Medisense Blood Glucose Meter Art06986 Users Manual Precision Xtra Advanced Diabetes Management System
MediSense Blood Glucose Meter ART06986 ART06986-Rev-B
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2015-02-09
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Advanced Diabetes Management System User’s Guide For in vitro diagnostic use. Colors: CMYK PMS 286 PMS 289 Bar Code (Code 39):PRT06986 Rev B 8/05 2:11 PM FILE INFORMATION — For Artwork and Packaging Department Use Only 8/15/05 Artwork File Name: ART06986-Rev-B Orig. Creation Date: 28/Apr/05 By: Donald McAtee Last Modified Date: 15/Aug/05 By: Donald McAtee Software/Version: QuarkXpress 5.0, Photoshop, Illustrator. Fonts: Please Refer to Collection report. ART06986-Rev-B-CVR Page 1 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 1 Table of Contents 1 2 3 4 5 Welcome Important Things to Know about Your Precision Xtra Advanced Diabetes Management System 1 Intended Use How Your Precision Xtra Advanced Diabetes Management System Works Precision Xtra Kit Contents Getting to Know Your Monitor’s Features 3 4 5 6 Setting Up Your Precision Xtra Monitor 9 Buttons to Use Setup Options How to Set the Beeper, Date, Time, & View Measurement Units Set Beeper Set Time Set Date Set Time Format Set Date Format Blood Glucose Measurement Units 9 9 11 11 13 15 18 19 20 Calibrating Your Precision Xtra Monitor 22 Why Calibrate Your Monitor? When to Calibrate Your Monitor What You Will Need How to Calibrate Your Monitor How to Recall the LOT Number or Calibration CODE 22 22 23 23 28 3 Monitoring Your Blood Glucose 30 What You Will Need Important Information about Monitoring Your Blood Glucose How to Monitor Your Blood Glucose Understanding Your Result 30 Monitoring Your Blood ß-Ketone 43 What You Will Need Important Information about Monitoring Your Blood ß-Ketone How to Monitor Your Blood ß-Ketone Understanding Your Result 43 30 31 39 44 45 52 ART06986-Rev-B-MAN 6 7 8 8/22/05 11:02 AM Page 3 Doing A Control Solution Test 55 Why Do A Control Solution Test? When Is Doing A Control Solution Test Recommended? Important Information about Control Solution Testing What You Will Need How to Do Control Solution Testing Understanding Your Result 55 55 55 57 57 64 Reviewing & Using Your Results 65 What Can Your Monitor Show You? How to See Results in Memory How to See Averages Transferring Your Results to A Computer 65 66 69 71 Understanding & Troubleshooting Error Messages 72 What An Error Message Means & What You Need to Do 9 10 11 Your Monitor’s Specifications & Limitations 72 77 Important Information about Using Blood Samples from the Forearm, Upper Arm, or Base of the Thumb 80 Caring For Your Monitor 82 Cleaning Your Monitor Replacing Your Monitor’s Battery 82 83 Support, Guarantee & Limited Warranty 87 References 89 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 4 Welcome Thank you for choosing the Precision Xtra™ Advanced Diabetes Management System. Important steps for using the System are inside this guide. Please read it carefully. Your new Precision Xtra Advanced Diabetes Management System is an important tool that can help you better manage your diabetes. The System measures both blood glucose (sugar) and blood ß-Ketone. Blood glucose and blood ß-Ketone results can help you understand your diabetes and what happens with: •Food •Exercise •Stress and illness •Diabetes medications Always monitor your blood glucose and blood ß-Ketone according to your healthcare professional’s recommendations. 1 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 5 In the United States, call Customer Care at 1-800-527-3339 with any questions you may have about the Precision Xtra Advanced Diabetes Management System. We are available 24 hours a day, 365 days a year. If you cannot reach Customer Care, contact your healthcare professional. Outside the United States, please contact your local Abbott Laboratories, Abbott Diabetes Care office or distributor. Please read the following items before using your Precision Xtra Advanced Diabetes Management System: •User guide •Blood glucose test strip instructions for use •Blood ß-Ketone test strip instructions for use •Lancing device instructions for use and other information •Warranty card IMPORTANT: Any user guide text shown in a shaded box like this one is important information. Please pay special attention to these boxes. 2 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 6 Important Things to Know about Your Precision Xtra Advanced Diabetes Management System ▼ Important Information CHAPTER 1 Intended Use Your Precision Xtra System: •Is indicated for home (lay user) or professional use in the management of Patients with diabetes. •Is for use outside the body (in vitro diagnostic use). •Is for monitoring glucose in fresh whole blood (for example, from the fingertip). •Is for monitoring ß-Ketone in fresh whole blood from the fingertip. •Measures ß-hydroxybutyrate (ß-Ketone), the most important of the three ketone bodies circulating in the bloodstream. •Is for use with Precision Xtra™ or Precision™ POC Blood Glucose Test Strips and Precision Xtra™ Blood ß-Ketone Test Strips. 3 Questions? Call Customer Care: 1-800-527-3339 11:02 AM Page 7 • Precision Xtra™ and Precision™ POC Blood Glucose Test Strips are different. Please refer to your test strip instructions for use for important information about sample types that may be used with these test strips. • Precision™ POC Blood Glucose Test Strips are for use by healthcare professionals only. Potential Infection Risk: Healthcare professionals performing blood tests with this system on multiple patients must always wear gloves and should follow the infection control policies and procedures approved by their facility. How Your Precision Xtra Advanced Diabetes Management System Works When you insert a test strip into your monitor, the Apply Blood message shows on your monitor’s display window. When a blood sample or control solution sample is applied to the test strip, the glucose or ß-Ketone reacts with the chemicals on the test strip. This reaction produces a small electrical current that is measured. The result shows on your monitor’s display window. 4 Important Information 8/22/05 ▼ ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 8 Important Information ▼ ART06986-Rev-B-MAN Precision Xtra Kit Contents Precision Xtra Monitor Precision Xtra User’s Guide – Contains system information and directions. Carrying Case – Use this to store and carry your monitor and other monitoring supplies. Your kit may also contain: Precision Xtra Quick Reference Guide – Gives the basic steps to calibrate your monitor and check your blood glucose. Logbook – Use this to record your test results, activities, and medications. Precision Friends for Life Card – Please fill this out and return to the address provided to activate your warranty. Filling out this card helps to ensure that you receive any updates regarding your Precision Xtra monitor. Lancing Device, Lancets, Instructions for Use and Other Information Blood Glucose Test Strips and Instructions for Use 5 8/22/05 11:02 AM Page 9 Display Window Backlight Button Back Button Strip Mode Port Button Forward Button Display Check ▼ Items not included: MediSense Control Solutions Blood ß-Ketone Test Strips and Instructions for Use Data Management System Getting to Know Your Monitor’s Features Display Window This shows: •Blood glucose and blood ß-Ketone results •Glucose LOT numbers and ß-Ketone calibration CODEs •Previous test results and error messages •Blood glucose averages IMPORTANT: Each time you turn your monitor on, a full display shows. This is called a Display Check. Look at the Display Check each time it appears on your monitor’s display window, especially before you check your blood glucose or blood ß-Ketone. The Display Check shows on the display window briefly. 