User's Guide

11NUCLEUS
®
7 REMOTE CONTROL USER GUIDE
Certification and applied standards
The Nucleus 7 Remote Control fulfils the essential
requirements listed in Annex 1 of the EC directive 90/385/EEC
on Active Implantable Medical Devices as per the conformity
assessment procedure in Annex 2.

The year in which authorisation to affix the CE mark was
granted was 2016.
It also fulfils the essential requirements listed in the EC
directive 1999/5/EC on Radio and Terminal
Telecommunication Equipment as per the conformity
assessment procedure in Annex IV.
Equipment classification
Your remote control is an accessory to a medical device as
described in the international standard IEC 60601-1:2005,
Medical Electrical Equipment – Part 1: General Requirements
for Basic Safety and Essential Performance.
DRAFT ONLY FOR USABILITY TESTING