User guide
ELI
O
S
ECH001XN111-A4 – 07/2022
6
1.2.1
Intended Use
The
ELI
O
S
is primarily intended for ENT doctors working in private practice or in a hospital environment. The
ELIOS
is able to integrate all the measures modules of our range of otologic diagnostic device, however it can accom-
modate other healthcare professionals. All tests can be performed directly from the touch screen of the device (except
ASSR), or from our software
ECH
O
SOFT
by connecting the device to a computer thanks to a USB cable. The
ELI
O
S
is
the only one of our devices to integrate the pressure measurement (DPMC and Shift-OAE) exclusive to
E
CHODIA
. This
method is intended for the screening of the Menière disease. These two measurements require advanced knowledge in
otology and neurology and are primarily intended (in their most complete form) to professionals of both areas.
By using different acoustic stimuli (click, sinusoid, complex signals) and different recording methods (acoustic or
electro-physiological), the
ELI
O
S
is designed to perform the following otologic diagnostics:
Evoked potentials:
Otoacoustic emissions:
Audiometry:
-Auditory brainstem response
(ABR)
Auditory Steady-State Responses
(ASSR)
-Vestibular Evoked Myogenic Potential
(VEMP)
-Electrocochleography
(EchoG
)
-Cochlear Microphonic Potential
(DPMC)
- Transient otoacoustic emissions
(TEOAE)
- Distortion products
(DPgramme
)
- Distortion products phase-shift
(Shift-
OAE)
-Air conduction
(AC)
-Bone conduction
(BC)
-Speech
1.2.2
Target population
Ages:
no age restrictions (from newborn to elderly, depending on the measurement)
Patient type:
men / women / children / newborn
Consultation context:
ENT diagnosis & newborn screening
1.2.3
Expected performance
The devices are designed to perform otologic tests according to ISO 60645 standards:
Otologic tests
Standards
Audiometry:
-Air conduction
(AC)
-Bone conduction
(BC)
IEC 60645-1 :2017 - Type 3
Compatible EHF
- Speech
IEC 60645-1 :2017 - Classe B
Evoked
potentials:
- Auditory brainstem response
(ABR)
IEC 60645-3 :2020
IEC 60645-7 :2009 - Type 1 et 2
- Auditory Steady-State Responses
(ASSR)
- Electrocochleography
(EchoG
)
- Cochlear Microphonic Potential
(DPMC)
IEC 60645-3 :2020
IEC 60645-7 :2009 - Type 1
- Vestibular Evoked Myogenic Potential
(VEMP)
IEC 60645-3 :2020
Otoacoustic
emissions:
- Transient otoacoustic emissions
(TEOAE)
IEC 60645-3 :2020
IEC 60645-6 :2009 - Type 1 et 2
- Distortion products
(DPgramme
)
IEC 60645-6 :2009 – Type 2
- Distortion products phase-shift
(Shift-OAE)
IEC 60645-6 :2009
1.2.4
Contraindications
We recommend not to diagnose (or to take precautions when diagnosing) patients with injured skin, open wounds or
acoustic hypersensitivity
The contraindications are not exhaustive and we advise the user to seek advice in case of doubt.
1.2.5
Side effects
No side effects identified to date
