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Guidance and Manufacturer's Declaration – Immunity
The AURA™ Intracranial Monitor System and AURA™ System Battery Charger are
intended for use in the electromagnetic environment specified below. The customer or
user of the AURA™ Intracranial Monitor System and AURA™ System Battery Charger
should ensure that it is used in such an environment.
IEC 60601 Test
Immunity
Level
Test
3V
Conducted
0.15MHz-80MHz
RF IEC
6V
61000-4-6
0.15MHz and
80MHz
80% AM at 1kHz
3V/m
Radiated RF
80MHz – 2.7GHZ
IEC 61000-
80% AM at 1kHz
4-3
r.m.s. before modulation is applied.
1)
The ISM (industrial, scientific, and medical) bands between 0.15 MHz and 80 MHz are
2)
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are
1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1
MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4
MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
24
in ISM between
1)
2)
Compliance Level
3V
0.15MHz-80MHz
6V
in ISM be-
1)
tween 0.15MHz
and 80MHz
2)
80% AM at 1kHz
3V/m
80MHz – 2.7GHZ
80% AM at 1kHz
Electromagnetic Environment –
Guidance
PROFESSIONAL HEALTHCARE
FACILITY ENVIRONMENT
PROFESSIONAL HEALTHCARE
FACILITY ENVIRONMENT
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