Acteon XMIND DC - Chapter 2: Radiographic System; Radiographic System Description

Page 13 of 61
ENGLISH
INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
CHAPTER 2
2.1. RADIOGRAPHIC SYSTEM
The “Xmind®dc” 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 21 CFR, 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 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 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 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 equip-
ment, 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
22