english manual xceed

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Table of ContentsWelcome 1

1 Important Things to Know about YourOptium Xceed Diabetes Monitoring System 3

Intended Use 3 How Your Optium Xceed DiabetesMonitoring System Works 4

Optium Xceed Kit Contents 4Getting to Know Your Meters Features 5

2 Setting Up Your Optium Xceed Meter 7Buttons to Use 7

Setup Options 7How to Set the Beeper, Date, Time, & ViewMeasurement Units 8

Set Beeper 8Set Time 9Set Date 10Set Time Format 12Set Date Format 12

Blood Glucose Measurement Units 13

3 Calibrating Your Optium Xceed Meter 14

Why Calibrate Your Meter? 14 When to Calibrate Your Meter 14 What You Will Need 14 How to Calibrate Your Meter 14 How to Recall the LOT Number 17

4 Monitoring Your Blood Glucose 18What You Will Need 18Important Information about Monitoring

Your Blood Glucose 18How to Monitor Your Blood Glucose 19 Understanding Your Result 24

5 Monitoring Your Blood -Ketone 27What You Will Need 27Important Information about Monitoring

Your Blood -Ketone 27How to Monitor Your Blood -Ketone 29

Understanding Your Result 33

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6 Doing A Control Solution Test 36 Why Do A Control Solution Test? 36 When Is Doing A Control Solution Test Recommended? 36 Important Information about Control Solution Testing 36 What You Will Need 37 How to Do Control Solution Testing 37 Understanding Your Result 41

7 Reviewing & Using Your Results 42 What Can Your Meter Show You? 42 How to See Results in Memory 43 How to See Averages 45 Transferring Your Results to A Computer 46

8 Understanding & TroubleshootingError Messages 47

What An Error Message Means & 47 What You Need to Do

9 Your Meters Specifications & Limitations 51Important Information about Using Blood 53

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

10 Caring For Your Meter 54Cleaning Your Meter 54

Replacing Your Meters Battery 54

11 Support & Guarantee 57

References 60

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Please contact your local Abbott Diabetes Care office ordistributor with any questions you may have about theOptium Xceed Diabetes Monitoring System (please seepage 57 for Customer Support phone numbers). If youcannot reach your local office or distributor, contact yourhealthcare professional.

Please read the following items before using your Optium

Xceed Diabetes Monitoring System:

User guideBlood glucose test strip instructions for useBlood -Ketone test strip instructions for useLancing device instructions for use and other informationWarranty card

Welcome

Thank you for choosing the Optium XceedDiabetesMonitoring System.

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

Your new Optium Xceed Diabetes Monitoring System isan important tool that can help you better manage yourdiabetes. The System measures both blood glucose (sugar)

and blood -Ketone. Blood glucose and blood -Ketoneresults can help you understand your diabetes and whathappens with:

FoodExerciseStress and illnessDiabetes medications

Always monitor your blood glucose and blood -Ketoneaccording to your healthcare professionals recommendations.

IMPORTANT:Any user guide text shown in a shaded box like this oneis important information. Please pay special attention tothese boxes.

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How Your Optium Xceed Diabetes MonitoringSystem WorksWhen you insert a test strip into your meter, the ApplySamplemessage shows on your meters display window.When a blood sample or control solution sample isapplied to the test strip, the glucose or -Ketone reactswith the chemicals on the test strip. This reaction producesa small electrical current that is measured. The resultshows on your meters display window.

Optium Xceed Kit Contents

Optium Xceed Meter

Optium Xceed Users Guide Contains system information and directions.

Carrying Case Use this to store and carry your meter and other monitoring

supplies.

Your kit may also contain:

Optium Xceed Quick Reference Guide Gives the basic steps to calibrate your meter and monitor

your blood glucose.

Logbook Use this to record your test results, activities, and medications.

Limited Warranty Card

Please fill this out and return to the address provided to startyour warranty. Filling out this card helps to ensure that youreceive any updates regarding your Optium Xceed meter.

Lancing Device, Lancets, Instructions for Use andOther Information.Blood Glucose Test Strips and Instructions for Use.

Items not included:

MediSense Control Solutions.Blood -Ketone Test Strips and Instructions for Use.Data Management System.

Important

Information

4

CHAPTER 1

Important Thingsto Know about YourOptium Xceed DiabetesMonitoring System

Intended Use Your Optium Xceed System:

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

Is for self testing or healthcare professionaluse outside the body (in vitrodiagnostic use).Is for monitoring glucose in fresh whole

blood (for example, from the fingertip).

Is for monitoring -Ketone in fresh wholeblood from the fingertip.

Measures -hydroxybutyrate (-Ketone), themost important of the three ketone bodiescirculating in the bloodstream.

Is for use onlywith Optium Blood Glucose Test Strips andOptium Blood -Ketone Test Strips.

Optium and Optium 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. Optium POC Blood Glucose Test Strips are for use byhealthcare professionals only.

Healthcare professionals:Please refer to the test strip instructions for use for moreinformation about sample types.

Potential Infection Risk:Healthcare professionals performing blood tests withthis system on multiple patients must always weargloves and should follow the infection control policiesand procedures approved by their facility.

Questions? Call

Customer Support:

See page 57.

Important

Information

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Important

Information

65

Strip Port

This is where you insert:

A blood glucose test strip.A blood -Ketone test strip.A glucose calibrator.A ketone calibrator.Data cable (not included) for uploading

results to a computer.

