Interacoustics OtoRead User manual

Operation Manual
OtoRead – Screener
Valid from serial number 4049004 - software version 7.65.01
8011609 D-0004788-D 11/2015

Table of Contents
TAbout this Manual ..........................................................................1
Intended Use .....................................................................................1
Important Safety Instructions..........................................................2
Precautions .....................................................................................2
Warranty..........................................................................................4
Printer AC Power Source Precautions............................................5
Use of Rechargeable Batteries.......................................................6
Cleaning and Disinfecting the Unit..................................................7
Waste Disposal...............................................................................7
Introduction.......................................................................................8
What is the OtoRead Instrument?....................................................8
How are the Results Stored and Reported?...................................9
Definition of OAEs...........................................................................9
Measurement of OAEs..................................................................10
Basic Functions..............................................................................12
Quick Start ....................................................................................12
Connection to the Printer ..............................................................12
Loading Paper into the Printer ......................................................13
Attaching the Eartips.....................................................................14
Connecting the Extension Cord....................................................15
Probe Tip Replacement ................................................................16
Operating Instructions...................................................................17
Testing in the Default Modes ........................................................18
Noise Sources...............................................................................24
Printing the Test Results...............................................................25
Setting the Clock...........................................................................26
Changing Instrument Settings ......................................................28
Test Mode .....................................................................................28
Clearing Test Results....................................................................29
Auto-Shutdown Time.....................................................................29
Save Mode/Storing Test Results ..................................................30
Minimum Amplitude.......................................................................31
Clock Mode ...................................................................................31
Language ......................................................................................32
Reset to Default ............................................................................32
Interpreting Test Results ...............................................................34
Understanding the Display............................................................34
Understanding the DPOAE Printed Results..................................35
Understanding the TEOAE Printed Results..................................36

A Note about Rounding of Results................................................37
Operation Panel Dictionary............................................................38
Program Flowchart.........................................................................40
Technical Specification..................................................................42
Preset Test Protocols....................................................................43
Parts..............................................................................................45
Unpacking and Inspection.............................................................46
Contents of Shipment....................................................................46
Reporting Imperfections................................................................47
Care and Maintenance..................................................................47
Troubleshooting .............................................................................48
Appendix A: Test Sequence..........................................................49
Appendix B: Pass/Refer Criteria ...................................................51
Return Report..................................................................................54

OtoRead Screener Intended Use Page 1
About this Manual
This manual is valid for the OtoRead™. These products are
manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
Intended Use
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.

OtoRead Screener Important Safety Instructions Page 2
Important Safety Instructions
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.
Note: The OtoRead Instrument probe tip must not
be inserted into an ear at any time without a
disposable eartip properly affixed.
Precautions
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE
THIS SYSTEM.
Use this device only as described in this
manual.
Use only the disposable eartips designed for
use with this instrument.
Never insert the probe tip into the ear canal
without affixing an eartip.
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

OtoRead Screener Important Safety Instructions Page 3
The eartips are disposable and for single use
only. Do not clean or reuse eartips.
Disposable 1.5v AA/UM-3/R6 Alkaline batteries
are recommended for use with OtoRead.
If other batteries are used, they must be 1.6v
AA Nickel Zinc rechargeable batteries. Care must be taken to avoid
bending the battery clips with incorrect sized batteries. Do not mix
battery types and do not mix old and new batteries.
Remove the batteries from the instrument if it
will not be used for 4 weeks or more.
Do not immerse the unit in any fluids. See Page
7 of this manual for proper cleaning
procedures.
Do not drop or otherwise cause undue impact
to this device. If the instrument is dropped or
otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the instrument
if any damage is suspected.
Use and store the instrument indoors only. Do
not use this instrument or its accessories in
temperatures below 4°C/40°F or above
38°C/100°F, or in relative humidity of more than 90%.
Do not attempt to open or service the
instrument. Return the instrument to the
manufacturer for all service. Opening the
instrument case will void the warranty.
Do not operate the printer if the power supply
has a damaged cord or plug. See the
instructions on the following page.
Do not expose the printed results to sunlight or
heat. Printing on thermal paper fades with
exposure to light or heat.

