Branchpoint Technologies AURA TK101-A Instructions For Use Manual page 25

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
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips/
Dropout
IEC 61000-
4-11
Power Frequency
50/60Hz
Magnetic
Field
IEC 61000-
4-8
IEC 60601 Compliance
Test Level Level
±4kV Contact ±4kV Contact
±8kV Air ±8kV Air
±2kV Mains ±2kV Mains
±1kV I/O's ±1kV N/A
±1kV ±1kV
Differential Differential
±2kV ±2kV
Common Common
>95% Dip for >95% Dip for
0.5 Cycle 0.5 Cycle
>95% Dip for >95% Dip for
1 Cycle 1 Cycle
30% Dip for 30% Dip for
25/30 Cycles 25/30 Cycles
>95% Dip for >95% Dip for
250/300 250/300
Cycles Cycles
3 A/m 3A/m
Electromagnetic Environment –
Guidance
Floors should be wood, concrete or
ceramic tile. If floors are synthetic,
the r/h 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
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 magnetic fields
should be that of a typical
commercial or hospital
environment.
23