GE Hot Lips Tube Sealer

1 Introduction
1.2 Regulatory information
8 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
CE conformity
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the
instrument 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 or explicitly authorized by
GE Healthcare.
Regulatory compliance of
connected equipment
Any equipment connected to HOT LIPS TUBE SEALER should meet the safety
requirements of EN 61010-1/IEC61010-1 or relevant harmonized standards. Within
the European Union, connected equipment must be CE-marked.
Directive Title
2006/42/EC Machinery Directive (MD)
2006/95/EC Low Voltage Directive (LVD)
2004/108/EC ElectroMagnetic Compatibility
(EMC) Directive