Optium Xceed User Manual

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Page 1

Table of Contents

Welcome 1

1 Important Things to Know about Your

Optium Xceed Diabetes Monitoring System

Intended Use 3

How Your Optium Xceed Diabetes Monitoring System Works 4

Optium Xceed Kit Contents 4

Getting to Know Your Meter’s Features 5

2 Setting Up Your Optium Xceed Meter 7

Buttons to Use 7

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

Set Beeper 8 Set Time 9 Set Date 10 Set Time Format 12 Set 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 18 What You Will Need 18

Important Information about Monitoring Your Blood Glucose 18 How to Monitor Your Blood Glucose 19

Understanding Your Result 24

5 Monitoring Your Blood β-Ketone 27 What You Will Need 27

Important Information about Monitoring Your Blood

β-Ketone 27

How to Monitor Your Blood

β-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 & Troubleshooting

Error Messages 47

What An Error Message Means & 47

hat You Need to Do

9 Your Meter’s Specifications & Limitations 51

Important Information about Using Blood 53

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

he Thumb

10 Caring For Your Meter

Cleaning Your Meter 54

Replacing Your Meter’s Battery 54

11 Support & Guarantee 57

References 60

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Page 3

Please contact your local Abbott Diabetes Care office or distributor with any questions you may have about the Optium Xceed Diabetes Monitoring System (please see page 57 for Customer Support phone numbers). If you cannot reach your local office or distributor, contact your healthcare professional.

Please read the following items before using your Optium Xceed Diabetes Monitoring System:

• User guide

• Blood glucose test strip instructions for use

• Blood β-Ketone test strip instructions for use

• Lancing device instructions for use and other information

• Warranty card

Welcome

Thank you for choosing the Optium™ Xceed

™

Diabetes

Monitoring System.

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

Your new Optium Xceed Diabetes Monitoring System is an important tool that can help you better manage your diabetes. The System measures both blood glucose (sugar) and blood β-Ketone. Blood glucose and blood β-Ketone results can help you understand your diabetes and what happens with:

• Food

• Exercise

• Stress and illness

• Diabetes medications

Always monitor your blood glucose and blood β-Ketone according to your healthcare professional’s recommendations.

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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How Your Optium Xceed Diabetes Monitoring System Works

When you insert a test strip into your meter, the Apply Sample message shows on your meter’s display window. When a blood sample or control solution sample is applied to the test strip, the glucose or β-Ketone reacts with the chemicals on the test strip. This reaction produces a small electrical current that is measured. The result shows on your meter’s display window.

Optium Xceed Kit Contents

Optium Xceed Meter Optium Xceed User’s 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 start

your warranty. Filling out this card helps to ensure that you receive any updates regarding your Optium Xceed meter.

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

Items not included:

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

Important

Information

▼

CHAPTER 1

Important Things to Know about Your Optium Xceed Diabetes Monitoring System

Intended Use – Your Optium Xceed System:

• Is indicated for home (lay user) or professional use in the

management of patients with diabetes.

• Is for self testing or healthcare professional

use outside the body (in vitro diagnostic use).

• Is for monitoring glucose in fresh whole

blood (for example, from the fingertip).

• Is for monitoring β-Ketone in fresh whole

blood from the fingertip.

• Measures β-hydroxybutyrate (β-Ketone), the

most important of the three ketone bodies circulating in the bloodstream.

• Is for use only with Optium™ Blood Glucose Test Strips and

Optium™ Blood β-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 by

healthcare professionals only.

Healthcare professionals:

Please refer to the test strip instructions for use for more information about sample types.

Potential Infection Risk:

Healthcare professionals performing blood tests with this system on multiple patients must always wear gloves and should follow the infection control policies and procedures approved by their facility.

Questions? Call

Customer Support:

See page 57.

Important

Information

▼

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Important

Information

Strip Port

This is where you insert:

• A blood glucose test strip.

• A blood β-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 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 Button

Use this button to:

• Turn backlight ON and OFF.

Battery Compartment

This is where the battery is installed.

• If your meter does not turn on, check that

your battery is installed properly.

• For new battery installation, see Chapter 10.

Important

Information

Getting to Know Your Meter’s Features

Display Window

This shows:

• Blood glucose and blood

β-Ketone results.

• Glucose and β-Ketone

LOT numbers.

• Previous test results and

error messages.

• Blood glucose averages.

IMPORTANT:

Each time you turn your meter on, a full display shows. This is called a Display Check. Look at the Display Check each time it appears on your meter’s display window, especially before you monitor your blood glucose or blood β-Ketone. The Display Check shows on the display window briefly.

