Glucomen Areo User Manual

MASTER

●Blood glucose monitoring system

User manual

Thank you for choosing the GlucoMen® areo meter.

We have designed this compact blood glucose meter for faster and easier testing of your blood glucose and we hope it will be of great help in the management of your diabetes. This manual explains how to use your new meter. Before testing, carefully read through this manual and the package inserts that come with it: GlucoMen® areo Sensor and GlucoMen® areo Control. Pay particular attention to listed warnings and cautions. Please keep this manual handy for future reference. If you have any questions, please contact A. Menarini Diagnostics for assistance (references at the end of this manual).

1. Intended use

Your GlucoMen® areo meter and GlucoMen® areo Sensor are in vitro diagnostic medical devices to quantitatively measure the glucose level in fresh capillary whole blood. They are intended for self testing to monitor and control blood glucose levels by people with diabetes mellitus; they can also be used in a clinical setting by healthcare professionals. They are not intended for diagnosis or screening of diabetes or for neonatal use. Do not alter your treatment on the basis of test results of this meter without previously consulting your doctor or healthcare professional.

2.System overview

2.1Meter

FRONT

TEST STRIP PORT

ENTER ( ) BUTTON

UP/DOWN (/) BUTTONS

TEST STRIP PORT

Test strip should be inserted here.

ENTER () BUTTON

Press and hold for 2 seconds to access meter memory (§5.1) or longer (4 seconds) to enter setup mode while not testing (§6).

UP/DOWN (/) BUTTONS

Pressorto scroll through different options and/or values.

BACK

RELEASE BUTTON

NFC ANTENNA

BATTERY HOLDER

DATA TRANSFER PORT

RELEASE BUTTON

Press this button to remove used test strip.

BATTERY HOLDER

Houses two CR2032 3V lithium coin cell batteries.

DATA TRANSFER PORT

Connection port for PC data cable and Bluetooth device from A. Menarini Diagnostics.

METER SCREEN

CLOCK/ALARM ICON

HYPO/HYPER ICONS

DROP ICON

MEMORY ICON

MAIN DISPLAY AREA

CTL ICON

NFC ICON

UNIT OF MEASUREMENT

LOW BATTERY ICON

TIME

AVERAGE

WRONG TEMPERATURE ICON MARKERS

DATE

ICONS

MEMORY ICON: indicates that you are using the memory (§5).

CLOCK/ALARM ICON: “clock” appears while setting the time (§6.1); “alarm” appears while setting the acoustic reminder(s), and will be displayed if any alarm is on (§6.2).

HYPO/HYPER ICONS: appear while setting the hypoglycaemic and hyperglycaemic thresholds and if your test results are below or above these values (§6.4).

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DROP ICON:	blinks to indicate that the meter is ready
	for blood or control solution testing (§4.2,
MAIN DISPLAY AREA:	4.3).
	displays test results, stored test values,
UNIT OF MEASUREMENT:	result averages and messages.
	shows the unit of measurement of your
	blood glucose meter (mg/dL or mmol/L,
TIME:	not changeable).
	shows time (HH:MM 12H am/pm or 24H
AVERAGE:	format)
	shows the period related to the displayed
DATE:	average (1, 7, 14, 30, 60 or 90 days – §5.2)
	shows the date (DD-MM format)
MARKERS ICONS:	displayed while marking a test result
	(§4.4) or reviewing a marked result.
	Before meal marker
	After meal marker
	Exercise marker
	Check marker

WRONG TEMPERATURE ICON: appears while testing outside the allowed

LOW BATTERY ICON:	temperature range.
	appears when the battery needs to be
NFC ICON:	replaced (§7.3).
	displayed while setting the NFC (Near
	Field Communication) function (§6.5)
	and when this function is enabled;
	blinks while data are transmitted via NFC
CTL ICON:	(§5.3.1)
	indicates a control solution test (§4.3).

