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USER MANUAL • Owandy-RX AC • 02/2020 • NXACEN160A
User Manual – Owandy-RX AC
RADIOGRAPHIC SYSTEM
2.1. RADIOGRAPHIC SYSTEM
The Owandy-RX 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
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 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 high frequency technology which is unaffected by voltage
fl uctuation and consequently capable to guarantee extremely accurate exposure parameters;
- 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 confi rmation 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 classifi ed as:
Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classifi cation rules indicated in attachment IX of the EEC Directive 93/42 on medical devices and
subsequent amendments the system is classifi ed as:
Class IIb
“E.M.C.” CLASSIFICATION
According to paragraph §4 of the CEI EN 55011, the system is classifi ed as:
Group 1 – Class B
2.2. SYSTEM COMPONENTS
