CEFLA NewTom GO - Requirements (Not Provided with the Product); Standards and Regulations; Classifications

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OPERATOR'S MANUAL
EN
1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT)
For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the
minimum requirements of the PC, refer to the paragraph TECHNICAL DATA.
The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950-
1:2007 standards for information technology devices.
1.4. STANDARDS AND REGULATIONS
This system has been designed in accordance with the following standards:
- Directive 93/42/EEC and subsequent amendments and integrations
(Dir. 2007/47/EC) - Medical Device Directive;
- Directive 2006/42/EC - Machinery Directive.
Technical standards:
IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366:2007
IEC 62304:2006
IEC 60825-1:1993
The CE mark certifies the compliance of the product described below with the European Community
Medical Device Directive 93/42/EEC and subsequent amendments.
1.5. CLASSIFICATIONS
The system is classified as Class I and Type B as regards safety according to IEC 60601-1.
The system is classified as a Class IIB medical electrical X-ray device in accordance with Medical Device Directive
93/42/EEC and subsequent amendments.