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BPAP System User Manual
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Guidance and manufacturer's declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
user of the device should make sure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floor 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
± 2 kV for
power supply
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)
± 1 kV
Line (s) to line (s)
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
0%
U
T
; 0.5 cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0%
U
T
; 1 cycle
70% U
T
; 25 / 30
cycle
At 0°
0%
U
T
; 250 /
300 cycle
0%
U
T
; 0.5 cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0%
U
T
; 1 cycle
70% U
T
; 25 / 30
cycle
At 0°
0%
U
T
; 250 /
300 cycle
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 supply
or a battery
Power frequency
(50 / 60 Hz)
magnetic 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
commercial or hospital
environment
Note: U
T
is the AC mains voltage prior to application of the test level.