User guide
ELI
O
S
ECH001XN111-A4 – 07/2022
145
Technical specifications
8.2 Standards/Certifications
8.2
Standards/Certifications
8.2.1
EMC compliance table
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
The Echodia range of products are intended for use in the electromagnetic environment specified below.
The customer or user of the equipment should ensure that it is used in such an environment.
Emissions testing
Compliance
Electromagnetic environment - guidelines
RF emissions
CISPR 11
Group 1
The Echodia range of devices uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are not
likely to cause interference in any nearby electronic device.
RF emissions
CISPR 11
Class B
The Echodia range is suitable for use in all premises, including
domestic premises and those directly connected to the public low-
voltage power supply to domestic buildings.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
Flicker
IEC 61000-3-3
Compliant
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
The Echodia range of products are intended for use in the electromagnetic environment specified below. The cus-
tomer or user of the equipment should ensure that it is used in such an environment.
IMMUNITY test
Test level IEC
60601-1-2
Level of compliance
Electromagnetic environment - guide-
lines
Electrostatic Discharge
(ESD)
IEC 61000-4-2
± 8 kV in contact
± 15 kV in air
± 8 kV in contact
± 15 kV in air
The floors should be made of wood, con-
crete or ceramic tiles. If the floors are
covered with synthetic materials, the rel-
ative humidity should be at least 30%.
Rapid transients in
bursts
IEC 61000-4-4
± 2 kV for lines
power supply
electric
± 1 kV for lines
input/output
± 2 kV for power
lines
The quality of the power supply should
be that of a typical commercial or hospi-
tal environment.
Transient overvoltage
IEC 61000-4-5
± 1 kV between
phases
± 2 kV between
phase and earth
± 1 kV between
phases
± 2 kV between
phase and earth
The quality of the power supply should
be that of a typical commercial or hospi-
tal environment.
Voltage dips, short in-
terruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
0% UT: 0.5 cycles at
0, 45, 90, 135, 180,
225, 270 and 315 de-
grees 0% UT: 1 cycle
and 70% UT; 25/30
cycles
Single-phase: at 0 de-
grees
0% UT; 250/300 cy-
cles
0% UT: 0.5 cycle at
0, 45, 90, 135, 180,
225, 270 and 315 de-
grees
0% TU: 1 cycle and
70% TU; 25/30 cy-
cles
Single-phase: at 0 de-
grees
0% UT; 250/300 cy-
cles
The quality of the power supply should
be that of a typical commercial or hospi-
tal environment. If the user of the equip-
ment requires continuous operation dur-
ing power outages, it is recommended
that the Echodia range be powered from
an uninterruptible power supply or bat-
tery.
NOTE UT is the AC mains voltage be-
fore the test level is applied.
Magnetic field at mains
frequency
(50/60 Hz)
IEC 61000-4-8
30 A/m
50Hz or 60Hz
30 A/m
50Hz or 60Hz
Magnetic fields at the frequency of the
power system should have levels charac-
teristic of a representative location in a
typical commercial or hospital environ-
ment.
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015)
The Echodia range of products is intended for use in the electromagnetic environment specified below. The customer
or user of the equipment should ensure that it is used in such an environment.
IMMUNITY test
Test level IEC
60601-1-2
Level of compliance
Electromagnetic environment - guide-
lines
Содержание ECHODIA ELIOS
Страница 100: ...User guide ELIOS ECH001XN111 A4 07 2022 99 Measurement on ECHOSOFT 6 1 Evoked potential modul ABR ECochG et VEMP...
Страница 118: ...User guide ELIOS ECH001XN111 A4 07 2022 117 Measurement on ECHOSOFT 6 3 Hydrops Shift OAE and DPMC...
Страница 137: ...User guide ELIOS ECH001XN111 A4 07 2022 136 Measurement on ECHOSOFT 6 6 Audiometry...