6 Important Information ART06986-Rev-B-MAN Important Information ART06986-Rev-B-MAN 8/22/05 11:02 AM Do not use the monitor if the monitor Display Check does not exactly match the picture here (for example, if you see a "3" instead of an "8"). The monitor may show an incorrect result when you use it. Please call Customer Care for assistance. Strip Port This is where you insert: •A blood glucose test strip •A blood ß-Ketone test strip •A glucose calibrator •A ketone calibrator •Data cable (not included) for uploading results to a computer Mode Button Use this button to: •Turn monitor ON and OFF •Access monitor setup options •Access and save monitor settings •Access previous results and averages 7 Page 10 8/22/05 11:02 AM Page 11 Forward Button Back Button Use these buttons to: •Review and select monitor settings •Review results and averages Backlight Button Use this button to: •Turn backlight ON and OFF Battery Compartment This is where the battery is installed. •If your monitor does not turn on, check that your battery is installed properly. •For new battery installation, see Chapter 10. 8 Important Information ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 12 CHAPTER 2 ▼ Buttons to Use Mode Button Forward Button Back Button ▼ Setting Up Your Monitor Setting Up Your Precision Xtra Monitor Setup Options Set Beeper If the beeper is set ON, it will beep when: •The calibrator is fully inserted •The test countdown starts •The test countdown finishes Set Time, Set Date Important: Set the correct time and date before you use the monitor for the first time. This will help you keep records of when you monitor and will help you and your healthcare professional make informed decisions about your care. You must set the time and date to review averages. 9 Questions? Call Customer Care: 1-800-527-3339 8/22/05 11:02 AM Page 13 You may need to re-set the time and date: •After you replace the battery. •When you travel between time zones or when the time zone you are in changes. In "Set Date", you set the year, month, and day. Set Time Format In "Set Time Format", you choose how the time shows on the monitor’s display window. Set Date Format In "Set Date Format", you choose how the month and day show on the monitor’s display window. Measurement Units Blood glucose measurement units are factory-set in mg/dL or mmol/L. Blood ß-Ketone measurement units are in mmol/L only. 10 Setting Up Your Monitor ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 14 Setting Up Your Monitor ▼ ART06986-Rev-B-MAN How to Set the Beeper, Date, Time, & View Measurement Units To begin, pull the battery tab out. Your monitor should be turned OFF. Before you start, please note: "Press and Hold" means that you press the button in for at least 2 seconds. "Press and Release" means that you press the button and let it go quickly. Press and Hold the button to turn the monitor off and save your settings at any time. The monitor automatically turns off after 30 seconds of no action. If you like the setting that you see on your monitor and do not want to change it, Press and Release the button to move to the next setup option. Beeper ON Set Beeper The means the beeper is ON. The means the beeper is OFF. Beeper OFF 11 8/22/05 11:02 AM Page 15 1 To turn your monitor ON, Press and Hold the button. The beeper ON message shows on the display window. The musical notes flash on and off, and the monitor beeps. Setting Up Your Monitor ART06986-Rev-B-MAN 2 To change the beeper setting, Press and Release the button or the button once. 3 Press and Release the button to save the beeper setting and to move to Set Time (Hour). 12 ART06986-Rev-B-MAN 8/22/05 11:02 AM Set Time Hour: Setting Up Your Monitor The Hour flashes on and off. 1 Press and Release the button to move the hour forward. 2 If you go past the correct hour, Press and Release the button to move the hour back. 3 Press and Release the button to save the hour and to move to Set Minutes. 13 Page 16 8/22/05 11:02 AM Page 17 Minutes: The Minutes flash on and off. 1 Press and Release the button to move the minutes forward. 2 If you go past the correct minute, Press and Release the button to move the minutes back. 3 Press and Release the button to save the minutes and to move to Set Date. 14 Setting Up Your Monitor ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Set Date Year: Setting Up Your Monitor The Year flashes on and off. 1 Press and Release the button to move the year forward. 2 If you go past the correct year, Press and Release the button to move the year back. 3 Press and Release the button to save the year and to move to Set Month. 15 Page 18 8/22/05 11:02 AM Page 19 Month: The Month flashes on and off. 1 Press and Release the button to move the month forward. 2 If you go past the correct month, Press and Release the button to move the month back. 3 Press and Release the button to save the month and to move to Set Day. 16 Setting Up Your Monitor ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Setting Up Your Monitor Day: The Day flashes on and off. 1 Press and Release the button to move the day forward. 2 If you go past the correct day, Press and Release the button to move the day back. 3 Press and Release the button to save the day and to move to Set Time Format. 17 Page 20 8/22/05 Choice #1 11:02 AM Page 21 Set Time Format You have two choices: Choice #1: For the 12-hour format, AM or PM shows. Choice #2: For the 24-hour format, AM or PM does not show. Choice #2 1 To change the Time Format, Press and Release the button or the button once. 2 Press and Release the button to save the Time Format and to move to Set Date Format. 18 Setting Up Your Monitor ART06986-Rev-B-MAN Setting Up Your Monitor ART06986-Rev-B-MAN 8/22/05 11:02 AM Set Date Format You have two choices: Choice #1: For the monthday format, " " shows with the date. - Example: "May 25" shows as "5-25". Choice #2: For the day.month format, "•" shows with the date. Example: "25 May" shows as "25.5". 1 To change the Date Format, Press and Release the button or the button once. 2 Press and Release the button to save the Date Format and to move to Measurement Units. 19 Page 22 8/22/05 11:02 AM Page 23 Blood Glucose Measurement Units Consult your healthcare professional if you have any questions about blood glucose measurement units. This screen shows the blood glucose measurement units (mg/dL or mmol/L). Press and release the button to return to Set Beeper. 20 Setting Up Your Monitor ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Setting Up Your Monitor Press and Hold the button to turn your monitor off. You have successfully set up your monitor. 21 Page 24 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 25 CHAPTER 3 Why Calibrate Your Monitor? Your Precision Xtra monitor must be calibrated so that it can recognize the test strip you are using. Calibration ensures that your results are accurate. Calibrating Your Monitor ▼ Calibrating Your Precision Xtra Monitor ▼ Questions? Call Customer Care: 1-800-527-3339 When to Calibrate Your Monitor • When you use the monitor for the first time. • EACH time you open and use a new box of blood glucose or blood ß-Ketone test strips. 