OMG plc OMGLIFEAP1 Manuale Utente
Version 1.3 6AUG13
Page 8 of 9
CE Declaration of Conformity
Declaration of Conformity (R&TTE)
We, OMG plc
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare under our sole responsibility that the product
Unit 14 Minns Estate
Oxford OX2 0JB
United Kingdom
declare under our sole responsibility that the product
OMG LIFE Autographer
to which the declaration relates, is in conformity with the following standards and/or
other normative documents.
SAFETY
IEC 60950-1: 2
nd
Edition 2005 +A1
EN60950-1:2006
SAR
EN62209-1:2006 Body Worn Configuration
EMC
EN60601-1-2:2007
EN301489-17v2.1.1 (EN 301489-1v1.9.2)
RADIO
EN300 328 V1.7.1 (2006)
Covering wide band transmission systems; data transmission equipment
operating in the 2.4 GHz ISM band covering Class II Bluetooth + EDR
operating in the 2.4 GHz ISM band covering Class II Bluetooth + EDR
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 OMG plc, Unit 14 Minns
Estate, Oxford OX2 0JB, United Kingdom that will be made available on request.
T.M.L. Shannon, TD, PhD, FIE (Aust), CPEng (Biomedical)
Director of Compliance
30
th
July 2013
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.