Origin
Setup &
Maintenance
Guide
Vicon Motion Systems Ltd.
11-Oct-2018
Page 37 of
44
CE Declaration of Conformity (Vicon Pulsar)
Declaration of Conformity
(Radio Equipment Directive 2014/53/EU)
We, Vicon Motion Systems Ltd
Unit 6, Oxford Industrial Park
Yarnton, Oxfordshire, OX5 1QU
UNITED KINGDOM
declare under our sole responsibility that the product
VICON Beacon Model MSU1
VICON Pulsar LED Clusters Model P1
to which the declaration relates, is in conformity with the following standards and/or other
normative documents.
SAFETY
1
EN 60601-1:2006/A12: 2014
Latex Free
RF Exposure Evaluation RED 2014/53/EU Article 3(1)(a)
EMC
EN61326:2013; ETSI EN301 489-17 V2.2.1:2012
using the common technical requirements of ETSI EN301 489-1 V2.1.1
RADIO
ETSI EN300 328 V2.1.1 (2016-11)
Covering wide band transmission systems; data transmission
equipment operating in the 2.4 GHz ISM band
We hereby declare that all essential radio test suites have been carried out and that the
above named product is in conformity to all the essential requirements of Directive 1999/5/
EC. The technical documentation is kept at Vicon Motion Systems Ltd, Unit 6, Oxford
Industrial Park, Yarnton, Oxfordshire, OX5 1QU, UNITED KINGDOM that will be made
available on request.
T.M.L. Shannon, TD, PhD, FIE (Aust.), CPEng (Biomed.)
Director
3rd September 2018
1. Risk analysis performed under ISO14971:2012 in compliance with Medical Devices
Directive 93/42/EEC applied as amended by EU Council Directive 2007/47/EC of 5th
September 2007 as the product is wearable.
Not a medical device. Not for use in an operating theatre, anaesthetic gas 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.
DRAFT