1-Introduction And Intended Use - Resonance R07A Benutzerhandbuch

1. Introduction and intended use
RESONANCE thanks you for having purchased one of its medical devices.
This manual contains information and warnings aiming at ensuring the correct and safe use of the
R07A Screening audiometer part number 4300104200.
Carefully store this manual away in a safe place for each future consultation.
The R07A Screening audiometer is designed and manufactured to meet or exceed all quality and safe-
ty requirements, and has been certified with CE-symbol according to Medical Directive. All the func-
tions are software-controlled, upgrading the software at a later date will be simple and cost-effective.
The R07AScreening audiometer is intended to be used by an audiologist, hearing healthcare profes-
sionals, or trained technicians in a quiet environment.
The user must therefore have an adequate knowledge of audiological diagnostic equipment, exper-
tise on the examination methods used and knowledge of English.
The instrument is intended for use in quiet environments, ideally sound treated to <35 dB (A).
It is recommended that the device be operated within an ambient temperature range of 15 - 35 de-
gree Celsius.
The R07A Screening audiometer is designed to be a device for screening for hearing loss; in order to
assess reliable audiometric results, some variables factors must be kept in mind as the may influence
and/or jeopardize test results as:
Test room installation
• noise level in the test room
• correct calibration of the audiometer
Audiometric tests
• correct position of the transducers
• full instructions to the patient to obtain reliable responses
• testing methods, ascending or descending
Failing to account for these factors may lead to inaccurate results.
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