User‟s MANUAL

Integrity™ V500

Preface
Model: Integrity™ V500 (also referred to as Integrity™ or Integrity)
REF: V500
Document No: 11049 rev 5.7

You are licensed to use this software to operate the Integrity V500 device. You do
not have permission to use this software in any manner not related to the intended
operation of this device. You may not supply or copy this software for use by any
third parties.
Integrity™ software is protected by US Pat. No. 6,463,411, 6,778,955, 7,286,983.
Other patents pending in the U.S. and other countries.
The Amplitrode® is protected by US Pat. No. 7,206,625 and 7,548,774. Other
patents pending in the US and other countries.

Amplitrode® , VivoLink™, and Vivosonic™ are all either registered trademarks or

trademarks of Vivosonic Inc. in the U.S. and other countries. All other trademarks
are the property of their respective owners.

COPYRIGHT NOTICE

© 2009 This User‟s Manual is copyrighted by:

Vivosonic Inc.
120-5525 Eglinton Avenue West
Toronto ON M9C 5K5 Canada
Voice: 1 (416) 231.9997
Fax: 1 (416) 231.2289
Toll-free: 1 (877) 255.7685 (Canada and U.S.)
E-mail: [email protected] (general)
[email protected] (Customer Support)
Website: www.vivosonic.com

MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany

CERTIFIED TO
IEC 60601

0120 3087966

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 Integrity™ V500

Safety
To ensure the safe operation of the Vivosonic Integrity™ system, please read and comply
with the following warning and caution statements.
The following symbols will be used throughout the manual.

WARNING
Messages with this heading indicate serious adverse reactions, potential safety hazards,
and limitations in use imposed by the issue labeled with a warning. The warning will
identify steps that should be taken if the incident occurs.

CAUTION

Messages with this heading indicate information regarding any special care to be
exercised by the practitioner and/or patient for the safe and effective use of the device.
All precautions should be followed to ensure data and system integrity.

ATTENTION
Messages with this heading indicate a possible loss of data. Follow the procedures to
ensure data integrity.

NOTE
Messages with this heading provide additional information that will increase the
technician‟s understanding of the operation of the system.

TIP
Messages with this heading provide tips or alternate instructions for a procedure.

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 Integrity™ V500

Table of Contents
PREFACE ....................................................................................................................................... 2
SAFETY .......................................................................................................................................... 3
TABLE OF FIGURES ................................................................................................................. 13
TABLE OF TABLES ................................................................................................................... 15
CHAPTER 1: INTRODUCTION ............................................................................................. 1
THE INTEGRITY™ SYSTEM ........................................................................................................... 1
Indications for Use of the Integrity™ System ......................................................................... 1
Intended Operator ................................................................................................................... 2
Intended Environment ............................................................................................................. 2
Auditory Brainstem Response (ABR) ...................................................................................... 3
Electrocochleography (ECochG) ............................................................................................ 3
AEP Electrode Impedance ...................................................................................................... 3
Electrical Interference in Auditory Evoked Potential Systems................................................ 4
Innovations in the Integrity™ System to Reduce Interference ................................................ 5
Otoacoustic Emissions (OAEs) ............................................................................................... 5
Other Features of the System .................................................................................................. 6
The Database .......................................................................................................................... 7
PRECAUTIONS AND WARNINGS .................................................................................................... 8
CHAPTER 2: CONFIGURATION ......................................................................................... 10
GENERAL CONFIGURATION ........................................................................................................ 10
COMPONENTS OF THE INTEGRITY SYSTEM ................................................................................. 11
VIVOLINK™ ............................................................................................................................... 12
VivoLink Functions ............................................................................................................... 13
On/Off Switch, Power LED Indicator ................................................................................... 15
Accessory Connectors ........................................................................................................... 15
Lanyard ................................................................................................................................. 16
Battery Compartment ............................................................................................................ 16
PROBES AND BENEFITS ............................................................................................................... 16
Amplitrode for ABR and ECochG Testing ............................................................................ 16
Clinical Benefits of Amplitrode for AEP Studies .................................................................. 18
ECochG Gold Electrode Ear Tip Cables .............................................................................. 18
OAE Probe ............................................................................................................................ 19
SPECIFICATIONS ......................................................................................................................... 19
CHAPTER 3: PREPARATION .............................................................................................. 20
UNPACKING INSTRUCTIONS ........................................................................................................ 20
INSTALLATION ............................................................................................................................ 20
System Setup by Manufacturer .............................................................................................. 20
System Setup for Customer-Installed Systems ....................................................................... 22
INSTALLATION OF NEW TEST TYPES .......................................................................................... 23
Activating Additional Modules.............................................................................................. 23
Initializing a Test Type.......................................................................................................... 24
CHAPTER 4: FIVE SCREENS OF INTEGRITY ................................................................ 25
THE PATIENTS SCREEN ......................................................................................................... 25
Entering Patient Information ................................................................................................ 26
Sorting the Table ................................................................................................................... 26
Adjusting the Columns and Rows .......................................................................................... 26
Entering Time of Birth .......................................................................................................... 27

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Selecting Patients ..................................................................................................................27

THE TEST SCREEN ....................................................................................................................28
SELECTING A TEST TYPE .............................................................................................................28
TEST-SPECIFIC CONTROLS AND INDICATORS ..............................................................................29
PROTOCOL SETTINGS SECTION ....................................................................................................29
TEST CONTROLS SECTION ...........................................................................................................29
Test Controls Drop-Down Menus ..........................................................................................30
Test Control Buttons ..............................................................................................................30
Current Day/Time ..................................................................................................................35
VIVOLINK™ STATUS ..................................................................................................................35
VivoLink Battery Indicator ....................................................................................................35
Bluetooth Connection Indicator.............................................................................................35
THE DATABASE SCREEN ........................................................................................................37
USING THE DATABASE ................................................................................................................37
Accessing the Database .........................................................................................................37
Documenting Test Results......................................................................................................37
Monitoring Data Changes Over Time ...................................................................................38
Quality Assurance..................................................................................................................38
DATABASE SCREEN DESCRIPTION ...............................................................................................38
Database Patient Table .........................................................................................................38
Database Waveform Information Windows ...........................................................................40
Database Controls .................................................................................................................42
THE PROTOCOL SCREEN .......................................................................................................47
Protocol List ..........................................................................................................................47
Protocol Query ......................................................................................................................48
Protocol Settings....................................................................................................................48
Activate and Deactivate protocols .........................................................................................48
Create a New Protocol ..........................................................................................................48
Discard Changes to a Protocol .............................................................................................49
Delete a Protocol ...................................................................................................................49
THE SYSTEM SCREEN ..............................................................................................................50
SYSTEM CONFIGURATION SELECTION AND CONTROLS ...............................................................50
Software Activation................................................................................................................50
Power Line Frequency Setting ...............................................................................................51
Battery Information ...............................................................................................................51
Birth Weight Unit Information ...............................................................................................51
DPOAE Settings ....................................................................................................................51
Transducers and Calibration Units .......................................................................................51
Unit ID ...................................................................................................................................53
Backup Database On Exit......................................................................................................53
Enable Tooltips ......................................................................................................................53
Changing the Password .........................................................................................................53
DATABASE CONTROLS ................................................................................................................55
Backing Up Records ..............................................................................................................55
Restoring the Database..........................................................................................................55
Saving Selected Records ........................................................................................................55
Merging Saved Records to the Database ...............................................................................56
Organization Information ......................................................................................................56
CHAPTER 5: OVERVIEW FOR ABR TESTING ................................................................57
GENERAL PREPARATION OF THE SYSTEM ......................................................................57

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ELECTRODES .............................................................................................................................. 58
Distinguishing Electrode Clips ............................................................................................. 58
Recommended Electrode Placement ..................................................................................... 58
PREPARING THE PATIENT............................................................................................................ 59
Skin Preparation ................................................................................................................... 59
Application of the Electrodes ................................................................................................ 60
ELECTRODE CONTACT ................................................................................................................ 61
Electrode Contact LED Indicator on the VivoLink ............................................................... 61
Electrode Contact Indicator on the Test Screen ................................................................... 61
CHECK IMPEDANCE MISMATCH.................................................................................................. 62
CHOOSE A TRANSDUCER ............................................................................................................ 62
ER-3A Earphones.................................................................................................................. 62
B-71 Bone Conductor ........................................................................................................... 63
SPECIFIC ABR TEST PREPARATION ................................................................................... 64
DEFINE AN ABR PROTOCOL ....................................................................................................... 64
STIMULUS SETTINGS................................................................................................................... 65
Recommended Stimulus Settings for Diagnostics ................................................................. 65
Recommended Stimulus Settings for Threshold Testing ........................................................ 65
Understanding the Settings on the Protocol Screen .............................................................. 65
TEST SETTINGS ........................................................................................................................... 68
Recommended Test Settings .................................................................................................. 68
High-Pass Filter Cutoff Frequency (Hz) ............................................................................... 68
Low-Pass Filter Cutoff Frequency (Hz) ................................................................................ 68
High-Pass Filter Rolloff and Low-Pass Filter Rolloff .......................................................... 68
Post-Amplitrode Gain (dB) ................................................................................................... 68
Recording Window (ms) ........................................................................................................ 68
Artifact Rejection .................................................................................................................. 68
Artifact Rejection Threshold ................................................................................................. 68
DURING THE TEST ................................................................................................................... 69
THE ABR TEST SCREEN ............................................................................................................. 69
Electrode Contact ................................................................................................................. 69
Right Ear/Left Ear Button ..................................................................................................... 69
TEST PROTOCOL PARAMETERS FOR ABR ................................................................................... 69
Algorithm .............................................................................................................................. 70
Status..................................................................................................................................... 70
Polarity ................................................................................................................................. 70
Ear Tip .................................................................................................................................. 71
Masker .................................................................................................................................. 71
Masking Level ....................................................................................................................... 71
Non-Inverting (+) and Inverting (-) Electrode ...................................................................... 71
Recording Side ...................................................................................................................... 71
Notch Filter ........................................................................................................................... 72
Electrodes Used .................................................................................................................... 72
Level (dB pe SPL)/ (dB nHL) ................................................................................................ 73
SIGNAL INFORMATION ................................................................................................................ 73
Stimulus Type ........................................................................................................................ 73
Transducer Type ................................................................................................................... 73
Number of Stimuli (Num of Stim) .......................................................................................... 74
% Rejected ............................................................................................................................ 74
Eq. Sweeps ............................................................................................................................ 74
Latency-Intensity ................................................................................................................... 74
EEG WINDOW ............................................................................................................................ 75
Electrode Contact ................................................................................................................. 75
What to do When Electrode Contact is Undetected .............................................................. 76

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Ongoing EEG ........................................................................................................................76

WAVEFORM WINDOW .................................................................................................................77
Waveform Handle ..................................................................................................................77
Label a Waveform ..................................................................................................................78
Waveform Labels ...................................................................................................................79
A,B Display ............................................................................................................................79
A-B Display ...........................................................................................................................79
Delete Waveform Button ........................................................................................................80
Page Break View ...................................................................................................................81
Latency Norms .......................................................................................................................81
Y-Axis Scale ...........................................................................................................................82
WAVEFORM INFORMATION CHART .............................................................................................83
CLOSE THE TEST SCREEN ............................................................................................................84
POST TEST REVIEW .................................................................................................................84
THE ABR DATABASE SCREEN WAVEFORMS...............................................................................84
DATABASE CONTROLS ................................................................................................................86
PERFORMING AN ABR TEST ..................................................................................................87
PLACE THE VIVOLINK ON THE PATIENT ......................................................................................87
DEFINE THE TEST ........................................................................................................................88
POST TEST PROCEDURES .............................................................................................................90
REVIEWING RESULTS ..................................................................................................................90
STORING THE INTEGRITY SYSTEM ...............................................................................................90
CHAPTER 6: OVERVIEW OF ECOCHG TESTING ..........................................................91
GENERAL PREPARATION OF THE SYSTEM ......................................................................91
ECOCHG GOLD ELECTRODE EAR TIP CABLE CONNECTION ........................................................91
PREPARING THE PATIENT ............................................................................................................91
Ear Preparation .....................................................................................................................92
Skin Preparation and Electrode Placement ...........................................................................92
SPECIFIC ECOCHG TEST PREPARATION ..........................................................................93
DEFINE AN ECOCHG PROTOCOL .................................................................................................93
PROTOCOL SCREEN STIMULUS SETTINGS ....................................................................................93
Recommended Stimulus Settings for ECochG .......................................................................93
Understanding the Settings on the Protocol Screen ..............................................................94
PROTOCOL SCREEN TEST SETTINGS ............................................................................................96
Recommended Test Settings ...................................................................................................96
High-Pass Filter Cutoff Frequency (Hz) ...............................................................................96
Low-Pass Filter Cutoff Frequency (Hz) ................................................................................96
High-Pass Filter Rolloff and Low-Pass Filter Rolloff ...........................................................96
Post-Amplitrode Gain (dB) ....................................................................................................96
Recording Window (ms) ........................................................................................................96
Artifact Rejection ...................................................................................................................96
Artifact Rejection Threshold ..................................................................................................97
DURING THE TEST ....................................................................................................................97
THE ECOCHG TEST SCREEN .......................................................................................................97
Electrode Contact ..................................................................................................................97
Right Ear/Left Ear Button ......................................................................................................97
TEST PROTOCOL PARAMETERS FOR ECOCHG .............................................................................97
Algorithm ...............................................................................................................................98
Status .....................................................................................................................................98
Polarity ..................................................................................................................................98

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 Integrity™ V500

Ear Tip .................................................................................................................................. 99

Masker .................................................................................................................................. 99
Masking Level ....................................................................................................................... 99
Non-Inverting (+) and Inverting (-) Electrode ...................................................................... 99
Recording Side .................................................................................................................... 100
Notch Filter ......................................................................................................................... 100
Electrodes Used .................................................................................................................. 101
Levels (dB pe SPL)/ (dB nHL) ............................................................................................. 101
SIGNAL INFORMATION .............................................................................................................. 101
Stimulus Type ...................................................................................................................... 101
Transducer Type ................................................................................................................. 102
Number of Stimuli (Num of Stim) ........................................................................................ 102
% Rejected .......................................................................................................................... 102
Eq. Sweeps .......................................................................................................................... 102
EEG WINDOW .......................................................................................................................... 102
Electrode Contact ............................................................................................................... 103
What to do when Electrode Contact is Undetected ............................................................. 103
Ongoing EEG ...................................................................................................................... 103
WAVEFORM WINDOW .............................................................................................................. 104
Waveform Handle ............................................................................................................... 105
Label a Waveform ............................................................................................................... 105
Waveform Labels ................................................................................................................ 106
A,B Display ......................................................................................................................... 106
A-B Display ......................................................................................................................... 107
Delete Waveform Button ..................................................................................................... 107
Page Break View ................................................................................................................. 107
Y-Axis Scale ........................................................................................................................ 108
WAVEFORM INFORMATION CHART .......................................................................................... 108
LEAVE THE TEST SCREEN ......................................................................................................... 109
POST TEST REVIEW ............................................................................................................... 109
THE ECOCHG DATABASE SCREEN WAVEFORMS ..................................................................... 110
DATABASE CONTROLS ............................................................................................................. 111
PERFORMING AN ECOCHG TEST ...................................................................................... 112
PLACE THE VIVOLINK ON THE PATIENT ................................................................................... 112
DEFINE THE TEST ..................................................................................................................... 113
POST TEST PROCEDURES .......................................................................................................... 115
REVIEWING RESULTS ............................................................................................................... 115
STORING THE INTEGRITY SYSTEM ............................................................................................ 115
CHAPTER 7: OVERVIEW OF ASSR TESTING .............................................................. 116
GENERAL PREPARATION OF THE SYSTEM ................................................................... 116
ELECTRODES ............................................................................................................................ 116
Distinguishing Electrode Clips ........................................................................................... 116
Recommended Electrode Placement ................................................................................... 117
PREPARING THE PATIENT.......................................................................................................... 118
Skin Preparation ................................................................................................................. 118
Application of the Electrodes .............................................................................................. 118
ELECTRODE CONTACT .............................................................................................................. 119
Electrode Contact LED Indicator on the VivoLink ............................................................. 120
Electrode Contact Indicator on the Test Screen ................................................................. 120
CHECK IMPEDANCE MISMATCH................................................................................................ 120
SPECIFIC ASSR TEST PREPARATION ............................................................................... 121

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DEFINE AN ASSR PROTOCOL ....................................................................................................121

Stimulus Settings ..................................................................................................................122
Threshold Search .................................................................................................................122
DURING THE TEST ..................................................................................................................123
THE ASSR TEST SCREEN ..........................................................................................................123
Electrode Contact ................................................................................................................123
EEG WINDOW...........................................................................................................................123
Electrode Contact ................................................................................................................123
What to do When Electrode Contact is not detected ............................................................124
Ongoing EEG ......................................................................................................................124
CLOSE THE TEST SCREEN ..........................................................................................................124
PERFORMING AN ASSR TEST ..............................................................................................125
PLACE THE VIVOLINK ON THE PATIENT ....................................................................................125
DEFINE THE TEST ......................................................................................................................125
REVIEWING RESULTS ................................................................................................................127
STORING THE INTEGRITY SYSTEM .............................................................................................127
CHAPTER 8: OVERVIEW OF TEOAE TESTING ...........................................................128
GENERAL PREPARATION OF THE SYSTEM ....................................................................128
THE PROBE................................................................................................................................128
PREPARING THE PATIENT ..........................................................................................................128
SPECIFIC TEOAE TEST PREPARATION ............................................................................129
DEFINE A TEOAE PROTOCOL ...................................................................................................130
STIMULI PARAMETERS ..............................................................................................................131
STI-Mode .............................................................................................................................131
Click Duration .....................................................................................................................131
Click Interval .......................................................................................................................131
Click Level ...........................................................................................................................132
TEST CONTROL .........................................................................................................................132
Recording Window ..............................................................................................................132
High Pass Filter Cutoff Frequency ......................................................................................132
Low Pass Filter Cutoff Frequency .......................................................................................132
Artifact Rejection Threshold ................................................................................................132
Number of Clicks .................................................................................................................132
OPERATING MODE ....................................................................................................................132
PASS/REFER CRITERIA ..............................................................................................................133
DURING THE TEST ..................................................................................................................133
THE TEOAE TEST SCREEN .......................................................................................................133
RESPONSE WAVEFORM AND RESPONSE SPECTRUM WINDOWS .................................................134
SNS CHART ..............................................................................................................................134
TEST CONTROL BUTTONS .........................................................................................................134
TEST VALUE FIELDS..................................................................................................................135
MESSAGE AND ASSESSMENT WINDOW .....................................................................................137
TEST PROTOCOL PARAMETERS .................................................................................................137
Ear Tip .................................................................................................................................138
Algorithm .............................................................................................................................138
Display .................................................................................................................................138
Bands ...................................................................................................................................138
POST TEST REVIEW ...............................................................................................................138
TEOAE DATABASE SCREEN .....................................................................................................138

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Monitoring OAE Changes Over Time ................................................................................. 139

Patient Test Information ..................................................................................................... 139
Database Waveform Information ........................................................................................ 139
Database Controls .............................................................................................................. 140
PERFORMING A TEOAE TEST ............................................................................................ 140
IN-THE-EAR TEST ..................................................................................................................... 140
DEFINE THE TEST ..................................................................................................................... 141
POST TEST PROCEDURES .......................................................................................................... 143
STORING THE INTEGRITY SYSTEM ............................................................................................ 143
CHAPTER 9: OVERVIEW OF DPOAE TESTING ........................................................... 144
SPECIFIC DPOAE TEST PREPARATION ........................................................................... 144
PREPARING THE PATIENT.......................................................................................................... 145
DEFINE A DPOAE PROTOCOL .................................................................................................. 146
DURING THE TEST ................................................................................................................. 149
THE DPOAE TEST SCREEN ...................................................................................................... 149
DP-GRAM................................................................................................................................. 150
TEST PROTOCOL PARAMETERS ................................................................................................. 152
Ear Tip ................................................................................................................................ 152
Maximum Effective Duration per Frequency (sec) ............................................................. 152
TEST VALUE FIELDS ................................................................................................................. 152
PROBE FIT CHECK .................................................................................................................... 153
SPLIT / MERGE CHARTS ............................................................................................................ 153
MESSAGE AND ASSESSMENT WINDOW ..................................................................................... 154
TEST CONTROL BUTTONS ......................................................................................................... 155
POST TEST REVIEW ............................................................................................................... 157
DPOAE DATABASE SCREEN .................................................................................................... 157
Monitoring DPOAE over time ............................................................................................ 157
Patient Test Information ..................................................................................................... 158
Database DP-Gram ............................................................................................................ 158
Database Controls .............................................................................................................. 159
PERFORMING A DPOAE TEST ............................................................................................ 159
DEFINE THE TEST ..................................................................................................................... 159
POST TEST PROCEDURES .......................................................................................................... 161
STORING THE INTEGRITY SYSTEM ............................................................................................ 161
CHAPTER 10: INTEGRITY SYSTEM CARE ................................................................ 162
CARING FOR THE PROBES .................................................................................................. 162
AMPLITRODE AND ELECTRODE CLIPS....................................................................................... 162
ABR TRANSDUCER AND ELECTRODES ...................................................................................... 162
ER-3A .................................................................................................................................. 162
B-71 Bone Conductor ......................................................................................................... 162
CLEANING THE OAE PROBE ..................................................................................................... 162
ECOCHG GOLD ELECTRODE EAR TIP ....................................................................................... 163
CARING FOR THE VIVOLINK ............................................................................................. 163
RECHARGING BATTERIES ......................................................................................................... 163
VivoLink .............................................................................................................................. 163
Computer ............................................................................................................................ 163
REPLACING BATTERIES ............................................................................................................ 163

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CARING FOR THE COMPUTER............................................................................................163

CHAPTER 11: TROUBLESHOOTING ............................................................................164
APPENDIX A: TECHNICAL SPECIFICATIONS ..........................................................167
APPENDIX B: ITEMS TRACKED BY THE INTEGRITY DATABASE .....................171
GENERAL DATA FOR ALL TEST TYPES ......................................................................................171
ABR TEST TYPE DATA PER WAVEFORM ...................................................................................172
ECOCHG TEST TYPE DATA PER WAVEFORM ............................................................................172
TEOAE TEST TYPE DATA ........................................................................................................173
DPOAE TEST TYPE DATA ........................................................................................................173
APPENDIX C: AUTOMATIC TEOAE SCREENING ALGORITHM ..........................174
APPENDIX D: AUTOMATIC DPOAE SCREENING ALGORITHM ..........................175
APPENDIX E: PRESET PROTOCOLS AND TEST SETTINGS ..................................177
ABR PRESET PROTOCOLS .........................................................................................................177
ABR Air-Conducted Default Protocols ................................................................................177
Test Screen Settings for All Air-Conducted Protocols .........................................................181
ABR Bone Conductor Default Protocols .............................................................................182
Test Screen Settings for All Bone Conductor Protocols ......................................................186
Other ABR Default Protocols ..............................................................................................186
Test Screen Settings for other ABR Protocols .....................................................................187
ECOCHG PRESET PROTOCOLS ...................................................................................................188
ECochG Default Protocols ..................................................................................................188
Test Screen Settings for ECochG Protocols ........................................................................188
TEOAE PRESET PROTOCOLS ....................................................................................................190
TEOAE Default Protocols ...................................................................................................190
Test Screen Settings for TEOAE Protocols ..........................................................................192
DPOAE PRESET PROTOCOLS ....................................................................................................193
DPOAE Default Protocols ...................................................................................................193
Test Screen Settings for DPOAE Protocols .........................................................................195
APPENDIX F: GUIDANCE AND MANUFACTURER’S DECLARATION ................196
EMISSIONS.................................................................................................................................196
IMMUNITY .................................................................................................................................196
RADIO TRANSMISSIONS .............................................................................................................197
APPENDIX G: RECOMMENDED SEPARATION DISTANCE ....................................199
APPENDIX H: SYMBOLS USED ON THE INSTRUMENT ..........................................200
APPENDIX I: CLINICAL APPLICATIONS FOR AEP ................................................202
APPENDIX J: CLINICAL APPLICATION FOR ELECTROCOCHLEOGRAPHY .203
APPENDIX K: CLINICAL APPLICATION FOR OTOACOUSTIC EMISSIONS .....204
OAE SPECIFICS .........................................................................................................................204
TEOAE SPECIFICS ....................................................................................................................204
DPOAE SPECIFICS ....................................................................................................................205
APPENDIX L: ABR LATENCY NORMS DATA ............................................................206
UCLA SCHOOL OF MEDICINE NORMS FOR INFANTS .................................................................206
BOYS TOWN NORMS FOR NEWBORNS .......................................................................................206
BOYS TOWN NORMS FOR INFANTS ............................................................................................207
ABSOLUTE AND INTERWAVE LATENCY VALUES .......................................................................208
APPENDIX M: DPOAE NORMS DATA ...........................................................................209

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APPENDIX N: REFERENCES .......................................................................................... 210

APPENDIX O: GLOSSARY OF TERMS ......................................................................... 212
APPENDIX P: BLUETOOTH® TROUBLESHOOTING ............................................... 220
INDEX ......................................................................................................................................... 222

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Table of Figures
FIGURE 1. INTEGRITY™ AND VIVOLINK™ ............................................................................................... 1
FIGURE 2. INTEGRITY™ SYSTEM ..........................................................................................................10
FIGURE 3. EAR TIPS FOR ABR .............................................................................................................11
®
FIGURE 4. GOLD ELECTRODE TIPTRODE EAR TIPS FOR ECOCHG .........................................................11
®
FIGURE 5. NEUROLINE 720 00-S ELECTRODES FOR AEP TESTS ..........................................................11
FIGURE 6. SINGLE-USE EAR TIPS FOR THE TEOAE AND DPOAE PROBE ..................................................12
®
FIGURE 7. VIVOLINK™(1), AMPLITRODE (2), AND OAE PROBE (3) ........................................................12
FIGURE 8. VIVOLINK FRONT PANEL ......................................................................................................14
FIGURE 9. VIVOLINK CONNECTOR PANEL ..............................................................................................15
FIGURE 10. VIVOLINK LANYARD ...........................................................................................................16
®
FIGURE 11. AMPLITRODE ...................................................................................................................17
FIGURE 12. ECOCHG ELECTRODE EAR TIP CABLES ..............................................................................18
FIGURE 13. OAE PROBE ATTACHED TO THE VIVOLINK ............................................................................19
FIGURE 14. CAUTION SCREEN .............................................................................................................21
FIGURE 15. MESSAGE FOR NEW SOFTWARE ACTIVATION CODE ................................................................24
FIGURE 16. MESSAGE INDICATING INCORRECT ACTIVATION CODE ............................................................24
FIGURE 17. MESSAGE TO RESTART THE PROGRAM .................................................................................24
FIGURE 18. PATIENTS SCREEN ............................................................................................................25
FIGURE 19. DROP-DOWN CALENDAR ...................................................................................................27
FIGURE 20. DROP-DOWN CLOCK .........................................................................................................27
FIGURE 21. SELECTED PATIENTS IN PATIENTS SCREEN ..........................................................................28
FIGURE 22. TEST SCREEN ...................................................................................................................28
FIGURE 23. TEST CONTROLS DROP-DOWN MENUS .................................................................................30
FIGURE 24. TEST CONTROL BUTTONS ..................................................................................................31
FIGURE 25. SAVE RESULT CONFIRMATION ............................................................................................32
FIGURE 26. DIALOG BOX - ARE YOU SURE YOU WANT TO DISCARD THIS RECORD? .....................................33
FIGURE 27. PRINT RESULT CONFIRMATION ...........................................................................................34
FIGURE 28. TEST CONTROLS DATE AND TIME .......................................................................................35
FIGURE 29. VIVOLINK BATTERY VOLTAGE INDICATOR ............................................................................35
®
FIGURE 30. BLUETOOTH CONNECTION INDICATOR ...............................................................................36
FIGURE 31. BLUETOOTH CONNECTION FAILED MESSAGE .......................................................................36
FIGURE 32. DATABASE SCREEN SHOWING TEOAE DATA .......................................................................37
FIGURE 33. DATABASE PATIENT LIST – INITIAL VIEW ...............................................................................38
FIGURE 34. DATABASE PATIENT LIST – OTHER FIELDS SCROLLED RIGHT ...................................................39
FIGURE 35. ABR DATABASE PREVIEW SCREEN.....................................................................................40
FIGURE 36. ECOCHG DATABASE PREVIEW SCREEN ..............................................................................41
FIGURE 37. TEOAE DATABASE PREVIEW SCREEN ................................................................................41
FIGURE 38. DPOAE DATABASE PREVIEW SCREEN ...............................................................................41
FIGURE 39. DATABASE CONTROLS .......................................................................................................42
FIGURE 40. DPOAE TEST RESULTS IN TABULAR FORMAT FOR MULTIPLE AVERAGED TEST RECORDS ............42
FIGURE 41. TEOAE TEST RECORD RESULT IN TABULAR FORMAT .............................................................43
FIGURE 42. CLINICAL SUMMARY W INDOW .............................................................................................43
FIGURE 43. PRINT REPORT DIALOG BOX ..............................................................................................44
FIGURE 44. PRINT A CUSTOM REPORT .................................................................................................45
FIGURE 45. REPORT OPTIONS DIALOG BOX ..........................................................................................45
FIGURE 46. EXPORT TEST RESULT ......................................................................................................46
FIGURE 47. PROTOCOL SCREEN SHOWING AN ECOCHG PROTOCOL ........................................................47
FIGURE 48. PROTOCOL QUERY ............................................................................................................48
FIGURE 49. PROTOCOL LIST WITH ACTIVATED PROTOCOLS .....................................................................48
FIGURE 50. PROTOCOL DIALOG BOX ....................................................................................................49
FIGURE 51. CHANGE PROTOCOL MESSAGE ...........................................................................................49
FIGURE 52. SYSTEM SCREEN ..............................................................................................................50
FIGURE 53. MERGING DATABASE CONFLICT W ARNING ...........................................................................56
FIGURE 54. TYPICAL ELECTRODE PLACEMENT DIAGRAM - FRONT VIEW ....................................................58
FIGURE 55. TYPICAL ELECTRODE PLACEMENT DIAGRAM - LEFT LATERAL VIEW ..........................................58
FIGURE 56. AMPLITRODE AND ELECTRODE CLIP PLACEMENT ON AN INFANT .............................................59
FIGURE 57. AMPLITRODE ....................................................................................................................60
FIGURE 58. CHECK IMPEDANCE MISMATCH DIALOG BOX ........................................................................62
FIGURE 59. ER-3A EARPHONES (A) AND THEIR FOAM EAR TIP DIMENSIONS (B) .......................................63

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 Integrity™ V500

FIGURE 60. PROTOCOL STIMULUS SETTINGS AND TEST SETTINGS ......................................................... 64

FIGURE 61. PROTOCOL TEST SETTINGS ............................................................................................... 69
FIGURE 62. NON-INVERTING (+) ELECTRODE DROP-DOWN LIST............................................................. 71
FIGURE 63. LIST OF ELECTRODES AVAILABLE FOR TESTING ................................................................... 72
FIGURE 64. STIMULUS LEVEL BAR (DB PE SPL) ................................................................................... 73
FIGURE 65. SIGNAL INFORMATION ....................................................................................................... 73
FIGURE 66. LATENCY-INTENSITY GRAPH .............................................................................................. 75
FIGURE 67. EEG W INDOW ................................................................................................................. 75
FIGURE 68. POOR ELECTRODE CONTACT............................................................................................. 76
FIGURE 69. W AVEFORM W INDOW WITH RECORDED DATA ....................................................................... 77
FIGURE 70. W AVEFORM HANDLE ......................................................................................................... 77
FIGURE 71. W AVEFORM LABELING BUTTONS ........................................................................................ 78
FIGURE 72. NOTE CALLOUT ................................................................................................................ 79
FIGURE 73. W AVEFORM W INDOW WITH A,B AND A-B DISPLAY ............................................................... 80
FIGURE 74. LINKED AND UNLINKED W AVEFORM ICON ............................................................................ 80
FIGURE 75. PAGE BREAK VIEW ........................................................................................................... 81
FIGURE 76. LATENCY NORMS ............................................................................................................. 82
FIGURE 77. W AVEFORM INFORMATION CHART ...................................................................................... 83
FIGURE 78. ARE YOU SURE YOU WANT TO DISCARD THIS RECORD? ......................................................... 84
FIGURE 79. DATABASE W AVEFORM INFORMATION FOR ABR .................................................................. 85
FIGURE 80. EXPANDED DATABASE W AVEFORM W INDOW ....................................................................... 85
FIGURE 81. DATABASE CONTROLS FOR ABR ....................................................................................... 86
FIGURE 82. LATENCY-INTENSITY GRAPH .............................................................................................. 87
FIGURE 83. ELECTRODE EAR TIP CABLE CONNECTS GOLD ELECTRODE EAR TIPS TO ER-3A TRANSDUCERS 91
®
FIGURE 84. GOLD ELECTRODES (TIPTRODE ) ATTACHED TO THE ELECTRODE EAR TIP CABLE ................. 92
FIGURE 85. AMPLITRODE GROUND CONNECTED TO THE PATIENT‟S FOREHEAD .......................................... 92
FIGURE 86. INVERTING AMPLITRODE CLIP CONNECTED TO ELECTRODE EAR TIP CABLE AND EAR TIPS ........ 93
FIGURE 87. PROTOCOL STIMULUS SETTINGS AND TEST SETTINGS ......................................................... 94
FIGURE 88. PROTOCOL SETTINGS ON THE TEST SCREEN....................................................................... 97
FIGURE 89. PATIENT STATUS DROP-DOWN LIST SHOWN ....................................................................... 98
FIGURE 90. EAR TIPS DROP-DOWN LIST .............................................................................................. 99
FIGURE 91. NON-INVERTING (+) AND INVERTING (-) ELECTRODE DROP-DOWN LIST ............................... 100
FIGURE 92. LIST OF ELECTRODES AVAILABLE FOR TESTING ................................................................. 101
FIGURE 93. STIMULUS LEVEL BAR (DB PE SPL) ................................................................................. 101
FIGURE 94. SIGNAL INFORMATION ..................................................................................................... 101
FIGURE 95. EEG W INDOW ............................................................................................................... 102
FIGURE 96. ELECTRODE CONTACT .................................................................................................... 103
FIGURE 97. W AVEFORM W INDOW OF THE TEST SCREEN ..................................................................... 104
FIGURE 98. W AVEFORM HANDLE ....................................................................................................... 105
FIGURE 99. W AVEFORM LABELING BUTTONS ...................................................................................... 105
FIGURE 100. NOTE CALLOUT ............................................................................................................ 106
FIGURE 101. LINKED AND UNLINKED W AVEFORM ICON ........................................................................ 107
FIGURE 102. W AVEFORM INFORMATION CHART .................................................................................. 108
FIGURE 103. ARE YOU SURE YOU WANT TO DISCARD THIS RECORD? ..................................................... 109
FIGURE 104. ECOCHG DATABASE PREVIEW SCREEN ......................................................................... 110
FIGURE 105. ECOCHG DATABASE FULL SCREEN WAVEFORM WINDOW (EXPAND) ................................... 110
FIGURE 106. DATABASE CONTROLS FOR ECOCHG ............................................................................. 111
FIGURE 107. SYSTEM SET-UP FOR ECOCHG TESTING ......................................................................... 112
FIGURE 54. TYPICAL ELECTRODE PLACEMENT DIAGRAM - FRONT VIEW ................................................. 117
FIGURE 55. TYPICAL ELECTRODE PLACEMENT DIAGRAM - LEFT LATERAL VIEW ....................................... 117
FIGURE 57. AMPLITRODE .................................................................................................................. 119
FIGURE 58. CHECK IMPEDANCE MISMATCH DIALOG BOX ..................................................................... 121
FIGURE 60. ASSR PROTOCOL STIMULUS SETTINGS AND THRESHOLD SEARCH ..................................... 121
FIGURE 67. EEG W INDOW ............................................................................................................... 123
FIGURE 68. POOR ELECTRODE CONTACT........................................................................................... 124
FIGURE 78. ARE YOU SURE YOU WANT TO DISCARD THIS RECORD? ....................................................... 125
FIGURE 108. CORRECTLY INSERTED OAE PROBE .............................................................................. 129
FIGURE 109. MESSAGE AND ASSESSMENT W INDOW ........................................................................... 130
FIGURE 110. OAE PROTOCOL PARAMETERS ..................................................................................... 131
FIGURE 111. TEOAE TEST SCREEN ................................................................................................. 133
FIGURE 112. RESPONSE W AVEFORM AND RESPONSE SPECTRUM W INDOWS......................................... 134
FIGURE 113. SIGNAL, NOISE AND SNR GRAPH ................................................................................... 134

