
Manufacturer's EMC declaration
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The
enShock
device was developed according to the recognised rules of engineering; the
information on use as intended of the components was taken into account.
enShock
should not be operated near active HF surgical devices or magnetic resonance
imaging devices which can cause significant electromagnetic interference.
enShock is exclusively intended and has been tested for professional healthcare facilities,
such as hospitals.
enShock does not have any key performance features which could be impaired through
electromagnetic interference.
WARNING
: The use of this device next to or stacked with other devices should be avoided
since this could lead to faulty operation. If such use is necessary, the device as well as the
other devices should be continuously observed to ensure that they are working normally.
The electromagnetic compatibility of the enShock device was tested on the original device
with the specified original accessories.
WARNING:
The use of accessories, converters and cables which are not specified or
provided by the manufacturer of this device can lead to increased electromagnetic
interference emissions or decreased electromagnetic immunity of this device, resulting in
improper operation.
The enShock device does not contain any exchangeable components, cables or other
parts which lead to worsening of the EMC.
WARNING:
Portable HF communication devices (including peripheral devices such as
antennas) should be used at a distance of at least 30 cm (12 inches) from any part of the
enShock device; this includes cables indicated by the manufacturer. There may otherwise
be a loss of performance of this device.
The device was tested for HF immunity with selected frequencies only. Transients with
other frequencies occurring in the vicinity can lead to malfunctions. The tested frequencies
are listed in Table 4.
The enShock device does not contain any components which can age during the life of the
device or which can lead to worsening of the electromagnetic compatibility. Thus no
maintenance is necessary during the service life of the device to ensure basic safety.
All tests according to standard IEC 60601-1-2 Ed. 4.0 were performed. Other standards
and regulations on electromagnetic compatibility were not applied.