22 8/22/05 11:02 AM Page 26 What You Will Need • Precision Xtra monitor • For glucose calibration: Blood glucose test strip Blood glucose test strip instructions for use Blood glucose test strip calibrator • For ß-Ketone calibration: Blood ß-Ketone test strip Blood ß-Ketone test strip instructions for use Blood ß-Ketone test strip calibrator ▼ Calibrating Your Monitor ▼ ART06986-Rev-B-MAN How to Calibrate Your Monitor When you insert a test strip for the first time, the display window shows: This means the monitor is not calibrated for blood glucose monitoring. This means the monitor is not calibrated for blood ß-Ketone monitoring. 23 ➡ ➡ 8/22/05 11:02 AM Page 27 IMPORTANT: •Use only the calibrator that is packaged in the box of test strips you are using. •Do not use test strips that have expired. Check the expiration date on the test strip foil packet and test strip box. If only the year and month are shown, the expiration date is the last day of the month. 1 Remove the glucose or ß-Ketone calibrator package from the new box of test strips. 2 Open the calibrator package. Find the three raised bumps on the calibrator package. Peel the clear cover away from the three raised bumps. 4. the the . it in until it stops. 24 Calibrating Your Monitor ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 28 3 Calibrating Your Monitor Hold the calibrator with the LOT number (glucose) or calibration CODE (ß-Ketone) facing you. 4 Insert the calibrator into the strip port. Push it in until it stops. The Display Check shows on the display window, followed by the time, month, and day. Next, the LOT number (glucose) or calibration CODE (ß-Ketone) shows on the display window. a. Example of glucose LOT number: LOT 13758 b. Example of ß-Ketone calibration CODE: CODE JC7 Then you hear the beeper, if the beeper is ON. ß-Ketone 25 Glucose 8/22/05 11:02 AM Page 29 5 Check that the LOT number or calibration CODE on all these items matches: ✓ Display window ✓ Test strip calibrator ✓ Test strip instructions for use ✓ Test strip foil packet When the LOT number or calibration CODE on all these items matches: What It Means: Calibration is complete. What to Do: You may now monitor your blood glucose or blood ß-Ketone. When the LOT number or calibration CODE on all these items DOES NOT match: What It Means: Your monitor may not be calibrated for the box of test strips you are using. What to Do: •Check that you are using the calibrator that came in the box of test strips you are using. •Try to calibrate again. 26 Calibrating Your Monitor ART06986-Rev-B-MAN Calibrating Your Monitor ART06986-Rev-B-MAN 8/22/05 11:02 AM IMPORTANT: If the LOT number or calibration CODE still does not match, contact Customer Care. Do not attempt to monitor your blood glucose or blood ß-Ketone. Your monitor may show an incorrect result. 6 Remove the calibrator from the monitor and store it in your monitor’s carrying case. IMPORTANT: Do not throw the calibrator away until you have used all of the test strips in the box. If you have any trouble calibrating your system, please contact Customer Care. 27 Page 30 11:02 AM Page 31 How to Recall the LOT Number or Calibration CODE To recall the glucose LOT number, Press and Hold the button. While holding the button, Press and Hold the button. The Display Check shows on the display window, then the glucose LOT number shows with the time, month, and day of the most recent glucose calibration. 1 2 After the glucose LOT number is displayed, you can recall the ß-Ketone calibration CODE. Press and Release the button or the button. The ß-Ketone calibration CODE shows with the time, month, and day of the most recent ß-Ketone calibration. 28 Calibrating Your Monitor 8/22/05 ▼ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Calibrating Your Monitor Note: If the LOT number or calibration CODE that shows on your monitor’s display window is not correct: What It Means: Your monitor may not be calibrated for the box of test strips you are using. What To Do: •Re-calibrate your monitor. •Check that you are using the calibrator that came in the box of test strips you are using. Remember, improper calibration will cause incorrect results. 3 Press and Hold the button to turn your monitor off. 29 Page 32 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 33 CHAPTER 4 Monitoring Your Blood Glucose ▼ What You Will Need •Blood glucose test strip with its instructions for use •Precision Xtra monitor calibrated to match the LOT number of the blood glucose test strip you are using •Lancing device and a new, sterile lancet C5 L O T 13758 E X P 2006/03 Example: Expiration date March 31, 2006 Important Information about Monitoring Your Blood Glucose •Do not use out-of-date test strips. Check the expiration date printed on the test strip box and on each test strip foil packet. If only the month and year are printed on the test strip, then the expiration date is the last day of that month. •For more detailed information about your test strip, please read its instructions for use before monitoring. •Use the test strip immediately when you take it out of its foil packet. 30 Monitoring Blood Glucose ▼ Questions? Call Customer Care: 1-800-527-3339 8/22/05 11:02 AM •Do not use a wet, bent, scratched, or damaged test strip. •Do not use the test strip if its foil packet has a puncture or tear in it. •Before you monitor your blood glucose or blood ß-Ketone, allow your monitor and test strip to reach the recommended operating range of the test strip. The test strip operating range is in the “Limitations of Procedure” section of your blood glucose test strip instructions for use. •Read the lancing device instructions for use. ▼ Monitoring Blood Glucose ART06986-Rev-B-MAN How to Monitor Your Blood Glucose Getting Started 1 Prepare your lancing device. 31 Page 34 8/22/05 11:02 AM Page 35 2 Wash your hands using warm soapy water and dry them completely. the test strip from its 3Remove foil packet. Note: For pictures that show how to open the blood glucose test strip foil packet, please see the information card in the box of blood glucose test strips. 4 Insert the three black lines at the end of the test strip into the strip port. 5 Push the test strip in until it stops. The monitor turns on automatically. These items show on the display window, one after the other: •Display Check – Remember to make sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.) 32 Monitoring Blood Glucose ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Monitoring Blood Glucose •Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. •LOT number for the box of blood glucose test strips you are using. •Apply Blood message, which tells you that the monitor is ready for you to apply blood to the blood glucose test strip. 33 Page 36 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 37 Obtaining A Blood Drop Use your lancing device to obtain a blood drop. Recommendations for Obtaining a Blood Drop •To obtain a sample from an alternative site (forearm, upper arm, or base of the thumb), use an appropriate alternative site lancing device. •Before you obtain a blood sample from the fingertip, Forearm sampling forearm, upper arm, or base of the thumb, make sure the sample site is clean, dry, and warm. To warm the sample site, wash it in warm water, rub the skin vigorously for a few seconds, or apply a warm pad to it. •Hang your arm down before pricking your finger or the base of the thumb to help blood flow. Upper arm sampling •To obtain a blood sample from the arm, use a fleshy area away from bone. Avoid areas where there is a lot of hair. •Avoid squeezing the puncture site. •Apply the blood sample to the Base of thumb sampling test strip immediately. 