11 PC requirements
* For the PC requirements of the 3D viewing software consult the 3D software manuals.
System requirements and connections
● The PC and any other external device(s) connected to the system outside the patient
area must meet the IEC 60950 standard and applicable EMC standard (minimum
requirement). Devices that do not meet the IEC 60950 standard and applicable
EMC standard shall not be connected to the system as they may pose a threat to
operational safety.
● The PC and any other external devices must be connected in accordance with IEC
60601-1-1.
● The x-ray unit must be connected to it’s own separate power supply. The PC and any
other external devices must NOT be connected to the same power supply as the x-ray
unit.
● The unit shall be connected directly to the acquisition PC with an Ethernet cable.
Connection through the LAN-network of the site is not allowed. Two network ports are
needed in the PC in order to connect also to the site network.
● Position the PC and any other external device at least 1.5 m (60”) from the xray unit
so that the patient cannot touch the PC or any other external device while being x-
rayed.
● The PC and any other external devices shall not be connected to an extension cable.
● Multiple extension cables shall not be used.
● Do not position the PC where it could be splashed 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.
11.2 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 CLINIVIEW software.
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OP 3D Pro