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User Manual 16-2009 | Revision 01/20 by
Ackermann
mAGnetIC AnD eleCtRomAGnetIC ImmunIty
Immunity test
Test level as per IeC 60601
Conformity level
electromagnetic environment /
comments
electrostatic discharge
(eSD)
(IeC 61000-4-2)
± 8 kV contact
± 2, 4, 8,15 kV air
± 8 kV contact
± 2, 4, 8,15 kV air
Professional healthcare facility
environment and home healthcare
environment
electrical fast
transient/burst
(IeC 61000-4-4)
± 2 kV for electrical supply lines
± 1 kV for ports
± 2 kV for electrical supply lines
± 1 kV for ports
Professional healthcare facility
environment and home healthcare
environment
Surges
(IeC 61000-4-5)
± 0.5 and 1 kV differential mode
± 0.5, 1 and 2 kV common mode
± 0.5 and 1 kV differential
mode
± 0.5, 1 and 2 kV common
mode
Professional healthcare facility
environment and home healthcare
environment
Magnetic field at rated
industrial frequency
(IeC 61000-4-8)
30 a/m
30 a/m
Professional healthcare facility
environment and home healthcare
environment
Voltage dips, short
interruptions and
voltage variations
(IeC 61000-4-11)
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°
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°
Professional healthcare facility
environment and home healthcare
environment.
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.
8.4
Ch
ap
te
r
8