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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 optical motion cameras as part of a Vero System manufactured by VICON MOTION SYSTEMS LIMITED contribute to meet ANNEX V and VII Section 5 of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Vero), detail the product configurations and software options that conform to the metrological requirements of the Directive.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:

Electromagnetic Compatibility to:
EN60601-1-2:2007

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

Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
EN ISO 62304:2006 + A1:2015

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance

9 September 2020
Date Expiration 27th May 2024 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V.

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