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0088 1912

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007

Electromagnetic Compatibility to EMC Directive 2014/30/EU.
Electrical Safety to Low Voltage Directive 2014/35/EU.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that the VICON VANTAGE Cameras cameras as part of a Vantage system manufactured by VICON MOTION SYSTEMS LIMITED meets contribute to meet ANNEX V and VII, Section 5 of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC in that the Quality Management System has been approved by Lloyd’s Register Quality AssuranceDare!! Services B.V, a notified body of the European Union (Reg No. 00881912) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Vantage cameras) detail the product configurations and software options that conform to the metrological requirements of the Directive.

...

General Requirements for Safety to:
Vantage Cameras EN60601-1:2006 + A12:2014

Network Hub UL60950–1, 2nd EditionSoftware Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance22 February 2018

4th May 2021
Date of Expiration 17th August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8th September, 2020.

Not for use in an operating theater, anesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, dust ingress, high vibration, sterile, or life- or safety-critical environments.

Note: The overall system classification is defined by the highest risk device installed, which may include the connection of approved third-party equipment such as electromyography apparatus by clients.