MediSense ART06986 User Manual

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Advanced Diabetes Management System
User’s Guide
For in vitro diagnostic use.
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Table of Contents
Welcome 1
1 Important Things to Know about
Your Precision Xtra Advanced Diabetes Management System 3
Intended Use 3 How Your Precision Xtra Advanced Diabetes
Management System Works 4 Precision Xtra Kit Contents 5 Getting to Know Your Monitor’s Features 6
2 Setting Up Your Precision Xtra Monitor 9
Buttons to Use 9 Setup Options 9 How to Set the Beeper, Date, Time, & View Measurement Units 11
Set Beeper 11
Set Time 13
Set Date 15
Set Time Format 18
Set Date Format 19 Blood Glucose Measurement Units 20
3 Calibrating Your Precision Xtra Monitor 22
Why Calibrate Your Monitor? 22 When to Calibrate Your Monitor 22 What You Will Need 23 How to Calibrate Your Monitor 23 How to Recall the LOT Number or Calibration CODE 28
4 Monitoring Your Blood Glucose 30
What You Will Need 30 Important Information about Monitoring
Your Blood Glucose 30 How to Monitor Your Blood Glucose 31 Understanding Your Result 39
5 Monitoring Your Blood ß-Ketone 43
What You Will Need 43 Important Information about Monitoring
Your Blood ß-Ketone 44 How to Monitor Your Blood ß-Ketone 45 Understanding Your Result 52
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6 Doing A Control Solution Test 55
Why Do A Control Solution Test? 55 When Is Doing A Control Solution Test Recommended? 55 Important Information about Control Solution Testing 55 What You Will Need 57 How to Do Control Solution Testing 57 Understanding Your Result 64
7 Reviewing & Using Your Results 65
What Can Your Monitor Show You? 65 How to See Results in Memory 66 How to See Averages 69 Transferring Your Results to A Computer 71
8 Understanding & Troubleshooting
Error Messages 72
What An Error Message Means & 72
What You Need to Do
9 Your Monitor’s Specifications
& Limitations 77
Important Information about Using Blood 80
Samples from the Forearm, Upper Arm,
or Base of the Thumb
10 Caring For Your Monitor 82
Cleaning Your Monitor 82 Replacing Your Monitor’s Battery 83
11 Support, Guarantee & Limited Warranty 87
References 89
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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.
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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.
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CHAPTER 1
Important Things to Know about Your Precision Xtra Advanced Diabetes
Important
Information
Management System
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 ß-Ketone Test Strips.
Blood
Questions? Call Customer Care: 1-800-527-3339
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• 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.
Important
Information
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Precision Xtra
Kit Contents
Precision Xtra Monitor Precision Xtra User’s Guide
Important
– Contains system information
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
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Items not included: MediSense Control Solutions Blood ß-Ketone Test Strips
and Instructions for Use Data Management System
Important
Information
Display Window
Back Button
Mode
Strip
Button
Port
Display Check
Backlight Button
Forward Button
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.
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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").
Important
Information
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
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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.
Important
Information
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CHAPTER 2
Setting Up Your Precision Xtra Monitor
Buttons to Use
Setting Up
Your 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
Questions? Call Customer Care:
1-800-527-3339
Mode Button Forward Button Back Button
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.
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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.
Setting Up
Your Monitor
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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
Setting Up
note: "Press and Hold" means
Your Monitor
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.
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Beeper OFF
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To turn your monitor ON,
1
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.
To change the beeper setting,
2
Press and Release the button or the button once.
Press and Release the
3
button to save the beeper setting and to move to Set Time (Hour).
Setting Up
Your Monitor
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Set Time
Hour:
Setting Up
Your Monitor
1
2
The Hour flashes on and off.
Press and Release the button to move the hour forward.
If you go past the correct
hour, Press and Release the button to move the hour back.
Press and Release the
3
button to save the hour and to move to Set Minutes.
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Minutes:
The Minutes flash on and off.
Press and Release the
1
button to move the minutes forward.
If you go past the correct
2
minute, Press and Release the button to move the minutes back.
Setting Up
Your Monitor
Press and Release the
3
button to save the minutes and to move to Set Date.
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Set Date
Year:
Setting Up
Your Monitor
1
2
The Year flashes on and off.
Press and Release the button to move the year forward.
If you go past the correct
year, Press and Release the
button to move the
year back.
Press and Release the
3
button to save the year and to move to Set Month.
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Month:
The Month flashes on and off.
Press and Release the button to move the
1
month forward.
If you go past the correct
month, Press and Release
2
the button to move the month back.
Setting Up
Your Monitor
Press and Release the
button to save the month
3
and to move to Set Day.
