COVVI THE NEXUS HAND, Техническое руководство

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00 | Page 59 www.covvi.com | Unit 4, Quayside Business Park, Leeds, LS10 1DJ | 020 3949 9500
We, COVVI Ltd. , Direct House (Unit 4), Quayside Business Park, George Mann Road, Leeds,
LS10 1DJ, United Kingdom declare under our sole responsibility that the product to which
this declaration relates is in conformity with the following standard(s) or other normative
document(s) and proves the conformity of the designated product with the provisions of
the EC Directive(s):
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Name
Type or Model
Nexus Hand CVXXXQXX00001)
Standards Applied
• BS EN 60601-1-2 2015 - Medical electrical equipment. General requirements for basic
safety and essential performance. Collateral Standard. Electromagnetic disturbances.
Requirements and tests
• BS EN 60601-1 2006+A12 2014 - Medical Electrical Equipment Part 1
• BS EN 50419 2006 - Marking of electrical and electronic equipment in accordance
with Article 11(2) of Directive 2002-96-EC (WEEE)
• BS EN ISO 15223-1 2016- Medical Devices - symbols
• BS EN ISO 14971 2012 - Medical Devices - Application of Risk Management to medical
devices
• EN 300328 v2.1.1 (2016 11) Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band
• Directive 2014/53/EU Radio Equipment Directive
Conformity Assessment Procedure:
Device Classification Annex
I (Annex IX rule 12) VII
Edward Varley,
Chief Technical Officer
November 8th 2019
18.0 EC Declaration of Conformity