Safety Instructions
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ACAM® is an audiometer and a class IIa medical device according to RL 93/42/EWG Supplement IX.


Audiometers provide hearing measurements for diagnostic, hearing preservation, and rehabilitation purposes. An audiometer has to ensure that hearing tests, especially hearing threshold tests in the frequency range from 125 Hz to 8000 Hz provide the same results, regardless of equipment used, for each patient. The measured results must provide an accurate threshold measure when compared to the patient's hearing sensitivity.


Safety features are included in the ACAM System to prevent injury to the patient from high decibel output.  However, these safety features are not a substitute for diligence and care on the part of the audiologist.

It is important to communicate the following safety instructions to all
employees in your company!


We recommend that you post a copy of the following warnings in a conspicuous area for the ACAM users in your test box.



WARNINGS

ACAM® Measuring System
    1. ACAM® is a medical device with measuring function. These Instruments may only be operated by educated and trained personnel!
    2. To avoid incorrect measurements and to ensure that your ACAM System will operate properly, always perform and document regular, subjective, and optical device controls and perform and document calibration and safety-related controls.
    3. Do not put on the headphones until you have started ACAM® System or until you have performed a system reset.
    4. The ACAM® Audiometer is able to emit high sound pressure levels. In case of an operating error this can lead to injury. Always begin a measurement with low sound pressure levels!
    5. The connecting cables of the ACAM® System should not be pulled off during operation. Please ensure that the cables cannot be removed accidentally.