Guidance And Manufacturer's Declaration - Omron BP653 Instruction Manual

GUIDANCE AND MANUFACTURER'S DECLARATION

OMRON Wrist Blood Pressure Monitor (BPM)
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 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 is to measure a blood pressure and a
pulse rate and using the memory function.
The BPM may be interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
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