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ENGLISH
Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
1.5. SAFETY WARNINGS
A few safety recommendations are listed here below which must be followed when using the “
X-MIND unity
x-ray system”.
CAUTION
GENERAL REQUIREMENTS
•
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the X-MIND unity system.
The training and preparation of personnel is the responsability of THE RESPONSIBLE ORGANIZATION.
•
X-MIND unity 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 biomedical 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 twelve months), which includes functional, performance and safety tests of the device, must be
carried out by qualified, authorized professional technicians.It is mandatory to ensure patients’ health and safety and proper X-MIND
unity operation (IEC 60601-1 etc.).These operations must be carried out according to the methods and frequency indicated in this
manual, the installation and maintenance manual and maintenance manual. Failure to comply with this requirement or with the mes-
sages 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 shall be held liable for any damage
and/or accidents and/or degeneration of patients’ or operators’ health or of the surrounding environment. The RESPONSIBLE ORGANIZA-
TION 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 modified).
•
Operators must know the environmental and operating specifications of the device, as well as the procedures to follow in the event of
hazards or emergency stops.
•
The X-MIND unity has been designed to acquire radiography images for dental intraoral x-ray imaging. The X-MIND unity medical device
must not be used for x-ray imaging of other body parts.
•
Carefully follow the instructions in this manual to install, operate and maintain the X-MIND unity device. 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 unity throughout the entire duration of the x-ray
examination.
•
It is prohibited to modify any part of the X-Mind unity 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.
•
The Installation of the
X-MIND unity
system and all its accessories must be executed only by trained, qualified and authorized service
personnel.