Optium Xceed User Manual

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Doing A Control Solution Test

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

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Reviewing & Using Your Results

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What Can Your Monitor Show You? How to See Results in Memory How to See Averages Transferring Your Results to A Computer

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Understanding & Troubleshooting Error Messages

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What An Error Message Means & What You Need to Do

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Your Monitor’s Specifications & Limitations Important Information about Using Blood Samples from the Forearm, Upper Arm, or Base of the Thumb

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Caring For Your Monitor

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Cleaning Your Monitor Replacing Your Monitor’s Battery

82 83

Support & Guarantee

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References

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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 ß-Ketone. Blood glucose and blood ß-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 ß-Ketone according to your healthcare professional’s recommendations.

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Call Customer Service in Australia at 1800 801 478, or in New Zealand at 0800 106 100 with any questions you may have about the Optium Xceed Diabetes Monitoring System. If you cannot reach Customer Service, contact your healthcare professional. Outside Australia and New Zealand, please contact your local Abbott Laboratories, MediSense Products office or distributor. Please read the following items before using your Optium Xceed Diabetes Monitoring System: •User guide •Blood glucose electrode instructions for use •Blood ß-Ketone electrode instructions for use •Lancing device instructions for use and other information •Warranty card

IMPORTANT: Any user guide text shown in a shaded box like this one is important information. Please pay special attention to these boxes.

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CHAPTER 1

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Important Information

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 ß-Ketone in fresh whole blood from the fingertip. •Measures ß-hydroxybutyrate (ß-Ketone), the most important of the three ketone bodies circulating in the bloodstream. •Is for use only with MediSense® OptiumTM Blood Glucose Electrodes and MediSense® OptiumTM Ketone Blood ß-Ketone Electrodes. 3

Questions? Call Customer Service. See page 87.

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Healthcare professionals: Please refer to the electrode 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. How Your Optium Xceed Diabetes Monitoring System Works When you insert an electrode into your monitor, the Apply Blood message shows on your monitor’s display window. When a blood sample or control solution sample is applied to the electrode, the glucose or ß-Ketone reacts with the chemicals on the electrode. This reaction produces a small electrical current that is measured. The result shows on your monitor’s display window.

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Optium Xceed Kit Contents Optium Xceed Monitor Optium Xceed User’s Guide – Contains system information and directions. Carrying Case – Use this to store and carry your monitor and other monitoring supplies. Your kit may also contain: Optium Xceed Quick Reference Guide – Gives the basic steps to calibrate your monitor and monitor your blood glucose. Lifetime 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 monitor. Lancing Device, Lancets, Instructions for Use and Other Information

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Display Window

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Display Check

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Items not included: MediSense Control Solutions Blood Glucose Electrodes and Instructions for Use Blood ß-Ketone Electrodes and Instructions for Use Data Management System

Backlight Button

Back Button

Electrode Port

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Getting to Know Your Monitor’s Features Display Window This shows: •Blood glucose and blood ß-Ketone results •Glucose LOT numbers and ß-Ketone calibration CODEs •Previous test results and error messages •Blood glucose averages IMPORTANT: Each time you turn your monitor on, a full display shows. This is called a Display Check. Look at the Display Check each time it appears on your monitor’s display window, especially before you monitor your blood glucose or blood ß-Ketone. The Display Check shows on the display window briefly. 6

Important Information

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Important Information

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

Electrode Port This is where you insert: •A blood glucose electrode •A blood ß-Ketone electrode •A glucose calibrator •A ketone calibrator •Data cable (not included) for uploading results to a computer Mode Button Use this button to: •Turn monitor ON and OFF •Access monitor setup options •Access and save monitor settings •Access previous results and averages 7

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Forward Button Back Button Use these buttons to: •Review and select monitor settings •Review results and averages Backlight Button Use this button to: •Turn backlight ON and OFF Battery Compartment This is where the battery is installed. •If your monitor does not turn on, check that your battery is installed properly. •For new battery installation, see Chapter 10.

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Important Information

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CHAPTER 2 Questions? Call Setting Up Your Customer Service. Optium Xceed Monitor ▼

Buttons to Use Mode Button Forward Button Back Button

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Setting Up Your Monitor

See page 87.

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 monitor 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. 9

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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 monitor’s display window. Set Date Format In "Set Date Format", you choose how the month and day show on the monitor’s display window. Set Measurement Units Consult your healthcare professional before changing the blood glucose measurement units. Blood glucose measurement units are in mg/dL or mmol/L. Blood ß-Ketone measurement units are in mmol/L only.

