Omron ne-c801 Guidance and Manufacturers Declaration, Electromagnetic emissions IEC60601-1-2

Guidance and Manufacturer's Declaration

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic interference may result in incorrect operation of the medical device and create a potentially unsafe situation.

Medical devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

Medical devices manufactured by OMRON HEALTHCARE conform to this IEC60601-1-2 standard for both immunity and emissions.

Nevertheless, special precautions need to be observed:

•The use of accessories and cables other than those specified by OMRON, with the exception of cables sold by OMRON as replacement parts for internal components, may result in increased emission or decreased immunity of the device.

•The medical devices should not be used adjacent to or stacked with other equipment.

In case adjacent or stacked use is necessary, the medical device should be observed to verify normal operation in the configuration in which it will be used.

•Do not use mobile (cellular) telephones and other devices, which generate strong electrical or electromagnetic fields, near the medical device. This may result in incorrect operation of the unit and create a potentially unsafe situation. Recommendation is to keep a minimum distance of 7 m. Verify correct operation of the device in case the distance is shorter.

The NE-C801 is intended for use in the electromagnetic environment specified below. The customer or the user of the NE-C801 should assure that it is used in such environment.

Electromagnetic emissions IEC60601-1-2

Emissions test	Compliance	Electromagnetic environment - guidance
		The NE-C801 uses RF energy only for its
RF emissions	Group 1	internal function. Therefore, its RF emissions
CISPR 11		are very low and are not likely to cause any
		interference in nearby electronic equipment.
RF emissions	Class B	The NE-C801 is suitable for use in all
CISPR 11
		establishments, including domestic
Harmonic emissions
	Class A	establishments and those directly connected to
IEC 61000-3-2
		the public low-voltage power supply network
Voltage fluctuations/
		that supplies buildings used for domestic
flicker emissions	Complies
		purposes.
IEC 61000-3-3

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