Optium FreeStyle Users Manual Rev A March 2011

Definition of Symbols These symbols are associated with your meter. CE Mark Batch code

The European Battery Directive requires separate collection of spent batteries, aiming to facilitate recycling and to protect the environment. The batteries in this product should be removed and disposed of in accordance with local regulations for separate collection of spent batteries.

Catalogue number

Caution

This packaging is capable of being recycled

Consult instructions for use

Manufacturer

Date of manufacture

Sterilised using irradiation (lancets only)

Do not drink

Temperature limitation

Do not reuse

Use by

In vitro diagnostic medical device

Serial number

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DO NOT PRINT FROM THIS FILE FOR REFERENCE ONLY

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Table of Contents

Intended Use... 1 Monitoring System Kit Contents... 3 Setting Up the Meter... 4 Enter Setup Mode...4 Beeper...4 Time...5 Date...5 Time Format... 5 Date Format... 6 Measurement Units... 6 Testing Your Blood Glucose... 7 Important Testing Notes...7 Test Site ... 8 Alternative Sites ... 9 Performing a Blood Glucose Test... 10 Understanding Blood Glucose Test Results... 13 Low and High Blood Glucose Results ... 13 Testing Your Blood β-Ketone... 16 Important Testing Notes... 16 Test Site ... 17 Performing a Blood β-Ketone Test ... 17

MediSense Glucose and Ketone Control Solutions... 23 Important Control Solution Testing Notes... 24 Performing a Control Solution Test... 25 Managing Your Results... 29 Viewing Test Results in Memory ... 29 Viewing Blood Glucose Averages... 31 Transferring Results to a Computer... 33 Error Messages... 33 E-1 to E-9, What It Means, What To Do... 33 Troubleshooting... 36 Maintaining the Meter... 39 Replacing the Battery... 39 Cleaning the Meter ... 41 Storing the Meter... 42 Specifications... 42 References... 45 Warranty Statement... 46

Understanding Blood β-Ketone Test Results... 21 High Blood β-Ketone Results... 21

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Intended Use Use outside the body only (in vitro diagnostic use) for self testing or professional use in the management of diabetes. Use for measuring blood glucose from samples taken from the forearm, upper arm, base of the thumb or fingers. • Test blood glucose in fresh whole blood samples • Test blood β-Ketone (β-hydroxybutyrate) in fresh whole blood samples from fingers only IMPORTANT: Use only FreeStyle Optium blood glucose test strips and FreeStyle Optium blood β-Ketone test strips. Other test strips may produce inaccurate results.

IMPORTANT: See 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. Read the instructions in this user’s manual. Failure to follow instructions will cause incorrect results. Practise the testing procedures before using the meter. Follow your healthcare professional’s advice when testing blood glucose levels and blood β-Ketone levels. Observe caution when using around children. Small parts may constitute a choking hazard.

How Your FreeStyle Optium Blood Glucose and Ketone 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. IMPORTANT: Avoid getting dust, dirt, blood, control solution, water or any other substance in the meter’s test strip port.

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Monitoring System Kit Contents

Setting Up the Meter

Monitoring System Kit contains:

Enter Setup Mode

• Meter • User’s Manual

• Carrying Case

Start with the meter off (no test strip inserted).

Your Kit may also contain:

• Blood Glucose Test Strips • Lancing Device

• Lancets Press and hold

Items not included:

• Blood β-Ketone Test Strips • Control Solutions

and

• Data Management System

until

and

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appear. This indicates the beeper is turned on.

indicate the beeper is turned off.

Beeper Press or to change the beeper setting. Press to save the beeper setting and move to set time.

3

Commands • Press to move between setup displays • Press to move forwards • Press to go back • Press to turn display light On and Off

The beeper sounds when: • The test countdown starts • The test countdown ends

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Time

Date Format The hour flashes. Press or until the correct hour appears. Press to save the hour and to move to set minutes. The minutes flash. Press or until the correct minutes appear. Press to save the minutes and to move to set date.

