GlucoMen Areo 2k User Manual

1
Thank you for choosing the GlucoMen® areo 2K meter.
We have designed this compact blood glucose and β-ketone meter for faster and easier testing of your blood glucose and β-ketone 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, GlucoMen® areo β-Ketone Sensor, GlucoMen® areo Control, and GlucoMen® areo Ket Control. Pay particular attention to listed warnings and cautions. Please keep this manual at hand 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 2K meter, GlucoMen® areo Sensor, and GlucoMen® areo β-Ketone Sensor are in vitro diagnostic medical devices to quantitatively measure glucose and β-ketone levels in fresh capillary whole
glucose and β-ketone 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 and DKA 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.
Blood Glucose and ß-Ketone Self-Monitoring System
2. System overview
2.1 Meter
FRONT
TEST STRIP PORT
UP/DOWN (
/ )
BUTTONS
ENTER (
) BUTTON
TEST STRIP PORT
Test strip should be inserted here.
ENTER (
) BUTTON
Press and hold
for 2 seconds to access meter memory (§6.1) or longer
(4 seconds) to enter setup mode while not testing (§7).
UP/DOWN (
/ ) BUTTONS
Press
or to scroll through different options and/or values.
BACK
BATTERY HOLDER
NFC ANTENNA
DATA TRANSFER PORT
RELEASE BUTTON
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
MAIN DISPLAY AREA
UNIT OF MEASUREMENT TIME AVERAGE
DATEMARKERS ICONS
MEMORY ICON
CTL ICON
GLUCOSE ICON
KETONE ICON
WRONG TEMPERATURE ICON
NFC ICON
LOW BATTERY ICON
MEMORY ICON: indicates that you are using the memory
(§6).
CLOCK/ALARM ICON: “clock” appears while setting the time
(§7.1); “alarm” appears while setting the acoustic reminder(s), and will be displayed if any alarm is on (§7.2).
HYPO/HYPER ICONS: appear while setting the hypoglycaemic
and hyperglycaemic thresholds and if
your test results are below or above these values (§7.4).
DROP ICON: blinks to indicate that the meter is ready
for blood or control solution testing (§4.2,
4.3).
MAIN DISPLAY AREA: displays test results, stored test values,
result averages and messages.
UNIT OF MEASUREMENT:
shows the unit of measurement of your
blood glucose meter (mg/dL or mmol/L for glucose, not changeable; mmol/L only for β-ketone).
USER MANUAL
MASTER
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TIME: shows time (HH:MM, 12H AM/PM or 24H
format).
AVERAGE: shows the period related to the displayed
average (1, 7, 14, 30, 60 or 90 days – §6.2).
DATE: 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.
GLUCOSE ICON: appears when the value shown in the Main
Display Area refers to glucose test results.
KETONE ICON: appears when the value shown in the
Main Display Area refers to β-ketone test results, while setting the β-ketone test alert threshold or, if blinking and displayed after a glucose test, to indicate that a β-ketone
measurement is suggested (§4.2).
WRONG TEMPERATURE ICON: appears while testing and temperature is
outside the allowed temperature range.
LOW BATTERY ICON: appears when the battery needs to be
replaced (§8.3).
NFC ICON: displayed while setting the NFC (Near
Field Communication) function (§7.6) and when this function is enabled; blinks while data are transmitted via NFC (§6.3.1).
CTL ICON: indicates a control solution test (§4.3).
2.2 TEST STRIP
The following picture describes the structure of both GlucoMen® areo Sensor and GlucoMen® areo β-Ketone Sensor. GlucoMen® areo Sensor is white, GlucoMen® areo β-Ketone Sensor is in
light purple colour.
APPLY BLOOD/CTRL SOLUTION DROP HERE
CHECK WINDOW
INSERT THIS END INTO
THE METER
3. Before testing
3.1 Caution when using the meter
Time and date are pre-set in the meter. Please make sure that time and date settings are correct before rst use, and adjust them if needed. Always check the settings after changing the battery (§8.3).
CAUTION
For accurate test results, allow the meter, test strips and control solution to adjust to the surroundings for 30 minutes before testing your blood glucose or β-ketone levels:
Glucose test
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH (Relative Humidity).
β-Ketone test
- temperature: 10 to 40 °C (50 to 104 °F);
- humidity: < 85% RH.
