Operating Instructions - Interacoustics OtoRead Instructions For Use Manual

3

Operating instructions

The OtoRead instrument is switched on by pressing the
TM
3.1 General precautions
When operating the instrument, please observe the following general precautions:
1. Use this device only as described in this manual.
2. Use only the disposable Sanibel ear tips designed for use with this instrument.
3. Always use a new ear tip for each patient to avoid cross-contamination. The ear tips are not
designed for reuse.
4. Never insert the probe tube into the ear canal without affixing an ear tip as this may damage the
patient's ear canal. Make sure that the ear tip covers the probe tube fully. Ear tips that are not
sufficiently attached to the probe tube risk getting detached from the probe during removal from
the ear canal.
5. Keep the ear tip box outside the reach of the patient.
6. Be sure to insert the probe in a way which will ensure a tight fit without causing any harm to the
patient. Use of a correct and clean ear tip is mandatory.
7. Be sure to use only stimulation intensities acceptable to the patient.
8. It is recommended to conduct a probe test at the beginning of each day to ensure that the probe
and/or cable is functioning correctly for TEOAE and DPOAE measurements.
9. Dispose of and replace any probe tube that is contaminated, to ensure wax or other debris stuck
in the probe tube does not affect the measurement. Do not attempt to clean it.
10. Contraindications to testing include recent stapedectomy or middle ear surgery, a discharging
ear, acute external auditory canal trauma, discomfort (e.g, severe otitis externa) or occlusion of
the external auditory canal. Testing should not be performed on patients with such symptoms
without a medical doctor's approval
NOTICE
1. Careful handling of the instrument whenever in contact with a patient should be given high
priority. Calm and stable positioning while testing is preferred for optimal accuracy.
2. The OtoRead
influenced by outside acoustic noise. This may be determined by an appropriately skilled person
trained in acoustics. ISO 8253 Section 11, defines a quiet room for audiometric hearing testing in
its guideline.
3. It is recommended that the instrument be operated within an ambient temperature range of 15°C
/ 59°F – 35°C / 95°F.
4. Never clean the transducer housing with water or insert non-specified instruments into the
transducer.
5. Do not drop the instrument and avoid any other undue impact to the device. If the instrument is
dropped or otherwise damaged, return it to the manufacturer for repair and/or calibration. Do not
use the instrument if any damage is suspected.
6. 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, caution must be taken to observe that no mutual
disturbance appears.
D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US
should be operated in a quiet environment, so that measurements are not
TM
DOWN key.
Page 19