Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration of Conformity document.
ContentRequirement
GE Healthcare Bio-Sciences AB, Björkgatan 30,Name and address of
manufacturer
SE-751 84 Uppsala, Sweden
CE conformity
This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.
A copy of the EC Declaration of Conformity is available on request.
TitleDirective
Machinery Directive (MD)2006/42/EC
Low Voltage Directive (LVD)2006/95/EC
Electromagnetic Compatibility (EMC) Directive2004/108/EC
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the instru-
ment when it is:
•
used as a stand-alone unit, or
•
connected to other CE marked instruments, or
•
connected to other products recommended or described in the user documentation,
and
•
used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
8 ÄKTAprime plus Operating Instructions 28-9597-89 AB
1 Introduction
1.2 Regulatory information