Malfunction - Interacoustics Affinity2.0 Instructions For Use Manual

7. Outside the European Union, local regulations should be f ollowed when disposing of the product
af ter end of lif e.
1.6

Malfunction

In the event of a product malf unction, it is important to protect patients, users, and other
persons against harm. Theref ore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmf ul and harmless malf unctions, 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, sof tware
version, connected accessories and any other relevant inf ormation.
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.
D-0004578-R – 2022/05
Affinity2.0/Equinox2.0 - Instructions for Use - US
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