Chapter 1. Information and safety
1.2 Presentation of the device
1.2.2
Target population
Ages
: The device can be used on any type of patient with the ability to respond to the presence or absence of an
acoustic stimulus (>5 years)
Patient types:
men / women / children
Consultation context:
ENT diagnosis / occupational medicine
1.2.3
Expected performance
The devices are designed to perform audiological tests according to ISO 60645 standards:
Families
Audiological tests
Standards
Audiometry:
- Tonal Air conduction
(AC)
IEC 60645-1:2017 - Type 4
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
1.2.6
Units of measure:
For all these devices, the units of measure are expressed in the units of the international system:
Basic size
Unit
Name
Symbol
Frequency
Hertz
Hz
Intensity (Decibel)
Acoustics
Perceived
dB SPL
dB HL
1.2.7
Accessories
This device is delivered as standard with the following accessories:
- Mini-USB cable 2m
The device is in contact with the patient through applied parts, some of which can be supplied by Electronique du
Mazet. These accessories can be single use or reusable.
The use of accessories not recommended by the manufacturer does not engage his responsibility
List of compatible accessories:
Name
ref
Manufacturer
Headset DD45
301765
Radioear
Headset DD65
301475
Radioear
Screening headset (HD206)
302956
Sennheiser
Screening headset (H840)
301785
Building
Inserts earphones
040070
Electronique du Mazet
Patient response switch audiometry
040084
Electronique du Mazet
Mini-USB cable 2m
300618
Lindy
Acoustic tubes
040054
Electronique du Mazet
USB power adapter (EU)
301526
CUI
USB power adapter (USA)
040048
CUI
USB power adapter (UK)
040047
CUI