Table 2: Guidance and Manufacturer's Declaration: Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
devices should assure that it is used in such an environment.
EN
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst IEC
61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power
frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
Note
Lipo UM 3385A FDA Canada ED228-05.indd 28
IEC 60601
Test Level
± 8 kV contact
± 15 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
2 kV
0, 90, 180 & 270
degree phase angles
100% drop, 0.5 periods
(0°, 45°, 90°, 135°, 180°,
225°, 270°, 315°)
100% dip, 1 period
30% dip, 25/30 periods
100% drop, 5 seconds
3 A/m
UT is the a.c. mains voltage prior to application of the test level.
Compliance Level
Electromagnetic
Environment Guidance
Floors should be wood,
± 8 kV contact
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
± 15 kV air
± 2 kV for power supply
Mains power quality should be
that of a typical commercial or
lines
hospital environment.
NA
Mains power quality should be
2 kV
0, 90, 180 & 270
that of a typical commercial or
hospital environment.
degree phase angles
100% drop, 0.5 periods
Mains power quality should be
that of a typical commercial or
(0°, 45°, 90°, 135°, 180°,
hospital environment. If the user
225°, 270°, 315°)
of the device requires continued
operation during power mains
interruptions, it is recommended
100% dip, 1 period
that the device be powered from
an uninterruptible power supply
30% dip, 25/30 periods
or a battery.
100% drop, 5 seconds
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
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