10 Symbols and labeling
60 SOREDEX 208396 rev 2
■ For ethernet connections, use an unshielded CAT6
RJ-45 LAN cable, so that multiple chassis must not
be connected! The PC / 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 ex-
ceeded.
■ 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 re-
quirements of 60601-1 standard.
■ The PC and any other external device(s) connect-
ed to the system outside the patient area must
meet the IEC 60950 standard (minimum require-
ment). 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.
■ Multiple extension cables shall not be used.
■ If this device will be used with 3rd party imaging ap-
plication software not supplied by the manufactur-
er, 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 applica-
ble.
■ Do not position the PC where it could be splashed
with liquids.
■ Clean the PC in accordance with the manufactur-
er’s instructions.
■ Image is not transferred from unit to PC imaging
application software in case of connection lost dur-
ing image processing. Image is stored in unit mem-
ory until it has been transferred to PC. Unit cannot
be turned off in that case. When network is opera-
tional again, image is automatically transferred to
imaging application software. Do not disconnect
unit PSU adapter before network is operational and
image has been transferred to imaging application
software.
To Previous Page
Loading...
