Intended Use; Important Safety Instructions - Interacoustics OtoRead Instructions For Use Manual

OtoRead Instruction for Use - English
The OtoRead™ OAE Test Instrument is designed to be a screening device for hearing loss. Sensitivity
and specificity of this type of device are based on the test characteristics defined by the user, and may
vary depending on environmental and operating conditions. The presence of otoacoustic emissions
suggests normal outer hair cell function, which in turn correlates to normal hearing. However, a
passing result using this instrument is not an indication that the full auditory system is normal. Thus, a
PASS result should not be allowed to override other indications that hearing is not normal. A full
audiologic evaluation should be administered if concerns about hearing sensitivity persist. A REFER
test result should not be assumed to be an indicator of a lack of auditory function; however, it should
be followed with full audiologic diagnostic testing.
The OtoRead™ Otoacoustic Emission Test System should be used only by those individuals trained
to perform the testing for which it has been designed. No person should attempt to use this instrument
without the necessary knowledge and training to understand how this equipment is to be properly
utilized and interpreted.
Never insert the probe tip into the ear canal without affixing an eartip.
Date: 2004-03-24

Intended Use

Under certain circumstances, especially in low-humidity environments,
common electrostatic discharge may cause this instrument to turn itself off.
This effect causes no permanent damage, and the instrument may be turned
on again by the normal procedure of holding the DOWN button.

Important Safety Instructions

Precautions
WARNING indicates a hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a
hazardous situation which, if not avoided, could result in minor
or moderate injury.
NOTICE is used to address practices not related to personal
injury.
Use only the disposable eartips designed for use with this instrument.
The eartips are disposable and for single use use only. Do not clean or reuse
eartips.
Use only disposable 1.5v AA/UM-3/R6 Alkaline batteries for the test
instrument. Do not use rechargeable cells in this device; do not mix battery
types and do not mix old and new batteries.
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