Villa Rotograph EVO, Service Manual

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SERVICE MANUAL
Technical data
Rotograph EVO (Rev. 1) 4-6
4.1. Applied safety regulations
Rotograph EVO complies with the following standards:
0051 The symbol CE grants that Rotograph EVO D complies
with directives 93/42 for medical devices issued by the
European Community.
• Canadian Medical Device Regulations
• 21 CFR Subchapter J (for 110-120V version)
• General safety:
IEC 60601-1:1988 + A1:1991 + A2:1995
IEC 60601-2-7:1998
IEC 60601-2-28:1993
IEC 60601-2-32:1994
• Electromagnetic compliance:
IEC 60601-1-2:2001
• Protection against radiation:
IEC 60601-1-3:1994
IEC 60825-1:1993 + A1:1997 + A2:2001
Classification
Rotograph EVO D is an electro-medical X-ray device belonging to Class 1
and Type B as per classification IEC 60601-1, foreseen for a continuous
working at intermittent load.
According to CE 93/42 directive for medical devices, the equipment
belongs to class II B.
According to Canadian MDR, the equipment belongs to class II.
According to FDA 21 CFR, the equipment belongs to class II
(for 110-120V version).