Advanced Diabetes Management System PMS 286 User ... - D-Mom

For in vitro diagnostic use.

Advanced Diabetes Management System

User’s Guide

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Table of Contents

Welcome 11 Important Things to Know about

Your Precision Xtra Advanced DiabetesManagement System 3Intended Use 3How Your Precision Xtra Advanced Diabetes

Management System Works 4Precision Xtra Kit Contents 5Getting to Know Your Monitor’s Features 6

2 Setting Up Your Precision Xtra Monitor 9Buttons to Use 9Setup Options 9How to Set the Beeper, Date, Time, & View Measurement Units 11

Set Beeper 11Set Time 13Set Date 15Set Time Format 18Set Date Format 19

Blood Glucose Measurement Units 20

3 Calibrating Your Precision Xtra Monitor 22Why Calibrate Your Monitor? 22When to Calibrate Your Monitor 22What You Will Need 23How to Calibrate Your Monitor 23How to Recall the LOT Number or Calibration CODE 28

4 Monitoring Your Blood Glucose 30What You Will Need 30Important Information about Monitoring

Your Blood Glucose 30How to Monitor Your Blood Glucose 31Understanding Your Result 39

5 Monitoring Your Blood ß-Ketone 43What You Will Need 43Important Information about Monitoring

Your Blood ß-Ketone 44How to Monitor Your Blood ß-Ketone 45Understanding Your Result 52

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6 Doing A Control Solution Test 55Why Do A Control Solution Test? 55When Is Doing A Control Solution Test Recommended? 55Important Information about Control Solution Testing 55What You Will Need 57How to Do Control Solution Testing 57Understanding Your Result 64

7 Reviewing & Using Your Results 65What Can Your Monitor Show You? 65How to See Results in Memory 66How to See Averages 69Transferring Your Results to A Computer 71

8 Understanding & Troubleshooting Error Messages 72What An Error Message Means & 72

What You Need to Do

9 Your Monitor’s Specifications & Limitations 77Important Information about Using Blood 80

Samples from the Forearm, Upper Arm, or Base of the Thumb

10 Caring For Your Monitor 82Cleaning Your Monitor 82Replacing Your Monitor’s Battery 83

11 Support, Guarantee & Limited Warranty 87

References 89

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1

Welcome

Thank you for choosing the Precision Xtra™

Advanced Diabetes Management System.

Important steps for using the System are inside thisguide. Please read it carefully.

Your new Precision Xtra Advanced DiabetesManagement System is an important tool that canhelp you better manage your diabetes. The Systemmeasures both blood glucose (sugar) and blood ß-Ketone. Blood glucose and blood ß-Ketone resultscan help you understand your diabetes and whathappens with:

•Food

•Exercise

•Stress and illness

•Diabetes medications

Always monitor your blood glucose and blood ß-Ketone according to your healthcareprofessional’s recommendations.

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In the United States, call Customer Care at 1-800-527-3339 with any questions you may haveabout the Precision Xtra Advanced DiabetesManagement System. We are available 24 hours aday, 365 days a year. If you cannot reach CustomerCare, contact your healthcare professional.

Outside the United States, please contact your local Abbott Laboratories, Abbott Diabetes Careoffice or distributor.

Please read the following items before using your Precision Xtra Advanced DiabetesManagement 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 1Questions? CallCustomer Care:1-800-527-3339

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Intended Use

Your Precision Xtra System:

•Is indicated for home (lay user)or professional use in themanagement of Patients with diabetes.

•Is for use outside the body (in vitro diagnostic use).

•Is for monitoring glucose in fresh whole blood (forexample, from the fingertip).

•Is for monitoring ß-Ketone in fresh whole blood from the fingertip.

•Measures ß-hydroxybutyrate (ß-Ketone), the mostimportant of the three ketone bodies circulating inthe bloodstream.

•Is for use with Precision Xtra™

or Precision™ POC BloodGlucose Test Strips andPrecision Xtra™ Blood ß-Ketone Test Strips.

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• Precision Xtra™ and Precision™

POC Blood Glucose Test Stripsare different. Please refer toyour test strip instructions foruse for important informationabout sample types that maybe used with these test strips.

• Precision™ POC Blood GlucoseTest Strips are for use byhealthcare professionals only.

Potential Infection Risk:Healthcare professionals performingblood tests with this system onmultiple patients must always weargloves and should follow theinfection control policies andprocedures approved by their facility.

How Your Precision XtraAdvanced DiabetesManagement System WorksWhen you insert a test strip intoyour monitor, the Apply Bloodmessage shows on your monitor’sdisplay window. When a bloodsample or control solution sample isapplied to the test strip, the glucoseor ß-Ketone reacts with thechemicals on the test strip. This reaction produces a smallelectrical current that is measured. The result shows on your monitor’s display window.

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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 othermonitoring supplies.

Your kit may also contain:

Precision Xtra Quick Reference Guide– Gives the basic steps to calibrateyour monitor and check yourblood glucose.

Logbook– Use this to record your testresults, activities, and medications.

Precision Friends for Life Card– Please fill this out and return tothe address provided to activateyour warranty. Filling out this cardhelps to ensure that you receiveany updates regarding yourPrecision Xtra monitor.

