Interacoustics OtoRead - Page 69

D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 63
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The OtoReadTM is intended for use in the electromagnetic environment specified below. The
customer or the user of the OtoReadTM should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
level
Compliance
Electromagnetic
Environment-Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
greater than 30%.
Electrical fast
transient/burst
IEC61000-4-4
+2 kV for power supply
lines
+1 kV for input/output
lines
+2 kV for power
supply lines
+1 kV for
input/output lines
Mains power quality should
be that of a typical
commercial or residential
environment.
Surge
IEC 61000-4-5
+1 kV differential mode
+2 kV common mode
+1 kV differential
mode
+2 kV common
mode
Mains power quality should
be that of a typical
commercial or residential
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
lines
IEC 61000-4-11
< 5% UT
(>95% dip in UT) for
0.5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5
sec
< 5% UT (>95%
dip in UT)
for 0.5 cycle
40% UT (60% dip
in UT) for
5 cycles
70% UT (30% dip
in UT) for
25 cycles
<5% UT
Mains power quality should
be that of a typical
commercial or residential
environment. If the user of
the OtoReadTM requires
continued operation during
power mains interruptions, it
is recommended that the
OtoReadTM be powered
from an uninterruptable
power supply or its battery.
Power frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or residential
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.