Important safety information
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 EN 60601-1-2: 2001+A1:2006 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.
This medical device manufactured by TV Products HK Ltd. conforms to this EN 60601-1-2:
2001+A1:2006 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
Do not use mobile (cellular) telephones and other devices, which generate strong electrical or
electromagnetic fields, near the medical device. This may result in incorrect operation of the
unit and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7m. Verify correct operation of the
device in case the distance is shorter.
BE109 needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in the
ACCOMPANYING
DOCUMENTS.
Portable and mobile RF communications equipment can affect the BE109
(Circulation Enhancer).
WARNING
that the use of accessories, transducers and cables other than those supplied
with the exception of the transducers and cables sold by the manufacturer of the BE109
(Circulation Enhancer) as replacement parts for internal components, may result in increased
EMISSIONS
or decreased IMMUNITY of BE109 (Circulation Enhancer).
WARNING
that BE109 (Circulation Enhancer) should not be used adjacent to or stacked
with other equipment.
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