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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 2004/108/EC.
Electrical Safety to Low Voltage Directive 2006/95/EC.

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 motion capture 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) 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 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 2004/108/EC: MX T-Series Systems (MX Giganet based).

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.

T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical)
Director of Regulatory Compliance
9 September 2020

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.