Guidance And Manufacturer's Declaration - Omron HEM-9200T Instruction Manual

9. 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.
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