GSI CORTI

User Manual

Part number D-0103241 rev G

Setting The Clinical Standard www.grason-stadler.com

Grason-Stadler, 10395 West 70th Street, Eden Prairie, MN, USA 55344
800-700-2282 • 952-278-4402 • fax 952-278-4401 • e-mail [email protected]
Title: GSI Corti™ OAE Instrument

EC REP
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1,
5500 Middelfart
Denmark

Copyright © 2013-2019 Grason-Stadler. All rights reserved. No part of this publication may be
reproduced or transmitted in any form or by any means without the prior written permission of GSI. The
information in this publication is proprietary to GSI.

Compliance
The CE 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.

0123
 Table of Contents
Standards Compliance ..............................................................................................................1
Indications For Use ....................................................................................................................2
Warranty ........................................................................................................................................3
Warnings, Cautions, and Errors .............................................................................................4
Status/Error Messages ............................................................................................................................... 6
Customer Responsibility ..........................................................................................................8
Safety Precautions......................................................................................................................9
Cautions - General .................................................................................................................................... 9
Warning - Electric Shock Hazards .......................................................................................................... 10
Warning - In Case of Emergency ............................................................................................................ 10
Warning - Explosion ............................................................................................................................... 10
Warning - Battery Safety ........................................................................................................................ 10
Warning - General................................................................................................................................... 10
Recycling/Disposal ................................................................................................................... 11
Regulatory Symbols ................................................................................................................. 12
Introduction ................................................................................................................................ 14
How Does the Corti Device Work? ........................................................................................................ 14
What are DPOAEs? ................................................................................................................................ 14
What Are TEOAEs? ............................................................................................................................... 15
What Do Otoacoustic Emission Results Tell Us? ................................................................................... 15
What Frequency Range of Hearing is Estimated? .................................................................................. 15
How are the Results Stored and Reported? ............................................................................................. 15
Sensitivity and Specificity ...................................................................................................................... 16
Setup ............................................................................................................................................ 17
Unpacking the System ............................................................................................................................ 17
Optional Accessories .............................................................................................................................. 17
Cradle (Optional) .................................................................................................................................... 17
Battery Charging ..................................................................................................................................... 17
Installing the Probe ................................................................................................................................. 18
Attaching Probe Tube ............................................................................................................................. 19
Attaching Eartips .................................................................................................................................... 19

i
 Probe Holder ........................................................................................................................................... 20
Operating Instructions............................................................................................................. 21
Preparing the Patient for Testing ............................................................................................................ 21
Turning On the Instrument...................................................................................................................... 21
Control Panel .......................................................................................................................................... 21
Main Menu .............................................................................................................................................. 22
Selecting the Test Protocol ..................................................................................................................... 22
Starting a Test ......................................................................................................................................... 22
AutoStart Probe Check ........................................................................................................................... 23
Test Phase ............................................................................................................................................... 23
SNR Bar Graph View ............................................................................................................................. 24
Value Graph View .................................................................................................................................. 24
Viewing Results ...................................................................................................................................... 24
Viewing DPOAE Results with Normative Data ..................................................................................... 25
Test Technique ........................................................................................................................................ 26
Noise Sources.......................................................................................................................................... 26
Turning Off the Instrument ..................................................................................................................... 26
Managing Results ..................................................................................................................... 28
Saving Results......................................................................................................................................... 28
Deleting Results ...................................................................................................................................... 29
Printing to a Thermal Printer .................................................................................................................. 30
Connecting to the Corti Data Manager ................................................................................................... 30
Understanding Printed Results ............................................................................................. 32
Understanding the DPOAE Printout ....................................................................................................... 32
Understanding the TEOAE Printout ....................................................................................................... 32
Rounding Results .................................................................................................................................... 33
Clock Settings ............................................................................................................................ 34
Accessing the Clock Menu ..................................................................................................................... 34
Changing the Date/Time ......................................................................................................................... 34
Instrument Settings .................................................................................................................. 35
Wireless Device Pairing .......................................................................................................................... 35
Clearing Test Results .............................................................................................................................. 36
Auto Shutdown Time .............................................................................................................................. 36

ii
 Save Mode/Storing Test Results ............................................................................................................. 36
Minimum Amplitude .............................................................................................................................. 37
Clock Mode............................................................................................................................................ 38
Graph Style ............................................................................................................................................ 38
Norms...................................................................................................................................................... 38
Language ................................................................................................................................................. 38
Reset to Default....................................................................................................................................... 39
Advanced Options for the DPOAE Diagnostic Unit ......................................................... 40
Instructions for Customizing a Test Protocol ......................................................................................... 40
Selecting the Level of Primary Tones ..................................................................................................... 41
Setting the Averaging Time .................................................................................................................... 41
Setting the PASS SNR Level .................................................................................................................. 41
Setting the Number of Frequencies for PASS ........................................................................................ 42
Reset Protocol ......................................................................................................................................... 42
Save Protocol .......................................................................................................................................... 42
Advanced Options for the TEOAE Diagnostic Unit ......................................................... 43
Instructions for Customizing a Test Protocol ......................................................................................... 43
Selecting the Averaging Time................................................................................................................. 44
Setting the PASS SNR Level .................................................................................................................. 44
Setting the Number of Frequencies for PASS ........................................................................................ 44
Reset Protocol ......................................................................................................................................... 45
Save Protocol .......................................................................................................................................... 45
Cleaning and Maintenance ..................................................................................................... 46
Cleaning and Disinfection....................................................................................................................... 46
Maintenance ............................................................................................................................................ 47
Probe tube Replacement ......................................................................................................................... 47
Troubleshooting ........................................................................................................................ 48
Appendix A: Specifications .................................................................................................... 51
Appendix B: Flowcharts .......................................................................................................... 52
Flowchart - Measurement ....................................................................................................................... 52
Flowchart – Setup Menus ....................................................................................................................... 53
Appendix C: Test Sequence ................................................................................................... 54
FOR DPOAE .......................................................................................................................................... 54

iii
 FOR TEOAE........................................................................................................................................... 54
Comment about Variations in the SNR Estimate.................................................................................... 55
Appendix D: Pass/Refer Criteria ........................................................................................... 56
Pass/Refer Criteria for DPOAE .............................................................................................................. 56
Pass/Refer Criteria for TEOAE............................................................................................................... 57
Appendix E: Configurations and Test Protocols.............................................................. 59
Appendix F: EMC Compatibility ............................................................................................ 61
Electromagnetic Compatibility ............................................................................................................... 61
Electrical Safety, EMC and Associated Standards ................................................................................. 61
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions .............................................. 62
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ............................................... 63
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ............................................... 64

iv
Standards Compliance
Standard Title

ANSI/ASA 3.6 Specification for Audiometers

IEC 60601-1 Medical Electrical Equipment – General Requirements for Basic

Safety and Essential Performance, Ed. 3.1
IEC 60645-1 Electroacoustics - Audiological equipment -- Part 1: Pure-tone
audiometers
IEC 60645-3 Electroacoustics - Audiometric equipment -- Part 3: Test signals of
short duration
IEC 60645-6 Electroacoustics – Audiometric Equipment – Part 6: Instruments for
the measurement of otoacoustic emissions

ISO 14971 Application of Risk Management to Medical Devices

ISO 10993 Biological Evaluation of Medical Devices

EN 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for

basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and Tests.

FCC Part 15 FCC 47CFR, Part 15.247 & 15.249 (Wireless)

EN ISO 15223 Medical devices. Symbols to be used with medical device

labels, labelling and information to be supplied. General
requirements.
Indications For Use
Intended Use: The GSI Corti is a test instrument that measures otoacoustic
emissions in infants, children, and adults.

Indications for Use: The GSI Corti series is indicated for testing of cochlear
function in infants, children and adults by measuring otoacoustic emissions
(OAEs). The OAEs are generated by a series of clicks that are directed into
the ear canal.

Otoacoustic emissions are low level audio-frequency sounds that are

produced by the cochlea as part of the normal-hearing process. Available
evidence suggests that otoacoustic emissions are generated by the
cochlea’s outer hair cells and that the presence of OAEs is an indication
that the outer hair cells are viable. Clinical evidence indicates that these
emissions normally occur with normal hearing, or at most, mild hearing loss
(usually 30-40 dB HL). The majority of hearing-impaired individuals will be
identified by a simple OAE test.
Warranty
We, Grason-Stadler, warrant that this product is free from defects in
material and workmanship and, when properly installed and used, will
perform in accordance with applicable specifications. If within one year
after original shipment, it is found not to meet this standard; it will be
repaired, or at our option, replaced at no charge except for transportation
costs, when returned to an authorized Grason-Stadler facility. If field
service is requested, there will be no charge for labor or material; however,
there will be a charge for travel expense at the service center’s current
rate.

NOTE: Changes in the product not approved in writing by Grason-Stadler

shall void this warranty. Grason-Stadler shall not be responsible for any
indirect, special or consequential damages, even if notice has been given in
advance of the possibility of such damages.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR

IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Warnings, Cautions, and Errors
In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures.

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

NOTE: Notes help you identify areas of possible confusion and avoid
potential problems during system operation.

The Corti Otoacoustic Emission Test System should be

charged using only the provided power supply. Injury to
personnel or damage to equipment can result when a
three-prong to two-prong adaptor is connected
between the Corti power supply and an AC outlet.

No modifications of the equipment are allowed by

anyone other than a qualified GSI representative.
Modification of the equipment could be hazardous.

The Corti product has been verified by an independent

laboratory to conform to international standards for
EMC (electromagnetic emissions and immunity). The
user is advised to avoid installation and use of this
instrument in proximity with other devices or
equipment that may emit or be susceptible to
electromagnetic interference, including mobile phones.
If the instrument is used adjacent to other devices or
equipment, the user is instructed to verify that no
disturbance is found in the operation of this or other
equipment in proximity.

This icon indicates that patient applied parts of the

instrument conform to IEC 60601-1:2005, Type B
requirements.
 Instruments which bear the Underwriters Laboratories, Inc.
label should be interconnected with accessories that have
the proper electrical compatibility and are listed as meeting
the requirements of the UL Medical and Dental Equipment
Standard. Connection of accessories not meeting these
E486032 requirements may result in electrical leakage currents in
excess of those allowed by the standard and present a
potential electrical shock hazard to the person being tested.

