ResMed Stellar 100 and 150, Stellar 150 manual English

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	Compliance	Electromagnetic environment - guidance
RF emissions CISPR11	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,
Harmonic Emissions	Class A	including domestic establishments and those directly
		connected to the public low-voltage network that
IEC 61000-3-2
		supplies buildings used for domestic purposes.
Voltage Fluctuations/Flicker	Complies
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	IEC60601-1-2 test	Compliance level	Electromagnetic environment –guidance
	level
Electrostatic	±6 kV contact	±6 kV contact	Floors should be wood, concrete or ceramic tile.
discharge (ESD)	±8 kV air	±8 kV air	If floors are covered with synthetic material, the
IEC 61000-4-2			relative humidity should be at least 30%.
Electrical fast	±2 kV for power	±2 kV	Mains power quality should be that of a typical
transient/burst	supply lines		commercial or hospital environment.
IEC 61000-4-4	±1 kV for input/output	±1 kV
	lines
Surge IEC	±1 kV differential	±1 kV differential	Mains power quality should be that of a typical
61000-4-5	mode	mode	commercial or hospital environment.
	±2 kV common mode	±2 kV common
		mode
Voltage dips,	<5% Ut (>95% dip in	< 12 V (>95% dip in	Mains power quality should be that of a typical
short	Ut) for 0.5 cycle	240V) for 0.5 cycle	commercial or hospital environment.
interruptions	40% Ut (60% dip in	96 V (60% dip in	If the user of the device requires continued
and voltage			operation during power mains interruptions, it is
	Ut) for 5 cycles	240 V) for 5 cycles
variations on			recommended that the device be powered from
	70% Ut (30% dip in	168 V (30% dip in
power supply			an uninterruptible power source.
input lines	Ut) for 25 cycles	240 V) for 25 cycles
IEC 61000-4-11	<5% Ut (>95% dip in	<12 V (>95% dip in
	Ut) for 5 sec	240 V) for 5 sec
Power	3 A/m	3 A/m	Power frequency magnetic fields should be at
frequency			levels characteristic of a typical location in a
(50/60 Hz)			typical commercial or hospital environment.
magnetic field
IEC 61000-4-8

English

Technical specifications 29