We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
declare that the VICON MX 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 meets 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 Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) BSI Assurance UK Ltd for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon MX T-Series) overleaf detail the product configurations and software options that conform to the metrological requirements of the Directiveproducts.
This declaration of conformity is issued under the sole responsibility of the manufacturer.
T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical)
Director of Regulatory Compliance
1617th March 2021
Date of Expiration 27th May 2024 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT04 8th September, 2020.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.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.