Any program aimed at obtaining reliable measurements

of otoacoustic emissions should be staffed and
supervised by appropriately-trained individuals.
Status/Error Messages

Display Messages:
Attach Probe No probe is detected at the start of a test.
Device not The printer is not responding to queries from the instrument.
Responding
Wireless Device The paired wireless device cannot be detected. The device may be
Not Found turned off or too far away.
Wireless Error #xxx There is an error condition with the wireless device. Check the status.
Wireless Not The Corti instrument is not paired with any wireless device.
Configured
Fit Error For a DP test, the desired level (L1 or L2) cannot be obtained within
Cannot Obtain P allowable limits. User should refit the probe and retry the test.
Fit Error For a DP test, the level of the calibration tone is too high. User should
Too High refit the probe and retry the test.
Fit Error For a DP test, the level of the calibration tone is too low. User should
Too Low refit the probe and retry the test.
Limit Error Overflow error during the calculation of the DFTs for a DP test. User
should repeat the test.
Memory Almost Saved tests are within 5 tests of the maximum limit.
Full
Memory Full! The maximum saved test limit is reached. The user will need to clear
the memory before any additional tests can be performed.
Power Low! The battery charge level is too low for operation. The user must
charge the battery before additional tests can be performed.
Printer Error Indicates a problem with the printer. Check the printer status.
Printer Paper Out! Indicates printer paper has run out.
Time/Date Error The clock is checked during power on to ensure it has not lost time
and been reset. In the case of clock reset, this message is shown. The
user should set the correct date/time.
Due for Service Daily reminder will appear when the calibration due date has passed.

Indicator LEDs (lights):

NOISE / Orange The indicator labeled ‘NOISE’ provides a visual indication (AMBER) that
the noise level measured during the test exceeds a nominal threshold.
Also used to indicate some error conditions and when the outcome of
test is REFER, NOISY, or NO SEAL.
TEST / Yellow The indicator labeled ‘TEST’ provides a visual indication (YELLOW) that
the selected test is being performed. This indicator will remain on
steady state during the test function.
READY / Green The indicator labeled ‘READY’ lets the user know that the instrument is
not currently performing a test function and that it is available to
perform a test function.
CHARGE / Blue The indicator labeled ‘CHARGE’ provides a visual indication (BLUE) of
the battery recharging function and battery status. The rate of
illumination of the indicator provides a means of identifying the status
of the charging function.
Customer Responsibility
This product and its components will perform reliably only when
operated and maintained in accordance with the instructions
contained in this manual, accompanying labels, and/or inserts. A
defective product should not be used. Make sure all connections to
external accessories are snug and secured properly. Parts which
may be broken or missing or are visibly worn, distorted, or
contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from GSI.

This product should not be used in the presence of fluid that can
come into contact with any of the electronic components or wiring.
Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used until
deemed safe by a GSI certified service technician.

Do NOT use in the presence of flammable gaseous mixtures. Users

should consider the possibility of explosions or fire when using this
device in close proximity to flammable anesthetic gases.

Do NOT use the Corti in a highly oxygen-enriched environment,

such as a hyperbaric chamber, oxygen tent, etc.

Equipment is not user repairable. Repairs and battery replacement

must be performed by a qualified service representative only.

This device complies with part 15 of the FCC Rules. Operation is

subject to the condition that this device does not cause harmful
interference.

Use and store the instrument indoors only. It is recommended that

the instrument be operated within an ambient temperature range
of 15°C / 59°F to 35°C / 95°F and in relative humidity between 30%
and 90% (non-condensing).

Transport and store the instrument in temperature between +5°C

to 40°C.

Annual calibration recommended. Have an authorized service

technician perform electrical safety checks on the unit in order to
maintain continued compliance to IEC and UL 60601-1.
Safety Precautions
The following safety precautions must be observed at all times.
General safety precautions must be followed when operating
electrical equipment. Failure to observe these precautions could
result in damage to the equipment and injury to the operator or
patient.

The employer should instruct each employee in the recognition and

avoidance of unsafe conditions and the regulations applicable to his
or her work environment to control or eliminate any hazards or
other exposure to illness or injury.

It is understood that safety rules within individual organizations vary.

If a conflict exists between the material contained in this manual and
the rules of the organization using this instrument, the more
stringent rules should take precedence.

The Corti 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.

Cautions - General
If the system is not functioning properly, do not operate it until all
CAUTION necessary repairs are made and the unit is tested and calibrated for
proper functioning in accordance with GSI published specifications.

Use only the disposable eartips designed for use with this instrument.

Never insert the probe tube into the ear canal without affixing an
eartip.

The eartips are disposable and for single patient use only. Do not
clean or reuse eartips.

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.

US federal law restricts this device to sale by or on the order of a

physician or licensed hearing care professional.
Warning - Electric Shock Hazards

Do not open the case of the Corti Instrument.

Refer servicing to qualified personnel.

Do not touch the contacts on the bottom of

the instrument and the patient at the same
time.

Do not connect the instrument to the patient

and the PC at the same time.

Warning - In Case of Emergency

In case of emergency, disconnect the

instrument from the supply mains by removing
the micro-USB cable from the connector as
shown in Figure 2 on page 15.

Warning - Explosion

This system is not explosion proof. Do not use

in the presence of flammable anesthetics or
other gases.

Warning - Battery Safety

This instrument contains a rechargeable

lithium-ion battery. The battery is not user
replaceable and must be returned to an
authorized GSI service location for repair.

Warning - General

Proper use of this device depends on careful

reading of all instructions.
Recycling/Disposal
Many local laws and regulations require special procedures to recycle or
dispose of electrical equipment-related waste including batteries, printed
circuit boards, electronic components, wiring and other elements of
electronic devices. Follow all your respective local laws and regulations for
the proper disposal of batteries and any other parts of this system.

Below is the contact address for proper return or disposal of electronic

wastes relating to GSI products in Europe and other localities.

Grason-Stadler (GSI)
10395 West 70th Street, Eden Prairie, MN 55344, USA

Batteries may explode or cause burns, if disassembled, crushed or exposed

to fire or high temperatures.
Regulatory Symbols
No. Symbol Description

Serial Number

Date of Manufacture

Manufacturer

Caution, Consult Accompanying Documents

Return to Authorized Representative, Special Disposal

Required

REF Reference Number

B Patient Applied Part According to IEC60601-1

Consult Operating Instructions

Keep Dry

Transport and Storage Temperature range

Logo

EC REP EU Authorized Representative

Follow Instructions for Use

No. Symbol Description

Nonionizing electromagnetic radiation

Global Trade Item Number

For Use by or on the order of a licensed medical

professional.

Recycle Lithium ion battery

Recycle - Taiwan

China RoHs

Direct Current (DC)

Only those products bearing the UL Classification Mark for

the U.S. and Canada should be considered as being covered
by UL's Classification and Follow-Up Service and meeting the
appropriate U.S. and Canadian requirements.
E486032

Conforms to European Medical Device Directive

93/42/EEC

FCC 47CFR, Part 15.247 & 15.249 (Wireless)

Introduction
The purpose of the Corti test system is to provide rapid measurement and
documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or
Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies.

How Does the Corti Device Work?

The system consists of the instrument,
Probe Connector probe, printer, single-use eartips
replaceable probe tubes and other
accessories. The Corti instrument
Test Status contains the hardware and software for
Indicators
generating the test stimuli, measuring
and displaying the OAEs, and storing the
results until they are printed. The plastic
Display housing contains circuit boards that
provide the signal processing and display
Charge Status
Indicator
the test results. The instrument also
contains a rechargeable lithium-ion
battery 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
status to the operator. Four push
User Interface buttons located on the keypad of the
Buttons device allow the user to control testing
and printing, and to reset test protocols.

The Probe houses the speaker and

microphone which produce test stimuli
and measure the sound pressure level
(SPL) present in the sealed ear canal.
Interface of the instrument to the ear
Micro-USB
Connector canal is accomplished through
disposable eartips, which fit onto the
Figure 1 probe tube. The disposable eartips are
color coded to facilitate easy selection by
size.

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.
 The Corti 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
Corti device provides an estimate of outer hair cell function over a
wide range of frequencies.

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.

The Corti 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 Corti device provides an estimate of outer hair cell
function over a wide range of frequencies.

What Do Otoacoustic Emission Results Tell Us?

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 or the
presence of pathology; however, it should be followed with full
audiologic diagnostic testing and/or medical evaluation as
appropriate.

What Frequency Range of Hearing is Estimated?

DPOAEs: Approximately 1 kHz to 12 kHz (depending on the
frequency range selected). TEOAEs: Roughly 500 Hz to 4 kHz.

How are the Results Stored and Reported?

When the Corti 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 Corti
instrument is capable of storing 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 and/or exported to a computer.
Test results are stored in the non-volatile memory so the operator
can delay printing until a later time if desired.
Sensitivity and Specificity
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.
Setup
Unpacking the System
The following parts are shipped standard with each Corti system:
(1) Corti Unit (System Part Number 8103744)
(1) Corti Probe (Part Number 8103763)
(1) GSI Corti Software and Manuals USB (Part Number 8104553)
(1) GSI Suite Software and Manuals USB (Part Number 8109060)
(1) Single Use Eartip Kit (Part Number 8103765)
(1) Communications Cable, USB A/Micro-B (Part Number 8104249)
(1) Charging Cable, PSU 5V/Micro-B (Part Number 8029254)
(1) Corti Quick Guide (Part Number 8104290)
(1) Calibration Certificate (Part Number 8104432)
(1) Sanibel Preemie Ear Tip Green (Part Number 8502837)
(1) Comply Ear Tip Sample Pack (Part Number 8504432)

If any of these parts are missing, contact your special equipment

distributor or GSI. We recommend that you save the shipping box
and packing materials in case you need to store or ship the system.

Optional Accessories
The Corti optional accessories include a wireless thermal printer
(Part Number 8103161), cradle (Part Number 8103766) and carry
case (Part Number 8104052).

Cradle (Optional)
The Corti unit can be placed in the optional cradle for charging the
Corti or connected to a PC via USB or wirelessly for communication
to the Corti Data Manager. Charging and connection to the PC can
also be conducted directly from the Corti unit. The remainder of
this manual assumes that charging and communication to the PC is
direct from the Corti unit, but note that either is possible.

Battery Charging
The Corti instrument is powered by an integrated rechargeable
lithium-ion battery providing 15 hours of operation between full
charging. The battery status is indicated by the battery icon shown
in the upper right corner of the Main Menu (Display 1). Full battery
charge is represented by a full battery symbol on the display and
reduces to an empty battery in increments corresponding to the
discharge of the battery.

