Steris HarmonyAIR G Series, Operator'S Manual

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9-2
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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 9-2. Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity for all ME Equipment and ME Systems
The HarmonyAIR Surgical Lighting System G Series is intended for use in the electromagnetic
environment specified below. The Customer or the user of the HarmonyAIR Surgical Lighting
System G Series should assure that it is used in such an environment.
Immunity test IEC 60601 4th
Edition Test Level
Compliance Level Electromagnetic Environment –
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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/Dropout
IEC 61000-4-11
0% UT for
0.5 cycle
@ 0, 45, 90, 135, 180,
225, 270 and 315
degrees.
0% UT for 1 cycle
>95% Dip for
0.5 cycle
60% Dip for
5 cycles
30% Dip for
25 cycles
>95% Dip for
5 seconds
0% UT for
0.5 cycle
@ 0, 45, 90, 135, 180,
225, 270 and 315
degrees.
0% UT for 1 cycle
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the HarmonyAIR
Surgical Lighting System G Series requires
continued operation during power mains
interruptions, it is recommended that the
HarmonyAIR Surgocal Lighting System G
Series be powered from an uninterruptible
power supply or a battery.
(Tested at UT = to 240V ac and UT=
100Vac, 50Hz for each all test levels).
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
30 A/m 30 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.