Lancing Device, Lancets,Instructions for Use and Other Information

Blood Glucose Test Strips and Instructions for Use

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Display Check

Back Button

BacklightButton

StripPort

ModeButton

Forward Button

DisplayWindow ▼

Items not included:

MediSense Control Solutions

Blood ß-Ketone Test Strips and Instructions for Use

Data Management System

Getting to Know YourMonitor’s Features

Display Window

This shows:

•Blood glucose and bloodß-Ketone results

•Glucose LOT numbers and ß-Ketone calibration CODEs

•Previous test results and error messages

•Blood glucose averages

IMPORTANT: Each time you turn yourmonitor on, a full display shows.This is called a Display Check.Look at the Display Check eachtime it appears on yourmonitor’s display window,especially before you check your blood glucose or blood ß-Ketone. The Display Checkshows on the display window briefly.

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Do not use the monitor if themonitor Display Check does not exactly match the picturehere (for example, if you see a "3" instead of an "8"). The monitor may show anincorrect 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 turnon, check that your battery isinstalled properly.

•For new battery installation,see Chapter 10.

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Setting Up Your Precision Xtra Monitor

Buttons to Use Mode Button

Forward Button

Back Button

Setup Options

Set Beeper

If the beeper is set ON, it willbeep when:

•The calibrator is fully inserted

•The test countdown starts

•The test countdown finishes

Set Time, Set Date

Important: Set the correct time and date before you use the monitor for the first time.This will help you keep records of when you monitor and willhelp you and your healthcareprofessional make informeddecisions about your care. You must set the time anddate to review averages.

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You may need to re-set thetime and date:

•After you replace the battery.

•When you travel betweentime zones or when the timezone you are in changes.

In "Set Date", you set the year,month, and day.

Set Time Format

In "Set Time Format", youchoose how the time shows onthe monitor’s display window.

Set Date Format

In "Set Date Format", youchoose how the month andday show on the monitor’sdisplay window.

Measurement Units

Blood glucose measurementunits are factory-set in mg/dL or mmol/L.

Blood ß-Ketone measurementunits are in mmol/L only.

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How to Set the Beeper,Date, Time, & ViewMeasurement Units To begin, pull the battery tabout. Your monitor should beturned OFF.

Before you start, pleasenote: "Press and Hold" meansthat you press the button in forat least 2 seconds. "Press andRelease" means that you pressthe button and let it go quickly.

Press and Hold the buttonto turn the monitor off andsave your settings at any time.The monitor automatically turnsoff after 30 seconds of no action.

If you like the setting that yousee on your monitor and donot want to change it, Pressand Release the button tomove to the next setup option.

Set Beeper

The means the beeper is ON.

The means the beeper is OFF.

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Beeper ON

Beeper OFF

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1To turn your monitor ON,Press and Hold the button.

The beeper ON messageshows on the display window. The musical notes flash on and off, and the monitor beeps.

2To change the beeper setting,Press and Release the button or the buttononce.

3Press and Release the button to save the beepersetting and to move to SetTime (Hour).

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Set Time

Hour:

The Hour flashes on and off.

1Press and Release the button to move the hour forward.

2If you go past the correcthour, Press and Release the button to move the hour back.

3Press and Release the button to save the hour and to move to Set Minutes.

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Minutes:

The Minutes flash on and off.

1Press and Release thebutton to move the minutes forward.

2If you go past the correctminute, Press and Releasethe button to move theminutes back.

3Press and Release thebutton to save the minutesand to move to Set Date.

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Set Date

Year:

The Year flashes on and off.

1Press and Release the button to move the year forward.

2If you go past the correctyear, Press and Release the

button to move the year back.

3Press and Release thebutton to save the year and to move to Set Month.

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Month:

The Month flashes on and off.

1Press and Release the button to move the month forward.

2If you go past the correctmonth, Press and Releasethe button to move themonth back.

3Press and Release the button to save the monthand to move to Set Day.

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Day:

The Day flashes on and off.

1Press and Release the button to move theday forward.

2If you go past the correctday, Press and Release the

button to move the day back.

3Press and Release thebutton to save the day 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-hourformat, AM or PM shows.

Choice #2: For the 24-hourformat, AM or PM does not show.

1To change the Time Format,Press and Release the button or the buttononce.

2Press and Release thebutton to save the TimeFormat and to move to SetDate Format.

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Set Date Format

You have two choices:

Choice #1: For the month-day format, "-" shows withthe date.

Example:

"May 25" shows as "5-25".

Choice #2: For the day.monthformat, "•" shows with the date.

Example:

"25 May" shows as "25.5".

1To change the Date Format,Press and Release the button or the button once.

2Press and Release the button to save the DateFormat and to move to Measurement Units.

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Blood Glucose Measurement Units

Consult your healthcareprofessional if you have any questions about blood glucose measurement units.

This screen shows the bloodglucose measurement units(mg/dL or mmol/L).

Press and release the buttonto return to Set Beeper.

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Press and Hold thebutton to turn your monitor off.

You have successfully setup your monitor.

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Questions? CallCustomer Care:1-800-527-3339


Calibrating YourPrecision 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 forthe first time.

• EACH time you open and use anew box of blood glucose orblood ß-Ketone test strips.

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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:

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 forthe first time, the displaywindow shows:

This means the monitor is notcalibrated for blood glucose monitoring.

This means the monitor is notcalibrated for blood ß-Ketone monitoring.

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IMPORTANT: •Use only the calibrator that ispackaged in the box of teststrips you are using.

•Do not use test strips thathave expired. Check theexpiration date on the teststrip foil packet and test stripbox. If only the year andmonth are shown, theexpiration date is the last day of the month.

