Guidance And Manufacturer's Declaration-Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - ResMed Lumis HFT Mode D'emploi

Guidance and manufacturer's declaration electromagnetic emissions and
immunity
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 Lumis HFT 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 customer
or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
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
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
Compliance
Group 1
Class B
Class A
Complies
Compliance level
±8 kV contact
±15 kV air
±2 kV
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
100V
240V
Electromagnetic environment — guidance
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.
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.
Electromagnetic environment — guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, 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.
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.
English 23