ResMed 2011-09, 248551/1 manual Iec, Classifications, Air travel requirements

IEC 60601-1	•	Class II (Clause 3.14—double insulation). This
classifications		adherence means the need for an protective earthing
	•	(ie, an earthed plug) is not necessary.
		Type BF
	•	Continuous operation
Air travel requirements	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.

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 H2O or hPa.

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
28			mode