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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 T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet as a support part of a supplied T-Series 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 products.

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:
T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet
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

T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical)
Director of Regulatory Compliance

17th March 2021
Date of Expiration Validity of the MD727611 Certificate

Not for use in an operating theatre, anaesthetic 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, sterile, or life- or safety-critical environments.