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0088

Declaration of Conformity

Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007 and
Electromagnetic Compatibility to EMC Directive 2014/30/EU.

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

Declare that the VICON SAT Interfaces (supplied as Lock and Lock+) manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V and VII Section 5 of the Medical Devices Directive 93/42/EEC 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 Lock+) 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:
EN60601-1:2006 + A1:2013

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

22 February 2018

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