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 Integrity™ V500

FIGURE 114. TEST CONTROL BUTTONS ..............................................................................................135

FIGURE 115. TEST VALUE FIELDS AND SHOW STIMULUS BUTTON .........................................................135
FIGURE 116. STIMULUS DISPLAY .......................................................................................................136
FIGURE 117. MESSAGE AND ASSESSMENT W INDOW (PASS-AUTO) .......................................................137
FIGURE 118. TEOAE DATABASE SCREEN ..........................................................................................139
FIGURE 119. DATABASE W AVEFORM INFORMATION FOR TEOAE ..........................................................140
FIGURE 120. DATABASE CONTROLS FOR TEOAE ...............................................................................140
FIGURE 121. PROBE-CHECK MESSAGE – PASSED ................................................................................141
FIGURE 122. PROBE-CHECK MESSAGE – ERROR .................................................................................141
FIGURE 123. PROBE-CHECK MESSAGE – NOISE ...................................................................................141
FIGURE 124. PROBE NOT CONNECTED MESSAGE BOX ........................................................................144
FIGURE 125. MESSAGE AND ASSESSMENT W INDOW (CAVITY CHECK - PASS).........................................146
FIGURE 126. MESSAGE AND ASSESSMENT W INDOW (CAVITY CHECK - FAIL) ..........................................146
FIGURE 127. DPOAE PROTOCOL PARAMETERS .................................................................................147
FIGURE 128. DPOAE TEST SCREEN – ASSESSMENT ..........................................................................149
FIGURE 129. SOUND LEVEL INDICATORS ............................................................................................151
FIGURE 130. DPOAE TEST PROTOCOL PARAMETERS .........................................................................152
FIGURE 131. DPOAE TEST VALUE FIELDS .........................................................................................152
FIGURE 132. DPOAE MERGE CHARTS ..............................................................................................153
FIGURE 133. DPOAE SPLIT CHARTS .................................................................................................154
FIGURE 134. MESSAGE AND ASSESSMENT W INDOW (ASSESSMENT) .....................................................154
FIGURE 135. SELECT TEST OUTCOME WHEN IN MANUAL MODE OF OPERATION .........................................155
FIGURE 136. TEST CONTROL BUTTONS ..............................................................................................156
FIGURE 137. CAVITY CHECK IN PROGRESS MESSAGE .........................................................................156
FIGURE 138. DPOAE DATABASE SCREEN WITH NORMS DATA .............................................................157
FIGURE 139. DATABASE DP-GRAM FOR DPOAE ................................................................................158
FIGURE 140. DATABASE CONTROLS FOR DPOAE ...............................................................................159

Table of Tables
TABLE 1. SIGNAL AND NOISES IN ABR/ECOCHG RECORDING .................................................................. 4
TABLE 2. DB NHL CONVERSION FOR BONE CONDUCTOR B-71 ................................................................52
TABLE 3. DB HL PURE TONE CONVERSION FOR INSERT EARPHONE ER-3A...............................................52
TABLE 4. DB NHL TRANSIENT SIGNAL CONVERSION FOR INSERT EARPHONE ER-3A ..................................52
TABLE 5. RECOMMENDED ABR STIMULUS RATES (STIMULI/SECOND) .......................................................66
TABLE 6. STIMULUS LEVELS RANGES ...................................................................................................67
TABLE 7. RECOMMENDED ECOCHG STIMULUS RATES (STIMULI/SECOND) ...............................................95
TABLE 8. RECOMMENDED TEOAE INTERVALS (IN MS) ..........................................................................132
TABLE 9. TROUBLESHOOTING PROBLEMS, CAUSES, AND SOLUTIONS .....................................................164
TABLE 10. UCLA SCHOOL OF MEDICINE NORMS FOR INFANTS ..............................................................206
TABLE 11. BOYS TOWN NORMS FOR NEWBORNS ..................................................................................206
TABLE 12. BOYS TOWN NORMS FOR INFANTS ......................................................................................207
TABLE 13. ABSOLUTE AND INTERWAVE LATENCY VALUES ......................................................................208

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Chapter 1: Integrity™ V500 Introduction

Chapter 1: Introduction
The Integrity™ System
The Integrity™ V500 is the world‟s first wireless interface module that performs auditory
electrophysiology with four test modalities: Auditory Brainstem Response (ABR),
Electrocochleography (ECochG), Transient Evoked Otoacoustic Emissions (TEOAE), and
Distortion Product Otoacoustic Emissions (DPOAE). It is multi-functional and was
developed to overcome evoked response recording difficulties.

Figure 1. Integrity™ and VivoLink™

Vivosonic™ solutions employed in this system include wireless Bluetooth® communications
between the computer and the data collecting module via the VivoLink™ and Linear
Minimum Mean Square Error filtering to allow recording in the presence of intermittent
noise such as muscle artifact in ABR and ECochG and acoustic noise in TEOAE and
DPOAE.
In addition, Integrity incorporates in situ amplification for Auditory Evoked Potential (AEP)
measurements with the Amplitrode®, a combination of an electrode clip and a pre-amplifier.
These technologies provide the following benefits:
• Largely reduced physiological and non-physiological noise resulting in fast, accurate,
and clear recordings.
• Mobility for the patient and the user.
• Electrodes can be quickly clipped and unclipped from the patient using easy release
buttons on the electrode clips.
• Shorter lead wires mean fewer inconveniences than experienced with long lead wires
and cables.
• Less risk of probe and electrode-lead misconnection.

Indications for Use of the Integrity™ System

The ABR and ECochG test options in the Integrity System are indicated for Auditory
Evoked Potential (AEP) testing as an aid in detecting hearing loss and lesions in the
auditory pathway.

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Introduction Integrity™ V500 Chapter 1:

The TEOAE and DPOAE options in the Integrity System are indicated for measuring
whether or not the cochlear outer hair cells are functioning. This device does not measure
hearing per se, but helps to determine whether or not a hearing loss may be present,
requiring further evaluation. The system does not determine hearing levels, but allows the
operator to establish specific pass or refer criteria.
This system can be used as a front-line objective audiometry tool together with other
audiometric techniques conducted with other devices such as conventional audiometry,
tympanometry, middle ear muscle reflexes, eustachian tube function test, visual
reinforcement audiometry, and other tests. However, the system is not intended to replace
all other audiometers or audiometric tests.
The Integrity is suited for testing patients of all ages: newborns, infants, children, and adults
through seniors.

Intended Operator
The intended operator is a trained physician, audiologist, or other trained health-care
professional licensed by local authorities to perform hearing assessment. This person must
be trained in the assessment of auditory difficulties. To use this device, the operator will be
required to fit the patient with the ER-3A ear tips (for ABR and ECochG studies) or an OAE
probe (for TEOAE and DPOAE studies), affix the B-71 Bone Conductor and the electrodes
to the patient, connect the patient to the VivoLink, and conduct the test procedure.

ATTENTION
Integrity is a prescription device. The labeling, instructions, and user operations are
designed for trained professionals.

CAUTION
The Integrity System (Model V500) is an ABR, ECochG, TEOAE, and DPOAE
recording system providing valuable information that allows estimating hearing
loss, and diagnosing cochlear and retro-cochlear function. While the Integrity
System indicates certain auditory problems, it should be used as a part of a wider
audiologic test battery to arrive at an auditory diagnosis. In addition to these tests
the patient must receive additional clinical testing using other techniques.
Use this device only as specified.

Intended Environment
The system is designed for use in a hospital, ambulatory setting, maternity ward, Intensive
Care Unit (ICU), doctors‟ office, Otolaryngology and Audiology clinic, school, or
occupational settings.
This system is sensitive to excessive acoustic noise. Although a sound-proof booth is not
required, tests should be performed in a quiet environment, as the acoustic noise floor in
TEOAE and DPOAE tests, and the signal level in all tests may be affected by the ambient
acoustic noise level.

WARNING
Medical instrumentation requires special precautions regarding Electromagnetic
Compatibility (EMC). Medical instruments need to be installed according to the
EMC shielding information provided in the accompanying documents.
The Electromagnetic Radiation (EMR) associated with portable and mobile radio
frequency communication devices can interfere with instrumentation, affecting the
operation or results.

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Chapter 1: Integrity™ V500 Introduction

Operation of the Integrity System below the amplitudes and/or values specified for
physiologic signals may cause inaccurate results.
The use of accessories, transducers, and/or cables with the Integrity System other
than those specified, with the exception of those sold by the manufacturer as the
replacement parts for internal components, may result in an increase in EMR
emissions or a decrease in the immunity of the system.
The Integrity System should not be used adjacent to or stacked with other medical
instrument components. When space requires other components to be adjacent to
or stacked with the Integrity System, the normal operation of those instruments
should be verified.
Other instruments adjacent to or stacked with the Integrity System may cause interference
with the VivoLink™ signal. This may be true even if those components comply with
International Special Committee on Radio Interference (CISPR) emission requirements.

Auditory Brainstem Response (ABR)

Auditory Brainstem Responses are short latency auditory evoked potentials that have
become widely accepted as a valuable test by a variety of professionals, such as
audiologists, otolaryngologists, otologists, neurologists, pediatricians, and neonatologists.
Auditory Brainstem Response (ABR) is an objective electrophysiological test of the function
and integrity of the auditory system from the inner ear to the brainstem. ABR is an
electrophysiological response, which starts in the inner ear and spreads through the
auditory nerve to the brainstem structures. It is recorded typically between 0 and 10 ms
after the onset of an auditory stimulus.
Click-evoked ABR is not frequency-specific and is used primarily for infant hearing
screening and differential diagnostics (cochlear vs. retro-cochlear, auditory neuropathy/dis-
synchrony).
Tone-burst ABR is frequency-specific and typically used for evaluating hearing thresholds,
mostly in newborns, infants, and young children. Tone-burst ABR does not measure
hearing loss, as does pure-tone audiometry; therefore, tone-burst ABR results should be
used as part of a test battery in conjunction with other audiometric tests, particularly with
behavioral pure-tone audiometry whenever possible.
ABR amplitude is quite small compared to the evoked potential activity recorded at longer
1
latencies. Wave V peak-to-trough amplitude rarely exceeds 1 microvolt (μV), even at high
supra-threshold stimulus levels. At stimulus levels near threshold, ABR wave V amplitude
may be 0.1 μV or smaller.

Electrocochleography (ECochG)
Electrocochleography focuses on the earliest component of ABR (Wave I), by placing the
recording electrode closer to the inner ear. ECochG focuses on the inner ear‟s and auditory
nerve‟s response to stimulation. This method of analysis is used for the diagnosis of
conditions like Meniere‟s disease.
VivoLink exclusively uses the gold electrode ear tips (ER3-26A, ER3-26B) in the ear canal,
to detect the low potential signals of the ECochG testing.

AEP Electrode Impedance

Significant care must be taken by the clinician to properly attach AEP electrodes. AEP
voltages are very small, which is why for AEP recording, critical signals (noise) are kept as

1
One microvolt is a millionth of a volt.

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Introduction Integrity™ V500 Chapter 1:

low as possible. When the impedance between the skin and the electrodes applied to the
skin is too high, there will be a high input impedance at the AEP pre-amplifier. Non-
physiological noise will be higher, the signal-to-noise ratio will be lower, and signal
recording and detection will take longer.
In summary, electrodes, lead wires, and cables introduce additional noise and affect AEP
recording.

Electrical Interference in Auditory Evoked Potential Systems

As a result of their small amplitude, an AEP signal is easily “drowned out” or lost due to
noise composed of electrical potentials appearing on the scalp, i.e., physiologic noise, and
non-physiologic noise, particularly low-frequency (LF) electric, LF magnetic, and radio-
frequency (RF) noise.
Sources of physiologic noise include the following: brain activity recorded as
electroencephalogram (EEG), heart activity – electrocardiogram (ECG), eye movements –
electrooculogram (EOG), and muscular activity – electromyogram (EMG). While EOG and
EMG can be largely reduced by sleep or sedation, EEG and ECG are not reduced by
sleep. Moreover, EEG typically increases in sleep due to synchronization of the brain
activity.
Sources of non-physiologic noise can be wireless computer networks, electronic
medical devices, Personal Digital Assistants (PDAs), cellular phones, fax machines,
photocopiers, power lines (mostly 50/60 Hz and its harmonics), luminescent lights, RF
broadcasts, high-voltage equipment, and stimulus artifact radiation from stimulating
transducers. Significant sources of electrical noise, which are often detected by the AEP
amplifier, are caused by the time-varying and time-invariant electromagnetic fields that are
present in many test environments where the electrode-lead wire-amplifier arrangement is
employed. These time-varying electromagnetic fields are inductively and capacitively
coupled with the lead wire that introduces noise from the electrode to the amplifier. A
second significant source of noise is motion artifact, i.e., the noise induced in the lead wire
as it moves through a static magnetic field.
ABR or ECochG and noise parameters are summarized in Table 1.

Table 1. Signal and Noises in ABR/ECochG Recording

Signal Frequency (Hz) Amplitude (nV)
AEP Signal
ABR/ECochG 50 - 3,000 100 - 1,000
Noises
Electrooculogram (EOG) 0.5-10 10,000 - 500,000
(Electroencephalogram) EEG awake 3-40 5,000 - 10,000
(Electroencephalogram) EEG asleep 3-16 2,000 - 400,000
Electrocardiogram (ECG) 0.5-50 (up to 100) 80,000 - 2,000,000
Electromyogram (EMG) 30-500 10,000 - 2,000,000
LF Electric, LF magnetic, RF Harmonics of 50/60 Hz, Up to 10,000,000
MHz, GHz

To reduce physiologic and non-physiologic noise, differential pre-amplifiers are used. In

such pre-amplifiers, the signal of interest is measured as the difference between the
electric potential in two signal electrodes called the non-inverting (positive) electrode and
the inverting (negative) electrode. A common ground electrode is used to provide a
common return path for current in the signal electrode leads. This differencing technique,

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Chapter 1: Integrity™ V500 Introduction

called common-mode rejection, rejects noise that is common to both signal electrodes
(non-inverting and inverting).

Innovations in the Integrity™ System to Reduce Interference

®
In situ pre-amplification: For recording ABR, the system employs the Amplitrode , the
world‟s first in situ audiometry pre-amplifier that largely reduces physiological noise and
electromagnetic interferences. The system provides fast and reliable results in most clinical
environments, even in those where an electromagnetically shielded room is unavailable.
Wireless communications: As in most conventional systems, a computer controls all
tests, and then records, displays, and stores the results. An interface module generates
stimuli and processes responses. A unique feature of the Integrity system is its capability to
provide wireless communication between the computer and interface module, via the
®
VivoLink™, using Bluetooth technology. The wireless interface reduces electric noise
normally picked up the wire in conventional systems and allows testing of a child who is
being held, and strolled, allowing the caregiver to soothe the child and reduce muscular
artifacts that are common in restless babies.
Signal-processing algorithms: The system uses a patented digital signal processing
technique called the Kalman Filter. The Kalman Filter allows ABR and ECochG testing to
proceed in the presence of excessive intermittent electrical noise produced by facial muscle
EMG, and it allows TEOAE testing to proceed in the presence of excessive intermittent
acoustic noise produced by a crying baby.

Otoacoustic Emissions (OAEs)

OAEs are the stimulated and non-stimulated faint sounds produced by oscillations of the
outer hair cells in the cochlea that can be measured in the occluded ear canal. Recording
the OAEs generated by the Outer Hair Cells provides valuable information on cochlear
function.
VivoLink™ automatically retrieves the OAE Probe calibration data and performs a system
self-test prior to beginning patient testing, adjusts stimulus levels according to the patient‟s
occluded ear canal volume, and conducts OAE measurements.

NOTE
Integrity does not measure hearing thresholds, but provides valuable information on
Cochlear function for hearing assessment and monitoring of the Cochlea. Integrity
helps to determine whether or not hearing loss may be present. If a hearing
problem is indicated, the patient must be referred to additional clinical hearing
testing that use other techniques.
Use this device only as specified.

Transient Evoked Otoacoustic Emissions (TEOAE)

For TEOAE testing, VivoLink™ generates acoustic signals via otoacoustic emissions. This
produces a response from the cochlea of the middle ear which is recorded by Integrity and
can be used to assess hearing damage.
Integrity records OAE waveform responses accurately using a patented digital signal
processing method based on the Linear Minimum Mean-Square Error Filter also known as
the Kalman Filter. This ensures that intermittent noise produced by the patient or from a
source external to the patient does not interfere with the measurement.
The test protocol can be set for automatic screening, manual screening, or assessment.
Reliability of the test results is also ensured by a check of the probe calibration using the
Cavity Check feature (Refer to Cavity Check on page 135 for details.)

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Introduction Integrity™ V500 Chapter 1:

Distortion Product Otoacoustic Emissions (DPOAE)

For DPOAE testing, VivoLink™ generates two stimulus pure tones (the primaries),
presented simultaneously into the occluded Ear Canal. In humans with normal auditory
function, a ratio between f2 and f1 of 1.2-1.22 tends to produce the largest DPOAEs.
Numerous intermodulation distortion products could be generated by the human Cochlea,
but the largest DPOAE occurs at a frequency equal to 2f1-f2, which is known as cubic
distortion product.

The test protocol can be set for automatic screening, manual screening, or assessment.
Reliability of the test results is also ensured by a check of the probe calibration using the
Cavity Check feature (Refer to Cavity Check on page 156 for details), and a check of the
probe insertion in the ear using the Probe Fit Check feature (Probe Fit Check – page 153
for details)
Probe calibration. The OAE Probe is calibrated by the manufacturer and does not require
calibration by the user. The probe calibration data is stored in a memory chip (EEPROM) in
the OAE Probe connector for each probe, and is automatically read by VivoLink prior to
running an OAE test.
Factory calibration methods are as follows:
 Stimuli are measured in an occluded ear simulator (Zwislocki Coupler), Brüel & Kjær
Type 4157 conforming to IEC 60711, ANSI S3.25, and ITU-T P.57 Type 2.
 Transient Stimuli (clicks and tone bursts) for ABR, ECochG, TEOAE, and DPOAE tests
are calibrated in decibels (dB) of peak-to-peak equivalent Sound Pressure Level (dB
peSPL), following the IEC 60645-3 procedure for calibrating short duration stimuli.

In TEOAE and DPOAE measurements, the probe output is automatically adjusted after
the first 100 clicks to compensate for the difference between the patient's ear canal
volume and the volume of the occluded ear simulator used for calibration.
 Acoustic input for TEOAE and DPOAE measurements are calibrated at the acoustic
inlet of the OAE Probe in free field. The calibration is performed in an Interacoustics
TBS25 soundproof test chamber with built-in loudspeaker, using a reference
microphone, Brüel & Kjær ½” Microphone Type 4190, and Brüel & Kjær
SoundCheck®1 Type 6714ANA acoustic analyzer. Both ½” Microphone and the OAE
Probe are positioned, facing each other, 3 mm apart at the manufacturer-defined test
point of the chamber, perpendicularly to the loudspeaker axis.

Other Features of the System

User friendly: The instrument allows flexible, user-defined test protocols, and provides
comprehensive data management and analysis. The protocol screen and test screen both
have a similar design, which allows for easy learning. The data-management system keeps
a common patient list and combines results from ABR, ECochG and TEOAE testing which
makes finding results, reviewing, and printing reports easy and efficient.
Data-management software includes a, patient database, and test-result database. It
provides comprehensive data management suitable for individual offices, clinics, hospitals,
research settings, and clinical networks.
Quality assurance: Information contained in the patient test files allows for traceability and
analysis of various factors that may affect the quality of testing.
Data integrity, confidentiality, and availability: Test results are password protected and
cannot be modified once they have been stored. The results can be backed up using the

1
SoundCheck® is a trade-mark of Brüel & Kjær A/S.

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Chapter 1: Integrity™ V500 Introduction

internal storage means of the computer, or any external USB-connected storage medium
such as a RAM drive or CD.
Full-page test report: The rest results can be printed on any optional office printer. The
content of printed reports is customizable. Standard reports contain test conditions, patient
identification, graphic test results, and numeric test results.
User interface: The user interface is very simple and intuitive, and requires a minimum
amount of training.

The Database
Integrity uses a database to store and retrieve test data. The database contains the patient
information, the test conditions, and the protocol settings used for the test. The Integrity
Database screen (Figure 32) is designed to function like commonly used spreadsheet
applications such as Microsoft Excel, making it very intuitive and easy to use. From this
screen, the health-care professional can review and analyze test results as well as print
and export the results.
The database is capable of storing millions of test results (depending on available hard disk
space) that are then accessible from one place.
Beyond reviewing individual test results, the user can select subsets of the test results
using a multi-query function to print, archive, un-archive, and export the subset data.

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Introduction Integrity™ V500 Chapter 1:

Precautions and Warnings

WARNING
This device is contraindicated for patients with these conditions:
Patients who display signs of excessive earwax
If, upon inspection, it appears that excessive earwax is present, DO NOT insert the ear tip in
the ear canal. Inserting the ear tip could force earwax to press against the eardrum resulting
in damage to the ear. It could also cause incorrect measurements and lead to an incorrect
assessment.
Patients with inflammation of the ear canal
If, upon inspection, it appears that the skin of the ear canal has signs of inflammation, DO
NOT use this device. The ear tip will cause slight pressure that may cause mild abrasion
and pain.
Patients who have ear canal blockage due to foreign particles
If, upon inspection, it appears that any foreign particles are present in the ear canal or any
foreign particles block access to the eardrum, DO NOT insert the ear tip into the patient‟s
ear.
Patients who display signs of discharge in the ear
If, upon inspection, any discharge is observed, DO NOT insert the ear tip into the patient‟s
ear.
Patients who display skin damage
If a patient displays any signs of skin damage at the site of an electrode application (such as
skin irritation (redness), scratches, bruises, sores, cuts, wounds, bleeding), DO NOT
conduct skin preparation and application of the electrodes for ABR testing. Consult a
dermatologist or other trained health-care professional.
Patients with involuntary sudden head motions
Do NOT place the ER-3A insert earphones, gold electrode ear tip, or the OAE Probe, in the
ear of patients who have involuntary sudden head motions. Such a motion could result in a
self-inflicted injury of the inner ear.
Patients who cannot be still
Do NOT place the ER-3A insert earphones, gold electrode ear tip, or the OAE Probe in the
ear of a patient who is actively resisting insertion or displays involuntary movements. Such a
motion could result in a self-inflicted injury of the inner ear.

WARNING
Hazard: The patient experiences discomfort when the ear tip is inserted into the ear canal.
Remedy: The operator must check whether the ear tip selection is incorrect and replace
with a properly fitting ear tip.
Hazard: Audible levels are uncomfortable for the patient.
Remedy: The operator must immediately select a lower setting for the stimulus levels.
Hazard: In ABR testing skin at the site of the electrode application is damaged, for
example, irritated (red), scratched, bruised, sore, cut, wounded, or bleeding.
Remedy: Do not conduct skin preparation and electrode application on areas of damaged
skin. Choose another electrode location, wait until healing is complete, consult a
dermatologist, or refer the patient to a health-care professional who is trained to deal with
skin damage.

8 User‟s Manual Rev. 5.6 Precautions and Warnings

Chapter 1: Integrity™ V500 Introduction

CAUTION
Following the "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf
Software Use in Medical Device", issued by FDA on September 9, 1999, the customers
should not use any software other than that specified, as it will violate the safety,
effectiveness and design controls of our Integrity V500 and that such use may result in an
increased risk to users and patients.

Unauthorized alteration of software provided, including downloading non-validated or

unauthorized off-the-shelf software may void or breach existing service agreements and
warranties. For additional information, contact Vivosonic Inc.'s Customer Support.

CAUTION
Please follow these recommendations to ensure the test data is accurate.
 Substitution of any supplied components with different components may result in
measurement error.
 No other software may be installed onto the computer on which the Integrity™
software is installed.
 Handle the system with care.
 The system requires calibration of the ABR testing transducers – ER-3A
Earphones and B-71 Bone Conductor – annually on each anniversary from the
date of manufacture, and every time a transducer is dropped, subjected to
mechanical shock, or immersed in a liquid substance. Otherwise, stimuli
presented to the patient as specified may lead to incorrect test results and
misdiagnoses.
 DO NOT force the ear tip into the ear canal.
 Always carry this device with you when traveling to avoid mishandling and
damage of stored or checked luggage.
 DO NOT ship this device for service in packaging other than the packaging
supplied with the system from the manufacturer, or comparable packaging.
 Signal inputs and outputs are intended for analysis only in connection to the
specified equipment described in this manual.

Precautions and Warnings User‟s Manual Rev. 5.7 9

Configuration Integrity™ V500 Chapter 2:

Chapter 2: Configuration
General Configuration
The Integrity™ V500 system is modular (Figure 2), consisting of four main components: the
computer, the VivoLink, the Amplitrode and the transducers.

Figure 2. Integrity™ System

1 – Computer with Integrity™ software

®
2 – Amplitrode
™
3 – VivoLink
4 – ER-3A Earphones (connected to ER-3A ear tips or gold electrode ear tips)
5 – B-71 Bone Conductor
®
6 – Bluetooth USB Adapter (not required if computer has built-in Bluetooth component)
7 – Mouse
8 – OAE Probe Holder
9 – OAE Probe
10- ECochG Electrode Ear Tip Cable

10 User‟s Manual Rev. 5.6 General Configuration

Chapter 2: Integrity™ V500 Configuration

Components of the Integrity System

The components of the Integrity system are illustrated below:

Figure 3. Ear Tips for ABR

®
Figure 4. Gold Electrode TIPtrode Ear Tips for ECochG

®
Figure 5. Neuroline 720 00-S Electrodes for AEP Tests

Components of the Integrity System User‟s Manual Rev. 5.7 11

Configuration Integrity™ V500 Chapter 2:

Figure 6. Single-use ear tips for the TEOAE and DPOAE probe

VivoLink™

®
Figure 7. VivoLink™(1), Amplitrode (2), and OAE Probe (3)

The VivoLink (1) is a battery-powered device that is operated by a microprocessor,

controlled from a remote computer through Bluetooth. Bluetooth establishes a connection
with the Integrity software when the test type is selected from the Test screen. Once this

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Chapter 2: Integrity™ V500 Configuration

occurs, the user is informed of the connection by a solid blue LED indicator on the VivoLink
and a virtual blue LED indicator in the Integrity software. When either LED is blinking, the
VivoLink is attempting to make a connection but has not yet completed the link.
When performing ABR testing, the VivoLink is used with the Amplitrode (2), the world's first
in situ EP pre-amplifier. The VivoLink also operates with a standard OAE Probe (3) or
audiometric transducers: two ER-3A Earphones and a B-71 Bone Conductor.
The VivoLink can be placed on an adult‟s chest and secured with a lanyard, placed next to
a baby, or held by the baby‟s mother. Testing with the VivoLink can be performed
anywhere within the reach of Bluetooth, including situations where cabled instruments
cannot be used at all.
Tests can be performed within approximately 30 ft (10m) of the computer, even in an
electromagnetically shielded booth. To perform a test in an electromagnetically shielded
®
room, connect the Bluetooth USB Adapter to your computer via a USB-extension cord and
put the cord through a hole in the booth wall. Remove the Notebook computer‟s power
adapter to help reduce electromagnetic noise pick-up and test time. Ideally the shielded
room will keep noise to a minimum.
In the case of an infant patient, the mother may carry the VivoLink and the baby and move
around the room without the need to disconnect any electrodes, connectors, or
transducers. This makes testing more comfortable and easier for the patient.

ABR testing
For ABR testing, VivoLink presents various auditory stimuli to the patient‟s through air and
bone conduction such as a click or tone burst. It then records electrical responses from the
Amplitrode to the Integrity System to be reviewed using the Integrity™ software.

ECochG testing
For ECochG testing, VivoLink presents auditory stimuli to the patient‟s ear through air
conduction using click stimuli. It then records electrical responses from the gold electrodes.

TEOAE testing
For TEOAE testing, VivoLink generates acoustic signals via the OAE probe. This evokes
an otoacoustic emission response (OAE) from the cochlea of the middle ear which is
recorded by Integrity and can be used to assess hearing damage.

DPOAE testing
For DPOAE testing, VivoLink generates two pure tones (primaries) that are presented
simultaneously to the cochlea via the OAE probe. This evokes an intermodulation distortion
product that is generated by the human cochlea and recorded by Integrity to be used to
assess hearing damage.

VivoLink Functions
VivoLink performs several essential functions.

1. Checks electrode contact and inter-electrode impedance mismatch for ABR and
ECochG testing.
2. Performs an OAE Probe functionality check.
3. Checks the wireless connection between VivoLink and the PC.
4. Checks the VivoLink battery voltage.
5. Presents appropriate auditory stimuli to the patient.

VivoLink™ User‟s Manual Rev. 5.7 13

Configuration Integrity™ V500 Chapter 2:

6. Transmits collected electrophysiological responses to the computer.

To avoid any confusion while connecting peripheral accessories to the VivoLink, all
locations are marked with specific symbols on the front panel of the VivoLink (Figure 8)
above the locations of the actual connectors.

Figure 8. VivoLink Front Panel

1. On/Off switch
2. Parking Snaps holding the Amplitrode and its clips
3. Electrode Contact LED Indicator
4. Power LED Indicator (battery indicator)
®
5. Bluetooth LED Indicator
6. Symbol for ER-3A Earphone connectors
7. Symbol for B-71 Bone Conductor connector
8. Symbol for OAE Probe connector
9. Symbol for Amplitrode connector
10. OAE Probe Holder
11. Lanyard rings (not shown)

See Appendix H: Symbols Used on the Instrument for a description of the symbols printed
on the front panel.

14 User‟s Manual Rev. 5.6 VivoLink™

Chapter 2: Integrity™ V500 Configuration

On/Off Switch, Power LED Indicator

The VivoLink runs on four (4) AA batteries. The ON/OFF switch is located on the right side
of the VivoLink. When the unit is switched ON, check that the Power LED Indicator is lit
(Figure 8 #5).
To ensure VivoLink will run properly and will last the entire test, ensure that the batteries
are fully charged, and insert the batteries properly into the battery compartment.
After selecting a test type and prior to running a test, check the status of the Power LED
Indicator.
 The indicator will remain green if the batteries are in good working condition.
 If the batteries are low the indicator will be amber.
 If the batteries are spent the indicator is off (not luminous).
Note that the power LED status is not valid until after a test type is selected and Bluetooth
communication has been established.

Accessory Connectors
Connectors for the ER-3A Earphones, and B-71 Bone Conductor, OAE Probe, and
Amplitrode are located on the connector panel (Figure 9). The connector panel is located
on the bottom of the VivoLink.

Figure 9. VivoLink Connector Panel

1. ER -3A Earphone connector

2. B -71 Bone Conductor connector
3. OAE Probe connector
4. Amplitrode connector

To perform any testing, there must be a proper connection between peripheral accessories
and the VivoLink. Plug each device into the correct socket as shown in the figure above.
Please check the specific symbols placed on the front panel of the VivoLink above the
connectors. Refer to Figure 8 for these locations.

VivoLink™ User‟s Manual Rev. 5.7 15

Configuration Integrity™ V500 Chapter 2:

Lanyard
The lanyard on the VivoLink (Figure 10) allows your patient to wear the VivoLink around the
neck. The lanyard is connected to two D-rings on the VivoLink with two detachable clips.

The lanyard has a breakaway feature which allows you to quickly disconnect and reconnect
it from the VivoLink. This protects your patient from strangulation and offers a quick release
in the case of an emergency.

Figure 10. VivoLink Lanyard

1. Lanyard
2. Breakaway connection
3. D-rings
4. Clips

Battery Compartment
The VivoLink is powered by four (4) AA non-rechargeable Alkaline or Nickel-Metal Hydride
(NiMH) rechargeable batteries. Only NiMH batteries with a minimum capacity of 2,200 mAh
may be used to power the VivoLink.
The battery compartment is located on the bottom panel of the VivoLink. To open the
battery compartment, slide the cover off. The four cells for AA batteries are marked with “+”
and “–” to ensure proper insertion of the batteries.

Probes and Benefits

Amplitrode for ABR and ECochG Testing
The Amplitrode is a new generation of pre-amplifiers used in Evoked Response Audiometry
(ERA). It amplifies a signal with higher signal-to-noise ratio than conventional electrode-to-
lead, wire-to-amplifier arrangements resulting in artifact noise reduction.
The Amplitrode (Figure 11) consists of an integrated pre-amplifier and electrode clip in a
combined unit that is affixed to the patient. It is controlled by the VivoLink using ABR
software modules.

16 User‟s Manual Rev. 5.6 Probes and Benefits

Chapter 2: Integrity™ V500 Configuration

Significantly less noise is introduced into the signal detected by the amplifier as a result of
the extremely short connection between the conductive portion of the electrode and the
amplifier. Traditionally this connection could be as long as a meter or more.

®
Figure 11. Amplitrode

View A – General View

View B (insert) – underside view of the pre-amplifier

1. Pre-amplifier combined with ground electrode clip

2. Non-inverting electrode clip
3. Inverting electrode clip
4. Clip buttons
5. Amplitrode connector with labeled serial number
6. Amplitrode cord
7. Negative clip cord
8. Positive clip cord
9. Release button
10. Amplitrode spring

The integrated circuit built into the Amplitrode enables the amplifier to be directly mounted
to the conductive pad. The extraordinarily small size of the Amplitrode and the absence of
long and cumbersome lead wires and cables make the unit exceptionally easy to use. The
Amplitrode contains a chip with calibration data in its connector, allowing for accurate
measurement of AEP voltage.

CAUTION
When attaching the Amplitrode to the VivoLink or electrodes, do not apply pressure to the
Amplitrode. Care should be taken to ensure that the spring of the Amplitrode does not
break with mishandling.

