Introduction; Classification; Safety Precautions - Sirona Dental SIROLaser Instrucciones De Uso

3 Introduction

12
3
Introduction
3.1

Classification

According to the applicable standards, the SIROLaser is classified as follows:
Class I Type B according to EN ISO 60601-1: 1990 + A1: 1993 + A2: 1
1995
Class IIb (according to Council Directive 93/42/EEC)
Class IV laser device according to IEC 60825-1: 1993 + A1: 1997 + A2:
2001
Degree of protection according to EN IEC 60601-1: 1990 + A1: 1993 + A2:
1 1995 Medical device: IP 20 (cover not waterproof); Foot switch: IPX5
CAUTION
The actual laser unit cannot be sterilized. However, those accessory parts
which come into direct contact must be sterilized.
WARNING
The unit is not suitable for use in the presence of anesthetics that are flamma-
ble when in contact with air, oxygen or nitrogen monoxide.
3.2

Safety precautions

SIROLaser is manufactured in compliance with the provisions of Council
Directive 93/42/EEC concerning medical devices (MDD).
Always observe the following precautions:
WARNING
When disconnecting the optical fiber from the laser, always cover the the con-
nector with one of the special protection caps supplied.
CAUTION
Any use of the controls or setting options in a manner other than the one de-
scribed here may lead to a dangerous exposure to radiation.
CAUTION
Never place your finger or any other objects in the exit ports. This could cause
damage to the optical instrument.
CAUTION
Switch the laser unit OFF immediately in case of an emergency. To do this,
press the "LASER STOP" button on the control panel.
60 56 092 D 3485
D 3485.201.01.10.02 03.2008