Instruction/ maintenance manual of the product ART06986 Abbott Diabetes Care
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For in vitro diagnostic use. Advanced Diabetes Management System User’ s Guide 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 .
T able of Contents Welcome 1 1 Important Things to Know about Y our Precision Xtra Advanced Diabetes Management System 3 Intended Use 3 How Y our Precision Xtra Advanced Diabetes Management System W o.
6 Doing A Control Solution T est 55 Why Do A Control Solution T est? 55 When Is Doing A Control Solution T est Recommended? 55 Important Information about Control Solution T esting 55 What Y ou Will N.
1 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 car efully . Y our new Precision Xtra Advanced Diabetes Management System is an important tool that can help you better manage your diabetes.
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 ar e available 24 hours a day , 365 days a year . If you cannot reach Customer Care, contact your healthcar e professional.
CHAPTER 1 Questions? Call Customer Care: 1-800-527-3339 ▼ Important Information Important Things to Know about Y our Precision Xtr a Advanced Diabetes Management System Intended Use Y our Precision Xtra System: • Is indicated for home (lay user) or professional use in the management of Patients with diabetes.
4 • Precision Xtra ™ and Precision ™ POC Blood Glucose T est 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 T est Strips are for use by healthcare professionals only .
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.
Important Information Display Check Back Button Backlight Button Strip Port Mode Button Forward Button Display Window ▼ Items not included: MediSense Control Solutions Blood ß-Ketone T est Strips a.
7 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 r esult when you use it. Please call Customer Care for assistance.
8 Forward Button Back Button Use these buttons to: • Review and select monitor settings • Review results and averages Backlight Button Use this button to: • T urn 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 .
CHAPTER 2 Questions? Call Customer Care: 1-800-527-3339 ▼▼ Setting Up Y our Monitor Setting Up Y our Precision Xtr a Monitor Buttons to Use Mode Button Forward Button Back Button Setup Options Set.
10 Y ou 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 T ime Format In "Set T ime Format", you choose how the time shows on the monitor’ s display window .
11 How to Set the Beeper , Date, Time, & View Measurement Units T o begin, pull the battery tab out. Y our 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.
1 T o 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. 2 T o 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 T ime (Hour).
Set T ime Hour: 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.
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.
Set Date Y ear: The Y ear 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.
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 .
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 T ime Format.
Choice #1 Choice #2 Set T ime Format Y ou 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 . 1 T o change the Time Format, Press and Release the button or the button once. 2 Press and Release the button to save the T ime Format and to move to Set Date Format.
Set Date Format Y ou have two choices: Choice #1: For the month- day 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.
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). P ress and r elease the button to return to Set Beeper .
Press and Hold the button to turn your monitor off. Y ou have successfully set up your monitor . Setting Up Y our Monitor 21 ART06986-Rev-B-MAN 8/22/05 11:02 AM Page 24.
Questions? Call Customer Care: 1-800-527-3339 CHAPTER 3 Questions? Call Customer Care: 1-800-527-3339 Calibrating Y our Precision Xtr a Monitor Why Calibrate Y our Monitor? Y our Precision Xtra monitor must be calibrated so that it can recognize the test strip you are using.
23 What Y ou 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-Ket.
24 IMPORT ANT : • 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.
3 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 .
5 Check that the LOT number or calibration CODE on all these items matches: ✓ Display window ✓ T est strip calibrator ✓ T est strip instructions for use ✓ T est strip foil packet When the LOT number or calibration CODE on all these items matches: What It Means: Calibration is complete.
27 Calibrating Y our Monitor IMPORT ANT : 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. Y our monitor may show an incorrect r esult. 6 Remove the calibrator from the monitor and store it in your monitor’ s carrying case.
How to Recall the LOT Number or Calibration CODE 1 T o r ecall 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.
29 Calibrating Y our Monitor Note : If the LOT number or calibration CODE that shows on your monitor’ s display window is not correct: What It Means: Y our monitor may not be calibrated for the box of test strips you are using. What T o Do: • Re-calibrate your monitor .
CHAPTER 4 Questions? Call Customer Care: 1-800-527-3339 L O T 13758 E X P 2006/03 C5 ▼ ▼ Example: Expiration date March 31, 2006 Monitoring Y our Blood Glucose What Y ou Will Need • Blood glucos.
Monitoring Blood Glucose • 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.
2 Wash your hands using warm soapy water and dry them completely . 3 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.
33 • T ime, 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.
Monitoring Blood Glucose Obtaining A Blood Drop Use your lancing device to obtain a blood drop. Recommendations for Obtaining a Blood Drop • T o obtain a sample fr om an alternative site (forearm, upper arm, or base of the thumb), use an appropriate alternative site lancing device.
35 Monitoring Blood Glucose 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-r esistant container , such as a plastic milk carton or detergent bottle.
