5. MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification in compliance with the technical specification EN 60601- 1 (3rd edition).
Technical data Value
Type of protection against the direct and indirect
contacts
Class II
Applied parts Type B
Protection degree against humidity
IPX0 (no protection against liquid or solid
infiltration)
Sterilization or disinfection method This device can be disinfected
Protection degree in presence of anesthetics or
inflammable detergents
No protection
Electrical connection degree between device and patient Appliances with part applied on the patient
Use conditions Continuous functioning
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%
Danger of device damages. During transport and storage, the device can be exposed to the
environmental conditions for a maximum period of 15 weeks, only if kept in the original packaging.
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