Strato X User Manual - Image Works
Strato X User Manual - Image Works
Strato X User Manual - Image Works
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USER'S MANUAL<br />
Technical specifications<br />
5.3 Applied safety relugations<br />
STRATO X complies with the following standard:<br />
FDA 21 CFR chapter J<br />
CE 93/42<br />
• General safety:<br />
IEC 601-1 and UL 2601-1<br />
IEC 601-1-1<br />
IEC 601-2-7<br />
IEC 601-2-28<br />
• Electromagnetic compliance:<br />
IEC 601-1-2<br />
• Protection against radiations:<br />
IEC 601-1-3<br />
IEC 825-1<br />
0434 The symbol CE grants that STRATO X complies with<br />
directives 93/42 for medical devices issued by the European<br />
Community.<br />
Classifications<br />
STRATO X is an electro-medical X-ray device belonging to Class I type B<br />
as per classifications IEC 601-1, foreseen for a continuous working at<br />
intermittent load.<br />
According to CE 93/42 Directives for medical devices, the equipment<br />
belongs to class II B.<br />
According to FDA 21 CFR, the equipment belongs to class II.<br />
STRATO X (120V) 24<br />
(Rev. 1)
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