Full Product Manual

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9. Guidance and Manufacturer’s Declaration
OMRON Automatic Blood Pressure Monitor
Information for accompanying documents in the scope of IEC60601-1-2:2007
Model: BP7100
Important information regarding Electromagnetic Compatibility (EMC)
With the increased number of electronic devices such as PCs 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 (Electromagnetic 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 BP7100 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 BP7100 is to measure a blood pressure and a pulse rate
and using the memory function.
The BP7100 may be interfered with by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.