OtoRead Screener Important Safety Instructions Page 4
Photocopies of test results should be made if
the records are to be kept indefinitely.
Although the instrument fulfils the relevant
EMC requirements precautions should be
taken to avoid unnecessary exposure to
electromagnetic fields, e.g. from mobile phones etc. If the device is
used adjacent to other equipment it must be observed that no mutual
disturbance appears.
Warranty
INTERACOUSTICS warrants that:
•The OtoRead is free from defects in material and
workman ship under normal use and service for a period
of 24 months from the date of delivery by Interacoustics
to the first purchaser.
•Accessories are free from defects in material and
workmanship under normal use and service for a period
of ninety (90) days from the date of delivery by
Interacoustics to the first purchaser.
If any product requires service during the applicable warranty
period, the purchaser should communicate directly with the local
Interacoustics service centre to determine the appropriate repair
facility. Repair or replacement will be carried out at Interacoustics’
expense, subject to the terms of this warranty. The product
requiring service should be returned promptly, properly packed,
and postage prepaid. Loss or damage in return shipment to
Interacoustics shall be at purchaser's risk.
In no event shall Interacoustics be liable for any incidental,
indirect or consequential damages in connection with the
purchase or use of any Interacoustics product.
This shall apply solely to the original purchaser. This warranty
shall not apply to any subsequent owner or holder of the product.

OtoRead Screener Important Safety Instructions Page 5
Furthermore, this warranty shall not apply to, and Interacoustics
shall not be responsible for, any loss arising in connection with
the purchase or use of any Interacoustics product that has been:
•repaired by anyone other than an authorized
Interacoustics service representative;
•altered in any way so as, in Interacoustics judgement, to
affect its stability or reliability;
•subject to misuse or negligence or accident, or which has
had the serial or lot number altered, effaced or removed;
or
•improperly maintained or used in any manner other than
in accordance with the instructions furnished by
Interacoustics.
This warranty is in lieu of all other warranties, express or implied,
and of all other obligations or liabilities of Interacoustics, and
Interacoustics does not give or grant, directly or indirectly, the
authority to any representative or other person to assume on
behalf of Interacoustics any other liability in connection with the
sale of Interacoustics products.
INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A
PARTICULAR PURPOSE OR APPLICATION.
Printer AC Power Source Precautions
READ THIS SECTION CAREFULLY BEFORE USE
•The printer AC power source converts main voltage (120V AC or
220V AC) to a low voltage (7V DC) for powering the printer. Use
only the power source supplied for this purpose.
•This product is for indoor use only. Do not expose to water or
excessive dust.

OtoRead Screener Important Safety Instructions Page 6
•This product is not suitable for operation in the presence of
flammable anesthetic mixture with air or with nitrous oxide.
Do not cover the power source body as it may result in excessive
heating. The power source operates when the plug is inserted into
an outlet. To turn it off, remove the plug from the outlet. The outlet
must be easily accessible and located near the printer. Should a
faulty condition occur, remove the plug from the outlet immediately.
Use of Rechargeable Batteries
The OtoRead is designed for use with 1.5v AA/UM-3/R6 Alkaline
batteries.
Rechargeable batteries are not recommended for use with the
OtoRead, however should you choose to use them, the OtoRead
requires the use of 1.6v high voltage Nickel Zinc rechargeable
battery types. Other types of rechargeable batteries such as 1.2v
Nickel-Metal Hydride rechargeable batteries must not be used as
they do not provide enough power to the device.
Rechargeable batteries can typically be purchased in a 4 pack with a
charger. A 3-5 hour fast charger is recommended as this type
charges the batteries at a lower current, increasing the life of the
batteries. The PowerGenix ZR-PGX5HRAA-4B, 3-5-Hour Fast
Charger with 4 AA 1.6v High Voltage Rechargeable Batteries fit this
description.
Be aware that using rechargeable batteries may cause the following:
1.The low battery message generated by the instrument mail fail
to be triggered. In this case, the instrument display may go
blank or the instrument may fail to power on without warning.
If this occurs, replace the current batteries with newly
recharged batteries.

