OT
O
WIN
User Guide
ECH001XN161-A4 - 07/2022
5
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:
male / female / child
Consultation framework:
Occupational medicine / ENT diagnosis
1.2.3
Expected performance
The devices are designed to perform audiological tests according to ISO 60645 standards:
Families
Otological diagnoses
Standards
Audiometry:
- Air conduction (
AC
)
- Bone conduction (
BC
)
IEC 60645-1 :2017 - Type 3
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 measurement:
For all these devices, the units of measurement are expressed in the units of the international system:
Basic size
Unit
Name
Symbol
Frequency
Hertz
Hz
Intensity (Decibel)
Sound pressure level
Hearing level
dB SPL
dB HL
1.2.7
Accessories
This device is delivered with the following accessories as standard:
- 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
DD45 headset
301765
Radioear
DD65 headset
301475
Radioear
DD450 headset
302427
Radioear
Insert Earphones
040070
Electronique du Mazet
Bone vibrator B71
040060
Electronique du Mazet
Patient response switch
040084
Electronique du Mazet
Mini-USB cable 2m
300618
Lindy
USB power adapter (EU)
301526
CUI
USB power adapter (USA)
040048
CUI
USB power adapter (UK)
040047
CUI