Comeg DUO Full HD Manual De Uso página 78

8
Electromagnetic compatibility
8.4 Magnetic and electromagnetic immunity
The medical device is designed for use in the magnetic and electromagnetic environment
described in the table below. The user and/or installer must ensure conformity of the
electromagnetic environment.
Immunity test
Electrostatic
discharge (ESD)
(IEC 61000-4-2)
Electrical fast
transient/burst
(IEC 61000-4-4)
Surges
(IEC 61000-4-5)
Magnetic field at
rated industrial
frequency
(IEC 61000-4-8)
Voltage
dips, short
interruptions
and voltage
variations
(IEC 61000-4-11)
78
Test level as per IEC
60601
± 8 kV contact
± 2, 4, 8,15 kV air
± 2 kV for electrical
supply lines
± 1 kV for ports
± 0.5 and 1 kV
differential mode
± 0.5, 1 and 2 kV
common mode
30 A/m
0% UT for 0.5 cycles
At 0°, 45°, 90°, 135°,
180°,
225°, 270° and 315°
0% UT for 1 cycle
70% UT
For 25 cycles at 50 Hz
For 30 cycles at 60 Hz
Single phase: at 0°
Conformity level
± 8 kV contact
± 2, 4, 8,15 kV air
± 2 kV for electrical
supply lines
± 1 kV for ports
± 0.5 and 1 kV
differential mode
± 0.5, 1 and 2 kV
common mode
30 A/m
0% UT for 0.5 cycles
At 0°, 45°, 90°, 135°,
180°,
225°, 270° and 315°
0% UT for 1 cycle
70% UT
For 25 cycles at 50 Hz
For 30 cycles at 60 Hz
Single phase: at 0°
Electromagnetic
environment / comments
Professional healthcare
facility environment
and home healthcare
environment
Professional healthcare
facility environment
and home healthcare
environment
Professional healthcare
facility environment
and home healthcare
environment
Professional healthcare
facility environment
and home healthcare
environment
Professional healthcare
facility environment
and home healthcare
environment.