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Vicon Vero - EU Declaration of Conformity (Vicon Vero cameras)

Vicon Vero
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Vicon Vero Quick Start Guide May 2016
Regulatory information
Waste Electrical and Electronic Equipment (WEEE)
The use of the symbol as a marking on the equipment,
accessories or literature indicates that this product
and its electronic accessories (e.g. USB cable) may not
be treated as household waste. By ensuring this
product is disposed of correctly, you will help prevent
potential negative consequences for the environment and
human health, which could otherwise be caused by
inappropriate waste handling of this product.
Household users should contact either the retailer where they
purchased this device, or their local government office, for
details of where and how they can take these items for
environmentally safe recycling.
Business users should contact their supplier and check the
terms and conditions of the purchasing contract. This device
and its electronic accessories should not be mixed with other
commercial waste for disposal.
EU Declaration of Conformity (Vicon Vero cameras)
0088
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 2014/30/EU
Electrical Safety to Low Voltage Directive 2014/35/EU.
We, Vicon Motion Systems Limited
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare that the VICON VERO Cameras 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(m) Medical device. Product
configurations and software options (Vicon Vero cameras)
right, 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:
Vero Cameras EN60601-1:2006 + A12:2014
Network Hub UL60950–1, 2nd Edition
Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance
20th April 2016
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, dust ingress, high vibration,
sterile, or life- or safety-critical environments.
Product configurations and software options
(Vicon Vero cameras)
This section provides information relating to the EU
Declaration of Conformity (Vicon Vero cameras).
Conformity of the Metrological Performance of CLASS 1
Products Manufactured in Accordance with Annex VII,
Section 5 of the Medical Devices Directive 93/42/EEC of the
14th June 1993. As amended by EU Council Directive
2007/47/EC of 5th September 2007.
We, Vicon Motion Systems Limited
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare that the VICON VERO Cameras manufactured by VICON
MOTION SYSTEMS LIMITED have been tested prior to shipment
and meet the following metrological performance:
Measurement criteria
Supporting software Blade 3.4 or later, Nexus 2.4 or later,
and Tracker 3.3 or later.
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.
About your Vicon camera packaging
The box in which your new Vicon Vantage,
Vicon Vero or Vicon Vue camera arrived has a
specially formed foam insert that holds the
camera. This insert is made of a protective
material that prevents most damage that
could be caused during shipping. Vicon
recommends that you retain this box as it
provides the most convenient and safe way to
ship your camera(s) in future.