34 Monitoring Blood Glucose Fingertip sampling Monitoring Blood Glucose ART06986-Rev-B-MAN 8/22/05 11:02 AM Lancets and Lancing Device •Lancets are for one-time use only. Use a new lancet each time you monitor. •Discard your used lancet properly. Put it in an empty puncture-resistant container, such as a plastic milk carton or detergent bottle. •Never share your lancing device or lancet with another person. Applying the Blood Drop to the Test Strip 1 Touch the blood drop to the white area at the end of the test strip. The blood is drawn into the test strip. Note: If the monitor shuts off before you apply blood to the test strip, remove the test strip from the monitor and try again. 35 Page 38 8/22/05 11:02 AM Status bar Countdown Page 39 2 Continue to touch the blood drop to the end of the test strip until the monitor begins the test. The monitor begins the test when: •You hear the beeper, if the beeper is ON. •The display window shows the status bar. •Then the display window shows the countdown. Note: Do not remove the test strip from the monitor or disturb the test strip during the countdown. 36 Monitoring Blood Glucose ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Important: If the countdown does not start: Monitoring Blood Glucose What It Means: You might not have applied enough blood to the test strip. What to Do: •Apply a second drop of blood to the test strip. Refer to your test strip instructions for use for the number of seconds you have to apply a second drop. •If the countdown still does not start, or if the number of seconds you have to apply a second drop have passed, discard the test strip, turn off your monitor, and try again with a new test strip. 3 At the end of the countdown: •If the beeper is ON, listen for the beeper. •The blood glucose result shows on the display window. •The result is stored in your monitor’s memory. You may also write the result in your logbook. 37 Page 40 Correct ✔ Apply second drop 8/22/05 11:02 AM Page 41 Shutting Off Your Monitor 1 Removing the test strip from the strip port turns off the monitor. You can use the opened foil packet to remove and discard your used test strip. 2 Discard the test strip properly. Note: You may also turn the monitor off by Pressing and Holding the button. If you do not turn your monitor off or pull the test strip out, the monitor shuts off automatically after 60 seconds. 38 Monitoring Blood Glucose ART06986-Rev-B-MAN 8/22/05 11:02 AM ▼ ART06986-Rev-B-MAN Understanding Your Result Monitoring Blood Glucose "LO" Result What It Means: Your monitor has determined that your blood glucose result is lower than 20 mg/dL (1.1 mmol/L) or there may be a problem with the test strip. What to Do: Monitor your blood glucose again with a new test strip. If LO shows on the display window again, contact your healthcare professional immediately. Result 300 mg/dL or Higher When your blood glucose result is 300 mg/dL (16.7 mmol/L) or higher, KETONES? flashes on and off on the display window. What to Do: If you check your ketones as part of your diabetes management program, it is recommended that you check your blood ß-Ketone. 39 Page 42 8/22/05 11:02 AM Page 43 "HI" Result What It Means: Your monitor has determined that your blood glucose result is higher than 500 mg/dL (27.8 mmol/L) or there may be a problem with the test strip. What to Do: Monitor your blood glucose again with a new test strip. If HI shows on the display window again, contact your healthcare professional immediately. If you check your ketones as part of your diabetes management program, it is recommended that you check your blood ß-Ketone. 40 Monitoring Blood Glucose ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM "E-4" Result Monitoring Blood Glucose What It Means: Your blood glucose may be too high to be read by the system, or there may be a problem with the test strip. What to Do: Monitor your blood glucose again with a new test strip. If E-4 shows on the display window again, contact your healthcare professional immediately. Important: It is recommended that you repeat the blood glucose test with a new test strip when: •LO shows on the display window. •You obtain a low blood glucose result, but you do not have symptoms of low blood glucose. •Your monitor displays a blood glucose result that is unusually low, lower than 50 mg/dL (2.8 mmol/L). 41 Page 44 8/22/05 11:02 AM Page 45 •HI shows on the display window. •You obtain a high blood glucose result, but you do not have symptoms of high blood glucose. •Your monitor displays a result that is unusually high, higher than 300 mg/dL (16.7 mmol/L). •You question your result. Important: A result that is incorrect may have a serious medical outcome. Consult your healthcare professional before changing your diabetes medication program. 42 Monitoring Blood Glucose ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 46 CHAPTER 5 Questions? Call Customer Care: 1-800-527-3339 Monitoring Your Blood ß-Ketone •You have an illness. •Your blood glucose is higher than 300 mg/dL (16.7 mmol/L). •You are experiencing unusual blood glucose results. •You and your healthcare professional determine that it is necessary. ▼ Monitoring Blood ß-Ketone It is important to check your ketones when: What You Will Need •Blood ß-Ketone test strip with its instructions for use •Precision Xtra monitor calibrated to match the calibration CODE of the blood ß-Ketone test strip you are using •Lancing device and a new, sterile lancet 43 8/22/05 11:02 AM Page 47 ▼ ART06986-Rev-B-MAN Made in UK. P/N 120-1025 Rev. 0 1/03 Example: Expiration date March 9, 2006 . 70208 2006/03/09 JC7 0.3-0.7 mmol/l 1.9-2.9 mmol/l 3.7-5.7 mmol/l Monitoring Blood ß-Ketone ß-Ketone Test Strip Abbott Laboratories Abbott Diabetes Care Alameda, CA 94502 USA Important Information about Monitoring Your Blood ß-Ketone •For more detailed information about your blood ß-Ketone test strip, please refer to its instructions for use before monitoring. •Do not use out-of-date test strips. Check the expiration date printed on the test strip box and on each test strip foil packet. •Do not put urine on the blood ß-Ketone test strip. •Use the test strip immediately when you take it out of its foil packet. •Do not use a wet, bent, scratched, or damaged test strip. •Do not use the test strip if its foil packet has a puncture or tear in it. •Use each test strip only once. •Before you monitor your blood glucose or blood ß-Ketone, allow your monitor and test strip to reach the recommended operating range of the test strip. The test strip operating range is in the “Limitations of Procedure” section of your blood ß-Ketone test strip instructions for use. 44 8/22/05 11:02 AM ▼ •Read the lancing device instructions for use. •The blood ß-Ketone test strip foil packet contains a desiccant tablet (Zeolite Sodium Calcium Aluminosilicate). Although this material is not considered dangerous1, the following safety advice should be observed: 1. Keep away from children. 2. Do not expose to water as product gets hot and could cause burns. 