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Electromagnetic Compatibility
Guidance and Manufacturer's Declaration Electromagnetic Immunity IEC 60601-1-2
The device is suitable for use in the specified electromagnetic environment. The customer
and/or the user of the device should assure that it is used in an electromagnetic environment
as described below:
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environ-
ment Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
discharge meth-
od
± 8 kV air dis-
charge method
± 6 kV contact
± 8 kV air
Floors should be wood, con-
crete, or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
according to
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for in-
put/output lines
Not applicable
Mains power quality should be
that of a typical commercial
and/or hospital environment
Surge according
to
IEC 61000-4-5
± 1 kV differen-
tial mode
± 2 kV common
mode
Not applicable
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Voltage dips,
short interrup-
tions and volt-
age variations
on power supply
input lines IEC
61000-4-11
< 5 % UT (>95
% dip in UT ) for
½ cycle
40 % UT (60 %
dip in UT ) for 5
cycles
70 % UT (30 %
dip in UT ) for 25
cycles
< 5 % UT (>95
% dip in UT ) for
5 seconds
Not applicable
Mains power quality should be
that of a typical commercial
and/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 uninter-
ruptible power supply or a
battery.
Power frequen-
cy (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Mains power quality should be
that of a typical commercial
and/or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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