Month – Day

to save

Day. Month

Date Year

Month – Day

The date format flashes. Press or to change the date format. Press the date format and to move to the measurement units.

The year flashes. Press or until the correct year appears. Press to save the year and to move to set month. The month flashes. Press or until the correct month appears. Press to save the month and to move to set day. The day flashes. Press or until the correct day appears. Press to save the day and to move to set time format.

IMPORTANT: Please check that the correct time and date are set 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.

Measurement Units The unit of measurement set by the factory appears. You cannot change this setting. Contact Customer Service for more information. Press to return to set beeper, or press and hold to turn off the meter.

Time Format 24 Hour Format

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Note: If using the 12-hour time format, AM and PM appear. The time format flashes. Press or to change the time format. Press save the time format and to move to set date format.

to

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Testing Your Blood Glucose

D5

45001

A138

2012/03

Important Testing Notes

E.g. Expiry date: March 31, 2012

This display always appears when the meter is turned on. You should check that your meter matches the example you see here exactly every time your meter turns on.

Note: See test strip instructions for use for operating range and more information on limitations of use.

Do not use the meter if the display check screen does not exactly match the example. If the screen does not match, the meter may show an incorrect result. Please contact Customer Service.

D5

45001

A138

2012/03

E.g. Expiry date: March 31, 2012

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• Use the meter within the test strip operating range • Use the test strip immediately after removing it from its foil packet • Use each test strip only once

Do not use expired test strips; they may produce inaccurate results. The expiry date is the last day of the month if only the month and year are shown. 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.

Test Site

Fingertips

IMPORTANT: Wash your hands and the test site with warm soapy water to ensure accurate results. Thoroughly dry your hands and the test site. To warm the site, apply a warm dry pad or rub vigorously for a few seconds. Note: Avoid areas near bones, areas with lots of hair, and squeezing the puncture site. Bruising may occur at alternate sites, but will disappear quickly. If bruising occurs, consider selecting another site. Finger tip testing is different from alternative site testing. (Adjust the lancing device accordingly for testing site. See lancing device instructions for use for more information.)

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• Alternative site results may differ from fingertip results when blood glucose

2

Base of thumb

levels change rapidly (e.g. after eating a meal or taking insulin, or during or after exercise) • Use alternative sites before, or more than two hours after, you eat a meal, take insulin or exercise

Upper arm 2

Forearm

Do not use blood samples from alternative sites when: • You think your blood glucose is low or changing rapidly • You have been diagnosed with hypoglycaemic unawareness • Alternative site results do not match the way you feel • You are within two hours of eating a meal, taking insulin or exercising

Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

Open the foil test strip packet at the notch and tear down to remove the test strip.

4˚C

Obtaining a blood sample from alternative sites – forearm, upper arm and base of the thumb – is subject to limitation. Contact your healthcare professional before beginning alternative site testing.

2

Performing a Blood Glucose Test

Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

Alternative Sites

Insert the Test Strip With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter. Note: The meter turns off after 3 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.

This display always appears when the meter is turned on. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service. See “Testing Your Blood Glucose” section for more information.

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Time and date (if set) appear next.

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Hold the blood drop to the white area until the meter beeps (if sound is on) and the status bar appears on the display. This indicates the test strip has obtained enough blood.

Obtain a Blood Sample Select a test site. Use the lancing device to obtain a blood sample. (See lancing device instructions for use for more information.)

The countdown appears on the display as the meter checks your glucose level. Note: Do not remove the test strip from the meter or disturb the test strip during the countdown.

Apply Blood to the Test Strip Bring the blood drop to the white area at the end of the test strip. The blood is drawn into the test strip.

View the Result The meter beeps (if sound is on) when the result appears on the display. The test is complete (example shown). The result is stored in memory or you can write it in a logbook. Turn Off the Meter Use the opened foil packet to remove the used test strip. This turns off the meter. Discard the used test strip correctly. Note: You can also press and hold for at least 2 seconds to turn off the meter. The meter also turns off after 60 seconds of inactivity.

