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
declare that the Vue Video Camera as part of a Vicon Vantage or Vero Gait Analysis System manufactured by VICON MOTION SYSTEMS LIMITED in that the Quality Management System has been approved by BSI Assurance UK Ltd for the manufacture and support of the aforementioned CLASS 1 Medical device.
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:
General Requirements for Safety to:
EN60601-1:2006 + A12:2014
Software 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 Compliance
17th March 2021
Date of Expiration Validity of the MD727611 Certificate
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.