GUIDANCE AND MANUFACTURER’S DECLARATION
ReliOn Blood Pressure Monitor
Model: HEM-741CRELN4
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 ReliOn, with the
exception of cables sold by ReliOn 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 HEM-741CRELN4 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 HEM-741CRELN4 is to measure a blood
pressure and a pulse rate and using the memory function.
The HEM-741CRELN4 may be interfered with by other equipment, even if that
other equipment complies with CISPR EMISSION requirements.
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