Mode ButtonUse this button to:

Turn meter ON and OFF.Access meter setup options.Access and save meter settings.Access previous results and averages.

Forward Button

Back Button

Use these buttons to:

Review and select meter settings.Review results and averages.

Backlight ButtonUse this button to:

Turn backlight ON and OFF.

Battery Compartment

This is where the battery is installed.

If your meter does not turn on, check thatyour battery is installed properly.

For new battery installation, see Chapter 10.

Important

Information

Getting to Know Your Meters Features

Display Window

This shows:

Blood glucose and blood-Ketone results.

Glucose and -KetoneLOT numbers.

Previous test results anderror messages.

Blood glucose averages.

IMPORTANT:Each time you turn your meter on,a full display shows. This is called aDisplay Check. Look at the DisplayCheck each time it appears on yourmeters display window, especiallybefore you monitor your blood glucoseor blood -Ketone. The Display Checkshows on the display window briefly.

Do notuse the meter if the meterDisplay Check does not exactly matchthe picture here (for example, if yousee a "3" instead of an "8"). The metermay show an incorrect result whenyou use it. Please call CustomerSupport for assistance.

BackButton

BacklightButton

DisplayWindow

StripPort

ModeButton

ForwardButton

Display Check



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CHAPTER 2

Set Date Format

In "Set Date Format", you choose how the month andday show on the meter s display window.

Measurement Units

Blood glucose measurement units are factory-set in mg/dLor mmol/L.

Blood -Ketone measurement units are in mmol/L only.

Setting Up Your OptiumXceed Meter

Buttons to Use

Mode Button.

Forward Button.

Back Button.

Setup Options

Set BeeperIf the beeper is set ON, it will beep when:The calibrator is fully inserted.The test countdown starts.The test countdown finishes.

Set Time, Set Date

IMPORTANT: Set the correct time and date before youuse the meter for the first time.

This will help you keep records of when you monitorand will help you and your healthcare professional makeinformed decisions about your care.

You must set the time and date to review averages.

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 onthe meter s display window.

Questions? Call

Customer Support:

See page 57.

How to Set the Beeper, Date, Time, &

View Measurement UnitsTo begin, pull the battery tab out. Yourmeter should be turned OFF. You willautomatically be prompted to set thetime and date the first time you press thebutton to turn your meter on (see Set Timeand Set Date sections in this chapter).

Before you start, please note:"Press andHold" means that you press the button infor at least 2 seconds. "Press and Release"means that you press the button and let itgo quickly.

Press and Hold the button to turn themeter off and save your settings at any

time. The meter automatically turns off after30 seconds of no action.

If you like the setting that you see on yourmeter and do not want to change it, Pressand Release the button to move to thenext setup option.

Set Beeper

The means the beeper is ON.The means the beeper is OFF.

Beeper OFF

SettingUp

YourMeter

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Beeper ON

SettingUp

YourMeter

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9

SettingUp

YourMeter

1To turn your meter ON,Press andHold the button. The beeper ON message shows on

the display window. The musicalnotes flash on and off, and themeter beeps.

2To change the beeper setting, Pressand Release the button or thebutton once.

3 Press and Release the button tosave the beeper setting and to moveto Set Time (Hour).

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SettingUp

YourMeter

Set Time

Hour:

The Hour flashes on and off.

1 Press and Release the button tomove the hour forward.

2 If you go past the correct hour, Pressand Release the button to movethe hour back.

3 Press and Release the button tosave the hour and to move toSet Minutes.

Minutes:

The Minutes flash on and off.

1 Press and Release the button tomove the minutes forward.2 If you go past the correct minute, Pressand Release the button to move the

minutes back.

3 Press and Release the button to savethe minutes and to move to Set Date.

Set Date

Year:

The Year flashes on and off.

1 Press and Release the button tomove the year forward.

2 If you go past the correct year, Pressand Release the button to move theyear back.

3 Press and Release the button to savethe year and to move to Set Month.



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SettingUp

YourMeter

11

Choice #1

Choice #2

Month:

The Month flashes on and off.

1 Press and Release the button tomove the month forward.2 If you go past the correct month,Press and Release the button to

move the month back.

3 Press and Release the button to savethe month and to move to Set Day.

Day:

The Day flashes on and off.

1 Press and Release the button tomove theday forward.

2

If you go past the correct day, Pressand Release the button to movethe day back.

3 Press and Release the button tosave the day and to move to SetTime Format.

Set Time Format

You have two choices:

Choice #1: For the 12-hour format, AMor PM shows.

Choice #2:For the 24-hour format, AMor PM does not show.

1To change the Time Format, Pressand Release the button or thebutton once.

2 Press and Release the button tosave the Time Format and to moveto Set Date Format.

Set Date Format

You have two choices:

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

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

Choice #2:For the day.month format,"" shows with the date.

Example: "25 May" shows as "25.5".

1To change the Date Format, Pressand Release the button or thebutton once.

2 Press and Release the button tosave the Date Format and to moveto Measurement Units.

Choice #1

Choice #2

SettingUp

YourMeter

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SettingUp

YourMeter

13

Blood GlucoseMeasurement Units

Consult your healthcare professionalif you have any questions about theblood glucose measurement units.

This screen shows the blood glucose

measurement units (mg/dL or mmol/L).Press and Release the button toreturn to Set Beeper.

Press and Hold the button to turnyour meter off.

You have successfully set up your meter.

C

alibrating

Y

ourMeter

CHAPTER 3

Why Calibrate Your Meter?

