NewTom GIANO Prescriptions De Sécurité Et Instructions Pour L'opérateur page 7

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
The system has been designed to meet the following standards:
- Directive 93/42/EEC and s.c.
(dir. 2007/47/EC) - Medical Device Directive;
- Directive 2006/42/EEC - 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 60825-1:1993
The CE marking certifies compliance of the product as described herein with 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.
1.6. STYLISTIC CONVENTIONS
The following symbols may be found on the X-ray device and in the manual:
Cefla S.C.–
V. Bicocca
Name of the manufacturer and place of manufacture.
14/c – Imola
(BO) ITALY
SN Product serial number.
Date of manufacture (month/year).
Manufacturer.
"Possible Danger: Read the user manual" symbol.
EN OPERATOR'S MANUAL
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