2

The Apply Sample symbols and appear next, indicating the meter is ready for you to apply a sample to the test strip.

IMPORTANT: If the countdown does not start, you may not have applied enough blood to the test strip. See test strip instructions for use for re-application instructions. If the countdown still does not start, remove the used strip and discard it correctly. Start a new test with a new test strip.

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Understanding Blood Glucose Test Results

Meter:

Low and High Blood Glucose Results The meter displays results in mg/dL or mmol/L. The unit of measurement is preset. You cannot change this setting. IMPORTANT: The meter displays results from 20–500 mg/dL

(1.1–27.8 mmol/L). Low or high blood glucose results can indicate a potentially serious medical condition.

Display

What It Means

What To Do

Appears when result is: Lower than 20 mg/dL (Lower than 1.1 mmol/L)

Severe low blood glucose or There may be a problem with the test strip

Repeat the test with a new test strip. If the result is LO, contact your healthcare professional immediately.

Blood glucose level is high

Check blood β-Ketone, if checking ketones is part of your diabetes management programme.

General: Result

What It Means

What To Do

Lower than 50 mg/dL (Lower than 2.8 mmol/L)

Low (hypoglycaemic)

Repeat the test with a new test strip, even if you do not feel that you have low blood glucose.

Higher than 300 mg/dL (Higher than 16.7 mmol/L)

High (hyperglycaemic)

Repeat the test with a new test strip, even if you do not feel that you have high blood glucose.

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Appears with result which is: Higher than or equal to 300 mg/dL (Higher than or equal to 16.7 mmol/L)

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Testing Your Blood β-Ketone

Meter: Display

What It Means

What To Do

Appears when result is: Higher than 500 mg/dL (Higher than 27.8 mmol/L)

Severe high blood glucose or There may be a problem with the test strip

Repeat the test with a new test strip. If the result is HI, contact your healthcare professional immediately. Check blood β-Ketone, if checking ketones is part of your diabetes management programme.

Note: If you see the error messages E-3 or E-4, consult the Error Messages section in this user’s manual. IMPORTANT: Contact your healthcare professional if you have symptoms that do not match your test result, and you have followed the instructions in this user’s manual.

Important Testing Notes D5

75001

A17

2012/ 03

E.g. Expiry date: March 31, 2012

• Use the meter within the test strip operating range • Use the test strip immediately after removing it from the foil packet • Use each test strip only once Do not use expired test strips; they may produce inaccurate results. The expiry date is the last day of the month if only the month and year are shown. Do not put urine on the test strip. 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. Note: See test strip instructions for use for operating range and more information on limitations of use.

Check your ketones: • When you have an illness • When your blood glucose is above 300 mg/dL (16.7 mmol/L) • When you are experiencing unusual blood glucose results • When you and your healthcare professional feel it is necessary

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Test Site

This display always appears when the meter is turned on.

IMPORTANT: Wash your hands with warm soapy water to ensure accurate results. Thoroughly dry your hands. To warm the site, apply a warm dry pad or rub vigorously for a few seconds.

Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service. See “Testing Your Blood Glucose” section for more information.

Note: Avoid squeezing the puncture site. Fingertips

Time and date (if set) appear next.

Use only fingertip blood samples for blood β-Ketone testing.

and the Apply Sample symbol appear, indicating the meter is ready for you to apply a sample to the test strip.

Open the foil test strip packet at the notch and tear down to remove the test strip.

Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

4˚C

Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

Performing a Blood β-Ketone Test

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2

Insert the Test Strip With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter. Note: The meter turns off after 3 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.

Obtain a Blood Sample Select a test site. Use the lancing device to obtain a blood sample. (See lancing device instructions for use for more information.)

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Apply Blood to the Test Strip Bring the blood drop to the white area at the end of the test strip. The blood is drawn into the test strip. IMPORTANT: If the countdown does not start, you may not have applied enough blood to the test strip. See test strip instructions for use for re-application instructions. If the countdown still does not start, remove the used strip and discard it correctly. Start a new test with a new test strip.

