Owandy Radiology i-max touch 3D, Руководство пользователя

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User Manual - Specification of the intended use
NIMXEN020I
Owandy Radiology SAS
2
2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose
I-MAX 3D is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two
dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of
teeth, jaw and oral structures.
Two dimensional images are taken using the narrow beam technique. Three dimensional exams
are taken using cone shaped x-ray beam technique; both of them are well known techniques.
The device is operated and used by dentists, radiologists and other legally qualified health care
professionals. It can be used with both paediatric and adult patients.
Caution
Federal law restricts this device to sale by or on the order of a dentist, a radiologist or another
legally qualified health care professional.
2.1.1 Intended patient population
I-MAX 3D system can be used with the following type of patient:
•
Age: paediatric (from about 7 years) to geriatric
•
Patient status:

self-sufficient patient (the patient can autonomously place himself as requested by the
physician)

non self-sufficient patient (the patient is assisted by medical personnel).

In any case the patient must be conscious, not anaesthetized and not incapacitated
•
Nationality: multiple.
2.1.2 Operator Profile
This system may only be operated by persons who have suitable experience in radiation
protection or knowledge of radiation protection and who have been instructed in the operation of
the X-ray equipment.
2.1.3 Application environments
I-MAX 3D may be used in professional buildings (e.g. hospitals, private clinics) or in residential
buildings. For the purpose of EMC environment classification both installations are classified as
"Professional healthcare facility environment".
Note
In the radiographic room, direct audio and visual communication between operator and
patient shall be always possible. Otherwise, provide proper support (i.e. lead glass or
similar, interphone, etc.).