GSI
Allegro Tympanometer
User Manual
D-0120695 Rev D 2022-06 Page ix
IMPORTANT SAFETY INSTRUCTIONS
WARNING
The GSI Allegro instrument must be used only by medical professionals including,
but not limited to, Physicians, Physician Assistants, Nurse Practitioners, Nurses,
Audiologists and Medical Technologists knowledgeable in the theory and
application of the screening tests provided by this instrument. It is intended for transient use as
a screening and diagnostic tool; however, no surgical or medical procedure should be undertaken
solely based on results obtained from the instrument.
PRECAUTIONS
READ THIS USER MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Grason-Stadler and the local national competent authority.
Users should use their professional skills when interpreting the results and this should be done
in conjunction with other testing as deemed appropriate given their professional skills. Incorrect
use could lead to wrong results.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for EMC the
tympanometer is designed to be used only with the medically-approved mains adapter supplied,
which is specified as part of the equipment. Do not use any other type of mains adapter with
this instrument.
The tympanometer is for indoor use only and should be used only as described in this manual.
Before the first use of the instrument each day, or if suspect or inconsistent results are apparent,
the checks specified in the Performing Daily Checks section should be carried out. If the system
is not functioning properly, do not operate it until all necessary repairs are made and the unit is
tested and calibrated for proper functioning in accordance with Grason-Stadler published
specifications.
Never insert the probe into a patient’s ear canal without a suitable ear tip fitted to the probe.
Use only the recommended disposable ear tips. These are for single use only - that is, each ear
tip is intended to be used once only for a single ear for a single patient. Do not reuse ear tips as
this will pose the risk of ear-to-ear or patient-to-patient cross infection.
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