SCIFIT REX Orbi-Linear, Руководство по эксплуатации для владельца

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SCIFIT • Scientific Solutions for Fitness • SCIFIT • Scientific Solutions for Fitness • SCIFIT
If your REX7000 machine has CE on the label followed by
“0434”, it is a medical machine. The label will be located at the
front of the machine next to the serial number.
CERTIFICATIONS
27
0434
DECLARATION OF CONFORMITY
Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: info@scifit.uk.com
Web:
www.scifit.uk.com
Manufacture: SCIFIT Ltd (UK)
Product: REX7000 – Orbi-Linear Trainer
Class IIa device per rule 10 of Annex IX of 93/42/EEC.
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in
conformity with the essential requirements of the EC Council Directive 93/42
EEC Medical Device Directive, as amended by 2007/47/EC and is in conformity
with the following standards and/or normative documents:
ISO 13485:2003
ISO 9001:2008
EN 957-1:2005
EN 957-9:2003
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
UK Managing Director
17 January, 2012
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                                                                                            
                                       
DECLARATION OF CONFORMITY
Address: SCIFIT Ltd (UK)
Lexham House, Forest Road
Binfield, Berkshire, RG42 4HP
United Kingdom
EU Support: +44 1344 300022
Email: info@scifit.uk.com
Web: www.scifit.uk.com
Manufacturer: SCIFIT Ltd (UK)
Product: REX7000 – Recumbent Elliptical Trainer
Class A (high accuracy class) per EN957-1:2005
Class S (commercial use class) per EN957-1:2005
We, SCIFIT Systems, Inc., hereby declare that the product listed above is in
conformity with the following standards and/or normative documents:
ISO 9001:2008
EN 957-1:2005
EN 957-9:2003
EN 60601-1-2:2006
EN 60601-1: A1 1993. A2 1995
Steve Wright
European Business Development Director
January 4, 2012