Interacoustics OtoRead User manual

Instructions for Use ─US
OtoRead™
D-0116685-A – 2017/02

Table of Contents
1INTRODUCTION ..............................................................................................................................1
2UNPACKING AND INSTALLATION................................................................................................5
Environmental factors............................................................................................... 8
Electrical and electrostatic safety ............................................................................. 9
Electromagnetic compatibility (EMC)........................................................................ 9
Explosion hazards .................................................................................................... 9
Measuring security.................................................................................................... 9
Miscellaneous........................................................................................................... 9
Use of equipment after transport and storage........................................................ 10
Battery charging...................................................................................................... 12
Installing the MPT-II printer..................................................................................... 12
Switching the printer on and off.............................................................................. 12
Light indicators........................................................................................................ 12
Using the printer ..................................................................................................... 13
The OtoReadTM test instrument.............................................................................. 13
Charging and powering the OtoReadTM.................................................................. 14
2.6.2.1 The battery.............................................................................................. 14
2.6.2.2 Battery lifetime and charging time........................................................... 15
2.6.2.3 Indication lights on OtoReadTM................................................................ 15
2.6.2.4 Connecting the Micro-Probe to the OtoReadTM....................................... 15
3OPERATING INSTRUCTIONS ......................................................................................................17
Battery charge status indicator............................................................................... 18
General................................................................................................................... 19
Attaching ear tips.................................................................................................... 19
Removing ear tips................................................................................................... 19
The probe tube ....................................................................................................... 20
Selecting the Test Protocol..................................................................................... 21
Select the test ear................................................................................................... 22
Probe check............................................................................................................ 22
Calibration after probe check.................................................................................. 22
Testing children with PE tubes ............................................................................... 23
Test phase.............................................................................................................. 23
Storing results......................................................................................................... 23

Viewing results........................................................................................................ 24
Viewing DPOAE results with normative data.......................................................... 24
Rounding results..................................................................................................... 25
General................................................................................................................... 26
Saving results......................................................................................................... 26
Deleting results....................................................................................................... 26
Printing to a thermal printer .................................................................................... 27
Connection to the PC module................................................................................. 28
Menu Structure....................................................................................................... 29
Accessing the menus.............................................................................................. 29
Date and time settings (menu M1) ......................................................................... 31
3.11.3.1 Setting initial date and time..................................................................... 31
3.11.3.2 Daylight saving time................................................................................ 31
3.11.3.3 Changing the date and time.................................................................... 31
Device settings (menu M2)..................................................................................... 32
3.11.4.1 Wireless device pairing ........................................................................... 32
3.11.4.2 Clearing test results................................................................................. 32
3.11.4.3 Power mode ............................................................................................ 33
3.11.4.4 Save mode / storing test results.............................................................. 33
3.11.4.5 Minimum value ........................................................................................ 34
3.11.4.6 Clock mode ............................................................................................. 34
3.11.4.7 Graph style.............................................................................................. 34
3.11.4.8 Language ................................................................................................ 35
3.11.4.9 Reset to default ....................................................................................... 35
Advanced options for DPOAE testing (DP menu)................................................. 35
3.11.5.1 General.................................................................................................... 35
3.11.5.2 Customizing a test protocol..................................................................... 36
3.11.5.3 Changing the levels................................................................................. 36
3.11.5.4 Setting the averaging time....................................................................... 36
3.11.5.5 Setting the PASS SNR level ................................................................... 37
3.11.5.6 Setting the number of frequencies for PASS .......................................... 37
3.11.5.7 Reset protocol ......................................................................................... 37
3.11.5.8 Save protocol .......................................................................................... 38
Advanced options for TEOAE testing (TE menu)................................................... 38
3.11.6.1 General.................................................................................................... 38
3.11.6.2 Customizing a test protocol..................................................................... 38
3.11.6.3 Setting the averaging time....................................................................... 39
3.11.6.4 Setting the PASS SNR level ................................................................... 39
3.11.6.5 Setting the number of frequencies for PASS .......................................... 39
3.11.6.6 Reset protocol ......................................................................................... 40
3.11.6.7 Save protocol .......................................................................................... 40
4CARE AND MAINTENANCE .........................................................................................................41
5TROUBLESHOOTING ...................................................................................................................45
6GENERAL TECHNICAL SPECIFICATIONS.................................................................................47

7APPENDICES.................................................................................................................................55

