D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
Page
21
3
Operating instructions
There is an inbuilt switch which is enabled when the software is launched, and it is connected via USB to the
computer. When operating the instrument, please observe the following general precautions:
Please place the instrument so that the power supply wire can be disconnected from the main unit with ease.
Use only specified power supply.
Note, to turn off the device disconnect from mains power
1. The intended operators of the instrument are ENT doctors, Audiologists, and other professionals with
similar knowledge. Using the instrument without adequate knowledge may lead to erroneous results
and may endanger the patients hearing.
2. The Affinity Compact should be operated in a quiet environment, so that measurements are not
influenced by external acoustic noises. This may be determined by an appropriately skilled person
trained in acoustics. ISO 8253-1 section 11, defines guidelines for permissible ambient noise for
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 for 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 foam eartips supplied with the optional IP30, or E
.
A
.
R Tone
5A insert transducers are replaced after each client tested. Disposable foam eartips also ensure that
sanitary conditions exist for each of your clients, and that periodic cleaning of a headband or cushion
is no longer required.
5. The instrument must warm up for at least 3 minutes in room temperature before use.
6. Be sure to use only intensity levels of the presentation signal which will be acceptable for 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 performing 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 disinfecting procedure between patients. This includes physically cleaning and
use of a recognized disinfectant. Individual manufacturer's instruction should be followed for use of
this disinfecting agent to provide an appropriated level of cleanliness.
9. To establish conformity with the IEC 60645-1 standard, it is important that the speech input level is
adjusted to 0VU. It is equally important that any free field installation is calibrated at the site where it
is used and under the conditions that exists during normal operation.