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Day:
Setting Up
Your Monitor
1
2
The Day flashes on and off.
Press and Release the button to move the day forward.
If you go past the correct day, Press and Release the
button to move the
day back.
Press and Release the button to save the day
3
and to move to Set Time Format.
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Choice #1
Choice
#2
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.
To change the Time Format,
1
Press and Release the button or the button once.
Setting Up
Your Monitor
Press and Release the
2
button to save the Time Format and to move to Set Date Format.
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Set Date Format
You have two choices:
Choice #1: For the month-
day format, " the date.
Example: "May 25" shows as "5-25".
Setting Up
Your Monitor
Choice #2: For the day.month
format, " the date.
Example: "25 May" shows as "25.5".
To change the Date Format, Press and Release the
1
button or the button once.
Press and Release the
2
button to save the Date Format and to move to Measurement Units.
-" shows with
" shows with
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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.
Setting Up
Your Monitor
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Press and Hold the button to turn your monitor off.
Setting Up
You have successfully set
Your Monitor
up your monitor.
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Questions? Call
Questions? Call Customer Care:
Customer Care: 1-800-527-3339
1-800-527-3339
CHAPTER 3
Calibrating Your Precision Xtra Monitor
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.
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.
Calibrating
Your Monitor
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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:
Calibrating
Your Monitor
Blood ß-Ketone test strip Blood ß-Ketone test strip
instructions for use Blood ß-Ketone test
strip calibrator
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.
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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.
Remove the glucose or
1
ß-Ketone calibrator package from the new box of test strips.
Open the calibrator
2
package. Find the three raised bumps on the calibrator package. Peel the clear cover away from the three raised bumps.
Calibrating
Your Monitor
4. the the . it in until it stops.
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Hold the calibrator with the
3
LOT number (glucose) or calibration CODE (ß-Ketone) facing you.
Calibrating
Your Monitor
Insert the calibrator into the strip port. Push it in
4
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 number: LOT 13758
b. Example calibration CODE: CODE JC7
Then you hear the beeper, if the beeper is ON.
of glucose LOT
of ß-Ketone
Glucose
25
ß-Ketone
Page 29
Check that the LOT number
5
or calibration CODE on all these items matches:
Display windowTest strip calibrator Test strip instructions for useTest 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:
Calibrating
Your Monitor
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.
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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.
Calibrating
Your Monitor
Remove the calibrator from
the monitor and store it in
6
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.
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How to Recall the
LOT Number or Calibration CODE
To recall the glucose LOT
1
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.
After the glucose LOT
2
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.
Calibrating
Your Monitor
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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:
Calibrating
Your Monitor
•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.
Press and Hold the
button to turn your
3
monitor off.
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CHAPTER 4
L OT 13758
E X P 2006/03
C5
Questions? Call Customer Care: 1-800-527-3339
Example: Expiration date March 31, 2006
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
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.
Monitoring
Blood Glucose
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Do not use a wet, bent,
Do not use the test strip if its
•Before you monitor your
Monitoring
Blood Glucose
•Read the lancing
How to Monitor Your
Blood Glucose
Getting Started
scratched, or damaged test strip.
foil packet has a puncture or tear in it.
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.
device instructions for use.
Prepare your lancing device.
1
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Wash your hands using
warm soapy water and
2
dry them completely.
Remove the test strip from its
3
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.
Insert the three black lines at the end of the test strip into
4
the strip port.
Push the test strip in until
it stops.
5
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.)
Monitoring
Blood Glucose
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•Time, month, and day (if set) If date and time are not
set, dashes will show instead of numbers.
Monitoring
Blood Glucose
•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.
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Obtaining A Blood Drop
Use your lancing device to obtain a blood drop.
Fingertip sampling
Forearm sampling
Upper arm sampling
Base of thumb sampling
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, 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.
•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 test strip immediately.
Monitoring
Blood Glucose
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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.
Monitoring
Blood Glucose
Applying the Blood Drop to the Test Strip
Touch the blood drop to the
white area at the end of the
1
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.
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Countdown
Status bar
Continue to touch the blood
2
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.
Monitoring
Blood Glucose
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Important: If the countdown does not start:
Correct
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.
Monitoring
•If the countdown still does not
Blood Glucose
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:
3
•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.
Apply second drop
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Shutting Off Your Monitor
Removing the test strip from
1
the strip port turns off the monitor. You can use the opened foil packet to remove and discard your used test strip.
Discard the test
2
strip properly.
Monitoring
Blood Glucose
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.
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Understanding
Your Result
"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:
Monitoring
Blood Glucose
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.