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Setting Up Your Monitor

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Setting Up Your Monitor

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How to Set the Beeper, Date, Time, & Measurement Units To begin, pull the battery tab out. Your monitor should be turned OFF. You will automatically be prompted to set the time and date the first time you press the mode button to turn your monitor 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 monitor off and save your settings at any time. The monitor automatically turns off after 30 seconds of no action. If you like the setting that you see on your monitor 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. 11

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Beeper ON

Beeper OFF

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1

To turn your monitor ON, Press and Hold the button. The beeper ON message shows on the display window. The musical notes flash on and off, and the monitor beeps.

Setting Up Your Monitor

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

3

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

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Set Time Hour: Setting Up Your Monitor

The Hour flashes on and off.

1

Press and Release the button to move the hour forward.

2

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

3

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

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Minutes: The Minutes flash on and off.

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Press and Release the button to move the minutes forward.

2

If you go past the correct minute, Press and Release the button to move the minutes back.

3

Press and Release the button to save the minutes and to move to Set Date.

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Setting Up Your Monitor

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Set Date Year: Setting Up Your Monitor

The Year flashes on and off.

1

Press and Release the button to move the year forward.

2

If you go past the correct year, Press and Release the button to move the year back.

3

Press and Release the button to save the year and to move to Set Month.

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Month: The Month flashes on and off.

1

Press and Release the button to move the month forward.

2

If you go past the correct month, Press and Release the button to move the month back.

3

Press and Release the button to save the month and to move to Set Day.

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Setting Up Your Monitor

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Setting Up Your Monitor

Day: The Day flashes on and off.

1

Press and Release the button to move the day forward.

2

If you go past the correct day, Press and Release the button to move the day back.

3

Press and Release the button to save the day and to move to Set Time Format.

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Choice #1

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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.

Choice #2

1

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

2

Press and Release the button to save the Time Format and to move to Set Date Format.

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Setting Up Your Monitor

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Setting Up Your Monitor

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Set Date Format You have two choices: Choice #1: For the monthday format, " " shows with the date.

-

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

Choice #2: For the day.month format, "•" shows with the date. Example: "25 May" shows as "25.5".

1

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

2

Press and Release the button to save the Date Format and to move to Set Measurement Units.

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Set Blood Glucose Measurement Units Consult your healthcare professional before changing the blood glucose measurement units. For mg/dL or mmol/L: The mg/dL measurement units flash on and off in the upper left corner of the display window. The mmol/L measurement units flash on and off in the upper right corner of the display window.

1

To change the measurement units, Press and Release the button or the button once.

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Setting Up Your Monitor

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2 Setting Up Your Monitor

Press and Release the button to save the measurement units and to return to Set Beeper.

Press and Hold the button to turn your monitor off.

You have successfully set up your monitor.

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CHAPTER 3 Questions? Call Customer Customer Service. See Service: page815 87.59

When to Calibrate Your Monitor • When you use the monitor for the first time. • EACH time you open and use a new box of blood glucose or blood ß-Ketone electrodes.

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Calibrating Your Monitor

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Why Calibrate Your Monitor? Your Optium Xceed monitor must be calibrated so that it can recognize the electrode you are using. Calibration ensures that your results are accurate.

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Calibrating Your Optium Xceed Monitor

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Calibrating Your Monitor

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What You Will Need • Optium Xceed monitor • For glucose calibration: Blood glucose electrode Blood glucose electrode instructions for use Blood glucose electrode calibrator • For ß-Ketone calibration: Blood ß-Ketone electrode Blood ß-Ketone electrode instructions for use Blood ß-Ketone electrode calibrator How to Calibrate Your Monitor When you insert an electrode for the first time, the display window shows: This means the monitor is not calibrated for blood glucose monitoring.

➡

This means the monitor is not calibrated for blood ß-Ketone monitoring.

➡

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IMPORTANT: •Use only the calibrator that is packaged in the box of electrodes you are using. •Do not use electrodes that have expired. Check the expiration date on the electrode foil packet and electrode box. If only the year and month are shown, the expiration date is the last day of the month.

1

Remove the glucose or ß-Ketone calibrator package from the new box of electrodes.

2

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

4. the the . it in until it stops.

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Calibrating Your Monitor

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3 Calibrating Your Monitor

Hold the calibrator with the LOT number (glucose) or calibration CODE (ß-Ketone) facing you.

