10 PC requirements
118 SOREDEX
206718 rev 9
with liquids.
- Clean the PC in accordance with the
manufacturer’s instructions.
- The PC to be used with the unit must be installed
in a location that meets all local and national safety
requirements with regards the connection of a PC
to an x-ray device.
- The connection of the unit to the PC must meet IEC
60601-1 requirements.
- Connecting the unit to an IT-network that includes
other equipment or changing the IT-network can
cause unidentified risks to patients or operators. It
is the responsibility of the organization controlling
the IT-network to identify, analyse, evaluate and
control these possible risks.
■ The use of accessory equipment not complying
with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of
the resulting system.
Consideration relating to the choice shall include:
- Use of the accessory in the PATIENT VICINITY.
- The safety certification of the accessory has been
performed in accordance to the appropriate IEC
601-1 and/or IEC 601-1-1 harmonized national
standard.
10.2 The dental imaging software
The dental imaging software installed in the PC that is
used with the unit must have CE-mark according to
Medical Device Directive, for example SCANORA
software.
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