Standards And General Precautions; Introduction; Description Of The Appliance; Reference Standards - Carlo De Giorgi Sterilintraplant Plus Manuel D'utilisation

STERILINTRAPLANT PLUS

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 micromotor for use in the dental sector for surgery and
implantology, only when equipped with an implantology handpiece.
This device must be used exclusively by suitably trained persons who are
authorised to perform the practices in question and who have
accumulated sufficient experience in the use of appliances of this type.
Before using the micromotor it is mandatory to read the contents of this
manual in their entirety, learning about the position of and function
performed by all the controls and paying due attention to all the warnings
and precautions that are prescribed. Failure to observe the above
obligatory instruction or improper use of the micromotor may cause injury
to the operator, to the patient, or to other persons present in the area.
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 Legislative Decree D.Lgs.
n° 46/1997)
- EEC Directive n°.98/37 – Machinery Directive (Italian Presidential Decree
D.P.R. n° 459/1996)
- 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
C G
ARLO DE IORGI
GB- 3
;
.