Probes and Benefits User‟s Manual Rev. 5.7 17

Configuration Integrity™ V500 Chapter 2:

Clinical Benefits of Amplitrode for AEP Studies

In situ AEP amplification achieves artifact noise reduction in at least three ways:
1. At least one lead wire, the ground-electrode wire which is a significant source of
wire-induced noise, is eliminated completely.
2. The remaining lead wires are as short as allowed by the size of the area of interest
on the subject. This is much shorter than the typical one-meter length (or greater)
used in conventional EP systems.
3. Motion artifacts are significantly reduced since both lead wires, electrodes, and the
pre-amplifier are each mounted to the patient and all move together. This reduces
differential movement, and hence, differential artifact noise that otherwise would be
induced in the lead wires through environmental electromagnetic fields.
To reduce the physiological and electromagnetic artifacts, the VivoLink filters signals before
the first stage of AEP amplification. This will optimize the AEP recording.
VivoLink performs ongoing monitoring of electrode contact on the patient‟s skin. In addition,
the clinician may initiate an impedance check to measure the inter-electrode difference, or
mismatch, between the inverting and non-inverting electrode impedances.

CAUTION
To prevent damage to the Amplitrode, it should always be clipped onto the electrodes on
the patient, or clipped onto the parking snaps on the VivoLink. Always have the Amplitrode
connected to the patient while in use or connected to the parking snaps when not in use.
DO NOT leave the Amplitrode dangling from the VivoLink.

ECochG Gold Electrode Ear Tip Cables

The ECochG Electrode Ear Tip Cable is used for adapting the ER-26A and ER-26B gold
electrode (TIPtrode) ear tips used in Electrocochleography (ECochG) to the Amplitrode.

Figure 12. ECochG Electrode Ear Tip Cables

18 User‟s Manual Rev. 5.6 Probes and Benefits

Chapter 2: Integrity™ V500 Configuration

The gold electrode (TIPtrode) ear tips provide both the stimulus to the ear as well as the
electrode to receive the electrical response from the ear. The outer surface of the ear tip is
covered in gold foil to conduct the received electrical responses back to the Amplitrode.
Because of the close proximity to the hearing site within the ear, the received response has
greater amplitude making it more sensitive to the response of certain pathologies.

OAE Probe
The OAE probe sends acoustic stimuli into and receives sounds from the occluded ear
canal. It contains a chip with calibration data in its connector, allowing for accuracy of
acoustic stimulus level and signal measurement.

Figure 13. OAE probe attached to the VivoLink

The Probe Holder found on the VivoLink (Figure 8 #10) has a 1cc cavity that also allows
the system to perform the OAE probe check to ensure the probe is working and is in good
condition, i.e. no acoustical change has occurred since the probe programming and
calibration.

Specifications
Specifications for the Integrity are found in Appendix A: Technical Specifications.

Specifications User‟s Manual Rev. 5.7 19

Preparation Integrity™ V500 Chapter 3:

Chapter 3: Preparation
Unpacking Instructions
Use these instructions when you first receive the Integrity System.
Retain the shipping carton and all packing materials in case the unit needs to be returned
for repair or shipped to another location. Carefully unpack the Integrity briefcase and
accessories.
Open the briefcase and identify each of the supplied parts. Refer to the packing list in the
shipping carton. A general component list can be found in Error! Reference source not
found..
Unpack the unit as follows:
1. Open the shipping carton.
2. Remove:
 packing list
 user manuals for the computer and printer if supplied by Vivosonic Inc.
 warranty certificate
 product registration form
3. Verify all parts were received by referring to the packing list. Please report any
missing or damaged parts to the vendor immediately.
4. Record the serial number of the instrument in a permanent location for future
reference.
The Integrity serial number can be found in 3 locations:
 On the outside of the shipping box on a gray sticker
 On the certificate of conformance inside the briefcase
 On the metal tag attached to the briefcase
5. Complete the product registration form and send it to the address on the form.

Installation
The Integrity system can be purchased two ways; as a complete system through Vivosonic
Inc. or using a non-Vivosonic configured computer. This section will describe how to set up
the system in the case of full component purchase from a Vivosonic vendor as well as in
the case when the computer is purchased separately from a non-Vivosonic vendor.

CAUTION
Test data may be affected. DO NOT use this device for any clinical application until all
steps of the installation procedure have been completed.

System Setup by Manufacturer

This procedure is for customers who purchased the Integrity System directly from a
Vivosonic Inc. dealer.
If you have purchased the Integrity System directly from a Vivosonic Inc. dealer, please
perform the following steps:
1. Follow the computer manufacturer‟s user manual to connect the power cable to the
computer and plug the power cord into the AC power supply of a wall outlet.

20 User‟s Manual Rev. 5.6 Unpacking Instructions

Chapter 3: Integrity™ V500 Preparation

2. Turn the computer ON.

3. If your printer and computer were both supplied by Vivosonic Inc., your printer
driver has been installed and fully tested by Vivosonic. However, you will need to
install the printer cartridge and paper. Refer to the manufacturer‟s user guide for
instructions.

ATTENTION
If your computer was purchased from Vivosonic Inc., installation of printer drivers
is NOT recommended. The computer has been tested and validated to work with
the system and will be covered by the warranty to operate in this state.
Installation of some printer drivers may cause a conflict with the Integrity software
and result in error messages and a failure to print.
4. Using a US regional time zone setting, adjust the clock and calendar settings of the
Windows operating system. The time and date can be adjusted from the Windows
Control Panel. Select Start | Control Panel.
Currently, the Integrity software supports only US regional time zone settings.
5. Connect all components of the Integrity System.
6. Insert four (4) AA batteries into the battery compartment of the VivoLink.
7. Turn the VivoLink power switch ON.
8. Start the Integrity program.
Double-click on the Integrity icon from the desktop. Or, click on the Start button (in
the lower left corner of your computer screen), then select All Programs |
Vivosonic Integrity.
9. Read the Caution Screen that is displayed.
10. Select Agree to start the Integrity software.

Figure 14. Caution Screen

Installation User‟s Manual Rev. 5.7 21

Preparation Integrity™ V500 Chapter 3:

11. The system is ready to perform a test.

Perform at least one successful measurement on a person. Chapters 5 to 8
describe typical operating steps for ABR, ECochG, TEOAE, and DPOAE tests.
Review these steps prior to using the Integrity System for patient testing.

CAUTION
Possible damage to the Integrity system and its components may occur.
DO NOT disconnect any of the devices or cables from the VivoLink when it is
operating.
ATTENTION
The Integrity System is supplied with pre-set test protocols. Prior to clinical use,
test-specific protocols must be defined. Pre-set default protocols recommended in
the literature are described in Appendix E: Preset Protocols and Test Settings for
ABR, ECochG, TEOAE, and DPOAE tests.

System Setup for Customer-Installed Systems

This procedure is for customers who purchased their computers from a source other than a
Vivosonic Inc. representative.
If you are supplying your own computer to run the Integrity software, please perform the
following steps:
1. Follow the computer manufacturer‟s user manual to connect the power cable to the
computer and plug the power cord into a wall outlet.
2. Turn the computer ON.
3. If your Integrity computer is not already Bluetooth-enabled, you will need to insert a
Bluetooth adapter into a USB port on your computer, and then install and configure
the Bluetooth driver.

ATTENTION
The Bluetooth adapter should always be inserted into the same USB port on the
computer. Inserting the USB Adapter in a different port may cause the operating
system to reinstall the Bluetooth software driver.
4. Install the necessary printer drivers, cartridges and paper. Refer to the applicable
manufacturer‟s user guide.

NOTE
Only Windows-compatible printers are recommended by Vivosonic Inc. for
use with the Integrity software. Color printers are preferred. The Integrity
software will use the default Windows printer. This printer may be on a
network or local to the computer.
Vivosonic Customer Support is only able to provide assistance for printers and
computers that have been purchased and configured by Vivosonic Inc.
5. Install the Integrity software from the Integrity CD. Follow the installation
instructions that appear.
6. Connect all components of the Integrity System.
7. Insert four (4) AA batteries into the battery compartment of the VivoLink.
8. Turn the VivoLink power switch ON.
9. Start the Integrity program.

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Chapter 3: Integrity™ V500 Preparation

Double-click on the Integrity icon from the desktop. Or, click on the Start button (in
the lower left corner of your computer screen), then select All Programs |
Vivosonic Integrity.
10. Read the Caution Screen that is displayed (Figure 14).
11. Select Agree to start the Integrity software.

CAUTION
Possible damage to the Integrity system and its components may occur.
DO NOT disconnect any of the devices or cables from the VivoLink when it is
operating.
12. The system is ready to perform a test on a person.
Perform at least one successful measurement on a person. Chapters 5 to 8
describe typical operating steps for ABR, ECochG, TEOAE, and DPOAE tests.
Review these steps prior to using the Integrity System for patient testing.

ATTENTION
The Integrity System is supplied with pre-set test protocols. Prior to clinical use,
test-specific protocols must be defined. Pre-set default protocols recommended in
the literature are described in Appendix E: Preset Protocols and Test Settings for
ABR, ECochG, TEOAE, and DPOAE tests.

Installation of New Test Types

If you purchased your Integrity system with only one module (e.g. ABR) and you want to
purchase additional modules (e.g. ECochG, TEOAE, or DPOAE), please contact your
Distributor. To install these modules, you will need to obtain a Software Activation Code
from Vivosonic Inc.

Activating Additional Modules

For each new module, you will need an Activation Code. This is provided when you
purchase your new module. You can order a new module by contacting your Distributor or
Customer Support (telephone: +1-877-255-7685 US and Canada; +1-416-231-9997
internationally). Customer Support will require your VivoLink serial number found on the
back of the VivoLink or listed on the System screen under Unit ID.
To activate an additional module follow these steps:
1. Contact your distributor for a registration code to activate additional test types.
Product support will give you a new activation code to activate all licensed
modules.
2. Select the System tab to go to the System screen.
3. On the System screen enter your new module‟s activation code into the Software
Activation Code field.
4. On the System screen enter the activation code into the Software Activation
Code field.
5. Press Register.
A message will prompt you to confirm your new registration key.

Installation of New Test Types User‟s Manual Rev. 5.7 23

Preparation Integrity™ V500 Chapter 3:

Figure 15. Message for new software activation code

6. Press OK to continue the activation process.

If the activation code is incorrect, the program will prompt you to re-enter your
activation code.

Figure 16. Message indicating incorrect activation code

7. A message will instruct you to restart the Integrity software program.

Figure 17. Message to restart the program

8. When the registration is complete the software will exit.

9. Restart your Integrity software from the Desktop icon.
10. Select Test to go to the Test screen.
11. Select the Test Type drop-down box to confirm that the new test type has been
added to the list.

Initializing a Test Type

1. Select a patient from the Patients screen.
2. Select the Test tab to go to the Test screen.
3. Select the desired Test Type from the drop-down box.

When changing modules the VivoLink must be reinitialized. When the test type is selected,
the Integrity system will lose connection with the VivoLink. The Bluetooth LED will turn off
and start blinking as the VivoLink reinitializes. When complete, the blue LED on the
VivoLink and the blue virtual LED on the Test screen will be lit.

24 User‟s Manual Rev. 5.6 Installation of New Test Types

Chapter 4: Integrity™ V500 Five Screens of Integrity

Chapter 4: Five Screens of Integrity

The Integrity software uses the Windows XP style to display the screens, dialog boxes,
buttons and other graphical elements that you see on your computer.
Integrity opens to the Patients tab by default, displaying the Patients screen. There are six
screens in the Integrity software: Patients, Test, Database, Protocol, and System. Each tab
opens a screen. Refer to the pages listed below for details of the functions and information
available on each screen.
 The Patients Screen on page 25
 The Test Screen on page 28
 The Database Screen on page 37
 The Protocol Screen on page 47
 The System Screen on page 50

The Patients Screen

The Patients screen contains patient information in a table. It lists patients who have been
tested previously, and those who will be tested in the future. A scroll bar at the bottom of
the screen allows you to view all columns of patient information.
To perform a test or plan a test, the patient must first be entered in this screen.

Figure 18. Patients Screen

The Patients Screen User‟s Manual Rev. 5.7 25

Five Screens of Integrity Integrity™ V500 Chapter 4:

Entering Patient Information

To create or update the patient list:
1. Select the Patients tab to open the Patients screen (Figure 18).
2. To enter patient information into the table, click on the desired cell with your mouse,
and type your information into the cell.
Several columns allow you to type information into a cell, or select information from
a list of items that you have previously entered.
3. To proceed to the next cell, press Enter on your keyboard (or click on the next cell
with your mouse).
You must complete at least one of the following fields for the patient: Family name, Given
name, or Hospital ID. All of these fields are commonly used to uniquely identify the patient
in the list.
There are additional columns to add information for newborns and infants: mother‟s
information, including mother‟s ID, family name, and given name, the infant‟s time of birth,
high-risk registry category, and birth weight.

Sorting the Table

The patients can be sorted by any field. Only one column at a time can be used to sort the
information.
1. Select a column heading to sort the patients using that column‟s information (e.g.,
Date of Birth). An arrow will appear in the column heading to indicate that the
column has been sorted in ascending or descending order.
2. Select the column again to sort the information in the opposite direction
(descending or ascending).
3. To sort by another column, select another column heading.

Adjusting the Columns and Rows

The width and height of the columns and rows are adjustable.
To widen a column:
1. Place the cursor on the line dividing the two column headings.
2. Click and hold the line and drag it to the right or left to increase or decrease the
size of the column on the left.
To adjust the height of a row:
1. Place the cursor on the line dividing the two row headers.
2. Click and hold the line and drag it up or down to increase or decrease the height of
the row below the line.

Entering Date of Birth

The Date of Birth column contains a drop-down calendar (Figure 19).
1. Select the arrow on the right side of the field to open the calendar.
2. Select a day from the appropriate year and month. This closes the calendar and
places the date of birth in the field.

26 User‟s Manual Rev. 5.7 The Patients Screen

Chapter 4: Integrity™ V500 Five Screens of Integrity

Figure 19. Drop-Down Calendar

Entering Time of Birth
This field is typically used when the patient is a newborn.
1. Select the appropriate field in the patient Time of Birth column to open a digital
clock. The time is shown in the HH/MM/SS/AM-PM format.
2. Highlight the hour, and adjust the hour using the up and down arrows.
3. Highlight the minutes, seconds, AM/PM, and select the correct time using the
arrows.
4. Press OK.

Figure 20. Drop-Down Clock

Selecting Patients
From the Patients screen, select one or more patients to test during a session.
1. Click the row header (the grey area of the table) to highlight the entire row of
patient information (Figure 21).
2. To select another patient, hold the Ctrl key on the keyboard and click the row
header to the left of another patient row.
To select a range of patients:
1. Select the first patient.
2. Hold the Shift key on the keyboard and click the last patient in the group.
Patients selected in the table appear in the Patients drop-down menu of the Test screen.
Refer to Test Controls Drop-Down Menus on page 30.

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Five Screens of Integrity Integrity™ V500 Chapter 4:

Figure 21. Selected Patients in Patients Screen

The Test Screen

The Test screen is the main screen used to control the operation of the VivoLink when
performing ABR, ECochG, TEAOE, or DPOAE tests. The screen is designed to start,
perform, and regulate testing, to monitor the results of the data collection, and to display
the test results. It is also possible to control some protocol parameters from this screen.
Before the Test screen tab is enabled a patient must be created and selected in the
Patients screen. Refer to Selecting Patients on page 27 for details.
Before any of the features on this screen can be used, the Test Type must be selected so
that the Bluetooth connection can be made.

Figure 22. Test Screen

Selecting a Test Type

You must select a Test Type before the Test screen is available for use. The Test Type
drop-down menu lists one or more test types or modalities (ABR, ECochG, TEOAE, or
DPOAE) for selection.

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Chapter 4: Integrity™ V500 Five Screens of Integrity

The Test Type drop-down menu is only available once your notebook computer has
established communication with the VivoLink.
To select a test type:
1. Switch on your VivoLink to establish a connection between your computer and
your VivoLink. The Test Type drop-down menu will become available for selection.
2. Select the desired test type from the Test Type drop-down menu.
Integrity currently supports these test types: ABR, ECochG, TEOAE, and DPOAE.
Only those test types registered with your software license Activation Code will
appear in the list. Refer to Installation of New Test Type on page 23 for details.
3. Upon selecting a test type, you must wait for your VivoLink to reinitialize. The
Bluetooth LED will turn off and then start blinking as the VivoLink® reinitializes.
Typically the VivoLink requires 30 to 60 seconds to download the test-specific
information. When complete, the blue LED on the VivoLink and the blue virtual LED
on the upper-right corner of the Test Screen are lit.
If the Bluetooth LED indicator continues to flash longer than 3 minutes, refer to
®
Appendix P: Bluetooth Troubleshooting.

Test-Specific Controls and Indicators

The Test screen has a Waveform Window that displays a graphical representation of the
collected waveforms as a function of time and other test-specific indicators and controls.
The ABR, ECochG, TEOAE, and DPOAE test screens have the same overall
function but differ in important test-specific details.
 The ABR Test Screen on page 69
 The ECochG Test Screen on page 97
 The TEOAE Test Screen on page 133
 The DPOAE Test Screen on page 149

Protocol Settings Section

The protocol settings section contains some captured test values and some selectable test
parameters. To define protocols please refer to the following pages:
 Define an ABR Protocol on page 64
 Define an ECochG Protocol on page 93
 Define a TEOAE Protocol on page 130
 Define a DPOAE Protocol on page 146

Test Controls Section

The test controls section includes four test control drop-down menus (Figure 23), test
control buttons (Figure 24), and the current date and time (Figure 28).

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Test Controls Drop-Down Menus

Figure 23. Test Controls drop-down menus

Patients
This list contains the names of patients selected from the Patients screen (Figure 18). The
list does not include all patients in your database.
To select a patient to test:
1. Check that you have selected the desired patients from the Patients screen.
2. Select the Patients option on the Test screen to activate the drop-down menu.
3. Select the patient to be tested from the Patients drop-down menu.

Test Type
The Test Type drop-down menu contains the available test modalities (ABR, ECochG,
TEOAE, or DPOAE). You must first select a Test Type before the Test screen becomes
available for use. Refer to Selecting a Test Type on page 28 for details.

Applied Protocol
This list contains all the preset and custom designed protocols that have been created and
are currently activated for the currently selected test type. The protocols specify all the test
parameters.

ATTENTION
Improper configuration of test protocols may result in poor quality test results.

Test Control Buttons

The set of available test control buttons corresponds to the test type in use.

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ABR and ECochG DPOAE and TEOAE

Figure 24. Test Control Buttons

Start/Stop button
A patient must be selected before a test can be started.
1. Start testing by pressing the Start button.
 If the probes required for the test (Amplitrode for ABR or ECochG, OAE probe
for TEOAE or DPOAE) are properly connected to the VivoLink, the test will
begin and the button label changes from Start to Stop.
 If the appropriate probe is not connected, a warning will be displayed “Probe
Not connected”, and the test cannot be started.
2. You can stop the test by pressing this same button now labeled Stop
When the Stop button is pressed the results for the data collected from the time
the Start button was pressed is displayed in the waveform window of the Test
screen. Use the Database screen to review any data collected before this run.

Pause/Resume button
The Pause button cannot be selected between test runs. The Pause button becomes
active when the Start button is pressed
1. Press the Pause button to temporarily stop the test run.
This may be required if, for example, the earphone falls out of the patient‟s ear.
2. To resume the data collection, press this same button now labeled Resume.

Save button
After completing the data recording, the results must be saved.
1. Press the Save button.
This opens the Save Result Confirmation dialog box (Figure 25).
2. Save the data to the pre-selected patient‟s file or choose another patient from the
Save to this patient’s file drop-down list.

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The Save to this patient’s file drop-down list contains the name and personal ID
of the patient.
3. Enter information into the desired fields (Examiner, Location, Comment 1, and
Comment 2), or select preset data from the drop-down lists.
Some information cannot be modified (Test Type, Protocol Used, Unit ID, Ear
Tested, Probe ID, and Ear Tip Used).
4. Press OK.
5. Press Yes when asked: Are you sure?

NOTE
When the DPOAE test type is used, only the last unsaved DP-gram is saved in the test
record, although multiple consecutive test results may be displayed on the screen.

Figure 25. Save Result Confirmation

Discard/Clear Graph button

Use the Discard/Clear Graph button to discard all collected data and clear the Waveform
Window and the Waveform Information.

CAUTION
Test data may be permanently lost.
Before discarding any data, please ensure that significant test results have been saved to
the database or they will be permanently discarded.

To discard or clear a graph:

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1. Press Discard/Clear Graph.

2. Press OK when asked Are you sure you want to discard this record? (Figure 26).
 If you choose OK, the test results will be erased from the system‟s memory. If
the test results have not been saved the data will be gone permanently.
 If you choose Cancel, the collected data will remain on the Test screen.

Figure 26. Dialog Box - Are you sure you want to discard this record?

Right Ear/Left Ear button

Select the ear to test to be tested by pressing the Right Ear or Left Ear button.
When the Right Ear is selected, the waveform trace in the Waveform Window (Figure 69)
is red, the standard color used in audiologic practice. When the Left Ear button is selected,
the waveform trace in the Waveform Window is blue.

NOTE
For ABR ER-3A and ECochG testing, the ear selected represents the earphone that the
stimuli will be delivered to. For TEOAE and DPOAE testing the ear selected represents the
ear the probe has been inserted into. If Masking is selected in ABR or ECochG, the
masking noise will be delivered to the ear that is contralateral to the ear selected for
stimulation.

Check Impedance (ABR and ECochG)

You require an up-to-date version of the VivoLink (V51) and Amplitrode (A51) to use this
feature. The Check Impedance button is not visible if you are using other versions of the
VivoLink and Amplitrode.
The Check Impedance button performs a test to measure the impedance mismatch
between the inverting and non-inverting electrodes applied to the patient. The difference
between the impedance values enables clinicians to make appropriate adjustments to the
electrodes.

Cavity Check (TEOAE and DPOAE)

The Cavity Check button runs a test to check that the OAE probe calibration is correct.
For TEOAE testing, the cavity check determines if the System Transient Response (TR) for
TEOAE and noise floor are within their tolerances.
Similarly, for DPOAE testing, the cavity check determines if the System Distortion Product
(DP) for DPOAE and noise floor are within their tolerances.

Print button
1. Use the Print button to print your test results.
The Print Report Confirmation (Figure 27) dialog box is displayed. The name and
patient ID of the current patient appears in the Print for this patient field.

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2. Print the data for the selected patient, or choose another patient from the Print for
this patient drop-down list.
The system does not allow results to be printed if the Print for this patient field
remains blank.
3. Enter new information into the desired fields (Examiner, Location, Comment 1, and
Comment 2) or select preset data from the drop-down lists.
You can view information about the Test Type, Protocol Used, Unit ID, Ear Tested,
Probe ID, and Ear Tip Used.
4. To initiate printing, press OK.
5. When the “Are you sure?” dialog box is displayed, press OK to continue printing.
Press Cancel to return to the Print Result Confirmation dialog box allowing
changes to be made before printing.

Figure 27. Print Result Confirmation

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Current Day/Time
Below the Test Control buttons is a box that displays the Current Date and Current Time.
®
The date or time can only be changed using the Windows configuration.

Figure 28. Test Controls Date and Time

NOTE
It is important that the date and time settings are correct. The date and time are used to
"stamp" the data files and to calculate the age of the patient at the time of testing.
If the date and time are incorrect, adjust the clock and calendar to a US regional time zone
setting from the Windows Control Panel. Select Start | Control Panel.

VivoLink™ Status
VivoLink Battery Indicator
The VivoLink power indicator, located at the upper right corner of the VivoLink‟s front panel
(Figure 8 #4) represents the power left in the battery. On the Test screen, a battery
indicator shows the measured voltage of the VivoLink batteries (Figure 29).

Figure 29. VivoLink Battery Voltage Indicator

Green indicates the amount of life in the battery. When the power in the battery reaches a
critically low value for testing, the battery indicator will be empty (show no green).
When the batteries are almost out of power, the battery indicator will show exclamation
marks. It is recommended that the batteries in the VivoLink be replaced before performing
any further tests.

Low Battery Indicator

When the VivoLink Battery Indicator shows low battery, perform the following steps:
1. Save the collected data.
2. Switch OFF the VivoLink and change the batteries. Refer to Battery Compartment
on page 16.

CAUTION
Failure to change low voltage VivoLink batteries will cause interruption in data
transmission between VivoLink and computer and may result in the loss of the collected
response.

Bluetooth Connection Indicator

The Bluetooth connection indicator is a virtual LED located in the upper right corner of
the Test Screen. It is blue when the computer and the VivoLink are connected after a Test
Type has been selected. It is dark (appears not lit) prior to downloading a Test Type or
when the Bluetooth connection has failed.

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NOTE
The computer on which the Integrity operates should be Bluetooth-enabled or have a
Bluetooth USB Adapter inserted into the computer’s USB port.

Bluetooth connected Bluetooth not connected (not lit)

®
Figure 30. Bluetooth Connection Indicator

The system can establish and maintain a wireless connection only when both the computer
and the Bluetooth USB Adapter are configured correctly. Refer to Installation on page 20
for information on configuring the Bluetooth USB Adapter.
The system requires up to 1 minute to download a Test Type to the VivoLink and establish
the wireless connection. If the wireless connection is not established a message is
displayed stating the connection has failed (Figure 31).
This same message is displayed during data collection if the wireless connection is lost
intermittently. If this wireless connection warning message appears, follow the
troubleshooting suggestions found in Table 9 on page 164.

Figure 31. Bluetooth Connection Failed Message

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The Database Screen

The Integrity System uses a database to store patient and test data for future analysis. The
Database screen retrieves this data and provides tools to review and analyze test results.
It is recommended that entry to the Database screen be password protected to ensure the
privacy of patient test results. Refer to Changing the Password on page 53 for details.

Figure 32. Database Screen showing TEOAE data

Using the Database

Accessing the Database
To access test results stored in the database:
1. Press the Database tab to open the Database screen. You will be prompted to
enter a password.
2. Enter your password and press OK.
The password is case-sensitive.
To protect the privacy of patient test results, use the System screen to set your
password. Refer to Changing the Password on page 53.

Documenting Test Results

The database is a powerful tool used to store and review test results electronically. It
contains records of patient information, as well as information about test results and test
conditions, including time and location, examiner, protocol used, outcomes, and comments.

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Test data is automatically stored in the database. It can be retrieved through the Database
screen as well as exported to other statistical software packages for further analysis.

Monitoring Data Changes Over Time

It is important to do baseline tests to compare future test data reliably. Comparability of the
results is necessary in order to statistically identify any changes in a patient‟s test results
over time. Baseline tests make it possible to accurately identify the development of
conditions such as ototoxicity and noise-induced hearing loss.

Quality Assurance
The database can be an essential part of your quality assurance system. To ensure reliable
diagnosis, the data analysis must be consistent even when the test conditions are not, for
instance results obtained by different examiners, at different test times, on different ages of
patients, and various test locations.
These variations must be taken into account when analyzing the patient data. When a
variation in a particular condition is affecting the data, changes can be made to correct the
issue, such as relocating tests to an appropriate room, acoustically modifying a test
location, additional personnel training, or strictly enforcing protocol use. These measures
may significantly improve the consistency of data collection, resulting in a reduction of post-
test analysis and increasing the reliability of the results.

Database Screen Description

The main Database screen is preview only. The display of the data can be changed but it
will not affect the data or the data point calculations. This is true for all modalities.

NOTE
To label and analyze the waveform in ABR and ECochG select the Expand button.
Refer to Label a Waveform on page 105 for information on editing labels.

The database screen has the following structure:

Database Patient Table is located at the upper part of the screen. This table contains
patients‟ information entered in the Patients screen.
Database Waveform Information is positioned at the lower part of the Database screen.
The top portion of this window displays collected waveforms, waveform peak numeric
values, and conditions of stimulation and recording. The lower part of this window contains
either the waveform details in a chart or graph format.
Database Controls are located on the right side of the Database screen. The controls
provide post-analysis functions on the data, such as report generation.

Database Patient Table

Figure 33. Database Patient List – initial view

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Figure 34. Database Patient List – other fields scrolled right

The Database Patient Table contains patient information entered in the Patients screen,
and test conditions and comments entered when the test results for the patient were saved.
The scroll bar allows scrolling the table to the right and back to the left, and seeing items in
all of the columns. The first three columns on the left, containing patient‟s family and given
names and Hospital ID, serve to uniquely identify the patient in the list, and do not scroll.
When the vertical size of the table exceeds the screen size, a vertical scroll bar appears to
the right of the table. It allows navigating through the table up and down.

NOTE
The patient’s Age is a calculated value. When the data is saved, Integrity calculates
the age using the time and date of the test and the Date of Birth entered into the
patient data.

Comments 1 and 2
The comment fields are filled automatically with information from the Patients screen and
from the comments that were entered when the test results were saved. The first set of
comment fields holds information entered in the Patients screen (Figure 18). The second
set of comment fields, found in the Test information block of the database patient list
contains information that was entered when the test data was saved (Figure 25).

Sort the table information and adjust the column width

These features operate the same way as the tables in the Patients screen. Refer to Sorting
the Table on page 26 for more details.

Select and unselect results

To display specific database entries in the Database Waveform Window, select the blank
cell to the left of the patient‟s name in the Database Patient List to highlight the record.
The collected waveforms are displayed in the Database Waveform Window and data is
displayed in the Database Waveform Information table.

Query the database

The database can be queried using the values available in each column.
To display specific database entries that match the selection criteria:
1. Select the arrow found in the first row under the specific column header. This
displays the query values for that field in a drop-down list.
2. Select as many of these values as needed.

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3. Click with the mouse anywhere outside the drop-down list. The table is updated to
include records that meet the query values selected.
4. Select values from as many columns as required to refine the database query.

The Date of Birth, Time of Birth, and Birth Weight columns allow querying of a range of
values. Set the first value of the range with the upper arrow and the second value with the
lower arrow.

TIP
To view only the records from a specific patient performed by a specific examiner, select
the patient’s name from the drop-down list under the Name column and the examiner’s
name from the drop-down list under the Examiner column. Only the records meeting
these two requirements will be displayed.

Select multiple test records

You can select more than one test record from the Database Patient Table. This allows
you to view or apply features on multiple records at one time.
1. Click the row header (the grey area of the table) to the left of the Patient Info
column. This highlights the entire test record.
2. To select another test record, hold the Ctrl key on the keyboard and click the row
header of another patient record.
To select a range of test records:
1. Select the first test record.
2. Hold the Shift key on the keyboard and click the last test record. All the patients
between the first and last selected record will be highlighted.

NOTE
System will blank out the Database Wave Information Window in case of multiple test
records selection, except for selecting DPOAE test records that are generated with the
same protocol.

Database Waveform Information Windows

This window displays patient data that has been saved to the database. The waveforms
and labeled peak numeric values are the same as those in the Waveform Window and
Waveform Information chart of the Test screen.

Figure 35. ABR Database Preview Screen

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Figure 36. ECochG Database Preview Screen

Figure 37. TEOAE Database Preview Screen

Figure 38. DPOAE Database Preview Screen

Refer to the following sections for test-specific details:

 The ABR Database Screen Waveforms on page 84
 The ECochG Database Screen Waveforms on page 110
 TEOAE Database Screen on page 138
 DPOAE Database Screen on page 157

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Database Controls
The database control buttons (Figure 39), located to the right of the Database Waveform
Window, provide options to create reports, print, view, and save the data from the test.
When multiple test records are selected, the control button functions are applied to all the
selected test records. Refer to Select multiple test records on page 40.
The set of database control buttons depends on the selected test type. Clinical Summary,
Print, Export Data, Delete, Archive, and Un-archive All are available for all test types.

ABR ECochG DPOAE and TEOAE

Figure 39. Database Controls

Table/Graph button (DPOAE and TEOAE)

When selected, the Table button displays the signal and noise information for the selected
records in a tabular format. This table replaces the graphical view of the data. At the same
time, the button label changes from Table to Graph.
Select the Graph button to restore the graphical view of the data. The button label changes
from Graph to Table.
The Table button is enabled only for multiple DPOAE test records that have been
generated using the same protocol.

Figure 40. DPOAE test results in tabular format for multiple averaged test records

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Figure 41. TEOAE test record result in tabular format

Clinical Summary button

Use the Clinical Summary feature to add comments about your test results.
1. Select the Clinical Summary button to open the Clinical Summary Window
(Figure 42).
2. You may write a report for the session and save it in the database.
3. Select the red X ( ) to save your comments with the patient‟s test record.

Figure 42. Clinical Summary Window

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Print button
You can print a report of your test results. Your report may include waveforms, test
conditions, protocol details, patient information, and comments.
To print a report:
1. Select the desired patient records to print.
2. Press Print. This displays the Print Report dialog box (Figure 43).

Figure 43. Print Report Dialog Box

3. Select the type of report you would like to print (Figure 44). In addition to a Clinical
Summary report, you can choose to print one of three types of reports: an
Abbreviated Report, a Comprehensive Report, or a Custom Report.
 A Clinical Summary includes the comments and observations you have
recorded for the test session.
 An Abbreviated Report is typically a short report. It contains essential graphs
and charts, in addition to key test conditions.
 A Comprehensive Report contains all available test data including graphs,
charts, tables, test conditions, protocol parameters, and detailed information
about the patient, the test facility, and the test instrumentation used.
 A Custom Report contains the information you have selected from the Report
Options dialog box (Figure 45).
For each test type, there are options to include graphs or charts; tables of data;
all test conditions or key test conditions only; and, protocol settings. You can
also include detailed information about the patient, the test facility, and the test
instrumentation used.
4. You may choose the Hide patient name on reports option.
5. Press OK to proceed to a standard Windows Print dialog box.
Or, press Preview to view the contents of your report before printing it.
6. From the Print dialog box, you can choose your printer.
If you choose the VivosonicPDF printer (installed with Integrity Version 4.50), your
reports will be saved in a PDF format on your computer. Your files will be located in
the following directory:
C:\Documents and Settings\user profile\My Documents\Vivosonic

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Each file is assigned a default file name that includes both the date and time that
the file was created. You can change the default file name from the Save As dialog
box.

Figure 44. Print a Custom Report

Figure 45. Report Options Dialog Box

Save To Spreadsheet button

This button allows you to export tabular data to a comma delimited file to be used with
database and spreadsheet software applications that can import this type of file, for
1
example Microsoft Excel .
1. Select the Save To Spreadsheet button.
2. Select a location to save the file. Press the folder button to browse to the correct
directory.
3. Enter a name for the exported file.

1
Excel is a registered trademark of Microsoft Corporation.

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4. Press Export Test Result. The comma delimited file will be created.

Figure 46. Export Test Result

Delete Record(s) button

Records can be deleted from the database. To delete a record:
1. Highlight the record to delete.
2. Press the Delete button. The record will be deleted from the database.

Archive button
The Archive feature allows you to “hide” selected patient records. This is useful when there
are too many records to review. It can be time-consuming to look through all of the data to
find a record that has “good” results which are representative of that patient‟s data.
1. Select the results that you want to hide.
2. Press Archive. The selected records will disappear from the database table.

NOTE
Archived data is not deleted or removed from the database. It is merely hidden from
the patient record table and not used.