Your Optium Xceed meter must be calibrated so that it canrecognize the test strip you are using. Calibration ensuresthat your results are accurate.

When to Calibrate Your Meter

When you use the meter for the first time.EACHtime you open and use a new box of blood glucose

or blood -Ketone test strips.

What You Will Need

Optium Xceed meter.For glucose calibration: - Blood glucose test strip.

- Blood glucose test strip instructions for use.

- Blood glucose test strip calibrator.

For -Ketone calibration: - Blood -Ketone test strip.

- Blood -Ketone test strip instructions for use.

- Blood -Ketone test strip calibrator.How to Calibrate Your Meter

When you insert a test strip for thefirst time, the display window shows:

This means the meter is notcalibratedfor blood glucose monitoring.

This means the meter is notcalibratedfor blood -Ketone monitoring.

Questions? Call

Customer Support:

See page 57.

Calibrating Your OptiumXceed Meter

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alibrating

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ourMeter

IMPORTANT: Use only the calibrator that is packaged inthe box of test strips you are using.

Do notuse test strips that have expired. Check theexpiration date on the test strip foil packet and test stripbox. If only the year and month are shown, the expirationdate is the last day of the month.

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5 Check that the LOT number on all these items matches:Display window Test strip calibratorTest strip instructions for use Test strip foil packet

When the LOT number on all theseitems matches:

What It Means:Calibration is complete.

What to Do:You may now monitor your blood glucose orblood -Ketone.

When the LOT number on all these itemsDOES NOT match:

What It Means:Your meter may not be calibrated for the box of test stripsyou 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.

IMPORTANT:If the LOT number still does not match,contact Customer Support. Do notattempt to monitoryour blood glucose or blood -Ketone. Your meter mayshow an incorrect result.

6 Remove the calibrator from the meter and store it in yourmeters carrying case.IMPORTANT:Do notthrow the calibrator away until youhave used all of the test strips in the box.

If you have any trouble calibrating your system, pleasecontact Customer Support.

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

2 Open the calibrator package. Find thethree raised bumps on the calibratorpackage. Peel the clear cover away fromthe three raised bumps.

3 Hold the calibrator (white for glucoseand purple for blood -Ketone) with theLOT number facing you.

4 Insert the calibrator into the stripport. Push it in until it stops.The Display Check shows on thedisplay window, followed by the

time, month, and day.Next, the LOT number shows on thedisplay window.

a.Example of glucose LOT number:LOT 13758

b. Example of -Ketone LOT number:CODE12345

Then you hear the beeper, if thebeeper is ON.

Glucose

-Ketone

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How to Recall the LOT Number

1To recall the glucose LOT number, Press and Hold thebutton. While holding the button, Press and Holdthe button.

The Display Check shows on thedisplay window, then the glucoseLOT number shows with thetime, month, and day of the mostrecent glucose calibration.

2 After the glucose LOT number is displayed, you canrecall the -Ketone LOT number. Press and Release thebutton or the button.

The -Ketone LOT number shows"CODE", the time, month, and dayof the most recent blood-Ketone calibration.

Note: If the LOT number that shows on your metersdisplay window is not correct:

What It Means:

Your meter may not be calibrated for the box of test stripsyou are using.

What To Do:

Re-calibrate your meter. Check that you are using the calibrator that came in

the box of test strips you are using.

Remember, improper calibration will causeincorrect results.

3 Press and Hold the button toturn your meter off.

CHAPTER 4

Monitoring Your Blood Glucose

What You Will Need

Blood glucose test strip with its instructions for use.Optium Xceed meter 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 YourBlood Glucose

Do notuse out-of-date test strips. Check the expirationdate printed on the test strip box and on each test strip foilpacket. If only the month and yearare printed on the test strip, thenthe expiration date is the last dayof that month.

For more detailed informationabout your test strip, please readits instructions for use beforemonitoring.

Use the test strip immediatelywhen you take it out of its

foil packet.Do notuse a wet, bent, scratched, or damaged test strip.Do notuse the test strip if its foil packet has a puncture or

tear in it.

Before you monitor, allow your meter and test strip toreach the recommended operating range of the teststrip. The test str ip operating range is in the What else doI need to know? section of your blood glucose test stripinstructions for use.

Read the lancing device instructions for use.

Questions? Call

Customer Service.

See page 57.

L O T 13758

EXP 2 008 /0 3

C5

Example:

Expiration date

March 31, 2008

Monitoring

BloodGlucose

18

L O T 13758

EXP 2008/03

C5



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Monitoring

BloodGluco

se

19

Monitoring

BloodGluco

se

20

How to Monitor Your Blood Glucose

Getting Started

1 Prepare your lancing device.

2 Wash your hands using warm soapywater and dry them completely.

3 Remove the test strip from its foil packet.Note:For pictures that show how to open the bloodglucose test strip foil packet, please see the informationcard in the box of blood glucose test strips.

4 Insert the three black lines at the endof the test strip into the strip port.

5

Push the test strip in until it stops.

The meter turns on automatically. These items show on the display

window, one after the other:

Display Check Remember to makesure that all items in the picturehere show on the display window.(See Chapter 1 for more informationabout the Display Check.)

Time, month, and day (if set)

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

LOT number for the box of bloodglucose test strips you are using.

Apply Sample message, which tellsyou that the meter is ready for you toapply blood to the blood glucosetest strip.



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21

Monitoring

BloodGluco

se

Monitoring

BloodGluco

se

22

Obtaining A Blood Drop

Use your lancing device to obtain a blood drop.