Figure 2 To charge the unit, connect the Micro-USB port on the bottom of
the instrument as shown in Figure 2, and connect the wall charger
to the mains outlet. To charge the Corti unit through the cradle,
connect the Micro-USB to the back of the cradle and the wall
charger to the mains outlet. Place the Corti unit firmly into the
cradle.
 NOTE: Misalignment of the plug and socket can cause damage. The
plug and socket should be visually inspected prior to each
installation of the charging cable. If damage is observed, contact
GSI.

The battery charge status indicator, located to the right of the

display, provides a visual indication (BLUE) of the battery
recharging function and battery status during operation.

During battery charging the indicator will be lit whenever the

Micro-USB connector is engaged and powered. The rate of
illumination of the indicator provides a means of identifying the
status of the charging function, and is defined as follows:

• Steady-state illumination indicates the battery is

fully charged. This identifies that the charging cycle
has been completed or was not implemented
because the battery was already fully charged.

• Slow blink illumination indicates the charging

function is in process.

• Fast blink illumination indicates a fault condition in

which the user would be directed by the user
manual to return the instrument for service.

During instrument operation, the user is warned of a low battery

condition by the following illumination of the battery status
indicator:

• Two fast blinks followed by a pause and then

repeated until the battery is charged.

Installing the Probe

Insert the Probe’s HDMI connector firmly into the socket on the
top of the Corti (Figure 3). The plug will fit in only one direction.
The GSI wave logo will align with the instrument control panel.

NOTE: Misalignment of the plug and socket can cause damage. The
plug and socket should be visually inspected prior to each
installation of the remote probe. If damage is observed, contact
Figure 3
GSI.

Figure 3
Attaching Probe Tube
A probe tube must be applied to the probe head before an eartip is
applied. Insert a new probe tube into the probe head until it is
fully seated (Figure 4). A properly inserted probe tube will snap
securely into place when it is fully seated in the probe head. It is
not necessary to replace the probe tube with each ear tip; the tube
is reusable as long as the probe tube is clear. To remove a probe
tube, grasp the tube and pull gently away from the probe head
Figure 4 with a slight twist.

Attaching Eartips
The Corti instrument comes with a box of disposable, single-use
eartips that fit a variety of ear canal sizes. The Corti probe must
have a probe tube applied (Figure 4) and an eartip attached (Figure
5) before inserting it into an ear canal. The determination of the
Figure 5 appropriate eartip size should be made by persons with proper
training and experience. 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 must be replaced after each patient.

After selecting an eartip, push it onto the probe tube until it is flush
against the base of the probe tube (Figure 5). Twisting the eartip
slightly while pushing it onto the probe tube is recommended. Be
sure the eartip is fully seated on the probe. There should be no
Figure 6 gaps between the eartip and the collar of the probe head (Figure
6).

To remove the eartip, grasp the eartip gently at the base and twist
it while pulling it straight off the end of the probe tube.

NOTE: Grasping the base of the eartip will prevent the probe tube
from being inadvertently pulled out of the probe head along with
the eartip.

NOTE: If the probe tube becomes dirty or clogged, it must be

replaced. See the section Probe Tube Replacement on page 42 for
further information.
Probe Holder
It is strongly recommended to place the probe into the probe
holder when the Corti is not in use. This should be done while the
Corti is placed on a counter top or table, or when the Corti unit is
resting in the Corti cradle. Placing the probe into the holder will
help to protect the probe head.

Figure 7

Make sure the probe holder is towards the end of the probe cable
at the GSI wave logo / HDMI connector end. Gently push the probe
cable into the probe holder at the point of the probe head. Refer
to Figure 7 for an example of the probe in the probe holder when
the Corti is resting on a table. Refer to Figure 8 for example of the
probe in the probe holder when placed in a Corti cradle.

Figure 8
Operating Instructions
Preparing the Patient for Testing
Otoscopic examination of the patient’s ear canals should be
performed prior to testing. Excessive cerumen or vernix in the ear
canals may interfere with the test and give invalid or incomplete
results. Patients with excessive cerumen, debris, or foreign bodies
in the ear canals should be referred to an audiologist or physician
for removal of the blockage prior to testing.

Place the patient in a position that will allow easy access to the ear
canal. The patient should remain still and quiet while the test is
being performed.

Turning On the Instrument

To turn on the Corti instrument, press the DOWN button located
below the instrument’s display screen (Figure 9). The yellow TEST
light will appear briefly just above the display. The green READY
light will remain on indicating the instrument is ready for use. A
Flash Screen will appear briefly, indicating the software version,
serial number, next calibration date, and type of instrument:

SCR Screener with TE or DP

SC+ Screener with TE and DP
STD Diagnostic TE or DP
CMB Diagnostic TE and DP

Control Panel
The Corti instrument uses 4 buttons to control all functions of the
instrument (Figure 9). These buttons are arranged in a directional
cursor format. The arrows on the keypad (LEFT, RIGHT, UP,
and DOWN) correspond to the arrows that are used on the
screen. The screen will indicate which button to push by showing
the appropriate arrow.

NOTE: The UP key will always bring the instrument back to either
the previous menu or the main menu. The UP key will also access
the print command from the Main Menu.

Figure 9
Main Menu

Selected Protocol

Battery Status
Date & Time

Number of Stored
Tests

Start Left Start Right

Ear Test Ear Test

Display 1

Change Protocol
and Settings

Selecting the Test Protocol

The currently selected protocol is shown on the Main Menu
(Display 1). To change the selected protocol press CHANGE at the
Main Menu. The Change Protocol display will appear (Display 2).
Use the CHANGE arrow buttons to change the selected
protocol. Press the up arrow to return to the Main Menu to begin
testing. Press the SETUP to enter the setup menus.
Display 2 For Diagnostic DPOAE or TEOAE units, there is one default test
protocol and a number of user definable protocols. For Screener
DPOAE or TEOAE units there are 2 fixed protocols. Appendix E
contains complete information on protocol settings. Instructions
for customizing protocols on the Diagnostic units can be found in
the sections Advanced Options for DPOAE Diagnostic Unit on page
35 or Advanced Options for TEOAE Diagnostic Unit on page 38.

NOTE: The default protocols: DP 4s, DP 2s, TE 64s and TE 32s

cannot be customized.

Starting a Test
To obtain a seal and measure emissions, gently insert the eartip
into the patient’s ear canal. It should fit snugly and comfortably.
The best test results are obtained when an eartip is inserted deeply
into the ear canal instead of flush with the ear canal.

To begin a test, insert the probe into the ear and select either the
LEFT or RIGHT arrow key to indicate which ear will be tested.
Display 3
AutoStart Probe Check
After the test ear is selected, the AutoStart Probe Check will begin
automatically. The Probe Check display shows a cone, larger at the
left and tapering toward the right, representing the ear canal
volume from very large (blue area) to very small (orange area).

The vertical white bar indicates the measured ear canal volume
and probe fit stability:
Display 4 Blue (Display 4) = The ear canal volume is too large for the
test to begin. The probe is not in the ear or there is a
large leak.
Gray (Display 5) = Ear seal indicator will remain gray until a
seal is obtained.
Green (Display 6) = The ear canal volume is in the target
range for testing. The test will begin automatically if
the probe fit is stable.
Display 5
Display 5 Orange (Display 7) = The ear canal volume is too small for
the test begin. The eartip may be pressed against the
ear canal wall or the probe tube may be completely
clogged.

Appropriate adjustments of the eartip position and size selection

should be made until the white indicator falls within the green area
and remains stable.

Display 6 If the test will not progress past the Probe Check phase, change the
probe tube, check that the probe connector is fully seated in the
socket, and try again.

NOTE: To test children with PE tubes, the Probe Check needs to be

disabled. This is accomplished by first inserting the probe with
appropriate ear tip into the ear canal and obtaining a proper seal.
To disable AutoStart at the main menu select the ear to be tested
Display 7 by holding down the RIGHT or LEFT arrow keys for 3 seconds until
the green “ready” light turns off. Once the key is released, the Corti
will calibrate and test as before. The appropriate in-the-ear
stimulus intensity levels are applied to ears with PE tubes.

Test Phase
The Corti instrument will automatically perform a calibration at the
start of each test. During calibration a series of tones will be
presented to the ear canal to calibrate the levels of the frequencies
to be tested. Following calibration of the test tones, the test phase
will begin automatically.
The display on the Corti test instrument will indicate the results of
the test with a graphic display. The display will be generated and
 shown during the test and can be reviewed after the test is
complete.
The Corti allows the user to select from two options for viewing the
results. The SNR graph view shows the signal-to-ratio for each DP
test frequency or TE test band. The Value graph view shows the
absolute emission and noise levels for each DP test frequency or TE
test band.

SNR Bar Graph View

Display 8 shows the SNR bar graph view. These are the signal-to-
noise ratio (SNR) test results which are displayed as the emissions
and noise floor are measured. Each column represents one DP test
frequency or TE frequency band. The height of each column
represents the SNR measured.

When a protocol with a Pass criteria has been selected, the user
Display 8 will see a horizontal green line at the decibel level corresponding to
the SNR required for a PASS. Green bars are a pass, yellow a non-
Pass.

Value Graph View

Display 9 shows the Value graph view for left ear test. Dark blue
“x” symbols represent the absolute emission levels at each DP test
frequency or TE frequency band. Light blue upside-down triangles
represent the noise floor at each DP test frequency or TE frequency
band.
Display 9
Display 10 shows the Value graph view for a right ear test. Red
circle symbols represent the absolute emission levels at each DP
test frequency or TE frequency band. The shaded area is the
Expanded Boys Town Norms template. See page 23 for a
description of the template.

Refer to pages 36 and 37 for instructions to switch the default

setting of the graphs and for turning on the normative template.
Display 10
NOTE: The  up arrow key can be used to abort a test in progress.
No record of an aborted test will be saved in memory.

Viewing Results
When testing is complete, the green “READY” light is illuminated
and a display similar to Display 11 or Display 12 will appear. The
results of the test are automatically saved in memory as soon as
the test is complete. The results will be saved even if the
instrument is turned off or the battery is temporarily depleted. This
screen indicates the test ear and further gives the results of the
test.
Display 11
 “PASS” on the screen indicates the patient passed screening
“REFER” indicates the patient did not pass screening
“NOISY” indicates excessive noise was present during the test
“NO SEAL” indicates a seal was not maintained throughout the
test
“FIT ERR” indicates inadequate probe placement in the ear
canal to produce target stimulus intensities

When the test result is “NOISY,” “NO SEAL,” or “FIT ERR,” the tester
should reposition the probe, selecting a different size eartip if
necessary, and retest. To review the results, push the DOWN arrow
key to return to the bar graph (Display 8). After reviewing the
results, again push the DOWN arrow key to return to the Results
Display 12
display (Display 11 or Display 12) or the up arrow to return to the
Main Menu (Display 1).

