– 66 –
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 device should assure that it is used in such an environ
-
ment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
• 6kV contact
• 8 kV air
• 6kV 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
• 2kVfor power
supply lines
• 1kVfor input/
output lines
• 2kVfor power
supply lines
• 1kVfor input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
• 1kV line(s) to
line(s)
• 2kV line(s) to
earth
• 1kV line(s) to
line(s)
• 2kV line(s) to
earth
Mains power quality
should be that of a
typical commercial or
hospital environment.
interruptions
and
voltage varia
-
tions on power
supply input
lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 %
UT
(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 sec
<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 sec
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 uninterrupti
-
ble power supply or
a battery.
Power frequen
-
cy (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency ma
-
gnetic 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 prior to application of the test level.
