Operator’s Manual G - 1
G EMC Guidance and
Manufacturer’s Declaration
The system complies with the EMC standard IEC 60601-1-2: 2014+A1:2020.
Intended Environments:
Professional healthcare environment (except for near active HF
SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic
resonance imaging
)
• The use of unapproved accessories may diminish system performance.
• Use of components, accessories, probes, and cables other than those
specified may result in increased emission or decreased immunity of
system.
• Operation of system, in the case that the patient physiological signal is
lower than the minimum amplitude or value specified in the product
specifications, results may not be obtained (results can be obtained when
the HR is in the range of 30-250 bmp or when the QRS wave amplitude is
between 0.5-5 mV.)
• Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
• Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the system, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
• The system is not intended for use in residential environments and can
possibly not provide adequate protection to radio reception in such
environments.
• The system should be away from RFID, MRI, diathermy, and electrocautery
testing, wireless power transfer, 5G cellular and security equipment (such
as electromagnetic anti-theft system and metal detector). If the devices are
near and are interfered by the concealed and undiscovered RF transmitter
(for example, scanning mode changes or image disturbances affecting
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