Status bar Countdown 36 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: • Y ou hear the beeper , if the beeper is ON. • The display window shows the status bar . • Then the display window shows the countdown.
37 Correct Apply second drop ✔ Important: If the countdown does not start: What It Means: Y ou 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.
Monitoring Blood Glucose Shutting Off Y our Monitor 1 Removing the test strip from the strip port turns off the monitor . Y ou can use the opened foil packet to remove and discar d your used test strip. 2 Discard the test strip properly . Note: Y ou may also turn the monitor off by Pr essing and Holding the button.
▼ Understanding Y our Result "LO" Result What It Means: Y our 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.
40 "HI" Result What It Means: Y our 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.
Monitoring Blood Glucose "E-4" Result What It Means: Y our blood glucose may be too high to be read by the system, or there may be a pr oblem 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 pr ofessional immediately .
42 • HI shows on the display window . • Y ou obtain a high blood glucose result, but you do not have symptoms of high blood glucose. • Y our monitor displays a result that is unusually high, higher than 300 mg/dL (16.7 mmol/L). • Y ou question your result.
CHAPTER 5 Questions? Call Customer Care: 1-800-527-3339 Monitoring Y our Blood ß-Ketone It is important to check your ketones when: • Y ou have an illness. • Y our blood glucose is higher than 300 mg/dL (16.7 mmol/L). • Y ou are experiencing unusual blood glucose results.
Made in UK. P/N 120-1025 Rev . 0 1/03 ß-Ketone T est Strip Abbott Laboratories Abbott Diabetes Care Alameda, CA 94502 USA 70208 2006/03/09 . JC7 0.3-0.
▼ • 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 danger ous 1 , the following safety advice should be observed: 1.
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 .
• T ime, 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.
48 Fingertip sampling Obtaining A Blood Drop Use your lancing device to obtain a blood drop. 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 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-r esistant container , such as a plastic milk carton or detergent bottle.
Monitoring Blood ß-Ketone Status bar Countdown 50 • Y ou 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 it during the countdown.
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 stor ed in your monitor’ s memory as a blood ß-Ketone result.
52 ▼ Understanding Y our 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 vigor ously , or if blood gl ucose levels are not controlled. 2-4 When: • Blood ß-Ketone result is between 0.
When: • Blood ß-Ketone result remains high or becomes higher than 1.5 mmol/L: What It Means: Y ou may be at risk of developing diabetic ketoacidosis (DKA). 3-7 What to Do: Contact your healthcare professional immediately . "HI" Result What It Means: Y our monitor has determined that your blood ß-Ketone result is higher than 6.
Monitoring Blood ß-Ketone "E-4" Result What It Means: There may be a pr oblem 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 pr ofessional immediately .
CHAPTER 6 Questions? Call Customer Care: 1-800-527-3339 ▼ ▼ Control Solution T esting ▼ 55 Doing A Control Solution T est Why Do A Control Solution T est? The control solution test tells you that your monitor and test strips are working corr ectly .
solutions, read the contr ol 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.
57 What Y ou 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.
58 Control Solution T esting 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.
4 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 her e show on the display window . (See Chapter 1 for more information about the Display Check.
Control Solution T esting Control Solution T esting • 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 contr ol solution to the test strip.
Applying Control Solution to the T est Strip 1 T ur n the control solution bottle upside down three to four times to mix the solution. 2 Remove the cap. 3 Apply a drop of control solution to the test strip in the area shown her e. The control solution is drawn into the test strip.
62 Glucose ß-Ketone Note: Do not remove the test strip from the monitor or disturb it during the countdown. Important: If the countdown does not start: What It Means: Y ou might not have applied enough control solution to the test strip. What to Do: • Apply a second drop of control solution to the test strip.
Control Solution T esting 63 Note: If you are doing a ß-Ketone control solution test, KETONE will also show with the result. • The result is stor ed in your monitor’ s memory as a contr ol result. In your logbook, r ecord the result as a contr ol result.
▼ Understanding Y our Result Compare the contr ol 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.
CHAPTER 7 Reviewing & Using Y our Results What Can Y our Monitor Show Y ou? Memory Y our Precision Xtra monitor has a memory that stores up to 450 events. This is a combination of control r esults, your personal blood glucose and blood ß-Ketone results, and other monitor information.
66 ▼ Important: • T o r eview 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.
67 2 Press and Release the button. • The Display Check shows on the display window . • Then your most recent r esult shows with its units on the monitor’ s display window , along with the time, month, and day that you got the result. (T o set the correct date and time, follow the steps in Chapter 2.
68 A control solution r esult in Memory shows with a control bottle, as long as you marked the test as a control solution test. 3 T o review pr evious results, Press and Release the button once per result.
Reviewing Results 4 When you reach the last result in Memory , the display window shows three dashes. 5 T o return to a result you previously r eviewed, Press and Release the button once per result. How to See A verages Important: • Results that show as LO during blood glucose monitoring are included as 20 mg/dL (1.