Do not store or use the meter where:
- there are sharp temperature uctuations;
- humidity is high and causes condensation (bathrooms, drying rooms, kitchen, etc.);
- there is a strong electromagnetic eld (close to a microwave oven, cell phone, etc.).
Do not use the meter 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.
The meter complies with applicable electromagnetic emission requirements (EMC). However, do not perform measurements with this
meter near mobile devices or electrical or electronical equipment that
are sources of electromagnetic radiation, as these may interfere with the
proper operation of the meter.
3.2 Caution when using the test strips
CAUTION
For testing with GlucoMen® areo 2K meter use GlucoMen® areo Sensor or GlucoMen® areo β-Ketone 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 either written on the test strip vial next to the
symbol (glucose sensor) or
on the foil pouch (β-ketone sensor).
For accurate test results, allow the meter and test strips to adjust to
the surroundings for at least 30 minutes before testing your blood glucose or β-ketone levels:
Glucose test
- temperature: 5 to 45 °C (41 to 113 °F);
- humidity: 20 to 90% RH.
β-Ketone test
- temperature: 10 to 40 °C (50 to 104 °F);
- humidity: < 85% RH.
Do not use the GlucoMen® areo Sensor test strips if 9 months or more have passed since rst 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
4.1 Blood 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 ngertip, palm and forearm. However, test results from sites other than the ngertip may differ from ngertip 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,
forearm
• Before meals.
• 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 hypoglycae-
mia such as perspiration, cold sweats, a oating
sensation or trembling.
• When immediate testing is needed for suspect­ed hypoglycaemia.
• When in poor physical condition, such as with a head cold, etc.
4.2 Testing your blood glucose
1. Insert a new GlucoMen® areo Sensor test strip (white colour) into the test strip port. The drop icon starts blinking on the screen and the
glucose icon “GLU” will be shown at the bottom left hand corner of the display. 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 drop of blood 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.
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 together with the glucose icon “GLU”.
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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 (§7.4).
β-Ketone test warning. If your own blood glucose is above a given
threshold (to be set, §7.5), the KETONE ICON will start blinking at
the bottom left hand corner of the display and an intermittent beep
will sound, reminding the user that a blood β-ketone test would be
recommended.
If test results do not match with how you feel: Make sure you have
performed the test correctly as explained in §4.2. Then, conduct a glucose control test to check that the system is working properly (§4.3). Repeat the test using a blood sample taken from a ngertip (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 rst 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 Glucose control test
Conduct a control test if:
you suspect the meter or GlucoMen® areo Sensor test strips are not
working properly;
the meter has been dropped;
the meter is damaged;
your blood glucose test results do not match with how you feel;
you want to check the performance of the meter and GlucoMen® areo
Sensor test strips when you rst get them or any time you want to check
their performance before a blood glucose test.
NOTE
To test your meter and GlucoMen® areo Sensor test strips only use the
GlucoMen® areo Control (provided separately).
Do not use the GlucoMen® areo Ket Control for testing the GlucoMen® areo Sensor: erroneous results would be obtained.
CAUTION
Do not use control solutions after their expiry date. The expiry date is
indicated on the control solution vial next to the
symbol.
For accurate test results, allow the meter, test strips and control solution to adjust to the 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 rst 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 inammation.
To perform a glucose control solution test, proceed as follows:
1. Insert a new GlucoMen® areo Sensor test strip into the test strip port. The drop icon starts blinking on the screen and the Glucose icon
“GLU” will be shown at the bottom left hand corner of the display. 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.
Always select the ctl icon before conducting a control solution test or the results may fall outside the acceptable range. To enable the ctl icon, just press one of the UP/DOWN (
/ ) buttons once
while the drop icon is blinking on the screen.
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 GlucoMen® areo Sensor test strip vial. If out of range, make sure that no procedural errors were made, then 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 conrmed it deselects any previously selected
marker).
2. Press
to conrm 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. Measuring your blood β-ketone levels
5.1. Blood 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.
The GlucoMen® areo β-Ketone Sensor is not intended for alternative site testing (AST). Use only fresh capillary whole blood from your ngertip for
testing.
5.2. Testing your blood β-ketone
1. Insert a new GlucoMen® areo β-Ketone Sensor test strip (light purple colour) into the test strip port. The drop icon starts blinking on the screen and the β-ketone icon “KET” will be shown at the bottom left
hand corner of the display. 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 drop of blood 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
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.
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