Do not use the meter if the meter Display Check does not exactly match the picture here (for example, if you see a "3" instead of an "8"). The meter may show an incorrect result when you use it. Please call Customer Support for assistance.

Back Button

Backlight Button

Display Window

Strip Port

Mode Button

Forward Button

▼

Display Check

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CHAPTER 2

Set Date Format

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

Measurement Units

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

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

Setting Up Your Optium Xceed Meter

Buttons to Use

Mode Button. Forward Button. Back Button.

Setup Options

Set Beeper

If the beeper is set ON, it will beep when:

• The calibrator is fully inserted.

• The test countdown starts.

• The test countdown finishes.

Set Time, Set Date

IMPORTANT: Set the correct time and date before you

use the meter for the first time. This will help you keep records of when you monitor

and will help you and your healthcare professional make informed decisions about your care.

You must set the time and date to review averages.

You may need to re-set the time and date:

• After you replace the battery.

• When you travel between time zones or when the time

zone you are in changes.

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

Set Time Format

In "Set Time Format", you choose how the time shows on the meter’s display window.

▼ ▼

Questions? Call

Customer Support:

See page 57.

How to Set the Beeper, Date, Time, & View Measurement Units

To begin, pull the battery tab out. Your meter should be turned OFF. You will automatically be prompted to set the time and date the first time you press the button to turn your meter on (see Set Time and Set Date sections in this chapter).

Before you start, please note: "Press and

Hold" means that you press the button in for at least 2 seconds. "Press and Release" means that you press the button and let it go quickly.

Press and Hold the

button to turn the meter off and save your settings at any time. The meter automatically turns off after 30 seconds of no action.

If you like the setting that you see on your meter and do not want to change it, Press and Release the

button to move to the

next setup option.

Set Beeper

The means the beeper is ON. The

means the beeper is OFF.

▼

Beeper OFF

Setting Up

Your Meter

Beeper ON

Setting Up

Your Meter

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Setting Up

Your Meter

To turn your meter ON, Press and

Hold the

button.

The beeper ON message shows on

the display window. The musical notes flash on and off, and the meter beeps.

To change the beeper setting, Press

and Release the

button or the

button once.

Press and Release the button to

save the beeper setting and to move to Set Time (Hour).

Setting Up

Your Meter

Set Time

Hour:

The Hour flashes on and off.

Press and Release the button to

move the hour forward.

If you go past the correct hour, Press

and Release the

button to move

the hour back.

Press and Release the button to

save the hour and to move to Set Minutes.

Minutes:

The Minutes flash on and off.

Press and Release the button to

move the minutes forward.

If you go past the correct minute, Press

and Release the

button to move the

minutes back.

Press and Release the button to save

the minutes and to move to Set Date.

Set Date

Year:

The Year flashes on and off.

Press and Release the button to

move the year forward.

If you go past the correct year, Press

and Release the

button to move the

year back.

Press and Release the button to save

the year and to move to Set Month.

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Setting Up

Your Meter

Choice #1

Choice #2

Month:

The Month flashes on and off.

Press and Release the button to

move the month forward.

If you go past the correct month,

Press and Release the

button to

move the month back.

Press and Release the button to save

the month and to move to Set Day.

Day:

The Day flashes on and off.

Press and Release the button to

move the

day forward.

If you go past the correct day, Press

and Release the

button to move

the day back.

Press and Release the button to

save the day and to move to Set Time Format.

Set Time Format

You have two choices:

Choice #1: For the 12-hour format, AM

or PM shows.

Choice #2: For the 24-hour format, AM

or PM does not show.

To change the Time Format, Press

and Release the

button or the

button once.

Press and Release the button to

save the Time Format and to move to 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".

To change the Date Format, Press

and Release the

button or the

button once.

Press and Release the button to

save the Date Format and to move to Measurement Units.

Choice #1

Choice #2

Setting Up

Your Meter

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Setting Up

Your Meter

Blood Glucose Measurement Units

Consult your healthcare professional if you have any questions about the blood glucose measurement units.

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

Press and Release the button to return to Set Beeper.

Press and Hold the

button to turn

your meter off.

You have successfully set up your meter.

Calibrating

Your Meter

CHAPTER 3

Why Calibrate Your Meter?

Your Optium Xceed meter 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 Meter

• When you use the meter for the first time.

• EACH time you open and use a new box of blood glucose

or blood β-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 β-Ketone calibration:

- Blood β-Ketone test strip.

- Blood β-Ketone test strip instructions for use.

- Blood β-Ketone test strip calibrator.

How to Calibrate Your Meter

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

This means the meter is

not calibrated

for blood glucose monitoring.

This means the meter is

not calibrated

for blood β-Ketone monitoring.