Recommendations for Obtaining a Blood Drop

To obtain a sample from an alternative site (forearm,upper arm, or base of the thumb), use anappropriate alternative site lancing device.

Before you obtain a blood sample from the fingertip,forearm, upper arm, or base of thethumb, make sure the sample site isclean, dry, and warm. To warm thesample site, wash it in warm water, rubthe skin vigorously for a few seconds, orapply a warm pad to it.

Hang your arm down before prickingyour finger or the base of the thumb tohelp blood flow.

To obtain a blood sample from the arm, use a fleshy areaaway from bone. Avoid areas where thereis a lot of hair.

Avoid squeezing the puncture site.

Apply the blood sample to the test stripimmediately.

Lancets and Lancing Device

Lancets are for one-time use only. Use a new lanceteach time you monitor.

Discard your used lancet properly. Put it in anempty puncture-resistant container, such as aplastic milk carton or detergent bottle.

Never share your lancing device or lancet withanother person.

Applying the Blood Drop to the Test Strip

1Touch the blood drop to the white areaat the end of the test strip. The blood isdrawn into the test strip.

Note:If the meter shuts off before you applyblood to the test strip, remove the test strip fromthe meter and try again.

2Continue to touch the blood drop to the end ofthe test strip until the meter begins the test. Themeter 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 notremove the test stripfrom the meter or disturb it during thecountdown.

Countdown

Status bar

Fingertip sampling

Upper arm sampling

Forearm sampling

Base of thumbsampling



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23 24

Monitoring

BloodGluco

se

Monitoring

BloodGlucose

Correct

IMPORTANT:If the countdown does not start:

What It Means:

You might not have appliedenough blood to the test strip.

What to Do:

Apply a second drop of blood tothe test strip. Refer to your test strip

instructions for use for the numberof seconds you have to apply asecond drop.

If the countdown still does not start,or if the number of seconds youhave to apply a second drop havepassed, discard the test strip, turnoff your meter, and try again witha new test strip.

3At the end of the countdown:

If the beeper is ON, listen forthe beeper.

The blood glucose result showson the display window.

The result is stored in your metersmemory. You may also write theresult in your logbook.

Shutting Off Your Meter

1 Removing the test strip from the strip port turns off themeter. You can use the opened foil packet to removeand discard your used test strip.

2 Discard the test strip properly.

Note:You may also turn the meter off by Pressingand Holding the button. If you do not turn yourmeter off or pull the test strip out, the meter shuts offautomatically after 60 seconds.

Understanding Your Result

"LO" Result

What It Means:

Your meter has determined that your bloodglucose result is lower than 20 mg/dL (1.1 mmol/L)or there may be a problem with the test strip.

What to Do:Monitor your blood glucose again with anew test strip. If LOshows on the displaywindow again, contact your healthcareprofessional immediately.



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25

Monitoring

BloodGlucose

26

Result 300 mg/dL or Higher

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

What to Do:

If you check your ketones as part of yourdiabetes management program, it isrecommended that you check your

blood -Ketone.

"HI" Result

What It Means:

Your meter has determined that yourblood glucose result is higher than500 mg/dL (27.8 mmol/L) or theremay be a problem with the test strip.

What to Do:

Monitor your blood glucose again with anew test strip. If HIshows on the displaywindow again, contact your healthcareprofessional immediately.

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

"E4" Result

What It Means:

Your meter has determined that yourblood glucose may be too high to be readby the system, or there may be a problemwith the test strip.

What to Do:

Monitor your blood glucose again with a new

test strip. If E4 shows on the display window again,contact your healthcare professional immediately.

IMPORTANT:It is recommended that you repeat the blood glucose testwith a new test strip when:

LOshows on the display window. You obtain a low blood glucose result, but you do not have

symptoms of low blood glucose. Your meter displays a blood glucose result that is unusually

low, lower than 50 mg/dL (2.8 mmol/L).

HIshows on the display window. You obtain a high blood glucose result, but you do not have

symptoms of high blood glucose.

Your meter displays a result that is unusually high, higherthan 300 mg/dL (16.7 mmol/L). You question your result. Your monitor displays an error message (for example, E-4).

IMPORTANT:

A result that is incorrect may have a serious medical outcome.Consult your healthcare professional before changing yourdiabetes medication program.

Monitoring

BloodGlucose



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CHAPTER 5

Monitoring

Blood-Ketone

28

MonitoringBlood

-Ketone

27

Monitoring Your

Blood -Ketone

It is important tocheck 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 professional determine that itis necessary.

What You Will Need

Blood -Ketone test strip with its instructions for use.Optium Xceed meter calibrated to match the LOT

number of the blood -Ketone test strip you are using.

Lancing device and a new, sterile lancet.

Important Information about Monitoring YourBlood -Ketone

For more detailed information about your blood -Ketonetest strip, please refer to its instructions for usebefore monitoring.

Do notuse out-of-date test strips. Check the expirationdate printed on the test strip box and on each test stripfoil packet.

Do notput urine on theblood -Ketone test strip.

Use the test strip immediatelywhen you take it out of its foilpacket.

Questions? Call

Customer Support:

See page 57.

Do notuse a wet, bent, scratched, or damagedtest strip.

Do not use the test strip if its foil packet has a puncture ortear in it.

Use each test strip only once.Before you monitor your blood -ketone, allow your meter

and test strip to reach the recommended operating range ofthe test strip. The test strip operating range is in the What elsedo I need to know? section of your blood -Ketone test stripinstructions for use.

