SCIFIT StepOne Manuel D'utilisation page 28

Si votre appareil StepOne dispose d'un marquage CE sur l'étiquette
suivi des chiffres 0434, il s'agit d'un appareil médical. L'étiquette sera
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
cERTIFIcATIONS
placée sur le devant de l'appareil à côté du numéro de série.







  
  
     
                                                                                             
                                         

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:
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
SCIFIT Scientific Solutions For Fitness
0434
SCIFIT Ltd (UK)
Steve Wright
UK Managing Director
14 October, 2013
 
  
 
 















 
 


  

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