▼

Questions? Call Customer Support: See page 57.

▼

Calibrating Your Optium Xceed Meter

➡ ➡

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Calibrating

Your Meter

Calibrating

Your Meter

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

Do not use test strips that have expired. Check the expiration date on the test strip foil packet and test strip box. If only the year and month are shown, the expiration date is the last day of the month.

Check that the LOT number on all these items matches:

✓ Display window ✓ Test strip calibrator ✓ Test strip instructions for use ✓ Test strip foil packet

When the LOT number on all these items matches:

What It Means:

Calibration is complete.

What to Do:

You may now monitor your blood glucose or blood β-Ketone.

When the LOT number on all these items DOES NOT match:

What It Means:

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

What to Do:

• Check that you are using the calibrator that came in the

box of test strips you are using.

• Try to calibrate again.

IMPORTANT: If the LOT number still does not match, contact Customer Support.

Do not attempt to monitor your blood glucose or blood β-Ketone. Your meter may show an incorrect result.

Remove the calibrator from the meter and store it in your

meter’s carrying case.

IMPORTANT: Do not throw the calibrator away until you have used all of the test strips in the box.

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

Remove the glucose or β-Ketone calibrator package

from the new box of test strips.

Open the calibrator package. Find the

three raised bumps on the calibrator package. Peel the clear cover away from the three raised bumps.

Hold the calibrator (white for glucose

and purple for blood β-Ketone) with the LOT number facing you.

Insert the calibrator into the strip

port. Push it in until it stops.

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

a. Example of glucose LOT number:

LOT 13758

b. Example of β-Ketone LOT number:

CODE 12345

Then you hear the beeper, if the beeper is ON.

Glucose

β-Ketone

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Calibrating

Your Meter

How to Recall the LOT Number

To recall the glucose LOT number, Press and Hold the

button. While holding the button, Press and Hold

the button.

The Display Check shows on the

display window, then the glucose LOT number shows with the time, month, and day of the most recent glucose calibration.

After the glucose LOT number is displayed, you can

recall the β-Ketone LOT number. Press and Release the

button or the button.

The β-Ketone LOT number shows

"CODE", the time, month, and day of the most recent blood β-Ketone calibration.

▼

Note: If the LOT number that shows on your meter’s display window is not correct:

What It Means:

Your meter may not be calibrated for the box of test strips you 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 cause incorrect results.

Press and Hold the button to

turn 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 Your Blood Glucose

• Do not use out-of-date test strips. Check the expiration

date printed on the test strip box and on each test strip foil packet. If only the month and year are printed on the test strip, then the expiration date is the last day of that month.

• For more detailed information

about your test strip, please read its instructions for use before monitoring.

• Use the test strip immediately when you take it out of its

foil packet.

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

• Do not use the test strip if its foil packet has a puncture or

tear in it.

• Before you monitor, allow your meter and test strip to

reach the recommended operating range of the test strip. The test strip operating range is in the “What else do I need to know?” section of your blood glucose test strip instructions for use.

• Read the lancing device instructions for use.

Questions? Call Customer Service. See page 57.

▼▼

L O T

13758

EXP 2008/03

Example: Expiration date March 31, 2008

Monitoring

Blood Glucose

L O T

13758

EXP 2008/03

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Page 12

Monitoring

Blood Glucose

Monitoring

Blood Glucose

How to Monitor Your Blood Glucose

Getting Started

Prepare your lancing device.

Wash your hands using warm soapy

water and dry them completely.

Remove the test strip from its foil packet.

Note: For pictures that show how to open the blood

glucose test strip foil packet, please see the information card in the box of blood glucose test strips.

Insert the three black lines at the end

of the test strip into the strip port.

Push the test strip in until it stops.

The meter turns on automatically.

These items show on the display

window, one after the other:

• Display Check – Remember to make

sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.)

▼

• Time, month, and day (if set)

If date and time are not set, dashes

will show instead of numbers.

• LOT number for the box of blood

glucose test strips you are using.

• Apply Sample message, which tells

you that the meter is ready for you to apply blood to the blood glucose test strip.

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Monitoring

Blood Glucose

Monitoring

Blood Glucose

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 an appropriate alternative site lancing device.

• Before you obtain a blood sample from the fingertip,

forearm, upper arm, or base of the thumb, make sure the sample site is clean, dry, and warm. To warm the sample site, wash it in warm water, rub the skin vigorously for a few seconds, or apply a warm pad to it.

• Hang your arm down before pricking

your finger or the base of the thumb to help blood flow.

• To obtain a blood sample from the arm, use a fleshy area

away from bone. Avoid areas where there is a lot of hair.

• Avoid squeezing the puncture site.

