Guidance And Manufacturer's Declaration - Electromagnetic Immunity - ResMed Astral Series Clinical Manual

Guidance and Manufacturer's Declaration Electromagnetic Emissions & Immunity
Guidance and manufacturer's declaration – electromagnetic immunity
These devices are intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that the device is used in such an environment.
Immunity test IEC60601-1-2 test
level, Ed. 4
Electrostatic ±8 kV contact
discharge (ESD) ±15 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power
transient/burst supply lines
IEC 61000-4-4 ±1 kV for
input/output lines
Surge ±1 kV differential
IEC 61000-4-5 mode
±2 kV common mode
Voltage dips, <5% Ut (>95% dip in
short Ut) for 0.5 cycle
interruptions
40% Ut (60% dip in
and voltage
Ut) for 5 cycles
variations on
70% Ut (30% dip in
power supply
Ut) for 25 cycles
input lines
<5% Ut (>95% dip in
IEC 61000-4-11
Ut) for 5 sec
Power 30 A/m
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted RF 3 Vrms
for life support outside ISM bands
IEC 61000-4-6
10 Vrms
inside ISM bands
150
Compliance level Electromagnetic environment—guidance
±8 kV contact Floors should be wood, concrete or ceramic tile. If
±15 kV air floors are covered with synthetic material, the
relative humidity should be at least 30%.
±2 kV for power Mains power quality should be that of a typical
supply lines commercial or hospital environment.
±1 kV for input/output
lines
±1 kV differential Mains power quality should be that of a typical
mode commercial or hospital environment.
±2 kV common mode
<12V (>95% dip in Mains power quality should be that of a typical
240V) for 0.5 cycle commercial or hospital environment.
96V (60% dip in 240V) If the user of the device requires continued
for 5 cycles operation during power mains interruptions, it is
recommended that the device be powered from an
168V (30% dip in
uninterruptible power source.
240V) for 25 cycles
The internal battery will provide backup power of
<12V (>95% dip in
eight hours.
240V) for 5 sec
30 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
10 Vrms Portable and mobile RF communications equipment
150 kHz to 80 MHz should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter. See separation
distance table below.
d = 0.35 √P outside ISM bands
d = 1.2 √P inside ISM bands