INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F
Pag. 12 of 51
RADIOGRAPHIC SYSTEM
2.1. RADIOGRAPHIC SYSTEM
The radiographic system guarantees the maximum safety both for the operator and the patient.
It is built in compliance with the following European Directives:
⋅ 93/42/EEC and subsequent amendments MEDICAL DEVICES
⋅ EURATOM 96/29 IONISING RADIATIONS
and in compliance with the following American Standard:
The following protective measures were adopted in the design and construction of the unit:
- protection against the risk of electric injuries, ensured by a grounded protection conductor;
- protection against leakage radiation, made negligible by the shielded casing;
- protection against excessive radiations, thanks to the immediate activation of the safety device;
- protection against continuous service, since the system is designed, according to standards, not to allow the use in
radioscopy;
- protection for the patient against dangerous radiations, obtained by means of the high frequency technology capable
of producing a constant and hard radiation
- protection against exposure mistakes obtained with the self-compensating technology which, by revealing voltage
fluctuation, is able to modulate the irradiation time ensuring the proper level of dose;
- protection for the operator against irradiation ensured by the extensible cable of the hand control which allows for a
safety distance of more than 2 meters (6 ft.);
- protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to standards,
by means of the confirming on the selection key.
“ELECTRO-MEDICAL” CLASSIFICATION
According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 on
safety of medical equipment, the system is classified as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classification rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and
subsequent amendments the system is classified as: Class IIb
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classified as: Group 1 – Class B
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