OtoRead Screener Important Safety Instructions Page 7
2.Some rechargeable batteries tend to be slightly longer in
length than regular alkaline AA batteries. This may cause the
battery contacts to be pushed outwards. When returning to
use standard alkaline AA batteries, it may be found that the
alkaline batteries no longer make proper contact. Ensure that
the rechargeable batteries used are the same length as
standard alkaline AA batteries.
Cleaning and Disinfecting the Unit
Wipe the surface with a cloth slightly dampened with mild detergent
or normal hospital bactericides. Do not immerse the unit. Do not
clean the unit with isopropyl alcohol or other solvents.
Waste Disposal
Note! Within the European Union it is illegal to dispose electric and
electronic waste as unsorted municipal waste. Electric and electronic
waste may contain hazardous substances and therefore has to be
collected separately. Such products will be marked with the crossed-
out wheeled bin shown below. The cooperation of the user is
important in order to ensure a high level of reuse and recycling of
electric and electronic waste. Failing to recycle such waste products
in an appropriate way may endanger the environment and
consequently the health of human beings.
Disposal of batteries must be made according to national
regulations.

OtoRead Screener Introduction Page 8
Introduction
The purpose of the OtoRead test system is to provide a rapid
measurement and documentation of Distortion Product Otoacoustic
Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions
(TEOAEs) at several frequencies.
What is the OtoRead Instrument?
The OtoRead Otoacoustic Emission test instrument 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. The OtoRead instrument may be used as a screening
tool or in conjunction with conventional tests as part of a full
audiological evaluation.
The OtoRead instrument contains the hardware and software for
generating the test stimuli, measuring and displaying the OAEs, and
storing the results until they are printed. The plastic housing contains
circuit boards that provide the signal processing and display the test
results. The instrument also contains 4 AA/UM-3/R6 alkaline
batteries to power the device. The instrument uses a liquid-crystal
display (LCD) and three light-emitting diodes (LEDs) to provide a
visual display of test data and test conditions to the operator. The
probe houses a microphone and two speaker tubes which produce
test stimuli and measure the sound pressure level (SPL) present in
the sealed ear canal. Interface of the instrument to the ear canal is
accomplished through disposable eartips made of industrial
elastomer, which fit onto the probe tip.
The disposable eartips are color coded to facilitate easy selection by
size. Four membrane-type push buttons located on the keypad of the
device allow the user to control testing and printing, and to reset test
protocols. Printing will commence upon placement of the instrument
into the cradle (if the printer is turned on).

OtoRead Screener Introduction Page 9
How are the Results Stored and Reported?
When the OtoRead is set in its default settings, the instrument will
store the results from one patient (left and right ear) in its non-volatile
memory for subsequent printing. However, the OtoRead instrument
can store up to 250 test results. The results are displayed via the
LCD on the front of the device and are stored in the device’s internal
memory. After testing is completed, results can be printed using the
printer. Test results are stored in the non-volatile memory so the
operator can delay printing until a later time if desired.
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.

OtoRead Screener Introduction Page 10
Measurement of OAEs
How Does the OtoRead Device Measure DPOAEs?
The OtoRead 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 OtoRead device provides an estimate of
outer hair cell function over a wide range of frequencies.
How Does the OtoRead Device Measure TEOAEs?
The OtoRead instrument generates a series of clicks, directs
them into the ear canal, and then analyzes the spectrum of the
returning signal, separating the noise and emission. By using
band pass filters, the OtoRead device provides an estimate of
outer hair cell function over a wide range of frequencies.
How Does the OtoRead Device Work?
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 OtoRead instrument.
What Frequency Range of Hearing is Estimated?
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 are estimated, 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.

OtoRead Screener Introduction Page 11
TEOAEs can be reliably recorded at lower frequencies than
DPOAEs, but cannot be measured reliably above 4 kHz.

