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2 Introduction
2.2 Intended use
The unit is intended for dental radiographic examination of teeth, jaw and TMJ areas
by producing conventional 2D x-ray images as well as x-ray projection images of an
examined volume for the reconstruction of a 3D view.
The unit is also intended for carpus imaging in assisting cephalometric analyses (Not in
USA).
2.3 Indications for use (USA only)
The ORTHOPANTOMOGRAPH OP300 panoramic, cephalometric and cone beam computed
tomography X-ray device is intended to image the head and neck areas for diagnostic
support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas,
and with the 13x15 cm Field of View (FOV) this additionally includes the ear, nose and
throat (ENT) regions. The X-ray device produces conventional 2D X-ray images and X-
ray projection images for the reconstruction of a 3D view. The device is operated and
used by qualified healthcare professionals.
CAUTION!
USA only: Federal law restricts this device to sale by or on the order of a dentist or
other qualified professional.
2.4 Intended user profile
Only for professionally qualified dental/medical personnel.
Typical user is a dental assistant with specific training for using dental X-ray devices.
2.5 Associated documentation
● OP 3D Pro User manual
● OP 3D Pro Installation manual
● CLINIVIEW software user manual
● CLINIVIEW software installation manual
● The user manual supplied with the 3D imaging software
● The installation manual supplied with the 3D imaging software
2.6 References
The following instructions are delivered with in the OP 3D Pro installation manual:
● Firmware update instructions
● Calibration instructions
● Cephalostat upgrade instructions
● Cephalostat side changing instructions
● 3D upgrade instructions are delivered with the 3D upgrade kit.
2.7 Abbreviations used in this manual
FOV = Field Of View. The cylindrical 3D volume that is reconstructed by the system.
ROI = Region Of Interest. The anatomical area or region of the patient that you are
interested to examine.
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ORTHOPANTOMOGRAPH
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OP 3D Pro
Содержание OP 3D Pro
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