NOTE: Completed tests are automatically saved. By default (Save

L/R Mode), the Corti instrument will save only the last test for each
ear. Starting a new test for the same ear will overwrite the existing
test.

See the section Managing Test Results for more information on

how the Corti saves results and how to print or transfer those
results to the Corti Data Manager.

See the section Instrument Settings - Save Mode on page 32 or

more information on the Corti save mode options.

Viewing DPOAE Results with Normative Data

The Corti will display the Expanded Boys Town Norms template for
eligible DPOAE test results. The norms template has no effect on
the overall test results and is for display purposes only. The values
used to create the template are shown in Table A1 from Gorga,
M.P., Neely, S.T., Ohlrich, B., Hoover, B., Redner, J. and Peters, J.
(1997). “From laboratory to clinic: a large scale study of distortion
product otoacoustic emissions in ears with normal hearing and ears
with hearing loss.” Ear & Hearing, 18, 440-455.

The template may be used as a guide when evaluating DPOAE test

results. The light shaded area at the top of the template
represents the 90th to 95th percentile of DP amplitudes from the
hearing impaired population. DP amplitudes within or above this
range indicate a high probability of normal hearing. The light
shaded area at the bottom of the template represents the 5th to
10th percentile of DP amplitudes from the normal hearing
population. DP amplitudes within or below this range indicate a
high probability of hearing loss. The dark shaded area in between
represents a range of uncertainty where the normal hearing and
hearing impaired populations overlap.
Test Technique
As with other otoacoustic emission test instruments, there is a
technique to learn when using the Corti instrument, especially
while testing infants. Experience with existing OAE systems
suggests that it may take up to 3 months to become completely
proficient at screening infants.

When testing an infant with the Corti instrument, the infant has to
be relatively quiet and calm; it is usually preferred for the infant to
be asleep. A pacifier may be used to calm the infant; however,
sucking will add noise to the test and decrease the likelihood of a
passing result. Pull gently down and back on the pinna to straighten
out the ear canal. Gently place the probe tube into the infant’s ear
canal.

When testing children and adults, pull gently up and back on the
outer ear during insertion to straighten the ear canal and ensure
proper placement.

Noise Sources
When the noise level exceeds the noise rejection limit of the
instrument, the red NOISE light will appear. It is common for the
NOISE light to appear while testing. The light will appear
infrequently if the noise level in the ear canal is low, and it will
appear more often if the noise level in the ear canal is high.
Otoacoustic emissions are very low-level sounds. Any noise in the
ear canal at the time of testing can mask this emission. This noise
can come from a variety of sources.

For TEOAE protocols, the test will pause when noise levels exceed
the noise rejection limit. Pause is indicated when the Noise, Test
and Ready lights turn on simultaneously. Testing will automatically
resume when noise levels decrease. Total pause time will not
exceed 30 seconds.

The largest source of noise can come from the patient. This is
biological noise, such as movement, coughing, sucking, talking, etc.
The patient must be calm and not move or talk. Ambient noise in
the testing environment can also be a large source of noise during
the test. A properly sealed eartip can block a large amount of this
noise, but performing the testing in a relatively quiet environment
is recommended.

Turning Off the Instrument

The Corti instrument has an automatic “shutdown” feature,
designed to prolong battery life. The unit will automatically shut
down after 1 minute (default) of inactivity. To turn it back on,
simply press the DOWN key. This feature can be re-programmed
for various periods of inactivity before “shutdown.” (See the
Changing Instrument Settings – Auto Shutdown Time on page 32.)

NOTE: The up arrow can be used to manually power off the

instrument.
Managing Results
Users have the option of printing to the optional thermal printer,
transferring results to the GSI Data Manager database or utilizing
Auto Print. Specific options will vary depending on the
configuration of the system purchased.

NOTE: GSI Corti test results may be transferred to GSI Suite v2.4 or
higher. See GSI Suite user manual for more information.

Saving Results
The Corti instrument automatically saves the results of completed
tests in the non-volatile memory (meaning tests are saved even if
the battery is temporarily discharged). However, the Corti is not
intended for long-term storage of test results.

NOTE: Users are strongly encouraged to print/transfer all test

results at the completion of testing to avoid potential loss of data.

When operating in the default "Save L/R" mode, the Corti

instrument will save the most recent test results for each ear and
print/transfer only these results. This allows the user to retest a
patient after a “REFER” result and to print/transfer only the most
recent test result for each ear. It is recommended that the results
be printed after each patient in the default mode.

When operating in the "Save 250" mode, the Corti will save up to
250 tests. There are two options in the Save 250 mode:
1. The Corti will automatically number each test from 1 to 250.
2. The Corti Data Manager is used to transfer patient names to
the Corti and the Corti will display the names.

The 250 Mode allows the user to save all tests for each patient
(tests of the same ear are NOT overwritten) and to test multiple
patients before printing or transferring results. When patient
names are used (patient names are uploaded from the Corti Data
Manager to the Corti unit) the patient names are displayed on the
Corti Unit in alphabetical order. To move to a different name than
the one displayed on the Corti screen, use the left or right arrows
to cycle through the names until the desired name is on the
display. A patient named “Unnamed” is always included at the
beginning of the Corti list for instances when a patient is being
tested but the patient name was not transferred to the Corti.

See Instrument Settings - Save Mode on page 32 for more

information.
 NOTE: When the Corti automatically numbers the tests, it is
important to manually keep a record of the test numbers for each
patient.

Deleting Results
The Corti holds data in non-volatile memory. The data stays in
the memory even after data is printed or downloaded to the
Corti Data Manager. Data can be deleted through a few
methods, depending on the Save mode.

Save L/R Mode:

• A single test for the Left ear and a single test for the Right
ear are held in memory. Data is deleted when a new test
for the left or right ear is acquired.
• Data can be deleted using the Clear function in the System
Menu (page 32).

NOTE: Following printing or data transfer to the PC software,

all tests saved in memory are marked for deletion and will be
permanently deleted when a new test is started. It is not
necessary to manually clear the results.

Save 250 Mode:

• Data is deleted when new Patient Names are uploaded
from the Data Manager to the Corti (a warning is provided
that data will be deleted).
• Data can be deleted using the Clear function in the System
Menu (page 32).
• Data can be deleted in the Corti from the Data Manager
when the device is connected to the Data Manager (cable
from OAE Screener to PC). When Names is selected, the
window allows data to be deleted via the Clear Instrument
button.
• Data printed using Auto Print will be deleted when a new
• test is started.
Printing to a Thermal Printer
Printing to an optional thermal printer is by way of wireless
connection. First establish wireless pairing between the Corti
instrument and the printer by following the instructions in the
section Instrument Settings - Wireless Device Pairing on page 33.

NOTE: See the printer operating manual for instructions on using

the printer.
Display 13

Following instructions provided with your printer, be sure the

printer is on and ready for communication/printing. From the Corti
instrument Main Menu (Display 1), press the UP button to enter
the device connection screen (Display 13). Press the CONNECT
button.

The Corti will search for the paired printer showing Display 14
while searching. When the printer is found, all test results stored in
memory will print out automatically.

The Corti instrument will power off when printing is complete.

Display 14
NOTE: All printed test results are marked for deletion, but will
continue to be stored in memory until a new test is started at
which time all tests in the memory will be erased. This allows the
user to reprint the tests if printing is unsuccessful (for example the
paper runs out before printing is complete).

Connecting to the Corti Data Manager

For the PC to Corti connection, plug the USB-A connector into an
available USB port on the computer and the Micro-USB of the cable
into the port found at the base of the Corti instrument (see
Figure 2).

For the PC to Corti Cradle connection, plug the USB-A of the cable
into a computer USB port and the USB-B connection to the back
port of the Cradle. Note the Cradle does not need to be charging
the Corti unit to transfer data.

For the PC to Corti wireless connection, make sure the Corti is

paired to the PC. From the main screen press the up arrow. Press
the left or right arrows at CONNECT for data transfer.

The Corti instrument will display “Waiting on PC”, detect the

connection to the PC and wait for an action or communication
from the Corti Data Manager. Refer to the Data Manager User
manual for detailed operation.
NOTE: See the Corti Data Manager Manual for instructions on using
the application.
NOTE: Corti must be in the main menu screen (Display 1) to
communicate with the PC
Understanding Printed Results
Results from the Corti can be transferred to Corti Data Manager or
Auto Print for a full page printout or to a portable thermal printer.
The following information is included on printouts.

Understanding the DPOAE Printout

The following information is provided for each test:
1) The time and date of the test, based on the setting of the
internal clock; if the clock is set correctly, this time and
date will be correct.
2) The test number (if operating in “Save 250” mode)
3) The protocol selected (e.g.: DP 4s)
4) The averaging time used for the test (e.g.: 2 sec avg.)
5) Instrument and Probe serial number (SN)
6) The software version number (e.g.: V105.05)
7) The ear tested(Right or Left)
8) A PASS/REFER indication if there is a criterion set for the
selected protocol.
9) The f2 frequency in kHz (e.g.: 2.0, 3,0, 4.0, 5.0)
10) The measured intensity level of f1 and f2 (L1, L2)
11) The noise floor (NF) in dB SPL
12) The emission level (DP) in dB SPL)
13) The signal-to-noise ratio (SNR)- DP level minus the noise
floor – in dB
14) A “P” to the right of the SNR if pass criteria were met for
that frequency
15) The Value or SNR graph as selected on the Corti.
16) “MIN*” if the Minimum Amplitude setting was enabled.

Understanding the TEOAE Printout

The following information is provided for each test:
1) The time and date of the test, based on the setting of the
internal clock; if the clock is set correctly, this time and
date will be correct
2) The test number (if operating in “Save 250” mode)
3) The protocol selected (e.g.: TE 64s)
4) The averaging time for the test (e.g.: 12 sec avg.)
5) Instrument and Probe serial number (SN)
6) The software version number (e.g.: V105.05)
7) The ear tested (Right or Left)
8) A PASS/REFER indication if there is a criterion set for the
selected protocol
9) The frequency band center (F)
10) The noise floor (NF) in dB SPL
11) The emission level (TE) in dB SPL
12) The signal-to-noise ratio (SNR) - TE level minus the noise
floor – in dB
13) A “P” to the right of the SNR if pass criteria were met for
that frequency
 14) The Value or SNR graph as selected on the Corti.
15) “MIN*” if the Minimum Amplitude setting was enabled.

