Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity - ResMed Stellar 100 Manuel D'utilisation

Air travel requirements
This device is not suitable for use in the presence of a flammable anesthetic mixture.
Notes:
• The manufacturer reserves the right to change these specifications without notice.
• Pressure may be displayed in cm H
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.
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 it is used in such an environment.
Emissions test
RF emissions CISPR11
RF emissions CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Warnings: The device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may
result in increased emissions or decreased immunity of the device.
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 it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC
61000-4-5
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Medical-Portable Electronic Devices (M-PED) that meet
the Federal Aviation Administration (FAA) requirements
of RTCA/DO-160 can be used during all phases of air
travel without further testing or approval by the airline
operator. ResMed confirms that the Stellar meets RTCA/
DO-160 requirements.
O or hPa.
2
Compliance
Group 1
Class B
Class A
Complies
IEC60601-1-2 test
Compliance level
level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
±2 kV for power ±2 kV
supply lines
±1 kV for input/output ±1 kV
lines
±1 kV differential ±1 kV differential
mode mode
±2 kV common mode ±2 kV common
mode
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.