Freestyle Libre 14 day - Page 130

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
± 1 kV for input/
output lines
± 2 kV for
power supply
lines
± 1 kV for input/
output lines
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
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