Appendix B– Electromagnetic Compatibility
2030047-001A
Patient Data Module
B-3
Guidance and manufacturer’s declaration –
electromagnetic immunity
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.
NOTE
U
t
is the AC mains voltage prior to application of the test level.
Immunity Test
EN 60601 Test Level
Compliance Level
Electromagnetic Environment – Guidance
Electrostatic
Discharge (ESD)
EN 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical Fast
Transient/Burst
EN 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply
lines
± 1 kV for input/output
lines
Mains power should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
Mains power should be that of a typical commercial
or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
EN 61000-4-11
<5% U
t
(>95% dip in U
t
) for 0.5
cycles
<40% U
t
(>60% dip in U
t
) for 5
cycles
<70% U
t
(>30% dip in U
t
) for
25 cycles
<5% U
t
(>95% dip in U
t
) for 5 s
<5% U
t
(>95% dip in U
t
)
for 0.5 cycles
<40% U
t
(>60% dip in
U
t
) for 5 cycles
<70% U
t
(>30% dip in
U
t
) for 25 cycles
<5% U
t
(>95% dip in U
t
)
for 5 s
Mains power should be that of a typical commercial
or hospital environment. If the user of the equipment
requires continued operation during power mains
interruptions, it is recommended that the equipment
be powered from an uninterruptible power supply or a
battery.
Power Frequency
(50/60 Hz)
Magnetic Field
EN 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Summary of Contents for PDM
Page 7: ...2030047 001A Patient Data Module 1 1 1 Introduction ...
Page 13: ...2030047 001A Patient Data Module 2 1 2 Equipment Overview ...
Page 21: ...2030047 001A Patient Data Module 3 1 3 Installation ...
Page 26: ...3 6 Patient Data Module 2030047 001A Installation ...
Page 27: ...2030047 001A Patient Data Module 4 1 4 Service Tool and Configuration ...
Page 38: ...4 12 Patient Data Module 2030047 001A Service Tool and Configuration ...
Page 39: ...2030047 001A Patient Data Module 5 1 5 Maintenance ...
Page 48: ...5 10 Patient Data Module 2030047 001A Maintenance ...
Page 49: ...2030047 001A Patient Data Module 6 1 6 Troubleshooting ...
Page 54: ...6 6 Patient Data Module 2030047 001A Troubleshooting ...
Page 55: ...2030047 001A Patient Data Module 7 1 7 Field Replaceable Units ...
Page 69: ...2030047 001A Patient Data Module A 1 A Appendix A Technical Specifications ...
Page 80: ...A 12 Patient Data Module 2030047 001A Appendix A Technical Specifications ...
Page 81: ...2030047 001A Patient Data Module B 1 B Appendix B Electromagnetic Compatibility ...
Page 90: ...B 10 Patient Data Module 2030047 001A Appendix B Electromagnetic Compatibility ...
Page 91: ......
