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8.3
Classification
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
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
EC Representative; DentalHolding Sp.Zo.o
90
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.
ul. Chalubinskiego 8
00-6 Warszawa Poland
Tel: +48-22-313-08-08
Fax: +48-22-313-08-90
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