Regulatory compliance
D-3
Electromagnetic immunity
Guidance and manufacturer's declaration - electromagnetic immunity
The V60/V60 Plus Ventilator is intended for use in the electromagnetic environment specified below.
The user of the V60/V60 Plus Ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level Compliance level
Electromagnetic environment
guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are cov-
ered with synthetic material, the
relative humidity should be at
least 30%.
Electrical fast tran-
sient/burst
IEC 61000-4-4
±2 kV for power sup-
ply lines.
±1 kV for input / out-
put lines
±2 kV for power sup-
ply lines.
±1 kV for input / out-
put lines
Mains power quality should be
that of a typical hospital environ-
ment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be
that of a typical hospital environ-
ment.
Voltage dips, short
interruptions and
voltage variations
on power supply in-
put lines
IEC 61000-4-11
0% U
T
for 0.5 cycles
0%
U
T
for 1.0 cycle
70%
U
T
for 25 cycles
(50 Hz)/
30 cycles (60 Hz)
0%
U
T
for 250 cycles
(50 Hz)/
300 cycles (60 Hz)
0%
U
T
for 0.5 cycles
0%
U
T
for 1.0 cycle
70%
U
T
for 25 cycles
(50 Hz)/
30 cycles (60 Hz)
0%
U
T
for 250 cycles
(50 Hz)/
300 cycles (60 Hz)
Mains power quality should be
that of a typical hospital environ-
ment. If the user of the V60/V60
Plus Ventilator requires continued
operation during power mains in-
terruptions, it is recommended
that the V60/V60 Plus Ventilator
be powered from an uninterrupt-
ible power supply or a battery.
Power frequency
(50/60 Hz) magnet-
ic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.
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