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30 Emitted Radiation & Electromagnetic Compatibility
Warning: The Optune
®
Treatment Kit, the ICH9100 charger and the SPS9100 power supply should not be used adjacent
to or stacked with other equipment
Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all
ME EQUIPMENT and ME SYSTEMS
Emitted Radiation & Electromagnetic Compatibility
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Optune Treatment Kit is intended for use in the electromagnetic environment specified below. The customer or the
user of Optune Treatment Kit should ensure that it is used in such an environment.
Emissions 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
N/A
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV line to earth
N/A
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 s
N/A
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.
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