Introduction And Intended Use - Resonance R16M Mode D'emploi

1.Introduction and intended use

RESONANCE thanks you for having purchased one of its medical devices.
This manual contains information and warnings aimed at ensuring the correct and safe use of the
R16M Middle Ear Analyzer available in the following versions:
Description
R16M
R16M-D
R16M OAE
R16M-D OAE
Carefully store this manual away in a safe place for each future consultation.
The R16M Middle Ear Analyzer is designed and manufactured to meet or exceed all quality and safety
requirements, and has been certified with CE-symbol according to European Medical De-vices
Directive. All the functions are software-controlled, upgrading the software at a later date will be
simple and free of charge.
The R16M Middle Ear Analyzer is intended to be used by audiologists, hearing healthcare
professionals, or trained technicians.
A middle ear analyzer is a medical device used to assess the condition and function of the outer and
middle ear. This is performed by inserting a small probe into the outer ear canal whilst presenting and
measuring changes in level via a small microphone. Changes in tone level detected in the ear canal
are monitored whilst the air pressure level is varied. These changes in level can be used to make
inferences about the status and condition of the tympanic membrane and middle ear ossicular chain.
Additional acoustic stimuli may also be presented in order to elicit reflex responses that can be of
further diagnostic value.
The Otoacoustic Emissions (OAE) Screener is a device testing the cochlear functionality which is
connected with the amplification activity by the external hair cells. When the cochlea is stimulated by
a sound the external hair cells vibrate producing in their turn an almost imperceptible sound which
goes back to the middle-ear. This subtle sound is measured by a tiny probe inserted into the ear canal.
The user must therefore have an adequate knowledge of audiological diagnostic equipment,
expertise on the examination methods used and knowledge of English.
This device is intended to be used in medical environments with low levels of background noise. The
operator must exercise caution in interpreting results where background noise has not been
sufficiently isolated.
It is recommended that the device be operated within an ambient temperature range of 15 -35 degree
Celsius.
This operating manual is not intended as a training manual for audiometry and
tympanometry. The reader should consult standard audiology texts for the theory and
application of the screening tests provided by this device.
Product code
4300104100
4300104145
4300104110
4300104115
4300104125
4300104135
4300104120
4300104130
4300104140
R16M User's Manual – Page 77