 1. Then, your blood glucose level appears on the display along with the unit of measure, and the date and time of the test. Gently squeeze and/or massage your fingertip until a round drop of blood of at least one microliter ( actual size) forms on your fingertip. If the test results are lower than, higher than, or not what you expect, see pages 28­29. iii Attaching flags or comments to your results Add a meal flag to track different types of averages While viewing your test result, press to get the MEAL FLAG screen. pg. 32 Reviewing past pg. 36 results and averages · Last result · All results · Result averages · Downloading results Add a comment While viewing a test result, press to get the COMMENT screen. to highlight BEFORE MEAL or AFTER MEAL. To confirm your selection, press . The meal flag you chose will appear above the result. If you do not wish to add a meal flag, select NO FLAG and press . This will return you to the glucose result screen. iv Press or Press or to highlight an appropriate comment. To confirm your selection, press . The comment you chose appears below the result. Meal flag Control solution testing Caring for your system pg. 42 pg. 47 Understanding error pg. 53 and other messages Detailed information pg. 60 about your system Comment Index pg. 65 Before you begin Before using this product to test your blood glucose, carefully read this booklet and the inserts that come with the OneTouch® Ultra® Test Strips and OneTouch® Ultra® Control Solution. Take note of warnings and cautions throughout this booklet, which are identified with . Many people find it helpful to practice the test with control solution before testing with blood for the first time. See page 42 in the Control solution testing section. Intended use The OneTouch® Ultra® 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® Ultra® 2 System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of diabetes or for testing newborns. Test principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current, calculates your blood glucose level, displays the result, and stores it in its memory. v Customer Service 1 800 227-8862 The OneTouch® Ultra® 2 Blood Glucose Monitoring System a b c Your new OneTouch® Ultra® 2 System Kit includes: f OneTouch® Ultra® 2 Meter (batteries included) OneTouch® Ultra® Control Solution OneTouch® UltraSoft® Blood Sampler If another type of lancing device was included, a see the separate instructions that came with that lancing device. e OneTouch® UltraClear® Cap OneTouch® UltraSoft® Sterile Lancets c Carrying Case d g You will also need OneTouch® Ultra® Test Strips. Some kits do not include strips. Strips are sold separately. Documents in your kit include this owner's booklet, a quick reference guide, a control solution insert and a warranty registration card. If any items are missing from your kit, call Customer Service. d e f g b WARNING: Keep the meter and testing supplies away from young children. Small items such as the battery door, batteries, test strips, lancets, protective disks on the lancets, and control solution vial cap are choking hazards. Customer Service 1 800 227-8862 1 Setting up your system Getting to know your OneTouch® Ultra® 2 Blood Glucose Meter and test strips Front Test port Display Insert test strip here to turn meter on for testing Back with battery door open Test strip Edge to apply sample Meter battery Confirmation window OK button Turns the meter on/off Turns the backlight on/off Confirms menu selections Data port Backlight battery mg/dL is the pre-set unit of measure Battery door Contact bars Insert into test port Up and down buttons Select or change information Indicates selection available using up or down button 2 Customer Service 1 800 227-8862 Turning your meter on CAUTION: If you see To perform a test, insert a test strip as far as it will go. any light areas within The meter will briefly perform system checks, then the the black start-up screen, display will turn on. there may be a problem or, with the meter. Call With the meter turned off, press and hold for two Customer Service. seconds to access MAIN MENU. Check that the screen shows solid black for two seconds. If it does, the display is working properly. If the meter does not power on, try changing the meter battery. See page 51. Using the meter display backlight When the meter is already on, press and hold backlight on or off. for two seconds to turn the Setting up your system Turning your meter off There are several ways to turn your meter off: · Press and hold for five seconds. · Your meter will turn off by itself if left alone for two minutes. · Go to MAIN MENU and press or to highlight METER OFF, then press . · Before or after completing a test, remove the test strip. If you advance from the test result screen to the MAIN MENU by pressing , removing the strip will not turn the meter off. Use one of the three methods above. Customer Service 1 800 227-8862 3 Setting up your system Setting the meter language, date and time You can change many of the settings that came pre-set with your meter. Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete steps 1 through 9 below to ensure your desired settings are saved. 1. Turn the meter on, see page 3 2. Get to the LANGUAGE screen When using the meter for the first time, or after changing the meter battery, you will automatically start in the LANGUAGE screen. In other cases, from the MAIN MENU, press or to select SET UP. To confirm your selection, press . Then, press or to select METER SETTINGS. To confirm your selection, press . The display now shows the LANGUAGE screen. 4 Customer Service 1 800 227-8862 3. Choose a language Now press or to highlight the language of your choice. To confirm your selection, press . The display now shows the DATE FORMAT screen. NOTE: If you select the wrong language, press and hold for five seconds to turn the meter off. Then, turn the meter back on and re-start from step 1. 4. Set the date format Press or to highlight the date format-- choose month first (MM-DD-YYYY) or day first (DD-MM-YYYY). To confirm your selection, press . The display now shows the DATE SET UP screen. Setting up your system Customer Service 1 800 227-8862 5 Setting up your system 5. Set the date In the DATE SET UP screen, press or to change the first value. To confirm your selection, press . Press or to change the second value. To confirm your selection, press . Press or to change the year. To confirm your selection, press . The display now shows the TIME FORMAT screen. 6. Set the time format Press or to select the time format you prefer--AM/PM or 24 HR. To confirm your selection, press . The display now shows the TIME SET UP screen. 6 Customer Service 1 800 227-8862 7. Set the hour and "AM" or "PM" Press or to set the hour. Setting up your system Check AM/PM. If not correct, continue to press the hour and "AM" or "PM" are correct. or until You can ONLY change "AM" and "PM" when you pass 12:00. Make sure "AM" or "PM" is correct while you are setting the hour. Press to confirm your selection. 8. Set the minutes Press or to set the minutes. Press to confirm your selection. The display now shows the SETTINGS screen. If "AM" or "PM" is not correct, press or to highlight "NO" and press to start over (Step 3 on page 5). Customer Service 1 800 227-8862 7 Setting up your system 9. Confirm your settings The choice YES will be highlighted at the bottom of the screen. If your settings are correct, press to confirm and save the settings and return to the MAIN MENU. WARNING: The unit of measure mg/dL must be displayed here. If your display shows mmol/L rather than mg/dL, contact Customer Service. You cannot change the unit of measure. Use of the wrong unit of measure may cause you to misinterpret your blood glucose level, and may lead to incorrect treatment. If you want to cancel your settings and start the settings process over again, press or to highlight NO and press . You will be returned to the LANGUAGE screen. Note that none of the settings you entered will be saved. Turning the flags/comments feature off or on Your OneTouch® Ultra® 2 Meter allows you to attach optional notes to any blood glucose test result. See pages 32­35 for the types of meal flags and comments you can attach to a result, and the reasons for using this feature. We suggest you talk to your healthcare professional to see how meal flags and comments may help you manage your diabetes. 8 Customer Service 1 800 227-8862 If you do not wish to track separate result averages for before and after meals, nor attach comments to any test result, you may turn this feature off. If you turn off the flags/comments feature, you will not see on the test result screen after you complete a blood glucose test. You will be able to review the ALL RESULTS AVG screen, but not before- or after-meal averages. See page 38 for more information about result averages. To turn the flags/comments feature off or on: 1. From MAIN MENU, press SET UP Setting up your system or to select . To confirm your selection, press 2. From the SET UP screen, select FLAGS/COMMENTS To confirm your selection, press . 3. Press or to highlight your response Select YES if you wish to change the setting, or NO if you wish to leave it as it is. Press to confirm your selection and return to MAIN MENU. Customer Service 1 800 227-8862 9 Starting the test process Have these things ready when you test your blood glucose level: · OneTouch® Ultra® 2 Meter · OneTouch® Ultra® Test Strips · Lancing device · Sterile lancets with protective disks · OneTouch® Ultra® Control Solution NOTE: · Use only OneTouch® Ultra® Test Strips with your OneTouch® Ultra® 2 ...