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Insert the calibrator into the electrode port. Push it in until it stops. The Display Check shows on the display window, followed by the time, month, and day. Next, the LOT number (glucose) or calibration CODE (ß-Ketone) shows on the display window. a. Example of glucose LOT number: LOT 13758 b. Example of ß-Ketone calibration CODE: CODE JC7 Then you hear the beeper, if the beeper is ON. ß-Ketone 25

Glucose

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Check that the LOT number or calibration CODE on all these items matches: ✓ Display window ✓ Electrode calibrator ✓ Electrode instructions for use ✓ Electrode foil packet When the LOT number or calibration CODE on all these items matches: What It Means: Calibration is complete. What to Do: You may now monitor your blood glucose or blood ß-Ketone. When the LOT number or calibration CODE on all these items DOES NOT match: What It Means: Your monitor may not be calibrated for the box of electrodes you are using. What to Do: •Check that you are using the calibrator that came in the box of electrodes you are using. •Try to calibrate again. 26

Calibrating Your Monitor

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Calibrating Your Monitor

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IMPORTANT: If the LOT number or calibration CODE still does not match, contact Customer Service. Do not attempt to monitor your blood glucose or blood ß-Ketone. Your monitor may show an incorrect result.

6

Remove the calibrator from the monitor and store it in your monitor’s carrying case.

IMPORTANT: Do not throw the calibrator away until you have used all of the electrodes in the box. If you have any trouble calibrating your system, please contact Customer Service.

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How to Recall the LOT Number or Calibration CODE 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.

1

2

After the glucose LOT number is displayed, you can recall the ß-Ketone calibration CODE. Press and Release the button or the button. The ß-Ketone calibration CODE shows with the time, month, and day of the most recent ß-Ketone calibration.

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Calibrating Your Monitor

Note: If the LOT number or calibration CODE that shows on your monitor’s display window is not correct: What It Means: Your monitor may not be calibrated for the box of electrodes you are using. What To Do: •Re-calibrate your monitor. •Check that you are using the calibrator that came in the box of electrodes you are using. Remember, improper calibration will cause incorrect results.

3

Press and Hold the button to turn your monitor off.

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CHAPTER 4 Questions? Call Customer Service. See page 87.

E X P 2006/03

Example: Expiration date March 31, 2006

Important Information about Monitoring Your Blood Glucose •Do not use out-of-date electrodes. Check the expiration date printed on the electrode box and on each electrode foil packet. If only the month and year are printed on the electrode, then the expiration date is the last day of that month. •For more detailed information about your electrode, please read its instructions for use before monitoring. •Use the electrode immediately when you take it out of its foil packet. 30

Monitoring Blood Glucose

▼ L O T 13758

What You Will Need •Blood glucose electrode with its instructions for use •Optium Xceed monitor calibrated to match the LOT number of the blood glucose electrode you are using •Lancing device and a new, sterile lancet

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Monitoring Your Blood Glucose

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Monitoring Blood Glucose

•Do not use a wet, bent, scratched, or damaged electrode. •Do not use the electrode if its foil packet has a puncture or tear in it. •Before you monitor, allow your monitor and electrode to reach the recommended operating range of the electrode. The electrode operating range is in the “Limitations of Procedure” section of your blood glucose electrode instructions for use. •Read the lancing device instructions for use. How to Monitor Your Blood Glucose Getting Started

1

Prepare your lancing device.

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2

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

the electrode from 3Remove its foil packet. Note: For pictures that show how to open the blood glucose electrode foil packet, please see the information card in the box of blood glucose electrodes.

4

Insert the three black lines at the end of the electrode into the electrode port.

5

Push the electrode in until it stops. The monitor 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.) 32

Monitoring Blood Glucose

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Monitoring Blood Glucose

•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 electrodes you are using.

•Apply Blood message, which tells you that the monitor is ready for you to apply blood to the blood glucose electrode.

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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 sampling 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. Upper arm sampling •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 Base of thumb sampling electrode immediately. 34

Monitoring Blood Glucose

Fingertip sampling

Monitoring Blood Glucose

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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 Electrode

1

Touch the blood drop to the white area at the end of the electrode. The blood is drawn into the electrode. Note: If the monitor shuts off before you apply blood to the electrode, remove the electrode from the monitor and try again.

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Status bar

Countdown

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2

Continue to touch the blood drop to the end of the electrode until the monitor begins the test. The monitor 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 electrode from the monitor or disturb it during the countdown.

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Monitoring Blood Glucose

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Important: If the countdown does not start:

Monitoring Blood Glucose

What It Means: You might not have applied enough blood to the electrode. What to Do: •Apply a second drop of blood to the electrode within 30 seconds of the first drop. •If the countdown still does not start or if more than 30 seconds have passed, discard the electrode, turn off your monitor, and try again with a new electrode.

3

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 monitor’s memory. You may also write the result in your logbook.

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Correct

✔

Apply second drop

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Shutting Off Your Monitor

1

Removing the electrode from the electrode port turns off the monitor. You can use the opened foil packet to remove and discard your used electrode.

