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0088

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by EU Council Directive 2007/47/EC of 5th September 2007
Electromagnetic Compatability 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 VICON VANTAGE Cameras 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 Lloyd’s Register Quality Assurance, a notified body of the European Union (Reg No. 0088) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Vantage) 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:
Vantage Cameras EN60601-1:2006 + A12:2014

Network Hub UL60950–1, 2nd Edition

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

22 February 2018

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.