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2.3.6 Environmental factors
CAUTION
2.3.7 Disposal
NOTICE
D-0127810-A – 2020/05
AS608 - Instructions for Use - US
Connect only accessories purchased from Interacoustics to the instrument.
Only accessories which have been stated by Interacoustics to be compatible
are allowed to be connected to the device.
Never insert, or in any way use, the insert headset without a new clean and
non-defective ear-tip. Always make sure that the foam or ear-tip is mounted
correctly. Ear-tips and foam are for single use only.
The instrument is not intended for use in environments exposed to fluid spills.
Check calibration if any parts of the equipment are exposed to shock or
rough handling.
Components marked for 'single use' are intended for a single patient during a
single procedure, and there is a risk of contamination if the component is re-
used. Components marked for 'single use' are not intended to be
reprocessed.
Use only transducers calibrated with the actual instrument.
In case of a serious incident with serious health impact for the patient or user
Interacoustics shall be informed. Beside that the competent authority in
patient's home country shall be informed. Interacoustics has a vigilance
system to help with this.
Storage outside temperature range as specified in Section 2.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can come into contact with
any of the electronic components or wiring. Should the user suspect fluids
have contacted the system components or accessories, the unit should not be
used until deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind and allow
sufficient space around the instrument to ensure proper ventilation.
To prevent system faults, take appropriate precautions to avoid PC viruses and
similar.
Within the European Union, it is illegal to dispose of electric and electronic items
in unsorted municipal waste. Electric and electronic waste may contain
hazardous substances and therefore has to be collected separately. Such
products will be marked with the crossed-out wheeled bin symbol, shown below.
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