10 
PM-1795-01-06/2018 
Accessories:  
 
AC ADAPTER-E1600 :  
 
 
 
 
 
Packaging specifications from Explanation Diagram 
 
 
List of Harmonized EN Standards  
 
The above mentioned medical device belongs to Class IIa (MDD Annex IX Rule 10) 
potential risk class. 
Applicable Directives & Standards: 
Medical Device Directive (MDD) 93/42/EEC :  
EN ISO 15223:1:2016 
EN 1041:2008+A1:2013 
EN 1060-1:1995+A2:2009 
EN 1060-3 :1997+A2:2009 
EN 60601-1:2006+A1:2013 
Package  Amount  Approx. weight 
Approx. dimensions 
W x D x H, mm 
Main Unit  1  520
123 x 201 x 99 mm 
Packa
e  1  1.63k
239 x 154 x 170 mm 
Master Carton  5  8.93k
808 x 262 x 211 mm 
EAN code  401567211129 5