Rounding Results
The user needs to be aware that the SNR and single PASS criterion
on the Corti are calculated from the full internal precision of the
instrument, and not from the values shown in the printout for the
emission (DP/TE) and noise floor (NF) estimates.

This approach is used to preserve the full precision of the test

results, but can result in some apparent errors in the printout due
to the effects of rounding. Assume the actual values at a given
frequency was DP = 5.5 dB, NF = -0.4 dB, which results in SNR = 5.9
dB. The printout values are rounded up to the nearest integer and
are shown as DP = 6, NF = 0, and SNR = 6. This can result in what
appears to be an error with regard to the pass criterion. If the pass
criterion is 6 dB while the actual SNR is 5.9, the printed value will
be 6 but the frequency will not be judged as a PASS with a “P”
printed.

Again, the pass/refer criterion is based on the full precision of the

results, and not the rounded values that are printed. The full
precision value for the SNR must be equal to or greater than the
pass criterion (6 dB in this example) for the “P” to be printed. To
view precise results, it is recommended that the test results be
transferred to the Data Manager where numeric test results are
displayed with an additional decimal place.
Clock Settings
When the Corti test instrument is first used, the correct date and
time may need to be set on its internal clock. The clock should be
set prior to testing, as changing it after tests are saved will not
change the date on the printout.

Seasonal time changes such as Daylight Saving Time will also

require resetting the clock. If the instrument is being powered on
for the first time or if the instrument’s battery is completely
discharged and the battery is not charged within approximately
one hour, Error! Reference source not found. may appear. If this m
essage appears, reset the time and date.

Accessing the Clock Menu

To change the time and date press CHANGE at the main menu
(Display 1) and then press SETUP at the protocol selection display
(Display 2). The current date and time presently set in the unit will
be shown (Display 15). If the time and date are correct, press the
UP key to escape back to the main menu.

Display 15

Changing the Date/Time

If either the date or time is incorrect, press the CHANGE key to
access the menu to change the month (Display 16). Press the
LEFT or RIGHT keys to scroll forward or backward through the
months.

The abbreviated name for each month will be displayed (Display

17). When the desired month appears on the display, press the
Display 16 NEXT key to enter the day selection screen. Pressing the LEFT
or RIGHT keys will scroll through the days of the month. After the
correct day is selected, press the NEXT key to enter the day
selection display. Again use the LEFT or RIGHT arrow keys to
set the correct day. Repeat this process for the year, hour, and
minute using the LEFT or RIGHT arrow keys to make the
selection and the NEXT key to advance to the next display.

When the correct minute is selected, pressing the DONE arrow

Display 17 key (Display 17) will return to the Main Menu.

The time and date changes are automatically saved.

Instrument Settings
The Corti instrument allows the user to change many of the
instrument's settings or functions. These settings include wireless
Device Pairing, Clearing Test Results, Auto Shutdown Time,
Minimum Amplitude Value, Save Mode, DPOAE Norms On/Off,
Clock Mode, Language, and Reset to Default Settings.

To access the menus to change these functions, press CHANGE at

the main menu (Display 1) and then press  SETUP at the Protocol
Change (Display 2) to enter the Clock menu (Display 15). At the
Clock menu, hold down the CHANGE key for 3 seconds until the
READY light (green LED) turns off and release the key.

NOTE: Releasing the key will access the menus to change the
instrument settings.

Wireless Device Pairing

The wireless pairing menu (Display 18) allows the user to pair the
Corti unit with a wireless device, such as a thermal printer or
personal computer, for printing test results and data transfer.

The Corti unit can be paired to only one device; for example either
the thermal printer or a PC. To establish wireless pairing, turn on
the device that will be paired with the Corti unit (e.g.: thermal
Display 18 printer). Follow the above instructions to access the menu in
Display 18 then select DISCOVER to initiate discovery of
available wireless devices. The Corti will search for available
wireless devices for approximately 15 seconds. The Corti will
display the message "Please Wait" and the yellow LED will flash.

When discovery is complete, all discovered devices are shown

(Display 19). A compatible thermal printer will appear as "PRT-##-
Display 19 ##" (example: PRT-5c-25) and other devices will be shown by their
name. Use the CHANGE buttons to find the desired device and
then use the PAIR button to pair the Corti to the device.

For PC Pairing: On the PC, select Devices and Printers. Select Add a
Device. From the list of identified devices, select OAE Device.
Select and enter the pairing code 1234. Select Next. A device
driver may be loaded automatically. The first time the Corti Data
Manager software is launched, select Detect Com Port to finalize
Display 20 the Corti and PC wireless connection.

Pairing will be confirmed (Display 20). The pairing process is

complete. Select Main Menu to exit the Wireless pairing menu.
 NOTE: See the Troubleshooting section on page 46 if wireless
pairing is unsuccessful or if any error messages are displayed.

Clearing Test Results

The Test Results Clear menu (Display 21) allows the user to clear
the test results stored in the unit without printing them. Select the
LEFT or RIGHT arrow key to clear the results and select Yes
or No to verify clearing or to cancel. To advance to the next
menu without clearing the results, press NEXT.

NOTE: Following printing or data transfer to the PC software, all

Display 21 tests saved in memory are marked for deletion and will be
permanently deleted when a new test is started. It is not necessary
to manually clear the results using this menu.

Auto Shutdown Time

The Power Off menu (Display 22) refers to the Auto Shutdown time
which controls how long the Corti instrument remains on before
shutting off after a period of inactivity. It is not necessary to
manually turn off the Corti unit. The Automatic Shutdown feature
is designed to prolong the battery life of the instrument when it is
not in use. By default, the instrument automatically shuts off after
1 minute of inactivity has elapsed.
Display 22
The Auto Shutdown time may be increased or decreased by
pressing the CHANGE keys. The times available are 30 seconds,
1, 2, or 4 minutes. Once you have made your selection, press
NEXT.

Save Mode/Storing Test Results

The Corti unit automatically stores only the most recent test result
for each ear L/R (Display 23), but has the capacity to store 250
individual tests. The number of stored tests will appear in the
upper left hand corner of the display. To change the mode to save
up to 250 tests, press the LEFT or RIGHT arrow keys to change
the menu to 250. The Verify Clear Menu will appear. Selecting
“Yes” will clear the stored tests and change the Save Mode.
Display 23 Selecting “No’ will not change the save Mode. Once you have made
your selection, press NEXT.

There are two options in the Save 250 mode:

1. The Corti will automatically number each test from 1 to 250
2. The Corti Data Manager is used to transfer patient names to
the Corti and the Corti will display the names.
 When numbers are used (no patient names are uploaded from the
Data Manager to the Corti), each test is automatically incremented,
starting with test number 1.

When patient names are used (patient names are uploaded from
the Corti Data Manager to the Corti unit) the patient names are
displayed on the Corti Unit in alphabetical order. To move to a
different name than the one displayed on the Corti screen, use the
left or right arrows to cycle through the names until the desired
name is on the display. A patient named “Unnamed” is always
included at the beginning of the Corti list for instances when a
patient is being tested but the patient name was not transferred to
the Corti.

NOTE: When using the 250 test mode for numbered tests, it is
important to keep a record of the test number for each patient.
When 245 tests have been saved, the user will be warned that the
memory is almost full. When the Corti unit reaches 250 saved tests,
it will not allow any further testing. When this occurs, the results
must be printed, transferred to the PC software, or they must be
cleared from memory.

Minimum Amplitude
The Minimum Amplitude setting allows the user to set the unit to
include minimum amplitude values in the pass/refer criterion
(Display 24). If the MIN VALUE is set to “ON,” a result is not
considered a pass unless the amplitude at each frequency is equal
to or greater than the minimum value programmed into the unit.
This is in addition to meeting the other pass criteria including the
minimum SNR and the number of passing frequencies for overall
Display 24 test “Pass.” The Corti is set with this feature turned OFF when it is
shipped from the factory.

To change the mode to Minimum Amplitude, press the LEFT or

RIGHT arrow keys to select ON or OFF. Once you have made your
selection, press NEXT. NOTE: When Value Graph is the selected
graph style, a horizontal green line will appear at the enabled
minimum amplitude level.

The minimum DP amplitude option is -5 dB SPL.

The minimum TE amplitude options are -5 dB and -10 dB SPL.
Clock Mode
The Clock Mode menu (Display 25) allows the user to change the
clock from a 24 hour mode to a 12 hour mode. To change the clock
mode, press the CHANGE keys. Press the NEXT to exit this
menu.

Display 25

Graph Style
The Graph Style menu (Display 26) allows the user to select from
two options for viewing the results. The SNR graph view shows the
signal-to-ratio for each DP test frequency or TE test band in bar
graph form. The Value graph view shows the absolute emission
and noise levels for each DP test frequency or TE test band.

Display 26

Norms
The Norms setting (Display 27) allows the user to display the
Expanded Boys Town Norms template on the Value Graph for
eligible DPOAE protocols. The norms template has no effect on the
overall test results and is for display purposes only.
______________________________________________________
NOTE: The template will display when target L1 and L2 levels are
65 and 55 dB SPL respectively.
Display 27 ______________________________________________________

Language
The Language setting (Display 28) allows the user to select among
several languages. To change the language, press the CHANGE
keys until the desired language is shown. Press theNEXT to exit
this menu.

Display 28
Reset to Default
The Reset to Default menu (Display 29) will return all instrument
settings and protocol settings to their original factory defaults.

Select the LEFT or RIGHT arrow key to reset and select Yes
or No to verify reset. To exit the System menu without resetting
the instrument, press NEXT to return to the Main Menu.

Display 29 NOTE: This will unpair the wireless device, clear the test results,
and reset ALL system and protocol settings.
Advanced Options for the DPOAE Diagnostic Unit
The Advanced Options menus permit modification of the test
parameters and pass criterion for the customizable protocols on
the DP Diagnostic unit. Changes to the protocol should be made
only by qualified personnel, usually the administrator. If you are
not familiar with the use of these variables, do not attempt to
change the protocols.

The Corti instrument comes with pre-programmed protocol

settings. See Appendix E for the manufacturer settings of these
protocols. Test protocol changes are saved in the non-volatile
memory so the settings will be retained even when the battery is
discharged temporarily.

