GSi CORTITM User Manual

™

GSI CORTI

USER MANUAL

Setting The Clinical Standard www.grason-stadler.com

Grason-Stadler, 10395 West 70th Street, Eden Prairie, Minnesota 55344

800-700-2282 • 952-278-4402 • fax [phone] • e-mail [e-mail]

Part Number D-0103241 Rev D

EC REP

Title: GSI Corti™ OAE Instrument

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

Copyright © 2013 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 0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason­Stadler is an ISO 13485 certified corporation.

0344

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 ............................................................................................................................................................. 13

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

Operating Instructions .......................................................................................................................................... 21

Preparing the Patient for Testing ............................................................................................................................. 21

i

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

Test Technique ........................................................................................................................................................ 25

Noise Sources .......................................................................................................................................................... 26

Turning Off the Instrument ..................................................................................................................................... 26

Managing Results ................................................................................................................................................... 27

Saving Results ......................................................................................................................................................... 27

Deleting Results ...................................................................................................................................................... 28

Printing to a Thermal Printer ................................................................................................................................... 28

Connecting to the Corti Data Manager .................................................................................................................... 29

Understanding Printed Results ........................................................................................................................... 30

Understanding the DPOAE Printout ....................................................................................................................... 30

Understanding the TEOAE Printout ........................................................................................................................ 30

Rounding Results .................................................................................................................................................... 31

Clock Settings .......................................................................................................................................................... 32

Accessing the Clock Menu ...................................................................................................................................... 32

Changing the Date/Time ......................................................................................................................................... 32

Instrument Settings ................................................................................................................................................ 33

Wireless Device Pairing .......................................................................................................................................... 33

Clearing Test Results .............................................................................................................................................. 34

Auto Shutdown Time .............................................................................................................................................. 34

Save Mode/Storing Test Results ............................................................................................................................. 34

Minimum Amplitude ............................................................................................................................................... 35

Clock Mode ................................................................................................ ............................................................. 35

Graph Style.............................................................................................................................................................. 35

Language ................................................................................................................................................................. 36

Reset to Default ....................................................................................................................................................... 36

ii

Advanced Options for the DPOAE Diagnostic Unit ...................................................................................... 37

Instructions for Customizing a Test Protocol .......................................................................................................... 37

Selecting the Level of Primary Tones ..................................................................................................................... 38

Setting the Averaging Time .................................................................................................................................... 38

Setting the PASS SNR Level .................................................................................................................................. 38

Setting the Number of Frequencies for PASS ......................................................................................................... 39

Reset Protocol ......................................................................................................................................................... 39

Save Protocol .......................................................................................................................................................... 39

Advanced Options for the TEOAE Diagnostic Unit ...................................................................................... 40

Instructions for Customizing a Test Protocol .......................................................................................................... 40

Selecting the Averaging Time ................................................................................................................................. 41

Setting the PASS SNR Level .................................................................................................................................. 41

Setting the Number of Frequencies for PASS ......................................................................................................... 41

Reset Protocol ......................................................................................................................................................... 42

Save Protocol .......................................................................................................................................................... 42

Cleaning and Maintenance ................................................................................................................................... 43

Cleaning and Disinfection ....................................................................................................................................... 43

Maintenance ............................................................................................................................................................ 44

Probe tube Replacement ................................ ................................ ................................................................ .......... 44

Troubleshooting ...................................................................................................................................................... 45

Appendix A: Specifications .................................................................................................................................. 47

Appendix B: Flowcharts ................................ ................................................................................................ ....... 48

Flowchart - Measurement ........................................................................................................................................ 48

Flowchart – Setup Menus ........................................................................................................................................ 49

Appendix C: Test Sequence ................................................................................................................................. 50

FOR DPOAE ........................................................................................................................................................... 50

FOR TEOAE ........................................................................................................................................................... 50

Comment about Variations in the SNR Estimate .................................................................................................... 51

Appendix D: Pass/Refer Criteria ........................................................................................................................ 52

Pass/Refer Criteria for DPOAE ............................................................................................................................... 52

Pass/Refer Criteria for TEOAE ............................................................................................................................... 53

Appendix E: Configurations and Test Protocols ............................................................................................ 54

Appendix F: EMC Compatibility ....................................................................................................................... 56