3. Do not eat, and avoid contact with eyes and skin. May cause burns to the mouth and throat. 4. If swallowed, drink two glasses of water. Seek medical help. ▼ Monitoring Blood ß-Ketone ART06986-Rev-B-MAN How to Monitor Your Blood ß-Ketone Getting Started 1 Prepare your lancing device. 45 Page 48 8/22/05 11:02 AM Page 49 2 Wash your hands using warm soapy water and dry them completely. 3 Remove the test strip from its foil packet. 4 Insert the three black lines at the end of the test strip into the strip port. 5 Push the test strip in until it stops. The monitor turns on automatically. These items show on the display window, one after the other: •Display Check – Remember to make sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.) 46 Monitoring Blood ß-Ketone ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Monitoring Blood ß-Ketone •Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. •Calibration CODE for the box of blood ß-Ketone test strips you are using. •KETONE and Apply Blood message, which tell you that the monitor is ready for you to apply blood to the blood ß-Ketone test strip. 47 Page 50 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 51 Obtaining A Blood Drop Use your lancing device to obtain a blood drop. Recommendations for Obtaining A Blood Drop •Before you obtain a blood sample from the fingertip, make sure the sample site is clean, dry, and warm. To warm the sample site, wash it in warm water or rub the skin vigorously for a few seconds. •Hang your arm down before pricking your fingertip to help blood flow. •Avoid squeezing the fingertip. •Apply the blood sample to the test strip immediately. 48 Monitoring Blood ß-Ketone Fingertip sampling Important: Blood ß-Ketone test strips have not been evaluated for alternative site monitoring. Use only fingertip blood samples for blood ß-Ketone monitoring. Monitoring Blood ß-Ketone ART06986-Rev-B-MAN 8/22/05 11:02 AM Lancets and Lancing Device •Lancets are for one-time use only. Use a new lancet each time you monitor. •Discard your used lancet properly. Put it in an empty puncture-resistant container, such as a plastic milk carton or detergent bottle. •Never share your lancing device or lancet with another person. Applying the Blood Drop to the Test Strip 1 Touch the blood drop to the purple area on the top of the test strip. The blood is drawn into the test strip. Note: If the monitor shuts off before you apply blood to the test strip, remove the test strip from the monitor and try again. 2 Continue to touch the blood drop to the purple area on the top of the test strip until the monitor begins the test. The monitor begins the test when: 49 Page 52 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 53 Status bar •You hear the beeper, if the beeper is ON. •The display window shows the status bar. •Then the display window shows the countdown. Important: If the countdown does not start: What It Means: You might not have applied enough blood to the test strip. Countdown What to Do: •Apply a second drop of blood to the test strip. Refer to your test strip instructions for use for the number of seconds you have to apply a second drop. •If the countdown still does not start, or if the number of seconds you have to apply a second drop have passed, discard the test strip, turn off your monitor, and try again with a new test strip 50 Monitoring Blood ß-Ketone Note: Do not remove the test strip from the monitor or disturb it during the countdown. ART06986-Rev-B-MAN 8/22/05 11:02 AM Monitoring Blood ß-Ketone 3 At the end of the countdown: •If the beeper is ON, listen for the beeper. •The blood ß-Ketone result shows on the display window with the word KETONE. •The result is stored in your monitor’s memory as a blood ß-Ketone result. You may also write the result in your logbook. Shutting Off Your Monitor 1 Removing the test strip from the strip port turns off the monitor. You can use the opened foil packet to remove and discard your used test strip. 2 Discard the test strip properly. Note: You may also turn the monitor off by Pressing and Holding the button. If you do not turn your monitor off or pull the test strip out, the monitor shuts off automatically after 60 seconds. 51 Page 54 11:02 AM Page 55 Understanding Your Result Blood ß-Ketone is expected to be lower than 0.6 mmol/L.3 Blood ß-Ketone may be higher when a person is ill, is fasting, exercises vigorously, or if blood glucose levels are not controlled.2-4 When: •Blood ß-Ketone result is between 0.6 and 1.5 mmol/L and blood glucose result is 300 mg/dL (16.7 mmol/L) or higher: What It Means: A problem requiring medical assistance may be occurring. What to Do: Contact your healthcare professional. Follow his or her instructions for sick day management. 52 Monitoring Blood ß-Ketone 8/22/05 ▼ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM When: •Blood ß-Ketone result remains high or becomes higher than 1.5 mmol/L: Monitoring Blood ß-Ketone What It Means: You may be at risk of developing diabetic ketoacidosis (DKA).3-7 What to Do: Contact your healthcare professional immediately. "HI" Result What It Means: Your monitor has determined that your blood ß-Ketone result is higher than 6.0 mmol/L, or there may be a problem with the test strip. What to Do: Monitor your blood ß-Ketone again with a new test strip. If HI shows on the display window again, contact your healthcare professional immediately. 53 Page 56 8/22/05 11:02 AM Page 57 "E-4" Result What It Means: There may be a problem with the test strip. What to Do: Monitor your blood ß-Ketone again with a new test strip. If E-4 shows on the display window again, contact your healthcare professional immediately. Important: It is recommended that you repeat the blood ß-Ketone test with a new test strip when: •HI appears in the display window. •Your result is unusually high. •You question your result. •You obtain a 0.0 mmol/L blood ß-Ketone result BUT your blood glucose is higher than 300 mg/dL (16.7 mmol/L). Important: A result that is incorrect may have a serious medical outcome. Consult your healthcare professional before changing your diabetes medication program. 54 Monitoring Blood ß-Ketone ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 58 CHAPTER 6 ▼ Why Do A Control Solution Test? The control solution test tells you that your monitor and test strips are working correctly. A control solution test is similar to when you monitor your blood glucose or blood ß-Ketone, except you use a MediSense Control Solution. You do not use a drop of blood in a control solution test. When Is Doing A Control Solution Test Recommended? •When you question your results •To make sure that your monitor and test strips are working properly Important Information about Control Solution Testing •For more detailed information about control. ▼ Control Solution Testing ▼ Doing A Control Solution Test 55 Questions? Call Customer Care: 1-800-527-3339 8/22/05 11:02 AM Page 59 solutions, read the control solution instructions for use. •MediSense Control Solutions may be used for glucose or ketone control solution testing. •Do not use the control solution if the expiration date has passed. Check the expiration date printed on the control solution bottle. •When you open a control solution bottle for the first time, count forward 90 days and write this date on the control solution bottle using a pen that won’t smear or wipe off. Throw away any remaining solution after this date. •The results obtained from control testing do not reflect your personal blood glucose or blood ß-Ketone levels in any way. •Do not swallow the control solution. •Do not inject the control solution or use the control solution as eye drops. 