10 Symbols and labeling
KaVo Scan eXam One 75
• For ethernet connections, use an unshielded
CAT6 RJ-45 LAN cable, so that multiple
chassis must not be connected! The work-
station / Ethernet switch to which unit is
connected to must be class I or class II ac-
cording IEC 60950. After installation check
that the IEC 60601-1 leakage current levels
are not exceeded.
• Connecting the device to an IT-network that
includes other equipment or changing the
IT-network configuration can cause un-
known safety or security risks to patients or
operators. It is the responsibility of the or-
ganization controlling the IT-network to
identify, analyze, evaluate and control these
possible risks.
•If the workstation / Ethernet switch to which
the device is connected to is used in the pa-
tient environment it should be approved ap-
propriately and meet the requirements of
60601-1 standard.
• The workstation and any other external de-
vice(s) connected to the system outside the
patient area must meet the IEC 60950 stan-
dard and applicable EMC standard (mini-
mum 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 opera-
tional safety.
• The workstation and any other external de-
vices shall not be connected to an extension
cable.
• Multiple extension cables shall not be used.
• If this device will be used with 3rd party im-
aging application software not supplied by
the manufacturer, the 3rd party imaging ap-
plication software must comply with all local
laws on patient information software. This
includes, for example, the Medical Device
Directive 93/42/EEC and/or FDA if applica-
ble.
• Do not position the workstation where it
could be splashed with liquids.
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