Introduction; Description Of The Appliance; Reference Standards; Obligatory Compliance - Carlo De Giorgi Electric Bistoury 645/00 Manuel D'utilisation Et D'entretien

ELECTRIC BISTOURY
1 - STANDARDS AND GENERAL PRECAUTIONS

1.1 - INTRODUCTION

This manual is the property of CARLO DE GIORGI S.r.l. The contents of
this manual cannot be reproduced or disclosed to other parties. All rights
reserved.

1.2 - DESCRIPTION OF THE APPLIANCE

The appliance is a diathermic coagulator (radio frequency ESK) designed
for use in medical, aesthetic (electro-epilation) and veterinary applications
for minor surgery of short duration (from 10 to 20 seconds), with
intermittent duty. This device must be used exclusively by persons who
are properly trained and qualified to perform surgery and who have
adequate experience in the use of electrosurgical knives.
Before using the electrosurgical knife it is mandatory to have read the
contents of this manual in their entirety and to know and understand the
position and function of all the relative commands, paying particular
attention to all the safety warnings and precautions prescribed herein.
Failure to comply with this requirement or incorrect use of the appliance
can result in injury to the operator, the patient and other persons in the
vicinity. This appliance is covered by the terms of the Medical Devices
Directive 93/42/EEC and is classified as type IIb in accordance with annex
IX, regulation 9.
I
T IS STRICTLY PROHIBITED TO ATTEMPT TO OPEN OR REPAIR THE APPLIANCE
IN THE EVENT OF FAULTS OR ANOMALIES ALWAYS CONTACT

1.3 - REFERENCE STANDARDS

1.3.1. - Obligatory compliance

- EEC directive n. 93/42 – Medical Devices (Italian legislation: Legislative decree
D.Lgs. n° 46/1997)
- EEC directive n.73/23 – Low voltage Directive (Italian legislation: Law n°
791/1977, Legislative decrees D.Lgs n° 626/1996 and D.Lgs. n° 277/97)
- EEC directive n.89/336 relative to Electromagnetic Compatibility (EMC) -
(Italian legislation: Legislative decree D.Lgs n° 615/1996)
- DPR 27.4.1955 n.547, "Norme per la prevenzione degli infortuni sul lavoro"
(work accident prevention regulations)
- DPR 27.4.1956 n.303, "Norme generali per l'igiene del lavoro" (general work
hygiene regulations)
- Italian Legislative Decree 12 August 1991 n.277 implementing EEC directives
n.80/605; n.83/477; n.86/188; n.88/642 concerning the protection of workers
against risks deriving from exposure to chemical, physical and biological
agents in the workplace, as defined by art. 7 of Italian Law 30 July 1990, n.212
Carlo de Giorgi
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ARLO DE IORGI
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