025-0169-311 Revision: B
Page 45 of 52
Table 8-3 IEC EMC Specifications (Immunity)
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Baylis Pain Management System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Baylis Pain Management System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 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
IEC 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 quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 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 seconds
<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 seconds
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Baylis
Pain Management System requires
continued operation during power mains
interruptions, it is recommended that the
Baylis Pain Management System be
powered from an uninterruptible power
supply or battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of typical
location in a typical commercial or
hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
