2 Introduction
Where it is likely that evaluation of soft tissues will be required as part of the patient’s
radiological assessment, the imaging should be done using conventional medical CT or
MR, rather than 3D imaging using Cone Beam technology.
Cone beam computed tomography images are not adequate for the analysis of soft
tissue.
Panoramic and 3D exposures should not be used if conventional intraoral radiographic
images (like bitewing exposures) would be sufficient.
Make sure that patient’s thyroid glands are protected by a lead apron during the
exposure.
The place where the unit is to be installed and the position from where the user will take
exposures must be correctly shielded from the radiation that is generated when the unit
is operated. Ensure to fulfill or exceed the requirements of your local regulations.
The unit or its parts must not be changed or modified in any way without approval and
instructions from the manufacturer.
When servicing use only approved replacement parts supplied by the manufacturer.
The use of accessories not complying with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the resulting system.
If this device is 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 the Medical Device Directive 93/42/EEC
and/or relevant legal requirements in the USA.
Do not connect any equipment to the unit that has not been supplied with the unit or
that is not recommended by the manufacturer. The use of accessory equipment not
complying with the equivalent safety requirements of this equipment may lead to a
reduced level of safety of the resulting system.
All protective covers must be properly installed before handing unit to the user or when
operating the unit.
The user must always ensure, especially after a system crash or break in the x-ray unit
- PC connection, or when scanning 2D images without patient ID, that images retrieved
from the unit are associated to the correct patient.
Correct sharp layer should be chosen when using multilayer PAN images. See user
manual chapter Multilayer PAN images for correct procedure.
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ORTHOPANTOMOGRAPH
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OP 3D Pro