Standards And General Precautions; Introduction; Description Of The Appliance; Reference Standards - Carlo De Giorgi 640/00 Manual De Instrucciones De Uso Y Mantenimiento

ELECTROSURGICAL KNIFE

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 FORBIDDEN TO OPEN OR REPAIR THE APPLIANCE
MALFUNCTIONS
OF

1.3 - REFERENCE STANDARDS

1.3.1 - Obligatory compliance

- EEC directive n. 93/42 – Medical Devices (D.Lgs. n° 46/1997)
- EEC directive n.73/23 – Low voltage Directive (Italian legislation: Law n°
791/1977, Decree Law n° 626/1996, Decree Law n° 277/97)
- EEC directive n.89/336 relative to Electromagnetic Compatibility (EMC) -
(Italian legislation: Decree Law 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 Decree Law 12 August 1991 n.277 implementing EEC directives
n.80/605; n.83/477; 86/188; 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 Law 30 July 1990, n.212
Carlo de Giorgi
ALWAYS CONSULT
C G
ARLO DE IORGI
;
IN THE EVENT
.
GB - 3