• Apply the blood sample to the test strip

immediately.

Lancets and Lancing Device

• Lancets are for one-time use only. Use a new lancet

each time you monitor.

• Discard your used lancet properly. Put it in an

empty puncture-resistant container, such as a plastic milk carton or detergent bottle.

• Never share your lancing device or lancet with

another person.

Applying the Blood Drop to the Test Strip

Touch the blood drop to the white area

at the end of the test strip. The blood is drawn into the test strip.

Note: If the meter shuts off before you apply blood to the test strip, remove the test strip from the meter and try again.

Continue to touch the blood drop to the end of

the test strip until 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.

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

Countdown

Status bar

Fingertip sampling

Upper arm sampling

Forearm sampling

Base of thumb

sampling

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23 24

Monitoring

Blood Glucose

Monitoring

Blood Glucose

Correct

✔

IMPORTANT: If the countdown does not start:

What It Means:

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

What to Do:

• Apply a second drop of blood to

the test strip. Refer to your test strip instructions for use for the number of seconds you have to apply a second drop.

• If the countdown still does not start,

or if the number of seconds you have to apply a second drop have passed, discard the test strip, turn off your meter, and try again with a new test strip.

At the end of the countdown:

• If the beeper is ON, listen for

the beeper.

• The blood glucose result shows

on the display window.

• The result is stored in your meter’s

memory. You may also write the result in your logbook.

Shutting Off Your Meter

Removing the test strip from the strip port turns off the

meter. You can use the opened foil packet to remove and discard your used test strip.

Discard the test strip properly.

Note: You may also turn the meter off by Pressing and Holding the

button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds.

▼

Understanding Your Result

"LO" Result

What It Means:

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

What to Do:

Monitor your blood glucose again with a new test strip. If

LO shows on the display window again, contact your healthcare professional

immediately.

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Page 15

Monitoring

Blood Glucose

Result 300 mg/dL or Higher

When your blood glucose result is 300 mg/dL (16.7 mmol/L) or higher,

KETONES? flashes on

and off on the display window.

What to Do:

If you check your ketones as part of your diabetes management program, it is recommended that you check your blood β-Ketone.

"HI" Result

What It Means:

Your meter has determined that your blood glucose result is higher than 500 mg/dL (27.8 mmol/L) or there may be a problem with the test strip.

What to Do:

Monitor your blood glucose again with a new test strip. If

HI shows on the display window again, contact your healthcare professional

immediately.

If you check your ketones as part of your diabetes management program, it is recommended that you check your blood β-Ketone.

"E4" Result

What It Means:

Your meter has determined that your blood glucose may be too high to be read by the system, or there may be a problem with the test strip.

What to Do:

Monitor your blood glucose again with a new test strip. If

E4 shows on the display window again,

contact your healthcare professional

immediately.

IMPORTANT:

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

• LO shows on the display window.

• You obtain a low blood glucose result, but you do not have

symptoms of low blood glucose.

• Your meter displays a blood glucose result that is unusually

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

• HI shows 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, higher

than 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 your diabetes medication program.

Monitoring

Blood Glucose

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Page 16

CHAPTER 5

Monitoring

Blood β-Ketone

Monitoring Blood

β-Ketone

Monitoring Your Blood β-Ketone

It is important to check your ketones when:

• You have an illness.

• Your blood glucose is

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

• You are experiencing unusual blood glucose results.

• You and your healthcare professional determine that it

is necessary.

What You Will Need

• Blood β-Ketone test strip with its instructions for use.

• Optium Xceed meter calibrated to match the LOT

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

• Lancing device and a new, sterile lancet.

Important Information about Monitoring Your Blood β-Ketone

• For more detailed information about your blood β-Ketone

test strip, please refer to its instructions for use before monitoring.

• Do not use out-of-date test strips. Check the expiration

date printed on the test strip box and on each test strip foil packet.

• Do not put urine on the

blood β-Ketone test strip.

• Use the test strip immediately

when you take it out of its foil packet.

Questions? Call

Customer Support:

See page 57.

▼▼

• Do not use a wet, bent, scratched, or damaged

test strip.

• Do not use the test strip if its foil packet has a puncture or

tear in it.

• Use each test strip only once.

• Before you monitor your blood β-ketone, allow your meter

and test strip to reach the recommended operating range of the test strip. The test strip operating range is in the “What else do I need to know?” section of your blood β-Ketone test strip instructions for use.

• Read the lancing device instructions for use.

Example: Expiration date March 31, 2008

L O T

13758

EXP 2008/03

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Page 17

Monitoring

Blood β-Ketone

Monitoring Blood

β-Ketone

How to Monitor Your Blood β-Ketone

Getting Started

Prepare your lancing device.