OtoRead™ Instructions for Use - US Page 1
1 Introduction
About this manual
This manual is valid for the OtoRead™ (valid from version 3.20). This product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middlefart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
1.2 Intended use
The OtoRead™ Otoacoustic Emission Test Instrument is designed to be a screening device for hearing loss
in infants, children, and adults by measuring otoacoustic emissions (OAE).
This instrument is suitable for use in all settings, including hospitals, schools, physicians’ offices, and
audiologists’ practices. The OtoRead™ is intended to be used by hearing healthcare professionals (i.e. ENT
doctors, audiologists) and/or technicians, neonatal nurses and school nurses who have been trained by a
hearing healthcare professional.
1.3 Definition of OAEs
What are DPOAEs?
Distortion Product Otoacoustic Emissions (DPOAEs) are acoustic signals that can be detected in the ear
canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a
pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at
the frequency 2f1 - f2.
What are TEOAEs?
Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear
canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a
series of wideband clicks.
What do Otoacoustic Emissions results tell us?
Available evidence suggests that otoacoustic emissions (OAEs) are generated by the cochlea’s outer hair
cells, and that the presence of OAEs is an indication that the outer hair cells are normal. Although OAE test
data provide no indication of inner hair cell function, or of hearing ability, current research indicates that the
majority of hearing-impaired individuals will be identified by a simple OAE test. Patients who fail to generate
OAEs should be rescreened and/or referred for additional audiological testing.
How does the OtoReadTM device measure DPOAEs?
The OtoReadTM instrument generates a series of test tones, directs them into the ear canal, and then
measures the level of the DPOAE tone generated by the cochlea. By using different test frequencies, the
OtoReadTM device provides an estimate of outer hair cell function over a wide range of frequencies.

OtoRead™ Instructions for Use - US Page 2
How does the OtoReadTM device measure TEOAEs?
The OtoReadTM instrument generates a series of clicks, directs them into the ear canal, and then analyzes
the spectrum of the returning signal, separating the noise from the emission. By using band pass filters, the
OtoReadTM device provides an assessment of outer hair cell function over a wide range of frequencies.
What frequency range of hearing is assessed?
DPOAEs: Approximately 1 kHz to 12 kHz (depending on the frequency range selected). Since the health of
the hair cells in the region of the f2 test frequency is assessed, and a) the 2f1-f2 emission frequency is at
about six-tenths of the f2 frequency, b) emissions tend to be weak below 600 Hz or so, and c) the ambient
noise tends to be highest at low frequencies, the lowest f2 test frequency that can be routinely measured is
about 1 kHz.
TEOAEs: Roughly 500 Hz to 4 kHz. TEOAEs can be reliably recorded at lower frequencies than DPOAEs,
but cannot be measured reliably above 4 kHz.
1.4 Contraindications
Contraindications to testing include recent stapedectomy or middle ear surgery, a discharging ear, acute
external auditory canal trauma, discomfort (e.g, severe otitis externa) or occlusion of the external auditory
canal. Testing should not be performed on patients with such symptoms without a medical doctor’s approval.
For US only: Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a
licensed medical practitioner.
1.5 Product description
The OtoReadTM is a hand-held device designed to provide an objective measure of outer hair cell function
through the measurement of cochlear emissions. It consists of the handheld unit, printer, single-use eartips
and other accessories.
Factory-defined protocols allow for simple screening measurements (Screener and Screener+ Version) and by
using customizable protocols it can also assist in diagnostic evaluations (Standard and Clinical Version).
The purpose of the OtoReadTM test system is to provide rapid measurement and documentation of Distortion
Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several
frequencies. The digital signal processor in the instrument generates two pure tones (f1 and f2) for DPOAEs
or a series of wideband clicks for TEOAEs through a digital-to-analog converter. These tones or clicks are
presented to the ear via speaker tubes located in the probe. A microphone in the probe measures the sound
in the ear canal and transmits the signal to the analog-to-digital converter. The digital signal processor then
uses Fast-Fourier Transforms (FFTs) to filter the signal into narrow frequency bands, and detects any
emissions present. The level of these emissions can be compared with the level of the noise. The SPL and
frequencies of the test tones and the averaging time used to process the signals can be determined by the
tester through adjustable settings maintained in static memory within the OtoReadTM instrument.
The OtoReadTM instrument may be used as a screening tool or in conjunction with conventional tests as part
of a full audiological evaluation.

OtoRead™ Instructions for Use - US Page 3
The system consists of the following included and optional parts:
Included Components
Item Number
OtoReadTM device
8504335
Micro-Probe1
8504337
Micro-USB Power Supply for Charging the Lithium-Ion Battery
8029254
Micro B to A USB Cable for PC Communication/Charging
8101864
Eartip Assortment BET55
8104678
Package of Probe Tubes
8104159
Instructions for Use
country specific
Cavity (0.2/0.5 cc)
8011356
Plug for Hook cavity
8504384
OtoReadTM PC software package
8505352
Accessories included only in Standard and Clinical version
Item Number
Carrying Case
8004645
Cradle
8504302
Hook
8504385
Optional Components
Item Number
Carrying Case
8030335
Cradle
8504302
Hook
8504385
MPT-II Printer
8029304
Printer Power Supply for Charging Printer
8031231
Serial printer cable MPT-II
8011310
Thermal Printer Paper Roll
8029305
Neckstrap
8011481
1.6 Warnings
Throughout this manual the following definitions of warnings and cautions are used:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
1Applied part according to IEC 60601-1
WARNING
CAUTION

OtoRead™ Instructions for Use - US Page 4