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The instrument has been tested and been found to comply with the limits for
electromedical devices imposed by IEC 60601-1-2 standard. These limits guarantee a
reasonable level of protection against harmful interference in a typical medical
installation.
The instrument generates, utilizes and radiates energy at radio frequency, and if not
correctly installed and used as indicated in the instructions, can cause harmful interference
to other devices located in the immediate vicinity. At all events, there can be no guarantee
that interference will not occur in certain situations.
This instrument is suitable for use in professional healthcare facilities, for example in
hospital buildings, although not in close proximity to high frequency surgical equipment
and RF shielded rooms housing MRI systems, where the intensity of electromagnetic
disturbance is typically high.
The instrument must not be used in close proximity to other equipment or
stacked together with other equipment. If this cannot be avoided, check the
operation of the instrument carefully to ensure that it is able to deliver normal
levels of performance in the configuration adopted.
Should the instrument appear to interfere with other devices — this can be verified by
switching off the instrument and then switching on again — it may be possible to remedy
the problem by adopting one or more of the following solutions:
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change the orientation and/or the position of the device affected by interference;
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distance the devices one from another;
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consult the manufacturer or a service center for assistance.
Cables, transducers and accessories
The cables, transducers and accessories for which Inventis declares compliance with IEC
60601-1-2 standard are those supplied with the device, in particular:
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Medical grade USB power adapter
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Shielded USB cable, maximum length: 2 m
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Docking station
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Transducers
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Patient button
The use of accessories, transducers and cables other than those specified,
with the exception of transducers and cables sold by Inventis as replacement
parts for internal components, can have the effect of increasing emissions
from the device and reducing its immunity.
Electromagnetic compatibility
Appendix C
47
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