Abbott FreeStyle Libre 2 - Using Your Glucose Reading to Make a Treatment Decision

Guidance and manufacturer’s declaration –
electromagnetic emissions
The System is intended for use in the electromagnetic environment specied below. The customer or
the user of the System should assure that it is used in such an environment.
Emissions test Compliance
Electromagnetic
environment – guidance
RF emissions
CISPR 11
Group 1 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.
RF emissions
CISPR 11
Class B 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration –
electromagnetic immunity
The System is intended for use in the electromagnetic environment specied below. The customer or
the user of the System should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601
test level
Compliance
Level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines (100kHz
frequency)
± 1 kV for signal
lines (100kHz
frequency)
± 2 kV for
power supply
lines (100kHz
frequency)
± 1 kV for signal
lines (100kHz
frequency)
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
125 126
ART43974_rev-A_manual.indd 125-126ART43974_rev-A_manual.indd 125-126 2/17/21 8:32 AM2/17/21 8:32 AM