2

Discard the electrode properly.

Note: You may also turn the monitor off by Pressing and Holding the button. If you do not turn your monitor off or pull the electrode out, the monitor shuts off automatically after 60 seconds.

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Monitoring Blood Glucose

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Understanding Your Result

Monitoring Blood Glucose

"LO" Result What It Means: Your monitor has determined that your blood glucose result is lower than 1.1 mmol/L (20 mg/dL) or there may be a problem with the electrode. What to Do: Monitor your blood glucose again with a new electrode. If LO shows on the display window again, contact your healthcare professional immediately. Result 16.7 mmol/L or Higher When your blood glucose result is 16.7 mmol/L (300 mg/dL ) 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 ß-Ketone. 39

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"HI" Result What It Means: Your monitor has determined that your blood glucose result is higher than 27.8 mmol/L (500 mg/dL) or there may be a problem with the electrode. What to Do: Monitor your blood glucose again with a new electrode. 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 ß-Ketone.

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Monitoring Blood Glucose

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"E-4" Result

Monitoring Blood Glucose

What It Means: Your blood glucose may be too high to be read by the system, or there may be a problem with the electrode. What to Do: Monitor your blood glucose again with a new electrode. If E-4 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 electrode 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 monitor displays a blood glucose result that is unusually low, lower than 2.8 mmol/L (50 mg/dL).

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•HI shows on the display window. •You obtain a high blood glucose result, but you do not have symptoms of high blood glucose. •Your monitor displays a result that is unusually high, higher than 16.7 mmol/L (300 mg/dL). •You question your result.

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

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Monitoring Blood Glucose

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CHAPTER 5 Questions? Call Customer Service. See page 87.

Monitoring Your Blood ß-Ketone It is important to check your ketones when:

▼

Monitoring Blood ß-Ketone

•You have an illness. •Your blood glucose is higher than 16.7 mmol/L (300 mg/dL). •You are experiencing unusual blood glucose results. •You and your healthcare professional determine that it is necessary. What You Will Need •Blood ß-Ketone electrode with its instructions for use •Optium Xceed monitor calibrated to match the calibration CODE of the blood ß-Ketone electrode you are using •Lancing device and a new, sterile lancet

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ß-Ketone Test β-Ketone Electrode

MediSense UK Limited Abbott Laboratories Units 14/15 Eyston Way MediSense Products Abingdon Bedford, MA1TR 01730 OXON 0X14 USA UK MadeininUK. UK. Made 0 11/01 Rev.120-1025 P/N Rev. 0 1/03

Example: Expiration date March 9, 2005

.

70208 2005/03/09 JC7 0.3-0.7 mmol/l 1.9-2.9 mmol/l 3.7-5.7 mmol/l

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Important Information about Monitoring Your Blood ß-Ketone •For more detailed information about your blood ß-Ketone electrode, please refer to its instructions for use before monitoring. •Do not use out-of-date electrodes. Check the expiration date printed on the electrode box and on each electrode foil packet. •Do not put urine on the blood ß-Ketone electrode. •Use the electrode immediately when you take it out of its foil packet. •Do not use a wet, bent, scratched, or damaged electrode. •Do not use the electrode if its foil packet has a puncture or tear in it. •Use each electrode only once. •Before you monitor, allow your monitor and electrode to reach the recommended operating range of the electrode. The electrode operating range is in the “Limitations of Procedure” section of your blood ß-Ketone electrode instructions for use. 44

Monitoring Blood ß-Ketone

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Monitoring Blood ß-Ketone

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•Read the lancing device instructions for use. •The blood ß-Ketone electrode foil packet contains a desiccant tablet (Zeolite Sodium Calcium Aluminosilicate). Although this material is not considered dangerous1, the following safety advice should be observed: 1. Keep away from children. 2. Do not expose to water as product gets hot and could cause burns. 3. Do not eat, and avoid contact with eyes and skin. May cause burns to the mouth and throat. 4. If swallowed, drink two glasses of water. Seek medical help. How to Monitor Your Blood ß-Ketone Getting Started

1Prepare your lancing device. 45

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2

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

3

Remove the electrode from its foil packet.

4

Insert the three black lines at the end of the electrode into the electrode port.

5

Push the electrode in until it stops. The monitor 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.) 46

Monitoring Blood ß-Ketone

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Monitoring Blood ß-Ketone

•Time, month, and day (if set) If date and time are not set, dashes will show instead of numbers.

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

•KETONE and Apply Blood message, which tell you that the monitor is ready for you to apply blood to the blood ß-Ketone electrode.

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