Laser Safety; Safety Instructions - KaVo Key Laser III 1243 Instructions For Use Manual

Instructions for use KEY Laser III 1243
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2 Safety

2.2 Laser safety

2.2 Laser safety

2.2.1 Safety instructions

Medical Device Law (only applicable for Germany)
The KEY Laser 1243 is a II b device according to EC directive 93/42/EEC.
In Germany, operators, equipment managers and users are obliged to operate their
equipment in accordance with the MPG regulations.
In particular, such devices may only be operated in accordance with the generally
recognized rules of technology and occupational health protection and accident
protection regulations.
Note
Country-specific provisions must be observed when operating a medical laser. In
the Federal Republic of Germany, the respectively valid version of the regulations
of German professional associations on safety (BGV) for laser radiation BGV B2
must also be observed.
Accessories by other manufacturers may not be used.
Note
The operator must install a warning light before each entrance door to the treatment
room in which the KEY Lasers 1243 is located. (identification of the laser treatment
room according to BGV B2)
In addition, operators in Germany are required to keep a medical device book. Our
service technician can be of assistance in filling it out.
Note
The medical device book is included in the delivery.
Legal provisions
Apply and meet the overarching guidelines and/or national laws, national regulati‐
ons and the rules of technology for medical devices applicable for startup and use
of the KaVo product for the intended purpose.
Observe IEC 825 in its entirety.
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