ResMed Elisee 350 Clinical Manual page 105

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
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions,
and voltage variations on power
supply lines IEC 61000-4-11
Power frequency magnetic field
(50/60 Hz)
IEC 61000-4-8
Conducted RF disturbances
IEC 61000-4-6
Radiated RF disturbances
IEC 61000-4-3
NOT013281-8
IEC 60601-1-2
Compliance level
test level
± 6 kV contact ± 6 kV contact
± 8 kV air ± 8 kV air
± 2 kV for electric power ± 2 kV for electric power
lines lines
± 1 kV for inlet/outlet ± 1 kV for inlet/outlet
lines lines
± 1 kV between phases ± 1 kV between phases
± 2 kV from phase to ± 2 kV from phase to
earth earth
<5% U (95% dip in U ) <5% U
T T
for 0.5 cycles for 0.5 cycles
<40% U (60% dip in U ) <40% U
T T
for 5 cycles for 5 cycles
<70% U (30% dip in U ) <70% U
T T
for 25 cycles for 25 cycles
<5% U (95% dip in U ) <5% U
T T
for 5 sec for 5 sec
3 A/m 3 A/m
3 Vrms 3 Vrms
150 kHz to 80 MHz
a
outside the ISM band
10 Vrms
10 Vrms
150 kHz to 80 MHz
a
inside the ISM band
10 V/m
10 V/m
80 MHz to 2.5 GHz
Electromagnetic environment
– Guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic materials, the relative
humidity should be at least 30%
Mains power quality should be that of
a typical commercial or hospital
environment
Mains power quality should be that of
a typical commercial or hospital
environment
(95% dip in U ) Mains power quality should be that of
T T
a typical commercial or hospital
environment. If the user of the Elisée
(60% dip in U )
T T
350 requires continuous operation
during mains power interruptions, it is
(30% dip in U )
T T
recommended that the Elisée 350 be
powered from an emergency power
(95% dip in U )
T T
supply
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:
P
d=1.17
P
d=1.20
P
d=1.20
P
d=2.30
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
b
meters (m)
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
be less than the compliance level in
each frequency range
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Technical specifications
80 MHz to 800 MHz
800 MHz to 2.5 GHz
c
, should
d
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