GlucoMen Areo 2k - Resolving Unexpected Test Results; Technical Specifications; General Meter Specifications; Glucose Measurement Specifications

7
The temperature was not within the recommended
range. Repeat the measurement after at least 30
minutes, when the operating temperature has been
restored.
9.3. Unexpected glucose test results
If the glucose test result is unusual compared to your previous test results
or does not match with how you feel:
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 GlucoMen® areo Sensor 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.
9.4. Unexpected β-ketone test results
If the β-ketone test result is unusual compared to your previous test results
or does not match with how you feel:
1. Repeat the measurement using a new test strip (§5.2).
2. Perform a control measurement using the GlucoMen® areo Ket Control
solution (§5.3).
3. Repeat the measurement using a new test strip from a different foil
pouch (§5.2).
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.
10. Technical specications
General specications
Product: GlucoMen® areo 2K
Manufacturer: A. Menarini Diagnostics srl
Tested items: Blood glucose level; blood β-ketone level.
Test strip coding: No coding required.
Sample: Fresh capillary whole blood.
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 (3 tests/
day).
Memory: 730 glucose and 100 β-ketone 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 six settable acoustic alarms (3 for glucose, 3
for β-ketone measurements).
Data transfer: Via dedicated data cable, NFC, or a Bluetooth
device.
Averages: Over 1, 7, 14, 30, 60, 90 days (for glucose results
only).
Automatic turn off: - After 60 seconds of inactivity before the test
(sensor strip inserted into the meter, drop icon
ashing).
- 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 to 45 °C (41 to 113 °F) for glucose
testing; 10 to 40 °C (50 to 104 °F) for β-ketone
testing.
-
Relative Humidity: 20 to 90% (no dew condensation)
for glucose testing; < 85% for β-ketone testing.
Meter Storage
Conditions:
- Temperature: -20 to 50 °C (-4 to 122 °F).
- Relative Humidity: 20 to 90%.
Control Solutions Storage Temperature: 4 to 30 °C
(39,2 to 86 °F).
Operating
environment:
The meter complies with applicable electromag netic
emission requirements (EMC).
EU directive/
classication:
98/79/EC / Annex II, List B
Device standard: ISO 15197:2003 and additional requirements
introduced by ISO 15197:2013.
Glucose measurement specications
Unit of
measurement:
mg/dL (mmol/L)
Test range: 20 - 600 mg/dL (1,1 - 33,3 mmol/L).
Haematocrit range: 10 - 70 % (haematocrit compensated).
Test strip: GlucoMen® areo Sensor
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 2K 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).
Test strip storage
conditions:
- Temperature: 4 to 30 °C (39,2 to 86 °F) (both for
unopened vial and after opening).
- Relative Humidity: 20 to 90% (both for unopened
vial and after opening).
β-Ketone measurement specications
Unit of
measurement:
mmol/L
Test range: 0,1 - 8,0 mmol/L
Haematocrit range: 20 - 60 % (haematocrit compensated).
Test strip: GlucoMen® areo β-Ketone Sensor
Sample size: Minimum 0,8 μL
Test time: 8 seconds.
Assay method: Electrochemical, β-Hydroxybutyrate
Dehydrogenase based method.
Mediator: 1,10-phenanthroline-5,6-dione.
Calibration and
traceability:
The GlucoMen® areo 2K system is calibrated using
capillary plasma values determined by means
of the Stanbio β-Hydroxybutyrate LiquiColor®
Procedure No. 2440 (Stanbio Laboratory, 1261
North Main Street, Boerne, Texas 78006). The
analyzer used to run the Stanbio kit (secondary
reference measurement procedure) is calibrated
using a series of β-hydroxybutyrate standards
(primary calibrators) prepared gravimetrically at
Stanbio Laboratory.
Test strip storage
conditions:
Temperature: 4 to 30 °C (39,2 to 86 °F).