Blood Glucose & Ketone Monitoring System User’s Manual
Definition of Symbols These symbols are associated with your meter. Batch code This packaging is capable of being recycled Catalog number Manufacturer Caution Sterilized using irradiation (lancets only) Consult instructions for use Temperature limitation Date of manufacture Use by Do not drink Serial Number Do not reuse The batteries in this product should be removed and disposed in accordance with local regulations for separate collection of spent batteries.
Table of Contents 1 Welcome Important Things to Know about Your Precision Xtra Blood Glucose and Ketone Monitoring System 1 3 Intended Use How Your Precision Xtra Blood Glucose and Ketone Monitoring System Works Precision Xtra Kit Contents Getting to Know Your Meter’s Features 3 2 9 Setting Up Your Precision Xtra Meter 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 Glucos
5 6 7 Doing A Control Solution Test 34 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 34 34 34 35 35 39 Reviewing & Using Your Results 40 What Can Your Meter Show You? How to See Results in Memory How to See Averages Transferring Your Results to a Computer 40 41 43 44 Understanding & Troubleshooting Error Messages 45 What An Err
Welcome Thank you for choosing the Precision Xtra® Blood Glucose and Ketone Monitoring System. Important steps for using the System are inside this manual. Please read it carefully. Your new Precision Xtra Blood Glucose and Ketone Monitoring System is an important tool that can help you better manage your diabetes. The System measures both blood glucose (sugar) and blood ketone.
In the United States, call Customer Service at 1-800-527-3339 with any questions you may have about the Precision Xtra Blood Glucose and Ketone Monitoring System. We are available 24 hours a day, 365 days a year. If you cannot reach Customer Service, contact your healthcare professional. Outside the United States, please contact your local Abbott Diabetes Care Inc. office or distributor.
Important Things to Know about Your Precision Xtra® Blood Glucose and Ketone Monitoring System Questions? Call Customer Service: 1-800-527-3339 Intended Use Your Precision Xtra System: ▼ Important Information CHAPTER 1 • Is indicated for home (lay user) or professional use in the management of patients with diabetes. • Is for self testing or healthcare professional use outside the body (in vitro diagnostic use). • Is for monitoring glucose in fresh whole blood (for example, from the fingertip).
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. ▼ Read the instructions in this user’s manual. Failure to follow instructions will cause incorrect results. Practice the testing procedures before using the meter. Follow your healthcare professional’s advice when testing blood glucose levels and blood ketone levels.
▼ Important Information Precision Xtra Kit Contents Precision Xtra Meter Precision Xtra User’s Manual – Contains system information and directions. Carrying Case – Use this to store and carry your meter and other monitoring supplies. Your kit may also contain: Logbook – Use this to record your test results, activities, and medications. Lancing Device, Lancets, Instructions for Use and Other Information. Blood Glucose Test Strips and Instructions for Use.
This shows: • Blood glucose and blood ketone results. • Previous test results and error messages. • Blood glucose averages. IMPORTANT: Each time you turn your meter on, a full display shows. This is called a Display Check. Look at the Display Check each time it appears on your meter’s display window, especially before you check your blood glucose or blood ketone. The Display Check shows on the display window briefly.
Important Information IMPORTANT: Avoid getting dust, dirt, blood, control solution, water, or any other substance in the test strip port. Strip Port Display Window This is where you insert: • A blood glucose test strip. • A blood ketone test strip. • Data cable (not included) for uploading results to a computer. Backlight Button Back Button Mode Button Use this button to: • Turn meter ON and OFF. • Access meter setup options. Strip • Access and save meter settings.
Backlight Button Important Information Use this button to: • Turn backlight ON and OFF. Battery Compartment This is where the battery is installed. • If your meter does not turn on, check that your battery is installed properly. • For new battery installation, see Chapter 9.
CHAPTER 2 ▼ Setup Options Set Beeper Setting Up Your Meter Buttons to Use Mode Button Forward Button Back Button ▼ Setting Up Your Precision Xtra Meter Questions? Call Customer Service: 1-800-527-3339 If the beeper is set ON, it will beep when: • The test countdown starts. • The test countdown finishes. Set Time, Set Date IMPORTANT: Please check that the correct time and date is set before you use the meter for the first time.
In "Set Date Format", you choose how the month and day show on the meter’s display window. Measurement Units Blood glucose measurement units are factory-set in mg/dL. Blood ketone measurement units are in mmol/L only. ▼ How to Set the Beeper, Date, Time, & View Measurement Units 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.
