Abbott 3599 Clinician Manual page 48

Medical external pulse generator
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Table 8. Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
Conducted RF IEC 61000-4-6
IEC 60601 Test Level
±8 kV contact
±15 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line to line
±2 kV line to ground
<5% U
T
40% U
T
70% U
T
30 A/m
3 Vrms
150 kHz to 80 MHz
6 Vrms (ISM/Radio bands
between 150 kHz to 80 MHz)
80% AM at 1 kHz
Compliance Level
±8 kV contact
±15 kV air
Not applicable
Not applicable
Not applicable
30 A/m
3 Vrms
6 Vrms
42
Electromagnetic Environment
Guidance
The relative humidity should be
at least 15%.
No guidance for battery‑powered
devices.
No guidance for battery‑powered
devices.
No guidance for battery‑powered
devices.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
The device is intended for use in
the electromagnetic environment
in which radiated RF disturbances
are controlled. The customer or
the user of the device can help
prevent electromagnetic
interference by maintaining a
minimum distance between
portable and mobile RF

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