▼

• Time, month, and day (if set)

If date and time are not set, dashes

will show instead of numbers.

• LOT number (CODE) for the box of blood

β-Ketone test strips you are using.

• KETONE and Apply Sample

message, which tell you that the meter is ready for you to apply blood to the blood β-Ketone test strip.

Obtaining A Blood Drop

Use your lancing device to obtain a blood drop.

IMPORTANT: Blood β-Ketone test strips have not been evaluated for alternative site monitoring.

Use only fingertip blood

samples for blood β-Ketone monitoring.

Fingertip sampling

Wash your hands using warm

soapy water and dry them completely.

Remove the test strip from its foil packet.

Note: For pictures that show how to open the blood β-Ketone test strip foil packet, please see the information card in the box of blood β-Ketone test strips.

Insert the three black lines at the end of the test strip

into the strip port.

Push the test strip in until it stops.

The meter turns on automatically.

These items show on the display

window, one after the other:

• Display Check – Remember to make

sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.)

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Page 18

Monitoring Blood

β-Ketone

Recommendations for Obtaining A Blood Drop

• Before you obtain a blood sample from the fingertip,

make sure the sample site is clean, dry, and warm. To warm the sample site, wash it in warm water or rub the skin vigorously for a few seconds.

• Hang your arm down before pricking your fingertip to

help blood flow.

• Avoid squeezing the fingertip.

• Apply the blood sample to the test strip immediately.

Lancets and Lancing Device

• Lancets are for one-time use only. Use a new lancet each

time you monitor.

• Discard your used lancet properly. Put it in an empty

puncture-resistant container, such as a plastic milk carton or detergent bottle.

• Never share your lancing device or lancet with

another person.

Applying the Blood Drop to the Test Strip

Touch the blood drop to the white area at the end

of the test strip. The blood is drawn into the test strip.

Monitoring

Blood β-Ketone

Continue to touch the blood drop to the white

area at the end of the test strip until 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.

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

IMPORTANT: If the countdown does not start:

What It Means:

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

What to Do:

• Apply a second drop of blood to the test strip. Refer

to your test strip instructions for use for the number of seconds you have to apply a second drop.

• If the countdown still does not start, or if the number of

seconds you have to apply a second drop have passed, discard the test strip, turn off your meter, and try again with a new test strip.

At the end of the countdown:

• If the beeper is ON, listen for the beeper.

• The blood β-Ketone result shows on the

display window with the word

KETONE.

• The result is stored in your meter’s

memory as a blood β-Ketone result. You may also write the result in your logbook.

Countdown

Status bar

Note: If the meter shuts off before you apply blood to the test strip, remove the test strip from the meter and try again.

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Monitoring

Blood β-Ketone

Monitoring Blood

β-Ketone

Shutting Off Your Meter

Removing the test strip from the strip port turns off

the meter. You can use the opened foil packet to remove and discard

your used test strip.

Discard the test strip properly.

Note: You may also turn the meter off by Pressing and Holding the

button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds.

Understanding Your Result

Blood β-Ketone is expected to be lower than 0.6 mmol/L.2 Blood β-Ketone may be higher when a person is ill, is fasting, exercises vigorously, or if blood glucose levels are not controlled.

1-3

When:

• Blood β-Ketone result is between 0.6 and 1.5 mmol/L and

blood glucose result is 300 mg/dL (16.7 mmol/L) or higher:

What It Means:

A problem requiring medical assistance may be occurring.

What to Do:

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

When:

• Blood β-Ketone result remains high or becomes higher

than 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 β-Ketone result is higher than 8.0 mmol/L, or there may be a problem with the test strip.

What to Do:

Monitor your blood β-Ketone again with a new test strip. If

HI shows on the display window again, contact your healthcare professional immediately.

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Monitoring Blood

β-Ketone

"E-4" Result

What It Means:

There may be a problem with the test strip.

What to Do:

Monitor your blood β-Ketone again with a new test strip. If

E-4 shows on the display window again, contact your healthcare professional

immediately.

IMPORTANT: It is recommended that you repeat the

blood β-Ketone test with a new test strip when:

• HI appears in the display window.

• Your result is unusually high.

• You question your result.

• You obtain a 0.0 mmol/L blood β-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 serious medical outcome. Consult your healthcare professional before 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 test strips are working correctly. A control solution test is similar to when you monitor your blood glucose or blood β-Ketone, except you use a MediSense Control Solution.

You do not use a drop of blood in a control solution test.

When Is Doing A Control Solution Test Recommended?

• When you question your results.

• To make sure that your meter and

test strips are working properly.

Important Information about Control Solution Testin

• 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 the

control solution instructions for use.

