User manual LIFESCAN ONETOUCH ULTRA METER IMPORTANT ADDENDUM

[. . . ] 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. [. . . ] After you have completed viewing or changing your option settings, simply turn the meter off. The meter will automatically turn itself off after two minutes of inactivity. TESTING YOUR BLOOD Abbreviated Test Procedure You can test your blood by following this 3-step testing procedure. Step 1: Press on/off button. Step 3: Accurate results in 45 seconds. TESTING (Example) 38 Be sure to read the following section carefully before testing. Detailed Test Procedure Choose a clean, dry work surface. Make sure you have all the items needed to test: OneTouch® Profile® Meter OneTouch® Test Strips Penlet® Plus Adjustable Blood Sampler Sterile lancet Ejection/Cocking Control Cap Release Button Depth Adjustment Knob Penlet® Plus Adjustable Blood Sampler Deep-Puncture Setting (Largest Bump) Shallow-Puncture Setting (Smallest Bump) Depth Indicator (7 different settings) TESTING 39 Getting a Drop of Blood CAUTION: To reduce the chance of infection: Step 1: Insert a Lancet into the Penlet ® Plus Adjustable Blood Sampler. To avoid contamination and to prevent the cap from rolling away, set the cap down on a flat surface with its small hole pointing up. TESTING Never share a lancet with another person. Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the Penlet Plus Sampler. 40 While the lancet is in the Penlet® Plus Sampler, twist off the protective disk. Make two full turns to ensure that the lancet separates from the protective disk. Replace the Penlet® Plus Cap. Turn the cap clockwise until it is snug but not overly tight. TESTING 41 Adjust the puncture depth setting if necessary. Twist the knob counterclockwise toward the smaller bumps for a shallower puncture. Twist the knob clockwise toward the larger bumps for a deeper puncture. Step 2: Cock the Penlet ® Plus Sampler. If it does not click, the Penlet Plus Sampler may have been cocked when the lancet was inserted. . TESTING 42 Step 3: Wash Your Hands. If your blood glucose test result is 60 mg/dL or below, your meter will beep in a low tone (if the Beep option is set to ) and display a special message: 49 TESTING If you take insulin, you may be producing ketones. Testing your urine with a ketone strip may be necessary. (Example) The message is warning you of low blood sugar (hypoglycemia). If your blood glucose level is still 60 mg/dL or below, call your doctor immediately. If your blood glucose test result is between 240 and 600 mg/dL, your meter will beep in a high tone (if the Beep option is set to ) and display a special message: TESTING Blood glucose results greater than 600 mg/dL are displayed as and your meter will beep in a high tone (if the Beep option is set to ). (Example) These messages indicate very high blood sugar (severe hyperglycemia). 50 (Example) Test results below 60 mg/dL3 (3. 3 mmol/L) mean low blood glucose (hypoglycemia). Test results greater than 240 mg/dL4 (13. 3 mmol/L) mean high blood glucose (hyperglycemia). If you get results below 60 mg/dL or above 240 mg/dL, and do not have symptoms, first repeat the test. If you have symptoms and continue to get results that fall below 60 mg/dL or above 240 mg/dL, call and follow the treatment advice of your healthcare professional. Checking the Amount of Blood on the Test Strip Although the OneTouch® Profile® System requires only a small drop of blood, it is very important that the drop be large enough to cover the test spot completely. In many cases, the meter can detect if the drop of blood was too small to give an accurate reading. However, it is important that you also look at the test strip to make sure that you applied enough blood. (If the blood sample is too small, you may get a false low result. ) TESTING 51 If the following message Note: If you are using event labeling, remove and check the test strip after you have linked the event label to your test result. [. . . ] Press forward on the base of the test strip holder to be sure it is properly in place. If the check strip will not slide into the test strip holder, repeat this step. 87 METER CARE Replacing the Batteries The OneTouch Profile Meter comes with batteries already installed. ® ® You will still be able to test with low batteries, but you should replace them as soon as possible. When the following appears flashing on the display battry replace now When the batteries need to be replaced, use two AAA, 1. 5-volt alkaline batteries. [. . . ]