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10.0 Appendix for Electromagnetic Compliance
IEC 60601-1-2:2004 Table 201 Requirements
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
equipment should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions
CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
IEC 60601-1-2:2004 Table 202 Requirements:
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
Equipment should assure that it is used in such an environment.
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
UT = 230 Vac
Power frequency (50 Hz)
magnetic field IEC 61000-
4-8
36
Compliance
Group 1
Class B
Class A
Complies
IEC 60601 test level
±6 kV contact ±8 kV air
±2 kV for power supply
lines ±1 kV for input/
output lines
±1 kV line(s) to line(s) ±2
kV line(s) to earth
<5 % UT (>95 % dip in
UT) for 0,5 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 sec
3 A/m
Electromagnetic environment – guidance
The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The equipment is suitable for use in all establishments including
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Compliance level
±6 kV contact ±8 kV
air with documented
necessary
±2 kV for power supply
lines ±1 kV for input/
output lines
±1 kV line(s) to line(s) ±2
kV line(s) to earth
<5 % UT (>95 % dip in
UT) for 0,5 cycle 40 %
UT (60 % dip in UT) for
5 cycles 70 % UT (30 %
dip in UT) for 25 cycles
No anomalies
95% dip meets
requirements.
3 A/m
Electromagnetic environment
– guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the equipment requires
continued operation during
power mains interruptions,
it is recommended that the
equipment be powered from an
uninterruptible power supply or a
battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
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