CEFLA RX DC - GENERAL WARNINGS; Foreword; Safety Instructions

5
GB
INSTALLATION
RX DC X-RAY UNIT
1. GENERAL WARNINGS
1.1 Foreword
The device described in this manual is manufactured by CEFLA s.c. - via Selice Prov.le 23/A - 40026 Imola (BO) Italy,
a manufacturer complying with the European Directive on medical devices 93/42/EC (Class 2, B).
These instructions are intended for all the personnel who service and/or repair the Cea s.c. equipments. All the spe-
cic information required is provided.
IMPORTANT READ CAREFULLY BEFORE USE
KEEP FOR FUTURE REFERENCE
1.2 Safety instructions
All the safety instructions that help prevent any hazardous situations and operate the equipment in a trouble-free man-
ner are given in the user’s manual as explained below:
WARNING: This alert symbol indicates that the users and/or the patients run high risks and can be seriously inju-
red if the equipment or certain devices are used incorrectly or improperly, or the recommended safety precautions
are not taken to avoid hazardous situations.
CAUTION: Indicates that the operator is to take all the required precautions in order for all devices and/or
equipment to be used safely and e󰀩ciently.
When the equipment is received, check the packing container for any damage su󰀨ered. If evident damage is found,
immediately call the shipping agents and le a claim for damage. Carefully inspect the equipment for any missing or
damaged parts. For any complaints, immediately contact Cea s.c..
Cea s.c. shall be responsible for the reliability and e󰀩ciency of the equipment as well as the safety of the operating
personnel provided that:
• the installation, modications, settings or repairs are made by authorised persons using Cea s.c. original spare parts;
• the electrical wiring in the surgery complies with IEC 60364-7-710:2002 engineering regulations ( (Standards
regarding electrical systems in a medical environment) or equivalent standards currently in force in the country where
the equipment is installed).;
• the equipment is used as outlined in User’s Manual.
• the place where the x-ray unit is installed must comply with o󰀩cial directives regulating radiation in the country where
the equipment is used.