User Manual – Specification of the intended use
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C
2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose
X-MIND prime is an extra-oral dental panoramic X-ray unit to radiograph teeth, jaw and
oral structures.
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
X-MIND prime 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
X-MIND prime 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.).
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