•MediSense Control Solutions may be used for glucose or

ketone control solution testing.

• Do not use the control solution if the expiration date has

passed. Check the expiration date printed on the control solution bottle.

• When you open a control solution bottle for the first time,

count forward 90 days and write this date on the control solution bottle using a pen that won’t smear or wipe off. Throw away any remaining solution after this date.

Control

Solution Testing

▼

Questions? Call Customer Support: See page 57.

▼▼

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Control Solution

Testing

Insert the three black lines at the end of

the test strip into the strip port.

Push the test strip in until it stops.

The meter turns on automatically.

These items show on the display window, one after the other:

• Display Check – Remember to make

sure that all items in the picture here show on the display window. (See Chapter 1 for more information about the Display Check.)

• Time, month, and day (if set)

If date and time are not set, dashes will

show instead of numbers.

• LOT number for the box of test strips

you are using.

• Apply Sample message, which tells you

that the meter is ready for you to apply control solution to the test strip.

Note: If you are a doing a β-Ketone control solution test,

KETONE will show on the meter’s display

window with the β-Ketone Apply Sample message.

Control

Solution Testing

• The results obtained from control testing do not reflect

your personal blood glucose or blood β-Ketone levels in any way.

• Do not swallow the control solution.

• Do not inject the control solution or use the control

solution as eye drops.

What You Will Need

• Optium Xceed meter calibrated to match the LOT

number of the test strip you are using

• Blood glucose or blood β-Ketone test strip and its

instructions for use

• MediSense Control Solutions and instructions for use

How to Do Control Solution Testing

Getting Started

Wash your hands using warm soapy water and dry

them completely.

Remove the test strip from its foil packet.

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

▼▼

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Control Solution

Testing

Control

Solution Testing

Control

Solution Testing

To mark the test as a control test, Press and Release

the

button once. shows on

the display window.

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

Applying Control Solution to the Test Strip

Turn the control solution bottle upside down three to

four times to mix the solution.

Remove the cap.

Apply a drop of control solution

to the test strip in the area shown here. The control solution is drawn into the test strip.

Continue to touch the control solution to the test strip

until 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.

Status bar

Countdown

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

IMPORTANT: If the countdown does not start:

What It Means:

You might not have applied enough control solution to the test strip.

What to Do:

• Apply a second drop of control solution to the

test strip. Refer to your test strip instructions for use for the number of seconds you have to apply a second drop.

• If the countdown still does not start, or

if the number of seconds you have to apply a second drop have passed, discard the test strip, turn off your meter, and try again with a new test strip.

At 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 β-Ketone control solution test, KETONE will also show with the result.

• The result is stored in your meter’s memory as a control

result. In your logbook, record the result as a control result.

Glucose

β-Ketone

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Page 23

Control Solution

Testing

Shutting Off Your Meter

Removing the test strip from the strip

port turns off the meter. You can use the opened foil packet to remove and discard your used test strip.

Discard the test strip properly.

Note: You may also turn the meter off by Pressing and Holding the

button. If you do not turn your meter off or pull the test strip out, the meter shuts off automatically after 60 seconds.

Understanding Your Result

Compare the control result to the "Expected Results for Use with MediSense Control Solutions" range printed on:

• The blood glucose test strip instructions for use, for

glucose control solution testing.

• The blood β-Ketone test strip instructions for use and foil

packet, for β-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 result does 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 the control solution testing instructions are followed completely. If the result is still not within the printed range, contact Customer Support.

▼

CHAPTER 7

Reviewing Results

What Can Your Meter Show You? Memory

Your Optium Xceed meter has a memory that stores up to 450 events. This is a combination of control results, your personal blood glucose and blood β-Ketone results, and other meter information.

You can review up to 450 of your most recent events on your meter’s display window.

Glucose Averages

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

IMPORTANT:

• To review blood glucose averages, you must set the

date and time before monitoring.

• If you do not mark control solution tests, this may affect

your glucose averages.

• Blood glucose averages do not include blood β-Ketone

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

• When there are no previous results or blood

glucose averages to review, the display window shows three dashes.

▼

Questions? Call Customer Support: See page 57.

Reviewing & Using Your Results

➡

CHAPTER 7

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Page 24

43 44

Reviewing Results

How to See Results in Memory

Begin with your meter turned off. Make sure there is

nothing in the strip port.

Press and Release the button.

• The Display Check shows on the

display window.

• Then your most recent result shows

with its units on the meter’s display window, along with the time, month, and day that you got the result. (To set the correct date and time, follow the steps in Chapter 2.)

A blood glucose result in Memory will show with the letters

MEM.

A blood β-Ketone result in Memory will show with the letters

KET MEM.

