Acteon x-mind ac - Radiographic System Overview; Radiographic System Description

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ENGLISH
INSTALLATION & MAINTENANCE MANUAL • X-MIND AC • V2 • (06) • 08/2016 • NXACEN020B
CHAPTER 2
2.1. RADIOGRAPHIC SYSTEM
The “x-mind ac®” 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:
} American Radiation Performance Standard 21CFR, Subchapter J, Sec. 1020.30 and 1020.31
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 uctuation, 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 conrming 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 classied as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classication rules indicated in attachment IX of the EEC Directive 93/42 on medical devices
and subsequent amendments the system is classied as: Class IIb
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classied as: Group 1 – Class B
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