Abbott FreeStyle Libre 2 User Manual page 56

ART41753-100_rev-A 5:36pm 18-JAN-2021
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:
a
Field strengths from fixed transmitters, such as base stations for radio (mobile/wireless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Sensor is used exceeds the applicable RF compliance level above, the Sensor
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orientating or relocating the Sensor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Immunity Test: Proximity fields from RF wireless communications equipment; IEC 61000-4-3
Test Level: See the table below
Compliance Level: Compliance to the tested levels Electromagnetic