59
A
dditional informa
tion
/
English
16.5
Labelling symbols
These symbols may be found on your GlucoMen Day
CGM System packaging.
Symbol Description
Operating
instructions
Manufacturer
Caution
Use-by date
Do not reuse
Type BF applied
part
MR unsafe
Do not use
if package is
damaged
Contents
Recycle:
Electronic
equipment
Serial number
Batch/Lot
number
Part/Catalogue
number
Authorised
Representative
in the European
Community
Symbol Description
CE Mark
Sterilised using
irradiation
Non-ionizing
radiation
Keep dry
Humidity
limitation
Temperature
limitation
Bluetooth
®
trademark
Protection
against insertion
of large objects
and immersion in
water
Direct current
16.7
Electromagnetic compatibility
The GlucoMen Day CGM system complies with the EU
Radio Equipment Directive for wireless transmission and
electromagnetic compatibility requirements defined in
2014/53/EU.
The complete text of the declaration of EU conformity is
available at www.red.menarinidiagnostics.com.
The Transmitter meets the essential data transmission
requirements for operating in the 2.4 GHz ISM band per
ETSI EN 300 328 v2.1.1. Due to the continuous nature
of the CGM system’s wireless communication, the user
should not enter or discontinue use in locations where
mobile phones and other radio transmitters are not per-
mitted, such as some hospitals and healthcare professio-
nal offices. Refer to
SECTION 14.2
Travelling with your
GlucoMen Day CGM for additional locations.
16.6
Accuracy Summary
Performance metrics
11.4%
Overall accuracy
Mean ARD% (percentage of average absolute
error versus reference across all glucose levels)
Clinical accuracy
Percentage of readings that were in the
Consensus Error Grid (CEG) Zone A
Percentage CEG Zone A+B
90%
99%
Reference is YSI (Yellow Springs Laboratory Instruments)
Summary of Contents for A.MENARINI diagnostics GlucoMen Day CGM
Page 1: ...User Guide...
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