Nucleus ESPrit 3G, User Manual

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Chapter 4
ESPrit 3G User Guide
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45
Other Information
Registration
In accordance with international practice and regulatory
legislation, each component of the cochlear implant
system is shipped with a registration card. Registering
your cochlear implant system secures your warranty rights
and enables Cochlear to track all devices for regulatory
and product improvement purposes.
Also provided is a patient identification card, which you
should carry at all times.
The implant centre and the cochlear implant user are
responsible for correctly completing both the registration
card and the patient identification card. Please return
registration cards to Cochlear within 30 days of receiving
the cochlear implant system.
This information is collected and used in accordance with
legal requirements concerning data protection.
Certification and Applied Standards
The Nucleus
®
24 cochlear implant systems fulfil the
essential requirements listed in Annex 1 of the EC
directive 90/385/EEC on Active Implantable Medical
Devices as last amended by EC Directive 93/68/EEC.
They were approved for CE-Mark according to Annex 2
by Notified Body 0197 in 1995/1996 (Nucleus
®
24
system).
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