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2）Guidance and manufacturer statement - Electromagnetic Immunity
Guidance and manufacturer statement - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device shouId assure that is used in such an environment.
Immunity test
IEC60601 test level
Compliance Level
Electromagnetic
environment - guide
Electrostatic
discharge(ESD)
EN 61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity shouId 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
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV differential
mode
±1 kV differential
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % U
T
( > 95 % dip in U
T
)
For 0.5 cycles
40% U
T
( 60 % dip in U
T
) for
5 cycles
< 5 % U
T
70 % U
T
( 30 % dip in U
T
)
for 25 cycles
< 5 % U
T
( > 95 % dip in U
T
)
for
5 s
< 5 % U
T
( > 95 % dip in U
T
)
For 0.5 cycles
40% U
T
( 60 % dip in U
T
) for
5 cycles
< 5 % U
T
70 % U
T
( 30 % dip in U
T
)
for 25 cycles
< 5 % U
T
( > 95 % dip in U
T
)
for
5 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the device
requires continued operation during
power mains interruptions, it is
recommended that the device be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