Unarchive All button

To Unarchive results that have been previously archived, press Unarchive All. All
archived results are re-displayed in the table.

Expand/Edit button (ABR and ECochG)

To make changes to the calculations of points on the waveform select Expand. A window
will open containing only the waveform graph and the activated waveform edit buttons (e.g.
peak labels, baseline label, stop and start peak labels, notes, etc.) Refer to Label a
Waveform on page 105 for information and editing labels.

Latency Intensity button (ABR)

This button is used to display a graph of the latency versus the intensity values of a patient
based on known data defined by the age of the patient. When selected, a window opens
displaying the Latency-Intensity Graph (Figure 66). Select the patient‟s age range from the
Latency Norms drop-down list to display the data supplied for that age. (Hood, 1998),
(Gorga, 1987), (Gorga, 1989), (Zimmerman, 1987)
The Latency-Intensity button is disabled during performing the test. It is enabled as soon
as the test is stopped, and there is an actual waveform displayed on the screen.

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The Protocol Screen

The Protocol screen allows you to create, save, activate, deactivate, and delete test
protocols. The screen is password protected with the same password set for the Database
screen. Refer to Changing the Password on page 53 for details.

NOTE
Access to the Protocol screen is password protected to ensure that only authorized
personnel can create and manage the test protocols.

The Protocol screen has three general sections:

 Protocol List
 Query
 Settings

Figure 47. Protocol Screen showing an ECochG protocol

Protocol List
All created protocols are saved in the Protocol database accessible from the Protocol
screen. All saved protocols are displayed in the list on the left side of the Protocol screen
(Figure 49). The Integrity System comes with several preset protocols. For a list of the
preset protocols refer to Appendix E: Preset Protocols and Test Settings.
Use the scroll bar on the bottom of the list to view all columns in the table.

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Protocol Query
Use the Query feature to find specific protocols based on one or more criteria: name, type,
creator, date/time of creation, and status of the protocol.
The Protocol List automatically updates to show only the protocols that match your
selected criteria.

Figure 48. Protocol Query

Protocol Settings
The configuration of a protocol depends on the test to be performed. For more details about
the protocol settings and defining a protocol refer to the following:
 Define an ABR Protocol on page 64
 Define an ECochG Protocol on page 93
 Define a TEOAE Protocol on page 130
 Define a DPOAE Protocol on page 146

Activate and Deactivate protocols

The Status column of the Protocol List indicates which protocols are active. Those
protocols marked with an “x” (Figure 49) are active and available for use in the Test screen.
To activate or deactivate a protocol, toggle the Status box on or off.

Figure 49. Protocol List with activated protocols

Create a New Protocol

You can create a new protocol from an existing protocol. You cannot modify a protocol and
then save the protocol with the same name.
To create a new protocol:
1. Select the protocol that you wish to modify. Highlight the protocol by selecting the
row header (the grey area of the Protocol List).
2. Modify the parameters of the protocol, including description and comments.
3. Press the Save Protocol button. The Protocol dialog box (Figure 50) appears.

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4. Enter your Protocol Name and the Creator of the protocol.

Save your protocol with a new name.
5. Press OK.

Figure 50. Protocol Dialog Box

If you modify a new protocol and then exit (or switch to a different protocol) without saving
your changes, the Change Protocol message (Figure 51) is displayed.

Figure 51. Change Protocol message

Discard Changes to a Protocol

You can undo all changes that you have made to the current protocol settings.
1. Press the Discard Changes button to undo all changes that you have made to a
protocol.
2. A message will prompt you to confirm your action before continuing.
Press OK to confirm that you want to discard all of your changes.

Delete a Protocol
Only protocols that have never been used can be deleted.
1. Select the unwanted protocol from the protocol list.
2. Press the Delete Protocol button in the protocol Query area (Figure 48). The
Delete Protocol dialog box appears.
3. Press OK to confirm the delete action.

NOTE
Once a protocol has been used to acquire patient data it cannot be deleted from this list.
Only protocols that have not been used to obtain any test results can be deleted from
the protocol database. This ensures the integrity of the test data saved in the database.

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The System Screen

The System screen is used to define the battery type, register new test modalities, change
the user password, define units, select transducers, and backup, merge, and restore the
database.
The first time you use Integrity, configure the system from the System screen before any
other task is started.
The System screen has four sections:
 System configuration
 System configuration controls
 Organizational information
 Database controls

Figure 52. System Screen

System Configuration Selection and Controls

The configuration section of the System screen provides specific information about the
Integrity components.

Software Activation
The System screen displays the test modules that have been activated for you to use.
To register new modules, refer to Installation of New Test Types on page 23.

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Power Line Frequency Setting

Use the Power Line Frequency Setting to specify the default value for the Notch Filter and
to optimize the Kalman Filter performance for different power line environments.
You can select either 50 Hz or 60 Hz from the Power Line Frequency Setting list.

Battery Information
The VivoLink uses one of two different types of batteries. This field defines which type is in
use, and is needed to determine how much power remains in the battery‟s life.
Select either NiMH (Nickel Metal Hydride) or Alkaline from the Battery Type list.

Birth Weight Unit Information

You can set the units that are used when specifying the patient‟s birth weight in the Patient
screen and the Database screen.
Select either Grams (metric) or lb:oz (Imperial measure) from the Birth Weight Unit
Information list.

DPOAE Settings
Both the Test screen and Database screen allow you to toggle the view of your DP-grams
from a merged view to a split view, and vice versa. Refer to Split / Merge Charts on page
153 for details.
To set the default view for your DP-grams, select either Split or Merge from the DPOAE
Settings list.

Transducers and Calibration Units

Selecting the appropriate transducer
Integrity is supplied with two types of transducers: ER3-A and B-71. Use ER3-A
transducers with ABR air-conduction and ECochG protocols, and B-71 transducers with
ABR bone-conduction protocols.
Before you begin a test session, check the System screen to ensure that the appropriate
transducers, identified by serial numbers, are selected in the transducer lists: ER-3A Left
and ER-3A Right, or B-71. This is important to acquire more accurate test results.
If your computer was purchased from Vivosonic Inc., the appropriate calibration files have
been installed for you. If your computer was not purchased from or configured by
Vivosonic, then you must install the calibration files using the Calibration CD.

Adding new transducers and calibration files

1. Exit the Integrity software program before you begin.
2. Copy all files from the Calibration CD to C:\Vivosonic Integrity\Calibration Data\
3. Start the Integrity software program, and go to the System screen.
4. Select the serial numbers of the transducers that you wish to use.

CAUTION
Selecting a serial number that does not match the transducer in use may result in test data
that cannot be confirmed or reproduced. The serial number ensures the correct calibration
data, specific to that transducer, is being used during data collection and analysis.

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Selecting the calibration units

The default calibration units for your transducers are set in the System screen.
 For ER-3A transducers, select either dB nHL or dB peSPL from the ER-3A Units
drop-down list.
 For B-71 transducers, select either dB nHL or dB peFL from the B-71 Units drop-
down list.
The units you select are used by the Stimulus Levels field of the Protocol screen, as well
as, the Level parameter of the Test screen.

Hearing level conversions

It is possible to change the conversion between dB nHL and dB peSPL. The default values,
rounded to the nearest dB, are listed in Table 3, Table 4, and Table 5.

Table 2. dB nHL conversion for Bone Conductor B-71

Frequency dB peFL at 0 dB nHL
500 Hz 67
1 kHz 54
2 kHz 49
3 kHz 46
4 kHz 41
Click 61

Table 3. dB HL pure tone conversion for Insert Earphone ER-3A

Frequency dB peSPL at 0 dB HL
500 Hz 10
1 kHz 6
2 kHz 12
3 kHz 13
4 kHz 15
Click 6

Table 4. dB nHL transient signal conversion for Insert Earphone ER-3A

Frequency dB peSPL at 0 dB nHL
500 Hz 25
1 kHz 26
2 kHz 31
3 kHz 33
4 kHz 35
Click 38

To change the values please edit the following text file on the Integrity (Windows XP)
computer. Use a text-only editing application (such as Windows Notepad®) to modify the
file and do not change the formatting of the file. Ensure it is saved with the .txt extension
after modifying the files.

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The conversion files are located in the following directories:

 Bone Conductor B-71
C:\Vivosonic Integrity\Conversion Files\ ABR B-71 dB nHL to dB pe FL.txt
 Insert Earphone ER-3A
C:\Vivosonic Integrity\Conversion Files\ ABR ER-3A dB HL to dB SPL.txt
C:\Vivosonic Integrity\Conversion Files\ ABR ER-3A dB nHL to dB pe SPL.txt

NOTE
The OAE Probe is calibrated by the manufacturer and does not require calibration by the
user. The probe calibration data is stored in a memory chip (EEPROM) in the OAE Probe
connector for each probe, and is automatically read by VivoLink prior to running an OAE
test.

Unit ID
Each VivoLink has its unique serial number, which will appear at the Unit ID information
control. This is an informational field only and cannot be edited.

Backup Database On Exit

When this is checked, the Integrity system will automatically make a backup of the entire
database when the program is shut down.

Enable Tooltips
When this is checked, the Tooltips on the buttons and features will be enabled. The user
simply moves the mouse over a control or button and after a brief pause an explanation will
be shown.

Changing the Password

The password will secure access to the Database and Protocol screens. To change the
password:
1. Press Change Password.
2. Enter the old password. The system is delivered with no set password. Leave this
field blank when configuring the password for the first time.
3. Enter the new password. If this field is left blank the password will be removed.
4. Enter the new password again in the Confirm Password field.
5. Make a note of the new password, and store it in a secure location.
6. Press OK.
If the old password was entered incorrectly or the new password confirmation was entered
incorrectly, the password will not be changed. Repeat the steps to attempt to change the
password again.

NOTE
The password is case sensitive and can include numbers and letters.
If your password is misplaced or forgotten, please contact customer support for help.

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CAUTION
A system without a password may compromise patient confidentiality.
A password is needed to access the Protocol and Database screens. A password will
prevent unauthorized users from having access to the patient test results stored in the
database. The password also prevents unauthorized users from deleting defined protocols.

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Database Controls
Backing Up Records
The Backup Database feature will make a backup copy of the entire database to a
specified file, on the Integrity System.
1. Press Backup Database. A dialog box labeled Save Backup File As will appear.
2. Select the drive and folder location. Use the button with a folder on it to browse the
computer and select a drive.
3. Press Save. The file will be saved on the selected drive with a default file name.
The file will be named as follows: Vivosonic Integrity (version number) Database
Backup – (current date) – (current time).BAK
For example, a file saved on July 1, 2008 at noon is saved as “Vivosonic Integrity
4.50 Database Backup – 2008.07.01 – 12.00.00.BAK”.
You can change the default file name.

CAUTION
To prevent permanent loss of data due to hard drive failure, it is recommended that the
database be backed up regularly. Vivosonic Inc. recommends a scheduled backup time,
for instance once a week, or after a set number of tests.

Restoring the Database

The database can be restored to the Integrity System.
1. Press Restore Database. A dialog box labeled Please choose a Database
backup file will appear.
2. Select the required database file from the saved drive and folder location. The
selected file should be a ZIP file with .BAK extension that is previously created
through the Backup Database option.
3. Press OK.

CAUTION
When a database is restored it will be permanently replaced with the database currently on
the Integrity System.

Saving Selected Records

The Save Records feature allows a user to save some or all of the test result records and
associated protocols on the hard drive of the notebook computer, USB Flash Drive, or any
other medium that is connected the computer.
1. Change to the Database screen.
2. Highlight the required records from the Database Patient List.
3. Select the System tab.
4. Press Save Record(s). The Save Record(s) dialog box is displayed.
5. Select Save Selected Records to save only the records highlighted in the list.
Select Save All Records to save the entire list of patient test records.
6. Press OK.

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Merging Saved Records to the Database

This feature is useful if you have more than one Integrity System and you want to combine
your records into one database.
Use the Merge Records to Database feature to integrate records that were saved using
the Save Selected Records function.
1. Press Merge Records to Database. A dialog box labeled Select a File will appear.
2. Select the file containing the saved records.
3. Press OK.
If the selected file does not exist, a dialog box labeled Select a File will appear with
“File not found. Please verify the correct file name was given”.
By pressing OK a dialog box labeled Select a File will appear for the user to select
the file.
4. Press Cancel to end the merging process.

In case of a mismatch between the imported record data and data that has already been
saved on the Integrity System‟s database, a message box will be displayed with the
patient/protocol record that has the mismatch.
 Press Yes to overwrite the already saved data in the Integrity System‟s database
with the newly imported data.
 Press No to ignore the conflict, and don‟t modify the already saved data in the
Integrity System‟s database.
 Press Cancel to cancel the whole importing process.

Figure 53. Merging Database Conflict Warning

Organization Information
Enter information about your organization in the appropriate fields. This information will
appear in the patient record printouts.

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Chapter 5: Integrity™ V500 Overview for ABR Testing

Chapter 5: Overview for ABR Testing

This chapter describes the general preparation of the system, including electrode
placement, patient preparation, and transducer selection. It is recommended that you are
familiar with the functionality of the Integrity System screens in Chapter 4: Five Screens of
Integrity.
Refer to Appendix E: Preset Protocols and Test Settings for a detailed description of the
default protocols provided with the Integrity System.

WARNING
Patient injury may occur. Testing is to be performed by a trained health-care professional
licensed by local authorities.

General Preparation of the System

To prepare for a test, perform the following operations:
1. To ensure there is no visible mechanical damage, inspect the VivoLink, Amplitrode,
Amplitrode clips, Amplitrode connectors, and Amplitrode cable; ER-3A Insert
Earphones and their connectors, cables, and silicone tubes; the B-71 Bone
Conductor and its cable and connector.
2. Visually inspect the Amplitrode and its clips to ensure they are clean of any debris.
3. Place the Amplitrode and its clips on the parking snaps located on the front panel of
the VivoLink (Figure 8 #2).

CAUTION
Do not conduct any AEP test if, by visual inspection, you discover any
visible mechanical damage. Report the problem to Vivosonic Inc.’s local
service representative or Vivosonic Customer Support. Do not try to repair
the device yourself.
Do not conduct any AEP test if the Amplitrode or its clips are congested with any
debris which may cause improper electrical contact with the electrode-pad snaps
and improper testing.
4. Switch ON the VivoLink.
5. Switch ON the computer.
6. Read the Caution statements (Figure 14), and choose Agree to proceed.
7. Choose a patient from the patient list.
To perform a test, select at least one patient name from the list of existing patients,
or add a new patient name.
8. Open the Test screen and select ABR from the Test Type list.
The Bluetooth LED starts to flash when your computer recognizes the presence of
the VivoLink and begins to download information to it.
When the download of information is complete, the Bluetooth LED stops flashing
and remains solid blue. If the connection is lost during the download process, the
Bluetooth LED indicator appears unlit.

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Electrodes
Distinguishing Electrode Clips
For the best ABR test results, it is important to position the electrode clips properly. The
Amplitrode is designed to significantly reduce the risk of electrode misplacement. The
Amplitrode is a combination of an electrode and an AEP pre-amplifier, which is mounted
directly on the ground electrode.
Refer to the Amplitrode diagram (Figure 11) for details on the configuration of leads and
electrodes.

Recommended Electrode Placement

Several electrode placement configurations are possible with the Amplitrode, which is
optimized for a single-channel recording (Figure 54). The filled circles represent the
recommended placement for most recordings. (Hall, 1990), (Hall, 1997), (Stapells, 2001)

Figure 54. Typical Electrode Placement Diagram - front view

Figure 55. Typical Electrode Placement Diagram - left lateral view

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The recommended electrode sites include:

 Non-inverting electrode (active or positive): High forehead (Fz)
 Inverting electrode (reference or negative): Left mastoid (M1), right mastoid (M2),
left earlobe (A1), right earlobe (A2); or nape (Oz). If you have the choice of placing
the electrode on the earlobe versus the mastoid, the earlobe is preferred.
 Amplitrode (ground): low forehead (Fpz); nasion (N); opposite ear lobe; or opposite
ear canal.

ATTENTION
When placing the electrode on the mastoid, check the placement as the correct positioning
is necessary for good results.
To ensure reliable waveforms, the patient’s skin must be carefully prepared before the
snap electrode pads are attached, and the electrode clips must be securely connected to
the snap electrode pads.

Figure 56. Amplitrode and Electrode Clip Placement on an infant

Preparing the Patient

The electrodes must be placed on the clean skin of the patient‟s head and the transducers
inserted into clean ears to ensure a good clean signal response.
These three steps must be performed:
1. Skin preparation
2. Electrode application
3. Ear preparation

Skin Preparation
The patient‟s skin must be clear and free of damage, malformations, or disease before
starting the test.
1. Visually inspect the area of skin where the electrodes will be placed. If the skin is
damaged, do not proceed with the test.
2. Remove oil, dead skin particles, or foreign matter from the skin areas that will be in
contact with the snap electrode pads.
3. Remove excessive moisture with a dry cotton ball or gauze pad.

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4. Apply abrasive skin preparation cream or jelly on the cleaned skin surface,
following the manufacturer‟s instructions for use.
5. Remove excessive abrasion cream or jelly with a cotton ball or gauze pad.

CAUTION
Do not proceed with the skin preparation or the placement of the electrodes if the patient’s
skin has wounds, scratches, bruises, or other signs of damage, disease, or malformation.

Application of the Electrodes

The correct and secure application of the electrodes on the patient is important to the
quality of the waveforms to be recorded.
Vivosonic Inc. recommends first connecting the Amplitrode to the ground electrode. Once
secure, connect the electrode clips to the snap electrode pads. The non-inverting (+) and
inverting (-) electrodes are identified by the “+” and “-” symbols on the surface of the clips.
1. Inspect the pouch of single-use electrode pads and check the expiration date on
the back of the pouch.
2. Remove the single-use snap electrode pads from the plastic base and apply them
to the prepared areas of the patient‟s skin. Refer to Figure 54 for details on the
recommended locations of the electrodes.
Press on the white line around the rim of the electrode pad and not on the center,
as this may cause the conductive gel to seep under the pad and will require you to
clean the skin again.
3. Hold the electrode clip with two fingers so that the index finger is in the Holding
Groove and the thumb depresses the Electrode Release Button.
4. Snap the Amplitrode and the two electrode clips onto the electrode pads. Release
the Electrode Release Button to securely clip the electrode to the electrode pad.
5. Check that the electrode is securely seated on the electrode pad.

Figure 57. Amplitrode

1 – Holding Groove, 2 – Electrode Release Button

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Ear Preparation
Before starting the test the ear canal must be clean, free of damage or disease, and clear
of any obstructions to ensure good continuity between the surface of the ear tip and the
tissue of the ear.
1. Inspect the patient‟s ear canal for obstructions.
If there is an excessive deposit of earwax, have an authorized health-care
professional remove the earwax, as defined by local health-care regulations.
2. Check the patient‟s ear canal and select an ear tip that fits tightly, yet comfortably,
in the patient‟s ear canal.
3. Attach the ear tip to the Electrode Ear Tip Cable through the compression fitting
end of the cable.
4. Hold the ear tip with two fingers and compress it.
5. Insert the ear tip slowly into the ear canal: place the red transducer into the right
ear, and the blue transducer into the left ear.
To avoid occluding the ear canal, make sure that the ear tip is inserted tightly in the
cartilaginous part of the ear canal, not in the bony part.

WARNING
Tympanic membrane and inner ear damage may occur resulting in hearing loss. The
cleaning of the ear canal should be performed by a trained health-care professional
licensed by local authorities.

Electrode Contact
Integrity continuously monitors electrode contact during ABR and ECochG data collection.
This ongoing monitoring provides a basic indication of whether the signal electrodes are in
contact with your patient‟s skin. Poor contact between the electrodes and your patient will
affect your test results.
Always start a test by ensuring that electrode contact is good. You may also check the EEG
signal. If the signal is very noisy with a peak-to-peak value greater than +/-20 µV, a contact
problem may exist. In addition, you may want to perform an impedance test to determine
the quality of contact and the presence of signal artifact.

Electrode Contact LED Indicator on the VivoLink

The Electrode Contact Indicator light (or LED) on the front panel of the VivoLink (Figure 8
#3) indicates whether the inverting (-) and non-inverting (+) electrodes on your patient‟s
skin are detected by the system.
 The LED is not lit when the VivoLink if OFF.
 A green LED indicates electrode contact is detected.
 A flashing amber LED may indicate that one of the electrode clips has lost contact
with the electrode, or that an electrode has fallen off and is no longer in contact
with your patient‟s skin. You should reconnect your electrodes to obtain proper
contact.

Electrode Contact Indicator on the Test Screen

The electrode contact indicator on the Test screen consists of two virtual LEDs, one for the
inverting contact and one for the non-inverting contact.
When one of the electrodes or electrode clips loses contact, the corresponding LED flashes
amber. Reconnect the electrode or clip to reestablish contact prior to testing.

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Check Impedance Mismatch

Before you begin a test, you can perform an impedance check to determine the difference
(or degree of mismatch) between the impedance values of the inverting and non-inverting
electrodes applied to your patient. This feature requires that you use VivoLink V51 with
Amplitrode A51.
Typically, an impedance mismatch of less than 5 kOhms will yield the best test results.
To check the level of inter-electrode impedance mismatch:
1. Press the Check Impedance button on the Test screen. The button is only visible
when you are using VivoLink V51 with Amplitrode A51.
A message instructs you to wait a few seconds for the test to complete.
2. The Check Impedance dialog box displays the mismatch value and the status of
the results.
 The indicator bar is green when the impedance mismatch is acceptable for
testing purposes. You may begin testing.
 The indicator bar is amber when the difference between the inverting (-)
electrode impedance and the non-inverting (+) electrode impedance is greater
than 5 kOhms. You should adjust your electrodes for better test results.
 The indicator bar is gray when the inverting (-) electrode, non-inverting (+)
electrode, or ground electrode are disconnected. Testing should not proceed.
You should check your electrodes.
3. Reconnect your electrodes as necessary.
4. Wait for the indicator bar to update and specify an acceptable value.
5. Close the Check Impedance dialog box and proceed with testing as appropriate.

Figure 58. Check Impedance Mismatch Dialog Box

Choose a Transducer
Use the ER-3A Earphones when performing ABR testing using air conduction. The B-71
bone conductor is used to perform ABR bone-conduction testing.

ER-3A Earphones
ER-3A earphones are used when performing ABR or ECochG testing. The protocol must
be configured to use the ER-3A Transducer Type. If it is not selected, the stimuli will not be
transmitted through the earphones.

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Figure 59. ER-3A Earphones (a) and their Foam Ear Tip Dimensions (b)
1 – Foam ear tip, 2 – silicone air-conducting tube inside the foam ear tip

When earphones are used for testing:

1. Inspect the patient‟s ear canal, preferably with an otoscope (not included) for
obstructions. If there is an excessive deposit of earwax, have an authorized health-
care professional remove the earwax, as defined by local health-care regulations.
2. Observe the patient‟s ear canal and evaluate its size. Select an ear tip that would fit
tightly yet comfortably in the patient‟s ear canal.
3. Install the ear tip onto the earphone. Gently place the ear tip into the earphone tube
until there is a full stop.

ATTENTION
Do not exceed hand force when inserting the ear tip. Make sure the silicone tube
inside the ear tip is not bent or pressed. A misaligned tube would result in a change
in the acoustic properties and may compromise the calibration or cause potential
misdiagnosis.

4. Hold the ear tip with two fingers and compress it.
5. Insert the ear tip into the ear canal: place the red transducer into the right ear, and
the blue transducer into the left ear. Insert the ear tip slowly. Make sure the ear tip
is inserted tightly in the cartilaginous part of the ear canal, not in the bony part,
which would occlude the ear canal.

CAUTION
Do not insert the ear tip in the ear canal too quickly. This may cause excessive
positive air pressure in the ear canal being occluded by the ear tip and may hurt the
eardrum of the patient. There is a pressure release vent in the transducer, but it may
not be sufficient to release excessive air pressure if the ear tip is inserted too
quickly.

B-71 Bone Conductor

the protocol must be configured to use the B-71 Transducer Type. If it is not selected, the
stimuli will not be transmitted through the bone conductor.
1. To perform data collection using bone conduction, connect the B-71 Bone
Conductor to either the left or right mastoid, or the forehead.
2. Secure the headband supplied with the B-71 Bone Conductor. Ensure that the
entire circular surface of the bone conductor is in full contact with the skin.

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WARNING
The bone conductor headband is a steel spring designed to hold the bone conductor in
place using no more than hand-tightened force. The headband may injure the patient if it
is released before full contact with the skin. When placing the bone conductor on the
patient’s head, do not release the headband until both the bone conductor and the
opposite cushioned pad are in full contact with the skin.
Strangulation may occur.
 Do not put the B-71 Bone Conductor cable around the patient’s neck.
 Do not leave a patient unattended while preparing and conducting the
bone-conduction test.

Specific ABR Test Preparation

Define an ABR Protocol
Protocol parameters are set from the Protocol screen using ABR Stimulus and Test
Settings (Hall, 1990), (Hall, 1997), (Stapells, 2002), (Stevens, 2001 Click), (Stevens, 2001
Tone Pip). To create a new protocol, modify an existing protocol, and then save it with a
new name.
Some protocol settings may also be modified from the Test screen. Refer to The ABR Test
Screen on page 68 for more details.

Figure 60. Protocol Stimulus Settings and Test Settings

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The parameters, which can be preset in this protocol, are divided into two categories:
Stimulus Settings and Test Settings.
 The Stimulus Settings are used to select the stimulation parameters such as
stimulus type, stimulus level, maximum number of stimuli, stimulus rate, stimulus
window, waveform ramp setting, and transducer type.
 The Test Settings control the acquisition conditions of the waveform recording,
such as high-pass and low-pass filter settings, high-pass and low-pass filter rolloff,
the amplifier gain, recording window duration, and the artifact rejection threshold
(relevant only when using the averaging algorithm).

Stimulus Settings
Recommended Stimulus Settings for Diagnostics
Stimulus Type: Click
Stimulus Rate (stimuli/second)
Certain stimulus rates are known to have high interference with AC Power Line, VivoLink
internal harmonics, and local environment. A slower stimulus rate will create a better ABR
waveform for diagnostics.
Refer to Table 5 on page 66 for Recommended ABR Stimulus Rates (stimuli/second).

Recommended Stimulus Settings for Threshold Testing

Stimulus Rate (stimuli/second)
Certain stimulus rates are known to have high interference with AC Power Line, VivoLink
internal harmonics, and local environment. A faster rate (such as 49.8 stimuli/s) will create
a better ABR waveform for threshold estimation. However, higher rates can also create a
mid-latency response overlap in awake subjects making the results hard to interpret.
Refer to Table 5 on page 66 for Recommended ABR Stimulus Rates (stimuli/second).

Understanding the Settings on the Protocol Screen

Stimulus Type
The following stimulus types can be selected from the drop-down menu: click or tone burst
frequencies of 500 Hz, 1 kHz, 2 kHz, 3 kHz, and 4 kHz.
Transducer Type
Two transducer types are available from the drop-down menu: the ER-3A Earphones and
the B-71 Bone Conductor.
Stimulus Rate (stimuli/second)
The Stimulus Rate can be set for click and tone-burst stimuli. Select the number of stimuli
to produce per second from the range of 7.1 to 99.0 (in 0.1 increments). Changing the
Stimulus Rate will result in a change in the wave latency delay and in the early wave‟s
amplitude.
Although the stimulus rate may be set anywhere in the above specified range, the use of
certain stimulus rates are recommended because when they are implemented by the
VivoLink internal clock they are not synchronized with 50 and 60 Hz power line frequencies
and their harmonics.
Refer to Table 5 on page 66 for Recommended ABR Stimulus Rates (stimuli/second).

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Table 5. Recommended ABR Stimulus Rates (stimuli/second)

7.6 30.8 52.3 74.8
8.3 31.0 53.1 75.7
9.8 32.9 54.4 76.6
10.3 33.8 55.4 77.7
11.3 34.0 56.8 78.3
12.4 35.6 57.3 79.8
13.8 36.3 58.0 80.5
14.7 37.7 59.4 81.5
15.4 38.3 60.3 82.4
16.4 39.9 61.9 83.7
17.7 40.3 62.6 84.5
18.6 41.2 63.6 85.9
19.3 42.1 64.5 86.3
20.2 43.9 65.9 87.1
21.5 44.5 66.8 88.6
22.9 45.8 67.0 89.6
23.9 46.5 68.0 90.3
24.9 47.5 69.9 91.3
26.7 48.7 70.1 92.6
27.5 49.8 71.8 93.5
28.3 50.2 72.3 94.6
29.3 51.6 73.2 95.7

Maximum Number of Stimuli

This setting depends on the selected Stimulus Rate. For the lowest Stimulus Rate of 7.1
stimuli/s, the Maximum Number of Stimuli is 5964. For the highest Stimulus Rate of 99
stimuli/s, the Maximum Number of Stimuli is 83160.

Windowing
This setting is applicable to the tone-burst stimulation type only. The window defines the
shape of the tone-burst waveform, which follows the rise, plateau, and fall portions of the
stimulus. The tone-burst signal can be Rectangular, Linear, or Blackman waveform. The
Blackman gated window is most commonly used.

Ramp Number of Cycles (Rise – Plateau – Fall)

This setting is applicable to the tone-burst stimulation type only. The number of sinusoidal
waves in the raise, plateau, and fall portions of the tone-burst‟s waveform is controlled by
this parameter. The selections available from the drop-down menu include:
 0-4-0, and 0-5-0 in case Rectangular option is selected for Windowing
 2-1-2 or 2-0-2 in case Linear option is selected for Windowing
 2-0-2, and 2.5-0.2.5 in case Rectangular option is selected for Windowing

NOTE
When Click is selected as the Stimulus Type both the Windowing and Ramp Number of
Cycles settings are unavailable.

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Stimulus Levels
A single stimulus level or a range of stimulus levels may be selected. The available levels
depend on the Stimulus Type preset through the Protocol screen.
A single fixed stimulus level may selected by clicking with the mouse on that level.

To select a range of levels for multiple-level tests:

1. Press and hold the Shift key on the keyboard.
2. Highlight the first and last stimulus level in the required range.

To select a set of non-contiguous (individual) stimulus levels:

1. Press and hold the Ctrl key on the keyboard.
2. Highlight each required level.

Table 6. Stimulus Levels Ranges

Transducer Type Unit Stimulus Type Stimulus Levels Range
Click 38 – 137
500 Hz 25 – 130
Air Conducted
dB pe SPL 1 kHz 26 – 130
ER-3A 2 kHz 31 – 130
3 kHz 33 – 130
4 kHz 35 – 130
Click 51 - 111
500 Hz 66 - 117
Bone Conducted
dB pe FL 1 kHz 60 - 114
B-71 2 kHz 56 - 109
3 kHz 50 - 106
4 kHz 48 - 101

TIP
During the test session, it is possible to change the stimulus level from the Test screen
using the Level (dB pe SPL)/ (dB nHL) slider bar. Refer to Level (dB pe SPL)/ (dB nHL)
on page 73 for details.

NOTE
Air-conducted stimuli are displayed in units of dB nHL or dB pe SPL.
Bone-conducted stimuli are displayed in units of dB nHL or dB pe FL.
These units are set in the System screen. Refer to
Selecting the calibration units on page 52 for more details.

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Test Settings
These control the acquisition parameters of the ABR recording, such as high-pass filter
cutoff frequency (Hz), low-pass filter cutoff frequency (Hz), high-pass filter rolloff, low-pass
filter rolloff, post-Amplitrode gain, recording window (ms), artifact rejection, and artifact
rejection thresholds.

Recommended Test Settings

High Pass Filter Cutoff Frequency (Hz): 30
Low Pass Filter Cutoff Frequency (Hz): 1500
High Pass Filter Rolloff: 12 dB/Octave
Low Pass Filter Rolloff: 24 dB/Octave
Post-Amplitrode Gain: 0
Recording Window (ms): 25

High-Pass Filter Cutoff Frequency (Hz)

The digital high-pass filter is used to filter out low frequency noise. The filter can be set to a
value in the range of 30 – 300 Hz.

Low-Pass Filter Cutoff Frequency (Hz)

The digital low-pass filter is used to filter out high frequency noise. The filter can be set to a
value in the range of 1000 – 3000 Hz.

High-Pass Filter Rolloff and Low-Pass Filter Rolloff

Rolloff is defined as the rate of attenuation of a filter, expressed in dB per octave. The high-
pass rolloff filters the low frequencies and the low-pass rolloff filters the high frequencies.
Select the high-pass rolloff to filter either 6dB/octave or 12dB/octave and the low-pass
rolloff to filter either 12 dB/octave or 24 dB/octave.

Post-Amplitrode Gain (dB)

®
This control regulates the post Amplitrode gain. The available values are 0 (system
default), 10, 20, and 40.

Recording Window (ms)

The Recording Window is a time period after the stimulus is presented to the patient,
during which the response is averaged and analyzed. The recording windows can be from
0.1 ms up to 30 ms depending of the selected Stimulus Rate.
The Recording Window for ER-3A transducer type should be at least 1.0 ms less than the
inter-stimulus interval, which is (1/Stimulus rate).
The Recording Window for B-71 transducer type should be less than or equal to the inter-
stimulus interval, which is (1/Stimulus rate).

Artifact Rejection
This selection box controls the availability of the Artifact Rejection Thresholds function.

Artifact Rejection Threshold

The Artifact Rejection Threshold is used to exclude certain noise levels from the averaging
calculations. The value selected (10, 15, 20, or 25 µV) defines the lowest level of the
incoming electrophysiological activity which contains excessive electric noise. This field is
only accessible when the Artifact Rejection control box is selected.

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During the Test

The ABR Test Screen
Electrode Contact
The status of the connections between the electrodes and the patient‟s skin is displayed
visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.
• A flashing amber LED indicates that the corresponding electrodes has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip
If a problem is evident, remove the electrode indicated, clean the skin, and apply a new
snap electrode pad and reconnect the electrode clip.

Right Ear/Left Ear Button

Select the ear to test by pressing the Right Ear or Left Ear button. When the Right Ear
button is selected, the stimuli is delivered to the patient‟s right ear through the red tube of
the ER-3A earphone. The waveform trace in the Waveform Window (Figure 69) is red to
follow the color standards for audiologic practice. When the Left Ear button is selected, the
stimuli is delivered to the left ear through the blue tube of the ER-3A earphone. The
waveform trace in the Waveform Window is blue.

Test Protocol Parameters for ABR

These Protocol Test Settings are found in the center of the Test screen. Not all of the
protocol settings are preset conditions available only from the Protocol screen. Vivosonic
has developed a set of protocols that can be manipulated during the test procedure (Hall,
1990), (Hall, 1997), (Stapells, 2002). These settings can be changed during a test session
between data collection.

