Specifications 57
DreamStation BiPAP autoSV User Manual
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions – This device is intended for use in
the electromagnetic environment specified below. The user of this device should make sure it is used in such
an environment.
E
missions
T
EsT
C
omplianCE
E
lECTromagnETiC
E
nvironmEnT
- g
uidanCE
RF emissions
CISPR 11
Group 1
The device 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.
RF emissions
CISPR 11
Class B
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker
emissions
IEC 61000-3-3
Complies
Emission of Radio Frequency
Energy
RTCA/DO-160G Section 21
Category M
This device is suitable for use onboard commercial airplanes
inside passenger cabin.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity – This device is intended for use in the
electromagnetic environment specified below. The user of this device should make sure it is used in such an
environment.
i
mmuniTy
T
EsT
iEC 60601 T
EsT
l
EvEl
C
omplianCE
l
EvEl
E
lECTromagnETiC
E
nvironmEnT
-
g
uidanCE
Electrostatic Discharge
(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 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
±1 kV for input-output
lines
±2 kV for supply mains
±1 kV for input/output
lines
Mains power quality should be
that of a typical home or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV for common mode
Mains power quality should be
that of a typical home or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
)
for
0.5 cycle at 45 degree
increments
70% U
T
(30% dip in U
T
)
for 0.5 seconds
<5% U
T
(>95% dip in U
T
)
for 5 seconds
<5% U
T
(>95% dip in U
T
)
for
0.5 cycle at 45 degree
increments
70% U
T
(30% dip in U
T
)
for 0.5 seconds
<5% U
T
(>95% dip in U
T
)
for 5 seconds
Mains power quality should be
that of a typical home 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 hospital
or home environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
