90
8.3 Classification
z Classification according to the degree of protection against ingress of water as detailed
in the current edition of IEC 529… IPXO Secondary collimator at CEPH to reduce
scattered radiation
z According to the mode of operation:
Continuous operation with intermittent loading
8.4 Standards
This product is designed and produced to meet the following standards:
EN 60601-1, EN 60601-1-3, EN 60601-2-7, EN 60601-2-28, EN 60601-2-32,
EN 60601-1-2, EN 61000-3-2, EN 61000-3-3
EN ISO 9001, EN ISO 13485
8.5 Marks & Graphic symbols
TYPE B Equipment
Radiation hazard
CE symbol grants the product compliance to the European Directive for
Medical Devices 93/42 as a class IIB device. Authorized by Grand-
Duche De Luxemburg.
EC Representative; DentalHolding Sp.Zo.o
ul. Chalubinskiego 8
00-6 Warszawa Poland
Tel: +48-22-313-08-08
Fax: +48-22-313-08-90
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