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8 Notes on Safety
In order to allow safe performance of Senti and Sentiero (handheld and desktop) please
read the following notes on safety carefully and follow the provided instructions. If not
followed, risks of danger to persons and/or the device may be the consequence. Retain this manual
for later use and make sure to hand over this manual to any person who uses this device. Applicable
local government rules and regulations must be followed at all times.
8.1 General Usage
Follow relevant regulations in your facility regarding maintenance and calibration of
audiometric equipment. This includes regular servicing of the device and calibration of
transducers. See section
4: Service and Maintenance .
Do not try to open or service the device and its components yourself. Return the device
to the authorized service partner for all service.
Do not operate the device if its power supply is connected to the device and shows a
damaged cord or plug. Likewise, this is true for any accessory with a separate power
supply (e.g. label printer).
The device is capable of producing high stimulus levels for diagnostic purposes. Always
make sure to use only stimulus levels, which will be acceptable for the patient. Do not
present high stimulus levels to a patient if it could cause a hearing damage.
Do not change a transducer during a test. This may result in wrong stimulus output and
potential wrong test results.
The patient is allowed to operate the device during self-controlled tests (e.g. MAGIC)
according to instructions from qualified personnel. Do not allow children, handicapped
persons (e.g. mentally handicapped subjects) or other persons who may need assistance
to operate the device without adequate supervision. Supervision by qualified personnel is
recommended for all subjects at all times.
Senti Desktop: The transducers supplied with the device are calibrated to a specific
device. In order to ensure proper stimulus calibration and output, always check that the
connected transducer matches the transducer specified in the system information screen
on the device. Failure to do so may result in a mismatch of the stimulus level displayed on
the device compared to the actual stimulus level delivered to the patient. This may result
in over or under-estimation of hearing. It can also result in higher than expected stimulus
levels being delivered to the patient which may damage hearing. This does not apply to
the flexibly exchangeable transducers for all other Senti and Sentiero devices.
The device needs to be operated in a quiet environment, so that measurements are not
influenced by ambient noises. This may be determined by an appropriately skilled person
trained in acoustics. DIN EN ISO 8253-1 section 11 defines maximum ambient noise levels
for audiometric hearing testing. If not followed, measurement data may not reliably
represent the actual hearing status. See also section
3.5.8: Test Module Information .
For AEP measurements the device needs to be operated in an environment with low
electromagnetic disturbance. It is recommended to perform AEP tests in a shielded cabin.
If not followed, measurement data may be deteriorated by electrical noise.