iBreeze BPAP Systems User Manual
31
Form B-2 Guidance and Declaration - Electromagnetic Immunity
Immunity test
IEC60601test
level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge
（
ESD
）
IEC61000-4-2
Contact
：
±8kV
Air
：
±15 kV
Contact
：
±8 kV
Air
：
±15V
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
IEC61000-4-4
Power supply
lines
：
±2 kV
input/output
lines
：
±1 kV
Power supply
lines
：
±2 kV
input/output
lines
：
±1 kV
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC61000-4-5
line(s) to line(s)
：
±1 kV
line(s) to earth
：
±2 kV
line(s) to
line(s)
：
±1 kV
line(s) to earth
：
±2 kV
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
IEC61000-4-11
0%, 70%, 0% of
UT
0% for 0.5 cycle
Mains power quality
should be that of a
typical commercial or
hospital environment.
0% for 1 cycle
70% for 25
cycles
0% for 250
cycles
Power frequency
（
50/60Hz
）
magnetic field
IEC61000-4-8
50Hz,60Hz
30A/m
50Hz:30A/m
60HZ:30A/m
Mains power quality
should be that of a
typical commercial or
hospital environment.
Conduced RF
IEC61000-4-6
150KHz to
80MHz 3Vrms
ISM and amateur
radio bands
between 150KHz
to 80MHz 6Vrms
3Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at
1kHz
Portable and mobile RF
communications
equipment should be
used no closer to any
part of the BPAP
system, including
cables, than the
recommended
separation distance
calculated from the
equation appropriate for
the frequency of the
transmitter.
Recommended
separation distances:
d=0.35√p
d=1.2√p