Read the lancing device instructions for use.

Example:

Expiration date

March 31, 2008

LO T 13758

E XP 2 00 8/ 03

C5



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Monitoring

Blood-Ketone

29

MonitoringBlood

-Ketone

30

How to Monitor Your Blood -Ketone

Getting Started

1 Prepare your lancing device.


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

LOT number (CODE) for the box of blood

-Ketone test strips you are using.

KETONEand Apply Samplemessage, which tell you that themeter is ready for you to apply bloodto the blood -Ketone test strip.

Obtaining A Blood Drop

Use your lancing device to obtain a blood drop.

IMPORTANT:Blood -Ketone test stripshave not been evaluated for alternative sitemonitoring. Use only fingertip bloodsamples for blood -Ketone monitoring.

Fingertip sampling

2 Wash your hands using warmsoapy water and dry themcompletely.

3 Remove the test strip from its foil packet.Note: For pictures that show how to open the blood-Ketone test strip foil packet, please see the informationcard in the box of blood -Ketone test strips.

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

5 Push the test strip in until it stops.

The meter turns on automatically.

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

Display Check Remember to makesure that all items in the picturehere show on the display window.(See Chapter 1 for more informationabout the Display Check.)



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32

MonitoringBlood

-Ketone

31

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. Towarm the sample site, wash it in warm water or rub theskin vigorously for a few seconds.

Hang your arm down before pricking your fingertip tohelp blood flow.

Avoid squeezing the fingertip.Apply the blood sample to the test strip immediately.

Lancets and Lancing Device

Lancets are for one-time use only. Use a new lancet eachtime you monitor.

Discard your used lancet properly. Put it in an emptypuncture-resistant container, such as a plastic milkcarton or detergent bottle.

Never share your lancing device or lancet withanother person.

Applying the Blood Drop to the Test Strip

1Touch the blood drop to the white area at the endof the test strip. The blood is drawninto the test strip.

Monitoring

Blood-Ketone

2 Continue to touch the blood drop to the whitearea at the end of the test strip until the meterbegins the test. The meter 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 notremove the test strip from themeter or disturb it during the countdown.

IMPORTANT: If the countdowndoes not start:

What It Means:

You might not have appliedenough blood to the test str ip.

What to Do:

Apply a second drop of blood to the test strip. Referto your test strip instructions for use for the number ofseconds you have to apply a second drop.

If the countdown still does not start, or if the number ofseconds you have to apply a second drop have passed,discard the test strip, turn off your meter, and try againwith a new test strip.

3 At the end of the countdown:If the beeper is ON, listen for the beeper.The blood -Ketone result shows on the

display window with the wordKETONE.

The result is stored in your metersmemory as a blood -Ketone result. Youmay also write the result in your logbook.

Countdown

Status bar

Note: If the meter shuts off before you apply blood tothe test strip, remove the test strip from the meter andtry again.



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34

Monitoring

Blood-Ketone

MonitoringBlood

-Ketone


1 Removing the test strip from the strip port turns offthe meter. You can use the openedfoil packet to remove and discardyour used test strip.

2 Discard the test strip properly.

Note:You may also turn the

meter off by Pressing andHolding the button. If you donot turn your meter off or pull thetest strip out, the meter shuts offautomatically after 60 seconds.

Understanding Your Result

Blood -Ketone is expected to be lower than 0.6 mmol/L.2Blood -Ketone may be higher when a person is ill, is fasting,exercises vigorously, or if blood glucose levels are notcontrolled.1-3

When:

Blood -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 herinstructions for sick day management.

33

When:

Blood -Ketone result remains high or becomes higherthan 1.5 mmol/L:

What It Means:

You may be at risk of developing diabetic ketoacidosis(DKA).2-6

What to Do:

Contact your healthcare professional immediately.

"HI" Result

What It Means:

Your meter has determined that your blood -Ketoneresult is higher than 8.0 mmol/L, or there may be aproblem with the test strip.

What to Do:

Monitor your blood -Ketone again witha new test strip. If HIshows on the displaywindow again, contact your healthcareprofessionalimmediately.



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MonitoringBlood

-Ketone

"E-4" Result

What It Means:

There may be a problem with the test strip.

What to Do:

Monitor your blood -Ketone again with anew test strip. If E-4shows on the displaywindow again, contact your healthcareprofessional immediately.

IMPORTANT:It is recommended that you repeat theblood -Ketone test with a new test strip when:

HIappears in the display window.Your result is unusually high.You question your result.You obtain a 0.0 mmol/L blood -Ketone result BUT your

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

IMPORTANT:A result that is incorrect may have a seriousmedical outcome. Consult your healthcare professionalbefore changing your diabetes medication program.

35 36

CHAPTER 6

Doing A Control Solution Test

Why Do A Control Solution Test?

The control solution test tells you that your meter and teststrips are working correctly. A control solution test is similarto when you monitor your bloodglucose or blood -Ketone, except

you use a MediSense Control Solution.You do not use a drop of blood ina control solution test.

When Is Doing A Control SolutionTest Recommended?

When you question your results.To make sure that your meter and

test strips are working properly.

Important Information about Control Solution Testing

For more detailed information on how to obtain control solutions,please contact Customer Support, see page 57.

For more detailed information about control solutions, read thecontrol solution instructions for use.

MediSense Control Solutions may be used for glucose orketone control solution testing.