1Remove the glucose or ß-Ketone calibrator packagefrom the new box of test strips.

2Open the calibratorpackage. Find the threeraised bumps on thecalibrator package. Peel theclear cover away from thethree raised bumps.

4. the the . it in until it stops.

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3Hold the calibrator with theLOT number (glucose) orcalibration CODE (ß-Ketone) facing you.

4Insert the calibrator into the strip port. Push it in until it stops.

The Display Check shows on the display window,followed by the time,month, and day.

Next, the LOT number(glucose) or calibrationCODE (ß-Ketone) shows on the display window.

a. Example of glucose LOTnumber: LOT 13758

b. Example of ß-Ketonecalibration CODE: CODE JC7

Then you hear the beeper, ifthe beeper is ON.

Glucose

ß-Ketone

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5Check that the LOT numberor calibration CODE on allthese items matches:

✓ Display window

✓ Test strip calibrator

✓ Test strip instructions for use

✓ Test strip foil packet

When the LOT number orcalibration CODE on allthese 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 orcalibration CODE on all theseitems DOES NOT match:

What It Means:

Your monitor may not becalibrated for the box of teststrips you are using.

What to Do:

•Check that you are using thecalibrator that came in the boxof test strips you are using.

•Try to calibrate again.

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rIMPORTANT: If the LOTnumber or calibration CODEstill does not match, contactCustomer Care. Do notattempt to monitor your bloodglucose or blood ß-Ketone.Your monitor may show anincorrect result.

6Remove the calibrator fromthe monitor and store it inyour monitor’s carrying case.

IMPORTANT: Do not throwthe calibrator away until youhave used all of the test stripsin the box.

If you have any troublecalibrating your system, pleasecontact Customer Care.

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How to Recall the LOT Number orCalibration CODE

1To recall the glucose LOTnumber, Press and Hold the

button. While holding thebutton, Press and Hold

the button.

The Display Check shows onthe display window, then theglucose LOT number showswith the time, month, and day of the most recent glucose calibration.

2After the glucose LOTnumber is displayed, youcan recall the ß-Ketonecalibration CODE. Press andRelease the button orthe button.

The ß-Ketone calibration CODEshows with the time, month,and day of the most recent ß-Ketone calibration.

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rNote: If the LOT number orcalibration CODE that showson your monitor’s displaywindow is not correct:

What It Means:

Your monitor may not becalibrated for the box of teststrips you are using.

What To Do:

•Re-calibrate your monitor.

•Check that you are using the calibrator that came in the box of test strips you are using.

Remember, impropercalibration will causeincorrect results.

3Press and Hold the button to turn your monitor off.

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L O T 13758

E X P 2006/03

C5

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Example:

Expiration date

March 31, 2006

Monitoring Your Blood Glucose

What You Will Need •Blood glucose test strip withits instructions for use

•Precision Xtra monitorcalibrated to match the LOTnumber of the blood glucosetest strip you are using

•Lancing device and a new,sterile lancet

Important Informationabout Monitoring YourBlood Glucose•Do not use out-of-date teststrips. Check the expirationdate printed on the test stripbox and on each test strip foilpacket. If only the month andyear are printed on the teststrip, then the expiration dateis the last day of that month.

•For more detailed informationabout your test strip, pleaseread its instructions for usebefore monitoring.

•Use the test stripimmediately when you take it out of its foil packet.

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•Do not use a wet, bent,scratched, or damaged test strip.

•Do not use the test strip if itsfoil packet has a puncture ortear in it.

•Before you monitor yourblood glucose or blood ß-Ketone, allow your monitorand test strip to reach therecommended operatingrange of the test strip. Thetest strip operating range is inthe “Limitations of Procedure”section of your blood glucosetest strip instructions for use.

•Read the lancing device instructions for use.

How to Monitor YourBlood Glucose

Getting Started

1Prepare your lancing device.

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2Wash your hands using warm soapy water and dry them completely.

3Remove the test strip from itsfoil packet.

Note: For pictures that showhow to open the blood glucose test strip foil packet,please see the information card in the box of bloodglucose test strips.

4Insert the three black lines atthe end of the test strip intothe strip port.

5Push the test strip in until it stops.

The monitor turns on automatically.

These items show on the displaywindow, one after the other:

•Display Check – Remember tomake sure that all items in thepicture here show on the displaywindow. (See Chapter 1 for more information about theDisplay Check.)

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•Time, month, and day (if set)

If date and time are not set, dashes will show insteadof numbers.

•LOT number for the box ofblood glucose test strips you are using.

•Apply Blood message, whichtells you that the monitor isready for you to apply bloodto the blood glucose test strip.

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Obtaining A Blood Drop

Use your lancing device toobtain a blood drop.

Recommendations forObtaining a Blood Drop•To obtain a sample from analternative site (forearm, upperarm, or base of the thumb),use an appropriate alternativesite lancing device.

•Before you obtain a bloodsample from the fingertip,forearm, upper arm, or baseof the thumb, make sure thesample site is clean, dry, andwarm. To warm the samplesite, wash it in warm water,rub the skin vigorously for afew seconds, or apply a warmpad to it.

•Hang your arm down beforepricking your finger or thebase of the thumb to helpblood flow.

•To obtain a blood sample fromthe arm, use a fleshy areaaway from bone. Avoid areaswhere there is a lot of hair.

