Intended Use - Interacoustics AT235 Impedance Audiometer Gebrauchsanweisung

AT235 Instruction for Use - English
Date: 2001-06-15
The AT235 is an automatic impedance audiometer suited for clinics performing screening, as well as
diagnostic work. The test battery includes tympanometry, acoustic reflex testing, ipsilateral and
contralateral reflex decay testing, Eustachian tube function test and AC audiometry.
The AT235 tympanometer is intended to be used by an audiologist, hearing healthcare professional,
or trained technician in a quiet environment (tymp and reflexes) and extremely quiet environment
(Audiometry). Careful handling of instrument whenever in contact with patient should be of high
priority. Calm and stable positioning while testing is preferred for optimal accuracy. It is recommended
that the instrument be operated within an ambient temperature range of 15-35 degree Celsius (59-95
degrees Fahrenheit).
Notice - Be sure to insert the probe tip in a way, which will assure an air tight fit without causing any
harm to the patient. Using a proper and clean ear tip is mandatory.
Notice - We recommend using a new ear tip for each patient.
If the clinician rinses the ear tips they should be subjected to standard disinfecting procedure between
patients. This includes physically cleaning the ear tip and use of a recognised disinfectant. Individual
manufacturer's instruction should be followed for use of this disinfecting agent to provide an
appropriated level of cleanliness.
Notice - Be sure to use only stimulation intensities, which will be acceptable for the patient.
Notice - The transducers (headphones, bone conductor, etc.) supplied with the instrument are
calibrated to this instrument - exchange of transducers require a re-calibration.
Notice - It is recommended that parts which are in direct contact with the patient (e.g. earphone
cushions) are subjected to standard disinfecting procedure between patients. This includes physically
cleaning and use of a recognised disinfectant. Individual manufacturer's instruction should be followed
for use of this disinfecting agent to provide an appropriated level of cleanliness.
Notice - 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
Notice - Please note that the CE Marking is only legal if this Instruction is translated into the national
language of the user no later than at the delivery to him, if the national legislation demands a text in
the national language according to MDD article 4.4.
If this apparatus is connected to one or more other devices with medical CE marking, to
make up a system or pack, the CE marking is only valid also for the combination if the
supplier has issued a declaration stating that the requirements in the Medical Device
Directive article 12 are fulfilled for the combination.

Intended use

Precautions
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