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"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.
Monitoring
Blood Glucose
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"E-4" Result
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
Monitoring
window again, contact your
Blood Glucose
healthcare professional
immediately.
Important:
It is recommended that you repeat the blood glucose test with a new test strip when:
LO shows on the
•You obtain a low blood
•Your monitor displays a blood
display window.
glucose result, but you do not have symptoms of low blood glucose.
glucose result that is unusually low, lower than 50 mg/dL (2.8 mmol/L).
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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.
Monitoring
Blood Glucose
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CHAPTER 5
Monitoring Your Blood ß-Ketone
It is important to check your ketones when:
•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
ß-Ketone
Monitoring Blood
professional determine that it is necessary.
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
Questions? Call Customer Care: 1-800-527-3339
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ß-Ketone Test Strip
Abbott Laboratories Abbott Diabetes Care Alameda, CA 94502 USA
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
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.
Monitoring
Blood ß-Ketone
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•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 dangerous 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.
Monitoring
3. Do not eat, and avoid
Blood ß-Ketone
contact with eyes and skin. May cause burns to the mouth and throat.
4. If swallowed, drink two glasses of water. Seek medical help.
1
,
How to Monitor Your
Blood ß-Ketone
Getting Started
Prepare your lancing device.
1
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Wash your hands using
2
warm soapy water and dry them completely.
Remove the test strip from
3
its foil packet.
Insert the three black lines
4
at the end of the test strip into the strip port.
Push the test strip in until
5
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.)
Monitoring
Blood ß-Ketone
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•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.
Monitoring
Blood ß-Ketone
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.
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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.
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.
Monitoring
Blood ß-Ketone
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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
Monitoring
Blood ß-Ketone
Touch the blood drop to
1
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.
Continue to touch the
blood drop to the purple
2
area on the top of the test strip until the monitor begins the test. The monitor begins the test when:
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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.
Note: Do not remove the test strip from the monitor or disturb it during the countdown.
Important: If the countdown does not start:
Countdown
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
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Monitoring
Blood ß-Ketone
Page 54
3
•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
Monitoring
Blood ß-Ketone
1
At the end of
the countdown:
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.
Discard the test
strip properly.
2
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.
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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.
Monitoring
Blood ß-Ketone
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When:
•Blood ß-Ketone result
Monitoring
Blood ß-Ketone
"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.
remains high or becomes higher than 1.5 mmol/L:
What It Means:
You may be at risk of developing diabetic ketoacidosis (DKA).
3-7
What to Do:
Contact your healthcare professional immediately.
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.
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"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).
Monitoring
Blood ß-Ketone
Important: A result that is incorrect may have a serious medical outcome. Consult your healthcare professional before changing your diabetes medication program.
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CHAPTER 6
Doing A Control Solution Test
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
Testing
Control Solution
Control Solution
Test Recommended?
•When you question your results
•To make sure that your monitor and test strips are working properly
Questions? Call
Customer Care:
1-800-527-3339
Important Information about Control Solution Testing
•For more detailed information about control.
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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.
Control
Solution Testing
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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
Testing
Control Solution
Wash your hands using
1
warm soapy water and dry them completely.
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Remove the test strip from
2
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.
Insert the three black lines
3
at the end of the test strip into the strip port.
58
Control
Solution Testing
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Push the test strip in until
4
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.)
Testing
Control Solution
•Time, month, and day (if set) If date and time are not set,
dashes will show instead of numbers.
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•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.
To mark the test as a control
test, Press and Release the
5
button once. shows
on the display window.
Control
Control
Solution Testing
Solution Testing
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.
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Applying Control Solution to the Test Strip
Turn the control solution
1
bottle upside down three to four times to mix the solution.
Remove the cap.
2
Apply a drop of control
3
solution to the test strip in the area shown here. The control solution is drawn into the test strip.
Testing
Glucose
ß-Ketone
Control Solution
Continue to touch the
4
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.
Status
bar
Countdown
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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:
You 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. 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
5
the countdown:
•If the beeper is ON, listen for the beeper.
•The control result shows on the display window.
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Control
Solution Testing
Page 66
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.
Shutting Off Your Monitor
Removing the test strip from the strip port turns off the
1
monitor. You can use the
Testing
opened foil packet to
Control Solution
remove and discard your used test strip.
Discard the test
strip properly.
2
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.
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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:
Control
Solution Testing
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.
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CHAPTER 7
Reviewing & Using Your 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
Reviewing Results
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.)
Questions? Call
Customer Care:
1-800-527-3339
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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
1
turned off. Make sure there is nothing in the strip port.
66
Reviewing Results
Page 70
Press and Release the
2
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.)
