Owandy Radiology i-max touch 3D, Руководство пользователя

Страница: 13 / 119

User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS 3
2.2 Applied parts
During normal use, I-MAX 3D is in contact with the patient via the handle, the chin rest and bite,
the temple clamp and the head strips for 3D exams, classified as Type B applied parts.
2.3 Typical doses delivered to the patient during extra-oral
exams
The dose per area of products delivered by I-MAX 3D to the patient during extra-oral exams is
indicated in the graphical user interface.
Note
The dosimetric indications result from the average of dose measures on a lot of X-
rays source assemblies.
The dose is taken at a certain distance from the focal spot of the X-ray source and then reported
to the imaging plane.
To get the DAP value, the dose on the imaging plane is multiplied by the X-ray field area measured
on the imaging sensor that is 52 cm far away from focal spot.
The typical size of the X-ray beam on the imaging sensor depends on the selected exam:
•
for 2D exams:140 mm x 4.5 mm
•
for 3D Dentition, 3D TMJ, 3D Sinus and Extended Volumes: 144 mm x 118.6 mm
•
for 3D Dentition, 3D TMJ and 3D Sinus (FOV 80 x 80 mm): 122.9 mm x 109.9 mm ( * )
•
for Mandibular and Maxillary dentition: 77 mm x 118.6 mm
•
for Mandibular and Maxillary dentition (FOV 80 x 50 mm): 77 mm x 109.9 mm ( * )
•
for 5x5 volumes is 73 mm x 69 mm
(*) values valid in case a 80 x 80 collimator (kit code 6604061200) is present
The distance between the focal spot and the patient skin is variable during the X-ray and on
average we can assume the mean distance between the focal spot and the patient skin as 264
mm.
The overall uncertainty of the indicated value of the air Kerma and dose per area product is 50%.
Note
As stated in IEC 60601-2-63, no deterministic effects are known with extra-oral dental
X-ray equipment.