Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Freestyle Libre 2 Manuel D'utilisation

ART41758-100_rev-A 3:14pm 18-JAN-2021
Compliance: Group 1
Electromagnetic environment – guidance: The Sensor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic
equipment.
Emissions test: RF emissions; CISPR 11
Compliance: Class B
Electromagnetic environment – guidance: The Sensor is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Guidance and manufacturer's declaration – electromagnetic immunity Guidance and manufacturer's declaration – electromagnetic immunity
The Sensor is intended for use in the electromagnetic environment specified below. The customer or
the user of the Sensor should assure that it is used in such an environment.
Immunity test: Electrostatic discharge (ESD); IEC 61000-4-2
IEC 60601 test level: ±8 kV contact; ±15 kV air
Compliance level: ±8 kV contact; ±15 kV air
Electromagnetic environment – guidance: Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at least 30%.
Immunity test: Power frequency (50/60 Hz); magnetic field; IEC 61000-4-8
IEC 60601 test level: 30 A/m
Compliance level: 30 A/m
Electromagnetic environment – guidance: Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical domestic, commercial or hospital environment.
Immunity test: Radiated RF; IEC 61000-4-3
IEC 60601 test level: 10 V/m; 80 MHz to 2.7 GHz
Compliance level: 10 V/m
a
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be
b
less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (mobile/wireless) telephones