KaVo SCAN EXAM, User Manual

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SCAN EXAM 37
7. Warnings and precautions
• This unit complies with IEC 60601-1 standard. Accessory equipment
connected to this device must be in compliance with the related
nationally harmonized IEC standards.
• Unit not suitable for use in the presence of fl ammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
• Select patient card before scanning images.
• For Ethernet connections, use an unshielded CAT6 LAN cable, so that
multiple chassis must not be connected! The PC / Ethernet switch to
which unit is connected to, should be approved appropriately (e.g.
EN 60950, IEC 60950, UL 60950). After installation check that the
IEC 60601-1 leakage current levels are not exceeded.
• If the PC / Ethernet switch, to which the device is connected to, is
used in the patient environment, it should be approved appropriately
and meet the requirements of 60601-1 standard.
• The PC and any other external device(s) connected to the system
outside the patient area must meet the IEC 60950 standard
(minimum requirement). Devices that do not meet the IEC 60950
standard must not be connected to the system as they may pose a
threat to operational safety.
• The PC and any other external devices shall not be connected to an
extension cable.
• If the unit needs to be connected to a multiple socket-outlet, it shall
not be placed on the fl oor.
• Multiple extension cables shall not be use.
• In order to maintain safe and correct functioning of the unit, only
the power supply unit (PSU) delivered with the unit or distributed
by authorized dealers shall be used. Refer to the unit technical
speci fi cations for a list of the approved PSUs.
• If this device will be used with 3rd party imaging application
software not supplied by the manufacturer, the 3rd party imaging
application 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 applicable.