Omron NE-C801 - Manual (Page 27)

27
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
RF emissions
CISPR 11
Group 1
The NE-C801 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 NE-C801 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
GUIdANCE ANd MANUfACTURER'S dECLARATION
NE-C801S-Z_A_M_E_SP_041311.indd 27 4/13/11 10:20:57 AM