INSTRUCTIONS FOR USE
Z8A9F9 | IFU323EN00
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CSO Costruzione Strumenti Oftalmici srl.
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2.5
MEDICAL ELECTRICAL DEVICES CLASSIFICATION
Classification in compliance with the technical specification 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
anesthetics or inflammable detergents No protection
Electrical connection degree between
device and patient
Appliances with part applied on the
patient
Use conditions
Continuous functioning
2.6
ENVIRONMENTAL CONDITIONS
Phase
Technical data
Min
Max
Transport
Temperature
-10°C
+60°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
90%
Storage
Temperature
-10°C
+60°C
Atmospheric pressure
500 hPa
1060 hPa
Relative humidity
10%
90%
Use
Temperature
+15°C
+30°C
Atmospheric pressure
700 hPa
1060 hPa
Relative humidity
30%
70%
