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Table 10: Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment—Guidance
This device is intended for use in the electromagnetic environment specified below. The user of this device
should ensure that it is used in such an environment.
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 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
± 500V for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential mode
± 2 kV for common
mode
± 1 kV differential
mode
± 2 kV for common
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 cycle
± 40% U
T
(60% dip in
U
T
) for 5 cycles
± 70% U
T
(30% dip in
U
T
) for 25 cycles
± 5% U
T
(>95% dip in
U
T
) for 5 cycles
± 5% U
T
(>95% dip in
U
T
) for 0.5 cycle
± 40% U
T
(60% dip in
U
T
) for 5 cycles
± 70% U
T
(30% dip in
U
T
) for 25 cycles
± 5% U
T
(>95% dip in
U
T
) for 5 cycles
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 battery pack.
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.
Note
: U
T
is the AC mains voltage before application of the test level.