Setting Up Your Meter 1 To turn your meter ON, Press and Hold the button. The beeper ON message shows on the display window. The musical notes flash on and off, and the meter beeps. 2 To change the beeper setting, Press button or the and Release the button once. 3 Press and Release the button to save the beeper setting and to move to Set Time (Hour). Set Time Hour: The Hour flashes on and off. 1 2 Press and Release the button to move the hour forward.
Minutes: 1 2 Press and Release the button to move the minutes forward. 3 Press and Release the button to save the minutes and to move to Set Date. If you go past the correct minute, Press and Release the button to move the minutes back. Set Date Year: The Year flashes on and off. 1 2 Press and Release the button to move the year forward. 3 Press and Release the button to save the year and to move to Set Month. If you go past the correct year, Press and Release the button to move the year back.
Month: Setting Up Your Meter The Month flashes on and off. 1 2 Press and Release the button to move the month forward. 3 Press and Release the button to save the month and to move to Set Day. If you go past the correct month, Press and Release the button to move the month back. Day: The Day flashes on and off. 1 2 Press and Release the button to move the day forward. 3 Press and Release the button to save the day and to move to Set Time Format.
Set Time Format Choice #1 You have two choices: Setting Up Your Meter Choice #1: For the 12-hour format, AM or PM shows. Choice #2: For the 24-hour format, AM or PM does not show. 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. Choice #2 Set Date Format Choice #1 You have two choices: Choice #1: For the month-day format, "-" shows with the date. Example: "May 25" shows as "5-25".
Setting Up Your Meter Blood Glucose Measurement Units Consult your healthcare professional if you have any questions about the blood glucose measurement units. This screen shows the blood glucose measurement units (mg/dL). Press and Release the return to Set Beeper. Press and Hold the your meter off. button to button to turn You have successfully set up your meter.
CHAPTER 3 Questions? Call Customer Service: 1-800-527-3339 Monitoring Your Blood Glucose ▼ 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. A138 45001 2014/03 • Use the test strip immediately when you take it out of its foil Example: packet.
Monitoring Blood Glucose ▼ How to Monitor Your Blood Glucose Getting Started 1 2 Prepare your lancing device. 3 Open the foil test strip packet at the notch and tear down to remove the test strip. 4 With the contact bars (3 black lines) facing up, insert the test strip into the strip port. 5 Push the test strip in until it stops. Wash your hands and the test site using warm soapy water and dry them completely. The meter turns on automatically.
• Display Check – Remember to make • Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. • LOT 45001 and the Apply Sample symbols and , indicating that the meter is ready for you to apply blood to the blood glucose test strip. Note: LOT 45001 must match the LOT number for the box of blood glucose test strips you are using. 18 Monitoring Blood Glucose sure that all items in the picture here show on the display window.
Obtaining A Blood Drop Use your lancing device to obtain a blood drop. Recommendations for Obtaining a Blood Drop Monitoring Blood Glucose • To obtain a sample from an alternative site (forearm, upper arm, or base of the thumb), use an appropriate alternative site lancing device. Results from alternative sites are subject to limitation. Fingertip sampling • Before you obtain a blood sample from the fingertip, forearm, upper arm, or base of the thumb, make sure the sample site is clean, dry, and warm.
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 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. Monitoring Blood Glucose another person.
IMPORTANT: If the countdown does not start: What It Means: You might not have applied enough blood to the test strip. What to Do: Monitoring Blood Glucose • 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 meter, and try again with a new test strip.
1 Removing the test strip from the strip port turns off the meter. 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 meter off by Pressing and Holding the button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds.
What to Do: If you check your ketones as part of your diabetes management program, it is recommended that you check your blood ketone. Monitoring Blood Glucose "HI" Result What It Means: Your meter has determined that your blood glucose result is higher than 500 mg/dL 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.
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.
CHAPTER 4 Questions? Call Customer Service: 1-800-527-3339 ▼ It is important to check your ketones when: • You have an illness. • Your blood glucose is higher than 300 mg/dL. • You are experiencing unusual blood glucose results. • You and your healthcare professional determine that it is necessary. What You Will Need • Precision Xtra blood ketone test strip with its instructions for use. • Precision Xtra meter. • Lancing device and a new, sterile lancet.