A blood glucose result in Memory will show with the letters MEM.
Reviewing Results
Blood Glucose result
in Memory
A blood ß-Ketone result in Memory will show with the letters KET MEM.
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Blood ß-Ketone result
in Memory
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Glucose control
solution result
in Memory
A control solution result in Memory shows with a control bottle, as long as you marked the test as a control solution test.
ß-Ketone control
solution result
in Memory
To review previous results,
3
Press and Release the button once per result.
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Reviewing Results
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When you reach the
last result in Memory,
4
the display window shows three dashes.
To return to a result you
previously reviewed, Press
5
and Release the button once per result.
How to See Averages
Important:
Reviewing Results
•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.
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While in Memory, Press and
Release the button at any
1
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.
Press and Release the
2
button once to see the 14-Day average of your blood glucose results.
Press and Release the
3
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.
Reviewing Results
Press and Release the
4
button at any time to return to Memory.
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Press and Hold the
5
button to turn off your monitor. Otherwise, the monitor turns off after 30 seconds.
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 Software Version 2.5 and a Precision Link communications cable. For information on how to purchase the software and cable, contact Customer Care
Reviewing Results
at 1-800-527-3339. To install the software, please follow the instructions provided in the Precision Link User's Guide.
®
Direct
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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.
Message What It What You
Means Need to Do
Temperature 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. 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.
Error Messages
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What It What You Message
Means Need to Do
Monitor error.
There may be a problem with the test strip.
Error Messages
• Turn the monitor off, then repeat previous monitoring steps.
• If the error message appears again, contact Customer Care.
• Review the monitoring instructions.
• Monitor again with a new test strip.
• If the error message appears again, contact Customer Care.
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Message What It What You
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.
• If the error message appears again, contact your healthcare professional
immediately.
• Review the monitoring instructions.
• Monitor again with a new test strip.
• If the error message appears again, contact Customer Care.
Error Messages
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What It What You Message
Means Need to Do
Calibration/Test strip error.
Test strip error. Test strip is
damaged, used,
Error Messages
or the monitor does not recognize it.
• Repeat the calibration 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.
• If the error message appears again, contact Customer Care.
• Monitor again using a test strip designed for use with Precision Xtra.
• If the error message appears again, contact Customer Care.
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Message What It What You
Means Need to Do
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.
Error Messages
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CHAPTER 9
Your Monitor’s Specifications
Questions? Call Customer Care:
1-800-527-3339
& Limitations
Size
Length 2.94" (7.47 cm) Width
Top 2.10" (5.33 cm) Bottom 1.70" (4.32 cm)
Thickness 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
& Limitations
Specifications
Memory Up to 450 events including
control results, personal blood glucose and blood ß-Ketone results, and other monitor information.
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Storage Temperature
Monitor: –13° to 131ºF (–25º to 55ºC) Test 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.
Blood ß-Ketone See blood ß-Ketone test strip Assay Range instructions for use.
Control Solution See blood glucose or blood Range 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
& Limitations
Specifications
Page 82
Data port 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.
Relative Humidity: 10% to 90%, non-condensing
& Limitations
Specifications
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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.
& Limitations
Specifications
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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.
& Limitations
Specifications
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CHAPTER 10
Questions? Call Customer Care: 1-800-527-3339
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.
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Caring for
Your Monitor
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
Monitor
Monitor
you install a new battery.
Caring for Your
Caring for Your
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How to Replace Your Monitor’s Battery
Gently push the battery cover in and up with
1
your thumb.
Lift the battery cover out of
the monitor.
2
Pull on the plastic tab
sticking out of the monitor
3
to remove the old battery.
84
Caring for
Your Monitor
Page 88
Insert a new CR 2032
4
Lithium (coin cell) battery with the plus sign (+) facing up.
Place the notches on the battery cover
5
into the appropriate molded areas.
Gently push the battery cover in and down until
6
you hear a click.
Monitor
Caring for Your
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Press and Hold the button
7
to turn your monitor on. If your monitor does not turn on, review the battery installation steps and reinstall the battery.
Check the date and time on
8
your monitor. You may need to reset the date and time. (See Chapter 2, Setting Up Your System).
Be sure to discard the
9
old battery in compliance with your local government’s regulations.
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Caring for
Your Monitor
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CHAPTER 11
Support, Guarantee & Limited Warranty
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
Questions? Call
Customer Care:
1-800-527-3339
& Guarantee
Support, Repair,
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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.
Support,
Repair, & Guarantee
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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.
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
References
bicarbonate in the treatment of diabetic ketoacidosis. Br Med J 1984; 289; 1035–8.
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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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