ResMed Elisee 350, Clinical Manual

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99/102 Technical specifications
NOT013281-8
Guidance and manufacturer’s declaration – electromagnetic
immunity
The Elisée 350 is intended for use in the electromagnetic environment specified below. The client
or user of the Elisée 350 should ensure that it is used only in such an environment.
Immunity test
IEC 60601-1-2
test level
Compliance level
Electromagnetic environment
– Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2 ± 6 kV contact
± 8 kV air ± 6 kV contact
± 8 kV air Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic materials, the relative
humidity should be at least 30%
Electrical fast transient/burst
IEC 61000-4-4 ± 2 kV for electric power
lines
± 1 kV for inlet/outlet
lines ± 2 kV for electric power
lines
± 1 kV for inlet/outlet
lines Mains power quality should be that of
a typical commercial or hospital
environment
Surge
IEC 61000-4-5 ± 1 kV between phases
± 2 kV from phase to
earth ± 1 kV between phases
± 2 kV from phase to
earth Mains power quality should be that of
a typical commercial or hospital
environment
Voltage dips, short interruptions,
and voltage variations on power
supply lines IEC 61000-4-11 <5% U
T
(95% dip in U
T
)
for 0.5 cycles
<40% U
T
(60% dip in U
T
)
for 5 cycles
<70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(95% dip in U
T
)
for 5 sec
<5% U
T
(95% dip in U
T
)
for 0.5 cycles
<40% U
T
(60% dip in U
T
)
for 5 cycles
<70% U
T
(30% dip in U
T
)
for 25 cycles
<5% U
T
(95% dip in U
T
)
for 5 sec
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Elisée
350 requires continuous operation
during mains power interruptions, it is
recommended that the Elisée 350 be
powered from an emergency power
supply
Power frequency magnetic field
(50/60 Hz)
IEC 61000-4-8 3 A/m 3 A/m
Conducted RF disturbances
IEC 61000-4-6
Radiated RF disturbances
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
outside the ISM band
a
10 Vrms
150 kHz to 80 MHz
inside the ISM band
a
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 Vrms
10 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Elisée 350, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter
Recommended separation
distance:
d=1.17
d=1.20
d=1.20 80 MHz to 800 MHz
d=2.30 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m)
b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
c
, should
be less than the compliance level in
each frequency range
d
Interference may occur in the vicinity
of equipment marked with the
following symbol:
P
P
P
P