• 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 Monitoring Blood Ketone tear in it. • Use each test strip only once. • Before you monitor your blood ketone allow your meter and test strip to reach the recommended operating temperature range of the test strip. The test strip operating temperature range is in the “What else do I need to know?” section of your blood ketone test strip instructions for use.
▼ Monitoring Blood Ketone How to Monitor Your Blood Ketone Getting Started 1 Prepare your lancing device. 2 Wash your hands using warm soapy water and dry them completely. 3 Remove the test strip from its foil packet. Note: See page 17 for instructions on how to open your foil test strip 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.
• Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. • CODE 75001 and the Apply Sample symbols . • Monitoring Blood Ketone Note: CODE 75001 must match the LOT number for the box of blood ketone test strips you are using. KETONE and the Apply Sample symbols , indicating that the meter is ready for you to apply blood to the blood ketone test strip. Obtaining A Blood Drop Use your lancing device to obtain a blood drop.
• Hang your arm down before pricking your fingertip to Monitoring Blood Ketone help blood flow. • Apply the blood sample to the test strip immediately. 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.
IMPORTANT: If the countdown does not start: 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. Countdown • 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 meter, and try again with a new test strip. 3• At the end of the countdown: If the beeper is ON, listen for the beeper.
2 Discard the test strip properly. Note: You may also turn the meter off by Pressing and Holding the button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds. Monitoring Blood Ketone ▼ Understanding Your Result Blood ketone is expected to be lower than 0.6 mmol/L.2 Blood ketone may be higher when a person is ill, is fasting, exercises vigorously, or if blood glucose levels are not controlled.1-3 When: • Blood ketone result is between 0.
When: • Blood ketone result is higher than 1.5 mmol/L and blood glucose result is higher than 300 mg/dL: What It Means: You may be at risk of developing diabetic ketoacidosis (DKA).2-6 "HI" Result What It Means: Your meter has determined that your blood ketone result is higher than 8.0 mmol/L, or there may be a problem with the test strip. What to Do: Monitor your blood ketone again with a new test strip. If HI shows on the display window again, contact your healthcare professional immediately.
"E-4" Result What It Means: There may be a problem with the test strip. Monitoring Blood Ketone What to Do: Monitor your blood 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 ketone test with a new blood ketone test strip when: • HI appears on the display • Your result is unusually high • You question your result • Your blood ketone result is 0.
CHAPTER 5 When Is Doing A Control Solution Test Recommended? • When using your meter for the first time. • To make sure that your meter and test strips are working properly. • When opening a new box of test strips. Important Information about Control Solution Testing • For more detailed information on how to obtain control solutions, please contact Customer Service. • For more detailed information about control solutions, read the control solution instructions for use.
▼ How to Do Control Solution Testing Control Solution Testing What You Will Need • Precision Xtra Meter • Precision Xtra Blood Glucose or Blood β-Ketone Test Strip and its instructions for use • MediSense Control Solutions and instructions for use ▼ • Do not use the control solution if the expiration date has passed. Check the expiration date printed on the control solution bottle.
3 Insert the three black lines at the end of the test strip into the strip port. 4 Push the test strip in until it stops. The meter turns on automatically. These items show on the display window, one after the other: • Display Check – Remember to make • Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers. • LOT 45001 and the Apply Sample symbols and . followed Note: CODE 75001 and and will appear if by performing a ketone control solution test.
5 To mark the test as a control solution test, Press and Release the button shows on the display once. window. IMPORTANT: If you do not mark the test as a control solution test, it will be saved in your meter’s memory as one of your personal blood glucose or blood ketone results. This could affect your blood glucose averages. Control Solution Testing Applying Control Solution to the Test Strip 1 2 3 4 Turn the control solution bottle upside down three to four times to mix the solution. Remove the cap.
Note: Do not remove the test strip from the meter or disturb it during the countdown. If the countdown does not start, remove and discard the used test strip, turn off your meter, and try again with a new test strip. Glucose 5• Note: If you are doing a ketone control solution test, KETONE will also show with the result. • The result is stored in your meter’s memory as a control solution result. In your logbook, record the result as a control solution result.
Shutting Off Your Meter 1 Removing the test strip from the strip port turns off the meter. You can use the opened foil packet to remove and discard your used test strip. 2 Discard the test strip properly. Control Solution Testing ▼ Note: You may also turn the meter off by Pressing and Holding the button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds.
