BIO-MED DEVICES Crossvent-2i+ - Appendix F: EMC Compatibility Information

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Guidance and manufacturer’s declaration – electromagnetic emissions
The Crossvent is intended for use in the electromagnetic environment specified below. The customer or the user of the
Crossvent should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Crossvent 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 A {Professional
equipment with
warning}
The Crossvent 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, provided the following warning is
heeded.
Warning: The equipment is intended for use by healthcare
professionals only. This may disrupt the operation on the nearby
equipment. It may be necessary to take migration measures, such
as re-orienting the Crossvent or shielding the location.
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The Crossvent is intended for use in the electromagnetic environment specified below. The customer or the user of the
Crossvent should assure that it is used in such an environment.
Immunity test Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 2, 4, 8 kV contact
+/- 2, 4, 8, and 15 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
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV
line to line
+/- 2 kV
line to earth
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
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
)
for25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec.
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the Crossvent requires
continued operation during power mains interruptions, it is
recommended that the Crossvent be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60Hz)
magnetic field
30 A/m
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital
environment.