10 Symbols and labeling
KaVo Scan eXam One
61
vice is connected to is used in the patient en-
vironment 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.
•
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 PC where it could be
splashed with liquids.
•
Clean the PC in accordance with the manu-
facturer’s instructions.
•
Image is not transferred from unit to PC im-
aging application software in case of connec-
tion lost during image processing. Image is
stored in unit memory until it has been
transferred to PC. Unit cannot be turned off
in that case. When network is operational
again, image is automatically transferred to
imaging application software. Do not discon-
nect unit PSU adapter before network is op-
erational and image has been transferred to
imaging application software.
•
Due to Occlusal 4C projection imaging ge-
ometry and imaging plate positioning, accu-
rate distance and angle measurements
cannot be taken from occlusal projection im-
ages.
Approved:
Reviewed: Jalkanen Joni 2017-02-13 16:00
Reviewed
See PDM system to determine the status of this document. Printed out: 2017-03-17 10:35:17
D510414, 5
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