Description Of Device Markings - Empi Dupel Manuel De L'utilisateur

  
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   
Empi, Clear Lake, South Dakota, 57226, USA, declares under
         
its sole responsibility, that the markings on your DUPEL device
         
are your assurance of its conformity to the highest applicable
         
standards of medical equipment safety and electromagnetic       
compatibility. One or more of the following markings may appear
          
on your device.
         
Council Directive 93/42/EEC Concerning Medical Devices
           
(Medical Device Directive)
    
   
CSA C22.2 No. 125-M1984
  
Electromedical equipment, Canadian
      
Electrical Code Part II: Safety Standards for
     
Electrical Equipment. CSA Risk Class 2.
   
EN60601-1-2: 1993 (EMC Directive)
        
In accordance with Article 10(1) of Council Directive 89/336/EEC.
       
Medical electrical equipment. Part 1: General requirements for
  
safety. Part 2.
  
Collateral standard: Electromagnetic
   
compatibility: Requirements and tests.
    
Classified by Underwriters Laboratories Inc
         
shock, fire and mechanical hazards only in accordance with
     
UL 60601-1, and CAN/CSA C22.2 No. 601.1-M90.
Do not wear electrode or controller during Magnetic
Resonance Imaging (MRI) scans as this may result in metal
overheating and causing skin burns in the area of the patch.
  
   
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with respect to electric
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