Malfunction - Interacoustics AT235 Instructions For Use Manual

NOTICE
1. To prevent system f aults, take appropriate precautions to avoid PC viruses and similar.
2. Use only transducers calibrated with actual instrument. To identif y a valid calibration, the serial number
f or the instrument will be marked on the transducer.
3. Although the instrument f ulf ils the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic f ields, e.g. f rom mobile phones etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance appears. Please also ref er
to EMC considerations in section 5.4
4. Use of accessories, transducers and cables other than specif ied, with the exception of transducers and
cables sold by Interacoustics or representatives may result in increased emission or decreased immunity
of the equipment. For list of accessories, transducers and cables that f ulf ils the requirements please
ref er to section 5.4
5. Within the European Union it is illegal to dispose electric and electronic waste as unsorted municipal
waste. Electric and electronic waste may contain hazardous substances and theref ore has
to be collected separately. Such products will be marked with the crossed-out wheeled bin
shown below. 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.
6. Outside the European Union, local regulations should be f ollowed when disposing of the product af ter its
usef ul lif e.

2.4 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-0128073-C – 2022/05
AT23 5 - Instructions for Use - US Page 8