Steris Harmony LED Wall Control Unit - Table 11-2. Guidance and Manufacturers Declaration - Electromagnetic Immunity for All ME Equipment and  ME Systems

11-2
10083002 Operator Manual Appendix - EMC Compliance Technical Data
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for all ME Equipment and ME
Systems (per IEC 60601-1-2 clause 5.2.2.1 f) Table 2)
Table 11-2. Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity for all ME Equipment and ME Systems
The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit is
intended for use in the electromagnetic environment specified below. The Customer or the user of
the HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit 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 line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
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% UT
(>95% dip in UT) for
0,5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5
sec
<5% UT
(>95% dip in UT) for
0,5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for
5 sec
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the HarmonyAIR
Surgical Lighting System M Series with
Har
mony LED Wall Control Unit requires
continued operation during power mains
interruptions, it is recommended that the
HarmonyAIR Surgical Lighting System M
Series with Harmony LED Wall Control Unit
be powered from an uninterruptible power
supply or a battery.
(Tested at UT = to 240V ac and UT=
100V ac, 50Hz for each all test levels).
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 a typical
location in a typical commercial or hospital
environment.
NOTE: UT is the ac mains voltage prior to application of the test level.