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13.
Guidance and Manufacturer’s Declaration
OMRON Blood Pressure Monitor (BPM) including AC-adapter
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
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 IEC60601-1-2:2007 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.
• The MEDICAL ELECTRICAL EQUIPMENT BPM including AC-adapter needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this documentations.
• The Essential Performance of the BPM including AC-adapter is to measure a blood pressure and a pulse rate and using the memory
function.
The BPM including AC-adapter may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION
requirements.
Guidance and manufacturer’s declaration - electromagnetic emissions
OMRON BPM including AC-adapter is intended for use in the electromagnetic environment specified below. The customer or the user of this
OMRON BPM including AC-adapter should assure that it is used in such environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1
The OMRON BPM including AC-adapter 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 OMRON BPM including AC-adapter 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
IEC61000-3-3
Complies
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