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1.3.1
EU directives
Introduction
This section describes the EU Directives that apply to SEMIPHOR TRANSPHOR UNIT series.
Conformity with EU Directives
This product fulfills the European Directives listed below. See the EU Declaration of
Conformity for the directives and regulations that apply for the CE marking.
If not included with the product, a copy of the EU Declaration of Conformity is available
on request.
Title
Directive
Electromagnetic Compatibility (EMC) Directive
2014/30/EU
Low Voltage Directive (LVD)
2014/35/EU
Restriction of Hazardous Substances (RoHS) Directive
2011/65/EU
CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•
used according to the Operating Instructions or user manuals, and
•
used in the same state as it was delivered from GE Healthcare, except for alterations
described in the Operating Instructions or user manuals.
SEMIPHOR TRANSPHOR UNIT series Operating Instructions 29281777 AA
9
1 Introduction
1.3 Regulatory information
1.3.1 EU directives