56 Control Solution Testing ART06986-Rev-B-MAN 8/22/05 11:02 AM ▼ ART06986-Rev-B-MAN Control Solution Testing ▼ What You Will Need •Precision Xtra monitor calibrated to match the LOT number (glucose) or calibration CODE (ß-Ketone) of the test strip you are using •Blood glucose or blood ß-Ketone test strip and its instructions for use •MediSense Control Solutions and instructions for use How to Do Control Solution Testing Getting Started 1 Wash your hands using warm soapy water and dry them completely. 57 Page 60 8/22/05 11:02 AM Page 61 2 Remove the test strip from its foil packet. Note: For pictures that show how to open the blood glucose test strip foil packet, please see the information card in the box of blood glucose test strips. 3 Insert the three black lines at the end of the test strip into the strip port. 58 Control Solution Testing ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM 4 Control Solution Testing Push the test strip in until it stops. The monitor turns on automatically. These items show on the display window, one after the other: •Display Check – Remember to make sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.) •Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. 59 Page 62 8/22/05 11:02 AM Page 63 •LOT number (glucose) or calibration CODE (ß-Ketone) for the box of test strips you are using. •Apply Blood message, which tells you that the monitor is ready for you to apply control solution to the test strip. Note: If you are a doing a ß-Ketone control solution test, KETONE will show on the monitor’s display window with the ß-Ketone Apply Blood message. Control Solution Testing ART06986-Rev-B-MAN 5 To mark the test as a control test, Press and Release the button once. shows on the display window. Important: If you do not mark the test as a control test, it will be saved in your monitor’s memory as one of your personal blood glucose or blood ß-Ketone results. This could affect your blood glucose averages. 60 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 64 Applying Control Solution to the Test Strip 1 Turn the control solution bottle upside down three to four times to mix the solution. 2 Control Solution Testing Remove the cap. 3 Apply a drop of control solution to the test strip in the area shown here. The control solution is drawn into the test strip. Glucose ß-Ketone Status bar 4 Continue to touch the control solution to the test strip until the monitor begins the test. The monitor begins the test when: •You hear the beeper, if the beeper is ON. •The display window shows the status bar. •Then the display window shows the countdown. Countdown 61 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 65 Note: Do not remove the test strip from the monitor or disturb it during the countdown. Important: If the countdown does not start: Glucose What to Do: •Apply a second drop of control solution to the test strip. Refer to your test strip instructions for use for the number of seconds you have to apply a second drop. •If the countdown still does not start, or if the number of seconds you have to apply a second drop have passed, discard the test strip, turn off your monitor, and try again with a new test strip. At the end of the countdown: •If the beeper is ON, listen for the beeper. •The control result shows on the display window. 5 ß-Ketone 62 Control Solution Testing What It Means: You might not have applied enough control solution to the test strip. ART06986-Rev-B-MAN 8/22/05 11:02 AM Note: If you are doing a ß-Ketone control solution test, KETONE will also show with the result. •The result is stored in your monitor’s memory as a control result. In your logbook, record the result as a control result. Control Solution Testing Shutting Off Your Monitor 1 Removing the test strip from the strip port turns off the monitor. You can use the opened foil packet to remove and discard your used test strip. 2 Discard the test strip properly. Note: You may also turn the monitor off by Pressing and Holding the button. If you do not turn your monitor off or pull the test strip out, the monitor shuts off automatically after 60 seconds. 63 Page 66 11:02 AM Page 67 Understanding Your Result Compare the control result to the "Expected Results for Use with MediSense Control Solutions" range printed on: •The blood glucose test strip instructions for use, for glucose control solution testing. •The blood ß-Ketone test strip instructions for use and foil packet, for ß-Ketone control solution testing. If the control result falls within the range: What It Means: Your monitor and test strips are working correctly. If the control result does not fall within the range: What It Means: Your monitor and test strips may not be working correctly. What to Do: Repeat the test with a new test strip and ensure the control solution testing instructions are followed completely. If the result is still not within the printed range, contact Customer Care. 64 Control Solution Testing 8/22/05 ▼ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 68 CHAPTER 7 ▼ Reviewing & Using Your Results Reviewing Results What Can Your Monitor Show You? Memory Your Precision Xtra monitor has a memory that stores up to 450 events. This is a combination of control results, your personal blood glucose and blood ß-Ketone results, and other monitor information. You can review up to 450 of your most recent events on your monitor’s display window. Glucose Averages You can view the average of all your blood glucose results from the last 7, 14, or 30 days. If you marked your control solution tests, the averages do not include control solution results. (For more information on marking control solution tests, see Chapter 6.) 65 Questions? Call Customer Care: 1-800-527-3339 Page 69 Important: •To review blood glucose averages, you must set the date and time before monitoring. •If you do not mark control solution tests, this may affect your glucose averages. •Blood glucose averages do not include blood ß-Ketone results, glucose control results, ß-Ketone control results, or results that do not show the time, month, and day. •When there are no previous results or blood glucose averages to review, the display window shows three dashes. How to See Results in Memory Begin with your monitor turned off. Make sure there is nothing in the strip port. 1 66 Reviewing Results 11:02 AM ▼ 8/22/05 ➡ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 70 2 Press and Release the button. •The Display Check shows on the display window. •Then your most recent result shows with its units on the monitor’s display window, along with the time, month, and day that you got the result. (To set the correct date and time, follow the steps in Chapter 2.) Reviewing Results A blood glucose result in Memory will show with the letters MEM. Blood Glucose result in Memory A blood ß-Ketone result in Memory will show with the letters KET MEM. 67 Blood ß-Ketone result in Memory ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 71 A control solution result in Memory shows with a control bottle, as long as you marked the test as a control solution test. Reviewing Results Glucose control solution result in Memory ß-Ketone control solution result in Memory 3 To review previous results, Press and Release the button once per result. 