The Intended user prole is an able-bodied specialized surgeon, dentist and authorized personnel, who meet
the requirements provided by the national laws in force in the country of installation; they must understand the
language of the country where the device is installed. The intended conditions of use are detailed in Annex A2
(“Intended Environment”).
PLEASE NOTE
This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations – since
they do vary from Country to Country – but only the most common ones.
The user must consult his country’s legislation so as to full all local obligations.
WARNING
This manual describes how to set and use the “x-mind ac” X-ray system.
The operator must read and understand the manual before using the medical device.
This manual must be always kept as a reference document.
Before using this device for the rst time, it is essential to thoroughly and carefully read the instructions, CAUTION and WARNING messages
listed in the present chapter.
It is mandatory to comply with these instructions every time the device is used.
“x-mind ac” is compatible with all kind of X-ray detectors which have been designed and certied for dental intra-oral radiology; in detail,
such a compatibility is ensured by the compliance of the “x-mind ac” device with the basic safety and essential performance requirements
of the IEC 60601-2-65: 2012.
1.3. QUALITY DETERMINANTS IN X-RAY INTRAORAL RADIOGRAPHY
Image quality is linked to the precise and accurate acquisition of information from the X-ray beam transmitted
through the patient (i.e., the X-ray detector). Most problems in dental radiography are not the result of X-ray
equipment failure: the production of consistent and high quality X-ray diagnostic images, concurrent with
minimal patient exposure, depends generally on different components:
quality performance of equipment, characteristics of the modules used which affect the imaging system
resolution (i.e.: X-ray image detector type and relevant image processing chain, analogue or digital) and optimal
performance of the operator.
Among the physical factors for achieving optimum image quality, the following can be considered:
- optimum optical density and Wiener spectrum,
- detectors for radiography must meet the needs of the specic radiological procedure where they will be used
and key parameters are spatial resolution, uniformity of response, contrast sensitivity, dynamic range, acquisition
speed and frame rate
- minimization of motion blurring (using short exposure times),
- minimization of geometric blurring (reducing the focal spot size and/or of the object-lm distance),
- geometric distortions,
- correct positioning: errors in patient positioning when using uncoupled positioning devices during the various
typologies of X-ray examinations may lead to exposure errors, which require additional X-ray exposures, thereby
increasing the radiation dose adsorbed by the patient.
This means that it is absolutely essential and mandatory that the operator consider the performances not only
of the “x-mind ac” equipment itself, but the whole chain of components that bring to the nal X-ray diagnostic
image.
The essential parameters and relevant metrics which describe the performance of dental X-ray system, with
regard to imaging properties and patient dose, methods of testing and whether measured quantities related to
those parameters comply with the specied tolerances, are stated by the respective manufacturers and by the
requirements specied by the respective applicable standards.
Radiographic lms, lm processing, digital X-ray image detectors, and imaging plates are vital parts in the
imaging chain. It is responsibility of the operator to ensure that these components perform in an acceptable way,
with respect to sensitivity, contrast and absence of artifacts. A test of the performance of these components shall
precede any acceptance test measurement involving the irradiation of the X-ray detectors using the “x-mind ac”.
To Next Page
Loading...
