Axonics 1601 Bedienungsanleitung Seite 8

Guidance and manufacturer's declaration - electromagnetic immunity
The Trial Stimulator is intended for use in the electromagnetic environment specified below. The customer or
the user of the Trial Stimulator should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-5
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
Radiated, radio-frequency,
electromagnetic field immunity
test acc. to IEC 61000-4-3
Immunity to conducted disturbances,
induced by radio-frequency fields
acc. to IEC 61000-4-6
Table 1 – Compliance level for Immunity tests
IEC/EN 60601
test level
±8 kV contact
±15 kV air
Not Applicable
Not Applicable
Not Applicable
30 A/m at
50 Hz / 60 Hz
10 V/m 80 MHz to
2.7 GHz
*Refer table 2 for
wireless Proximity
RF field test levels
Not Applicable
Compliance
level
±8 kV Floors should be wood, concrete,
contact or ceramic tile. If floors are covered
±15 kV air with synthetic material, the relative
humidity should be at least 30%.
Not Not Applicable
Applicable
Not Not Applicable
Applicable
Not Not Applicable
Applicable
30 A/m Power frequency magnetic fields
at 50 Hz / should be at levels characteristic
60 Hz of a typical location in a typical
commercial or hospital environment.
10 V/m Refer to Table 3
80 MHz to
2.7 GHz
Not Not Applicable
Applicable
8
Electromagnetic environment -
guidance