•Avoid squeezing the puncture site.

•Apply the blood sample to thetest strip immediately.

Fingertip sampling

Upper arm sampling

Forearm sampling

Base of thumb sampling

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Lancets and Lancing Device

•Lancets are for one-time useonly. Use a new lancet eachtime you monitor.

•Discard your used lancetproperly. Put it in an emptypuncture-resistant container,such as a plastic milk carton ordetergent bottle.

•Never share your lancingdevice or lancet with another person.

Applying the Blood Drop tothe Test Strip

1Touch the blood drop to thewhite area at the end of thetest strip. The blood isdrawn into the test strip.

Note: If the monitor shuts offbefore you apply blood to thetest strip, remove the test stripfrom the monitor and try again.

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Status bar

Countdown

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2Continue to touch the blooddrop to the end of the teststrip until the monitorbegins the test. The monitorbegins the test when:

•You hear the beeper, if thebeeper is ON.

•The display window showsthe status bar.

•Then the display windowshows the countdown.

Note: Do not remove the teststrip from the monitor ordisturb the test strip during the countdown.

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Correct

Apply second drop

✔Important: If the countdowndoes not start:

What It Means:

You might not have appliedenough blood to the test strip.

What to Do:

•Apply a second drop of bloodto the test strip. Refer to yourtest strip instructions for usefor the number of seconds youhave to apply a second drop.

•If the countdown still does notstart, or if the number ofseconds you have to apply asecond drop have passed,discard the test strip, turn offyour monitor, and try againwith a new test strip.

3At the end of thecountdown:

•If the beeper is ON, listen forthe beeper.

•The blood glucose resultshows on the display window.

•The result is stored in yourmonitor’s memory. You may also write the result in your logbook.

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Shutting Off Your Monitor

1Removing the test strip fromthe strip port turns off themonitor. You can use theopened foil packet toremove and discard yourused test strip.

2Discard the test strip properly.

Note: You may also turn themonitor off by Pressing andHolding the button. If youdo not turn your monitor off orpull the test strip out, themonitor shuts off automaticallyafter 60 seconds.

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▼Understanding Your Result

"LO" Result

What It Means:

Your monitor has determinedthat your blood glucose result is lower than 20 mg/dL (1.1mmol/L) or there may be aproblem with the test strip.

What to Do:

Monitor your blood glucoseagain with a new test strip. IfLO shows on the displaywindow again, contact yourhealthcare professionalimmediately.

Result 300 mg/dL or Higher

When your blood glucose resultis 300 mg/dL (16.7 mmol/L) orhigher, KETONES? flashes onand off on the display window.

What to Do:

If you check your ketones as part of your diabetesmanagement program, it is recommended that you check your blood ß-Ketone.

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"HI" Result

What It Means:

Your monitor has determinedthat 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 glucoseagain with a new test strip. IfHI shows on the displaywindow again, contact yourhealthcare professionalimmediately.

If you check your ketones as part of your diabetesmanagement program, it is recommended that youcheck your blood ß-Ketone.

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"E-4" Result

What It Means:

Your blood glucose may be toohigh to be read by the system,or there may be a problem withthe test strip.

What to Do:

Monitor your blood glucoseagain with a new test strip. If E-4 shows on the displaywindow again, contact yourhealthcare professionalimmediately.

Important:It is recommended that yourepeat the blood glucose testwith a new test strip when:

•LO shows on the display window.

•You obtain a low bloodglucose result, but you do not have symptoms of lowblood glucose.

•Your monitor displays a bloodglucose result that is unusuallylow, lower than 50 mg/dL (2.8 mmol/L).

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•HI shows on the display window.

•You obtain a high bloodglucose result, but you do not have symptoms of highblood 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 mayhave a serious medicaloutcome. Consult yourhealthcare professional beforechanging your diabetesmedication program.

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Monitoring Your Blood ß-Ketone

It is important to check yourketones when:

•You have an illness.

•Your blood glucose is higher than 300 mg/dL (16.7 mmol/L).

•You are experiencing unusualblood glucose results.

•You and your healthcareprofessional determine that itis necessary.

What You Will Need

•Blood ß-Ketone test strip withits instructions for use

•Precision Xtra monitorcalibrated to match thecalibration CODE of the blood ß-Ketone test strip youare using

•Lancing device and a new,sterile lancet

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Made in UK. P/N 120-1025Rev. 0 1/03

ß-Ketone Test StripAbbott LaboratoriesAbbott Diabetes CareAlameda, CA 94502 USA

70208 2006/03/09 . JC7 0.3-0.7 mmol/l 1.9-2.9 mmol/l 3.7-5.7 mmol/l

Example:

Expiration date

March 9, 2006

Important Informationabout Monitoring YourBlood ß-Ketone•For more detailed informationabout your blood ß-Ketone teststrip, please refer to itsinstructions for use before monitoring.

•Do not use out-of-date teststrips. Check the expiration dateprinted on the test strip box andon each test strip foil packet.

•Do not put urine on the blood ß-Ketone test strip.

•Use the test strip immediatelywhen 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 itsfoil packet has a puncture ortear in it.

•Use each test strip only once.

•Before you monitor your bloodglucose or blood ß-Ketone, allowyour monitor and test strip toreach the recommendedoperating range of the test strip.The test strip operating range isin the “Limitations of Procedure”section of your blood ß-Ketonetest strip instructions for use.