▼

Blood β-Ketone

result in Memory

Blood Glucose

result in Memory

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

To review previous results, Press and

Release the

button once per result.

When you reach the last result in

Memory, the display window shows three dashes.

To return to a result you previously

reviewed, Press and Release the button once per result.

Glucose control

solution result

in Memory

β-Ketone control

solution result

in Memory

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Reviewing Results

4645

How to See Averages

IMPORTANT:

• Results that show as LO during blood glucose

monitoring are included as 20 mg/dL (1.1 mmol/L) in blood glucose averages.

• Results that show as HI during blood glucose

monitoring are included as 500 mg/dL (27.8 mmol/L) in blood glucose averages.

▼

While in Memory, Press and

Release the

button at any time to see the 7-Day average of your blood glucose results.

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

Press and Release the button

once to see the 14-Day average of your blood glucose results.

Press and Release the button

again to see the 30-Day average of your blood glucose results. If you Press and Release the button again, the display window shows the 7-Day average.

Press and Release the button

at any time to return to Memory.

Press and Hold the button to turn off your meter.

Otherwise, the meter turns off after 30 seconds.

Transferring Your Results to a Computer

The results in your Optium Xceed meter's memory, along with the time and date of the reading, can be transferred to a computer with the use of the Precision Link

Direct Software Version 2.5 and a Precision Link communications cable. For information on how to purchase the software and cable, contact Customer Support. To install the software, please follow the instructions provided in the Precision Link User's Guide.

▼

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Error Messages

CHAPTER 8

Understanding & Troubleshooting Error Messages

There are times when error messages may show on your meter’s display window.

In the next few pages, we describe the error messages that may show on your meter’s display window, what they mean, and what you need to do.

Questions? Call

Customer Support:

See page 57.

Temperature is too hot or too cold for the system to work properly.

• Move your meter

and test strips to a location where the temperature is appropriate and monitor again with a new test strip. You may have to wait for your meter to adjust to the new temperature. Refer to your test strip instructions for use for the appropriate operating range.

• If the error message

appears again, contact Customer Support.

Message

What It What You

Means Need to Do

Message

What It What You

Means Need to Do

Meter error.

There may be a problem with the test strip.

Blood glucose result may be too high to be read by the system.

There may be a problem with the blood glucose or blood β-Ketone test strip.

• Turn the meter off,

then repeat previous monitoring steps.

• If the error message

appears again, contact Customer Support.

• Review the monitoring

instructions.

• Monitor again with a

new test strip.

• If the error message

appears again, contact Customer Support.

• Monitor again with

a new test strip.

• If the error

message appears again, contact your healthcare professional immediately.

Error Messages

4847

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Page 27

Blood applied to test strip too soon.

Calibration/Test strip error.

Test strip error.

Test strip is damaged, used, or the meter does not recognize it.

• Review the monitoring

instructions.

• Monitor again with a

new test strip.

• If the error message

appears again, contact Customer Support.

• Repeat the calibration

using the calibrator bar that came with the test strip you are using.

• Check the date setting

on your meter.

• Check the expiration

date on the test strip foil packet.

• If the error message

appears again, contact Customer Support.

• Monitor again using

a test strip designed for use with Optium Xceed.

• If the error message

appears again, contact Customer Support.

Message

What It What You

Means Need to Do

Message

What It What You

Means Need to Do

Meter error.

Meter err

or.

• Remove test strip, turn

meter off, and try to monitor again.

• If the error message

appears again, contact Customer Support.

• Remove test strip, turn

meter off, and try to monitor again.

• If the error message

appears again, contact Customer Support.

Error Messages

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CHAPTER 9

Questions? Call

Customer Support:

See page 57.

Specifications

& Limitations

Specifications

& Limitations

Your Meter’s Specifications & 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 control

results, personal blood glucose and blood β-Ketone results, and other meter information

Storage Temperature

Meter: Test Strips: Control Solution:

–25º to 55ºC See test strip instructions for use See control solution instructions for use

Blood Glucose Assay Range

See blood glucose test strip instructions for use

Blood β-Ketone Assay Range

See blood β-Ketone test strip instructions for use

Control Solution Range

See blood glucose or blood β-Ketone test strip instructions for use

Functions - Blood glucose monitoring

- Blood β-Ketone monitoring

- Memory 450 events

- Glucose averaging: 7-Day, 14-Day, and 30-Day Averages

- Control solution marking and testing

- Backlight: If ON – Stays ON during countdown; turns OFF 30 seconds after result is displayed. If OFF – Stays OFF during countdown; stays OFF during data upload

- Beeper: If ON – Beeps when calibrator is fully inserted and when countdown starts and finishes

Data port Yes

Meter Operating Range

Temperature: Relative Humidity:

10º to 50ºC 10% to 90%, non-condensing

System Operating Range

Temperature:

Relative Humidity:

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

10% to 90%, non-condensing

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CHAPTER 10

Specifications

& Limitations

Caring For Your Meter

Caring for

Your Meter

Questions? Call Customer Support: See page 57.

