Grason-Stadler GSI Corti User manual

CORTI
DPOAE
TEOAE
DEVICE
USER MANUAL

Title: GSI Corti™ User Manual
EC REP
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1,
5500 Middelfart
Denmark
Copyright © 2020 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
Caution: US Federal law restricts this device to sale by or on the order of a physician or licensed
hearing care professional.

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TABLE OF CONTENTS
Table of Contents .....................................................................................................................1
Preface.......................................................................................................................................5
Manual Conventions.............................................................................................................5
Regulatory Symbols ..............................................................................................................6
Warnings and Cautions............................................................................................................9
Important Safety Instructions..............................................................................................9
Safety Precautions ................................................................................................................9
Charging...............................................................................................................................11
Electric Shock Hazard .........................................................................................................11
Explosion .............................................................................................................................11
Battery .................................................................................................................................11
Environmental Factors .......................................................................................................11
Calibration ...........................................................................................................................11
Introduction ............................................................................................................................12
Intended Use.......................................................................................................................12
Indications For Use .............................................................................................................12
How Does the Corti Device Work?.....................................................................................13
What are DPOAEs?..............................................................................................................13
What Are TEOAEs? ..............................................................................................................14
What Do Otoacoustic Emission Results Tell Us? ..............................................................14
What Frequency Range of Hearing is Estimated? ............................................................14
How are the Results Stored and Reported?......................................................................14
Sensitivity and Specificity ...................................................................................................15
Setup........................................................................................................................................16
Unpacking the System........................................................................................................16
Optional Accessories ..........................................................................................................16
Cradle (Optional) .............................................................................................................16
Battery Charging .................................................................................................................17
Installing the Probe.............................................................................................................18
Attaching Probe Tube .........................................................................................................18
Attaching Eartips.................................................................................................................18

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Probe Holder .......................................................................................................................19
Operating Instructions ...........................................................................................................20
Preparing the Patient for Testing ......................................................................................20
Turning On the Instrument................................................................................................20
Control Panel.......................................................................................................................20
Main Menu ..........................................................................................................................21
Selecting the Test Protocol.................................................................................................21
Starting a Test .....................................................................................................................22
AutoStart Probe Check .......................................................................................................22
Test Phase ...........................................................................................................................23
SNR Bar Graph View ...........................................................................................................23
Value Graph View................................................................................................................24
Viewing Results ...................................................................................................................24
Viewing DPOAE Results with Normative Data ..................................................................26
Test Technique ....................................................................................................................27
Noise Sources..................................................................................................................27
Turning Off the Instrument................................................................................................27
Managing Results................................................................................................................28
Saving Results......................................................................................................................28
Deleting Results ..................................................................................................................29
Printing to a Thermal Printer .............................................................................................30
Connecting to the Corti Data Manager .............................................................................31
Understanding Printed Results..........................................................................................31
Rounding Results.............................................................................................................32
Clock Settings ......................................................................................................................33
Accessing the Clock Menu ..............................................................................................33
Changing the Date/Time.................................................................................................33
Instrument Settings................................................................................................................34
Wireless Device Pairing ......................................................................................................34
Clearing Test Results ..........................................................................................................35
Auto Shutdown Time ..........................................................................................................35
Save Mode/Storing Test Results ........................................................................................35
Minimum Amplitude Value ................................................................................................36