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▼•Read the lancing deviceinstructions for use.

•The blood ß-Ketone test stripfoil packet contains adesiccant tablet (Zeolite -Sodium CalciumAluminosilicate). Although this material is not considered dangerous1, the following safety adviceshould be observed:

1. Keep away from children.

2. Do not expose to water asproduct gets hot and couldcause burns.

3. Do not eat, and avoidcontact with eyes and skin.May cause burns to themouth and throat.

4. If swallowed, drink twoglasses of water. Seek medical help.

How to Monitor YourBlood ß-Ketone

Getting Started

1Prepare your lancing device.

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2Wash your hands usingwarm soapy water and drythem completely.

3Remove the test strip fromits foil packet.

4Insert the three black lines at the end of the test stripinto the strip port.




•Display Check – Remember tomake sure that all items in thepicture here show on thedisplay window. (See Chapter1 for more information aboutthe Display Check.)

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If date and time are not set,dashes will show instead of numbers.

•Calibration CODE for the box of blood ß-Ketone teststrips you are using.

•KETONE and Apply Bloodmessage, which tell you thatthe monitor is ready for you toapply blood to the blood ß-Ketone test strip.

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48

Fingertip sampling

Obtaining A Blood Drop

Use your lancing device toobtain a blood drop.

Important: Blood ß-Ketonetest strips have not beenevaluated for alternative sitemonitoring. Use onlyfingertip blood samples forblood ß-Ketone monitoring.

Recommendations forObtaining A Blood Drop

•Before you obtain a bloodsample from the fingertip,make sure the sample site isclean, dry, and warm. Towarm the sample site, wash itin warm water or rub the skinvigorously for a few seconds.

•Hang your arm down beforepricking your fingertip to helpblood flow.

•Avoid squeezing the fingertip.

•Apply the blood sample to thetest strip immediately.

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Lancets and Lancing Device

•Lancets are for one-time useonly. Use a new lancet eachtime you monitor.

•Discard your used lancetproperly. Put it in an emptypuncture-resistant container,such as a plastic milk carton ordetergent bottle.

•Never share your lancingdevice or lancet with another person.

Applying the Blood Drop tothe Test Strip

1Touch the blood drop to the purple area on the topof the test strip. The blood is drawn into the test strip.

Note: If the monitor shuts offbefore you apply blood to thetest strip, remove the test stripfrom the monitor and try again.

2Continue to touch the blood drop to the purplearea on the top of the teststrip until the monitorbegins the test. The monitorbegins the test when:

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Status bar

Countdown

50


•The display window shows thestatus bar.


Note: Do not remove the test strip from the monitor or disturb it during the countdown.

Important: If the countdowndoes not start:

What It Means:

You might not have appliedenough blood to the test strip.

What to Do:

•Apply a second drop of bloodto the test strip. Refer to yourtest strip instructions for usefor the number of secondsyou have to apply a seconddrop.

•If the countdown still does not start, or if the number ofseconds you have to apply asecond drop have passed,discard the test strip, turn offyour monitor, and try againwith a new test strip

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3At the end of the countdown:


•The blood ß-Ketone resultshows on the display windowwith the word KETONE.

•The result is stored in yourmonitor’s memory as a blood ß-Ketone result. You may also write the result in your logbook.




Note: You may also turn themonitor off by Pressing andHolding the button. If youdo not turn your monitor off orpull the test strip out, the monitor shuts off automaticallyafter 60 seconds.

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▼Understanding Your ResultBlood ß-Ketone is expected tobe lower than 0.6 mmol/L.3

Blood ß-Ketone may be higherwhen a person is ill, is fasting,exercises vigorously, or if blood glucose levels are not controlled.2-4

When:•Blood ß-Ketone result isbetween 0.6 and 1.5 mmol/Land blood glucose result is300 mg/dL (16.7 mmol/L) or higher:

What It Means:

A problem requiring medicalassistance may be occurring.

What to Do:

Contact your healthcareprofessional. Follow his or her instructions for sick day management.

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When:•Blood ß-Ketone result remains high or becomeshigher than 1.5 mmol/L:

What It Means:

You may be at risk ofdeveloping diabeticketoacidosis (DKA).3-7

What to Do:

Contact your healthcareprofessional immediately.

"HI" Result

What It Means:

Your monitor has determinedthat your blood ß-Ketoneresult is higher than 6.0mmol/L, or there may be aproblem with the test strip.

What to Do:

Monitor your blood ß-Ketoneagain with a new test strip. IfHI shows on the displaywindow again, contact yourhealthcare professionalimmediately.

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"E-4" Result

What It Means:

There may be a problem withthe test strip.

What to Do:

Monitor your blood ß-Ketoneagain with a new test strip. If E-4 shows on the displaywindow again, contact yourhealthcare professionalimmediately.

Important: It is recommendedthat you repeat the blood ß-Ketone test with a new teststrip when:

•HI appears in the display window.

•Your result is unusually high.

•You question your result.

•You obtain a 0.0 mmol/Lblood ß-Ketone result BUTyour blood glucose is higherthan 300 mg/dL (16.7 mmol/L).

Important: A result that isincorrect may have a seriousmedical outcome. Consult yourhealthcare professional beforechanging your diabetesmedication program.

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Doing A ControlSolution Test

Why Do A ControlSolution Test?The control solution test tellsyou that your monitor and teststrips are working correctly. Acontrol solution test is similar towhen you monitor your bloodglucose or blood ß-Ketone,except you use a MediSenseControl Solution. You do notuse a drop of blood in acontrol solution test.

