Malfunction - Interacoustics AS608 Instructions D'utilisation

Malfunction

In the event of a product malfunction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please remember
to include as many details as possible e.g. the type of harm, serial number of the product,
software version, connected accessories and any other relevant information.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.
AS608 - Instructions for Use - EN
The cooperation of the user is important in order to ensure a high level of reuse
and recycling of electric and electronic waste. Failing to recycle such waste
products in an appropriate way may endanger the environment and consequently
the health of human beings.
Outside the European Union, local regulations should be followed when disposing
of the product after end of life.
Be sure to use only stimulation intensities, which will be acceptable for the
patient.
The transducers (headphones, bone conductor, etc.) supplied with the instrument
are calibrated to this instrument - exchange of transducers require a recalibration.
It is recommended that parts which are in direct contact with the patient (e.g.
earphone cushions) are subjected to standard disinfecting procedure between
patients. This includes physically cleaning and use of a recognised disinfectant.
Individual manufacturer's instruction should be followed for use of this disinfecting
agent to provide an appropriated level of cleanliness.
Please note that the CE Marking is only legal if this Instruction is translated into
the national language of the user no later than at the delivery to him, if the
national legislation demands a text in the national language according to MDD
article 4.4.
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