Freestyle Libre 2 Manual Del Usuario página 154

Changes or modifications not approved by Abbott could void the user's authority to operate the
equipment.
Guidance and manufacturer's declaration – electromagnetic emissions
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System should assure that it is used in such an environment.
Emissions test: RF emissions; CISPR 11
Compliance: Group 1
Electromagnetic environment – guidance: The System 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
Emissions test: Harmonic emissions; IEC 61000-3-2
Compliance: Class A
Emissions test: Voltage fluctuations / flicker emissions; IEC 61000-3-3
Compliance: Complies
Electromagnetic environment – guidance: The System 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
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System 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: Electrical fast transient/burst; IEC 61000-4-4
IEC 60601 test level: ± 2 kV for power supply lines (100kHz frequency); ± 1 kV for signal lines (100kHz
frequency)
Compliance level: ± 2 kV for power supply lines (100kHz frequency); ± 1 kV for signal lines (100kHz
frequency)
Electromagnetic environment – guidance: Mains power quality should be that of a typical domestic,
ART46983-001_rev-A 24-Aug-2022 2:30pm