This topic provides information relating to the EU Declaration of Conformity (Vicon MX T-Series).
Conformity of the Metrological Performance of CLASS 1 Products in accordance with
Annex VII, Section 5 of the Medical Devices Directive 93/42/EEC of 14th June 1993.
Aas amended by EU Council Directive 2007/47/EC of 5th September 2007.
We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
declare that the 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 has been tested prior to shipment and meets the following metrological performance:
- Supporting software Nexus 2.10 or later, Shogun 1.4 or later, Tracker 3.8 or later.
- Using a minimum of four cameras, resolution of the distance between the centers of two static 14 mm spherical markers located within a volume no less than 4 m x 4 m x 1.5 m to within 1 mm Mean; 1 mm Standard Deviation; sample size no less than 1,000.
Analogue Digital Conversion
Resolution to ± 10 mV mean and ± 10 mV (1 Standard Deviation).
Difference within one video frame.