Operating Instructions - Interacoustics Affinity Compact Instructions For Use Manual

3 Operating instructions

There is an inbuilt switch which is enabled when the sof tware is launched, and it is connected via USB to the
computer. When operating the instrument, please observe the f ollowing general precautions:
Please place the instrument so that the power supply wire can be disconnected f rom the main unit with ease.
Use only specif ied power supply.
Note, to turn of f the device disconnect f rom mains power
1. The intended operators of the instrument are ENT doctors, Audiologists, and other prof essionals with
similar knowledge. Using the instrument without adequate knowledge may lead to erroneous results
and may endanger the patients hearing.
2. The Af f inity Compact should be operated in a quiet environment, so that measurements are not
inf luenced by external acoustic noises. This may be determined by an appropriately skilled person
trained in acoustics. ISO 8253-1 section 11, def ines guidelines f or permissible ambient noise f or
audiometric hearing testing
3. Only recorded speech material with a stated relationship with the calibration signal should be used.
In the calibration of the instrument, it is assumed that the calibration signal level is equal to the
average level f or the speech material. If this is not the case, the calibration of the sound pressure
levels will be invalid and the instrument needs recalibration.
4. It is recommended that the disposable f oam eartips supplied with the optional IP30, or E
5A insert transducers are replaced af ter each client tested. Disposable f oam eartips also ensure that
sanitary conditions exist f or each of your clients, and that periodic cleaning of a headband or cushion
is no longer required.
5. The instrument must warm up f or at least 3 minutes in room temperature bef ore use.
6. Be sure to use only intensity levels of the presentation signal which will be acceptable f or the patient.
6. The transducers (headphones, bone conductor, etc.) supplied with the instrument are calibrated to
this instrument - exchange of transducers requires a new calibration.
7. It is advised that you apply masking when perf orming Bone Conduction Audiometry to ensure that
correct results are obtained.
8. It is recommended that parts which are in direct contact with the patient (e.g. earphone cushions) are
subjected to standard disinf ecting procedure between patients. This includes physically cleaning and
use of a recognized disinf ectant. Individual manuf acturer's instruction should be f ollowed f or use of
this disinf ecting agent to provide an appropriated level of cleanliness.
9. To establish conf ormity with the IEC 60645-1 standard, it is important that the speech input level is
adjusted to 0VU. It is equally important that any f ree f ield installation is calibrated at the site where it
is used and under the conditions that exists during normal operation.
D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
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