Figure 61. Protocol Test Settings

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Algorithm
This control regulates application of the methods of processing the ABR waveforms. There
are two processing algorithms to choose from: Averaging and Kalman Weighted. Kalman
Weighted is the system‟s default algorithm.
Averaging is a signal processing algorithm which utilizes the standard time averaging
technique so that equal weighting is given to the collected ABR data. Weights are based on
the noise in the response. Waveforms contaminated with artifacts above certain Artifact
Rejection Thresholds (ART) are excluded from averaging.
Kalman Weighted is a signal processing algorithm that is used in ABR testing to optimally
weight the patients' responses so that responses with less myogenic artifact are given more
weight than responses that are more contaminated with artifact. Kalman filtering allows
ABR acquisition with subjects who are awake and not relaxed. This method processes
signals in real time without rejecting any time segments, even those containing significant
artifacts. (Li 2002)
When ABR is collected on a subject who is relaxed throughout the test, Kalman Filtering
yields the same result as conventional averaging. When the subject moves intermittently
during the test and produces myogenic artifacts, the Kalman Filter will yield a result that is
less contaminated by noise than a result that would be obtained under the same conditions
with conventional averaging.

Status
Select the patient‟s status of wakefulness from the drop-down menu. The choices include:
Awake, Mixed, Natural Sleep, Sedation, and Anesthesia. Awake is the default setting.

Polarity
This control regulates the voltage characteristic of the stimulus. Stimulus polarity selection
depends on the goal of the testing. From the drop-down menu select Condensation,
Rarefaction, Alternating, or Alternating split.
Condensation denotes a polarity as the initial displacement of the stimulus, produced with
a positive-voltage electrical signal and an outward movement of the acoustic transducer.
Rarefaction denotes a polarity as the initial displacement of the stimulus, produced with a
negative-voltage electrical signal and an inward movement of the acoustic transducer.
Alternating denotes a polarity as interchangeable, presenting rarefaction and
condensation polarity stimuli characteristics. The responses of two consecutive stimuli are
sent to one buffer (A), then the responses of the next two consecutive stimuli are sent to
the other buffer (B). Thus, each buffer will get the responses from both condensation and
rarefaction stimuli.
Alternating split denotes a polarity as interchangeable, presenting rarefaction and
condensation polarity stimuli characteristics. The polarity alternates which buffer the
responses are sent to. Buffer (A) will receive only responses from condensation stimuli and
the other buffer (B) will receive only responses from the rarefaction stimuli. Thus, each
buffer only receives responses from a specific stimulus polarity.

NOTE
If you are performing a test at low frequencies (at or below 1000 Hz) using tone bursts and
have alternating polarity the ABR morphology will most likely be poor and it may be

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difficult to detect Wave V.

Ear Tip
Select the size of the ear tip from the drop-down menu. Refer to Figure 3 on page 11 to
view the types available.

Masker
This control regulates the introduction of contralateral wideband masking noise.
 Select Wide Band Noise to apply masking through the ER-3A transducer opposite
to the ear which is stimulated with ABR stimuli (clicks or tone bursts).
 Select None to test without masking. This is the system default.

Masking Level
The masking level defines the contralateral masking noise (dB HL). When a masking value
is selected, the VivoLink produces wide band noise.
There are no necessary adjustments to the Reference Equivalent Threshold Sound
Pressure Level (RETSPL) values that accompany narrow band noise, as per ANSI S3.6-
2004, 6.3.1. The conversion from dB HL to dB SPL is based on the RETSPL value for the
insert earphones in an occluded ear simulator (Table 7 in ANSI S3.6-2004 Manual).
The masking dB SPL value is calculated for the root mean square (rms) of the masking
signal. As such, the dB SPL of the overall masking signal will differ with the type of
stimulus, such that the rms of the masking signal will match that of the dB HL at the
corresponding frequency of the stimulus signal. Click signals are considered to have a
frequency of 1 kHz.
Select the level from 10 to 100 dB HL in 1 dB increments.

Non-Inverting (+) and Inverting (-) Electrode

These two fields allow you to select the location of the non-inverting (+) and inverting (-)
electrodes on your patient.
The possible electrode locations available from the drop-down menu are as follows:

Figure 62. Non-Inverting (+) Electrode Drop-Down List

Refer to the recommended electrode placement diagram in Figure 54 on page 58. (Hall,
1990), (Hall, 1997), (Stapells, 2001)

Recording Side
This field is not user-selectable. Its selection is dependent on the non-inverting (+) or
inverting (-) electrode selected and the ear chosen for stimulation.

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Ipsilateral – the non-inverting electrode is located on the same side of the head as the ear
being stimulated.
 With the right ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz
locations for the non-inverting (+) electrode and A2, M2, EAC2 for the inverting (-)
electrode.
 With the left ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz
locations for the non-inverting (+) electrode and A1, M1, EAC1 for the inverting (-)
electrode.
Contralateral – the non-inverting electrode is located on the opposite side of the head as
the ear being stimulated.
 With the right ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz
locations for the non-inverting (+) electrode and A1, M1, EAC1 for the inverting (-)
electrode.
 With the left ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz
locations for the non-inverting (+) electrode and A2, M2, EAC2 for the inverting (-)
electrode.
Medial – the non-inverting and inverting electrodes are located along the sagittal plane of
the head with any combination of Cz, Fz, Fpz, Nz, Oz locations.
Horizontal – the non-inverting electrode is located on the stimulus-contralateral mastoid,
earlobe or ear canal, while the inverting electrode is located on the stimulus-ipsilateral
mastoid, earlobe or ear canal with any combination of A1, A2, M1, M2, EAC1, and EAC2
locations.

NOTE
The Recording Side entries provide important information about the location of data
collection relative to the stimulation location. (Hall, 1990), (Hall, 1997), (Stapells, 2001)
These settings do not affect the recording. The information is saved with the data and
may be used when the data is reviewed. Ensure that the information is correct before
saving the results. This information cannot be changed after it is saved.

Notch Filter
The notch filter is designed to reduce the interference from electrical activity or power line
noise of 50 Hz, 60 Hz. To disable the notch filter select Off from the drop-down menu.
The default frequency for the notch filter, either 50 Hz or 60 Hz, can be set from the
System screen using the Power Line Frequency Setting. Refer to on Power Line
Frequency Setting on page 51.

Electrodes Used
Select the type of electrode from the drop-down menu or type the electrode brand into the
field.

Figure 63. List of Electrodes Available for Testing

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Level (dB pe SPL)/ (dB nHL)

Figure 64. Stimulus Level Bar (dB pe SPL)

The stimulus level slider bar displays and regulates the levels of stimulation provided to the
data recording. The initial position of the slider depends on the Stimulus Levels (dB nHL)
defined in the protocol selected.
 When testing with a single level protocol, the slider is positioned at the specified
stimulus level.
 When testing with a multi-level protocol, the slider is positioned at the lowest
stimulus level for that protocol. The full range of values is selected on the Protocol
screen. Use the slider bar on the Test screen to change the initial stimulus level.
The units displayed are defined in the System screen on page 50. Refer to Table 6 on
page 67 for values that can be selected based on the transducer type.

NOTE
The bone conductor stimulation range depends on the Stimulus Type defined in
the protocol selected. VivoLink has a maximum stimulus level of 50 dB nHL for
click, and 500 Hz for tone-burst stimulus types. The maximum of 60 dB nHL level
applies to 1000 - 4000 Hz tone-burst stimulus types.
The increment in Level (1, 2, 5, 10, 15, 20, etc. dB) depends on the Stimulus
Levels control settings defined in the selected protocol.

Signal Information
During and after data collection, the Signal Information area of the Test screen displays
information about the collected waveform.

Figure 65. Signal Information

Stimulus Type
Click or tone-burst frequency is displayed in this field as defined by the protocol.

Transducer Type
ER-3A or B-71 is displayed in this field as defined by the protocol. This information also
includes the serial number of the selected transducer.

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Number of Stimuli (Num of Stim)

The Number of Stimuli applies only when the Averaging algorithm is in use.
This information box displays the number of stimuli presented in the test. The value counts
up as the test is running. If the test runs to completion, the value should be equal to the
value of the Maximum Number of Stimuli defined in the selected protocol, otherwise it
displays the number of stimuli counted at the time the test was stopped.

% Rejected
This information box displays the percentage of the rejected ABR responses. Responses
are rejected when the amplitude exceeds the preset Artifact Rejection Threshold value
defined in the selected protocol.

NOTE
The system displays the percentage of rejected stimuli only when the Averaging algorithm
is selected on the Test screen.

Eq. Sweeps
The number of Eq. Sweeps, or Equivalent Sweeps, applies only when the Kalman
Weighted algorithm is in use.
Although Kalman filtering makes ABR acquisition on awake, non-relaxed subjects more
practical, more sweeps are required to acquire an ABR on a non-relaxed subject with the
same signal-to-noise ratio that would have been obtained if the subject were completely
relaxed. The Eq. Sweeps value indicates the number of sweeps that would yield the same
signal-to-noise-ratio as the current Kalman-filtered ABR waveform if the patient's EEG had
remained minimally quiet throughout the test.
For example, if the total number of sweeps is 2000, then, if Kalman Filtering is selected, the
Eq. Sweeps will read less than 2000 unless the myogenic and other electric and magnetic
interference remains constant throughout the test.
Using the Kalman Weighted algorithm, 2000 “equivalent sweeps” is comparable to 2000
“accepted sweeps” used in conventional averaging.

Latency-Intensity
The Latency-Intensity button is used to display a graph of the latency versus the intensity
values of a patient‟s recording based on the age of the patient. When selected, a window
opens displaying the Latency-Intensity Graph (Figure 66). Select the patient‟s age range
from the Latency Norms drop-down list to display the data appropriate for that age. (Hood,
1998), (Gorga, 1987), (Gorga, 1989), (Zimmerman, 1987)
The Latency-Intensity button is available for selection when a waveform is displayed on the
screen. However, before the Latency-Intensity graph can be populated, the waves must
first be labeled with I, III, or V wave labels in the Waveform Window (Figure 69).
When more than one waveform is collected for the same ear, at the same level of
stimulation, and the waves are marked with the average latency value, these waves are
displayed on the Latency-Intensity graph.
The latency values (in ms) for the I, III, and V waves are plotted against the intensity level.
The latency graphs and dots are color coded (red for the right ear and blue for the left).
Normative data is displayed on the Latency-Intensity graph as an average value ± 2
standard deviations in the form of vertical bars (Figure 76).
To view normative (raw) data open the following file:
C:\Vivosonic Integrity\Integrity Norms\ABR\ LatencyNormals.ini

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Figure 66. Latency-Intensity Graph

EEG Window
This area of the Test screen displays the Electrode Contact Indicator and a real-time
EEG graph.

Figure 67. EEG Window

Electrode Contact
The status of the connections between the electrodes and the patient‟s skin is displayed
visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.

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• A flashing amber LED indicates that the corresponding electrode has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip.
If a problem is evident, remove the electrode indicated, clean the skin, and apply a new
snap electrode pad and reconnect the electrode clip.

Figure 68. Poor Electrode Contact

What to do When Electrode Contact is Undetected

1. Check the status of the snap electrode pads. Fix, replace, or reapply one or both of
the snap electrode pads if necessary.
2. Check the connection between the disposable electrodes and Amplitrode clips. If it
is not a good connection, reconnect, replace, or fix it.

CAUTION
When attaching the Amplitrode to the VivoLink or electrodes, avoid applying pressure to
the Amplitrode. Use the electrode release button (Figure 57) to place the Amplitrode on
the snap instead of forcing the Amplitrode on the electrode snap. Care should be taken to
ensure that the spring of the Amplitrode does not break.

Ongoing EEG
A real-time EEG signal is displayed in the EEG window of the Test screen. This EEG signal
is recorded by the electrodes and 150 ms of the signal is displayed at a time. The
amplitude scale on the graph changes automatically when the amplitude of the recorded
EEG signal changes. Usually EEG collected from a relaxed patient are within ± 40 µV.
However, to obtain better recordings, if the EEG amplitude increases beyond ± 20 µV you
may want the patient to relax further. If the EEG amplitude does not decrease, the problem
may be poorly placed electrodes. Readjust the electrodes and start again.

NOTE
The Ongoing EEG graph shows a filtered EEG signal that passes through the ABR (30 –
3000 Hz, slope 12 dB/octave) analog electrical filters of the Amplitrode, not an unfiltered
“raw” EEG signal. If the analog notch filter (50 Hz or 60 Hz) of the VivoLink is switched
ON, then the Ongoing EEG passes through this filter as well.
This signal does not pass through the digital high-pass and low-pass filters, which are set
in the protocol and affect only the digitally processed (averaged or Kalman-filtered)
recordings.

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Waveform Window
This Waveform Window displays the graphic representation of the collected waveform as a
function of the amplitude (µV) of the signal over time (ms).

The waveforms collected from the left and right ears are displayed on the same graph and
are distinguished by the color of the waveform. Recordings for the right ear are indicated by
red waveforms, and recordings for the left ear are indicated by blue waveforms.

Figure 69. Waveform Window with recorded data

The Waveform Window is used when monitoring data in real time and when analyzing and
labeling waveforms. Each Start and Stop during a test session produces a new waveform.
To zoom or magnify the waveform window, drag your mouse from left to right. To restore
the display to its original magnification, drag your mouse from right to left.
You can also view a single latency value by pointing to a waveform with your mouse
pointer. The Latency and Amplitude values are displayed in a small window in the upper
right corner of the window.

Waveform Handle
Each waveform is supplied with an individual handle located to the left of the graph.

Figure 70. Waveform Handle

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All waveform handles have a tagging line which displays the following information:
 The waveform number identifies the relative order in which the waveform was
collected. The same number is also displayed in the Waveform Information Chart
(Figure 77 on page 83) to associate the waveform with its corresponding data.
 The stimulus level of this test according to the unit selected in the System screen.
 R or L indicates the recording as the right ear or the left ear.

To select a waveform, click on its handle. You can use the handle to drag the waveform
along the vertical axis.
To select multiple waveforms, press the Ctrl key on your keyboard and click on the handle
of each waveform. You can move all selected waveforms at once.

Label a Waveform
To label a waveform and calculate its latency, follow these steps:
1. Select the handle of the waveform to be labeled.
2. Select a label from the labeling buttons (Figure 71) at the top of the Waveform
Window.
A labeling button remains active until a different labeling button, or the arrow
(selection) button, is selected.

Figure 71. Waveform Labeling Buttons

3. Place the cursor over the waveform to be labeled. Note that the location jumps to
the peaks (peak positives) and troughs (peak negatives) of the wave.
4. When the correct peak or valley has been identified, click the mouse to place the
label.
The selected peak will be marked with the chosen wave number and the calculated
peak-related latency values (Hood, 1998), (Gorga, 1987), (Gorga, 1989),
(Zimmerman, 1987) will appear in the Waveform Information Chart (Figure 77).
Once placed on the wave, the label can be deleted or moved.
5. Select another labeling button to place a different label, or use the arrow button to
select another waveform.

To move a label, select the label and place it again following the steps above.

NOTE
Use the I, II, III, IV, and V buttons with Roman numerals to label the positive peaks.
Use the I’ and V’ buttons to label the negative peaks of waves I and V.
Labeling the negative peaks is essential for calculating the peak-to-peak amplitude.
Labeling the negative peaks will not affect the latency calculation.
A labeling button remains active until another labeling button is selected or the arrow
button is selected.

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Waveform Labels
There are 10 waveform label buttons used to characterize the peaks and valleys of the
waveform. Seven of these buttons are identified by the Roman numerals. Two (SS and SE)
are used to mark the start and end of the statistical data. The final button Note, allows the
technician comment the waveforms.

SE and SE
Mark the start and end of the desired statistical data using the SS and SE buttons.

Note
The Note button is used to add comments to the graph.

Figure 72. Note Callout

To add a note:
1. Select the Note button.
2. Please the cursor over the waveform in the location desired.
3. Click the location to place the note.
4. Click inside the note box to start typing the content.
5. Use the pen icon in the top right corner to edit a previous note.
6. Use the minimize icon in the top right corner to reduce the size of the note.
7. Use the X icon in the top right corner to delete the icon.

A,B Display
The A,B display mode is used to change the displayed waveform into the recorded
components of the A and B buffered information.
1. Select the desired waveform.
2. Press the A,B button located next to the Waveform Labeling buttons (Figure 71).
The single waveform splits into A and B components.
3. To switch back to the combined waveform, select one of the split waveforms and
press A,B again.

A-B Display
The A-B button displays the waveform as a calculation of component A minus component B
of the received signal. This display represents the noise floor.

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Figure 73. Waveform Window with A,B and A-B Display

Moving waveform displays together

Select the handle of the A-B waveform to move it around the graph. Select the handle of
the original waveform to move both the original (A+B) and the A-B waveforms together.

Unlink waveform displays

To unlink the two waveforms point the cursor at the original waveform handle (A+B). A
chain icon will appear above the handle. Double-click the chain icon and the image will
change to a broken chain. The waveforms can now be moved independently of each other.

Figure 74. Linked and Unlinked Waveform Icon

Delete Waveform Button

To delete a wave from the Waveform Window:
1. Select a waveform handle.

2. Press the button to delete the selected waveform.

3. Answer Yes when asked if you want to delete the wave.

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To delete multiple waveforms, press and hold the Ctrl key while you select each waveform,
then press the Delete (X) button. You will be prompted to confirm the deletion of all the
selected waveforms.

NOTE
The Delete button is unavailable when there is only one waveform selected, or when all
waveforms have been selected. To remove all waveforms on the graph, select the
Discard/Clear Graph button.

Page Break View

This button ( ) is used to view the waveforms on a page. This allows you to make
adjustments to the layout of your waveforms before printing.

Figure 75. Page Break View

Latency Norms
Integrity provides a graphical presentation of the normative data for latencies I, III and V.
The list contains normative data for click stimulus only.
To view normative latency data for waves I, III and V, do the following:
1. Select one or more waveforms.
2. Select the Latency Norms drop-down list to view the normative data list.
Latency norms that match, or most closely match, the stimulus intensity level of the
selected waveform, are listed at the top. All available norms are listed below this.

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3. The normative data graphs for waves I, III and V latencies will be shown in the
Waveform Window as short yellow vertical bars representing +/- 2 standard
deviations from the population mean (Figure 76).
4. The Waveform Information Chart (Figure 77) displays the normative data title and
the level of intensities for the latency norms shown.
You can also view a single latency value by pointing to a waveform with your
mouse pointer. The Latency and Amplitude values are displayed in a small window
in the upper right corner of the screen.

Figure 76. Latency Norms

For the source and value of the ABR latency normative data, refer to Appendix L: ABR
Latency Norms Data.

NOTE
Normative data is available for click stimulus only. When the selected waveform uses tone-
burst stimulus, the text “No Norms Available” replaces the Latency Norms drop-down list.
Custom latency norms can be introduced to the system by editing the Latency Norms file:
C:\Vivosonic Integrity\Integrity Norms\ABR\ LatencyNormals.ini
When editing the Latency Norms file, use the same data entry standard as the predefined
latency data already in the file to add custom data. Once added, the new data will appear
as a selection in the Latency Norms drop-down box.
It is recommended that each clinic create its own normative data which reflect the specific
character of the tested population and the protocols used for their data collection. The
preset normative data can be used to compare the results collected with the same
stimulus, recording, and subject parameters. There are no international standardized data
available at this time.

Y-Axis Scale

Use the Y-axis scale ( ) located at the top of the Waveform Window to
change the scale of the amplitude. The scale can be any value between 0.05 to 100.0 µV.
Changing the scale affects only the display – it does not affect the recorded data.
Use the up or down arrow to increase or decrease the scale by steps of 0.05 µV. If you type
a value in the field, the scale will display to the nearest 0.05 µV step.

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Waveform Information Chart

This chart contains the numeric representation of the peak, and peak-to-peak latencies, of
the waves shown in the Waveform Window (Figure 69).

Figure 77. Waveform Information Chart

For each collected waveform, the Waveform Information Chart displays this information:
1. The wave number corresponding to the handle of each waveform. This appears as
the first number in each row of the Test Conditions column.
2. The Test Conditions column also lists the test conditions for each waveform.
 Stimulated ear: Right ear, Left ear
 Transducer type: ER-3A or B-71
 Ear tip type and size (if selected on the Test screen)
 Protocol used (Pro)
 Recording side: Ipsi (Ipsilateral), Contra (Contralateral)
 Stimulus type: Click, 0.5K, 1.0K, 2.0K, 4.0K
 Stimulus Polarity (Pol), Con (Condensation), Rare (Rarefaction), Alt
(Alternating), and Alt Split (Alternating split)
 Response processing algorithm (Alg): Kal (Kalman Weighted), Ave (Averaging)
 Patient status (Sta): Awake or Mixed
 Number of stimuli (N)
 Percentage of rejected stimuli (will be displayed only if averaging signal
processing algorithm was applied)
 Equivalent sweeps (Neq)
 Stimulus rate
3. Latency values for each labeled peak, in milliseconds with an accuracy of 0.01 ms
 I – III interpeak latency. The value is displayed only when peaks I and III have
been labeled.
 III – V interpeak latency. The value is displayed only when peaks III and V have
been labeled.
 I – V interpeak latency. The value is displayed only when peaks I and V have
been labeled.
 Wave I amplitude. The value is displayed only when the positive (I) and
negative (I’) peaks of wave I are labeled.
 Wave V amplitude. The value is displayed only when the positive (V) and
negative (V’) peaks of wave V are labeled.

4. Statistics start and end points (Stat-S and Stat-E)

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5. Correlation Coefficient (Corr, Coef). The Correlation Coefficient indicates the

degree to which the collected waveforms in A and B are repeatable in a specific
interval that is defined by Stat-S and Stat-E.

Use the Latency-Intensity button to display your latency values graphically. Refer to
Latency-Intensity Graph on page 74.

NOTE
The SS value must be placed so that the SE is greater than SS. If SS is greater than SE
than the Correlation value (Corr.) of the two points will be invalid.

TIP
To find specific data in the Waveform Information Chart use the chart’s vertical scroll bar
to find the desired waveform. Alternatively, select the handle of the waveform in the
Waveform Window to display the corresponding data at the top of the chart.

Close the Test Screen

Your test data must first be saved or discarded before you leave the Test screen.
To exit the Test screen:
1. Press the Save button to save your data to records in the database.
2. Press the Discard/Clear Graph button to remove all test data from the screen.
Any data that has not been saved will be deleted. A warning dialog box will prompt
you to confirm your action.

Figure 78. Are you sure you want to discard this record?

Post Test Review

The ABR Database Screen Waveforms
To view test data that has been saved in the database:
1. Select the Database tab to view the initial preview screen (Figure 79).
2. Select the Expand button for a full screen view of your data (Figure 80). This view
allows you to label waveforms and use the analysis functions.

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Figure 79. Database Waveform Information for ABR

Figure 80. Expanded Database Waveform Window

The following functions are available from the Expanded Database Waveform Window:
 Activate (highlight) a waveform by selecting the waveform‟s handle.
 Move highlighted waveforms along the vertical axis.
 Label the peaks of the highlighted waveform using the waveform markers.
 Place Stat-S (SS) and Stat-E (SE) to define the period in which correlation
coefficient will be calculated
 View A-B, A, or B trace.
 Change the waveform‟s presentation scaling.
 Delete the highlighted waveform.

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 View the page break preview

 Print a complete test record for the selected trace.
 Introduce or remove latency norms by selecting the appropriate age related
normative values from the Norms list.
 Review the conditions of the stimulation and the waveform‟s numerical values of
the labeled peaks in the Database Waveform Information Chart.

NOTE
All peaks previously labeled on the Test screen during or after the testing are
stored in the database and displayed in the Database Waveform Window of the
Database screen.
All numeric values of the previously labeled peaks will be displayed in the Database
Waveform Information Chart.

Database Controls
The database controls for ABR include two unique buttons: Expand and Latency-
Intensity. Refer to Database Controls on page 42 for details about the other buttons.

Figure 81. Database Controls for ABR

Expand/Edit button
The waveforms can be displayed in a full screen format for easier viewing (Figure 80).
1. Select the Expand/Edit button.
2. Select the red X ( ) to close the Expanded Database Waveform Window.

Latency-Intensity button
The Latency-Intensity button opens a view of the results in a Latency-Intensity graph.
1. Press Latency Intensity to view the graph.

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2. Select the red X ( ) to close the graph.

Figure 82. Latency-Intensity Graph

Performing an ABR Test

Place the VivoLink on the Patient
This procedure includes preparing the skin and connecting the electrodes.
Begin with the VivoLink off and the Amplitrode and electrode clips connected to the parking
snaps.

Adult Patient or an Older Child

1. Connect the lanyard clips to the D-rings on the VivoLink.
2. Disconnect the breakaway of the lanyard and place the longer part of the lanyard
around the patient‟s neck.
3. Connect the breakaway of the lanyard to the VivoLink (Figure 10). The patient may
then be placed in a chair or on a couch, whichever is more comfortable for the
patient and the operator.

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Infant Patient
 Place the VivoLink next to the infant on a flat surface, close enough for the
Amplitrode, ER-3A, and B-71 Bone Conductor cables to reach the infant.
 Alternatively, if the infant is held by a caregiver, the caregiver may hold the
VivoLink in the hands along with the infant.

CAUTION
Injury to an infant may occur. Do not hold the VivoLink or any transducers over
the infant’s body or head. If any of the components are accidentally dropped, the
infant may be injured.

Define the Test

To conduct an ABR measurement, perform the following steps:
1. Switch on the VivoLink. Check the status of the VivoLink batteries and Bluetooth
connection.
2. Check that the Electrode Contact LED on the VivoLink is off, and the Amplitrode
and its clips are snapped on the designated parking snaps of the VivoLink.
ATTENTION
Poor electrode contact with the patient’s skin may lead to incorrect
measurements or misdiagnoses.
Amber light – indicates one of the electrodes has poor contact with the patient’s
skin. Check the inverting (-) electrode and the non-inverting (+) electrode and, if
necessary, re-position the electrode, replace the snap electrode pad and prepare
the skin again.
Green light – indicates good electrode contact with the patient’s skin.
3. Prepare the patient‟s skin as described in Skin Preparation on page 59.
4. Place the electrode pads on the skin and connect the Amplitrode and electrode
clips as described in Application of the Electrodes on page 60.

CAUTION
Do not use electrodes if their expiration date has passed.
5. To prepare for an air-conduction test, install the ear tip into the testing ear as
directed in the ER-3A Earphones procedure on page 62.
To prepare for a bone-conduction test, place the B-71 Bone Conductor on the
patient. Refer to Application of the Electrodes on page 60 for placement details.
ATTENTION
To ensure proper fit of the transducer and proper operation, use only ear
tips supplied by Vivosonic Inc.
6. In the Test screen, select ABR as the Test Type.
7. Select an appropriate protocol from the Applied Protocol drop-down menu.

CAUTION
Improper configuration of test protocols may result in poor quality test results. Use
clinically validated protocols for screening and assessment.
8. Press either the Right Ear or Left Ear button.
9. Press Start to begin a test. The Start button changes to a Stop button.

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 Press Pause to stop the test temporarily.

 Press Continue or the Stop button to proceed.
Refer to Test Control Buttons on page 30 for more information about Start/Stop,
Pause/Continue, and Save features.

TIP
Every Start and Stop creates a new record. If you save each record, you can
display your results in the Test Waveform Window graph while the next test is
taking place. If a record is not saved, it will not show on the graph when the
next test is started.
10. Monitor the EEG Window (Figure 67) and visually estimate the amplitude of the
EEG signal.

TIP
The lower the EEG value, the better the electrode contact. Re-apply the
electrodes if the EEG remains above +/- 50 µV.
 +/- 10 µV or less is best
 +/- 20 µV may still be acceptable
 +/- 50 µV indicates a problem, reapply the electrodes
The noise floor in ABR tests depends on the number of sweeps and the recorded
EEG noise. For example, to achieve a 0.1 μV noise floor in an ABR test, you will
need to observe the ongoing EEG amplitude within the following limits:
 For 1,000 sweeps – within approximately ± 3-4 μV
 For 2,000 sweeps – within approximately ± 4-5 μV
 For 10,000 sweeps – within approximately ± 10 μV
When excessive noise is found in an AEP test, do the following:
1. Monitor the status of the Electrode Contact LED Indicator. If the LED is
amber, adjust your electrodes for better contact. If necessary, replace
electrodes or re-prepare the skin area.
2. You may also Check Impedance to identify the level of mismatch between
the inverting and non-inverting electrodes. If the indicator bar is amber or
gray, then check and adjust your electrodes.
Remove the electrodes, re-prepare the patient’s skin and replace the
electrodes. When the noise is reduced, reconnect the Amplitrode and its
clips to the patient and continue patient testing.

11. Press Save to save the data collected.

Press Discard/Clear Graph to clear the Test Waveform Window. If the graph is
cleared before the results are saved, the data will be lost.
Press Print to print the test results.
12. Repeat the above procedure to test the other ear.

ATTENTION
If there is no AEP response for either ear, check that the ER-3A earphone is
producing a sound. Listen to the earphone using a reasonably audible stimulus
setting such as 50 dB nHL.

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Post Test Procedures

1. To remove the ear tips, slowly pull the ear tip from the ear canal. While removing
the ear tip, push it slightly to the side to open a gap between the ear tip and the wall
of the ear canal. This allows air to enter the ear canal occluded by the ear tip.
If you have used the B-71 Bone Conductor, remove it from your patient‟s head.

CAUTION
Removing the ear tip from the ear canal too quickly may cause a negative air
pressure in the occluded ear canal and result in injury to the eardrum.
WARNING
To avoid accidental swallowing or inhalation of an ear tip, do not leave ear tip(s)
within reach of a child. Patients should be attended during preparation or testing.
2. Carefully remove the electrode pads from the patient‟s skin.

CAUTION
The ear tips and electrode pads are single-use only and should be disposed of
immediately after use. To avoid transfer of disease, do not re-use the ear tips or the
electrode pads on other patients.
3. Disinfect the Amplitrode and its clips using disinfecting wipes.

CAUTION
To avoid transfer of disease do not reuse the Amplitrode and its clips without first
disinfecting them.

Reviewing Results
1. Select the Database tab.
2. Select the patient required.
3. Review the data in the Waveform Preview Window.
4. Select Expand to view the waveform‟s full screen.
5. Perform data analysis by labeling peaks on the waveform.
6. Press the Clinical Summary button to add comments about the test.
7. Press Print.

Storing the Integrity System

1. Press Exit in the top right corner of the screen.
2. Confirm that you would like to exit the software program.
3. Wait until the program closes.
4. Select Start from the lower left corner of the screen and press Turn Off Computer
to shut down Microsoft Windows.
5. Close the computer lid. This is recommended for protecting the screen and
keyboard from collecting excessive dust.
6. Turn OFF the computer power switch.
7. Turn the optional printer OFF. Refer to the computer and printer manufacturer‟s
User‟s Guide for details.
8. Unplug the computer power cord from the wall outlet.
9. Pack the VivoLink and accessories and place them back into their storage cases.

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Chapter 6: Overview of ECochG Testing

General Preparation of the System
Before starting a test, review the Integrity System screens. Refer to Chapter 4: Five Screens
of Integrity.

ATTENTION
The Integrity System provides default protocols. Refer to Appendix E: Preset Protocols
and Test Settings.
Prior to clinical use, an appropriate user-defined protocol must be created. Refer to
Define an ECochG Protocol on page 93.

ECochG Gold Electrode Ear Tip Cable Connection

®
The gold electrode (TIPtrode ) ear tip for ECochG provides both the sound delivery and a
®
recording electrode in one unit. TIPtrode connects to the Electrode Ear Tip Cable that is
connected to left and right ER-3A transducers.

Figure 83. Electrode Ear Tip Cable connects gold electrode ear tips to ER-3A transducers

Preparing the Patient

Before you begin testing, your patient‟s ear canal must be clean, free of damage or
disease, and clear of any obstructions to ensure good continuity between the gold surface
®
of the TIPtrode ear tips and the tissue of the ear.
Evaluate the size of your patient‟s ear canal, and select an electrode size that fits tightly yet
comfortably in the ear canal.

WARNING
Tympanic membrane and inner ear damage may occur resulting in possible infection and
hearing loss. Cleaning of the ear canal and insertion of the electrode ear tip should be
performed by a trained and licensed health-care professional.
DO NOT force the gold electrode ear tip into the patient’s ear canal. Excessive force
could cause damage to the Tympanic membrane, rupturing the eardrum and possibly
damaging the inner ear.

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Ear Preparation
1. Inspect the patient‟s ear canal for obstructions. If there is an excessive deposit of
earwax, have an authorized health-care professional remove the earwax, as
defined by local health-care regulations.
2. Observe the patient‟s ear canal and evaluate its size. Select a gold electrode ear tip
that would fit tightly yet comfortably in the patient‟s ear canal.
3. Attach the gold electrode ear tip into the Electrode Ear Tip Cable through the
compression fitting end of the cable.
4. Hold the ear tip with two fingers and compress it.
5. Insert the ear tip into the ear canal: place the red transducer into the right ear, and
the blue transducer into the left ear. Insert the ear tip slowly. Make sure the ear tip
is inserted tightly in the cartilaginous part of the ear canal, not in the bony part,
which would occlude the ear canal.

®
Figure 84. Gold electrodes (TIPtrode ) attached to the Electrode Ear Tip Cable

Skin Preparation and Electrode Placement

Prepare the area of your patient‟s forehead where the Amplitrode ground will be connected
(Figure 85). Refer to Skin Preparation on page 59 and Application of the Electrodes on
page 60 for further details.
The inverting and non-inverting electrodes are attached to the short end of the Electrode
Ear Tip Cable as in Figure 86.

Figure 85. Amplitrode ground connected to the patient‟s forehead

CAUTION
Do not insert the ear tip into the ear canal too quickly. This may cause excessive positive
air pressure in the ear canal which may damage the eardrum of your patient. Although
there is a pressure release vent in the transducer, it may not be sufficient to release

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excessive air pressure if the ear tip is inserted too quickly.

In addition, do not use force when inserting the ear tip. Make sure the silicone tube inside
the ear tip is not bent or pressed. A misaligned tube would result in a change in the
acoustic properties and may compromise the calibration or cause potential misdiagnosis.

Figure 86. Inverting Amplitrode clip connected to Electrode Ear Tip Cable and ear tips

Specific ECochG Test Preparation

Define an ECochG Protocol
To create a new protocol, modify an existing protocol, and save it with a new name. Refer
to Protocol Settings on page 48 for instructions.
Protocol parameters which can be preset from the Protocol screen include Stimulus
Settings and Test Settings (Figure 87).
 Stimulus Settings are used to select the stimulation parameters such as stimulus
level, the maximum number of stimuli, and stimulus rate.
 Test Settings control the acquisition conditions of the waveform recording, such as
high-pass and low-pass filter settings, high-pass and low-pass filter rolloff, the
amplifier gain, recording window duration, and the artifact rejection threshold
(relevant only when using the averaging algorithm).
Some ECochG protocol settings may be modified from the Test screen. Refer to Test
Protocol Parameters for ECochG on page 97 for more details.

Protocol Screen Stimulus Settings

Recommended Stimulus Settings for ECochG
Stimulus Type: Click
Stimulus Rate: Certain stimulus rates are known to have high interference with AC Power
Line, VivoLink internal harmonics, and local environment. A slower stimulus rate will create
a better ECochG waveform for diagnostics.

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Figure 87. Protocol Stimulus Settings and Test Settings

Understanding the Settings on the Protocol Screen

Stimulus Type
Click is the only stimulus type available for ECochG.

Transducer Type
ER-3A is the only transducer type available for ECochG.