Electromagnetic Compatibility................................................................................................................................ 56

Electrical Safety, EMC and Associated Standards .................................................................................................. 56

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ............................................................... 57

iii

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the GSI

Corti ........................................................................................................................................................................ 57

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ................................................................ 58

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ................................................................ 59

iv

Standards Compliance

Standard

Issue
Date

Title

ANSI/ASA 3.6

2010

Specification for Audiometers

IEC 60601-1

2005

Medical Electrical Equipment – General Requirements for Basic
Safety and Essential Performance, Ed. 3

IEC 60645-1

2004

Electroacoustics - Audiological equipment -- Part 1: Pure-tone
audiometers

IEC 60645-3

2007

Electroacoustics - Audiometric equipment -- Part 3: Test signals of
short duration

IEC 60645-6

2010

Electroacoustics – Audiometric Equipment – Part 6: Instruments for
the measurement of otoacoustic emissions

ISO 14971

2007

Application of Risk Management to Medical Devices

ISO 10993

2009

Biological Evaluation of Medical Devices

EN 60601-1-2

2007

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)

IEC 60601-1

2005

Clause 8.9.1.8; Pollution Degree Classification: 2

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

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

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.

WARNING
CAUTION

WARNING

In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures.

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

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
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

Attach Probe

No probe is detected at the start of a test.

Device not
Responding

The printer is not responding to queries from the instrument.

BT Device Not
Found

The paired wireless device cannot be detected. The device may be
turned off or too far away.

BT Error #xxx

There is an error condition with the wireless device. Check the
status.

BT Not
Configured

The Corti instrument is not paired with any wireless device.

Fit Error
Cannot Obtain P

For a DP test, the desired level (L1 or L2) cannot be obtained within
allowable limits. User should refit the probe and retry the test.

Fit Error
Too High

For a DP test, the level of the calibration tone is too high. User
should refit the probe and retry the test.

Fit Error
Too Low

For a DP test, the level of the calibration tone is too low. User
should 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
Full

Saved tests are within 5 tests of the maximum limit.

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.

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

Display Messages:

Indicator LEDs (lights):

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.

WARNING

Safety Precautions

If the system is not functioning properly, do not operate it until all
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.

CAUTION

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

Warning - Electric Shock Hazards

WARNING

WARNING
WARNING

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 micro­USB 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

Warning - General

This instrument contains a rechargeable lithium­ion battery. The battery is not user replaceable
and must be returned to an authorized GSI
service location for repair.

Proper use of this device depends on careful
reading of all instructions.

Recycling/Disposal

WARNING

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

IEC Pub.

Description

980 & 60601-1

Serial Number

980 & 60601-1

Date of Manufacture

980 & 60601-1

Manufacturer

980 & 60601-1

Caution, Consult Accompanying
Documents

980 & 60601-1

Return to Authorized Representative,
Special Disposal Required

980 & 60601-1

Reference Number

60601-1

B Patient Applied Part According to
IEC60601-1

980 & 60601-1

Consult Operating Instructions

60601-1

Keep Dry

60601-1

Transport and Storage Temperature
range

Logo

EC REP

980 & 60601-1

EU Authorized Representative

ISO 7010-

M002&60601-

1

Where Appropriate

REF

No.

Symbol

IEC Pub.

Description

CAN/CSA-

C22.2 No.

60601-1 (2008)

(Medical

Electrical

Equipment -

Part 1: General

Requirements

for Basic Safety

and Essential

Performance).

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.

980 & 60601-1

Conforms to European Medical
Device Directive 93/94/EEC

FCC part 15

FCC 47CFR, Part 15.247 & 15.249
(Wireless)

Introduction

User Interface

Buttons

Probe Connector

Micro-USB

Connector

Figure 1

Charge Status

Indicator

Display

Test Status

Indicators

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, printer, single-use eartips
replaceable probe tubes and other
accessories. The Corti instrument
contains the hardware and software for
generating the test stimuli, measuring and
displaying the OAEs, and storing the
results until they are printed. The plastic
housing contains circuit boards that
provide the signal processing and display
the test results. The instrument also
contains 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 buttons
located on the keypad of the 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 canal
is accomplished through disposable
eartips, which fit onto the 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