A. Menarini Diagnostics GlucoMen areo 2K Gebruikershandleiding - Pagina 7
Blader online of download pdf Gebruikershandleiding voor {categorie_naam} A. Menarini Diagnostics GlucoMen areo 2K. A. Menarini Diagnostics GlucoMen areo 2K 9 pagina's. Blood glucose and b-ketone self-monitoring system
Pagina afdrukken
d. 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:
a. Repeat the measurement using a new test strip (§5.2).
b. Perform a control measurement using the GlucoMen® areo Ket Control
control solution (§5.3).
c. Repeat the measurement using a new test strip from a different foil
pouch (§5.2).
d. 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 specifications
General specifications
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
Automatic compensation using a built-in thermo
compensation:
sensor.
Batteries:
Two 3.0 V lithium batteries (CR2032).
Battery life:
A minimum of 900 tests or about 1 year (2-3 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
available.
Alarms:
Up to six settable acoustic alarms (3 for glucose, 3
for β-ketone measurements).
Data transfer:
Via dedicated USB cable or NFC (all results) or a
Bluetooth device (glucose results only).
Averages:
Over 1, 7, 14, 30, 60, 90 days (for glucose results
only).
Automatic turn off:
- After 90 seconds of inactivity before the test
(sensor strip inserted into the meter, drop icon
flashing).
- After 60 seconds of inactivity after the test and
Error messages Er2, Er3, Er4, HI and LO.
- After 5 seconds for Error messages Er1,
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
- Temperature: 5 to 45 °C (41 to 113 °F) for glucose
Conditions:
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
- Temperature: -20 to 50 °C (-4 to 122 °F).
Conditions:
- Relative Humidity: 20 to 90%.
Control Solutions
4 to 30 °C (39,2 to 86 °F).
Storage Temperature:
Operating
The meter complies with applicable electromag netic
environment:
emission requirements (EMC).
meals,
exercise,
check
markers
Operating radio
13,56 MHz
frequency band(s)
Maximum
0,67 nW
radiofrequency
power transmitted
in the operating
frequency band(s)
EU directive/
98/79/EC / Annex II, List B
classification:
Device standard:
EN ISO 15197:2015
Glucose measurement specifications
Unit of
mg/dL (mmol/L)
measurement:
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,
Aspergillus niger sourced) based method.
Mediator: Hexacyanoferrate(III) ion.
Calibration and
The results are equivalent to the plasma glucose
traceability:
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
- Temperature: 4 to 30 °C (39,2 to 86 °F) (both for
conditions:
unopened vial and after opening).
- Relative Humidity: 20 to 90% (both for unopened
vial and after opening).
β-Ketone measurement specifications
Unit of
mmol/L
measurement:
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
The GlucoMen® areo 2K system is calibrated using
traceability:
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
Temperature: 4 to 30 °C (39,2 to 86 °F).
conditions:
7
Glucose
Oxidase
(GOD,