OtoRead Screener Basic Functions Page 12
Basic Functions
Quick Start
These steps will allow you to quickly start using the OtoRead OAE
Test System. Be sure to perform the necessary otoscopic
examination prior to testing. Read the entire manual before testing
patients.
Step 1 Insert 4 AA/UM-3/R6 Alkaline batteries into the OtoRead .
Step 2 Place an eartip as far down as possible on the probe tip.
Step 3 Turn on the OtoRead by pressing the large DOWN arrow
button.
Step 4 Select the test ear by pressing the LEFT or RIGHT arrow key.
Step 5 Insert the eartip deeply into the patient’s ear canal to obtain a
seal. When a seal is obtained, the OtoRead will automatically begin
the test first calibrating and then testing emissions. The red ERROR
LED will illuminate if there is noise in the environment. This flashing
is normal and will often occur and testing can be made anyhow,
though it may influence the result. Once the testing is finished, the
unit will display “PASS” or “REFER” on the LCD display.
Step 6 When testing is completed on both ears, turn the printer on
by pressing the round button on top and place the hand-held unit on
the cradle. The most recent test results for both ears will
automatically print out.
Connection to the Printer
Connect the appropriate end of the connector cable into the port
located on the underside of the cradle. After firmly pushing the broad
connector end into place, turn the screws on either side to tighten it.

OtoRead Screener Basic Functions Page 13
Return the cradle to right side up. The end of the connector cable
should be plugged firmly into the inlet at the rear of the printer. The
fat side on the connector (look for arrow) goes to the bottom of the
printer. Finally, plug the appropriate ends of the power cord into the
power adapter and an outlet.
To turn the printer on, press the button on the front of the printer. The
printer indicator light will flash green briefly and then continue
flashing orange to indicate it is ready to receive data from the
OtoRead unit. The printer will automatically power off after one minute
of inactivity.
Figure 1
Loading Paper into the Printer
Open the lid by pushing on the sides, insert paper roll as shown, and
close the lid.
Figure 2

OtoRead Screener Basic Functions Page 14
Battery pack insertion:
Insert battery as shown
Figure 3
Power on:
Push POWER BUTTON for two seconds to power ON or OFF.
One short beep will be heard at power ON, two short beeps at power
OFF.
Green Power Indicator will be lit if battery powered
Attaching the Eartips
The OtoRead instrument comes with a box of disposable eartips that
fit a variety of ear canal sizes. The probe tip must have an eartip
attached before inserting it into an ear canal. The eartip kit has 12
different size eartips that are color-coded for easy selection. The
determination of the appropriate eartip size should be made by
persons with proper training and experience.

OtoRead Screener Basic Functions Page 15
The eartip must seal the ear canal. The best test results are obtained
when the eartip is inserted deeply into the ear canal instead of flush
with the ear canal opening. Caution must be taken, however, to
ensure that the eartip does not extend too deeply into the ear canal.
Use only the eartips approved for use with the instrument. The
eartips are disposable and should be replaced after each patient.
Do not attempt to clean or reuse these eartips.
After selecting an eartip, push it onto the probe tip until it is flush
against the base of the probe tip. The sound outlet tubes on the
probe tip are recessed to minimize the likelihood of clogging. If the
probe tip does become plugged or clogged, it must be replaced. See
the section Probe Tip Replacement on page Error! Bookmark not
defined. for further information. To remove the eartip, grasp the
eartip at the base and twist it while pulling it straight off the end of the
probe tip.
Connecting the Extension Cord
It is possible to extend the reach of the OtoRead by pulling off the top
and inserting the extension cord between the instrument and the top
(see Figure 4). A regular test situation can be seen in Figure 5. The
extension of the OtoRead is particularly useful in situations where
more flexibility is needed e.g. as in Figure 6.
Figure 4

OtoRead Screener Basic Functions Page 16
Figure 5
Figure 6
Probe Tip Replacement
To replace the probe tip, squeeze the tabs as shown in the picture
Figure 7. The tabs should audibly snap off the probe assembly. Pull
the probe tip directly off the probe and discard it.
Figure 7 Figure 8 Figure 9 Figure 10
Obtain a replacement probe tip and orient the tip as shown in the
picture Figure 9. The probe tip will only fit on one way; be careful not
to force the tip in place. Push the tip directly down onto the probe.
Once the probe tip is in place on the probe, push firmly downward on
the top of the tabs one at a time until a click is heard. Tug lightly on
the probe tip to verify that the tip is securely attached.
NOTE: If the probe tip is not inserted completely, the OtoRead
will not perform a test.