D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN
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4
Operating instructions
4.1 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
TM
ear tips designed for use with this instrument.
3. Always use a new ear tip, foam insert or EarCup for each patient to avoid cross-contamination. The
ear tips, foam inserts or EarCups are not designed for reuse.
4. Never insert the probe tip into the ear canal without affixing an ear tip as this may damage the
patient’s ear canal.
5. Keep the box of ear tips outside the reach of the patient.
6. Be sure to insert the probe tip 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 an Integrity Check at the beginning of each day to ensure that the
transducers, the probe and/or cable is functioning correctly for Automated ABR, TEOAE and DPOAE
measurements.
9. Clean the probe tip regularly to ensure wax or other debris stuck in the probe tip does not affect the
measurement.
Please note:
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 Sera
TM
should be operated in a quiet environment, so that measurements are not influenced by
outside acoustic noises. 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. Never clean the transducer housing with water or insert non-specified instruments into the
transducer.
4. Do not drop and avoid other undue impact to this device. If the instrument is dropped or in any other
way damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if
any damage is suspected.
See the Sera
TM
Additional Information for symptoms, possible causes and suggested
troubleshooting.
