FONA XPan 3D Operating Instructions
69 683 70110
- 150831
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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.
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.
Destination of 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 x-ray and cone beam tomography x-ray.
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.
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.
Safety measures
during switch-on
Following extreme temperature fluctuations, condensate formation
may occur; therefore please do not switch on the device until normal
room temperature has been reached (see chapter 7.1, Preparing for
exposure).
Electromagnetic Compatibility
This unit may be operated in a residential/hospital area, provided it is
used under the responsibility of a trained medical operator, and
following the recommendations reported in chapter 13,
Electromagnetic Compatibility.
FONA XPan 3D needs special precautions regarding EMC, and needs
to be installed and put into service according to the EMC information
provided in Chapter 13.
Portable and mobile Radio Frequency communications equipment can
affect medical electrical equipment like FONA XPan 3D
.
The use of accessories and cables other than those provided, with the
exception of accessories and cables sold by the FONA as replacement
parts for internal components, may result in increased emissions or
decreased immunity of the device.
FONA XPan 3D should not be used adjacent to or stacked with other
equipment; if adjacent or stacked use is necessary, FONA XPan 3D
should be observed to verify normal operation in the configuration in
which it will be used.
Interference with medical devices by
radio telephones
To guarantee the operational safety of medical devices, it is
recommended that the operation of mobile radio telephones in the
