BIO-MED DEVICES Crossvent-2i+ Operation & Service Manual page 92

Intensive care/transport ventilator
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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
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonics emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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
Electrostatic
discharge (ESD)
+/- 2, 4, 8, and 15 kV air
IEC 61000-4-2
Electrical fast
+/- 2 kV for power supply
transient/burst
IEC 61000-4-4
+/- 1 kV for input/output
Surge
IEC 61000-4-5
Voltage dips, short
<5% U
interruptions and
for 0.5 cycle
voltage variations
on power supply
40% U
lines
5 cycles
IEC 61000-4-11
70% U
for25 cycles
<5% U
Power frequency
30 A/m
(50/60Hz)
magnetic field
Compliance
Group 1
Class A {Professional
equipment with
warning}
Class A
Complies
Compliance level
+/- 2, 4, 8 kV contact
lines
lines
+/- 1 kV
line to line
+/- 2 kV
line to earth
(>95% dip in U
)
T
T
(60% dip in U
) for
T
T
(30% dip in U
)
T
T
(>95% dip in U
)
T
T
for 5 sec.
Electromagnetic environment - guidance
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.
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.
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 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 magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital
environment.
87

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