12.6 PATIENT POPULATION RESTRICTION
This medical device must not be used on the following patient population:
• Infants,
• pregnant women
• Before exposing patients with pacemakers, contact the manufacturer of the latter to ensure that the X-rays
generated by the medical device do not interfere with its functionality
The user is the only person who can decide whether or not to make the radiologic acquisition with his/her
patients.
12.7 PARTS OF THE BODY OR TYPES OF TISSUES FOR DIAGNOSIS
The medical device has been designed to acquire digital radiography images and reconstruct tomographic
images of the dental maxillofacial and otolaryngological regions.
12.8 ESSENTIAL PERFORMANCE
ACTEON Imaging considered the essential performances, as stated in the applicable safety standard pertaining
to the electrical medical device, in the Risk Management Process.
12.9 NORMAL USAGE CONDITIONS
The normal usage conditions are as follows:
• Storage;
• Installation;
• Use;
• Maintenance;
• Disposal.
12.10 X-RAY PROTECTION
This symbol draws the ATTENTION to X-ray hazards:
The medical device is a device that generates X-rays; therefore, both the patients and the operator are exposed
to risks due to ionising radiation.
Installation
The medical device must be shielded and used in compliance with the local standards in force and with the
international directives concerning radiation protection for the operator, patient and other people against X-rays.
Operator
The operator and other subjects must keep clear from the patient during the scan.
The personnel involved in the radiographic examination must take all the safety measures concerning radiation
protection.
Patient
The «General principles for safeguarding and protecting the personnel and patients» must always be applied
during the use of the X-ray unit.
• Justication of the practice
• Optimisation of protection principle (ALARA principle)
• Individual risk and dose limits
It is the operator’s responsibility to protect the patient against unnecessary or excessive radiation doses.
Additional protection devices (aprons, collars, etc.) are required to protect the patient from radiation.
12.11 MECHANICAL SAFETY
Improper installation of the medical device can expose the operator and patients to fall and crushing hazards.
Prevent situations that can compromise the stability of the medical device, such as:
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