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In accordance with the EMC-regulations for medical products we are obliged by
law to provide the following information.
Guidance and manufacturer's declaration — electromagnetic emissions
The equipment is intended for the use in the electromagnetic environment specified below. The customer or the user
of the equipment should ensure the compliance with this stipulation
Emissions test
RF emissions,
CISPR 11
RF emissions,
CISPR 11
Harmonic emissions,
IEC 61000-3-2 (*)
Voltage fluctuation/flicker
emissions, IEC 61000-3-3 (*)
(*) Note: For devices with a power consumption between 75 W and 1000 W only.
Guidance and manufacturer's declaration — electromagnetic immunity
The equipment is intended for the use in the electromagnetic environment specified below. The customer or the user
of the equipment should ensure the compliance with this stipulation
Immunity test
electrostatic discharge (ESD),
IEC61000-4-2
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
Power frequency (50/60 Hz)
magnetic field,
IEC 61000-4-8
Note: U
is the a.c. mains voltage prior to application of the test level.
gbo Medizintechnik AG
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 differential mode
2 kV common mode
<5% U
for ½ cycle
(>95% dip)
40% U
for 5 cycles
60% dip)
70% U
for 25 cycles
30% dip)
<95% U
for 5 s
(>5% dip)
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 establishments 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
2 kV for power supply
lines
1 kV for input/output
lines
1 kV differential mode
2 kV common mode
<5% U
for ½ cycle
(>95% dip)
40% U
for 5 cycles
60% dip)
70% U
for 25 cycles
30% dip)
<95% U
for 5 s
(>5% dip)
3 A/m
Electromagnetic environment –
guidance
Floors should be made of wood, concrete
or ceramic tiles. 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.
Version 1.3
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