X-RAY SYSTEM OVERVIEW
The “X-MIND unity” is manufactured in compliance with the following European Directives:
▪ 93/42/EEC and subsequent amendements
MEDICAL DEVICES
▪ EURATOM 96/29
IONIZING RADIATIONS
and in compliance with the following American Standard:
▪ American Radiation Performance Standard 21 CFR, Subchapter J
Many protective measures have been adopted in the design and construction of the unit, such as:
protection against the risk of electric injuries, ensured by a grounded protection conductor and in accordance
with the 2nd and 3ed of the IEC 60601-1, together with the applicable worldwide international deviations.
protection against leakage radiation, made negligible by the shielded casing;
protection against excessive radiations, thanks to the immediate activation of the safety device and the ACE
option (if enabled);
protection against continuous service, since the system is designed, according to standards, to not be used in
radioscopy;
protection for the operator against irradiation due to the extendable hand control and cable which allows for a
safety distance of more than 2 meters (6 ft.)
protection against accidental selection of the x-ray technique button selected (FILM or DIGIT) obtained, accor-
ding to standards, by means of
“ELECTRO-MEDICAL” CLASSIFICATION
According to the general safety regulations EC EN 60601-1 2nd and 3rd edition on safety of medical equipment,
the system is classied as: Class I - Type B
“MEDICAL DEVICES” CLASSIFICATION
According to the classication rules indicated in attachment IX of the EEC Directive 93/42 on medical devices
and subsequent amendments, this system is classied as: Class IIb
“EMC” CLASSIFICATION
According to paragraph §4 of the EN 55011, this system is classied as: Group 1 - Class B
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