23
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.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
–
Guidance
ESD
IEC 61000-4-2
±4kV Contact
±8kV Air
±4kV Contact
±8kV Air
Floors should be wood, concrete or
ceramic tile. If floors are synthetic,
the r/h should be at least 30%
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/O’s
±2kV Mains
±1kV N/A
Mains power quality should be that
of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV
Differential
±2kV
Common
±1kV
Differential
±2kV
Common
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage Dips/
Dropout
IEC 61000-
4-11
>95% Dip for
0.5 Cycle
>95% Dip for
1 Cycle
30% Dip for
25/30 Cycles
>95% Dip for
250/300
Cycles
>95% Dip for
0.5 Cycle
>95% Dip for
1 Cycle
30% Dip for
25/30 Cycles
>95% Dip for
250/300
Cycles
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
AURA™ System Battery Charger
requires continued operation
during power mains
interruptions, it is recommended
that the AURA™ System Battery
Charger be powered
from an uninterruptible power
supply or a battery.
Power Frequency
50/60Hz
Magnetic
Field
IEC 61000-
4-8
3 A/m
3A/m
Power frequency magnetic fields
should be that of a typical
commercial or hospital
environment.