When Is Doing A Control Solution Test Recommended?•When you question your results

•To make sure that your monitor and test strips areworking properly

Important Informationabout Control Solution Testing•For more detailed informationabout control.

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solutions, read the controlsolution instructions for use.

•MediSense Control Solutions may be used forglucose or ketone controlsolution testing.

•Do not use the controlsolution if the expiration datehas passed. Check theexpiration date printed on thecontrol solution bottle.

•When you open a controlsolution bottle for the firsttime, count forward 90 daysand write this date on thecontrol solution bottle using a pen that won’t smear orwipe off. Throw away anyremaining solution after this date.

•The results obtained fromcontrol testing do not reflectyour personal blood glucoseor blood ß-Ketone levels inany way.

•Do not swallow the control solution.

•Do not inject the controlsolution or use the controlsolution as eye drops.

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What You Will Need •Precision Xtra monitorcalibrated to match the LOTnumber (glucose) orcalibration CODE (ß-Ketone)of the test strip you are using

•Blood glucose or blood ß-Ketone test strip and itsinstructions for use

•MediSense Control Solutionsand instructions for use

How to Do ControlSolution Testing

Getting Started

1Wash your hands usingwarm soapy water and drythem completely.

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2Remove the test strip fromits foil packet.

Note: For pictures thatshow how to open theblood glucose test strip foilpacket, please see theinformation card in the boxof blood glucose test strips.

3Insert the three black lines at the end of the test stripinto the strip port.

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•Display Check – Remember tomake sure that all items in thepicture here show on thedisplay window. (See Chapter 1for more information about theDisplay Check.)


If date and time are not set,dashes will show instead of numbers.

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•LOT number (glucose) orcalibration CODE (ß-Ketone)for the box of test strips youare using.

•Apply Blood message, whichtells you that the monitor isready for you to apply controlsolution to the test strip.

Note: If you are a doing a ß-Ketone control solution test, KETONE will show on the monitor’s display windowwith the ß-Ketone Apply Blood message.

5To mark the test as a controltest, Press and Release the

button once. showson the display window.

Important: If you do not markthe test as a control test, it will besaved in your monitor’s memoryas one of your personal bloodglucose or blood ß-Ketone results.This could affect your bloodglucose averages.

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Applying Control Solution tothe Test Strip

1Turn the control solutionbottle upside down three to four times to mix the solution.

2Remove the cap.

3Apply a drop of controlsolution to the test strip inthe area shown here. Thecontrol solution is drawninto the test strip.

4Continue to touch thecontrol solution to the teststrip until the monitorbegins the test.

The monitor begins the test when:


•The display window showsthe status bar.


Glucose

ß-Ketone

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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 countdowndoes not start:

What It Means:

You might not have appliedenough control solution to thetest strip.

What to Do:

•Apply a second drop ofcontrol solution to the teststrip. Refer to your test stripinstructions for use for thenumber of seconds you haveto apply a second drop.

•If the countdown still does not start, or if the number ofseconds you have to apply asecond drop have passed,discard the test strip, turn offyour monitor, and try againwith a new test strip.

5At the end of the countdown:


•The control result shows onthe display window.

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Note: If you are doing a ß-Ketone control solution test,KETONE will also show withthe result.

•The result is stored in yourmonitor’s memory as a controlresult. In your logbook, recordthe result as a control result.




Note: You may also turn themonitor off by Pressing andHolding the button. If youdo not turn your monitor off orpull the test strip out, themonitor shuts off automaticallyafter 60 seconds.

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▼ Understanding Your ResultCompare the control result tothe "Expected Results for Usewith MediSense ControlSolutions" range printed on:

•The blood glucose test strip instructions for use, for glucose control solution testing.

•The blood ß-Ketone test stripinstructions for use and foilpacket, for ß-Ketone controlsolution testing.

If the control result fallswithin the range: What It Means:

Your monitor and test strips areworking correctly.

If the control result doesnot fall within the range:

What It Means: Your monitor and test stripsmay not be working correctly.

What to Do: Repeat the test with a new teststrip and ensure the controlsolution testing instructions arefollowed completely. If the resultis still not within the printedrange, contact Customer Care.

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CHAPTER 7

Reviewing & UsingYour Results

What Can Your MonitorShow You?

Memory

Your Precision Xtra monitor has a memory that stores up to 450 events. This is acombination of control results,your personal blood glucoseand blood ß-Ketone results,and other monitor information.

You can review up to 450 ofyour most recent events onyour monitor’s display window.

Glucose Averages

You can view the average of allyour blood glucose results fromthe last 7, 14, or 30 days. If youmarked your control solutiontests, the averages do notinclude control solution results.(For more information onmarking control solution tests,see Chapter 6.)


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▼

Important:

•To review blood glucoseaverages, you must set the date and time before monitoring.

•If you do not mark controlsolution tests, this may affectyour glucose averages.

•Blood glucose averages donot include blood ß-Ketoneresults, glucose control results,ß-Ketone control results, orresults that do not show thetime, month, and day.

•When there are no previousresults or blood glucoseaverages to review, the displaywindow shows three dashes.

How to See Results in Memory

1Begin with your monitorturned off. Make sure there is nothing in the strip port.

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2Press and Release the button.

•The Display Check shows onthe display window.

