R 17A User’s Manual – Page 63
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
R17A Audiometer available in the following versions:
Description Product code
R17A AC Screening 4300104000
R17A BC Basic Diagnostic 4300104010
4300104050
R17A HDA Basic Diagnostic 4300104020
Carefully store this manual away in a safe place for each future consultation.
The R17A Audiometer 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 R117A Audiometer is intended to be used by audiologists, hearing healthcare professionals, or trained
technicians.
The audiometer is a medical device used to assess different forms of deafness and diseases affecting the
auditory system. It generates stimulus and masking signals with the possibility to vary the pressure level
within a wide and dynamic value range. This test requires the active patient’s participation, who must
provide an answer to the various input signals, presented using headphones or other transducers.
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.
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