Abbott FreeStyle Libre 2 User Manual page 86

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 Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3
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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.
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.
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.
IMMUNITY IEC 60601 Compliance
test test level Level
Electrostatic ± 8 kV contact ± 8 kV contact
discharge (ESD)
± 15 kV air ± 15 kV air
IEC 61000-4-2
Electrical fast ± 2 kV for ± 2 kV for
transient/burst power supply power supply
lines lines
IEC 61000-4-4
± 1 kV for input/ ± 1 kV for input/
output lines output lines
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 %.
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
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