68 ART06986-Rev-B-MAN 8/22/05 11:02 AM 4 When you reach the last result in Memory, the display window shows three dashes. 5 ▼ Reviewing Results To return to a result you previously reviewed, Press and Release the button once per result. How to See Averages Important: •Results that show as LO during blood glucose monitoring are included as 20 mg/dL (1.1 mmol/L) in blood glucose averages. •Results that show as HI during blood glucose monitoring are included as 500 mg/dL (27.8 mmol/L) in blood glucose averages. 69 Page 72 8/22/05 11:02 AM Page 73 1 While in Memory, Press and Release the button at any time to see the 7-Day average of your blood glucose results. Note: n means how many tests were performed within the 7-, 14-, or 30-Day average period. 2 Press and Release the button once to see the 14-Day average of your blood glucose results. 3 Press and Release the button again to see the 30-Day average of your blood glucose results. If you Press and Release the button again, the display window shows the 7-Day average. 4 Press and Release the button at any time to return to Memory. 70 Reviewing Results ART06986-Rev-B-MAN ART06986-Rev-B-MAN 5 8/22/05 11:02 AM Press and Hold the button to turn off your monitor. Otherwise, the monitor turns off after 30 seconds. Reviewing Results ▼ Transferring Your Results to a Computer The results in your Precision Xtra monitor's memory, along with the time and date of the reading, can be transferred to a computer with the use of the Precision Link® Direct Software Version 2.5 and a Precision Link communications cable. For information on how to purchase the software and cable, contact Customer Care at 1-800-527-3339. To install the software, please follow the instructions provided in the Precision Link User's Guide. 71 Page 74 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 75 CHAPTER 8 Questions? Call Customer Care: 1-800-527-3339 Understanding & Troubleshooting Error Messages There are times when error messages may show on your monitor’s display window. In the next few pages, we describe the error messages that may show on your monitor’s display window, what they mean, and what you need to do. What It Means What You Need to Do Temperature is • Move your monitor and test too hot or too strips to a location cold for the where the system to work temperature is properly. appropriate and monitor again with a new test strip. You may have to wait for your monitor to adjust to the new temperature. Refer to your test strip instructions for use for the appropriate operating range. • If the error message appears again, contact Customer Care. 72 Error Messages Message ART06986-Rev-B-MAN What It Means 8/22/05 11:02 AM What You Need to Do Monitor error. • Turn the monitor off, then repeat previous monitoring steps. • If the error message appears again, contact Customer Care. There may be a problem with • Review the monitoring the test strip. instructions. Error Messages • Monitor again with a new test strip. • If the error message appears again, contact Customer Care. 73 Page 76 Message 8/22/05 Message 11:02 AM Page 77 What It Means What You Need to Do • Monitor again Blood glucose with a new result may be test strip. too high to be • If the error read by the message system. appears again, contact your OR healthcare There may be a professional problem with immediately. the blood glucose or blood ß-Ketone test strip. Blood applied to test strip too soon. • Review the monitoring instructions. • Monitor again with a new test strip. • If the error message appears again, contact Customer Care. 74 Error Messages ART06986-Rev-B-MAN ART06986-Rev-B-MAN What It Means 8/22/05 11:02 AM What You Need to Do Calibration/Test • Repeat the calibration strip error. using the calibrator bar that came with the test strip you are using. • Check the date setting on your monitor. • Check the expiration date on the test strip foil packet. Error Messages • If the error message appears again, contact Customer Care. Test strip error. • Monitor again using a test Test strip is strip designed damaged, used, for use with or the monitor Precision Xtra. does not • If the error message recognize it. appears again, contact Customer Care. 75 Page 78 Message 8/22/05 Message 11:02 AM Page 79 What It Means What You Need to Do Monitor error. • Remove test strip, turn monitor off, and try to monitor again. • If the error message appears again, contact Customer Care. Monitor error. • Remove test strip, turn monitor off, and try to monitor again. • If the error message appears again, contact Customer Care. 76 Error Messages ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 80 CHAPTER 9 Questions? Call Customer Care: 1-800-527-3339 Specifications & Limitations Your Monitor’s Specifications & Limitations Size Length Width Top Bottom Thickness 2.10" (5.33 cm) 1.70" (4.32 cm) 0.64" (1.63 cm) Weight 1.48 ounces (42 grams) Power Source One CR 2032 Lithium (coin cell) battery Battery Life Approximately 1,000 tests Memory Up to 450 events including control results, personal blood glucose and blood ß-Ketone results, and other monitor information. 2.94" (7.47 cm) 77 8/22/05 11:02 AM Storage Temperature Monitor: Test Strips: Control Solution: Page 81 –13° to 131ºF (–25º to 55ºC) See test strip instructions for use. See control solution instructions for use. Blood Glucose Assay Range See blood glucose test strip instructions for use. Blood ß-Ketone Assay Range See blood ß-Ketone test strip instructions for use. Control Solution Range See blood glucose or blood ß-Ketone test strip instructions for use. Functions - Blood glucose monitoring - Blood ß-Ketone monitoring - Memory - Glucose averaging: 7-Day, 14-Day, and 30-Day Averages - Control solution marking and testing - Backlight: If ON – Stays ON during countdown; turns OFF 30 seconds after result is displayed. If OFF – Stays OFF during countdown; stays OFF during data upload. - Beeper: If ON – Beeps when calibrator is fully inserted and when countdown starts and finishes. 78 Specifications & Limitations ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 Data port 11:02 AM Page 82 Yes Monitor Operating Range Temperature: 50º to 122ºF (10º to 50ºC) Relative Humidity: 10% to 90%, non-condensing System Operating Range Temperature: The system operating range is the operating range of the test strip you are using. See “Limitations of Procedure” section in test strip instructions for use. 10% to 90%, non-condensing Specifications & Limitations Relative Humidity: 79 11:02 AM Page 83 Important Information about Using Blood Samples from the Forearm, Upper Arm, or Base of the Thumb: •Contact your healthcare professional before you begin using any one of these alternative sites to test your blood glucose. •Sampling from any one of these alternative sites may cause minor bruising and may leave marks that go away in a short time. •There may be times when alternative site results are different from fingertip results. This happens when blood glucose levels change rapidly (for example, after you eat a meal, after you take insulin, or during or after exercise). •Use alternative sites to monitor your blood glucose before, or more than two hours after, you eat a meal, take insulin, or exercise. 