GSi AUDIOSTAR PRO Manuel D'instructions page 19

I
NTRODUCTION
Thank you for purchasing the GSI AudioStar Pro™ system. The GSI AudioStar Pro is a stand-
alone, two channel, advanced clinical\research audiometer. 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.
I U
NDICATIONS FOR
The AudioStar Pro is intended to be used for the identification of hearing loss in patients of
any age. It is intended to be used by an audiologist, ENT, hearing healthcare professional,
or trained technician in a hospital, clinic, healthcare facility or other suitable quiet
environment as defined in ANSI S3.1 or equivalent.
I U
NTENDED SE
The GSI AudioStar Pro is intended to be used for the purposes of determining patient
hearing sensitivity. It is intended to quantify the patient's level of hearing by presenting
pure tones stimuli through specific transducers at different frequencies and at different
sound pressure levels.
C
ONTRAINDICATIONS
There a no known contraindications for use.
E P
SSENTIAL ERFORMANCE
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 of Essential Performance cannot lead to any unacceptable immediate risk.
Final diagnosis shall always be based on clinical knowledge.
D-0131088 Rev C, 2022-07
GSI AudioStar Pro Instructions for Use
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