CEFLA NewTom 5G, User Manual, Page: 29 / 110

4 Getting started
4 Getting started
This chapter provides a brief introduction for the NewTom 5G system, its power on and off routines and
control devices.
4.1 Introduction to the system
4.1.1 Intended use
The device NewTom 5G is a cone beam computed tomography x-ray system. It is intended for diagnostic
use obtaining geometric information and radiologic density from two-dimensional and three-dimensional
images of anatomic particulars and objects in the examined area.
4.1.2 Indications for use
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires sequences of
the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw,
temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine,
and upper and lower extremities for use in diagnostic support. The device accomplishes this task by
reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of
this volume, displaying both two and three dimensional images.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified
professionals.
WARNING:
NewTom 5G is able to produce panoramic reconstructions from
CBCT acquisitions. This may reduce dose in the case where both
CBCT and panoramic images are needed. However, if the
system is used to simulate a panoramic image when a CBCT is
not necessary, this can lead to excess radiation dose to the
patient.
WARNING:
Federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the State in which he practices
to user or order the use of x-ray imaging systems
21CFR801.109(b)
WARNING:
Cone beam imaging should not be used for 'routine' (or
'screening') examinations. Other diagnostic tools must be
considered. The imaging examinations must be justified for
each patient to demonstrate that the benefits outweigh the
risks.
WARNING:
Where it is likely that evaluation of soft tissues will be required
as part of patient's radiological assessment, the appropriate
imaging should follow the Diagnostic Imaging Referral
Guidelines of the Canadian Association of Radiologists, rather
than using cone beam technology
NewTom 5G – User Manual 4-1