Guidance And Manufacturer's Declaration - Electromagnetic Immunity - GE PDM Service Manual

Guidance and manufacturer's declaration –
electromagnetic immunity
Immunity Test
Electrostatic ± 6 kV contact
Discharge (ESD)
± 8 kV air
EN 61000-4-2
Electrical Fast ± 2 kV for power supply lines
Transient/Burst
± 1 kV for input/output lines
EN 61000-4-4
Surge ± 1 kV differential mode
EN 61000-4-5 ± 2 kV common mode
<5% U
cycles
Voltage dips, short
interruptions and
<40% U
voltage variations
cycles
on power supply
input lines
<70% U
25 cycles
EN 61000-4-11
<5% U
Power Frequency 3 A/m
(50/60 Hz)
Magnetic Field
EN 61000-4-8
2030047-001A
The Patient Data Module is intended for use in the electromagnetic environment
specified below. It is the responsibility of the customer or user to assure that the
Patient Data Module is used in such an environment.
EN 60601 Test Level
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV differential mode
± 2 kV common mode
(>95% dip in U ) for 0.5 <5% U
t t
for 0.5 cycles
(>60% dip in U ) for 5 <40% U
t t
U
(>30% dip in U ) for
<70% U
t t
U
(>95% dip in U ) for 5 s
t t <5% U
for 5 s
3 A/m
NOTE
U is the AC mains voltage prior to application of the test level.
t
Compliance Level
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Mains power should be that of a typical commercial
or hospital environment.
Mains power should be that of a typical commercial
or hospital environment.
(>95% dip in U )
t t
Mains power should be that of a typical commercial
or hospital environment. If the user of the equipment
(>60% dip in
t
requires continued operation during power mains
) for 5 cycles
t
interruptions, it is recommended that the equipment
be powered from an uninterruptible power supply or a
(>30% dip in
t
battery.
) for 25 cycles
t
(>95% dip in U )
t t
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Patient Data Module
Appendix B– Electromagnetic Compatibility
Electromagnetic Environment – Guidance
B-3