Guidance And Manufacturer's Declaration - Electromagnetic Immunity - ResMed Astral 100 Series User Manual

Adult and pediatric ventilator
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Technical specifications
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
Electrostatic
±6 kV contact
discharge (ESD)
±8 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
3 A/m
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
10 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
a
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
72
Compliance level
Electromagnetic environment—guidance
±6 kV contact
Floors should be wood, concrete or ceramic tile. If
±8 kV air
floors are covered with synthetic material, the
relative humidity should be at least 30%.
±2 kV
Mains power quality should be that of a typical
commercial or hospital environment.
±1 kV
±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
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
3 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.
10 V/m
Recommended separation distance
80 MHz to 2.5 GHz
d = 1.17 √P
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 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). Field strengths
from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than
the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:

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