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Clock Mode..........................................................................................................................37
Graph Style ..........................................................................................................................37
Norms ..................................................................................................................................37
Reverse Frequency..............................................................................................................38
Auto Stop .............................................................................................................................38
Language .............................................................................................................................38
Reset to Default...................................................................................................................38
Advanced Options ..................................................................................................................39
DPOAE Diagnostic Unit.......................................................................................................39
Instructions for Customizing a Test Protocol................................................................39
Selecting the Level of Primary Tones.............................................................................40
Setting the Averaging Time.............................................................................................40
Setting the PASS SNR Level.............................................................................................40
Setting the Number of Frequencies for PASS ...............................................................41
Reset Protocol..................................................................................................................41
Save Protocol...................................................................................................................42
TEOAE Diagnostic Unit........................................................................................................42
Instructions for Customizing a Test Protocol................................................................42
Selecting the Averaging Time .........................................................................................43
Setting the PASS SNR Level.............................................................................................43
Setting the Number of Frequencies for PASS ...............................................................44
Reset Protocol..................................................................................................................44
Save Protocol...................................................................................................................44
Cleaning and Maintenance ....................................................................................................45
Cleaning and Disinfection ..................................................................................................45
Maintenance........................................................................................................................46
Probe tube Replacement ...................................................................................................46
Status/Error Messages ...........................................................................................................47
Display Messages:...............................................................................................................47
Indicator LEDs (lights) .........................................................................................................48
Troubleshooting .....................................................................................................................49
Appendix A: Specifications.....................................................................................................52
PROBE SPECIFICATIONS .....................................................................................................52

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INSTRUMENT SPECIFICATIONS ..........................................................................................52
POWER SUPPLY SPECIFICATIONS (use only approved power supply)............................53
ENVIRONMENTAL REQUIREMENTS ...................................................................................53
Appendix B: Flowcharts..........................................................................................................54
Measurement......................................................................................................................54
Setup Menus .......................................................................................................................55
Appendix C: Test Sequence ...................................................................................................57
DPOAE..................................................................................................................................57
TEOAE...................................................................................................................................57
Comment about Variations in the SNR Estimate .............................................................58
Appendix D: Pass/Refer Criteria ............................................................................................59
DPOAE..................................................................................................................................59
TEOAE...................................................................................................................................60
Appendix E: Configurations and Test Protocols...................................................................62
Diagnostic Configurations..................................................................................................62
DPOAE Diagnostic Default Protocols.................................................................................63
TEOAE Diagnostic Default Protocols .................................................................................64
GSI Corti Screening Configurations...................................................................................64
DPOAE Screening Default Protocols..................................................................................65
TEOAE Screening Default Protocols ..................................................................................65
Appendix F: Standards Compliance ......................................................................................66
Appendix G: Specification of Input/output Connections.....................................................67
OAE Probe ...........................................................................................................................67
Appendix H: Warranty............................................................................................................68
Appendix I: Recycling and Disposal.......................................................................................69
Appendix J: Electromagnetic Compatibility ..........................................................................70
Electrical Safety, EMC and Associated Standards.............................................................70

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PREFACE
This user manual provides information about the GSI Corti OAE instrument. This
manual is intended for technically qualified personnel.
Please note: This User Manual is not intended as a training manual. The reader should
consult standard audiology texts for the theory and application of the tests provided by
this instrument.
This operating manual contains information pertinent to the use of the GSI Corti system
including safety information as well as maintenance and cleaning recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THE SYSTEM!
MANUAL CONVENTIONS
Throughout this manual, the following meaning of warnings, cautions and notices are
used.
WARNING
The WARNING symbol identifies conditions or practices that may present
danger to the patient and/or user.
CAUTION
The CAUTION Symbol identifies conditions or practices that could result in
damage to the equipment or loss of data.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during operation.

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REGULATORY SYMBOLS
Symbol
Description
Serial Number
Date of Manufacture
Manufacturer
Caution, Consult Accompanying Documents
Return to Authorized Representative, Special
Disposal Required
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

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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.
Conforms to European Medical Device Directive
93/42/EEC
FCC 47CFR, Part 15.247 & 15.249 (Wireless)
Consult the operating instructions/directions for
use. A copy of the operating manual is available on
this website: www.grason-stadler.com
A printed copy of the operating instructions can be
ordered from Grason-Stadler for shipment within 7
days; or you can contact your local representative.
E486032

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Symbol
Description
Consult the operating instructions/directions for
use. A copy of the operating manual is available on
this website: www.grason-stadler.com
A printed copy of the operating instructions can be
ordered from Grason-Stadler for shipment within 7
days; or you can contact your local representative.
Indicates that the device is a Medical Device
Class II medical equipment