Malfunction - Interacoustics AT235 Instructions For Use Manual

NOTICE
1. To prevent system faults, take appropriate precautions to avoid PC viruses and similar.
2. Use only transducers calibrated with actual instrument. To identify a valid calibration, the serial
number for the instrument will be marked on the transducer.
3. Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g., from mobile phones etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance appears. Please also
refer to EMC considerations in section 5.4
4. Use of accessories, transducers, and cables other than specified, except for 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 fulfils the requirements please refer
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 therefore
must be collected separately. Such products will be marked with the crossed-out
wheeled bin shown below. The cooperation of the user is important 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 followed when disposing of the product after
its useful life.

2.4 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.
D-0133834-A – 2022/09
AT235 - Instructions for Use - EN Page 7