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15.2 Guidance and manufacturer’s declaration – electromagnetic immunity
The PhysioTouch® - LymphaTouch® is intended for use in the electromagnetic environment specified
below. The customer or the user of the PhysioTouch® - LymphaTouch® should assure that it is used
in such an environment. Portable and mobile RF communications equipment can aect medical
electrical equipment. Wireless communications equipment such as wireless home network devices,
mobile phones, cordless telephones and their base stations, walkie-talkies can aect this equipment
and should be kept at least a distance d (see tables on pages 40-41) away from the any part of the
PhysioTouch® - LymphaTouch® including cables.
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.
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