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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
NSerial number
Batch/Lot
number
Part/Catalogue
number
Symbol
Description
Authorised
Representative
in the European
Community
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
Medical Device
Assembler
17.6
Accuracy Summary
Refer to www.glucomenday.com website.
17.7
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.
The GlucoMen Day CGM system complies with the electro-
magnetic compatibility immunity requirements defined in
ETSI EN 301 489-1 v2.1.1, ETSI EN 301 489-17 v3.1.1,
and IEC 60601-1-2.
Emissions from nearby electronic equipment are not likely
to interfere with the GlucoMen Day CGM system when
used in a home healthcare environment. These may inter-
fere with the proper operation of the GlucoMen Day CGM
system. Moving away from or turning off these electronic
devices may allow communication.
English
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