Do notuse the control solution if the expiration date haspassed. Check the expiration date printed on the controlsolution bottle.

When you open a control solution bottle for the first time,count forward 90 days and write this date on the controlsolution bottle using a pen that wont smear or wipe off.Throw away any remaining solution after this date.

Control

SolutionTesting

Questions? Call

Customer Support:

See page 57.



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37

ControlSolution

Testing

38

3 Insert the three black lines at the end ofthe test strip into the strip port.

4 Push the test strip in until it stops.The meter turns on automatically.

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

Display Check Remember to makesure that all items in the picture hereshow on the display window. (SeeChapter 1 for more information about theDisplay Check.)


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

LOT number for the box of test stripsyou are using.

Apply Sample message, which tells youthat the meter is ready for you to applycontrol solution to the test strip.

Note:If you are a doing a -Ketone control solutiontest, KETONEwill show on the meters displaywindow with the -Ketone Apply Sample message.

Control

SolutionTesting

The results obtained from control testing do not reflectyour personal blood glucose or blood -Ketone levels inany way.

Do notswallow the control solution.Do notinject the control solution or use the control

solution as eye drops.

What You Will Need

Optium Xceed meter calibrated to match the LOTnumber of the test strip you are using

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

MediSense Control Solutions and instructions for use

How to Do Control Solution Testing

Getting Started

1 Wash your hands using warm soapy water and drythem completely.

2 Remove the test strip from its foil packet.

Note:For pictures that show how to open the bloodglucose test strip foil packet, please see the informationcard in the box of blood glucose test strips.



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ControlSolution

Testing

Control

SolutionTesting

Control

SolutionTesting

39

5To mark the test as a control test, Press and Releasethe button once. shows onthe display window.

IMPORTANT: If you do not mark the testas a control test, it will be saved in yourmeters memory as one of your personalblood glucose or blood -Ketone results.This could affect your blood glucose averages.

Applying Control Solution to the Test Strip

1Turn the control solution bottle upside down three tofour times to mix the solution.

2Remove the cap.

3Apply a drop of control solutionto the test strip in the area shownhere. The control solution is drawninto the test strip.

4 Continue to touch the control solution to the test stripuntil the meter begins the test.The meter 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.

40

Status bar

Countdown

Note: Do notremove the test strip from the meter or disturb itduring the countdown.

IMPORTANT: If the countdown does not start:

What It Means:

You might not have applied enough controlsolution to the test strip.

What to Do:

Apply a second drop of control solution to thetest strip. Refer to your test strip instructionsfor use for the number of seconds you have toapply a second drop.

If the countdown still does not start, orif the number of seconds you have toapply a second drop have passed, discardthe test strip, turn off your meter, and tryagain with a new test strip.

5At the end of the countdown:If the beeper is ON, listen for the beeper.The control result shows on the display window.

Note:If you are doing a -Ketone control solution test,KETONEwill also show with the result.

The result is stored in your meters memory as a controlresult. In your logbook, record the result as a control result.

Glucose

-Ketone



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ControlSolution

Testing

41


1 Removing the test strip from the stripport turns off the meter. You can usethe opened foil packet to remove anddiscard your used test strip.

2 Discard the test strip properly.Note: You may also turn the meteroff by Pressing and Holding the

button. If you do not turn yourmeter off or pull the test strip out,the meter shuts off automaticallyafter 60 seconds.

Understanding Your ResultCompare the control result to the "Expected Results forUse with MediSense Control Solutions" range printed on:

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

The blood -Ketone test strip instructions for use and foilpacket, for -Ketone control solution testing.

If the control result falls within the range:

What It Means

Your meter and test strips are working correctly.If the control resultdoes not fall within the range:

What It Means

Your meter and test strips may not be working correctly.

What to Do

Repeat the test with a new test strip and ensure thecontrol solution testing instructions are followedcompletely. If the result is still not within the printedrange, contact Customer Support.

42

CHAPTER 7

ReviewingResults

What Can Your Meter Show You?

Memory

Your Optium Xceed meter has a memory that stores up to450 events. This is a combination of control results, yourpersonal blood glucose and blood -Ketone results, and

other meter information.You can review up to 450 of your most recent events onyour meters display window.

Glucose Averages

You can view the average of all your blood glucoseresults from the last 7, 14, or 30 days. If you marked yourcontrol solution tests, the averages do not include controlsolution results. (For more information on marking controlsolution tests, see Chapter 6.)

IMPORTANT:

To review blood glucose averages, you mustset thedate and time before monitoring.

If you do notmark control solution tests, this may affect

your glucose averages.Blood glucose averages do notinclude blood -Ketone

results, glucose control results, -Ketone control results,or results that do not show the time, month,and day.

When there are no previous results or bloodglucose averages to review, the displaywindow shows three dashes.

Questions? Call

Customer Support:

See page 57.Reviewing & Using Your Results

CHAPTER 7



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43 44

ReviewingResults

ReviewingResults

How to See Results in Memory

1 Begin with your meter turned off. Make sure there isnothing in the strip port.

2 Press and Release the button.The Display Check shows on the

display window.

Then your most recent result showswith its units on the meters displaywindow, along with the time,month, and day that you got theresult. (To set the correct date andtime, follow the steps in Chapter 2.)

A blood glucose result in Memory willshow with the letters MEM.

A blood -Ketone result in Memorywill show with the letters KET MEM.

Blood -Ketoneresult in Memory

Blood Glucoseresult in Memory

A control solution result in Memory shows with a controlbottle, as long as you marked the test as a controlsolution test.

