CAUTION
GENERAL REQUIREMENTS
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the “x-mind ac” radiographic system.
Training and preparation of personnel is responsibility of THE RESPONSIBLE ORGANIZATION.
“x-mind ac” radiographic system is an X-ray generator and must be used and handled only by specialised surgeons, dentists and authorized
personnel, who meet the requirements provided by the national laws in force in the country of installation.
It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for medical equipment; this
schedule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be
performed at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualied,
authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper “x-mind ac” radiographic system operation
(IEC 60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation
and maintenance manual. Failure to comply with this requirement or with the messages concerning anomalies will release the manufacturer
from any liability for direct and indirect injuries to persons and/or damage to property or the environment. Furthermore, the managers of the
facility, customers or collaborators will be held liable for any damage and/or accidents and/or degeneration of patients’ or operators’ health or
of the surrounding environment.
The RESPONSIBLE ORGANIZATION must also provide for the safe and proper use of the equipment.
(*) For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modied).
Operators must know the environmental and operating specications of the device, as well as the procedures to follow in the event of hazards or
emergency stops.
“x-mind ac” radiographic system has been designed to acquire radiography images for dental intraoral X-ray imaging. The “x-mind ac” medical
device must not be used for X-ray imaging of other body parts.
Carefully follow the instructions of this manual to install, operate and maintain the “x-mind ac” radiographic system. In the event that local laws
and standards are more restrictive than the manufacturer’s indications, the former supersede the latter.
The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical device in
consideration of the place of installation.
The operator is cautioned to monitor the patient and the parameters of the “x-mind ac” radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the “x-mind ac”medical device.
de Götzen S.r.l. – ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local standards
concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the country of installation.
The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force.
Before each examination, it is mandatory to apply to the collimator cone (Beam Limiting Device) a disposable protection sheath designed to
cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device
Directive 93/42/EEC and subsequent amendments). It can come into contact with the patient’s skin: verify biocompatibility according to the
principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use.
Before operating the “x-mind ac” radiographic system you must assure that the device has no visible signs of damage.
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