Stimulus Rate (Stimuli/s)

Stimulus Rate for ECochG is set for Click stimuli. Select the number of stimuli to produce
per second from the range of 7.1 to 99.0 stimuli/s (in increments of 0.1 stimuli/s). Changing
the Stimulus Rate will result in a change in the wave latency delay and in the early wave‟s
amplitude.
Although the stimulus rate may be set anywhere in the above specified range, the use of
certain stimulus rates are recommended because when they are implemented by the
VivoLink internal clock they are not synchronized with 50 and 60 Hz power line frequencies
and their harmonics.
The Stimulus Rate can be set several different ways: by dragging the control bar, entering
the number in the control field, or clicking on the up arrow to increase the stimulus rate, or
clicking on the down arrow to decrease the stimulus rate.
Refer to Table 7 for Recommended ECochG Stimulus Rates (Stimuli/second).

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Table 7. Recommended ECochG Stimulus Rates (Stimuli/second)

7.6 30.8 52.3 74.8
8.3 31.0 53.1 75.7
9.8 32.9 54.4 76.6
10.3 33.8 55.4 77.7
11.3 34.0 56.8 78.3
12.4 35.6 57.3 79.8
13.8 36.3 58.0 80.5
14.7 37.7 59.4 81.5
15.4 38.3 60.3 82.4
16.4 39.9 61.9 83.7
17.7 40.3 62.6 84.5
18.6 41.2 63.6 85.9
19.3 42.1 64.5 86.3
20.2 43.9 65.9 87.1
21.5 44.5 66.8 88.6
22.9 45.8 67.0 89.6
23.9 46.5 68.0 90.3
24.9 47.5 69.9 91.3
26.7 48.7 70.1 92.6
27.5 49.8 71.8 93.5
28.3 50.2 72.3 94.6
29.3 51.6 73.2 95.7

Maximum Number of Stimuli

The Maximum Number of Stimuli depends on the selected Stimulus Rate. For the lowest
Stimulus Rate of 7.1 stimuli/s the Maximum Number of Stimuli is 6390. For the highest
Stimulus Rate of 99.0 stimuli/s the Maximum Number of Stimuli is 89100. The smallest
value this parameter can be set to is 1.

Windowing
This setting does not apply to ECochG protocols.

Ramp Number of Cycles (Rise – Plateau - Fall)

This setting does not apply to ECochG protocols.

Stimulus Levels
A single stimulus level or a range of stimulus levels may be selected. The range of stimulus
levels include values from 38 to 137 dB peSPL with 1 dB increments.
To select a range of levels for multiple-level tests:
1. Press and hold the Shift key on the keyboard.
2. Highlight the first and last stimulus level in the required range.

To select a set of non-contiguous (individual) stimulus levels:

1. Press and hold the Ctrl key on the keyboard.
2. Highlight each required level.

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NOTE
Stimulus Levels for ECochG testing are displayed in units of dB nHL or dB pe SPL. These
units are set in the System screen. Refer to
Selecting the calibration units on page 52 for more details.

TIP
During the test session, it is possible to change the stimulus level from the Test screen
using the Level (dB pe SPL)/ (dB nHL) slider bar. Refer to Level (dB pe SPL)/ (dB nHL)
on page 73 for details.

Protocol Screen Test Settings

The Test Settings control the acquisition parameters of the ECochG recording, such as
high-pass filter cutoff frequency (Hz), low-pass filter cutoff frequency (Hz), high-pass filter
rolloff, low-pass filter rolloff, post-Amplitrode gain, recording window (ms), artifact rejection,
and artifact rejection thresholds.

Recommended Test Settings

High Pass Filter Cutoff Frequency (Hz): 30
Low Pass Filter Cutoff Frequency (Hz): 2400
High Pass Filter Rolloff: 12 dB/Octave
Low Pass Filter Rolloff: 24 dB/Octave
Post-Amplitrode Gain: 0
Recording Window (ms): 7

High-Pass Filter Cutoff Frequency (Hz)

The digital high-pass filter is used to filter out low frequency noise. The filter can be set to a
value in the range of 30 – 300 Hz.

Low-Pass Filter Cutoff Frequency (Hz)

The digital low-pass filter is used to filter out high frequency noise. The filter can be set to a
value in the range of 1000 – 3000 Hz.

High-Pass Filter Rolloff and Low-Pass Filter Rolloff

Rolloff is defined as the rate of attenuation of a filter, expressed in dB per octave. The high-
pass rolloff filters the low frequencies and the low-pass rolloff filters the high frequencies.
Select the high-pass rolloff to filter either 6dB/octave or 12dB/octave and the low-pass
rolloff to filter either 12 dB/octave or 24 dB/octave.

Post-Amplitrode Gain (dB)

This control regulates the post Amplitrode gain. The available values are 0 (system
default), 10, 20, and 40.

Recording Window (ms)

The Recording Window is a time period after the stimulus is presented to the patient,
during which the response is averaged and analyzed. The recording windows can be from
5 ms up to 20 ms depending of the selected Stimulus Rate.

Artifact Rejection
This selection box is used to switch on and off the Artifact Rejection Thresholds. When
this control box is selected the Artifact Rejection Thresholds field becomes active. If the
control box is not selected the Artifact Rejection Thresholds field is unavailable.

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Artifact Rejection Threshold

The Artifact Rejection Threshold is used to exclude certain noise levels from the averaging
calculations. The value selected (10, 15, 20, or 25 µV) defines the lowest level of the
incoming electrophysiological activity which contains excessive electric noise. This field is
only accessible when the Artifact Rejection control box is selected.

During the Test

The ECochG Test Screen
Electrode Contact
The status of the connections between the electrodes and the patient‟s skin is displayed
visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.
• A flashing amber LED indicates that the corresponding electrode has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip.
If a problem is evident, remove the electrode indicated, clean the skin, and apply a new
snap electrode pad and reconnect the electrode clip.

Right Ear/Left Ear Button

Select the ear to test by pressing the Right Ear or Left Ear button. When the Right Ear
button is selected, the stimuli is delivered to the patient‟s right ear through the red tube of
the ER-3A earphone. The waveform trace in the Waveform Window (Figure 69) is red to
follow the color standards for audiologic practice. When the Left Ear button is selected, the
stimuli is delivered to the left ear through the blue tube of the ER-3A earphone. The
waveform trace in the Waveform Window is blue.

Test Protocol Parameters for ECochG

Protocol Test Settings are found on the Test screen. Some of the protocol settings are
preset conditions, only available from the Protocol screen, while others can also be
selected in the Test screen. Vivosonic has developed a set of protocol values that can be
manipulated during the test procedure (Hall, 1990), (Hall, 1997), (Stapells, 2002).

Figure 88. Protocol Settings on the Test Screen

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Algorithm
This control regulates application of the methods of processing the ECochG waveforms.
There are two processing algorithms to choose from: Averaging and Kalman Weighted.
Kalman Weighted is the system‟s default algorithm.

Averaging
This filter is a signal processing algorithm, which utilizes the standard time averaging
technique so that equal weighting is given to the collected ECochG data. Weights are
based on the noise in the response. Waveforms contaminated with artifacts above certain
Artifact Rejection Thresholds (ART) are excluded from averaging.

Kalman Weighted
Kalman Weighted is a signal processing algorithm that is used in ECochG testing to
optimally weight the patients' responses so that responses with less myogenic artifact are
given more weight than responses that are more contaminated with artifact. Kalman
filtering allows ECochG acquisition with subjects who are awake and not relaxed. This
method processes signals in real time without rejecting any time segments, even those
containing significant artifacts. (Li 2002)
When ECochG is collected on a subject who is relaxed throughout the test, Kalman
Filtering will yield the same result as conventional averaging. When the subject moves
intermittently during the test and produces myogenic artifacts, the Kalman Filter will yield a
result that is less contaminated by noise than a result that would be obtained under the
same conditions with conventional averaging.

Status
Select the patient‟s status of arousal from the drop-down menu. The entries are Awake,
Mixed, Natural Sleep, Sedation, and Anesthesia. Awake is the default setting.

Figure 89. Patient Status Drop-Down List Shown

Polarity
This control regulates the voltage characteristic of the stimulus. Stimulus polarity selection
depends on the goal of the testing. You can select Condensation, Rarefaction, Alternating,
or Alternating split.
Condensation denotes a polarity as the initial displacement of the stimulus, produced with
a positive-voltage electrical signal and an outward movement of the acoustic transducer.
Rarefaction denotes a polarity as the initial displacement of the stimulus, produced with a
negative-voltage electrical signal and an inward movement of the acoustic transducer.
Alternating denotes a polarity as interchangeable, presenting rarefaction and
condensation polarity stimuli characteristics. The responses of two consecutive stimuli are
sent to one buffer (A), then the responses of the next two consecutive stimuli are sent to
the other buffer (B). Thus, each buffer will get the responses from both condensation and
rarefaction stimuli.

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Alternating split denotes a polarity as interchangeable, presenting rarefaction and

condensation polarity stimuli characteristics. The polarity alternates which buffer the
responses are sent to. Buffer (A) will receive only responses from condensation stimuli and
the other buffer (B) will receive only responses from the rarefaction stimuli. Thus, each
buffer only receives responses from a specific stimulus.

Ear Tip
Select the size of the ear tip from the drop-down menu. Refer to Figure 3 and Figure 4 to
view the available types of ear tips for ECochG.

Figure 90. Ear Tips Drop-Down List

Masker
This control regulates the introduction of contralateral wideband masking noise.
 Select Wide Band Noise to apply masking through the ER-3A transducer opposite
to the ear which is stimulated with stimuli.
 Select None to test without masking. This is the system default.

Masking Level
The masking level defines the contralateral masking noise (dB HL). When a masking value
is selected, the VivoLink will produce wide band noise.
There are no necessary adjustments to the Reference Equivalent Threshold Sound
Pressure Level (RETSPL) values that accompany narrow band noise, as per ANSI S3.6-
2004, 6.3.1. The conversion from dB HL to dB SPL is based on the RETSPL value for the
insert earphones in an occluded ear simulator (Table 7 in ANSI S3.6-2004 Manual).
The masking dB SPL value is calculated for the root mean square (rms) of the masking
signal. As such, the dB SPL of the overall masking signal will differ with the type of
stimulus, such that the rms of the masking signal will match that of the dB HL at the
corresponding frequency of the stimulus signal. Click signals are considered to have a
frequency of 1 kHz.
Select the level from 10 to 100 dB HL in 1 dB increments.

Non-Inverting (+) and Inverting (-) Electrode

These two fields allow you to select the location of the non-inverting (+) and inverting (-)
electrodes on your patient. Refer to Figure 91 for electrode locations available from the
drop-down menu.
Refer to the recommended electrode placement diagram in Figure 54 on page 58.(Hall,
1990), (Hall, 1997), (Stapells, 2001)

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Figure 91. Non-Inverting (+) and Inverting (-) Electrode Drop-Down List

Recording Side
This field is not user-selectable. Its selection is dependent on the non-inverting (+) or
inverting (-) electrode selected and the ear chosen for stimulation.
Ipsilateral – the non-inverting electrode is located on the same side of the head as the ear
being stimulated.
 With the right ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz locations
for the non-inverting (+) electrode and A2, M2, EAC2, TM2, PR2 for the inverting (-)
electrode.
 With the left ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz locations
for the non-inverting (+) electrode and A1, M1, EAC1, TM1, PR1 for the inverting (-)
electrode.
Contralateral – the non-inverting electrode is located on the opposite side of the head as
the ear being stimulated.
 With the right ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz locations
for the non-inverting (+) electrode and A1, M1, EAC1, TM1, PR1 for the inverting (-)
electrode.
 With the left ear selected for testing any combination of Cz, Fz, Fpz, Nz, Oz locations
for the non-inverting (+) electrode and A2, M2, EAC2, TM2, PR2 for the inverting (-)
electrode.
Medial – the non-inverting and inverting electrodes are located along the sagittal plane of
the head (any combination of Cz, Fz, Fpz, Nz, Oz locations).
Horizontal – the non-inverting electrode is located on the stimulus-contralateral mastoid,
earlobe or ear canal, while the inverting electrode is located on the stimulus-ipsilateral
mastoid, earlobe or ear canal (any combination of A1, A2, M1, M2, TM1, TM2, PR1, PR2,
EAC1, and EAC2 locations).

NOTE
The Recording Side provides important information about the location of data collection
with respect to the stimulation location. (Hall, 1990), (Hall, 1997), (Stapells, 2001)
These settings will not affect the data. The information will be saved with the data and
may be used when the data is reviewed. This information cannot be changed after it is
saved. Ensure that the information is correct before saving the results.

Notch Filter
The notch filter is designed to reduce the interference from electrical activity or power line
noise of 50 Hz, 60 Hz. To disable the notch filter select Off from the drop-down menu.

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The default frequency for the notch filter, either 50 Hz or 60 Hz, can be set from the
System screen using the Power Line Frequency Setting. Refer to Power Line Frequency
Setting on page 51.

Electrodes Used
Select the electrode type from the drop-down menu or type the electrode brand into the
field.

Figure 92. List of Electrodes Available for Testing

Levels (dB pe SPL)/ (dB nHL)

Figure 93. Stimulus Level Bar (dB pe SPL)

The stimulus level slider bar displays and regulates the levels of stimulation provided to the
data recording. The initial position of the slider depends on the Stimulus Levels (dB nHL)
defined in the protocol selected.

 When testing with a single level protocol, the slider is positioned at the specified
stimulus level.
 When testing with a multi-level protocol, the slider is positioned at the lowest
stimulus level for that protocol. The full range of values is selected on the Protocol
screen. Use the slider bar on the Test screen to change the initial stimulus level.
The units displayed are defined in the System screen on page 50. Refer to Table 6 on
page 67 for values that can be selected based on the transducer type.

Signal Information
During and after the data collection the Signal Information section of the Test screen will
display information about the collected waveform.

Figure 94. Signal Information

Stimulus Type
The Stimulus Type (click) is displayed in this field displayed in this field as defined by the
protocol.

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Transducer Type
ER-3A is displayed in this field as defined by the protocol. This information also includes
the serial number of the selected transducer.

Number of Stimuli (Num of Stim)

The Number of Stimuli applies only when the Averaging algorithm is in use.
This information box displays the number of stimuli presented in the test. The value counts
up as the test is running. If the test runs to completion, the value should be equal to the
value of the Maximum Number of Stimuli defined in the selected protocol, otherwise it
displays the number of stimuli counted at the time the test was stopped.

% Rejected
This information box displays the percentage of the rejected ABR responses. Responses
are rejected when the amplitude exceeds the preset Artifact Rejection Threshold value
defined in the selected protocol.
NOTE
The system displays the percentage of rejected stimuli only when the Averaging algorithm
is selected on the Test screen.

Eq. Sweeps
The number of Eq. Sweeps, or Equivalent Sweeps, applies only when the Kalman
Weighted algorithm is in use.
Although Kalman filtering makes acquisition on awake, non-relaxed subjects more
practical, more sweeps are required to acquire a proper recording on a non-relaxed subject
with the same signal-to-noise ratio that would have been obtained if the subject were
completely relaxed. The Eq. Sweeps value indicates the number of sweeps that would yield
the same signal-to-noise-ratio as the current Kalman-filtered waveform if the patient's EEG
had remained minimally quiet throughout the test.
For example, if the total number of sweeps is 2000, then, if Kalman Filtering is selected, the
Eq. Sweeps will read less than 2000 unless the myogenic and other electric and magnetic
interference remains constant throughout the test.
Using the Kalman Weighted algorithm, 2000 “equivalent sweeps” is comparable to 2000
“accepted sweeps” used in conventional averaging.

EEG Window
This area of the Test screen displays the Electrode Contact Indicator and a real-time
EEG graph.

Figure 95. EEG Window

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Electrode Contact
The status of the connections between the TIPtrode ear tips and the patient‟s skin is
displayed visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.
• A flashing amber LED indicates that the corresponding electrode has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip.
If a problem is evident, remove the TIPtrode indicated. Have a trained health-care
professional inspect and clean the patient‟s ear canal, and then insert a new TIPtrode.

Figure 96. Electrode ContactFigure 97Figure 98Figure 99

What to do when Electrode Contact is Undetected

1. Check the position of the inverting (-) and non-inverting (+) electrodes for proper
contact with the patient‟s skin.
2. Check the status of the TIPtrode. Fix, replace, or reapply one or both TIPtrodes, if
necessary.
3. Check the connection between the (Clip-Snap) Electrode Ear Tip Cable and
electrode snap, disposable electrodes and Amplitrode clips. If it is not a good
connection, reconnect, replace, or fix it.
4. Ensure that the Clip-Snap is properly positioned on the gold foil surrounding the
TIPtrode tube, and that there is good contact.

CAUTION
When attaching the Amplitrode to the VivoLink or electrodes, avoid applying pressure to
the Amplitrode. Use the electrode release button (Figure 57) to place the Amplitrode on
the snap instead of forcing the Amplitrode on the electrode snap. Care should be taken to
ensure that the spring of the Amplitrode does not break.

Ongoing EEG
A real-time EEG signal is displayed in the Ongoing EEG graph of the Test screen. This
EEG signal is recorded by the electrodes and 150 ms of the signal is displayed at a time.
The amplitude scale on the graph changes automatically when the amplitude of the
recorded EEG signal changes. Usually EEG collected from a relaxed patient are within
± 40µV. However, for better recordings, when the EEG amplitude increases beyond ± 20µV

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you may want the patient to relax further. If the EEG amplitude does not decrease, the
problem may be poorly placed electrodes. Readjust the electrodes and start again.

NOTE
The Ongoing EEG graph shows a filtered EEG signal that passes through the ABR (30 –
3000 Hz, slope 12 dB/octave) analog electrical filters of the Amplitrode, not an unfiltered
“raw” EEG signal. If the analog notch filter (50 Hz or 60 Hz) of the VivoLink is switched
ON, then the Ongoing EEG passes through this filter as well.
This signal does not pass through the digital high-pass and low-pass filters, which are set
in the protocol and affect only the digitally processed (averaged or Kalman-filtered)
recordings.

Waveform Window
This Waveform Window displays the graphic representation of the collected waveform as a
function of the amplitude (µV) of the signal over time (ms).
The waveforms collected from the left and right ears are displayed on the same graph and
are distinguished by the color of the waveform. Recordings for the right ear are indicated by
red waveforms, and recordings for the left ear are indicated by blue waveforms.

Figure 100. Waveform Window of the Test Screen

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The Waveform Window is used when monitoring data in real time and when analyzing and
labeling waveforms. Each Start and Stop during a test session produces a new waveform.
To zoom or magnify the waveform window, drag your mouse from left to right. To restore
the display to its original magnification, drag your mouse from right to left.
You can also view a single latency value by pointing to a waveform with your mouse
pointer. The Latency and Amplitude values are displayed in a small window in the upper
right corner of the window.

Waveform Handle
Each waveform is supplied with an individual handle located to the left of the graph.

Figure 101. Waveform Handle

All waveform handles have a tagging line which displays the following information:
 The waveform number identifies the relative order in which the waveform was
collected. The same number is also displayed in the Waveform Information Chart
(Figure 77 on page 83) to associate the waveform with its corresponding data.
 The stimulus level of this test according to the unit selected in the System screen.
 R or L indicates the recording as the right ear or the left ear.

To select a waveform, click on its handle. You can use the handle to drag the waveform
along the vertical axis.
To select multiple waveforms, press the Ctrl key on your keyboard and click on the handle
of each waveform. You can move all selected waveforms at once.

Label a Waveform
To label a waveform and calculate its latency, follow these steps:
1. Select the handle of the waveform to be labeled.
2. Select a label from the labeling buttons (Figure 102) at the top of the Waveform
Window.
3. Place the cursor over the waveform to be labeled. Note that the location jumps to
the peaks (peak positives) and troughs (peak negatives) of the wave.
4. When the correct peak or valley has been identified, click the mouse to place the
label.
5. Select another labeling button to place a different label, or use the arrow button to
select another waveform.
To move a label, select the label and place it again following the steps above.
To delete a label, select the label, and then click (X). A warning message will be displayed
to confirm the deletion.

Figure 102. Waveform Labeling Buttons

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Waveform Labels
There are 6 waveform label buttons used to characterize the peaks and valleys of the
waveform.

SP and AP
The Summating Potential (SP) and the Action Potential (AP) represents (X,Y) point for the
location of the label. The chart in the Waveform Window displays SP(ms), SP(µV), AP(ms)
and AP(µV) which are representing the latency (ms), and the amplitude (µV) of the
summating and action potentials. The ms is calculated relative the recording window, while
the amplitude is calculated relative to the baseline.

SS and SE
Mark the start and end of the desired statistical data using the SS and SE buttons.

Baseline (BL)
The baseline is automatically calculated and placed at zero (O) µV. Select the BL button to
move the baseline anywhere between the upper and lower limit of the waveform peaks.

NOTE
The baseline cannot be deleted.

Note
The Note button is used to add comments to the graph.

Figure 103. Note Callout

To add a note:
1. Select the Note button.
2. Please the cursor over the waveform in the location desired.
3. Click the location to place the note.
4. Click inside the note box to start typing the content.
5. Use the pen icon in the top right corner to edit a previous note.
6. Use the minimize icon in the top right corner to reduce the size of the note.
7. Use the X icon in the top right corner to delete the icon.

A,B Display
The A,B display mode is used to change the displayed waveform into the recorded
components of the A and B buffered information.
1. Select the desired waveform.
2. Press the A,B button located next to the Waveform Labeling buttons (Figure
102Figure 71).

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The single waveform splits into A and B components.

3. To switch back to the combined waveform, select one of the split waveforms and
press A,B again.

A-B Display
The A-B button displays the waveform as a calculation of component A minus component B
of the received signal. This display represents the noise floor.

Moving waveform displays together

Select the handle of the A-B waveform to move it around the graph. Select the handle of
the original waveform to move both the original (A+B) and the A-B waveforms together.

Unlink waveform displays

To unlink the two waveforms point the cursor at the original waveform handle (A+B). A
chain icon will appear above the handle. Double-click the chain icon and the image will
change to a broken chain. The waveforms can now be moved independently of each other.

Figure 104. Linked and Unlinked Waveform Icon

Delete Waveform Button

To delete a wave from the Waveform Window:
1. Select a waveform handle.

2. Press the button to delete the selected waveform.

3. Answer Yes when prompted to delete the wave.

In case of selection of multiple waveforms, then press the Delete button. All selected
waveforms will be deleted after the user‟s confirmation.

NOTE
The Delete button is unavailable when there is only one waveform selected, or when all
waveforms have been selected. To remove all waveforms on the graph, select the
Discard/Clear Graph button.

Page Break View

This button ( ) is used to view the waveforms on a page. This allows you to make
adjustments to the layout of your waveforms before printing.
The display labels the background with the page number. Drag waveforms to the desired
page location.
Refer to Figure 75 on page 81 to view the Waveform Window with page breaks.

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Y-Axis Scale

Use the Y-axis scale ( ) located at the upper corner of the Waveform
Window to change the scale of the amplitude. The scale can be any value between 0.05 to
100.0 µV.
Changing the scale affects only the display – it does not affect the recorded data.
Use the up or down arrow to increase or decrease the scale by steps of 0.05 µV. If you type
a value in the field, the scale will be approximated to the nearest 0.05 µV step.

Waveform Information Chart

This chart contains the numeric representation of the peak and peak-to-peak calculations of
the waves shown in the Waveform Window.

Figure 105. Waveform Information Chart

NOTE
The waveform must first be labeled. If no labels have been placed on the waveforms,
the information chart will be empty except for the test conditions and baseline value

For each collected waveform, the Waveform Information Chart displays this information:
1. The wave number corresponding to the handle of each waveform. This appears as
the first number in each row of the Test Conditions column.
2. The Test Conditions column also lists the conditions of the stimulation for each
waveform.
 Stimulated ear: Right ear, Left ear
 Transducer type: ER-3A
 Ear tip type and size (if specified): ER3-26A or ER3-26B (13mm or 10mm)
 Protocol used (Pro)
 Recording side: Ipsi (Ipsilateral), Contra (Contralateral), Horizontal
 Stimulus type: Click
 Stimulus Polarity (Pol), Con (Condensation), Rare (Rarefaction), Alt
(Alternating), and Alt Split (Alternating split)
 Response processing algorithm (Alg): Kal (Kalman Weighted), Ave (Averaging)
 Patient status (Sta): Awake, Mixed, Natural Sleep, Sedation, and Anesthesia
 Number of stimuli (Num of Stim)
 Percentage of rejected stimuli (will be displayed only if averaging signal
processing algorithm was applied)
 Equivalent sweeps (Neq)
 Stimulus rate

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3. SP and AP values (ms)

4. Baseline values (µV) - BL
5. SP and AP microvolt values (µV)
6. SP as a percentage of AP (SP/AP %)
7. Statistics start and end points (Stat-S and Stat-E)
8. Correlation Coefficient (Corr, Coef). The Correlation Coefficient indicates the
degree to which the collected waveforms in A and B are repeatable in a specific
interval that is defined by Stat-S and Stat-E.

NOTE
The AP data point must be placed so that the action potential is greater than
summating potential. If SP is greater than AP than the SP/AP % will be invalid.
The SS value must be placed so that the SE is greater than SS. If SS is greater
than SE than the Correlation value (Corr.) of the two points will be invalid.

TIP
To find specific data in the Waveform Information Chart use the chart’s vertical scroll
bar to find the desired waveform. Alternatively, select the handle of the waveform in the
Waveform Window to display the corresponding data at the top of the chart.

Leave the Test screen

Your test data must first be saved or discarded before you leave the Test screen.
To exit the Test screen:
1. Press the Save button to save your data to records in the database.
2. Press the Discard/Clear Graph button to remove all test data from the screen.
Any data that has not been saved will be deleted. A warning dialog box will prompt
you to confirm your action.

Figure 106. Are you sure you want to discard this record?

Post Test Review

To view test data that has been saved in the database:
1. Select the Database tab to view the initial preview screen (Figure 107).
2. Select the Expand button for a full screen view of your data (Figure 108). This view
allows you to label waveforms and use the analysis functions.

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The ECochG Database Screen Waveforms

Figure 107. ECochG Database Preview Screen

Figure 108. ECochG Database full screen waveform window (Expand)

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The following functions are available from the Expanded Database Waveform Window:
 Activate (highlight) a waveform by selecting the waveform‟s handle.
 Move highlighted waveforms along the vertical axis.
 Label the peaks of the highlighted waveform using the waveform markers.
 Place Stat-S (SS) and Stat-E (SE) to define the period in which correlation
coefficient will be calculated
 View A-B, A, or B trace.
 Delete the highlighted waveform.
 View the page break preview
 Print a complete test record for the selected trace.
 Change the waveform‟s presentation scaling.
 Review the conditions of the stimulation and the waveform‟s numerical values of
the labeled peaks in the Database Waveform Information chart.

NOTE
All peaks previously labeled on the Test screen during or after the testing are
stored in the database and displayed in the Database Waveform Window of the
Database screen.
All numeric values of the previously labeled peaks will be displayed in the
Database Waveform Information Chart.

CAUTION
Loss of data may occur.
Any subsequent peak labeling changes made to the database and saved will overwrite the
previously stored label values, including values stored during the test.

Database Controls
The database controls have nine functions. Refer to Database Controls on page 42 for
details.

Figure 109. Database Controls for ECochG

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Expand/Edit button
The waveforms can be displayed in a full screen format for easier viewing (Figure 108).
1. Select the Expand/Edit button.
2. Select the red X ( ) to close the Expanded Database Waveform Window.

Performing an ECochG Test

Place the VivoLink on the Patient
This procedure includes preparing the skin and connecting the electrodes.
Begin with the VivoLink off and the Amplitrode and electrode clips connected to the parking
snaps.

Figure 110. System set-up for ECochG testing

Adult Patient or an Older Child

1. Connect the lanyard clips to the D-rings on the VivoLink.
2. Disconnect the breakaway of the lanyard and place the longer part of the lanyard
around the patient‟s neck.
3. Connect the breakaway of the lanyard to the VivoLink(Figure 10). The patient may
then be placed in a chair or on a couch, whichever is more comfortable for the
patient and the operator.
Infant Patient
 Place the VivoLink next to the infant on a flat surface, close enough for the
Amplitrode and ER-3A cables to reach the infant.
 Alternatively, if the infant is held by a caregiver, the caregiver may hold the
VivoLink in the hands along with the infant.

CAUTION
Injury to an infant may occur. Do not hold the VivoLink or any transducers over
the infant’s body or head. If any of the components are accidentally dropped, the
infant may be injured.

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Define the Test

To conduct an ECochG measurement, perform the following steps:
1. Switch on the VivoLink. Check the status of the VivoLink batteries and Bluetooth
connection.
2. With the Amplitrode and the electrode clips snapped on the designated parking
snaps on the VivoLink, check that the Electrode Contact LED on the VivoLink is
green. This indicates that the contact indicator is operating.
3. Prepare the patient‟s ear canal and skin as described on page 92.
4. Place the electrode pads on the skin and connect the Amplitrode and electrode
clips as described in Application of the Electrodes on page 60.

CAUTION
Do not use electrodes if their expiration date has passed.
5. To prepare for the test, insert the gold electrode (TIPtrode) ear tip into the testing
ear.
Refer to Ear Preparation on page 92 for placement details.
ATTENTION
To ensure proper fit of the transducer and proper operation, use only TIPtrodes
supplied by Vivosonic Inc.
Ensure the walls of the ear canal are clean and free from obstructions. The
TIPtrode must make a good connection with the wall of the ear canal to
signal conductivity.

WARNING
Tympanic membrane and inner ear damage may occur resulting in possible
infection and hearing loss.
DO NOT force the TIPtrode into the patient’s ear canal. Excessive force
could cause damage to the Tympanic membrane, rupturing the eardrum
and possibly damaging the inner ear, which could result in infection and
hearing loss
The ear tip insertion and testing should be performed by a trained and licensed
health-care professional.

6. In the Test screen, select ECochG as the Test Type.

7. Select an appropriate protocol from the Applied Protocol drop-down menu.

CAUTION
Improper configuration of test protocols may result in poor quality test results. Use
clinically validated protocols for screening and assessment.
8. Press either the Right Ear or Left Ear button.
9. Press Start to begin a test. The Start button changes to a Stop button.
 Press Pause to stop the test temporarily.
 Press Continue or the Stop button to proceed.
Refer to Test Control Buttons on page 30 for more information about Start/Stop,
Pause/Continue, and Save features.

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TIP
Every Start and Stop creates a new record. If you save each record, you can
display your results in the Test Waveform Window graph while the next test is
taking place. If a record is not saved, it will not show on the graph when the
next test is started.
10. Monitor the EEG Window and visually estimate the amplitude of the EEG signal.

TIP
The lower the EEG value, the better the electrode contact. Reapply the
electrodes if the EEG remains above +/- 50 µV.
 +/- 10 µV or less is best
 +/- 20 µV may still be acceptable
 +/- 50 µV indicates a problem, reapply the electrodes
The noise floor in ECochG tests depends on the number of sweeps and the
recorded EEG noise. Typically, the higher the EEG noise, the greater the number
of sweeps required for better recordings.
Particularly at high intensity stimulus levels such as 95 dB nHL, efforts
should be taken to reduce excessive noise levels as much as possible. It is
not recommended to apply high intensity stimulation to the ear for
prolonged periods of time.
When excessive noise is found in an ECochG test, do the following:
 Monitor the status of the Electrode Contact LED Indicator. If the LED is
amber, adjust your electrodes for better contact. If necessary, replace
electrodes or re-prepare the skin area.
 You may also Check Impedance to identify the level of mismatch between
the inverting and non-inverting electrodes. If the indicator bar is amber or
gray, then check and adjust your electrodes.
Remove the electrodes, re-prepare the patient’s skin and replace the
electrodes. When the noise is reduced, reconnect the Amplitrode and its
clips to the patient and continue patient testing.

11. Press Save to save the data collected.

Press Discard/Clear Graph to clear the Test Waveform Window. If the graph is
cleared before the results are saved, the data will be lost.
Press Print to print the test results.
12. Repeat the above procedure to test the other ear.

ATTENTION
If there is no AEP response for either ear, check that the ER-3A earphone is
producing a sound. Listen to the earphone using a reasonably audible stimulus
setting such as 50 dB nHL.

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Post Test Procedures

1. Slowly remove the TIPtrode from the ear canal and dispose of it. While removing
the TIPtrode, push it slightly to the side to open a gap between the ear tip and the
wall of the ear canal. This allows air to enter the ear canal occluded by the ear tip.

WARNING
Removing the gold electrode ear tip from the ear canal too quickly may cause a
negative air pressure in the occluded ear canal and result in injury to the eardrum.
To avoid accidental swallowing or inhalation of an ear tip, do not leave ear tip(s)
within reach of a child. Patients should be attended during preparation or testing.
2. Carefully remove the electrode pads from the patient‟s skin.

CAUTION
The ear tips and electrode pads are single-use only and should be disposed of
immediately after use. To avoid transfer of disease, do not re-use the ear tips or the
electrode pads on other patients.
3. Disinfect the Amplitrode and its clips using disinfecting wipes.

CAUTION
To avoid transfer of disease do not reuse the Amplitrode and its clips without first
disinfecting them.

Reviewing Results
Review your test results from the Database screen or print a report.
1. Select the Database tab.
2. Select the patient required.
3. Review the data in the Waveform Preview Window.
4. Select Expand to view the waveform‟s full screen.
5. Perform data analysis by labeling peaks on the waveform.
6. Press Report to add a description of the test.
7. Press Print.

Storing the Integrity System

1. Press Exit in the top right corner of the screen.
2. Confirm that you would like to exit the software program.
3. Wait until the program closes.
4. Select Start from the lower left corner of the screen and press Turn Off Computer
to shut down Microsoft Windows.
5. Close the computer lid (recommended for protecting the screen and keyboard from
collecting excessive dust).
6. Turn off the computer the power switch.
7. Turn the optional printer off. Refer to the computer and printer manufacturer‟s
User‟s Guide for details.
8. Unplug the computer power cord from the wall outlet.
9. Pack the VivoLink and accessories and place them back into their storage cases.

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Chapter 7: Overview of ASSR Testing

General Preparation of the System
To prepare for a test, perform the following operations:
1. To ensure there is no visible mechanical damage, inspect the VivoLink, Amplitrode,
Amplitrode clips, Amplitrode connectors, and Amplitrode cable; ER-3A Insert
Earphones and their connectors, cables.
2. Visually inspect the Amplitrode and its clips to ensure they are clean of any debris.
3. Place the Amplitrode and its clips on the parking snaps located on the front panel of
the VivoLink (Figure 8 #2).

CAUTION
Do not conduct any AEP test if, by visual inspection, you discover any
visible mechanical damage. Report the problem to Vivosonic Inc.’s local
service representative or Vivosonic Customer Support. Do not try to repair
the device yourself.
Do not conduct any AEP test if the Amplitrode or its clips are congested with any
debris which may cause improper electrical contact with the electrode-pad snaps
and improper testing.
4. Ensure that the VivoLink is powered by a fully charged battery pack. The ASSR test
modality draws higher than usual amount of energy from the batteries and hence
users should use only Vivosonic supplied battery packs (REF 100020).
5. Switch ON the VivoLink.
6. Switch ON the computer.
7. Read the Caution statements (Figure 14), and choose Agree to proceed.
8. Choose a patient from the patient list.
To perform a test, select at least one patient name from the list of existing patients,
or add a new patient name.
9. Open the Test screen and select ASSR from the Test Type list.
The Bluetooth LED starts to flash when your computer recognizes the presence of
the VivoLink and begins to download information to it.
When the download of information is complete, the Bluetooth LED stops flashing
and remains solid blue. If the connection is lost during the download process, the
Bluetooth LED indicator appears unlit.