70 Reviewing Results 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.
71 Reviewing Results 5 Press and Hold the button to turn off your monitor . Otherwise, the monitor turns off after 30 seconds. T ransferring Y our Results to a Computer The results in your Pr ecision .
CHAPTER 8 T emperatur e is too hot or too cold for the system to work properly . • Move your monitor and test strips to a location where the temperature is appropriate and monitor again with a new test strip. Y ou may have to wait for your monitor to adjust to the new temperature.
What It What Y ou Message Means Need to Do Monitor error . There may be a problem with the test strip. • T ur n the monitor off, then repeat previous monitoring steps. • If the error message appears again, contact Customer Care. • Review the monitoring instructions.
Message What It What Y ou Means Need to Do 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 ß-Ketone test strip. Blood applied to test strip too soon. • Monitor again with a new test strip.
What It What Y ou Message Means Need to Do Calibration/T est strip error . T est strip err or . T est strip is damaged, used, or the monitor does not recognize it. • Repeat the calibration using the calibrator bar that came with the test strip you are using.
Monitor error . Monitor error . • Remove test strip, turn monitor off, and try to monitor again. • If the error message appears again, contact Customer Care. • Remove test strip, turn monitor off, and try to monitor again. • If the error message appears again, contact Customer Care.
CHAPTER 9 Y our Monitor’ s Specifications & Limitations Size Length 2.94" (7.47 cm) W idth T op 2.10" (5.33 cm) Bottom 1.70" (4.32 cm) Thickness 0.
Specifications & Limitations Storage T emperatur e Monitor: –13° to 131ºF (–25º to 55ºC) T est Strips: See test strip instructions for use. Control Solution: See control solution instructions for use. Blood Glucose See blood glucose test strip Assay Range instructions for use.
Specifications & Limitations Data port Ye s Monitor Operating Range T emperatur e: 50º to 122ºF (10º to 50ºC) Relative Humidity: 10% to 90%, non-condensing System Operating Range T emperatur e: The system operating range is the operating range of the test strip you are using.
80 ▼ Important Information about Using Blood Samples from the Forearm, Upper Arm, or Base of the Thumb: • Contact your healthcare professional befor e you begin using any one of these alternative sites to test your blood glucose.
81 • Do not use blood samples from alternative sites when: 1.Y ou think your blood glucose is low or is changing rapidly , 2.Y ou have been diagnosed with hypoglycemic unawareness, 3.The results fr om alternative sites do not match the way you feel, 4.
Questions? Call Customer Care: 1-800-527-3339 CHAPTER 10 ▼ 82 Caring For Y our Monitor Cleaning Y our Monitor Store your monitor in its carrying case.
▼ Caring for Y our Monitor Replacing Y our Monitor’ s Battery When your monitor needs its batteries replaced, the display window shows one of two things: This means the battery is low . Y ou may still use your monitor and the results will be accurate.
How to Replace Y our 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 .
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.
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 . Y ou may need to reset the date and time. (See Chapter 2, Setting Up Y our System).
Questions? Call Customer Care: 1-800-527-3339 Support, Guarantee & Limited W arranty 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.
88 Guarantee & Limited W arranty Precision Xtra Advanced Diabetes Management System: Abbott Laboratories Inc., Abbott Diabetes Care (“Abbott”) of fers a Limited W arranty , as set forth below, to consumers who buy a Precision Xtra Advanced Diabetes Management System (“Monitor”) within the United States.
References References 1. Directive 1999/45/EC of the Eur opean Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, r egulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous pr eparations.
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.
An important point after buying a device Abbott Diabetes Care ART06986 (or even before the purchase) is to read its user manual. We should do this for several simple reasons:
If you have not bought Abbott Diabetes Care ART06986 yet, this is a good time to familiarize yourself with the basic data on the product. First of all view first pages of the manual, you can find above. You should find there the most important technical data Abbott Diabetes Care ART06986 - thus you can check whether the hardware meets your expectations. When delving into next pages of the user manual, Abbott Diabetes Care ART06986 you will learn all the available features of the product, as well as information on its operation. The information that you get Abbott Diabetes Care ART06986 will certainly help you make a decision on the purchase.
If you already are a holder of Abbott Diabetes Care ART06986, but have not read the manual yet, you should do it for the reasons described above. You will learn then if you properly used the available features, and whether you have not made any mistakes, which can shorten the lifetime Abbott Diabetes Care ART06986.
However, one of the most important roles played by the user manual is to help in solving problems with Abbott Diabetes Care ART06986. Almost always you will find there Troubleshooting, which are the most frequently occurring failures and malfunctions of the device Abbott Diabetes Care ART06986 along with tips on how to solve them. Even if you fail to solve the problem, the manual will show you a further procedure – contact to the customer service center or the nearest service center
