User's Manual

RXiBreeze PAP System User Manual
35
Form A-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 CPAP
system, including
cables, than the
recommended
separation distance