User's Guide

English 23
Guidance and manufacturer’s declaration
electromagnetic emissions and immunity
WARNING
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 3.9" (10 cm) to any part of the device. Otherwise,
degradation of the performance of this equipment could result.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to EMC information provided in this document.
The AirSense device has been designed to meet EMC standards. However, should you suspect that the
device performance (eg, pressure or flow) is affected by other equipment, move the device away from the
possible cause of interference.
Guidance and manufacturer's declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The patient or the user
of the device should assure that the device is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
RF emissions CISPR 11 Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage network that supplies
buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Complies
Guidance and manufacturer's declaration - electromagnetic immunity
The device is 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
Compliance level
Electromagnetic environment — guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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
±1 kV for input/output
lines
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
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in
Ut) for 5 sec
<5% Ut (>95% dip in Ut)
for 0.5 cycle
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the device requires continued operation
during power mains interruptions, it is recommended that
the device be powered from an uninterruptible power
source.