CSO sirius+ - Medical Electrical Devices Classification; Environmental Conditions

sirius+ | IFU327EN00 - 01/2021
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2.5 MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification complying with the standard EN 60601-1:2005 + A1:2012
Technical data
Value
Type of protection against the direct
and indirect contacts
Class I
Applied parts
Type B
Protection degree against humidity
IP20 (no protection against liquid
infiltration)
Sterilization or disinfection method
This device can be disinfected
Protection degree in presence of
anaesthetics or inflammable
detergents
No protection
Electrical connection degree between
device and patient
Appliances with applied part on the
patient
Use conditions
Continuous functioning
2.6 ENVIRONMENTAL CONDITIONS
Phase
Technical data
Min
Max
Transport
Temperature
-40°C
+70°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
95%
Storage
Temperature
-10°C
+55°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
10%
95%
Use
Temperature
+10°C
+35°C
Atmospheric pressure
800 hPa
1060 hPa
Relative humidity
30%
90%
Phase
Technical data
Min
Vibration
Sinusoidal
10 Hz to 500 Hz, 0.5g
Shock
30g duration 6ms
Bumb
10g duration 6ms