CHAPTER 6 Reviewing & Using Your Results What Can Your Meter Show You? Memory Your Precision Xtra meter has a memory that stores up to 450 events. This is a combination of control solution results, your personal blood glucose and blood ketone results, and other meter information. You can review up to 450 of your most recent events on your meter’s display window. Glucose Averages You can view the average of all your blood glucose results from the last 7, 14, or 30 days.
▼ How to See Results in Memory Begin with your meter turned off. Make sure there is nothing in the strip port. 1 2• Press and Release the button. The Display Check shows on the display window. • Then your most recent result shows Reviewing Results with its units on the meter’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.) A blood glucose result in Memory will show with the letters MEM.
A control solution result in Memory shows with a control solution bottle, as long as you marked the test as a control solution test. 3 To review previous results, Press button once and Release the per result. 4 When you reach the last result in Memory, the display window shows three dashes. 5 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 in blood glucose averages. • Results that show as HI during blood glucose monitoring are included as 500 mg/dL in blood glucose averages. 1 While in Memory, Press and Release the button at any time to see the 7-Day average of your blood glucose results. Reviewing Results Note: n means how many tests were performed within the 7-, 14-, or 30-Day average period.
4 Press and Release the button at any time to return to Memory. 5 Press and Hold the button to turn off your meter. Otherwise, the meter turns off after 30 seconds. 44 Reviewing Results ▼ Transferring Your Results to a Computer Download of test results to a computer requires a compatible data management system. For more information, please go to our website or contact Customer Service.
CHAPTER 7 Understanding & Troubleshooting Error Messages Questions? Call Customer Service: 1-800-527-3339 There are times when error messages may show on your meter’s display window. In the next few pages, we describe the error messages that may show on your meter’s display window, what they mean, and what you need to do. What It Means What You Need to Do Temperature is too hot or too cold for the system to work properly.
What It Means What You Need to Do Meter error. • Turn the meter off, then repeat previous monitoring steps. • If the error message appears again, contact Customer Service. Blood glucose result may be too low to be read by the system. OR There may be a problem with the blood glucose or blood ketone test strip. Blood glucose result may be too high to be read by the system. OR There may be a problem with the blood glucose or blood ketone test strip. 46 • Review the monitoring instructions.
Message What It Means What You Need to Do 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 Service. Meter Error. • Monitor again using a test strip designed for use with Precision Xtra. • If the error message Error Messages appears again, contact Customer Service. No coding required. OR Test strip may be damaged, used or the meter does not recognize it.
What It Means What You Need to Do Meter error. • Remove test strip, turn meter off, and try to monitor again. • If the error message appears again, contact Customer Service. Meter error. • Remove test strip, turn meter off, and try to monitor again. • If the error message appears again, contact Customer Service.
CHAPTER 8 Your Meter's Specifications & Limitations Questions? Call Customer Service: 1-800-527-3339 Specifications & Limitations Size Length: 7.47 cm Width: 5.33 cm 4.32 cm Thickness: 1.
- Blood glucose monitoring - Blood ketone monitoring - Memory: 450 events - 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.
Specifications & Limitations ▼ 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.
CHAPTER 9 Questions? Call Customer Service: 1-800-527-3339 Caring For Your Meter ▼ ▼ Cleaning Your Meter Store your meter in its carrying case. Avoid getting dirt, dust, blood, control solution, or liquid in the meter test strip port. Clean the outside of the meter using a damp cloth and mild soap.
How to Replace Your Meter’s Battery Gently push the battery cover in and up with your thumb. 2 Lift the battery cover out of the meter. 3 To remove the battery, push the battery upward to release the battery. 4 Insert a new CR 2032 Lithium (coin cell) battery with the plus sign (+) facing up.
Place the notches on the battery cover into the appropriate moulded areas. 6 Gently push the battery cover in and down until you hear a click. 7 Press and Hold the button to turn your meter on. If your meter does not turn on, review the battery installation steps and reinstall the battery. 8 Check the date and time on your meter. You may need to reset the date and time. (See Chapter 2, Setting Up Your Precision Xtra Meter).
References 1. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special Topics in Endocrinology and Metabolism 1982; 4:1–27. 2. 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. 3. Harano Y, Kosugi K, Hyosu T, Suzuki M, Hidaka H, Kashiwagi A, Uno S, Shigeta Y.
Manufacturer: Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service available 24 hours a day, 7 days a week at 1-800-527-3339 or visit us online at: AbbottDiabetesCare.com For in vitro diagnostic use. Precision Xtra is a trademark of the Abbott Group of Companies in various jurisdictions. © 2008 Abbott ART24315 Rev.