Electrodes
Distinguishing Electrode Clips
For the best ASSR test results, it is important to position the electrode clips properly. The
Amplitrode is designed to significantly reduce the risk of electrode misplacement. The
Amplitrode is a combination of an electrode and an AEP pre-amplifier, which is mounted
directly on the ground electrode.
Refer to the Amplitrode diagram (Figure 11) for details on the configuration of leads and
electrodes.

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Recommended Electrode Placement

Several electrode placement configurations are possible with the Amplitrode, which is
optimized for a single-channel recording (Figure 54). The filled circles represent the
recommended placement for most recordings. (Hall, 1990), (Hall, 1997), (Stapells, 2001)

Figure 111. Typical Electrode Placement Diagram - front view

Figure 112. Typical Electrode Placement Diagram - left lateral view

For an ASSR test of both ears simultaneously, we recommend the following medial
montage, in order to get symmetrical results:
 Non-inverting electrode (active or positive): High forehead (Fz)
 Inverting electrode (reference or negative): Nape (Oz).
 Amplitrode (ground): low forehead (Fpz)

ATTENTION
To ensure reliable waveforms, the patient’s skin must be carefully prepared before the

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snap electrode pads are attached, and the electrode clips must be securely connected to
the snap electrode pads.

Preparing the Patient

The electrodes must be placed on the clean skin of the patient‟s head and the transducers
inserted into clean ears to ensure a good clean signal response.
These three steps must be performed:
1. Skin preparation
2. Electrode application
3. Ear preparation

Skin Preparation
The patient‟s skin must be clear and free of damage, malformations, or disease before
starting the test.
1. Visually inspect the area of skin where the electrodes will be placed. If the skin is
damaged, do not proceed with the test.
2. Remove oil, dead skin particles, or foreign matter from the skin areas that will be in
contact with the snap electrode pads.
3. Remove excessive moisture with a dry cotton ball or gauze pad.
4. Apply abrasive skin preparation cream or jelly on the cleaned skin surface,
following the manufacturer‟s instructions for use.
5. Remove excessive abrasion cream or jelly with a cotton ball or gauze pad.

CAUTION
Do not proceed with the skin preparation or the placement of the electrodes if the patient’s
skin has wounds, scratches, bruises, or other signs of damage, disease, or malformation.

Application of the Electrodes

The correct and secure application of the electrodes on the patient is important to the
quality of the waveforms to be recorded.
Vivosonic Inc. recommends first connecting the Amplitrode to the ground electrode. Once
secure, connect the electrode clips to the snap electrode pads. The non-inverting (+) and
inverting (-) electrodes are identified by the “+” and “-” symbols on the surface of the clips.
1. Inspect the pouch of single-use electrode pads and check the expiration date on
the back of the pouch.
2. Remove the single-use snap electrode pads from the plastic base and apply them
to the prepared areas of the patient‟s skin. Refer to Figure 54 for details on the
recommended locations of the electrodes.
Press on the white line around the rim of the electrode pad and not on the center,
as this may cause the conductive gel to seep under the pad and will require you to
clean the skin again.
3. Hold the electrode clip with two fingers so that the index finger is in the Holding
Groove and the thumb depresses the Electrode Release Button.
4. Snap the Amplitrode and the two electrode clips onto the electrode pads. Release
the Electrode Release Button to securely clip the electrode to the electrode pad.

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5. Check that the electrode is securely seated on the electrode pad.

Figure 113. Amplitrode

1 – Holding Groove, 2 – Electrode Release Button
Ear Preparation
Before starting the test the ear canal must be clean, free of damage or disease, and clear
of any obstructions to ensure good continuity between the surface of the ear tip and the
tissue of the ear.
1. Inspect the patient‟s ear canal for obstructions.
If there is an excessive deposit of earwax, have an authorized health-care
professional remove the earwax, as defined by local health-care regulations.
2. Check the patient‟s ear canal and select an ear tip that fits tightly, yet comfortably,
in the patient‟s ear canal.
3. Attach the ear tip to the Electrode Ear Tip Cable through the compression fitting
end of the cable. In the case of infants, use a pair of Electrode Ear Tip Cable
equipped with infant-tip adaptors.
4. Hold the ear tip with two fingers and compress it.
5. Insert the ear tip slowly into the ear canal: place the red transducer into the right
ear, and the blue transducer into the left ear.
To avoid occluding the ear canal, make sure that the ear tip is inserted tightly in the
cartilaginous part of the ear canal, not in the bony part.

WARNING
Tympanic membrane and inner ear damage may occur resulting in hearing loss. The
cleaning of the ear canal should be performed by a trained health-care professional
licensed by local authorities.

Electrode Contact
Integrity continuously monitors electrode contact during data collection. This ongoing
monitoring provides a basic indication of whether the signal electrodes are in contact with

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your patient‟s skin. Poor contact between the electrodes and your patient will affect your
test results.
Always start a test by ensuring that electrode contact is good. You may also check the EEG
signal. If the signal is very noisy with a peak-to-peak value greater than +/-20 µV, a contact
problem may exist. In addition, you may want to perform an impedance test to determine
the quality of contact and the presence of signal artifact.

Electrode Contact LED Indicator on the VivoLink

The Electrode Contact Indicator light (or LED) on the front panel of the VivoLink (Figure 8
#3) indicates whether the inverting (-) and non-inverting (+) electrodes on your patient‟s
skin are detected by the system.
 The LED is not lit when the VivoLink if OFF.
 A green LED indicates electrode contact is detected.
 A flashing amber LED may indicate that one of the electrode clips has lost contact
with the electrode, or that an electrode has fallen off and is no longer in contact
with your patient‟s skin. You should reconnect your electrodes to obtain proper
contact.

Electrode Contact Indicator on the Test Screen

The electrode contact indicator on the Test screen consists of two virtual LEDs, one for the
inverting contact and one for the non-inverting contact.
When one of the electrodes or electrode clips loses contact, the corresponding LED flashes
amber. Reconnect the electrode or clip to reestablish contact prior to testing.

Check Impedance Mismatch

Before you begin a test, you are required to perform an impedance check to determine the
difference (or degree of mismatch) between the impedance values of the inverting and non-
inverting electrodes applied to your patient. This feature requires that you use VivoLink
V51 with Amplitrode A51.
Typically, an impedance mismatch of less than 5 kOhms will yield the best test results.
To check the level of inter-electrode impedance mismatch:
1. Press the Check Impedance button on the Test screen. The button is only visible
when you are using VivoLink V51 with Amplitrode A51.
A message instructs you to wait a few seconds for the test to complete.
2. The Check Impedance dialog box displays the mismatch value and the status of
the results.
 The indicator bar is green when the impedance mismatch is acceptable for
testing purposes. You may begin testing.
 The indicator bar is amber when the difference between the inverting (-)
electrode impedance and the non-inverting (+) electrode impedance is greater
than 5 kOhms. You should adjust your electrodes for better test results.
 The indicator bar is gray when the inverting (-) electrode, non-inverting (+)
electrode, or ground electrode are disconnected. Testing should not proceed.
You should check your electrodes.
3. Reconnect your electrodes as necessary.
4. Wait for the indicator bar to update and specify an acceptable value.
5. Close the Check Impedance dialog box and proceed with testing as appropriate.

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Figure 114. Check Impedance Mismatch Dialog Box

Specific ASSR Test Preparation

Define an ASSR Protocol
Test parameters are set from the Protocol screen. To create a new protocol, modify an
existing protocol, and then save it with a new name. All ASSR protocol settings may also
be modified from the Test screen.

Figure 115. ASSR Protocol Stimulus Settings and Threshold Search

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The parameters of ASSR protocol are divided into two categories: Stimulus Settings and
Threshold Search.
The Stimulus Settings are used to select the stimulation parameters such as modulation
frequency, automatic threshold search steps (largest and smallest step sizes) and
Algorithm Time.
The Threshold Search controls the specific frequencies to be tested (500Hz, 1kHz, 2kHz
and 4kHz) in each ear and, maximum and minimum stimulus levels for automated
searching of threshold.

Stimulus Settings
Modulation Frequency: The user may select either 40Hz or 80Hz family of modulation
frequencies. The 80Hz modulation frequency is recommended for a calm and relaxed
subject. Response to 40Hz modulation frequency is only present in awake subjects.
Largest Step: This parameter determines the step size of successive stimulus levels when
an ASSR response is detected at the preceding level.
Smallest Step: This parameter determines the step size of successive stimulus levels
when an ASSR response is not detected at the preceding level.
Algorithm Time: This is approximately the maximum test time allotted per level per
frequency per ear. If an ASSR response is not obtained with this allotted time, a stimulus at
a higher level is delivered to that ear at the same frequency. If the automated search
reaches either end of the range of stimulus levels and no responses are obtained within the
allotted Algorithm Time, a corresponding symbol is placed at that level to indicate that the
true threshold exists beyond the threshold.

Threshold Search
Maximum/minimum stimulus levels: Use the slider controls indicated in above figure to
adjust maximum and minimum stimulus levels for automated threshold searching.
Initial stimulus levels: The initial stimulus level for each frequency can be adjusted. Use the
slider control to adjust the default stimulus level set in the protocol. To set the initial stimulus
level for a specific frequency, move the individual “threshold search control” for that frequency
to the desired stimulus level. For example, if you are testing the right ear and you wish to set
the initial stimulus level for 2kHz to 60 dB, drag the corresponding threshold search control
(i.e. red circle) to 60 dB.
Test frequencies: Stimulus frequencies presented to each ear may be selected using check
boxes located immediately below each of the four frequencies per ear. These frequencies are
approximately the centre frequency of the chirp stimulus that is specific to Integrity‟s ASSR test
modality.

CAUTION
Prolonged testing at high levels of stimulation can cause damage to the hearing
system. The practitioner should exercise professional judgment when setting the
maximum stimulus level.

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During the Test

The ASSR Test Screen
Electrode Contact
The status of the connections between the electrodes and the patient‟s skin is displayed
visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.
• A flashing amber LED indicates that the corresponding electrodes has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip
If a problem is evident, remove the electrode indicated, clean the skin, and apply a new
snap electrode pad and reconnect the electrode clip.

EEG Window
This area of the Test screen displays the Electrode Contact Indicator and a real-time
EEG graph.

Figure 116. EEG Window

Electrode Contact
The status of the connections between the electrodes and the patient‟s skin is displayed
visually using the virtual LEDs.
• The LED is not lit when the VivoLink if OFF.
• A green LED indicates that the corresponding electrode contact is detected.
• A flashing amber LED indicates that the corresponding electrode has lost contact with
the patient`s skin, or with the electrode clip. Check the electrode corresponding to the
flashing LED for proper contact with the patient‟s skin and the electrode clip.
If a problem is evident, remove the electrode indicated, clean the skin, and apply a new
snap electrode pad and reconnect the electrode clip.

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Figure 117. Poor Electrode Contact

What to do When Electrode Contact is not detected

1. Check the status of the snap electrode pads. Fix, replace, or reapply one or both of
the snap electrode pads if necessary.
2. Check the connection between the disposable electrodes and Amplitrode clips. If it
is not a good connection, reconnect, replace, or fix it.

CAUTION
When attaching the Amplitrode to the VivoLink or electrodes, avoid applying pressure to
the Amplitrode. Use the electrode release button (Figure 57) to place the Amplitrode on
the snap instead of forcing the Amplitrode on the electrode snap. Care should be taken to
ensure that the spring of the Amplitrode does not break.

Ongoing EEG
A real-time EEG signal is displayed in the EEG window of the Test screen. This EEG signal
is recorded by the electrodes and 150 ms of the signal is displayed at a time. The
amplitude scale on the graph changes automatically when the amplitude of the recorded
EEG signal changes. Usually EEG collected from a relaxed patient are within ± 40 µV.
However, to obtain better recordings, if the EEG amplitude increases beyond ± 5 µV
(highlighted in the graph using a pair of horizontal blue lines) you may want the patient to
relax further. If the EEG amplitude does not decrease, the problem may be poorly placed
electrodes. Readjust the electrodes and start again.

Close the Test Screen

Your test data is automatically saved throughout testing.
To exit the Test screen:
1. If you want to save your results in the database, press the Save button to save your
data to records in the database.
2. Press the Discard/Clear Graph button to remove all test data from the screen.
Any data that has not been saved will be deleted. A warning dialog box will prompt
you to confirm your action.

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Figure 118. Are you sure you want to discard this record?

Performing an ASSR Test

Place the VivoLink on the Patient
This procedure includes preparing the skin and connecting the electrodes.

Adult Patient or an Older Child

3. Connect the lanyard clips to the D-rings on the VivoLink.
4. Disconnect the breakaway of the lanyard and place the longer part of the lanyard
around the patient‟s neck.
5. Connect the breakaway of the lanyard to the VivoLink (Figure 10). The patient may
then be placed in a chair or on a couch, whichever is more comfortable for the
patient and the operator.
6. Tests are conducted with patient relaxed, lying down or in a chair with neck
supported. Patients are encouraged to sleep during the test.

Infant Patient
1. Tests are conducted with the infant sleeping or lying down and very relaxed.
2. Place the VivoLink next to the infant on a flat surface, close enough for the
Amplitrode and ER-3A cables to reach the infant.

CAUTION
Injury to an infant may occur. Do not hold the VivoLink or any transducers over
the infant’s body or head. If any of the components are accidentally dropped, the
infant may be injured.

Define the Test

To conduct an ASSR measurement, perform the following steps:
1. Switch on the VivoLink. Check the status of the VivoLink batteries and Bluetooth
connection.
2. Check that the Electrode Contact LED on the VivoLink is off, and the Amplitrode
and its clips are snapped on the designated parking snaps of the VivoLink.
ATTENTION
Poor electrode contact with the patient’s skin may lead to incorrect
measurements or misdiagnoses.
Amber light – indicates one of the electrodes has poor contact with the patient’s

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skin. Check the inverting (-) electrode and the non-inverting (+) electrode and, if
necessary, re-position the electrode, replace the snap electrode pad and prepare
the skin again.
Green light – indicates good electrode contact with the patient’s skin.
3. Prepare the patient‟s skin as described in Skin Preparation on page 59.
4. Place the electrode pads on the skin and connect the Amplitrode and electrode
clips as described in Application of the Electrodes on page 60.

CAUTION
Do not use electrodes if their expiration date has passed.
5. Install the ear tip into the testing ear as directed in the ER-3A Earphones procedure
on page 62.
6. You may use noise attenuating headphones on adult subject.

7. In the Test screen, select ASSR as the Test Type.

8. Select an appropriate protocol from the Applied Protocol drop-down menu.

CAUTION
Improper configuration of test protocols may result in poor quality test results. Use
clinically validated protocols for screening and assessment.
9. You may choose to override protocol parameters (such as frequencies to be tested)
and the range of stimulus levels in the Test screen.
1. The specific frequencies to be tested for each ear can be selected
using the frequency selection boxes located in the ASSR-gram.
2. The range of levels for all the stimuli can be adjusted using the slider
controls shown below.
3. The starting level of each of the stimuli may be set to the same level
using the universal adjustment bar or individually set by sliding the
starting point indicator
10. Press Start to begin a test. The Start button changes to a Stop button.
 Press Pause to stop the test temporarily.
 Press Resume or the Stop button to proceed.
Refer to Test Control Buttons on page 30 for more information about Start/Stop,
Pause/Continue, and Save features.
11. Monitor the EEG Window (Figure 67) and visually estimate the amplitude of the
EEG signal.

TIP
The lower the EEG value, the better the electrode contact. Re-apply the
electrodes if the EEG remains above +/- 50 µV.
 +/- 5 µV (illustrated via two horizontal blue lines) or less is best
 +/- 20 µV may still be acceptable
 +/- 50 µV indicates a problem, reapply the electrodes
When excessive noise is found in an AEP test, do the following:
1. Monitor the status of the Electrode Contact LED Indicator. If the LED is
amber, adjust your electrodes for better contact. If necessary, replace

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electrodes or re-prepare the skin area.

2. You may also Check Impedance to identify the level of mismatch between
the inverting and non-inverting electrodes. If the indicator bar is amber or
gray, then check and adjust your electrodes.
Remove the electrodes, re-prepare the patient’s skin and replace the
electrodes. When the noise is reduced, reconnect the Amplitrode and its
clips to the patient and continue patient testing.

12. The ASSR-Gram in the Test Screen will illustrate the progress of the test. Check
marks in each of the four frequencies indicate that these frequencies are being
tested and a threshold has not been found. A green halo around a test point
indicates that the corresponding frequency and level is being tested. A yellow halo
around a test point indicates that testing at that frequency and level has been
temporarily paused. Testing will resume automatically.
13. Tests may pause when stimulus from that run exceeds OSHA recommendations for
daily noise exposure; however, the audiologist can chose to override this warning.
The audiologist should use their professional judgment when performing ASSR
tests over prolonged period.
14. Testing may be paused at any time by pressing the PAUSE button in the Test
Screen. This may be necessary when the subject moves a lot; however, small
movement and coughing will not affect the overall measurement process.
15. The Probability graphs indicate the likelihood of presence of an ASSR at the
corresponding frequency for the particular stimulus level.
16. Press Save to save the data collected.
Press Discard/Clear Graph to clear the ASSR-gram Window. If the graph is
cleared before the results are saved, the data will be lost.
Press Print to print the test results.

Reviewing Results
1. Select the Database tab.
2. Select the specific patient name.
3. Press the Clinical Summary button to add comments about the test.
4. Press Print.

Storing the Integrity System

1. Press Exit in the top right corner of the screen.
2. Confirm that you would like to exit the software program.
3. Wait until the program closes.
4. Select Start from the lower left corner of the screen and press Turn Off Computer
to shut down Microsoft Windows.
5. Close the computer lid. This is recommended for protecting the screen and
keyboard from collecting excessive dust.
6. Turn OFF the computer power switch.
7. Turn the optional printer OFF. Refer to the computer and printer manufacturer‟s
User‟s Guide for details.
8. Unplug the computer power cord from the wall outlet.
9. Pack the VivoLink and accessories and place them back into their storage cases.

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Chapter 8: Overview of TEOAE Testing

General Preparation of the System
The Probe
The Probe should be in one of three locations at ALL times to avoid its damage:
 In the Probe Holder on VivoLink
 In the examiner‟s hand
 In the subject‟s ear canal
To prepare for a test, perform the following operations.
1. Verify that none of the OAE Probe‟s connections are loose on the VivoLink.
2. Check that the probe is inserted all the way, to the full stop, into the probe holder of
the Probe Adapter. Refer to Figure 8 for the location of the OAE Probe holder.

CAUTION
To avoid breaking the OAE Probe do not apply too much force to the OAE Probe
when parking it in the probe holder.
3. Switch ON your VivoLink.
4. Switch ON your Integrity computer.
5. Read the Caution statements, and choose Agree to proceed.
6. Choose a patient from the Patients screen.
To perform a test, select at least one patient name from the list of existing patients,
or add a new patient name.
7. Open the Test screen and select TEOAE from the Test Type list.
The Bluetooth LED starts to flash when your computer recognizes the presence of
the VivoLink and begins to download information to it.
When the download of information is complete, the Bluetooth LED stops flashing
and remains solid blue. If the connection is lost during the download process, the
Bluetooth LED indicator appears unlit.

Preparing the Patient

This procedure requires the use of ear tips. The ear tips are color-coded by size. Refer to
Error! Reference source not found. and Figure 6 for the description of the ear tips.

1. Inspect the patient‟s ear canal, preferably with an otoscope (not included).
If there is an excessive deposit of earwax, remove it or refer to an appropriate
health care professional for earwax removal, as regulated by local health-care
regulations.
2. Evaluate the size of your patient‟s ear canal, and select an ear tip that fits tightly yet
comfortably in the ear canal.

CAUTION
To ensure proper fit and operation of the OAE Probe, use only ear tips supplied by
Vivosonic Inc.
3. Gently place the ear tip onto the OAE Probe to the full stop.

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4. Slowly insert the ear tip into the ear canal. Make sure that the ear tip is inserted
tightly in the cartilaginous part of the ear canal, not in the bony part, which would
occlude the ear canal.

Figure 119. Correctly inserted OAE Probe

CAUTION
Do not insert the ear tip in the ear canal too quickly. This may cause excessive positive air
pressure in the ear canal being occluded by the ear tip and may hurt the eardrum of the
patient. There is a pressure release vent in the transducer, but it may not be sufficient to
release excessive air pressure if the ear tip is inserted too quickly.

Use HAND FORCE ONLY. Ear tips are flexible. Ensure that the probe tip has not
damaged the ear tip and is protruding from the ear tip to avoid injuring the ear canal.

Specific TEOAE Test Preparation

To prepare for a test, perform the following operations:
1. To ensure there is no visible mechanical damage, inspect the VivoLink, the OAE
Probe and the Probe Adapter, and all cables.
2. Place the OAE Probe on the Probe Holder located on the front panel of the
VivoLink (Figure 8).

CAUTION
Do not conduct any test if, by visual inspection, you discover any visible
mechanical damage. Report the problem to Vivosonic Inc.’s local service
representative or Vivosonic Customer Support. Do not try to repair the device
yourself.

3. Switch on the computer.

4. Read the Caution statements, and choose Agree to proceed.
5. Select a patient‟s name from the list of existing patients, or add a new patient name
and select it for testing.
6. Open the Test screen and select TEOAE from the Test Type list.

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The Bluetooth LED starts to flash when your computer recognizes the presence of
the VivoLink and begins to download information to it.
When the download of information is complete, the Bluetooth LED stops flashing
and remains solid blue. If the connection is lost during the download process, the
Bluetooth LED indicator appears unlit.
7. The OAE Probe calibration and the system may then be checked by pressing the
Cavity Check button on the Test screen. The Cavity check is measured in the 1 cc
cavity of the OAE Probe holder on the VivoLink.
 If the Probe calibration is correct and the System Transient Response (TR) and
noise floor are within their tolerances, the system status is reported in the
Message and Assessment Window as “Cavity Check Passed” (Figure 120).
 If there is a problem with OAE Probe calibration, excessive System TR, system
noise, or ambient noise, then a message describing the problem(s) will appear
in the Message and Assessment Window.
8. Follow the instructions on the screen. If a problem persists, contact Customer
Support.

Figure 120. Message and Assessment Window

Define a TEOAE Protocol

Protocol parameters for TEOAE are set from the Protocol screen (Figure 121).
Integrity provides a set of default protocols. Refer to Appendix E: Preset Protocols and Test
Settings. To create a new protocol, you must modify an existing protocol, and save it with a
new name. Refer to Protocol Settings on page 48 for instructions.
Protocol parameters which can be preset from the Protocol screen include: Stimulus
Parameters, Test Controls, Operating Mode, Pass/Refer Criteria, and Validity Criteria.
 Stimulus Parameters are used to select the stimulus type, stimulus level,
maximum number of stimuli, stimulus rate, stimulus window, waveform ramp
setting, and the transducer type.
 Test Controls set the acquisition conditions of the waveform recording, such as
high-pass and low-pass filter settings, recording window duration, and the artifact
rejection threshold (relevant only when using the averaging algorithm).
 Operating Mode has an assessment criteria section that allows the user to define
the Pass/Refer criteria of an assessment screening.
 Pass/Refer Criteria and Validity Criteria are used for TEOAE screening to
determine whether the result is Pass, Refer or Insufficient.
Refer to Appendix C: Automatic TEOAE Screening Algorithm for details about the
decision-making algorithms used.

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Figure 121. OAE Protocol Parameters

Stimuli Parameters
STI-Mode
The Stimulus mode (STI-Mode) can be selected has two selectable options, Linear or Non-
Linear. In the Linear mode, all clicks are of the same amplitude. In the Non-linear mode,
clicks are presented in series of four, one “large” and three “small”, which cancels out the
linear contribution of the stimulus artifact.

Click Duration
The click duration is the duration of the electrical pulse that drives the OAE probe‟s
receiver, measured from 50% of its maximum value during turn-on until it reaches 50% of
its maximum value during turn-off. There are two selectable options – 80 and 120
microseconds.
The electrical pulse drives the receiver in the OAE probe to produce the transient acoustic
stimulus. The duration of the actual acoustic stimulus depends on the characteristics of the
cavity in which it is placed.

Click Interval
The Click Interval setting is the time (in milliseconds) from the onset of one click to the
onset of the next click. The interval may be set in the range of 10 milliseconds to 25
milliseconds.
Although the Click Interval may be set anywhere in the above specified range, the use of
certain intervals are recommended because when they are implemented by the VivoLink
internal clock they are not synchronized with 50 and 60 Hz power line frequencies and their
harmonics. The recommended intervals are listed in Table 8.

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Table 8. Recommended TEOAE Intervals (in ms)

10.33 18.29
10.16 19.49
10.95 20.79
11.26 21.05
12.82 21.12
13.55 22.67
14.07 22.98
14.85 23.14
16.83 24.39
17.77 24.80

Click Level
The Click Level setting is the peak equivalent (dB peSPL) value of the click stimulus
adjusted based on the measured volume in the ear (60 to 85 dB peSPL).

Test Control
Recording Window
The Recording Window is the period of time following the stimulus in which the TEOAE
response is recorded (0.5 ms to “n” ms, where “n” = Click Interval - 1.1 ms).

High Pass Filter Cutoff Frequency

The High Pass Filter Cutoff Frequency parameter is the cutoff frequencies for the high-pass
filter that may be used to reduce the effect of ambient noise and artifacts caused by the
stimulus in the response (750 Hz to 2000 Hz).

Low Pass Filter Cutoff Frequency

The Low Pass Filter Cutoff Frequency parameter is the cutoff frequencies for the low-pass
filter that may be used to reduce the effect of ambient noise and artifacts caused by the
stimulus in the response (2000 Hz to 6000 Hz).

Artifact Rejection Threshold

The Artifact Rejection Threshold (ART) is the sound pressure level in dB SPL above which
the detected acoustic signal is considered an artifact (24 to 47 dB SPL).

Number of Clicks
The Number of Clicks is the total number of clicks presented to record a TEOAE response,
including accepted, with artifacts below Artifact Rejection Threshold, and rejected due to
excessive artifacts.

Operating Mode
This drop-down field allows the user to select three operating modes:
 Automatic Screening (which uses Pass/Refer Criteria)
 Manual Screening
 Assessment

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Pass/Refer Criteria
The Pass/Refer Criteria and Validity Criteria are used for TEOAE screening to determine
whether the result is Pass, Refer, or Insufficient.
 Bands to Pass refers to the number of frequency bands required to satisfy the PASS
criteria.
 Whole-Wave Reproducibility (%) refers to the percentage of recorded A and B
waveforms that require a cross-correlation to satisfy the PASS criteria.
 SNR Criterion refers to the maximum allowable Signal-to-Noise Ratio, i.e. the
difference between the TEOAE level and Noise Floor level in decibels (dB).
 Response Levels are the minimum TEOAE signal levels at specific frequencies that
have to be reached for a response to qualify as a Pass in Automatic Screening.
 Auto Stop is a function that stops Automatic Screening once the set criteria has been
met.

During the Test

The TEOAE Test Screen
The TEOAE Test screen has features similar to the test screens of other test modalities.
This section of the manual describes the unique functions of the TEOAE Test screen.

Figure 122. TEOAE Test Screen

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Response Waveform and Response Spectrum Windows

The two graphs at the top of the Test screen display the TEOAE Response Waveform in
the time domain on the left and Response Spectrum in the frequency domain on the right.
st rd
For the purposes of analysis, TEOAE responses are divided into two phases, the 1 , 3 ,
th nd th th
5 , etc. responses are called the A phase and the 2 , 4 , 6 , etc. responses are called the
B phase. When the average A response is highly correlated to the average B response, this
is an indication that a repeatable TEOAE has been detected. The difference between the A
and B responses is a measure of the noise in the system.

Figure 123. Response Waveform and Response Spectrum Windows

SNS Chart
Beneath these Response Waveform and Response Spectrum windows is a chart that
displays the Signal, Noise and SNR (Signal-to-Noise Ratio) for a range of frequency
bands. The bandwidth and center frequency of each band can be selected from the Test
Value fields (Figure 126) at the bottom of screen labeled Bands.

Figure 124. Signal, Noise and SNR graph

Test Control Buttons

Only the Check Cavity button is specific to OAE procedures.
Refer to page 30 for more information about the operation of the Start/Stop,
Pause/Resume, Save, Discard/Clear Graph, Right/Left Ear, and Print buttons.

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Figure 125. Test Control Buttons

Cavity Check
Procedure performed to ensure the probe is working and is in good condition, i.e. no
acoustical change has occurred since the probe programming. The procedure is performed
with the probe inserted in the Probe Holder on the VivoLink.
VivoLink applies a TE stimulus to the probe receiver.
Integrity measures the actual sound pressure levels of the of the transient stimulus
received by the microphones of the probe at the probe inlet.
Integrity reads the actual sound pressure levels with the Probe Characteristic Constants
(PCC ) stored in the built-in EEPROM of the probe and compares it to the measured value.
Integrity measures the residual signal from 3.5 to 25 ms after the stimulus to ensure that
System TR (a false transient response synchronized to the stimulus due to inherent non-
linear system) is within specification.
Integrity measures noise from 3.5 to 25 ms after the stimulus to ensure that System Noise
(a false response due not synchronized to the stimulus) is within specification.
If the differences between the actual levels and PCC are within ±3 DB, and the noise and
System TR are within tolerance the probe passes the cavity check. Otherwise the probe
fails cavity check and the test status area of the screen (bottom right hand corner) reports
the failure.

Test Value Fields

Figure 126. Test Value Fields and Show Stimulus Button

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Click Number – are the number of clicks presented to the ear so far
Rejected Clicks – are the number of click rejected because the response exceeded the
Artifact Rejection Threshold (ART) set in the protocol
DOS (ms) – is the duration of stimulus so far in milliseconds (= number of clicks x inter-
pulse interval)
ARR (%) – Artifact Rejection Rate in per cent (=100% x Rejected Clicks / Click Number)
WWR (%) – Whole Wave Reproducibility (= correlation of A and B responses)
SSS (%) – Stimulus Stability Score in per cent (= 100% x Average stimulus instantaneous
peak value / Maximum stimulus instantaneous peak value).
TE Level (dB SPL) – is the overall root mean square level of the TE response.

Show Stimulus Display

Use the Show Stimulus button (Figure 126) to display the raw recording of the signal
showing clicks and the click spectrum (Figure 127). This button is available during testing.
In the Linear mode, the click signals must be equal in size, while the Non-linear mode
requires a larger click followed by three smaller clicks of an opposite polarity. During
testing, check that the click spectrum is reasonably flat between 500-5000 Hz. The click
spectrum will not be absolutely flat because of standing waves in the ear canal.

Figure 127. Stimulus Display

NOTE
The Probe microphone is intended to measure TEOAE responses coming from the
eardrum, not the clicks coming from the OAE Probe. Because of standing sound waves in
the occluded ear canal, the measured click spectrum typically should not be flat,
especially at frequencies higher than 2 kHz. This occurs because the clicks are calibrated
and their spectra are validated using an Occluded Ear Simulator (Zwislocki Coupler) in
which the position of the microphone’s membrane mimics the position of the eardrum.
In contrast, the Click Spectrum is measured at the inlet of the microphone sound canal
of the OAE Probe, i.e. at a distance from the eardrum. Such a distance introduces
standing waves that make the click spectrum different at the eardrum and at the inlet to
the microphone sound canal of the OAE Probe. Nevertheless, the Click Spectrum is
important because it shows that the clicks are actually presented into the ear canal and
are reasonably flat.

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Message and Assessment Window

The top section of this window displays messages about the assessment as well as
messages about the probe generated by the Check Cavity feature.

Figure 128. Message and Assessment Window (Pass-Auto)

In Automatic Screening mode, a Pass, Refer, or Test Insufficient message appears in

the assessment field immediately upon completion of an assessment. The assessment field
directly below the message window informs the technician that the patient has passed
preset screening values, or that the patient should be referred for further diagnosis.
There are three possible values that are displayed as a result of an assessment:
 Pass-auto – indicates that the patient has passed all the criteria pre-set in the
screening protocol. The parameters and their pass value will be listed in the
message window directly above the Pass-Auto message.
 Refer-auto – indicates that the patient has not passed all the criteria pre-set in the
screening protocol and that the patient should be referred to a specialist for a
complete diagnosis. The parameters and their pass/refer value will be listed in the
message window directly above the Refer-Auto message.
 Insuff – indicates that the results are too inconsistent to make an automated
pass/refer decision. If this message appears, the acoustic conditions of the test
may be inadequate to make the screening decision according to the criteria pre-set
in the screening protocol.
If this is the case, try the following:
Check the Probe fit in the ear and reinsert probe. It may be partly blocked by
the ear canal wall or it may have become loose in the ear canal during the rest run.
Choose another ear tip. If an ear tip is too small it can let excessive noise in the
occluded Ear Canal and cause an increase of the noise floor; if the tip is too big, it
may get wrinkled and also let excessive noise in the occluded Ear Canal.
Reduce ambient noise or change test location for a quieter place if possible.
Use ear muffs. The Probe design allows using various types of ear muffs. The
deeper the ear muff cups, the better. Ear muffs can significantly reduce ambient
noise and make OAE testing possible in otherwise excessively noisy places, such
as noisier general offices, schools, and occupational settings. To use ear muffs,
first insert the Probe, then place the muffs on the patient‟s head as described in the
user‟s manual for the ear muffs. Make sure the Probe is not misplaced by the ear
muffs.

Test Protocol Parameters

There are no protocol parameters set in the Test screen for TEOAE tests. However, there
are four (4) selectable fields that may be defined for each test. These fields include: Ear
Tip, Algorithm, Display, and Bands.

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Ear Tip
This field allows you to specify the type of ear tip used on the probe. A variety of predefined
ear tips are available for selection.

Algorithm
This control regulates application of the methods of processing the TEOAE waveforms.
There are two processing algorithms to choose from: Averaging and Kalman Weighted.
Kalman Weighted is the system‟s default algorithm.

Averaging is a signal processing algorithm, which utilizes the standard time averaging
technique so that equal weighting is given to the collected TEOAE data. Weights are based
on the noise in the response. Waveforms contaminated with artifacts above certain Artifact
Rejection Thresholds (ART) are excluded from averaging.

Kalman Filter is a signal processing algorithm that is used in TEOAE testing to optimally
weight the patients' responses so that responses with less artifact from patient and
environmental noise are given more weight than responses that are more contaminated
with artifact. Kalman filtering allows TEOAE acquisition with subjects who are in
environments that are intermittently noisy. This method processes signals in real time
without rejecting any time segments, even those containing significant artifacts. (Li 2002)
When TEOAE is collected on a subject who is in an environment with a constant amount of
noise throughout the test, Kalman Filtering will yield the same result as conventional
averaging. When the subject makes noise intermittently during the test, the Kalman Filter
will yield a result that is less contaminated by noise than a result that would be obtained
under the same conditions with conventional averaging.

