D-0120588-B – 2019/03
Eclipse – Instructions for Use - EN Page 2
1.2 Indications for use
EP15 & EP25
The Eclipse EP15 and EP25 are intended for use in the electrophysiological evaluation, documentation and
diagnosis of ear disorders in humans. EP15/EP25 is a 2 channel evoked potential system that allows for
recording waveforms that can be used for screening and diagnostic applications.
The EP15 allows for the recording of ABRs (Auditory Brainstem Responses) while the EP25 allows for
recording ABRs, middle and late latency potentials. The target population for EP15 and EP25 includes all
ages.
cVEMP & oVEMP
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic
potential testing to assist in the assessment of vestibular function. The target population for Eclipse VEMP
includes children from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific
facts underlying the procedure.
TEOAE
The Eclipse TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders
using Transient Evoked Otoacoustic Emissions. The target population for Eclipse TEOAE includes all ages.
DPOAE
The Eclipse DPOAE system is intended for use in the audiologic evaluation and documentation of ear
disorders using Distortion Product Otoacoustic Emissions. The target population for the Eclipse DPOAE
includes all ages.
ABRIS
The Eclipse ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve
disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The
target population for Eclipse ABRIS is newborns.
ASSR
The Eclipse ASSR (Auditory Steady-State Response) is intended for use in the recording and analysis of
human physiological data for the diagnosis of auditory and hearing-related functions. The target population
for Eclipse ASSR includes all ages.
1.2.1 Intended operator
General for Eclipse System and all modules, is to be used by trained personnel only, such as audiologists,
ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The
device should not be used without the necessary knowledge and training to understand its use and how
results should be interpreted.
1.2.2 Patient population
The patient target population includes all ages for all modules, with the exception of VEMP testing, which is
from the age of 8 years and up.
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