34
D-0116492-B (OM022)
– Otosure Operating Manual
Guidance and manufacturer’s declaration – electromagnetic immunity
The Otosure Audiometer is intended for use in the electromagnetic environment specified below. The
customer or user of the Otosure Audiometer should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
–
guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% U
T
(>95% dip in U
T
) for
0.5 cycle
40% U
T
(60% dip in U
T
) for 5
cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95% dip in U
T
) for
5 sec
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Otosure Audiometer
requires continued operation
during power mains interruptions,
it is recommended that the
Otosure Audiometer be powered
from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE U
T
is the a.c. mains voltage prior to the application of the test level
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