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AEROSOL CHARACTERISTICS IN ACCORDANCE WITH REGULA-
TION EN 13544-1 APPENDIX CC
Aerosol output: 0.15 ml.
Aerosol output rate: 0.03 ml/min.
Particle size (MMAD): 4.12 µm
Standards applied:
Electric safety standards CEI EN 60601-1 Electromagnetic compat-
ibility according to CEI EN 60601-1-2 The device is a Class IIa medi-
cal device according to Directive 93/42/EEC "Medical devices".
ENVIRONMENTAL CONDITIONS
Storage and Transport
Temperature:
Humidity:
Atmospheric pressure: 700 hPa - 1060 hPa
Operation
Temperature:
Humidity:
Atmospheric pressure: 700 hPa - 1060 hPa
100110_MedelSmart_USERmanual_REV.02.21.04.2017.indd 31
2.0
y = 1.4337ln(x) - 2.0789
1.5
R = 0.99817
1.0
Z
0.5
0.0
-0.5
-1.0
-1.5
-2.0
1.00
Aerodynamic Diameter ( m)
MIN -20°C - MAX +60°C
MIN 10%RH - MAX 95%RH
MIN +10°C - MAX +40°C
MIN 10%RH - MAX 95%RH
EN
10.00
31
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