Guidance And Manufacturer's Declaration - Omron HN-290T Instruction Manual

11. Guidance and Manufacturer's Declaration

OMRON Digital Weight Scale
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 Digital Weight Scale 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 Digital Weight Scale is to measure weight.
The Digital Weight Scale may be interfered with by other equipment, even if
that other equipment complies with CISPR EMISSION requirements.
21