Zertifizierungen - SCIFIT STEP ONE Bedienungsanleitung

Wenn sich auf dem Etikett Ihres StepOne-Geräts das Zeichen CE gefolgt
von „0434" befindet, handelt es sich um ein Medizinprodukt. Das Etikett
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: Step One – Stepper
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 957-8:1998
EN 60601-1-2:2007
EN 60601-1:2006
EN 62304:2006
Steve Wright
European Business Development Director
April 2, 2013
 
 
 
 




















 




SCIFIT Scientific Solutions For Fitness
SPEZIFIKATIONEN

ZERTIFIZIERuNGEN

befindet sich vorne am Gerät neben der Seriennummer.







  
  
     
                                                                                              
                                       

SCIFIT
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: Step One – Recumbent Stepper 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 13485:2012
ISO 9001:2008
EN 957-1:2005
EN 957-8:2009
EN 60601-1-2:2007
EN 60601-1: 2005
EN 62304:2006


















26
Scientific Solutions For Fitness
0434
Steve Wright
UK Managing Director
14 October, 2013
 
 
 
 














  
  
   
 
                                                    

SCIFIT