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CE Marking inforMation
The product ERS 2 system bears the CE marking CE-0123 (notified body TÜV SÜD
Produkt Service GmbH, Ridlerstrasse 65, 80339 München, Germany) indicating its
compliance with the provisions of the Council Directive 93/42/EEC about medical
devices and fulfills the essential requirements of Annex I of this directive.
The product ERS 2 system has been assigned to class IIa in accordance with Annex
IX of the Directive 93/42/EEC.
The product fulfills the requirements of the standard EN 60601-1 “Medical Electri-
cal Equipment, Part 1: General Requirements for Safety“ as well as of the standard
DIN EN 62304 “Medical Device Software“.
Magnetic and electrical fields are capable of interfering with the proper perfor-
mance of the device. For this reason make sure that all external devices operated
in the vicinity of the equipment comply with the relevant EMC requirements.
X-ray equipment, MRI devices, radio systems, cellular telephones, etc. are possible
sources of interference as they may emit higher levels of electromagnetic radi-
ation. Keep the equipment away from these devices and verify its performance
before use.
LiCEnsE tErMs
By installing the software, you accept the following terms:
Subject of this agreement is the granting of a license to use the software program
and the product documentation.
Ergoline GmbH grants you the personal, non-exclusive and non-transferable right
to use the software and documentation. The software and the accompanying
documentation are protected by copyright. The licensee shall comply with the
provisions of copyright law.
Ownership and all other rights to the software are retained by Ergoline GmbH. You
are not entitled to transfer the software to another computer via network or data
channel. The program and the accompanying product documentation shall not be
modified, copied or, in an altered version, merged with other software and made
accessible to third parties.
The licensee is liable to the licenser for any damage arising from the breach of the
copyright or infringement of the conditions of this agreement.
Introdu CtIon
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