Freestyle Libre 14 day User Manual page 130

Flash glucose monitoring system
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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.
IMMUNITY
test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
125
IEC 60601
Compliance
test level
± 8 kV contact
± 8 kV contact
± 15 kV air
± 15 kV air
± 2 kV for
± 2 kV for
power supply
power supply
lines
lines
± 1 kV for input/
± 1 kV for input/
output lines
output lines
Level
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.
Electromagnetic

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