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

4 When you reach the last result inMemory, the display window showsthree dashes.

5To return to a result you previouslyreviewed, Press and Release thebutton once per result.

Glucose control

solution resultin Memory

-Ketone control

solution resultin Memory



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ReviewingResults

ReviewingResults

4645

How to See Averages

IMPORTANT:

Results that show as LO during blood glucosemonitoring are included as 20 mg/dL (1.1 mmol/L)in blood glucose averages.

Results that show as HIduring blood glucosemonitoring are included as 500 mg/dL (27.8 mmol/L)in blood glucose averages.

1 While in Memory, Press andRelease the button at anytime to see the 7-Day average ofyour blood glucose results.

Note:nmeans how many tests were performedwithin the 7-, 14-, or 30-Day average period.

2Press and Release the buttononce to see the 14-Day averageof your blood glucose results.

3 Press and Release the buttonagain to see the 30-Day averageof your blood glucose results.If you Press and Release thebutton again, the display windowshows the 7-Day average.

4Press and Release the buttonat any time to return to Memory.

5 Press and Hold the button to turn off your meter.Otherwise, the meter turns offafter 30 seconds.

Transferring Your Results to a Computer

The results in your Optium Xceed meter's memory, along withthe time and date of the reading, can be transferred toa computer with the use ofthe Precision LinkDirect SoftwareVersion 2.5 and a Precision Linkcommunications cable. For informationon how to purchase the software andcable, contact Customer Support. To

install the software, please followthe instructions provided inthe Precision Link User's Guide.



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ErrorMessages

CHAPTER 8

Understanding &TroubleshootingError Messages

There are times when error messages may show on yourmeters display window.

In the next few pages, we describe the error messagesthat may show on your meters display window, whatthey mean, and what you need to do.

Questions? Call

Customer Support:

See page 57.

Temperature is toohot or too cold forthe system to workproperly.

Move your meterand test strips toa location wherethe temperatureis appropriate andmonitor again witha new test strip. Youmay have to waitfor your meter toadjust to the newtemperature. Referto your test stripinstructions for usefor the appropriate

operating range.If the error message

appears again, contactCustomer Support.

Message What It What YouMeans Need to Do


Meter error.

There may be aproblem with thetest strip.

Blood glucoseresult may be toohigh to be read bythe system.

OR

There may be aproblem with theblood glucose orblood -Ketone teststrip.

Turn the meter off,then repeat previousmonitoring steps.

If the error messageappears again, contactCustomer Support.

Review the monitoringinstructions.

Monitor again with anew test strip.


Monitor again witha new test strip.

If the errormessage appears

again, contactyour healthcareprofessionalimmediately.

ErrorMessages

4847



27/33

Blood applied totest strip too soon.

Calibration/Teststrip error.

Test strip error.

Test strip isdamaged, used, orthe meter does notrecognize it.

Review the monitoringinstructions.

Monitor again with anew test strip.


Repeat the calibrationusing the calibratorbar that came withthe test strip you areusing.

Check the date settingon your meter.

Check the expirationdate on the test stripfoil packet.


Monitor again usinga test strip designedfor use with OptiumXceed.




Meter error.

Meter error.

Remove test strip, turnmeter off, and try tomonitor again.


Remove test strip, turnmeter off, and try tomonitor again.


49

ErrorMessages

50

ErrorMessages



28/33

CHAPTER 9

Questions? Call

Customer Support:

See page 57.

Specifications

&Limitatio

ns

Specifications

&Limitations

Your MetersSpecifications& Limitations

5251

Size Length:

Width:

Thickness:

7.47 cm

5.33 cm (Top)4.32 cm (Bottom)

1.63 cm

Weight 42 grams

Power Source One CR 2032 Lithium (coin cell) battery

Battery Life Approximately 1,000 tests

Memory Up to 450 events including controlresults, personal blood glucose andblood -Ketone results, and other meterinformation

Storage Temperature Meter: Test Strips: Control Solution:

25 to 55CSee test strip instructions for useSee control solution instructions for use

Blood GlucoseAssay Range See blood glucose test stripinstructions for use

Blood -KetoneAssay Range

See blood -Ketone test stripinstructions for use

Control SolutionRange

See blood glucose or blood -Ketonetest strip instructions for use

Functions - Blood glucose monitoring

- Blood -Ketone monitoring

- Memory 450 events

- Glucose averaging: 7-Day, 14-Day, and30-Day Averages

- Control solution marking and testing

- Backlight: If ON Stays ON duringcountdown; turns OFF 30 seconds afterresult is displayed. If OFF Stays OFFduring countdown; stays OFF duringdata upload

- Beeper: If ON Beeps when calibratoris fully inserted and when countdownstarts and finishes

Data port Yes

Meter OperatingRange

Temperature: Relative Humidity:

10 to 50C10% to 90%, non-condensing

System OperatingRange Temperature:

Relative Humidity:

The system operating range is theoperating range of the test strip youare using. See Limitations of Proceduresection in test strip instructions for use

10% to 90%, non-condensing



29/33

CHAPTER 10

53

Specificatio

ns

&Limitatio

ns

54

Caring For Your Meter

Caringfo

r

YourMeter

Questions? Call

Customer Support:

See page 57.

Important Information about Using BloodSamples from the Forearm, Upper Arm, or Baseof the Thumb:

Contact your healthcare professional before youbegin using any one of these alternative sites to testyour blood glucose.