•Then your most recent resultshows with its units on themonitor’s display window,along with the time, month,and day that you got theresult. (To set the correct dateand time, follow the steps inChapter 2.)

A blood glucose result inMemory will show with theletters MEM.

A blood ß-Ketone result inMemory will show with theletters KET MEM.

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A control solution result inMemory shows with acontrol bottle, as long asyou marked the test as acontrol solution test.

3To review previous results,Press and Release the button once per result.

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4When you reach the last result in Memory, the display window shows three dashes.

5To return to a result youpreviously reviewed, Pressand Release the buttononce per result.

How to See Averages

Important:•Results that show as LOduring blood glucosemonitoring are included as 20 mg/dL (1.1 mmol/L) inblood glucose averages.

•Results that show as HIduring blood glucosemonitoring are included as500 mg/dL (27.8 mmol/L) inblood glucose averages.

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1While in Memory, Press andRelease the button at anytime to see the 7-Dayaverage of your bloodglucose results.

Note: n means how many testswere performed within the 7-,14-, or 30-Day average period.

2Press and Release the button once to see the 14-Day average of yourblood glucose results.

3Press and Release the button again to see the 30-Day average of yourblood glucose results. If you Press and Release the button again, thedisplay window shows the7-Day average.

4Press and Release thebutton at any time to returnto Memory.

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5Press and Hold thebutton to turn off yourmonitor. Otherwise, themonitor turns off after 30 seconds.

Transferring Your Resultsto a Computer The results in your PrecisionXtra monitor's memory, alongwith the time and date of thereading, can be transferred to a computer with the use of the Precision Link® DirectSoftware Version 2.5 and aPrecision Link communicationscable. For information on howto purchase the software andcable, contact Customer Careat 1-800-527-3339. To installthe software, please follow the instructions provided in the Precision Link User's Guide.

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CHAPTER 8

Temperature istoo hot or toocold for thesystem to workproperly.

• Move yourmonitor and teststrips to a locationwhere thetemperature isappropriate andmonitor againwith a new teststrip. You mayhave to wait for your monitor to adjust to the newtemperature.Refer to your teststrip instructionsfor use for theappropriateoperating range.

• If the errormessage appearsagain, contactCustomer Care.

Message What It What You Means Need to Do


Understanding &Troubleshooting Error MessagesThere are times when errormessages may show on yourmonitor’s display window.

In the next few pages, wedescribe the error messages thatmay show on your monitor’sdisplay window, what theymean, and what you need to do.

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What It What You MessageMeans Need to Do

Monitor error.

There may be a problem withthe test strip.

• Turn themonitor off,then repeatpreviousmonitoringsteps.

• If the errormessageappears again,contactCustomer Care.

• Review themonitoringinstructions.

• Monitor againwith a new test strip.


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Message What It What YouMeans Need to Do

Blood glucoseresult may betoo high to beread by thesystem.

OR

There may be aproblem withthe bloodglucose orblood ß-Ketonetest strip.

Blood appliedto test strip too soon.

• Monitor againwith a newtest strip.

• If the errormessageappears again,contact yourhealthcareprofessionalimmediately.

• Review themonitoringinstructions.

• Monitor again with a new test strip.


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What It What You MessageMeans Need to Do

Calibration/Teststrip error.

Test strip error.

Test strip isdamaged, used,or the monitordoes notrecognize it.

• Repeat thecalibrationusing thecalibrator barthat came withthe test stripyou are using.

• Check the datesetting on yourmonitor.

• Check theexpiration dateon the teststrip foilpacket.


• Monitor againusing a teststrip designedfor use withPrecision Xtra.


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Monitor error.

Monitor error.

• Remove teststrip, turnmonitor off, and try tomonitor again.


• Remove teststrip, turnmonitor off, and try tomonitor again.

• If the errormessageappears again, contactCustomer Care.

Message What It What You Means Need to Do

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CHAPTER 9

Your Monitor’sSpecifications & 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

Memory Up to 450 events including control results, personal blood glucose and blood ß-Ketone results, and othermonitor 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 OFF30 seconds after result isdisplayed. If OFF – Stays OFFduring countdown; stays OFFduring data upload.

- Beeper: If ON – Beeps whencalibrator is fully inserted and when countdown startsand finishes.

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Monitor Operating RangeTemperature: 50º to 122ºF (10º to 50ºC)

Relative Humidity: 10% to 90%, non-condensing

System Operating RangeTemperature: 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

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80

▼ Important Informationabout Using BloodSamples from the Forearm, Upper Arm, orBase of the Thumb:•Contact your healthcare professional before you beginusing any one of these alternative sites to test yourblood glucose.

•Sampling from any one ofthese alternative sites maycause minor bruising and mayleave marks that go away in ashort time.

•There may be times whenalternative site results are different from fingertip results.This happens when blood glucose levels change rapidly(for example, after you eat ameal, after you take insulin, orduring or after exercise).

•Use alternative sites to monitor your blood glucosebefore, or more than twohours after, you eat a meal,take insulin, or exercise.

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•Do not use blood samplesfrom alternative sites when:

1.You think your blood glucose is low or ischanging rapidly,

2.You have been diagnosed with hypoglycemic unawareness,

3.The results from alternative sites do notmatch the way you feel,

4.It is within two hours of eating a meal, takinginsulin, or exercising, or

5.You monitor your bloodß-Ketone.