▼

Important Information about Using Blood Samples from the Forearm, Upper Arm, or Base of the Thumb:

• Contact your healthcare professional before you

begin using any one of these alternative sites to test your blood glucose.

• Sampling from any one of these alternative sites may

cause minor bruising and may leave marks that go away in a short time.

• There may be times when alternative site results are

different from fingertip results. This happens when blood glucose levels change rapidly (for example, after you eat a meal, after you take insulin, or during or after exercise).

• Use alternative sites to monitor your blood glucose

before, or more than two hours after, you eat a meal, take insulin, or exercise.

• Do not use blood samples from alternative sites

when:

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

2. You have been diagnosed with hypoglycemic unawareness,

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

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

5. You monitor your blood β-Ketone.

▼

Cleaning Your Meter

Store 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 not try to clean the strip port. Do not pour liquid into the strip port or buttons. Do not place your meter in water or any other bath.

Replacing Your Meter’s Battery

When your meter needs its batteries replaced, the display window shows one of two things:

This means the battery is low. You may still use your meter and the results will be accurate. However, the backlight is not useable. It is recommended that you replace the battery at this time.

This means the battery must be replaced. The meter is not useable.

The meter turns off automatically.

IMPORTANT:

Do not remove the old battery until you have a new battery to install. It may be necessary to reset the time and date once you install a new battery.

➡

▼

➡

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Caring for Your

Meter

Caring for Your

Meter

Caring for

Your Meter

How to Replace Your Meter’s Battery

Gently push the battery cover in and

up with your thumb.

Lift the battery cover out of the meter.

Pull on the plastic tab sticking out of

the meter to remove the old battery.

Insert a new CR 2032 Lithium (coin

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

Place the notches on the battery cover

into the appropriate molded areas.

Gently push the battery cover in and

down until you hear a click.

Press and Hold the button to

turn your meter on. If your meter

does not turn on, review the battery installation steps and reinstall the

battery.

Check the date and time on your

meter. You may automatically be prompted to reset the time and date when you first press the button to turn your meter on. (See Chapter 2, Setting Up Your System).

Be sure to discard the old battery

in compliance with your local government’s regulations.

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Support

CHAPTER 11

Support

Questions? Call

Customer Support.

Abbott Laboratorios Uruguay SA Abbott Diabetes Care HELPLINE: 000-405-4342

Abbott Laboratorios Guatemala Abbott Diabetes Care HELPLINE: 597-4109

Abbott Laboratorios C.A. Abbott Diabetes Care HELPLINE: 0-800-372-3300

Abbott Laboratorios Peru Abbott Diabetes Care HELPLINE: 0-800-1-1215

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

Support & Guarantee

Support

Abbott Laboratories is committed to providing you with support. Call us with any questions you may have about your Optium Xceed meter:

Abbott Laboratorios Argentina SA Abbott Diabetes Care HELPLINE: 0-800-8006334 EMAIL: [email protected]

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

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

Abbott Laboratorios de Colombia SA Abbott Diabetes Care HELPLINE: 01-8000-522-268

Abbott Laboratorios Republica Dominacana Abbott Diabetes Care HELPLINE: 809-566-7181 (ext 263)

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Guarantee

59 60

References

1. Schade DS, Eaton RP. Metabolic and clinical significance of ketosis. Special Topics in Endocrinology and Metabolism 1982; 4:1–27.

2. Wiggam MI, O’Kane MJ, Harper R, Atkinson AB, Hadden DR, Trimble ER, Bell PM. Treatment of diabetic ketoacidosis using normalization of blood 3hydroxybutyrate concentration as the endpoint of emergency management. Diabetes Care 1997; 20:1347–52.

3. Harano Y, Kosugi K, Hyosu T, Suzuki M, Hidaka H, Kashiwagi A, Uno S, Shigeta Y. Ketone bodies as markers for Type 1 (insulin-dependent) diabetes and their value in the monitoring of diabetes control. Diabetologia 1984; 26:343–8.

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 Metab 1990; 34:333–42.

5. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzo RA. Metabolic effects of low-dose insulin therapy on glucose metabolism in diabetic ketoacidosis. Diabetes 1988; 37:1470–77.

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

Br Med J 1984; 289; 1035–8.

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. Abbott’s 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 such instructions, 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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