Sampling from any one of these alternative sites maycause minor bruising and may leave marks that goaway in a short time.

There may be times when alternative site results aredifferent from fingertip results. This happens whenblood glucose levels change rapidly (for example,after you eat a meal, after you take insulin, or duringor after exercise).

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

Do notuse blood samples from alternative siteswhen:

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

2. You have been diagnosed with hypoglycemicunawareness,

3. The results from alternative sites do not matchthe way you feel,

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

5. You monitor your blood -Ketone.

Cleaning Your MeterStore your meter in its carrying case.If the surface of your meter 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 nottry to clean the strip port.Do notpour liquid into the strip port or buttons.Do notplace your meter in water or any other bath.

Replacing Your Meters BatteryWhen your meter needs its batteries replaced, the displaywindow shows one of two things:

This means the battery is low. Youmay still use your meter and the resultswill be accurate. However, the backlightis not useable. It is recommended thatyou replace the battery at this time.

This means the battery must bereplaced.The meter is not useable.The meter turns off automatically.

IMPORTANT:Do notremove the old battery untilyou have a new battery to install. It may be necessary toreset the time and date once you install a new battery.



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56

CaringforYour

Meter

CaringforYour

Meter

Caringfor

YourMeter

55

How to Replace Your Meters Battery

1 Gently push the battery cover in andup with your thumb.

2Lift the battery cover out of the meter.

3 Pull on the plastic tab sticking out ofthe meter to remove the old battery.

4 Insert a new CR 2032 Lithium (coin

cell) battery with the plus sign (+)facing up.

5 Place the notches on the battery coverinto the appropriate molded areas.

6 Gently push the battery cover in anddown until you hear a click.

7 Press and Hold the button toturn your meter on. If your meterdoes not turn on, review the batteryinstallation steps and reinstall thebattery.

8 Check the date and time on yourmeter. You may automatically beprompted to reset the time and datewhen you first press the button toturn your meter on. (See Chapter 2,Setting Up Your System).

9 Be sure to discard the old batteryin compliance with your localgovernments regulations.



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58

Support

CHAPTER 11

57

Support

Questions? Call

Customer Support.Abbott Laboratorios Uruguay SAAbbott Diabetes CareHELPLINE: 000-405-4342

Abbott Laboratorios GuatemalaAbbott Diabetes CareHELPLINE: 597-4109

Abbott Laboratorios C.A.

Abbott Diabetes CareHELPLINE: 0-800-372-3300

Abbott Laboratorios PeruAbbott Diabetes CareHELPLINE: 0-800-1-1215

Abbott Laboratorios MexicoAbbott Diabetes CareHELPLINES: Mexico City (DF) 55-24-4175Outside Mexico City (DF) 01-800-711-2208

Support & GuaranteeSupport

Abbott Laboratories iscommitted to providing youwith support. Call us with anyquestions you may have aboutyour Optium Xceed meter:

Abbott Laboratorios Argentina SA

Abbott Diabetes CareHELPLINE: 0-800-8006334EMAIL: [email protected]

Abbott Laboratorios do Brasil Ltda.Abbott Diabetes CareHELPLINE: 0800 703-0128URL: www.abbottbrasil.com.br

Abbott Laboratorios de Chile Ltda.Abbott Diabetes CareHELPLINE: 800-802-226

Abbott Laboratorios de Colombia SAAbbott Diabetes Care

HELPLINE: 01-8000-522-268

Abbott Laboratorios Republica DominacanaAbbott Diabetes CareHELPLINE: 809-566-7181 (ext 263)



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Guarantee

59 60

References

References

1. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special

Topics in Endocrinology and Metabolism 1982; 4:127.

2. Wiggam MI, OKane 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 Care1997;

20:134752.

3. 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 theirvalue in the monitoring of diabetes control. Diabetologia1984; 26:3438.

4. 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 Metab1990; 34:33342.

5. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzo RA. Metabolic effects

of low-dose insulin therapy on glucose metabolism in diabetic ketoacidosis.

Diabetes1988; 37:147077.

6. Hale PJ, Crase J, Nattrass M. Metabolic effects of bicarbonate in the

treatment of diabetic ketoacidosis. Br Med J1984; 289; 10358.

Guarantee

Abbott Laboratories (Abbott) guarantees that the Optium Xceed Meter

shall be free from defects in material and workmanship for a period

of two (2) years (24 months) from the date of purchase. Abbotts sole

obligation shall be limited to replacing the defective meter with a new or

reconditioned unit. The guarantee extends only to the original purchaser

and is not assignable or transferable, and shall not apply to auxiliary

equipment or disposable accessories.

Abbott guarantees that the equipment is fit for the purpose and

indications described in the labeling when used in accordance with the

directions for use. Unless the equipment is used in accordance with suchinstructions, this guarantee is void and of no effect. Abbott guarantees

the performance of the Optium Xceed Meter if it is used as directed and

provided that the failure to perform or misperformance of the Optium

Xceed Meter has not been caused in whole or in part by the use of test

strips that are not MediSense Optium test strips manufactured by Abbott

Laboratories. In the unlikely even that your Optium Xceed Meter should

fail, it will be replaced free of charge. Contact Customer Support or your

local Abbott Laboratories office or distributor.



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ART10825 Rev A Man indd 64 11/10/06 1:11:02 PM

english manual xceed

Documents

optium xceed meter

monitoringyour blood

blood ketoneaccording

blood ketoneresults

monitoringyour blood

important information

optium xceed kit contents

system measures