Instructions for Customizing a Test Protocol

To enter the DPOAE Menu:

1) Press CHANGE at the main menu (Display 1)

2) Using the CHANGE buttons, select the DPOAE protocol
you want to customize (the "DP 4s" protocol is not
customizable)
3) Press SETUP at the Protocol menu (Display 2)
4) At the Clock menu (Display 15) hold down the CHANGE
key for 3 seconds until the Ready light (green LED) turns off
5) At the Wireless Device Discover menu (Display 18) hold
down the CHANGE key for 3 seconds until the Ready
light (green LED) turns off

You will see the Level L1 screen (Display 30). You are in the DPOAE
menu and will be able to scroll the available protocol parameters
with the NEXT button and make changes by using the LEFT or
RIGHT arrow keys to CHANGE the selection.

NOTE: If you push the DOWN arrow key without holding it for 3
seconds, you will scroll through date and time, etc., rather than
accessing the displays that allow you to make changes to the
custom protocols.
Selecting the Level of Primary Tones
The intensity of the primary tones (L1, L2) may be changed to any
level between 40 dB SPL and 70 dB SPL. The level L1 (Display 30)
will change in 1 dB increments by pushing the LEFT or RIGHT
arrow keys and press NEXT to move to the L2 screen.

Press the NEXT key to set the level of L2 as with L1 above.

Display 30

Setting the Averaging Time

The DP Averaging Time can be changed to one of four settings. The
Averaging Time will impact the time required to perform the test
and the signal-to-noise ratio (SNR). A 2 second average for 4
frequencies would produce a test in 8 seconds. A 4 second average
for 4 frequencies would produce a test in 16 seconds. The possible
settings for the Averaging Time are as follows:

Display 31 0.5 sec., 1.0 sec., 2.0 sec., or 4.0 sec.

Press the CHANGE keys to select an option and the NEXT key
to exit (Display 31).

NOTE: Longer averaging times help to reduce the noise floor which
can improve the likelihood of obtaining a passing result,
particularly with a noisy patient (like a baby sucking a pacifier) or in
a noisy environment. However, shorter averaging times may be
preferred for young children and/or uncooperative patients.

Setting the PASS SNR Level

To provide a PASS/REFER determination for each test, the PASS
SNR must be set. This number refers to the number of decibels that
the DPOAE signal must be above the noise to be considered a PASS
at that frequency. The limits for the PASS SNR are 3 dB to 10 dB.
Pressing the LEFT or RIGHT arrow keys will increase or
decrease the requirement. This requirement is used in combination
with the number of frequencies (discussed below) to determine an
Display 32 overall PASS/REFER for each test.

Press the CHANGE keys to select an option and the NEXT key
to exit (Display 32).
Setting the Number of Frequencies for PASS
The number of frequencies required for determining a PASS can be
set from 0 to 12 depending on the protocol selected. If the setting
is on 0, then no indication of PASS/REFER will be made. This
setting is used in conjunction with the PASS SNR (Display 32) to set
the criteria for the overall test PASS/REFER indication. For example,
if the PASS SNR is set to 5 dB and the number of frequencies for
PASS is set to 3, then the test must contain at least 3 frequencies
Display 33 where the emission is at least 5 dB above the noise to indicate a
PASS.

The number of frequencies for PASS should also be based on the

number of frequencies being tested. Setting the number of
frequencies for PASS to 5 when only 4 frequencies are being tested
would result in every test being labeled as a REFER.

NOTE: To disable the PASS/REFER indication set the number of

frequencies for pass to 0.

Press the CHANGE keys to select an option and the NEXT key
to exit (Display 3).

Reset Protocol
Selecting the RESET arrow key in the Reset Protocol menu
(Display 4) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.

NOTE: This does not affect the instrument settings or the settings
of any other protocol.
Display 34

Save Protocol
Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 5).
Press the NEXT key to exit.

NOTE: If a protocol has been modified, a * will appear in the

protocol name. For example, if protocol DP 2.0-5.0 has been
Display 35 modified, it will appear on the Corti as DP*2.0-5.0.
Advanced Options for the TEOAE Diagnostic Unit
The Advanced Options menu permits modification of the test
stimuli and measurement values for the Custom Protocols of the TE
Diagnostic unit. Changes to the protocol should be made only by
qualified personnel, usually the administrator. If you are not
familiar with the use of these variables, do not attempt to change
the protocols. Changes to any of these characteristics may yield
test results that differ from those obtained in other test modes.

The Corti instrument comes with pre-programmed settings for the

TE and TE Custom protocols. See Appendix E for the manufacturer
settings of these protocols. Test protocol changes are saved in the
non-volatile memory.

Instructions for Customizing a Test Protocol

To enter the TEOAE Menu:

1) Press CHANGE at the main menu (Display 1)

2) Using the CHANGE buttons, select the TEOAE protocol
you want to customize (the "TE 64s" protocol is not
customizable)
3) Press SETUP at the Protocol menu (Display 2)
4) At the Clock menu (Display 15) hold down the CHANGE
key for 3 seconds until the Ready light (green LED) turns off
5) At the Wireless Device Discover menu (Display 18) hold
down the CHANGE key for 3 seconds until the Ready
light (green LED) turns off

The Averaging Time menu (Display 36) should appear on the

display. You are in the TEOAE menu and will be able to scroll the
available protocol parameters with the NEXT button and make
changes by using the LEFT or RIGHT arrow keys to CHANGE the
selection.

NOTE: If you push the DOWN arrow key without holding it for 3
seconds, you will scroll through date and time, etc., rather than
accessing the displays that allow you to make changes to the
custom protocols.
Selecting the Averaging Time
The Averaging Time can be changed to one of four settings. The
Averaging Time will have a significant impact on the time required
to perform the test and on the signal-to-noise ratio (SNR). An 8
second average would produce a test in about 8 seconds. A 64
second average would produce a test in about 64 seconds. The
possible settings for the Averaging Time are as follows:

8, 16, 32, or 64 seconds.

Display 36
The instrument will automatically stop the test when the pass
criterion is met prior to the averaging time. Press the CHANGE
keys to select an option and the NEXT key to exit (Display 36).

Setting the PASS SNR Level

To provide a PASS/REFER determination for each test, the PASS
SNR must be set. This number refers to the number of decibels that
the TEOAE signal must be above the noise to be considered a PASS
at that frequency. The limits for the PASS SNR are 3 dB to 10 dB.
Pressing the LEFT or RIGHT arrow keys will increase or
decrease the requirement. This requirement is used in combination
with the number of frequencies (discussed below) to determine an
Display 37 overall PASS/REFER for each test.

Press the CHANGE keys to select an option and the NEXT key
to exit (Display 37).

Setting the Number of Frequencies for PASS

The number of frequencies for determining a PASS can be set from
0 to 6. If the setting is on 0, then no indication of PASS/REFER will
be made. This setting is used in conjunction with the PASS SNR to
set the criteria for the overall test PASS/REFER indication. For
example, if the PASS SNR is set to 4 dB and the number of
frequencies for PASS is set to 3 then the test must contain at least 3
frequencies where the emission is at least 4 dB above the noise to
Display 38 indicate a PASS.

Press the CHANGE keys to select an option and the NEXT key
to exit (Display 38).
Reset Protocol
Selecting the RESET arrow key in the Reset Protocol menu
(Display 39) will return the selected protocol settings to their
original factory settings. Press the NEXT key to exit.

NOTE: This does not affect the instrument settings or the settings
of any other protocol.
Display 39

Save Protocol
Once all of the settings have been selected for the protocol, these
settings can be saved by selecting the SAVE keys (Display 40).
Press the NEXT key to exit.

NOTE: If a protocol has been modified, a * will appear in the

protocol name. For example, if protocol TE 1.5-4.0 has been
modified, it will appear on the Corti as TE*1.5-4.0.
Display 40
Cleaning and Maintenance
Cleaning and Disinfection
Use a new eartip for each patient. Eartips are for single patient use
only. The probe tube, which does not make direct contact with the
patient, should be replaced if there is any sign of contamination or
if the test will not progress past the AutoStart phase. Disinfection
of the probe tube between patients is not required.

External parts of the instrument/probe can be cleaned to remove

visible particulate contamination. Do not attempt to insert any
object into probe.

This instrument is not designated as a ‘sterile’ device. Wiping with

a clean cloth or towel and a mild non-alcohol based disinfecting
solution, provides a suitable form of cleaning and low-level
disinfection of the housing and probe exterior. Repeat this weekly,
or as often as conditions warrant, to prevent a build-up of grime
from normal handling and use.

We believe low-level disinfection is appropriate for this type of

instrument. This may not conform to the infection control
guidelines of the user’s facility. The disinfection materials and
procedures applied in the users’ facility may be more appropriate
for their circumstances than the methods outlined above (see
cautions below). The frequency of cleaning and disinfecting is
dependent on the facility’s risk assessment, usage, and test
environment.

Important:

• Do not immerse the instrument or probe in fluids or

attempt to sterilize the instrument or any of its
accessories.
• Do not allow any fluid to enter the device.
• Do not use autoclave sterilization.
• Do not use alcohol-based disinfectants.
• Take care not to put excessive pressure on the clear
display window or allow any utensil to puncture the
display window or control panel.

NOTE: Long-term exposure to any disinfecting agents has the

potential to alter the material properties of the plastic housing and
labeling of the device.

Always follow the safety and disposal guidelines given by the

manufacturer of cleaning and disinfectant chemicals.
Maintenance
This instrument requires no regular maintenance beyond routine
cleaning and annual calibration. The probe tube requires
replacement only when it becomes clogged.

A defective product should not be used. Make sure all connections

to external accessories are snug and secured properly. Parts which
may be broken or missing or are visibly worn, distorted or
contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from GSI.

Equipment is not user repairable. Repairs and battery replacement

must be performed by a qualified service representative only.

Annual calibration is recommended. A Due for Service screen will

appear once daily after 1 year has elapsed from the calibration
date. Have an authorized service technician perform electrical
safety checks on the unit in order to maintain continued
compliance to IEC and UL 60601-1.

Probe tube Replacement

Probe tubes are disposable and should be replaced when they
become clogged. Replacement probe tubes are included with this
instrument. Do not attempt to clean the probe tube.

To replace the probe tube, use the eartip to grasp the probe tube
(the plastic tube) and twist slightly while pulling the probe tube
straight out of the probe head ( Figure 4). Dispose of the used
Figure 4 probe tube immediately to avoid confusing used tubes and new
tubes. Take a new probe tube from the package and insert the
tube into the probe head until it is fully seated (Figure 5). A
properly inserted probe tube will snap securely into place when it
is fully seated in the probe head.