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CHAPTER 10

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Caring For Your Monitor

Cleaning Your MonitorStore your monitor in its carrying case.

If the surface of your monitorgets dirty, you may clean it. Usea damp cloth and mild soap.

Healthcare professionals:Acceptable cleaning solutionsinclude 10% Bleach, 70%Alcohol, or 10% Ammonia.

Important:Do not try to clean the strip port.

Do not pour liquid into thestrip port or buttons.

Do not place your monitor inwater or any other bath.

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rReplacing Your Monitor’s BatteryWhen your monitor needs itsbatteries replaced, the displaywindow shows one of two things:

This means the battery islow. You may still use yourmonitor and the results will beaccurate. However, thebacklight is not useable. It isrecommended that you replacethe battery at this time.

This means the battery must be replaced. Themonitor is not useable. Themonitor turns off automatically.

Important:

Do not remove the old batteryuntil you have a new battery toinstall. It may be necessary toreset the time and date onceyou install a new battery.

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How to Replace Your Monitor’s Battery

1Gently push the batterycover in and up with your thumb.

2Lift the battery cover out ofthe monitor.

3Pull on the plastic tabsticking out of the monitorto remove the old battery.

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4Insert a new CR 2032Lithium (coin cell) batterywith the plus sign (+) facing up.

5Place the notches on the battery cover into the appropriate molded areas.

6Gently push the batterycover in and down until you hear a click.

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7Press and Hold the buttonto turn your monitor on. Ifyour monitor does not turnon, review the batteryinstallation steps and reinstallthe battery.

8Check the date and time onyour monitor. You may needto reset the date and time.(See Chapter 2, Setting UpYour System).

9Be sure to discard the old battery in compliance with your local government’s regulations.

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Support, Guarantee &Limited Warranty

SupportAbbott Laboratories, AbbottDiabetes Care, is committed toproviding you with support.Call us with any questions youmay have about your PrecisionXtra monitor: 1-800-527-3339.

Outside the United States,please contact your localAbbott Laboratories, AbbottDiabetes Care office or distributor.

You can view interactiveproduct demonstrations onlineat: AbbottDiabetesCare.com

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Guarantee & Limited WarrantyPrecision 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, pleasecontact your local authorized Abbott distributor for informationabout possible guarantee and/or warranty coverage for your purchase.90-day Guarantee: Abbott offers consumer purchasers a 90-daymoney back guarantee. If you are not fully satisfied with yourMonitor, call Customer Care at 1-800-300-0978 (toll free) for a fullrefund. Refund will be limited to amount paid by consumer net ofany rebates. You must have a copy of the dated itemized purchasereceipt and the original packaging to obtain this refund.Limited Warranty: Under the standard warranty your newMonitor is covered for a period of four years from the original dateof purchase, as long as it has not been modified, altered, ormisused. Lifetime Warranty is a benefit of enrollment in thePrecision Friends for Life Program and choice of replacementmonitor will be at the discretion of Abbott.Under the warranty, Abbott will replace, free of charge, thisMonitor, if it is defective in material or workmanship. NO OTHERWARRANTIES, EXPRESS OR IMPLIED, ARE MADE. ABBOTT WILLNOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIALDAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM THEFAILURE OF THE PRODUCT TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS.Some states do not allow the exclusion or limitation of otherexpress or implied warranties or incidental or consequentialdamages, 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 obtainingwarranty service, that you return the Monitor, postage prepaid, toan address specified by Customer Care. Your Rights Under State Law: This warranty gives you specificlegal rights, and you may also have other rights that vary fromstate to state.Free Lifetime Monitor Upgrades: Monitor upgrade requiresenrollment in the Precision Friends for Life Program and use of your Monitor for a minimum of three years. Choice ofreplacement monitor will be at the discretion of Abbott.

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References1. Directive 1999/45/EC of the European Parliamentand of the Council of 31 May 1999 concerning theapproximation of the laws, regulations andadministrative provisions of the Member Statesrelating to the classification, packaging and labellingof dangerous preparations.

2. Schade DS, Eaton RP. Metabolic and clinicalsignificance of ketosis. Special Topics inEndocrinology and Metabolism 1982; 4:1–27.

3. Wiggam MI, O’Kane MJ, Harper R, Atkinson AB,Hadden DR, Trimble ER, Bell PM. Treatment ofdiabetic ketoacidosis using normalization of blood 3-hydroxybutyrate concentration as the endpoint ofemergency 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 asmarkers for Type 1 (insulin-dependent) diabetes andtheir value in the monitoring of diabetes control.Diabetologia 1984; 26:343–8.

5. Ubukata E. Diurnal variation of blood ketonebodies in insulin-dependent diabetes mellitus andnon-insulin-dependent diabetes mellitus patients: Therelationship to serum C-peptide immunoreactivityand free insulin. Ann Nutr Metab 1990; 34:333–42.

6. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzoRA. Metabolic effects of low-dose insulin therapy onglucose metabolism in diabetic ketoacidosis. Diabetes1988; 37:1470–77.

7. Hale PJ, Crase J, Nattrass M. Metabolic effects ofbicarbonate in the treatment of diabetic ketoacidosis.Br Med J 1984; 289; 1035–8.

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Distributed by:Abbott LaboratoriesAbbott Diabetes CareAlameda, CA 94502USA

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.: 70297-01MediSense and Precision Xtra are trademarks of Abbott Laboratories.© 2005 Abbott Laboratories.

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