Table A-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity For All Equipment
and Systems (per IEC 60601-2 Clause 6.8.3.201 a – 6 Table 202)
The STERIS 4095 General Surgical Table and related components are intended for use in the electromagnetic
environment specified below. The Customer or the user should ensure this STERIS 4095 General
Surgical Table
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 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/
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 STERIS
4095 General Surgical Table requires
continued operation during power mains
interruptions, it is recommended that the
STERIS 4095 General Surgical Table be
powered from the equipped internal
battery.
(Tested at UT = to 230V ac and UT=
100V ac, 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.
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