User guide
BABYS
C
REEN
ECH001XN121-A4 – 07/2022
59
Chapter 7. Technical specifications
7.2 Standards/Certifications
7.1.1
Test parameters :
Measurement
Characteristic
DP-gram
- Acoustic stimulation: 1kHz to 5kHz
- Digital resolution 16 bits @ 32kHz
- Sound intensity: 50 to 75 dB SPL
TEOAE
- 25 clicks per second
- Alternating clicks by buffer of 4
- Digital resolution 16 bits @ 32KHz
- Sound intensity: 40 to 95 dB SPL
ABR
- Up to 50 clicks per second
- Alternating clicks
- Digital resolution 16 bits @ 32KHz
- Impedance test
- Measurement window from 10 to 25 ms
- Sound intensity: 0 to 95 dB HL
7.2
Standards/Certifications
7.2.1
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.