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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 EMC information provided in this document.
Guidance and manufacturer’s declaration – electromagnetic emissions
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 environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR11 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 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
Warnings: 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.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may
result in increased emissions or decreased immunity of the device.
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 environment.
Immunity test
IEC60601-1-2 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
l
ines
±2 kV
±1 kV
Mains power quality should be that of a typical
co
mmercial or hospital environment.
Surge IEC
61
000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common
mod
e
Mains power quality should be that of a typical
co
mmercial or hospital environment.
Voltage dips,
sho
rt
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<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
< 12 V (>95% dip in
240V) for 0.5 cycle
96 V (60% dip in
240 V) for 5 cycles
168 V (30% dip in
240 V) for 25 cycles
<12 V (>95% dip in
240 V) 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 uninterruptible power source.
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.