CEFLA NewTom 5G Vet, Руководство по присоединению, Страница: 14 / 68

4 Getting started
4 Getting started
This chapter provides a brief introduction for the NewTom 5G Vet 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 Vet 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 Vet is a cone beam computed tomography x-ray imaging system that acquires sequences
of images within anatomical regions of interest according to system specifications.
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 x-ray technologists, and licensed veterinary professionals and other
legally qualified professionals.
This device is for Veterinary Use Only.
WARNING:
NewTom 5G Vet 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
21CFR801.100(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.
Veterinary Application 4-1