2.2 TEST STRIP

INSERT THIS END INTO							APPLY BLOOD/CTRL
THE METER							SOLUTION DROP HERE
					CHECK WINDOW

3.Before Testing

3.1Caution when using the Meter

Time and date are pre-set in the meter. Please make sure that time and date settings are correct before first use, and adjust them if needed. Always check the settings after changing the battery (§7.3).

CAUTION

●For accurate test results, allow the meter to adjust to its surroundings for 15 to 20 minutes before testing your blood glucose levels:

-temperature: 5 to 45°C (41 to 113°F);

-humidity: 20 to 90% RH (Relative Humidity).

●Do not store or use the meter where:

-there are sharp temperature fluctuations;

-humidity is high and causes condensation (bathrooms, drying rooms, kitchen, etc.);

-there is a strong electromagnetic field (close to a microwave oven, cell phone, etc.).

●Do not use the meter after if it has been dropped in a liquid or liquids have entered inside, even if dried afterwards.

●Avoid hand contact with test strip port on the meter. A thermo sensor is housed inside the meter to minimize any errors.

●Do not connect the data cable to the data transfer port during testing. The meter may be damaged, leading to inaccurate test results.

●Do not apply blood directly to the test strip port on the meter.

●Do not share your meter with anyone else to avoid the risk of infection.

3.2 Caution when using the Test Strips

CAUTION

●For testing with GlucoMen® areo meter use GlucoMen® areo Sensor only. Do not use other test strips, it causes inaccurate test results.

●Do not use test strips after their expiry date. The expiry date is written on the test strip vial next to symbol.

For accurate test results, allow the test strips to adjust to the their surroundings for at least 30 minutes before testing your blood glucose levels:

-temperature: 5 to 45°C (41 to 113°F);

-humidity: 20 to 90% RH.

●Do not use the test strips if 3 months or more have passed since first opening the vial.

●The test strips are for single-use only. Do not use test strips that have already absorbed blood or control solution.

●Keep all unused test strips in the original vial and after having removed one, immediately close the cap tightly to preserve their quality. Do not transfer them into any other container.

4.Measuring your blood glucose levels

4.1Blood sampling

For information on how to use the lancing device, read the relevant instructions for use.

CAUTION

●Wash the puncture site with soap and water and dry the site thoroughly before sampling blood.

●Do not share the same lancet or lancing device with anyone else to avoid the risk of infection.

●Always use a new lancet. Lancets are for single-use only. Do not reuse a lancet that has already been used.

4.1.1 Alternative site testing (AST)

This meter can test the glucose levels of blood from your fingertip, palm and forearm. However, test results from sites other than the fingertip may differ from fingertip measurements. Consult your doctor or healthcare professional before testing blood from the palm or forearm.

Use blood from:	If you are going to test:
Fingertip, palm,	• Before meals
forearm	• Two hours or more after meals
	• Two hours or more after exercise
Fingertip	• When there is the possibility of your blood glu-
	cose levels changing rapidly (e.g. after meals or
	exercise)

•When experiencing symptoms of hypoglycaemia such as perspiration, cold sweats, a floating sensation or trembling

•When immediate testing is needed for suspected hypoglycaemia

•When in poor physical condition, such as with a head cold, etc.

4.2Testing your Blood Glucose

1. Insert a new test strip into the test strip port. The drop icon starts blinking on the screen. If nothing appears on the screen, remove the test strip, insert it into the test strip port again and wait for the drop icon to start blinking.

2. Apply the blood of drop to the tip of the test strip until the check window is full. A beeper sounds (if enabled) and a countdown timer starts on the screen.

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NOTE

●For accurate test results, apply the drop of blood to the tip of the test strip within 20 seconds after puncturing.

●Do not test blood that runs or spreads out from the puncture site.

●Do not smear blood onto the test strip.

●Do not forcefully press the test strip into your puncture site.

●Do not touch the test strip once the meter has started the countdown.

3. Read your test result. You will hear a beep when the test result appears on the screen.

CAUTION

●If “LO” or “HI” appears on the screen:

Repeat the test. If “LO” or “HI” still appears, contact your doctor or healthcare professional. “LO” appears if your test result is less than 20 mg/dL (1.1 mmol/L). “HI” appears if your test result is more than 600 mg/dL (33.3 mmol/L).