View the Result The meter beeps (if sound is on) when the result and appears on the display. The test is complete (example shown). The result is stored in memory or you can write it in a logbook. Turn Off the Meter Use the opened foil packet to remove the used test strip. This turns off the meter. Discard the used test strip correctly. Note: You can also press and hold for at least 2 seconds to turn off the meter. The meter also turns off after 60 seconds of inactivity.

Hold the blood drop to the white area until the meter beeps (if sound is on) and the status bar appears on the display. This indicates the test strip obtained enough blood.

The countdown appears on the display as the meter checks your β-Ketone level. Note: Do not remove the test strip from the meter or disturb the test strip during the countdown.

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Understanding Blood β-Ketone Test Results High Blood β-Ketone Results The meter displays results in mmol/L. The unit of measurement is preset. You cannot change this setting. IMPORTANT: The meter displays results from 0.0–8.0 mmol/L. Consult your healthcare professional before changing your diabetes medication programme.

Blood β-Ketone is expected to be below 0.6 mmol/L.2 High blood β-Ketone may be caused by illness, fasting, vigorous exercise or uncontrolled blood glucose levels.1-3 Repeat a blood β-Ketone test using a new blood β-Ketone test strip when: • HI appears on the display • Your result is unusually high • You question your result • Your blood β-Ketone result is 0.0 mmol/L, but your blood glucose is higher than 300 mg/dL (16.7 mmol/L)

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Meter: Display

What It Means

What To Do

Result is between: 0.6–1.5 mmol/L and your blood glucose result is: Higher than 300 mg/dL (Higher than 16.7 mmol/L)

High blood β-Ketone

Result remains: 0.6–1.5 mmol/L or becomes: Higher than 1.5 mmol/L

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

Contact your healthcare professional immediately.

Very high blood β-Ketone or There may be a problem with the test strip

Repeat the test with a new test strip. If the result is HI, contact your healthcare professional immediately.

Appears when result is: Higher than 8.0 mmol/L

A problem requiring medical assistance may be occurring

Contact your healthcare professional for sick-day management instructions.

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MediSense Glucose and Ketone Control Solutions IMPORTANT: 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 solutions may be used with either glucose or β-Ketone test strips. Use control solution: • To practise testing without using your own blood • To confirm that the meter and test strips work together correctly • When you are unsure of your blood glucose or blood β-Ketone test results Contact Customer Service for information on how to obtain control solutions.

Important Control Solution Testing Notes

• Use only MediSense Glucose and Ketone control solutions with the meter • Replace the cap securely on the bottle immediately after use Do not use control solution past the expiry date. Do not add water or other liquid to control solution. Do not swallow or inject the control solution. Do not use the control solution as eye drops. IMPORTANT: Control solution results should fall within the control solution range printed on the test strip instructions for use. Check that the lot number printed on the test strip packet and instructions for use match.

• Repeat the test if control solution results are outside this range • Stop using the meter if control solution results are continually outside the range printed on the test strip instructions for use. Contact Customer Service

IMPORTANT: Control solution results do not reflect your blood glucose or blood β-Ketone level.

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Open the foil test strip packet at the notch and tear down to remove the test strip.

Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

4˚C

Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.

Performing a Control Solution Test

Insert the Test Strip With the contact bars (3 black lines) facing up, insert the test strip into the meter until it stops. This turns on the meter. Note: The meter turns off after 3 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.

This display always appears when the meter is turned on. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service.

The Apply Sample symbols

and

Note: solution test.

will appear if performing a β-Ketone control

and

also appear.

Press to mark the test as a control solution test. The appears. The meter is now ready for you to apply control solution to the test strip. IMPORTANT: The test result will be saved to memory as a blood glucose or blood β-Ketone result if not marked as a control solution test. This may affect your blood glucose averages.

Apply Control Solution to the Test Strip Shake the control solution bottle to mix the solution. Apply a drop of control solution to the white area at the end of the test strip in the area shown. The control solution is drawn into the test strip.

