60 90 570 D 3485
12
D 3485.201.04.09.02
09.2007
3 Introduction
3
Introduction
3.1
Classification
According to the applicable standards, the SIROLaser is classified as follows:
z
Class I Type B according to EN IEC 60601-1:1990 + A1:1993 + A2:1 1995
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Class IIb according to Council Directive 93/42/EEC
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Class IV laser product according to IEC 60825-1: 1993 + A1:1997 +
A2:2001
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Degree of protection according to EN IEC 60601-1:1990 + A1:1993 +
A2:1 1995 medical unit: IP 20 (enclosure not water-proof); foot switch:
IPX5
CAUTION
The laser unit itself cannot be sterilized. However, some accessories must be
sterilized when used for contact applications.
WARNING
The laser unit is not suitable for use in the presence of anesthetics that are
flammable 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
Always cover the optical fiber connection with the special protection caps pro-
vided, if the fiber is disconnected from the laser
CAUTION
Use of the operating controls or adjustment options in a way other than de-
scribed herein can lead to dangerous radiation.
CAUTION
Never insert your fingers or any objects into the exit ports. This is important in
order to avoid damage to the optical system.
CAUTION
In case of an emergency, switch the laser unit OFF immediately. To do this,
press the "LASER STOP" button on the control panel.
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