6
Low battery. Change the batteries according to
the instructions (§7.3).
The temperature was not within the recom-
mended range. Repeat the measurement after at
least 30 minutes, when the operating tempera-
ture has been restored.
8.3. Unexpected test results
If the test result is unusual compared to your previous test results:
1. Repeat the measurement using a new test strip (§4.2).
2. Perform a control measurement using the GlucoMen® areo Control
solution (§4.3).
3. Change the test strip vial and repeat the measurement using a new
test strip (§4.2).
4. If you are still uncertain about the test results, contact your doctor or
healthcare professional.
WARNING
● In case of an unexpected reading, consult your doctor or healthcare
professional before altering your treatment.
● If the test results continue to be unusual, please, contact the
A. Menarini Diagnostics customer service.
9. Technical specifications
Product: GlucoMen® areo
Manufacturer: A. Menarini Diagnostics srl
Tested item: Blood Glucose level
Unit of
measurement:
mmol/L
Test Range: 1.1 – 33.3 mmol/L
Haematocrit range:
10 – 70 % (haematocrit compensated)
Test strip: GlucoMen® areo Sensor
Test strip coding: No coding required
Sample: Fresh capillary whole blood
Sample size: Minimum 0.5 µL
Test time: 5 seconds
Assay Method: Electrochemical, Glucose Oxidase (GOD,
Aspergillus Niger sourced) based method.
Mediator: Hexacyanoferrate (III) ion.
Calibration and
traceability:
The results are equivalent to the plasma glucose
concentration (capillary plasma referenced).
The GlucoMen® areo system is calibrated using
capillary plasma values determined with a
Yellow Springs 2300 analyser (YSI). The YSI
analyser is calibrated (as a secondary reference
measurement procedure) using a series of YSI
standards (primary calibrators) which are taken
from the NIST (National Institute of Standards
and Technology, USA).
Temperature
compensation:
Automatic compensation using a built-in thermo
sensor.
Batteries: Two 3.0 V lithium batteries (CR2032).
Battery life: A minimum of 1000 tests or about 1 year
(about 1000 runs for 1 transmission/day & 3
tests/day).
Memory: 730 test results with markers, dates and times.
When the memory is full, the new results will
replace the oldest ones.
Data
management:
Before/after meals, exercise, check markers
available.
Alarms: Up to three settable acoustic alarms.
Data transfer: Via dedicated data cable, NFC, or a Bluetooth
device.
Averages: Over 1, 7, 14, 30, 60, 90 days.
Automatic turn
off:
- After 50 seconds of inactivity before the test
(sensor strip inserted into the meter, drop icon
flashing).
- After 45 seconds of inactivity after the test and
Error messages Err2, Err3, Err4, HI and LO.
- After 5 seconds for Error messages Err1, Err5,
Temperature icon and Battery icon.
Dimensions: 85.5 mm (L) x 56 mm (W) x 18.2 mm (H)
Weight: 46 g (without batteries)
Meter Operating
Conditions:
- Temperature: 5 - 45 °C (41 - 113 °F).
-
Relative Humidity: 20 - 90% (no dew condensation).
Meter Storage
Conditions:
- Temperature: -20 – 50°C (-4 – 122 °F).
- Relative Humidity: 20 - 90%.
Test strip Storage
Conditions:
- Temperature: 4 - 30°C (39.2 - 86 °F) (both for
unopened vial and after opening).
- Relative Humidity: 20 - 90% (both for unopened
vial and after opening).
Control Solution
Storage
Temperature:
4 - 30 °C (39.2 - 86 °F)
Operating
environment:
The GlucoMen® areo meter complies with elec-
tromagnetic compatibility standards and has
been tested for electrostatic discharge and
electromagnetic fields according to EN 60601-1-
2:2007 +AC:2010.
Classification according to IEC/EN 60601-1: 2006
+AC:2010.
Electromagnetic compatibility: the equipment
complies with the EN 60601-1-2 EMC require-
ments.
EU directive/
classification:
98/79/EC / Annex II, List B
Device Standard: ISO 15197:2003
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