See “Testing Your Blood Glucose” section for more information. Hold the control solution drop to the white area until the meter beeps (if sound is on) and the status bar appears on the display. This indicates the test strip has obtained enough control solution. Time and date (if set) appear next.

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

Compare the control solution result to the range printed on the blood glucose or blood β-Ketone test strip instructions for use. The result should fall within the range. Causes of out-of-range results include: • The meter and test strips may not be working correctly

If the countdown does not start, remove and discard the used test strip, turn off the meter and try again with a new strip.

Repeat the test with a new test strip. Follow the testing instructions carefully. Contact Customer Service if the result is still outside the printed range.

The countdown appears on the display as the meter checks the glucose or β-Ketone level.

View the Result The meter beeps (if sound is on) when the result appears on the display. The test is complete (examples shown). The result is stored in memory as a control solution result or you can write it in a logbook as a control result. Note: solution test.

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Turn Off the Meter Use the opened foil packet to remove the used test strip. This turns off the meter. Discard the used test strip correctly. Note: You can also press and hold for at least 2 seconds to turn off the meter. The meter also turns off after 60 seconds of inactivity.

appears with the result if performing a β-Ketone control

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Managing Your Results Meter memory stores up to 450 events – control solution, blood glucose and blood β-Ketone results, and other meter information. The most recent events appear first.

Viewing Test Results in Memory Start with the meter off (no test strip inserted). Press

to turn the meter on.

Your most recent result, with the time and date (if set) when it was obtained, appears next. The following symbols indicate the type of result: = Blood glucose result = Blood β-Ketone result = Glucose control solution result = Ketone control solution result

This display always appears when the meter is turned on. Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service. See “Testing Your Blood Glucose” section for more information.

Press to review the previous result. Repeat this for each result you wish to review. Note: To exit meter memory at any time, press and hold

.

Appear on the display when there are no previous results to view.

Press to return to a previously reviewed result. Repeat this for each result you wish to review. Note: To exit meter memory at any time, press and hold

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.

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Viewing Blood Glucose Averages IMPORTANT: • Set the date and time before testing to be able to review averages • Averages do not include glucose and β-Ketone control solution results, blood β-Ketone results and results that do not show time and date • Control solution results not marked as control solution tests may cause averages to be inaccurate • appear on the display when there are no current averages to view • blood glucose test results appear in averages as 20 mg/dL (1.1 mmol/L) • blood glucose test results appear in averages as 500 mg/dL (27.8 mmol/L)

While in memory, press

Note: n = number of results included in your 7-, 14- or 30-day average.

Press

to view the 14-day average.

Press

to view the 30-day average.

Press

to return to the 7-day average or

Press

to return to the memory screen.

Press and hold inactivity.

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. Your 7-day average appears.

to turn off the meter. The meter turns off after 30 seconds of

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Transferring Results to a Computer

Message

Transferring test results to a computer requires a compatible data management system. For more information, please go to our website or contact Customer Service.

Error Messages Message

What It Means

What To Do

The temperature is too hot or too cold for the meter to work correctly

1. Move the meter and test strips to a location where the temperature is within the test strip operating range. (See test strip instructions for use for the appropriate range.) 2. Wait for the meter and test strips to adjust to the new temperature. 3. Repeat the test using a new test strip. 4. If the error reappears, contact Customer Service.

Meter error

1. Turn off the meter. 2. Repeat the previous testing steps. 3. If the error reappears, contact Customer Service.

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What It Means The blood glucose level may be too low to be read by the system or

What To Do 1. Review the testing instructions. 2. Repeat the test using a new test strip. 3. If the error reappears, contact your healthcare professional immediately.

There may be a problem with the test strip

The blood glucose level may be too high to be read by the system or There may be a problem with the test strip

1. Repeat the test using a new test strip. 2. If the error reappears, contact your healthcare professional immediately.

Blood was applied to the test strip too soon

1. Review the testing instructions. 2. Repeat the test using a new test strip. 3. If the error reappears, contact Customer Service.

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