ResMed Flow Generator S8 Elite System - Manual (Page 40)

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Guidance and manufacturer’s declaration—electromagnetic immunity
The S8 series of devices is intended for use in the electromagnetic environment specified below. The
customer or the user of the S8 device should assure that the device is used in such an environment.
Immunity test
IEC60601-1-2
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 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
Not Applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5 ±1 kV differential
mode
±2 kV common
mode ±1 kV differential
mode
±2 kV common
mode
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.
IEC 61000-4-11 <5% Ut
(>95% dip in Ut)
for 0.5 cycle
40% Ut
(60% dip in Ut)
for 5 cycles
70% Ut
(30% dip in Ut)
for 25 cycles
<5% Ut
(>95%dip in Ut)
for 5 sec
< 12V
(>95% dip in 240V)
for 0.5 cycle
96V
(60% dip in 240V)
for 5 cycles
168V
(30% dip in 240V)
for 25 cycles
<12V
(>95%dip in 240V)
for 5 sec
Mains power quality should
be that of a typical
commercial or hospital
environment.
If the user of the S8 device
requires continued operation
during power mains
interruptions, it is
recommended that the S8
device be powered from an
uninterruptible power
source.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.