
INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F
Pag. 8of 51
GENERAL REQUIREMENTS
RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the radiographic system.
The training and preparation of personnel is the responsibility of THE RESPONSIBLE ORGANIZATION.
the radiographic system is an X-ray generator and must be used and handled only by specialized 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 qualified, authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper
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.
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 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 radiographic system has been designed to acquire radiographic images for dental intraoral X-ray imaging. The 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 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 responsible to monitor the patient and the parameters of the radiographic system throughout the entire duration of
the X-ray examination.
It is prohibited to modify any part of the 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 in 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 radiographic system, you must assure that the device has no visible signs of damage.
,the power supply must be adequate to supply the required power indicated in the radiographic system’s
nameplate data;
,the system must be checked completely at least each 12 months by professionally qualified technicians
according to the regulation in force; use the manuals provided with the device for reference;
,in case of repair, please use only spare parts from the manufacturer; otherwise basic safety and essential
performances of the device will not be guaranteed.
1.4. TRANSPORT CONDITIONS
The radiographic system travels at the receiver’s own risk.
All claims for damage or miscarriage regarding the shipment must be pointed out in the presence of the shipping agent.
In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the transport
documentation or on the consignment note.
1.5. SAFETY WARNINGS
A few safety recommendations which should be followed when using the radiographic system are listed here below.
CAUTION