Interacoustics OtoRead Instructions For Use Manual page 58

OtoRead™ Instructions for Use - US
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
TM
The OtoRead is intended for use in the electromagnetic environment specified below. The
customer or the user of the OtoRead
Immunity Test IEC 60601 Test
Level
Electrostatic ±6 kV contact
Discharge ±8 kV air
(ESD)
IEC 61000-4-2
Electrical Fast ±2 kV for power
Transient/Burst supply lines
IEC 61000-4-4 ±1 kV for
input/output lines
Surge ±1 kV differential
IEC 61000-4-5 mode
±2 kV common mode
Voltage Dips, <5 % UT
Short (>95 % dip in UT) for
Interruptions 0.5 cycle
and Voltage 40 % UT
Variations on (60% dip in UT) for 5
Power Supply cycles
Lines 70 % UT
IEC 61000-4- (30% dip in UT) for
11 25 cycles
5 % UT
(>95% dip in UT) for
5 sec
Power 3 A/m
Frequency
(50/60 Hz)
IEC 61000-4-8
UT is the a.c. mains voltage prior to application of the test level.
TM
should ensure that it is used in such an environment.
Compliance
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for
input/output lines
±1 kV differential
mode
±2 kV common
mode
<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
3 A/m
Electromagnetic Environment-
Guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material the relative
humidity should be greater than 30%.
Mains power quality should be that of
a typical commercial, hospital, or
residential environment.
Mains power quality should be that of
a typical commercial, hospital, or
residential environment.
Mains power quality should be that of
a typical commercial, hospital, or
residential environment. If the user of
TM
the OtoRead requires continued
operation during power mains
interruptions, it is recommended that
TM
the OtoRead be powered from an
uninterrupted power supply.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
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