EMCinfo - Nebuliser - NE - C 900 - v01 Date: 23/11/ 20 12 OMRON mains - operated Nebuliser CompAir Pro ( NE - C 900 series)
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OMRON mains-operated Nebuliser CompAir Pro (NE-C900 series) Information for accompanying documents in the scope of IEC60601-1-2:2007 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 EN60601-1-2 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 EN60601-1-2:2007 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. • Refer to further guidance below regarding the EMC environment in which the device should be used. (Table 1) Guidance and manufacturer’s declaration – electromagnetic emissions OMRON mains-operated Nebuliser NE-C900 is intended for use in the electromagnetic environment specified below. The customer or the user of these OMRON Nebulisers should assure that it is used in such environment. Emissions test Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3 Electromagnetic environment - guidance The NE-C900 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The NE-C900 is not suitable for interconnection with other equipment.

(Table 2) Guidance and manufacturer’s declaration – electromagnetic immunity OMRON mains-operated Nebuliser NE-C900 is intended for use in the electromagnetic environment specified below. The customer or the user of these OMRON Nebulisers should assure that it is used in such environment. IEC 60601 Compliance Electromagnetic environment – Immunity test Test level level guidance Floor should be wood, concrete, or Electrostatic ±6 kV contact ±6 kV contact ceramic tile. If floors are covered with discharge (ESD) ±8 kV air ±8 kV air synthetic material, the relative IEC 61000-4-2 humidity should...

(Table 4) Guidance and manufacturer’s declaration – electromagnetic immunity OMRON mains-operated Nebuliser NE-C900 is intended for use in the electromagnetic environment specified below. The customers or the users of these OMRON Nebulisers should assure that it is used in such environment. IEC 60601 Compliance Electromagnetic environment – Immunity test Test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the OMRON nebuliser NE-C900 including cables, than the recommended separation distance calculated from the equation...

(Table 6) Recommended separation distance between portable and mobile RF communications equipment and the OMRON Nebuliser NE-C900 OMRON Nebuliser NE-C900 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customers or the users of these OMRON Nebulisers can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OMRON Nebuliser NE-C900 as recommended below, according to the maximum output power of the communications equipment. Separation...