Package
Main Unit
Package
Master Carton
EAN code
The device is classified as a medical device, class IIa.
Applicable Medical Device Directive (93/42/EEC) standards:
Cleaning of the device
Clean the parts after each use to remove residual medication or mucus. This will
prevent inefficient nebulization or aspiration and reduce the risk of infection.
Packaging specifications
Amount
Approx. weight
1
1.1 kg
1
1.45 kg
6
9.75 kg
401567211121 9
List of Harmonized EN Standards
EN 13544-1:2009
EN 15223-1:2016
INI EN 1041:2013
UNI EN ISO10993-1:2010
EN 10993-5:2009
EN 10993-10:2010
EN 60 601-1:2006+A1 :2013 (Ed3.1)
EN 60 601-1-2:2015 4
EN 60 601-1-11:2015
EN 60 601-1-6:2010
EN 62366:2008
EN 14971:2012
Operation and care
PM-1655-E-01-01/2018
Approx. dimensions
W x D x H mm
145 x 222 x 124 mm
152 x 233 x 181 mm
330 x 722 x 210 mm
th
edition
12