zebris ARCUSdigma 3, Руководство пользователя

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When operating the ARCUSdigma 3 system, the user [2] must be sure
never to touch the PC [3] and the patient [1] at the same time.
The same applies to all other nonmedical electrical components
that are only to be used outside the patient environment.
Failure to comply can lead to the occurrence of dangerous leakage
currents.
The computer, the inductive charger and other non-medical
electrical accessories have to be set up outside of the patient
environment (1.5 m clearance).
If multiple sockets are used for connecting the ARCUSdigma 3 system or
its components (especially PC and inductive charger), the following safety
regulations are to be observed:
It is extremely dangerous to use multiple sockets for combining the
mains connection of components of Medical Electrical Equipment
Systems with non medical components that. It is possible for excessive
touch currents to occur, if mains are connected without the user having
any respective expert knowledge. In the worst case, the impedance of
the protective conductor system limits the short-circuit current in such
a way that the fuse does not trip.
The manufacturer advises to connect the power supply of the face
bow always directly to a wall socket with a tested protective earth
and separate fuse.
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The following components of the ARCUSdigma 3 system may only be used within the patient
environment:
●
ARCUSdigma 3 system (face bow, lower jaw sensor, accessories)
●
IR foot switch
8.2.3. Multiple sockets
■
If multiple sockets are used jointly for face bow and PC/inductive charger the multiple socket
and complete interconnection of the system must adhere to all the requirements of DIN EN 60601-
1:2013 Section 16. If necessary, an isolating transformer is to be used for an arrangement of this
kind, and the ground leakage current in the protective earth conductor of the multiple sockets must
not exceed 5 mA. The adherence to the maximum permissible patient leakage currents is to be
verified by measuring. If a multiple socket was integrated after setting the system into operation for
the first time, no additional device may be connected to it (use multiple sockets with locking covers
for this purpose)
■
Multiple sockets must not be placed on the floor to avoid accidentally penetration of liquids or
mechanical damages.
■
It is forbidden to use several multiple sockets connected in series.
■
Multiple sockets can be used without causing any danger for connecting the PC and inductive
charger outside the patient‘s vicinity.