24 AVACEN 100 User Guide 171208
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions and
Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this document.
This declaration applies to the model AVACEN 100. The device is intended for use in the electromagnetic
environment specified. The customer or the user of the device should assure that it is used in such an environment.
Electromagnetic Emissions
Emissions test Compliance Electromagnetic environment
guidance
RF emissions
CISPR 11
Group 1 The device 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.
RF emissions
CISPR 11
Class B The device 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary,
the device should be observed to verify normal operation in the configuration in which it will be used.
Electromagnetic Immunity
Immunity test IEC 60601 test
level
Compliance Level Electromagnetic environment
guidance
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
± 1 kV for
input/output
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV differential
mode
± 2 kV 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
) for 5 s
<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
) for 5 s
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the AVACEN 100 requires continued operation
during power mains interruptions, it is
recommended that the AVACEN 100 be powered
from an uninterruptible power supply or a battery.
NOTE U
is the a.c. mains voltage prior to application of the test level.
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.
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