FONA XPan 3D Plus
5
1. WARNING AND SAFETY NOTES
Instructions
The accompanying documents among which the Operating Instructions
and the Installation Instructions supplied with the unit are integral parts of
the product.
The original language of the Operating Instructions is English.
The manual information are subject to changes without any notice.
The manufacturer is not responsible for direct, indirect or accidental
damage resulting from or relating to the provision or use of this
information.
This document may not be reproduced, adapted or translated, in part or
in full, without the prior written permission of the manufacturer.
Labeling of warning and safety
information
In order to prevent injury to persons and damage to the equipment you
must also read the warning and safety notes given in these Operating
Instructions.
Indication for use
The unit is intended to produce two dimensional images and three
dimensional volume reconstructions, including partial volumes and
selected projections of the dentomaxillofacial areas, for use in planning
and
diagnostic
support.
Image
acquisition
modes
include
panoramic/cephalometric X-ray and cone beam tomography x-ray.
Contraindications
There are no contraindications to the use of the equipment within the
indication for use other than those related to exposure of the patient to
ionizing radiation, which should be limited to the maximum.
Prescription for use
Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
Responsibilities of the User
The user has the following responsibilities:
x
Use the system following the instructions and recommendations
contained in this user manual.
x
Keep the machine in perfect working condition following the
maintenance instructions given by the manufacturer. Failure to
observe the instructions relieves the manufacturer or his agent from
any responsibility for injury, damage or non-conformities that may
derive there from.
x
Promptly notify the competent Health Authority and the manufacturer
in the event of an accident involving this medical device and/or
operations that may cause death or put the patient and/or the user at
risk. The type and serial numbers of the components involved,
indicated on the external labels, are to be communicated to the
manufacturer.
General safety information
As manufacturers of medical devices, we can assume responsibility for
safety-related performance of the equipment only if maintenance, repair
and modifications are carried out only by us or agencies we have
authorized for this purpose, and if components affecting safe operation of
the unit that may be needed are replaced with original parts.
We suggest that you request a certificate showing the nature and extent
of the work performed, from those who carry out such work, and specify
that the certificate show any changes in rated parameters or working
ranges, as well as the date, the name of the firm, and a signature.
For safety reasons only use original accessories indicated in this
Operating Instructions. It is the user's risk when using non-released
accessories.
Exposures of patients may only be taken if the unit functions fault-free.
Never leave the unit unattended.
System assembly at installation
The system is fully tested in manufacturing and can be operated once the
major modules are mechanically assembled at installation and then
connected to the power line.
