OMG plc VICP1 Manual De Usuario

Origin 
Setup & 
Maintenance 
Guide 

Vicon Motion Systems Ltd.

04-Sep-2018

Page 38 of 45

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

EN61236:2013; 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.