Guidance And Manufacturer's Declaration - Omron BP710N Instruction Manual

GUIDANCE AND MANUFACTURER'S DECLARATION

OMRON Automatic Blood Pressure Monitor
Information for accompanying documents in the scope of IEC60601-1-2:2007
Model: BP710N
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 BP710N 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 BP710N is to measure a blood pressure and a pulse
rate and using the memory function.
The BP710N may be interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
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