8
OPERATOR'S MANUAL
EN
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.
–
via Selice
Provinciale
23/A - 40026
Imola (BO)
Italia
Name of the Manufacturer and place of production.
SN
Product serial number.
Date of manufacture (month / year).
Manufacturer.
Symbol “Possible hazard: Read the user manual”.
Patient or operator safety-related warnings.
Consult the enclosed documentation before using the relevant part of the equipment.
It is necessary to read the user's manual before using the device.
This symbol in the Manual identifies the paragraphs containing important information on the use of
the product.
Applied part of type B, according to IEC 60601-1.
Equipment compliant with directive 93/42/EEC as amended.
Notified body: IMQ spa.
Ionizing radiation warning symbol.
Class 1 LASER radiation warning symbol.
Crushing hazard.
Disposal symbol in accordance with Directive 2012/19/EU.