80 Specifications & Limitations 8/22/05 ▼ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Specifications & Limitations •Do not use blood samples from alternative sites when: 1.You think your blood glucose is low or is changing rapidly, 2.You have been diagnosed with hypoglycemic unawareness, 3.The results from alternative sites do not match the way you feel, 4.It is within two hours of eating a meal, taking insulin, or exercising, or 5.You monitor your blood ß-Ketone. 81 Page 84 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 85 CHAPTER 10 Caring For Your Monitor ▼ Cleaning Your Monitor Store your monitor in its carrying case. If the surface of your monitor gets dirty, you may clean it. Use a damp cloth and mild soap. Healthcare professionals: Acceptable cleaning solutions include 10% Bleach, 70% Alcohol, or 10% Ammonia. Important: Do not try to clean the strip port. Do not pour liquid into the strip port or buttons. Do not place your monitor in water or any other bath. Caring for Your Monitor Questions? Call Customer Care: 1-800-527-3339 82 Caring Caring for for Your Your Monitor ▼ ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 86 Replacing Your Monitor’s Battery When your monitor needs its batteries replaced, the display window shows one of two things: This means the battery is low. You may still use your monitor and the results will be accurate. However, the backlight is not useable. It is recommended that you replace the battery at this time. ➡ This means the battery must be replaced. The monitor is not useable. The monitor turns off automatically. ➡ Important: Do not remove the old battery until you have a new battery to install. It may be necessary to reset the time and date once you install a new battery. 83 8/22/05 11:02 AM Page 87 How to Replace Your Monitor’s Battery 1 Gently push the battery cover in and up with your thumb. 2 Lift the battery cover out of the monitor. 3 Pull on the plastic tab sticking out of the monitor to remove the old battery. Caring for Your Monitor ART06986-Rev-B-MAN 84 ART06986-Rev-B-MAN 8/22/05 11:02 AM 4 Insert a new CR 2032 Lithium (coin cell) battery with the plus sign (+) facing up. 5 Place the notches on the battery cover into the appropriate molded areas. 6 Caring for Your Monitor Gently push the battery cover in and down until you hear a click. 85 Page 88 8/22/05 11:02 AM Page 89 7 Press and Hold the button to turn your monitor on. If your monitor does not turn on, review the battery installation steps and reinstall the battery. 8 Check the date and time on your monitor. You may need to reset the date and time. (See Chapter 2, Setting Up Your System). 9 Be sure to discard the old battery in compliance with your local government’s regulations. Caring for Your Monitor ART06986-Rev-B-MAN 86 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 90 CHAPTER 11 ▼ Support, Guarantee & Limited Warranty Support, Repair, & Guarantee Support Abbott Laboratories, Abbott Diabetes Care, is committed to providing you with support. Call us with any questions you may have about your Precision Xtra monitor: 1-800-527-3339. Outside the United States, please contact your local Abbott Laboratories, Abbott Diabetes Care office or distributor. You can view interactive product demonstrations online at: AbbottDiabetesCare.com 87 Questions? Call Customer Care: 1-800-527-3339 8/22/05 11:02 AM Page 91 Guarantee & Limited Warranty Precision Xtra Advanced Diabetes Management System: Abbott Laboratories Inc., Abbott Diabetes Care (“Abbott”) offers a Limited Warranty, as set forth below, to consumers who buy a Precision Xtra Advanced Diabetes Management System (“Monitor”) within the United States. Other purchasers, please contact your local authorized Abbott distributor for information about possible guarantee and/or warranty coverage for your purchase. 90-day Guarantee: Abbott offers consumer purchasers a 90-day money back guarantee. If you are not fully satisfied with your Monitor, call Customer Care at 1-800-300-0978 (toll free) for a full refund. Refund will be limited to amount paid by consumer net of any rebates. You must have a copy of the dated itemized purchase receipt and the original packaging to obtain this refund. Limited Warranty: Under the standard warranty your new Monitor is covered for a period of four years from the original date of purchase, as long as it has not been modified, altered, or misused. Lifetime Warranty is a benefit of enrollment in the Precision Friends for Life Program and choice of replacement monitor will be at the discretion of Abbott. Under the warranty, Abbott will replace, free of charge, this Monitor, if it is defective in material or workmanship. NO OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE MADE. ABBOTT WILL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM THE FAILURE OF THE PRODUCT TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS. Some states do not allow the exclusion or limitation of other express or implied warranties or incidental or consequential damages, so the above limitations or exclusions may not apply to you. For Warranty Service, contact Customer Care for assistance and/or instructions for obtaining a replacement monitor at 1-800-527-3339. Abbott may require, as a condition to obtaining warranty service, that you return the Monitor, postage prepaid, to an address specified by Customer Care. Your Rights Under State Law: This warranty gives you specific legal rights, and you may also have other rights that vary from state to state. Free Lifetime Monitor Upgrades: Monitor upgrade requires enrollment in the Precision Friends for Life Program and use of your Monitor for a minimum of three years. Choice of replacement monitor will be at the discretion of Abbott. 88 Support, Repair, & Guarantee ▼ ART06986-Rev-B-MAN ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 92 References 1. Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. 2. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special Topics in Endocrinology and Metabolism 1982; 4:1–27. 3. Wiggam MI, O’Kane MJ, Harper R, Atkinson AB, Hadden DR, Trimble ER, Bell PM. Treatment of diabetic ketoacidosis using normalization of blood 3-hydroxybutyrate concentration as the endpoint of emergency management. Diabetes Care 1997; 20:1347–52. 4. Harano Y, Kosugi K, Hyosu T, Suzuki M, Hidaka H, Kashiwagi A, Uno S, Shigeta Y. Ketone bodies as markers for Type 1 (insulin-dependent) diabetes and their value in the monitoring of diabetes control. Diabetologia 1984; 26:343–8. References 5. Ubukata E. Diurnal variation of blood ketone bodies in insulin-dependent diabetes mellitus and non-insulin-dependent diabetes mellitus patients: The relationship to serum C-peptide immunoreactivity and free insulin. Ann Nutr Metab 1990; 34:333–42. 6. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzo RA. Metabolic effects of low-dose insulin therapy on glucose metabolism in diabetic ketoacidosis. Diabetes 1988; 37:1470–77. 7. Hale PJ, Crase J, Nattrass M. Metabolic effects of bicarbonate in the treatment of diabetic ketoacidosis. Br Med J 1984; 289; 1035–8. 89 ART06986-Rev-B-CVR 8/15/05 2:11 PM Page 2 Distributed by: Abbott Laboratories Abbott Diabetes Care Alameda, CA 94502 USA Customer Care available 24 hours a day, 7 days a week at 1-800-527-3339 or visit us online at: AbbottDiabetesCare.com Reorder No.: 70297-01 MediSense and Precision Xtra are trademarks of Abbott Laboratories. © 2005 Abbott Laboratories. PRT06986 Rev. B 8/05 ART06986 Rev. B 8/05
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