GSI TympStar Pro User Manual
D-0129427 Rev. B Page 20 of 162
INTRODUCTION
Thank you for purchasing the GSI TympStar Pro™ system. The TympStar Pro Middle-Ear
Analyzer is a clinical aural acoustic impedance/admittance instrument (Type 1). It supports
data transfer to a computer but does not rely on the computer to perform tests and will
not lose data if the computer connection fails. User login and password controls provide
security for patient data. Test data can be transferred to software such as GSI Suite and
Noah and can be integrated into your EMR/EHR system.
INDICATIONS FOR USE
The TympStar Pro is intended to be used for the measurement of acoustic
impedance/admittance and otoacoustic emissions within the human external ear canal.
These measures are useful in the evaluation, identification, documentation, and diagnosis
of ear disorders. The device is intended to be used on patients of any age.
INTENDED USE
The TympStar Pro is intended to be used by an audiologist, ear nose and throat physician
(ENT), hearing healthcare professional, or trained technician. The TympStar Pro is intended
to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing
environment.
CONTRAINDICATIONS
Ear canal examination with an illuminated otoscope is an essential prerequisite to
successful middle-ear testing. Make sure that the canal is free of any obstruction. If the
canal is completely plugged at the entrance or if fluid is running from the ear canal,
tympanometry should not be attempted until the condition is cleared. Testing should not
be performed on patients with conditions listed below without a medical doctor’s approval.
• Recent stapedectomy or another middle ear surgery
• Discharging ear
• Acute external auditory canal trauma
• Discomfort (e.g., severe otitis externa)
• Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may
contraindicate testing when high intensity level stimuli are used
ESSENTIAL PERFORMANCE
Essential Performance for this instrument as per IEC 60601-1 is defined by the
manufacturer as: This instrument does not have an Essential Performance. Absence or loss
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