Optium FreeStyle Users Manual Rev A Nov 2010

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

Catalogue number

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 in accordance with local regulations for separate collection of spent batteries.

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

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Monitoring System Kit Contents... 3

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Setting Up the Meter... 4 Enter Setup Mode...4 Beeper...4 Time...5 Date...5 Time Format... 5 Date Format... 6 Measurement Units... 6

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Testing Your Blood Glucose... 7 Important Testing Notes...7 Test Site ... 8 Alternative Sites ... 9 Performing a Blood Glucose Test... 10

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Understanding Blood Glucose Test Results... 13 Low and High Blood Glucose Results ... 13

MediSense or Optium 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

Testing Your Blood β-Ketone... 16 Important Testing Notes... 16 Test Site ... 17 Performing a Blood β-Ketone Test ... 17 Understanding Blood β-Ketone Test Results... 21 High Blood β-Ketone Results... 21

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Observe caution when using around children. Small parts may constitute a choking hazard.

How Your FreeStyle Optium Blood Glucose 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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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.

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IMPORTANT: Use only FreeStyle Optium blood glucose test strips and FreeStyle Optium blood β-Ketone test strips. Other test strips may produce inaccurate results.

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.

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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: See test strip instructions for use for more information about sample types.

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Intended Use

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Monitoring System Kit contains:

Enter Setup Mode

• Logbook • Warranty Card

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

• Blood Glucose Test Strips • Lancing Device

• Lancets

Press and hold

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and

until

and

appear. This indicates the beeper is turned on.

indicate the beeper is turned off.

Items not included:

• Blood β-Ketone Test Strips • Control Solutions

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• Data Management System

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

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

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Your Kit may also contain:

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• Meter • User’s Manual • Carrying Case

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

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Setting Up the Meter

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Monitoring System Kit Contents

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Time

Date Format

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Measurement Units

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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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IMPORTANT: Please check that the correct time and date is 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.

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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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.

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Month – Day

to

Day.Month

Date Year

Month – Day

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

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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.

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Important Testing Notes Language

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.

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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.

Test Site

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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.

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 to alternative site testing. (Adjust the lancing device accordingly for testing site. See lancing device instructions for use for more information.)

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A138

2012/03

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45001

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D5

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Testing Your Blood Glucose

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Alternative Sites

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Forearm

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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.

Time and date (if set) appear next.

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4˚C

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Upper arm

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

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.

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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

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.

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

Base of thumb

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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.

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

Performing a Blood Glucose Test

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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.

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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 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.

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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.

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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.)

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.

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

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Understanding Blood Glucose Test Results

Meter:

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

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

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

Low (hypoglycaemic)

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

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

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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What To Do

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IMPORTANT: The meter displays results from 1.1–27.8 mmol/L (20–500 mg/dL). Low or high blood glucose results can indicate a potentially serious medical condition.

What It Means

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

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The meter displays results in mmol/L or mg/dL. The unit of measurement is preset. You cannot change this setting.

Display

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Low and High Blood Glucose Results

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Testing Your Blood β-Ketone

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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

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What To Do

• 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 16.7 mmol/L (300 mg/dL) • When you are experiencing unusual blood glucose results • When you and your healthcare professional feel it is necessary

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

What It Means

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Display

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Meter:

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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.

See “Testing Your Blood Glucose” section for more information. Note: Avoid squeezing the puncture site. Time and date (if set) appear next.

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

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

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4˚C

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

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

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

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Performing a Blood β-Ketone Test

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2

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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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Fingertips

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Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service.

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Test Site

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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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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.

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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.

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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.

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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

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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 16.7 mmol/L (300 mg/dL)

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What To Do

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

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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IMPORTANT: The meter displays results from 0.0 - 8.0 mmol/L. Consult your healthcare professional before changing your diabetes medication programme.

What It Means

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The meter displays results in mmol/L. The unit of measurement is preset. You cannot change this setting.

Display

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High Blood β-Ketone Results

Meter:

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Understanding Blood β-Ketone Test Results

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Contact Customer Service for information on how to obtain control solutions.

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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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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

• Use only MediSense or Optium Glucose and Ketone control solutions with the meter • Replace the cap securely on the bottle immediately after use

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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.

Important Control Solution Testing Notes

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MediSense or Optium Glucose and Ketone Control Solutions

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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.

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Do not use the meter if the display check screen does not exactly match the example. Contact Customer Service.

will appear if performing a β-Ketone control solution

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.

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and

also appear.

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Note: test.

and

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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.

The Apply Sample symbols

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

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

4˚C

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

Performing a Control Solution Test

Time and date (if set) appear next.

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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.

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appears with the result if performing a β-Ketone control solution

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Note: test.

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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.

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.

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

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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

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

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Press

to turn the meter on.

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

= Blood β-Ketone result = Glucose control solution result

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Viewing Test Results in Memory

= Blood glucose result

= Ketone control solution result

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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

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.

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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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.

Your most recent result, with time and date (if set) it was obtained, appears next. The following symbols indicate the type of result:

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Managing Your Results

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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.

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. Your 7-day average appears.

Press and hold of inactivity.

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

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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 1.1 mmol/L (20 mg/dL) • blood glucose test results appear in averages as 27.8 mmol/L (500 mg/dL)

While in memory, press

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Viewing Blood Glucose Averages

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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.

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What It Means

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Meter error

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

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

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

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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What To Do

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Error Messages

What It Means

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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.

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Transferring Results to a Computer

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