Axonics 2501 Bedienungsanleitung Seite 8

Guidance and manufacturer's declaration – electromagnetic immunity
The Clinician Programmer is intended for use in the electromagnetic environment specified below. The user of
Clinician Programmer should make sure that it is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD) acc. to IEC
61000-4-2
Rapid transient
electrical
Interferences/bursts
acc. to IEC 61000-4-4
Surges
acc. to IEC 61000-4-5
Voltage dips, short
interruptions
and fluctuations of the
supply voltage acc. to
IEC 61000-4-11
Table 1 – Compliance level for Immunity tests
IEC/EN 60601 test level
± 8 kV Contact
discharge
± 15 kV Air discharge
± 2 kV for power lines
± 1 kV for input and
output lines
100kHz repetition
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage Dip:
Dip to 0% for 1 cycles @
0°phase angle
Dip to 70% for 25/30
cycles @ 0° phase angle
Dropout to 0% for 0.5
cycles @ 0°, 45°, 90°,
135° , 180°, 225°, 270°
& 315° phase angles
Voltage interruption:
100% for 250/300
cycles
Compliance level
± 8 kV Contact
discharge
± 15 kV Air discharge
± 2 kV/1 kV
± 1 kV for input and
output lines
100kHz repetition
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage Dip:
Dip to 0% for 1 cycles @
0°phase angle
Dip to 70% for 25/30
cycles @ 0° phase angle
Dropout to 0% for 0.5
cycles @ 0°, 45°, 90°,
135° , 180°, 225°, 270°
& 315° phase angles
Voltage interruption:
100% for 250/300
cycles
8
Electromagnetic environment
- guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
If the user of the Clinician
Programmer requires continued
operation during power mains
interruptions, it is recommended
that the Clinician Programmer be
powered from an uninterruptible
power supply or a battery.