User guide
BABYS
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ECH001XN121-A4 – 07/2022
5
Chapter 1. Information and safety
1.2 Presentation of the device
1.2
Presentation of the device
The
BABYS
C
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is designed for screening, documentation and monitoring of hearing function. It is intended for use
by otolaryngologists, pediatricians and other healthcare professionals in offices and hospitals. The hearing of a subject
can be evaluated objectively, without requiring the subject's participation, via evoked potentials or induced otoacoustic
emissions. The evoked potentials term refers to the collection of the electrophysiological activity induced by acoustic
stimuli. It allows the diagnosis of neurosensory and retrocochlear damages.
The provoked otoacoustic emissions term indicates the collection in the external auditory meatus of a sound wave
induced by an acoustic stimulation. These sounds of low amplitude are the reflection of the smooth running of the external
hair cells active mechanisms. They allow the diagnosis of the neurosensory damages but also pressure disorders of the
internal ear.
BABYS
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is based on a system of measures modules, which can be entirely purchased from the acquisition of the
equipment or be added in a later update.
1.2.1
Intended Use
The
BABYS
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is a device dedicated to health professionals who want to perform objective hearing screenings,
whether on newborns, young children or even adults. It allows for rapid and automated measurements of PEA, TEOAE
and DPgram. The launching of the measurement as well as the reading of the result, in the form of "PASS", "REFER"
are simplified so that unqualified staff in otology can carry out and exploit the measurements following a short training.
By using different acoustic stimuli (click, sinusoid, complex signals) and different recording methods (acoustic or
electro-physiological), the
BABYS
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is designed to perform the following otologic diagnostics:
Evoked potentials:
Otoacoustic emissions:
-Auditory brainstem response
(ABR)
- Transient otoacoustic emissions
(TEOAE)
- Distortion products
(DPgramme
)
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
Evoked
potentials:
- Auditory brainstem response
(ABR)
IEC 60645-3 :2020
IEC 60645-7 :2009 - Type 2
Otoacoustic
emissions:
- Transient otoacoustic emissions
(TEOAE)
IEC 60645-3 :2020
IEC 60645-6 :2009 - Type 2
- Distortion products
(DPgramme
)
IEC 60645-6 :2009 – Type 2
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