DO NOT ATTEMPT TO CLEAN PROBE TUBES. THIS

MAY CAUSE DAMAGE TO THE PROBE.
CAUTION
Figure 5
Troubleshooting
Problem Solutions
Instrument does not • The DOWN arrow must be pressed for a full second (the Yellow
turn on test LED will illuminate).
• Connect the charger as shown in Figure 2 on page 15. Confirm that
blue "Charging" LED is illuminating in a slow blink pattern. Wait at
least 10 minutes and then attempt to turn on the instrument
• Contact GSI for service if the problem persists.
The test will not • Select a different sized eartip.
start • Reposition the probe.
• Be sure the probe cable is secured with the shirt clip.
• Change the probe tube.
• Verify that the eartip is sealed in the ear canal via feedback from
the Probe check during AUTOSTART.
• Check that the instrument will start in your own ear with the proper
eartip for testing yourself. If the test will not start or if the AutoStart
tones sound unusual, replace the probe tube.
• Contact GSI for service if the problem persists across several
patients.
The results will not • Check the printer status. Turn the thermal printer on (wake from
print sleep mode) by pressing the power button.
• If the printer doesn't turn on, plug in the power supply to charge
the battery.
• Be sure the printer has paper.
• If paper comes out of the printer but there is no text on the paper
then the paper is in backwards.
• Perform a self-test by pressing the power button and the paper
feed button simultaneously for 3 seconds when powered off.
Contact GSI for service if the problem persists.
Display is frozen and • Press and hold the DOWN arrow button for 10 seconds to force the
instrument will not instrument to power off. Powering the instrument back on again
respond to button should reset/restore normal function.
presses • Contact GSI for service is the problem persists.

TE screening test is • Re-insert probe tip into ear canal

paused • Reposition the probe tip
• Wait for noise levels to decrease; test will resume
 Problem Solutions
Attach • Probe not detected. Check that the probe connector is fully seated
Probe in the socket.
• Disconnect and reconnect the probe.
• Cycle instrument power.
• Contact GSI for service if problem persists.
Wireless Device • Paired to Printer:
Not Found o Check that the printer is turned on.
o Move closer to the printer.
o Try again.
• Paired to PC Computer or wireless dongle:
o Check that the serial port is open. Establishing the serial
port is handled by the PC and/or the software, not by the
Corti instrument.
Wireless Error • Check Wireless device (printer or PC) status.
#xxx • Attempt to connect to wireless device again.
• Contact GSI if problem persists.
Wireless Not • Printing has been attempted, but no wireless device is paired with
Configured the Corti Instrument. Establish wireless pairing.
Device Not • The printer is not responding to queries from the instrument. Check
Responding printer status.
• Awaken printer from sleep mode.
• Charge printer battery if necessary.
Fit Error • For a DP test, the desired level (L1 or L2) cannot be obtained within
Cannot Obtain P allowable limits. User should refit the probe and retry the test.
• Replace the probe tube.
• Contact GSI for service if problem persists across several patients.
Fit Error • For a DP test, the level of the calibration tone is too high. User
Too High should refit the probe and retry the test.
• Replace the probe tube.
• Contact GSI for service if problem persists across several patients.
Fit Error • For a DP test, the level of the calibration tone is too low. User
Too Low should refit the probe and retry the test.
• Replace the probe tube.
• Contact GSI for service if problem persists across several patients.
Limit • Overflow error during the calculation of the DFTs for a DP test. User
Error should repeat the test.
• Cycle instrument power.
• Contact GSI for service if problem persists.
Memory almost full • Saved tests are within 5 tests of the maximum limit. Print or
transfer test result to avoid interruption in testing.
Memory Full! • The maximum saved test limit is reached. The user will need to
clear the memory before any additional tests can be performed.
Power Low! • The battery charge level is too low for operation. The user must
charge the battery before additional tests can be performed.
Printer Error • Indicates a problem with the printer. Check the printer status.
• Reset the printer or cycle the printer power.
 Problem Solutions
Printer Paper Out! • Replace the paper roll.
Time/Date Error • The clock is checked during power on to ensure it has not lost time
and been reset. In the case of clock reset, this message is shown.
The user should set the correct date/time.
Appendix A: Specifications
PROBE SPECIFICATIONS
Measurement Type: Distortion Product Otoacoustic Emissions (DPOAE)
Transient Evoked Otoacoustic Emissions (TEOAE)
Frequency Range: DPOAE: 1.5 to 12 kHz
TEOAE: 0.7 to 4 kHz
Stimulus Intensity Range: DPOAE: 40 to 70 dB SPL
TEOAE: 80 dB SPL peak equivalent (±3 dB)
Microphone System Noise: -20 dB SPL @ 3 kHz (1 Hz bandwidth) / -13 dB SPL @ 1
kHz (1 Hz bandwidth)
Dimensions and Weight: Length: 40 in. (1.0 meter)
Weight: 1.00 oz. (28 gm)
Connector: HDMI

INSTRUMENT SPECIFICATIONS
Power Supply: Lithium-Ion rechargeable
Battery Life: 20 hours on-time
Dimensions and Weight: 7 in. x 2.75 in x 1.25 in (17.78 cm x 6.98 cm x 3.17 cm)
Instrument Weight: 6.4 oz. (180 gm)
User Interface: OLED Display to provide user information and progress
of measurement.
4-button keypad to control instrument functions
Connectors / Communications: Integrated USB communication capability for battery
charging and communication with PC-based database
programs or an optional PC printer
HDMI Connector for connection to the Probe
Integrated wireless Class 2 + EDR with SPP Protocol for
communication with optional printer

POWER SUPPLY SPECIFICATIONS (use only approved power supply)

Model No: UE08WCP-050160SPA
Output: 5.0V DC, 1.6A
Input 100-240V AC, 50-60Hz, 400 mA

ENVIRONMENTAL REQUIREMENTS
Operating Temperature: 15°C to 35°C (59°F to 95°F)
Operating Relative Humidity: 30% to 90% (non-condensing)
Maximum Operating Altitude: 2000 meters (6000 feet)
Transport and Storage 5°C to 40°C (41°F to 104°F)
Temperature:
Appendix B: Flowcharts
Flowchart - Measurement
To Start:
Press DOWN arrow
for 1 second

Press UP
arrow to
return to Main
Menu
Flowchart – Setup Menus
 Press and hold DOWN arrow for three seconds to enter next menu
Clock Menu  System Menu  DP Settings  TE Settings
Appendix C: Test Sequence
A complete test sequence consists of an AutoStart, calibration, and test phase. The AutoStart phase
determines when the calibration phase should proceed, while the calibration phase calibrates the
level of the tones that will be applied during the actual test phase. Artifact rejection is employed
during the test phase to reduce the effect of transient noise bursts.

Immediately after the test button is pressed, the AutoStart phase of the test begins. AutoStart
checks both the quality and stability of the seal by measuring the response obtained from a
sequence of test tones. The stability of the seal is determined by comparing the responses obtained
over time. When the level of the response is within an acceptable range and is stable over time, the
unit proceeds to the calibration phase.

FOR DPOAE
The calibration phase automatically measures the response obtained from a sequence of
calibration tones and calculates the voltage needed to obtain the desired pressures. If the desired
peak pressure cannot be obtained, the unit will use the maximum voltage. A successful calibration
leads to the actual test phase.

The test phase consists of measuring the response obtained from the pairs of test frequencies (f1,
f2) applied to the receivers. Two receivers are used, with each receiver generating one frequency in
order to reduce intermodulation distortion. Frequency domain estimates of the actual L1, L2,
distortion (DP) and noise floor (NF) are obtained via the discrete Fourier Transform, with a bin
resolution of approximately 31 Hz. The NF estimate is obtained by averaging the power in the 4
closest (+/-2) bins to the DP bin.

FOR TEOAE
The calibration phase automatically measures the peak pressure obtained from a sequence of clicks
and calculates the voltage required to obtain the target peak pressure. If the desired peak pressure
cannot be obtained, the unit will use the maximum voltage.

The test phase consists of measuring the response obtained from repeated sequences of clicks
applied to the receivers. The click sequence is 3-1-1-1 repeated twice. Signal and noise floor
estimates are obtained by adding/subtracting the two response sequences, respectively. The
energy of the signal and noise floor estimates in various frequency bands is obtained in real time
and displayed once per second. The average peak pressure of the stimulus is calculated after
completion of the test.

Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts by
the use of an adaptive rejection threshold. The unit attempts to accept the quieter sections of the
test, while rejecting the noisier portions of the test. When the noise level is approximately constant
during the test, the instrument will tend to accept most of the data in the test. However, as the
level of the noise becomes more variable over time, the instrument will attempt to accept the
quieter portions of the recording. Noise estimates are obtained approximately 32 times per second
and a suitable threshold is estimated from the data. Data segments with a noise floor above this
threshold are rejected, which tends to lower the noise floor of the test. In order to reduce the
possibility of obtaining an artificially low noise floor, the minimum threshold level is limited.
Comment about Variations in the SNR Estimate
The user needs to be aware that the SNR estimate has an inherent statistical variation due to the
effects of random noise, especially when no emission is actually present. If a test is performed with
the instrument’s probe placed in a test cavity, it can be shown theoretically that the SNR will be
greater than 6 dB approximately 7 times out of 100. This is not a limitation of the instrument, but a
fundamental property of the method used to estimate the SNR in all emission testing. In order to
reduce the occurrence of this “false” emission, the instrument limits the minimum value of NF,
which has the effect of reducing the SNR for tests that have a low noise floor. As the noise level of
the test increases, the user will notice that more “false” emissions will appear, which is to be
expected.
Appendix D: Pass/Refer Criteria
Pass/Refer Criteria for DPOAE
The decision that a DPOAE exists is based on detecting a signal whose level is significantly above the
background noise level. This requires a statistical decision, since the random noise level in the
DPOAE filter channel can be expected to exceed the average of the random noise levels in the four
adjacent filter channels — used as the reference for comparison — roughly half the time.

Extended measurements of the noise distributions in both the DPOAE filter channel “DP level” and
the rms average of the 4 adjacent channels “N level” indicate that the signal-to-noise ratio (the
difference between DP and N) has a standard deviation of 5.5 dB. As shown in the figure below, this
implies a 10% probability of seeing a 7 dB SNR simply from the variability of the noise levels in the 2
filter sets.

Requiring an SNR of 6 dB in three out of four frequencies drops the probability of passing an ear
with significant hearing loss to 1% or less. Note: By the binomial distribution, two of three
frequencies at >8.4 dB or three of six frequencies at >7 dB should also ensure less than 1%
probability of passing a moderately-severe hearing-impaired infant.

