Malfunction - Interacoustics VRA Screen Instructions For Use Manual

Interacoustics will make available on request circuit diagrams, component part lists, descriptions, cali-
bration instructions, or other inf ormation that will assist authorized service personnel to repair those
parts of this instrument that are designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the patient.
The instrument is not intended f or use in environments exposed to f luid spills.

2.4 Malfunction

In the event of a product malf unction, it is important to protect patients, users, and other per-
sons 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 immedi-
ately 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 ver-
sion, 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 imme-
diately be reported to Interacoustics and the local national competent authority.
D-0128588-D – 2022/02
VRA Screen - Instructions for Use - EN
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