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Medical devices directive
The following information relates to the Medical Devices Directive:
❙ CE Declaration of Conformity
❙ Product configurations and software options
❙ Approval of Conformity certificate
CE Declaration of Conformity
0088
Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC.
Electromagnetic Compatability to EMC Directive2004/108/EC.
Electrical Safety to Low Voltage Directive 2006/95/EC.
We, Vicon Motion Systems Limited
Unit 14 Minns Estate
Oxford OX2 0JB
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 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 Medical device. The topic Product configurations and software options details the product configurations and software options that conform to the metrological requirements of the Directive.
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
20th March 2010
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, sterile, or life- or safety-critical environments.
Product configurations and software options
This section provides information relating to the CE Declaration of Conformity.
Conformity of the Metrological Performance of CLASS 1 Products in accordance with Annex V and VII Section 5 of the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC
We, Vicon Motion Systems Limited
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare that the VICON MX T-Series motion capture system manufactured by VICON MOTION SYSTEMS LIMITED has been tested prior to shipment and meets the following metrological performance:
❙ 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
❙ Resolution of a given analog voltage to within +/-20 mV RMS within the following configurations and constraints:
– No fewer than two cameras of any variant fully viewing static markers
– Independent of lens and strobe variants fitted to each camera
– Controlled lighting (no greater than 100 lux) and temperature (17-25° C)
– Single termination to each analog input
– Testing using the following Vicon application software: Nexus Version 1.4 or later
Approval of Conformity certificate
