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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 20042014/10830/ECEU.
Electrical Safety to Low Voltage Directive 20062014/9535/ECEU.

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

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 motion capture system 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 TÜV SÜD Product Service GmbH Zertifizierstellen, a notified body of the European Union (Reg No. 0123) BSI Assurance UK Ltd for the manufacture and support of the aforementioned CLASS 1 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.

VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 20042014/10830/EC: MX T-Series Systems (MX Giganet based).EU:

Electromagnetic Compatibility to:
EN60601-1-2:2007

Immunity to paragraph 6.2.3.1 to:
Immunity test level of 3V/m over 50 - 60 Hz

Electrical Safety of MxGiganet Power Supply Unit (Low Voltage Directive 2006/95/EC)
IEC 60601-1:1:1988 + A1:1991 + A2:1995 EN 60601-1:1990 A1,A2 and A13, excluding clause 36 and Korean national differences.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 Compliance11 September 2019

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.