Freestyle Libre User Manual page 67

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 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
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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.
IMMUNITY IEC 60601 Compliance
test test level Level
Surge ±1 kV ±1 kV
differential differential
IEC 61000-4-5
mode mode
±2 kV common ±2 kV common
mode mode
Voltage <5 % U <5 % U
T T
dips, short (>95 % dip in (>95 % dip in
interruptions and ) for 0.5 cycle ) for 0.5 cycle
U U
T T
voltage variations
40 % U 40 % U
T T
on power supply
(60 % dip in U ) (60 % dip in U
T
input lines
for 5 cycles for 5 cycles
IEC 61000-4-11
70 % U 70 % U
T T
(30 % dip in U ) (30 % dip in U
T
for 25 cycles for 25 cycles
<5 % U <5 % U
T T
(>95 % dip (>95 % dip
in U ) for 5 in U ) for 5
T T
seconds seconds
Electromagnetic
environment – guidance
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment. If the user
of the System requires continued
operation during power mains
)
T
interruptions, it is recommended
that the System be powered from
an uninterruptible power supply or
)
T
a battery.
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