Vicon IX 2000 L Información técnica Pagina 20

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System Information
xx
Vicon MX Hardware System Reference
CE Declaration of Conformity
0088
Declaration of Conformity
Medical Devices Directive 93/42/EEC 14th June 1993
Electromagnetic Compatibility as defined by the EMC Directive
89/336/EEC of the 1st of January, 1992
We, Vicon Motion Systems Limited
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare that the VICON MX+ motion capture system manufactured by VICON MOTION
SYSTEMS LIMITED meets ANNEX V and VII Section 5 of Medical Devices 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 Medical device. Appendix F 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 89/336/EEC:
Emissions to:
EN55022:1998 Radiated, Class A,
EN55022:1998, Conducted, Class A
Immunity to:
EN55024:1998 (EN60601-1-2)
Low Voltage Directive to:
EN60950:2001
Not for use in an operating theater or anesthetic gas environment. Not suitable for use
in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical environments.
T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical), FRSA
Director of Operations
20th November 2006
MXhardware_Reference.book Page xx Monday, April 30, 2007 1:56 PM
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