Preliminary trials with infants indicate that the tester’s technique is the single most important
variable in the pass rate on normal-hearing infants. Some testers pick up the technique (see
Operating Instructions section, page 19) with only a couple of days’ practice, producing pass rates
comparable to those for other DPOAE equipment they have used for months; other testers take
longer.

Occasional claims of extraordinarily low probabilities of missing an ear with hearing loss appear to
be based on poor statistics. As discussed by Gorga (Mayo Clinic Teleconference, 1998), since the
incidence of significant hearing loss is roughly 2 per 1,000, verifying a 99.7% accuracy would require
testing hundreds of thousands of babies with a given system. Thus to demonstrate that only 3
babies out of 1,000 with hearing loss were missed would require follow-up testing on 500,00
babies. To our knowledge, no one has performed such tests to date.
Pass/Refer Criteria for TEOAE
The same basic principles that underlie DPOAE Pass/Fail criteria underlie TEOAE Pass/Fail criteria. In
the case of transients, requiring SNR of 4 dB at any three out of the six test frequencies drops the
probability of passing an ear with a significant hearing loss to less than 1%.

NOTE: The SNR limits for transients are lower than the corresponding limits for distortion products
primarily because the traditional noise calculation used in TEOAE measurements (and in the Corti
instrument) gives a 3 dB lower SNR than the calculation used for DPOAEs. Without that difference,
the numerical SNR value for a PASS with the two methods would be quite similar.

The Corti uses a patented noise-rejection algorithm that permits accurate DPOAE and TEOAE
measurements in background noise and babble as high as 55 to 65 dB SPL (A-weighted). Briefly
explained, use of available memory in the Corti processor permits a post-hoc statistical analysis that
identifies those samples whose retention would improve the overall accuracy. Those samples are
included in the final analysis; the noisier samples are rejected.

The improved operation in noise with the new algorithm was so substantial that a complete replica
of the original validation tests in "fully impaired ear" cavities was conducted and it was verified that
no increase in false negatives (false passes) was introduced. Under no test conditions was any such
degradation uncovered.

The artifact rejection can only reject the noisiest samples in a measurement period. If the ambient
noise level rises too high (and/or the eartip seal is poor), then all samples will be noisy and accurate
measurements will be impossible, in which case the test result will indicate “noisy.”
Appendix E: Configurations and Test Protocols
GSI Corti Diagnostic Configurations

Configuration Protocols Included

DP Diagnostic: DP 4s (default - not customizable)
DP 2.0-5.0
DP 1.5-6.0
DP 1.6-8.0
DP 1.5-12

TE Diagnostic: TE 64s (default - not customizable)

TE 1.5-4.0
TE 0.7-4.0

DP and TE
Diagnostic Combo: DP 4s (default - not customizable)
DP 2.0-5.0
DP 1.5-6.0
DP 1.6-8.0
DP 1.5-12
TE 64s (default - not customizable)
TE 1.5-4.0
TE 0.7-4.0

DPOAE Diagnostic Default Protocols

# of # Passing
Protocol Frequ Averaging Pass Freq. for
Name encies F2 Frequency L1/L2 Time SNR Test Pass
DP 4s 4 2.0, 3.0, 4.0, 5.0 kHz 65/55 4 sec 6 dB 3
DP 2.0-5.0 4 2.0, 3.0, 4.0, 5.0 kHz 65/55 4 sec 6 dB 3
1.5, 2.0, 3.0, 4.0, 5.0, 6.0
DP 1.5-6.0 6 65/55 4 sec. - 0
kHz
1.6, 2.0, 2.5, 3.2, 3.6, 4.0,
DP 1.6-8.0 12 4.5, 5.0, 5.6, 6.3, 7.1, 8.0 65/55 4 sec. - 0
kHz
1.5,2,3,4,5,6,7,8,9,10,11,12
DP 1.5-12 12 65/55 4 sec. - 0
kHz
TEOAE Diagnostic Default Protocols
# of # Passing
Protocol Frequency Frequency Averaging Freq. for Test
Name Bands Center Bands Time (max) Pass SNR Pass
1.5, 2, 2.5, 3, 3.5,
TE 64s 6 64 sec 4 dB 3
4 kHz
1.5, 2, 2.5, 3, 3.5,
TE 1.5-4.0 6 64 sec 4 dB 3
4 kHz
0.7, 1.0, 1.4, 2.0,
TE 0.7-4.0 6 64 sec. - 0
2.8, 4.0 kHz

NOTE: Those protocols for Diagnostic Units with "0" for the Pass SNR and the number of passing
frequencies required for a test "PASS" do not have a factory provided pass criteria. Users may
establish a custom pass criterion based on normative data collected in their own clinics or
information available by literature review.

GSI Corti Screening Configurations

Configuration Protocols Included (not customizable)

DP Screener: DP 2s
DP 4s

TE Screener: TE 32s
TE 64s
DP and TE Screener
Combo: DP 2s
DP 4s
TE 32s
TE 64s

DPOAE Screening Default Protocols

# of # Passing
Protocol Frequ Averaging Pass Freq. for
Name encies F2 Frequency L1/L2 Time SNR Test Pass
DP 2s 4 2.0, 3.0, 4.0, 5.0 kHz 65/55 2 sec 6 dB 3
DP 4s 4 2.0, 3.0, 4.0, 5.0 kHz 65/55 4 sec 6 dB 3

TEOAE Screening Default Protocols

# of # Passing
Protocol Frequency Frequency Averaging Freq. for Test
Name Bands Center Bands Time (max) Pass SNR Pass
1.5, 2, 2.5, 3, 3.5,
TE 32s 6 32 sec 4 dB 3
4 kHz
1.5, 2, 2.5, 3, 3.5,
TE 64s 6 64 sec 4 dB 3
4 kHz
Appendix F: EMC Compatibility
Portable and Mobile RF communications equipment can affect the GSI Corti. Install and operate the
GSI Corti according to the EMC information presented on this page and the next 4 pages.

The GSI Corti has been tested for EMC emissions and immunity as a standalone instrument. Do not
use the GSI Corti adjacent to or stacked with other electronic equipment. If adjacent or stacked use
is necessary, the user should verify normal operation in the configuration.

The use of accessories, transducers and cables other than those specified, with the exception of
servicing parts sold by GSI as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is
responsible for making sure the system complies with the IEC 60601-1-2 standard.

Electromagnetic Compatibility
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.

Electrical Safety, EMC and Associated Standards

1. UL 60601-1: Medical Electrical Equipment, Part 1 General
Requirements for Safety

2. IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General

Requirements for Safety

3. CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1

General Requirements for Safety Electrical Equipment for
Laboratory Use

4. IEC/EN 60601-1-1: Collateral Standard, Safety Requirements for

Medical Electrical Systems

5. IEC/EN 60601-1-2: Medical Electrical Equipment, Part 1 -

Electromagnetic Compatibility - Requirements and Tests

6. Essential Requirements of the current European Union Medical

Device Directive 93/42/EEC

7. RoHS (Restriction of the use of certain Hazardous Substance)

8. WEEE (Waste Electrical & Electronic Equipment) Legislation

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the
user of the GSI Corti should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - Guidance
RF Emissions Group 1 The GSI Corti uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions Class B Limits The GSI Corti is suitable for use in all
CISPR 11 commercial, industrial, business, hospital, and
Harmonic Emissions Class A Category residential environments.
IEC 61000-3-2
Voltage Fluctuations / Complies
Flicker Emissions
IEC 61000-3-3

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the GSI Corti
The GSI Corti is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the GSI Corti can help prevent electromagnetic interferences by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Corti as recommended below, according to the maximum output power of the communications
equipment.
Rated Maximum Separation distance according to frequency of transmitter
Output Power of m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter
d = 1.17√𝑃 d = 1.17√𝑃 d = 2.23√𝑃
W
0.01 0.12 0.12 0.22
0.1 0.37 0.37 0.74
1 1.17 1.17 2.23
10 3.70 3.70 7.05
100 11.70 11.70 22.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitters, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the
user of the Corti should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Electromagnetic
Environment-Guidance
Electrostatic Discharge ±8 kV contact ±8 kV contact Floors should be wood,
(ESD) concrete or ceramic tile. If
±15 kV air ±15 kV air floors are covered with
IEC 61000-4-2 synthetic material the
relative humidity should
be greater than 30%.
Electrical Fast ±2 kV for power supply ±2 kV for power supply Mains power quality
Transient/Burst lines lines should be that of a typical
±1 kV for input/output ±1 kV for input/output commercial, hospital, or
IEC 61000-4-4 lines lines residential environment.
Surge ±1 kV differential mode ±1 kV differential mode Mains power quality
should be that of a typical
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode commercial, hospital, or
residential environment.
Voltage Dips, Short <5% UT <5% UT Mains power quality
Interruptions and (>95% dip in UT) for 0.5 (>95% dip in UT) for 0.5 should be that of a typical
Voltage Variations on cycle cycle commercial, hospital, or
Power Supply Lines 40% UT 40% UT residential environment. If
(60% dip in UT) for 5 (60% dip in UT) for 5 the user of the GSI Corti
IEC 61000-4-11 cycles cycles requires continued
70% UT 70% UT operation during power
(30% dip in UT) for 25 (30% dip in UT) for 25 mains interruptions, it is
cycles cycles recommended that the
5% UT 5% UT Corti be powered from an
(>95% dip in UT) for 5 (>95% dip in UT) for 5 uninterrupted power
sec sec supply.
Power Frequency 3 A/m 3 A/m Power frequency
(50/60 Hz) magnetic fields should be
at levels characteristic of a
IEC 61000-4-8 typical location in a
typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the user of
the Corti should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Compliance Electromagnetic Environment-Guidance
Level
Portable and mobile RF communications equipment
Conducted RF 3 Vrms 150 kHz 3 Vrms should be used no closer to any part of the Corti,
IEC 61000-4-6 to 80 MHz including cables than the recommended separation
distance calculated from the equation applicable to
Radiated RF 3 V/m 80 MHz to 3 V/m the frequency of the transmitter.
IEC 61000-4-3 2.5 GHz
Recommended separation distance

d = 1.17√𝑃

d = 1.17√𝑃 80 MHz to 800 MHz

d = 1.17√𝑃 800 MHz to 2.5 GHz

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field Strengthens from fixed RF transmitters, as
determined by an electromagnetic site survey (a*),
should be less than the compliance level in each
frequency range (b*).
Interference may occur in the vicinity of equipment
marked:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

(a*) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Corti is used exceeds the applicable RF compliance level above, the Corti should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the Corti.

(b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.