●The“hypo”or“hyper”icons may appear depending on the threshold limit you have set (§6.4).

●If test results do not match how you feel:

Make sure you have performed the test correctly as explained in §4.2. Then, conduct a control test to check that the system is working properly (§4.3). Repeat the test using a blood sample taken from a fingertip (do not use an alternative site). If the test result still does not match how you feel, contact your doctor or healthcare professional.

●Do not ignore test results. Do not alter your blood glucose management or treatment without first consulting your doctor or healthcare professional.

4. Press the release button to remove the test strip. The meter will switch off.

CAUTION

●When ejecting the used test strip, point your meter downwards and away from others.

●Disposal of Biohazardous Waste

Used test strips and lancets are biohazardous waste. They must therefore be disposed according to local regulations on biohazardous waste.

4.3 Control Test

Conduct a control test if:

●you suspect the meter or test strips are not working properly;

●the meter has been dropped;

●the meter is damaged;

●your test results do not match how you feel;

●you want to check the performance of the meter and test strips when you first get them or any time you want to check their performance before a blood glucose test.

NOTE

To test your meter and test strips only ever use the GlucoMen® areo Control (provided separately).

CAUTION

● Do not use control solutions after their expiry date. The expiry date is indicated on the control solution vial next to symbol.

●For accurate test results, allow the control solution to adjust to its surroundings for at least 30 minutes before running the control test:

-temperature: 5 to 45°C (41 to 113°F);

-humidity: 20 to 90% RH.

●Do not use the control solutions if 3 months or more have passed since first opening the vial.

●Do not drink the control solution. It is not intended for human consumption.

●Avoid contact of the solution with the skin and the eyes as this could cause inflammation.

To perform a control solution test, proceed as follows:

1. Insert a new test strip into the test strip port. The drop icon starts

blinking on the screen. If nothing appears on the screen, remove the test strip, insert it into the test strip port again and wait for the drop icon to start blinking.

2. Select the ctl test icon (§2.1).

WARNING

●If the ctl icon has not been selected before performing the control solution test, the result will be stored as a blood test and used for calculating averages.

3. Gently shake the control solution vial before testing. Discard a drop before use. Squeeze a drop of control solution onto a clean, hard, dry surface.

4. Touch the control solution drop with the tip of the test strip until the check window is full. A beeper will sound (if enabled) as the countdown timer starts on the screen.

NOTE

●The test will not start if you apply your control solution directly to the check window. The test starts when the meter detects the control solution. During the test the meter counts down from 5 to 1.

●Tightly close the control solution vial.

●Do not touch the test strip once the meter has started the countdown.

5. Check that your test result is within the acceptable range indicated on the label of the test strip vial. If out of range, repeat the control solution test.

CAUTION

●If you still have test results that fall outside the acceptable range, stop using the system, and contact the A. Menarini Diagnostics customer service.

6. Press the release button to remove the test strip. The meter will switch off.

4.4 Marking Test Results

After a blood (not control) glucose test is performed with a valid result, you can mark the result as follows:

1. Start from point 3 of the glucose testing procedure (result displayed on the screen, §4.2)

Press until the markers icons start blinking. Press or to scroll through the icons (backwards or forwards) according to the following sequence:

Before meal marker

After meal marker

Exercise marker

Check marker (General Purpose marker).

Void (Once confirmed it deselects any previously selected marker).

2. Press to confirm the marker you selected. You can select more markers (but only one when setting or ) by repeating steps 1 & 2.

3. Return to point 4 of the glucose testing procedure (§4.2).

5. Managing your Test Results

5.1. Reviewing past results

You can review past results stored in the memory. Your meter stores up to 730 test results with dates, times and markers.

WARNING

Please make sure that the time and date are correct before the first use, and adjust them if needed (§6.1). If the time and date settings are not correct the meter will memorize the test results in the wrong order.

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