2.2
Laser safety
2.2.1
Safety instructions
Medical Device Law (only applicable for Germany)
The KEY 3+ / III upgraded is a class 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 Medical Device Act 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 and warning sign before each entrance
door to the treatment room in which the KEY Laser 3+ / III upgraded 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 regula‐
tions and the rules of technology for medical devices applicable for startup and use
of the KaVo product for the intended purpose.
Observe IEC 60825-1 in its entirety.
Instructions for use KEY Laser 3+ 1343 KEY Laser III 1243 upgraded
2 Safety | 2.2 Laser safety
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