Display
st rd
For the purposes of analysis, TEOAE responses are divided into two phases, the 1 , 3 ,
th nd th th
5 , etc. responses are called the A phase and the 2 , 4 , 6 , etc. responses are called the
B phase. When the average A response is highly correlated to the average B response,
there is an indication that a repeatable TEOAE has been detected. The difference between
the A and B responses is a measure of the noise in the system.
The user may choose from one of two Display modes in the TEOAE. In “A+B” mode the
average of the A and B responses are displayed in dark blue (or red for the right ear) and
the noise is displayed in light blue (or pink). In “A and B” mode, the A response is displayed
in dark blue (or red) and the B response in light blue (or pink).

Bands
This field allows the user to define the length of the viewable bandwidth The bandwidths
available are: 1 KHz (linearly spaced), or 1,1/2,1/4 and 1/6 octaves, logarithmically spaced.

Post Test Review

TEOAE Database Screen
The TEOAE Database screen is similar to other test modalities. The functions unique to the
TEOAE Database screen are described in this section.
Refer to The Database Screen on page 37 for a general description of the Database
screen.

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Figure 129. TEOAE Database Screen

The Database screen displays the following information:

 Patient Test Information
 Waveform Information
 Database Controls

Monitoring OAE Changes Over Time

The database allows you to compare baseline tests and follow-up tests at later dates. By
comparing tests over time it is possible to monitor changes in OAE results which indicate
the potential development of ototoxicity and noise-induced hearing loss, as well as
treatment of otitis media. Refer to Appendix K: Clinical Application for Otoacoustic
emissions on page 204 for more information.

Patient Test Information

This table contains patient information entered in the Patients screen. Refer to Database
on page 38 for a full description of the function of this portion of the database screen.

Database Waveform Information

This window displays waveform data in the form of a Signal, Noise and SNR (SNS) Graph,
along with conditions of stimulation and recording (Figure 130).
The SNS Graph contains the signal, noise and SNR responses in a bar graph format. Use
the Signal, Noise and SNR checkboxes to display the corresponding information in the bar
graph.

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Figure 130. Database Waveform Information for TEOAE

Database Controls
The Database Controls are located on the right side of the Database screen. The controls
provide post-analysis functions on the data, such as report generation. Refer to Database
Controls on page 42 for a description of these buttons.

Figure 131. Database Controls for TEOAE

Performing a TEOAE Test

In-the-Ear Test
Begin with the VivoLink off and the OAE Probe in the Probe Holder.
The In-the-Ear test checks to ensure the position of the OAE Probe in the ear canal, with
the ear tip installed on the probe, fit correctly for the patient. This ensures that there is no
leakage of sound from the ear canal, and that the acoustic outlets and inlets of the probe
are not blocked.
Adult Patient or an Older Child
1. Connect the lanyard clips to the D-rings on the VivoLink.
2. Disconnect the breakaway of the lanyard and place the longer part of the lanyard
around the patient‟s neck.

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3. Connect the breakaway of the lanyard to the VivoLink (Figure 10). The patient may
then be placed in a chair or on a couch, whichever is more comfortable for the
patient and the operator.
Infant Patient
 Place the VivoLink next to the infant on a flat surface, close enough for the OAE
Probe cables to reach the infant.
 Alternatively, if the infant is held by a caregiver, the caregiver may hold the
VivoLink in the hands along with the infant.

CAUTION
Injury to an infant may occur. Do not hold the VivoLink over the infant’s body or head. If
any of the components are accidentally dropped, the infant may be injured.

With the OAE probe in the cavity, confirm the OAE Probe and the system is working
correctly by selecting Cavity Check on the Test screen. Refer to Cavity Check on page
135 for details. Three of the most common probe-check messages are displayed below.

Figure 132. Probe-check message – Passed

Figure 133. Probe-check message – Error

Figure 134. Probe-check message – Noise

Define the Test

To conduct a TEOAE measurement, perform the following steps:
1. Switch on the VivoLink.
Integrity recognizes the OAE Probe and will display its ID number in the Probe ID
field on the test screen.
2. In the Test screen, select TEOAE from the Test Type drop-down menu. Wait for
the Bluetooth LED to turn solid blue to indicate that the software has initialized the
TEOAE test.

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3. Select an ear to test. Refer to Preparing the Patient on page 128 for instructions on
inserting the OAE Probe.
4. Select the patient to test from the Patients drop-down list in the Test Screen.
5. Select an appropriate protocol from the Applied Protocol drop-down menu. Refer
to Define a TEOAE Protocol on page 130 for information on defining a custom
protocol.

CAUTION
Improper configuration of OAE test protocols may result in poor quality test results.
Only use clinically validated protocols for screening and assessment.

6. Press either the Right Ear or Left Ear button.

7. Press Start to begin a test. The Start button changes to a Stop button.
 Press Pause to stop the test temporarily.
 Press Continue or the Stop button to proceed.
Refer to Test Control Buttons on page 30 for more information about Start/Stop,
Pause/Continue, and Save features.
8. If the test is Automatic Screening the test outcome window will show PASS-auto,
REFER-auto, or TEST INSUFFICIENT-auto.
If TEST INSUFFICIENT- auto appears, the acoustic conditions of the test may be
inadequate to make the screening decision according to the criteria pre-set in the
protocol. In this case try the following:
 Check the OAE Probe fit in the ear and reinsert probe. It may be partly
blocked by the ear canal wall or it may have become loose in the ear canal
during the rest run. The probe fit checks to ensure the position of the OAE
Probe in the ear canal, with the ear tip installed on the probe is fit correctly for
the patient. This will ensure there is no leakage of sound from the ear canal
and that the probe‟s acoustic outlets and inlets are not blocked by ear wax or
the ear canal wall.
If the probe is inserted properly the ear tip end will be positioned approximately
at the end of the cartilaginous part of the ear canal.
 Choose another ear tip. If an ear tip is too small it can let excessive noise in
the occluded ear canal and cause an increase of the noise floor. If the tip is too
big, it may get wrinkled and also let excessive noise in the occluded ear canal.
 Reduce ambient noise or change the test location for a quieter place if
possible.
 Use ear muffs. The OAE Probe design allows using various types of ear
muffs. The deeper the ear muff cups, the better. Ear muffs can significantly
reduce the ambient noise and make OAE testing possible in otherwise
excessively noisy places, such as noisier general offices, schools, and
occupational settings. To use ear muffs, first insert the OAE Probe, then place
the ear muffs on the patient‟s head over the probe as described by the
manufacturer. Make sure the probe is not misplaced by the ear muffs.
9. Press Save to save the test results to the database.
Press Discard/Clear Graph to clear the Test Waveform Window. If the graph is
cleared before the results are saved, the data will be lost.
Press Print to print the test results.

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CAUTION
To ensure that the data is saved in the correct patient’s file you must ensure that
the patient’s name and ID are both correct as they appear in the dialog box. If the
name or the ID is incorrect press Cancel and select the correct patient from the
patient list or enter a new patient in the Patient screen.
10. Slowly remove the probe from the ear. Gently pull the ear tip from the ear canal.
While removing the ear tip, slightly push it sidewise to open some gap between the
ear tip and the wall of the ear canal. This allows air to enter the ear canal occluded
by the ear tip.
CAUTION
Removing the ear tip from the ear canal too quickly may cause negative air
pressure in the occluded ear canal and may hurt the eardrum. There is a pressure
release vent in the Probe, but it may not be sufficient to equalize air pressure in the
occluded ear canal if the Probe is removed too quickly.
11. Repeat the above procedure to test the other ear.
12. Remove the VivoLink from the patient.

Post Test Procedures

1. Remove ear tip from the OAE Probe.
WARNING
To avoid accidental swallowing of inhalation of an ear tip, do not leave ear tip(s)
within reach of a child. Patients should be attended during preparation and testing.
2. Properly dispose of the used ear tip.

CAUTION
The ear tips are single patient use only and should be disposed of immediately
after use. To avoid transfer of disease, do not re-use the ear tips on other patients.
3. If the grooves on the OAE Probe are congested with earwax, clean them using the
cleaning tools provided (brush, pick, and loop).
4. Disinfect the OAE Probe using disinfecting wipes.

CAUTION
To prevent damage to the probe:
While wiping the probe, hold the sound canals in the tapered tip down to avoid
wipe fluid from entering the sound canals and saturating the acoustic dampers.
The acoustic dampers are the red pieces in the two microphone sound canals.
Damaging the acoustic dampers will cause the probe to malfunction.
If wipe fluid has entered the sound canals, perform a Check Cavity test on the
probe. If a Probe Error is reported allow the probe to dry for an hour and repeat
the cavity test. If the problem persists, contact Customer Support.

Storing the Integrity System

1. Insert the Probe into the Probe Holder on the VivoLink.
2. If no other tests are planned in this test session press Exit in the right top corner of
the screen.
3. Shut down the computer.
4. Pack the VivoLink and accessories and place them back into their storage cases.

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Chapter 9: Overview of DPOAE Testing

Specific DPOAE Test Preparation
To prepare for a DPOAE test, perform the following operations:
1. Verify that the connections between the OAE Probe and the VivoLink are not loose.
Inspect the VivoLink, the OAE Probe and the Probe Adapter, and all cables, to
ensure that there is no visible mechanical damage.
A test cannot be performed unless the OAE probe is connected properly to the
VivoLink. A message box is displayed when the OAE probe is not connected.

Figure 135. Probe Not Connected Message Box

CAUTION
Do not conduct any test if, by visual inspection, you discover any visible
mechanical damage. Report the problem to Vivosonic Inc.’s local service
representative or Customer Support. Do not try to repair the device yourself.

2. Place the OAE Probe on the Probe Holder located on the front panel of the
VivoLink (Figure 8). Check that the probe is inserted all the way, to the full stop,
into the probe holder.

CAUTION
To avoid breaking the OAE Probe do not apply too much force to the OAE Probe
when parking it in the probe holder.
3. Switch on your VivoLink.
4. Switch on your Integrity computer.
5. Read the Caution statements, and choose Agree to proceed.
6. Select a patient‟s name from the Patient screen, or add a new patient name.
7. Open the Test screen and select DPOAE from the Test Type list.
The Bluetooth LED starts to flash when your computer recognizes the presence of
the VivoLink and begins to download information to it.
When the download of information is complete, the Bluetooth LED stops flashing
and remains solid blue. If the connection is lost during the download process, the
Bluetooth LED indicator appears unlit.

NOTE
The Probe should be in one of three locations at ALL times to avoid its damage:
 In the Probe Holder on VivoLink
 In the examiner‟s hand
 In the subject‟s ear canal

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Preparing the Patient

This procedure requires the use of ear tips. The ear tips are color-coded by size. Refer to
Error! Reference source not found. and Figure 6 for the description of the ear tips.
1. Inspect the patient‟s ear canal, preferably with an otoscope (not included).
If there is an excessive deposit of earwax, remove it or refer to an appropriate
health care professional for earwax removal, as regulated by local health-care
regulations.
2. Evaluate the size of your patient‟s ear canal, and select an ear tip that fits tightly yet
comfortably in the ear canal.

CAUTION
To ensure proper fit and operation of the OAE Probe, use only ear tips supplied by
Vivosonic Inc.
3. Gently place the ear tip onto the OAE Probe to the full stop (Figure 119).
4. Slowly insert the ear tip into the ear canal. Make sure that the ear tip is inserted
tightly in the cartilaginous part of the ear canal, not in the bony part, which would
occlude the ear canal.

CAUTION
Do not insert the ear tip in the ear canal too quickly. This may cause excessive positive air
pressure in the ear canal being occluded by the ear tip and may hurt the eardrum of the
patient. There is a pressure release vent in the transducer, but it may not be sufficient to
release excessive air pressure if the ear tip is inserted too quickly.

Use HAND FORCE ONLY. Ear tips are flexible. Ensure that the probe tip has not
damaged the ear tip and is protruding from the ear tip to avoid injuring the ear canal.

Adult Patient or an Older Child

1. Connect the lanyard clips to the D-rings on the VivoLink.
2. Disconnect the breakaway of the lanyard and place the longer part of the lanyard
around the patient‟s neck.
3. Connect the breakaway of the lanyard to the VivoLink (Figure 10). The patient may
then be placed in a chair or on a couch, whichever is more comfortable for the
patient and the operator.

Infant Patient
 Place the VivoLink next to the infant on a flat surface, close enough for the OAE
Probe cables to reach the infant.
 Alternatively, if the infant is held by a caregiver, the caregiver may hold the
VivoLink in the hands along with the infant.

CAUTION
Injury to an infant may occur. Do not hold the VivoLink over the infant’s
body or head. If any of the components are accidentally dropped, the infant
may be injured.

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The OAE Probe calibration and the system may then be checked by pressing the Cavity
Check button on the Test screen. The Cavity check is measured in the 1 cc cavity of the
OAE Probe holder on the VivoLink.
 If the Probe calibration is correct and the system Distortion Product (DP) and
noise floor are within their tolerances, the status will be reported as “Cavity
Check Passed” in the Message and Assessment Window (Figure 136).
 If there is a problem with OAE Probe calibration, excessive system DP, or
system noise, then a message describing the problem(s) will appear in the
Message and Assessment Window (Figure 137).
Follow the instructions on the screen. If the problem persists, contact Customer Support.

Figure 136. Message and Assessment Window (Cavity Check - Pass)

Figure 137. Message and Assessment Window (Cavity Check - Fail)

Perform a Probe Fit Check to ensure that the position of the OAE Probe in the ear canal,
with the ear tip installed on the probe is fit correctly for the patient. This will ensure that
there is no leakage of sound from the ear canal, and that the acoustic outlets and inlets of
the probe are not blocked. Refer to Probe Fit Check on page 153 for details.

Define a DPOAE Protocol

DPOAE protocol parameters are entered using DPOAE controls on the Protocol screen.
To create a new protocol, select the Protocol tab, modify an existing DPOAE protocol, and
then save it with a new name.
Refer to Appendix E: Preset Protocols and Test Settings for default protocol parameters.

NOTE
It is not possible to overwrite or edit an existing protocol. When an existing protocol
is modified it must be saved under a new name.

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Figure 138. DPOAE Protocol Parameters

The Stimulus Parameters are used to select the stimulus and frequencies settings.
F2/F1 Ratio can be selected from the drop-down menu as 1.20 or 1.22.
Frequency order can be selected from the drop-down menu as Ascending or Descending.
Descending order is sometimes chosen when the higher frequencies are of more interest,
and the patient, particularly infant or child, is restless.
L1 and L2, the levels of primary tones, f1 and f2, can be set at 40-75 dB SPL with 1 dB step.
You can set them in two ways: (a) simply place the pointer on the bar and drag its right end
to the required position, while watching the number above indicating the exact value of the
parameters, and (b) by clicking on the window and entering the necessary number.
Number of Runs, which defines the number of automatic repetitions of the test, can be
selected from the drop-down menu as 1 or 2.

NOTE
If the number of runs is set to 1, then repeatability cannot be calculated and repeatability
Criterion will be disabled.
F2 Frequency can be selected from 16 frequencies: 500, 750, 1000, 1500, 2000, 2500,
3000, 3200, 3500, 4000, 4500, 5000, 5500, 6000, 7000, and 8000 Hz. A minimum of two
frequencies should be selected per DPOAE protocol.

DPOAE DSP Stability, which defines the speed and accuracy of DPOAE measurement.
This parameter can be set at Accurate, Medium, and Fast.
 Accurate setting requires the DPOAE signal to be stable for 0.4 seconds within ±1 dB
SPL from its median value. It yields the most accurate DPOAE measurement, and is
the default setting of this control. This setting can be used in any test, but particularly

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when accuracy is a priority, for example for ototoxicity or noise-induced hearing loss
monitoring and diagnostic tests.
 Medium setting requires the DPOAE signal to be stable for 0.3 seconds within ±2 dB
SPL and can be used for assessment tests.
 Fast setting requires the DPOAE signal to be stable for 0.2 seconds within ±3 dB SPL.
This setting can be used when the speed of testing is more important than its accuracy.
A fast setting helps to avoid transient acoustic artifacts such as baby‟s noises,
footsteps, door slamming, equipment beeps, etc.
It is recommended that you use the Accurate setting when possible, and switch to Medium
or Fast only when measuring with Accurate is difficult or impossible because of significant
transient noises.
Operating mode includes: DPOAE Automatic Screening, DPOAE Manual Screening, and
DPOAE Assessment. A test decision made in Automatic operating mode cannot be
changed.
 When Automatic is selected, the program makes a pass-refer decision automatically
according to the set screening criteria.
 When Manual is selected, the program makes a PASS, REFER, or Test Insufficient
decision automatically.
After a test run, three decision buttons appear at the bottom of the Test screen; these
allow you to modify the decision manually.
 When Assessment is selected, the DP-gram is recorded, but there is no screening
decision.

The Pass/Refer Criteria are used to determine whether the result is Pass, Refer, or
Insufficient.
 Criterion Levels which include Response Levels and No. of Frequencies to Decide
can be enabled or disabled.
 Response Levels are the minimum DPOAE signal levels at corresponding frequencies
that have to be reached for a response to qualify as a Pass in Automatic Screening.
You can set them from -10 to +5 dB SPL - with 1 dB step - by dragging the bars up and
down, or entering the number in the window above each bar. When this criterion is
enabled and, these boundary levels are shown as a dashed blue line in the DP-gram
graphs in the Test Screen. The decision algorithm treats the measured DPOAE levels
differently depending on whether they are below or above this boundary line.
 No. of Frequencies to Decide refers to the minimum number of F2 points in the DP-
gram that need to satisfy the set PASS criteria in order to produce an overall Pass
decision. This is the number in the left field that should be set to at least half number of
selected frequencies in this protocol. However, the number in the right field shows
automatically the total number of selected test frequencies.
If the No. of Frequencies to Decide is disabled, then all of the frequencies are required
to pass in order to make a PASS decision.
 SNR Criterion refers to the maximum allowable Signal-to-Noise Ratio, i.e. the
difference between DPOAE level and Noise Floor level in decibels (dB). SNR Criterion
allowed range is from 3 to 10 with 1 dB step.
 Repeatability Criterion refers to the maximum allowable difference in decibels (dB)
between two runs of the DP-gram in a single test at each of the test frequencies, if
there are two automatic runs of the test. The allowable criterion range is from 1 dB to
10 dB.

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 SNR Criterion and Repeatability Criterion can be enabled or disabled.

Refer to Appendix C: Automatic TEOAE Screening Algorithm for details about these
parameters.
 Description text box allows you to type in an extended description of the protocol
which may reflect the use of the protocol, key parameters etc., for example: DP
screening at 2, 3, 4 kHz 60/50 3/5, which means a protocol for DPOAE screening at f2
= 2, 3, and 4 kHz, with L2/L1 = 60/50 dB SPL, and with the number of frequency to
decide equal to 3 out of 3 frequencies tested.
 Comment text box allows you to enter information associated with the protocol you
create. For example, you may wish to type a note that the protocol you create is based
on a certain published study, or created for a particular population, test setting, clinical
use, or research project. These factors may also be reflected in the name of the
protocol you create, for example: M. Gorga et al. (2000).

During the Test

The DPOAE Test Screen
The DPOAE test screen has the same components as other test types screen (Waveform
Information and Test Controls) with some different functions. This section of the manual will
describe the unique functions of the DPOAE test screen.

Figure 139. DPOAE Test Screen – Assessment

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DP-Gram
The graph on the top right shows the DP-gram: The y-axis represents sound levels in dB
SPL, while the x-axis represents the frequency of f2 in kHz.
DPOAE levels at each f2 frequency are shown as color dots: red for the right ear and blue
for the left ear if the DPOAE levels are equal to or above the noise floor, and yellow for both
ears if DPOAE level is below the noise floor (thick gray lines). The color lines connect the
measured DPOAE levels: red for the right ear and blue for the left ear.
Noise Floor levels at the DPOAE frequencies corresponding to the respective f2
frequencies are shown as thick gray lines.
You can view the specific frequency, DPOAE (DP) level, noise floor (NF), and signal to
noise ratio (SNR) for each point recorded on your DP-gram. To view the values for a
specific point, use your mouse pointer to hover near that point on your DP-gram. The
values are displayed in a small window in the upper right corner of the DP-gram.
DP Norms are displayed on the DP-gram using two bands.
 95% of the normal hearing population (threshold less than 20 dB at all frequencies)
will have DPOAE levels above the top light colored band on the graph.
 95% of the hearing impaired population (with 20 dB hearing loss at the frequency
displayed) will have DPOAE levels that are below the bottom light colored band on
the graph.
 90% of the normal hearing population (threshold less than 20 dB at all frequencies)
will have DPOAE levels above the dark colored band on the graph.
 90% of the hearing impaired population (with 20 dB hearing loss at the frequency
displayed) will have DPOAE levels that are below the dark colored band on the
graph.

This means that, with 95% and 90% confidence, one can rule out the probability of hearing
impairment in patients whose DPOAE‟s are all above the light and dark colored bands,
respectively.
Similarly, one can rule out the probability that the patient has normal hearing at any given
frequency, with 95% and 90% confidence, for patients whose DPOAE‟s are below the light
and dark bands, respectively.
For patients whose DPOAE levels are within the dark colored band, one cannot make any
statistically significantly conclusions about the patient‟s hearing from the DPOAE test alone.
The provided DPOAE Norms values are automatically displayed if the protocol parameters
for the current test match the parameters that were used in collecting these norms, i.e. L1,
and L2 are 65 and 55 dB SPL respectively, and F2/F1 ratio is 1.22.
To view normative data (raw) go to the following file on your Integrity computer:
C:\Vivosonic Integrity\Integrity Norms\DPOAE\Default_DPOAE_Norm.xml
For the source and value of the DPOAE norms data please refer to Appendix M: DPOAE
Norms Data.

NOTE
It is recommended that each clinic create its own norms data which reflect the specific
character of the tested population and the protocols used for their data collection. The
preset norms data can be used to compare the results collected with the same stimulus
parameters.

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DPOAE Criterion Levels, in case of applying a screening protocol, DPOAE Response

Levels Criterion defined in the Protocol Screen are shown as the dashed black line in the
DP-Gram. Refer to page 146 for more details about the DPOAE Criterion Levels.
The DP-Gram that is obtained from consecutive multiple test results overlapped on the
graph and identified by colors for the right and left ear, until the user chooses to clear the
graph.

Sound Level indicators

Bars in the lower right corner of the screen represent the sound-level indicators. The two
blue bars (titled L1 and L2) on the left show the levels of the two primary stimulus tones,
the two right bars indicate the Noise Floor (NF) and DPOAE (DP) levels in dB SPL as
measured by the Probe microphone at the acoustic inlet of the Probe. These four
indicators are continuously updated.

Figure 140. Sound Level Indicators

The bar next to the right (titled NF) shows the Noise Floor level at the DPOAE frequency in
dB SPL as measured at the inlet to the microphone sound canal of the Probe. The Noise
Floor is measured the following way: first, the algorithm calculates an average of the signal
power at two frequencies around the DPOAE frequency, one frequency below and one
frequency above the DPOAE frequency, separated by 1 Hz steps. Then the obtained
average value is converted into dB SPL and presented as the Noise Floor.
The bar titled DP shows the measured DPOAE level in dB SPL. This bar is color-coded: it
turns yellow when the DPOAE level is below the Noise Floor level and either red (if the
right ear is being tested) or blue (if the left ear is being tested) when the DPOAE level is
equal to or above the Noise Floor level.

NOTE
The Probe microphone is intended to measure primarily OAEs coming from the eardrum,
not the levels L1 and L2 of the primaries coming from the Probe. Because of standing sound
waves in the occluded ear canal, the measured levels L1 and L2 typically are not equal to
the set primary levels, especially at frequencies higher than 2 kHz. This happens because
the primary levels L1 and L2 are calibrated using an Occluded Ear Simulator (Zwislocki
Coupler) in which the microphone membrane’s position mimics the position of the eardrum.
In contrast, L1 and L2 indicators show the levels measured at the inlet of the microphone
sound canal of the Probe, i.e. at a distance from the eardrum. Such a distance introduces
standing waves that make the primary levels different at the eardrum and at the inlet to the
microphone sound canal of the Probe. Nevertheless, these indicators are important
because they show that the primary tones are actually presented into the ear canal.
The Noise Floor (NF) indicator is also very useful for checking the seal of the ear canal.
When the NF value is fluctuating around a level of 10 dB SPL or higher, it indicates that the

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seal is poor. In such a case, you may need to reinsert the Probe, or select another ear tip,
or use ear muffs.
You can also check background noise using the NF indicator. When the Probe is inserted in
the Probe Holder, the level should be below -15 dB SPL. The level of a reasonably quiet
office is about -20 dB SPL.

Test Protocol Parameters

There are no protocol parameters that can be set in the Test screen for the DPOAE tests.
However, there are two (2) selectable fields that help define the test: Ear Tip and Maximum
Effective Duration per Frequency.

Figure 141. DPOAE Test Protocol Parameters

Ear Tip
This field allows the user to define the type of ear tip used on the probe. A variety of
predefined ear tips are in the list.

Maximum Effective Duration per Frequency (sec)

This field allows optimizing the measurement duration for a particular testing situation.
Users can set the maximum duration for detection of a stable DPOAE signal among
possible artifacts.

This parameter can be changed using its control buttons with up and down arrows found on
the left of this control, or by simply typing a number in its edit box. The available range for
this control is 0.5 to 120 sec. Higher values may be useful in noisier environments. This
will depend on the testing situation: in a quiet environment and cooperating patient you will
typically need no more than 2-3 seconds per frequency; in more complicated situations you
may allow for a longer duration.

Test Value Fields

Figure 142. DPOAE Test Value Fields

Test Duration (sec) – is the duration of the DPOAE test to detect the DP levels for all
tested frequencies. If the test includes two runs, test duration represents time for the latest
run only.
Probe ID – is a unique ID for the OAE probe that is used during the test.

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Probe Fit Check

With the probe in the ear of the patient, you can perform the Probe Fit Check to ensure that
there is no leakage of sound from the ear canal, and that the acoustic outlets and inlets of
the probe are not blocked
The probe fit check includes the following steps:
1. The system applies simultaneously two signals to two receivers of the OAE probe
to produce two pure tones with a frequency ratio 1.22
2. The system measures the actual sound pressure levels of the two tones received
by the microphones of the probe at the probe inlet.
3. The test result is displayed in the Message and Status Window.
Possible failure messages include:
 Ear probe is loose
When the Ear probe is loose, try using a larger ear tip. Also, clean the probe
and then restart the test.
 Ear probe is blocked
When the Ear probe is blocked, clean the probe and then restart the test.

Split / Merge Charts

This feature allows you to activate a single button to toggle your view of the DP-gram from
a split view to a merged view. The button changes its label to Split Charts or Merged Charts
when activated.
 A merged view displays both the left and right ears in one chart.
 A split view displays the results of each ear in separate charts.
You can set the default view in the System screen. Refer to DPOAE Settings on page 51.

Figure 143. DPOAE Merge Charts

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Figure 144. DPOAE Split Charts

Message and Assessment Window

The message and assessment window appears below the DPOAE chart. The top section of
this window displays messages about the current test being performed and its status. This
includes used protocol, probe insertion, probe calibration, the cavity check test, or the test
in process.

Figure 145. Message and Assessment Window (Assessment)

The bottom section displays the test outcome. Test outcome is Assessment for tests
performed in assessment mode. In Automatic Screening mode, either PASS, REFER, or
Insufficient message will appear in test outcome field immediately after completion of the
test. The test outcome field is provided as a screening feature that will indicate if a patient
has passed preset screening criteria whether the patient should be referred for further
diagnosis. There are three possible values that are displayed as a result of an automatic
screening:
In Automatic Screening mode, a Pass, Refer, or Test Insufficient message appears in
the assessment field immediately upon completion of an assessment. The assessment field
directly below the message window informs the technician that the patient has passed
preset screening values, or that the patient should be referred for further diagnosis.

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There are three possible values that are displayed as a result of an assessment:
 Pass-auto – indicates that the patient has passed all the criteria pre-set in the
screening protocol. The parameters and their pass value will be listed in the
message window directly above the Pass-Auto message.
 Refer-auto – indicates that the patient has not passed all the criteria pre-set in the
screening protocol and that the patient should be referred to a specialist for a
complete diagnosis. The parameters and their pass/refer value will be listed in the
message window directly above the Refer-Auto message.
 Insuff – indicates that the results are too inconsistent to make an automated
pass/refer decision. If this message appears, the acoustic conditions of the test
may be inadequate to make the screening decision according to the criteria pre-set
in the screening protocol.
If this is the case, try the following:
Check the Probe fit in the ear and reinsert probe. It may be partly blocked by
the ear canal wall or it may have become loose in the ear canal during the rest run.
Choose another ear tip. If an ear tip is too small it can let excessive noise in the
occluded Ear Canal and cause an increase of the noise floor; if the tip is too big, it
may get wrinkled and also let excessive noise in the occluded Ear Canal.
Reduce ambient noise or change test location for a quieter place if possible.
Use ear muffs. The Probe design allows using various types of ear muffs. The
deeper the ear muff cups, the better. Ear muffs can significantly reduce ambient
noise and make OAE testing possible in otherwise excessively noisy places, such
as noisier general offices, schools, and occupational settings. To use ear muffs,
first insert the Probe, then place them on the patient‟s head as described in the
manual for the ear muffs. Make sure the Probe is not misplaced by the ear muffs.

NOTE
Test result for Automatic Screening protocols is detected automatically by the System, and
cannot be modified by the user. To be able to modify the test result, Manual Screening
protocol should be used instead.

In Manual Screening mode, the algorithm detects the test outcome at the end of the test
or when you stop the test. At this point, you can select an alternative assessment result that
will be saved in the database along with the test record.
A message box will prompt you to confirm the assessment result that you have selected.

Figure 146. Select test outcome when in manual mode of operation

Test Control Buttons

The Start/Stop, Pause/Resume, Save, Discard/Clear Graph, Right/Left Ear and Print
buttons operate in the same manner for all test types. Refer to page 30 for details.

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Figure 147. Test Control Buttons

Cavity Check Button

Cavity check is a procedure performed to ensure the probe is working and is in good
condition, i.e. no acoustical change has occurred since the probe was calibrated. The
procedure is performed with the probe inserted in the Probe Holder on the VivoLink.
The cavity check includes the following steps:
1. VivoLink applies two signals to the two receivers of the probe to produce two pure
tones with frequency ratio: 1.22
2. Integrity measures the sound pressure level of the system DP received by the
microphones of the probe at the inlet of the probe.
3. Integrity measures noise after the stimulus to ensure that System Noise (a false
response due not synchronized to the stimulus) is within specification.
4. VivoLink reads the actual sound pressure levels with the Probe Characteristic
Constants (PCC ) stored in the built-in EEPROM of the probe and compares it to
the measured value .
5. If the differences between the actual levels and PCC are within ±3 DB, and the
noise and system DP are within tolerance the probe passes the cavity check.
Otherwise the probe fails cavity check
6. Test result will be displayed in the message and assessment area of the screen
(bottom right hand corner).

You can stop the Cavity Check by selecting the Cancel button on the Cavity Check
message.

Figure 148. Cavity Check In Progress Message

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Post Test Review

DPOAE Database Screen
The DPOAE Database screen is similar to other test modalities. The functions unique to the
DPOAE Database screen are described in this section.
Refer to The Database Screen on page 37 for a general description of the Database
screen.

Figure 149. DPOAE Database Screen with Norms Data

Monitoring DPOAE over time

The database allows the user to compare baseline tests and follow-up tests at later dates.
By comparing tests over time it is possible to monitor changes in DPOAE results which
indicate the potential development of ototoxicity and noise-induced hearing loss, as well as
treatment of otitis media. Refer to Appendix J: Clinical Application for Electrocochleography
for more information on the applications of OAE testing.
Multiple DPOAE test results that are saved in different records, provided that they are
generated using the same protocol, can be displayed on one DP-Gram graph on the
Database screen.
The Database screen contains the following information:
 Patient Test Information
 Waveform Information
 Database Controls

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Patient Test Information

This table is located at the upper part of the screen. This table contains patient information
entered in the Patients screen, and the test conditions entered when the test is saved.
Refer to Database on page 38 for a full description of the function of this portion of the
database screen.

Database DP-Gram

Figure 150. Database DP-Gram for DPOAE

The DP-gram window displays collected DPOAE data. You can view the specific frequency,
DPOAE (DP) level, noise floor (NF), and signal-to-noise ratio (SNR) for each point recorded
on your DP-gram.
To view the values for a specific point, use your mouse pointer to hover near that point on
your DP-gram. The values are displayed in a small window in the upper right corner of the
DP-gram.

NOTE
The provided DPOAE Norms values are automatically displayed if the protocol parameters
for the selected test records are matching the parameters that are used in collecting these
norms data.
For the source and value of the DPOAE norms data please refer to Appendix M: DPOAE
Norms Data.

Average Results
This option allows averaging selected data. Data to be averaged are all runs from all
records selected in the Patient Test Information Chart. Average results option will
average both DPOAE, and noise floor NF levels. It is required that all the selected records
be from the same protocol.

Compare Results
This option allows comparing the DPOAE and Noise Floor (NF) level differences across
two test records. It is required that the two selected test records use the same protocol.

NOTE
The Compare Results button is only available when two test records are selected.
The Print button is unavailable when comparing results.

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Restore
This button is provided to allow restoring the DP-Gram to its original status as it is
generated in the test screen after performing an averaging or comparing calculation

NOTE
Averaged or compared DP, and Noise Floor levels may be represented in a tabular numeric
format by clicking on the Table button of the Database Controls.

Split / Merge Charts

This feature allows you to activate a single button to toggle your view of the DP-gram from
a split view to a merged view. The button changes its label to Split Charts or Merged Charts
when activated.
 A merged view displays both the left and right ears in one chart.
 A split view displays the results of each ear in separate charts.
You can set the default view in the System screen. Refer to DPOAE Settings on page 51.

Database Controls
The Database Controls are located on the Database screen. The controls provide post-
analysis functions on the data, such as report generation.
The Print button is unavailable when the Average Results or Compare Results view is
active.
Refer to Database Controls on page 42 for details about these buttons.

Figure 151. Database Controls for DPOAE

Performing a DPOAE Test

Define the Test
To conduct a DPOAE measurement, perform the following steps:
1. Prepare the patient and the Integrity system as per Specific DPOAE Test
Preparation instruction on page 144.
2. Select an appropriate protocol from the Applied Protocol drop-down menu. Refer
to Define a TEOAE Protocol on page 130 for information on defining a custom
protocol.

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CAUTION
Improper configuration of OAE test protocols may result in poor quality test results.
Only use clinically validated protocols for screening and assessment.

3. Press either the Right Ear or Left Ear button.

4. Press Start to begin a test. The Start button changes to a Stop button.
 Press Pause to stop the test temporarily.
 Press Continue or the Stop button to proceed.
Refer to Test Control Buttons on page 30 for more information about Start/Stop,
Pause/Continue, and Save features.
5. If the test is Automatic Screening the test outcome window will show PASS-auto,
REFER-auto, or TEST INSUFFICIENT-auto.
If TEST INSUFFICIENT- auto appears, the acoustic conditions of the test may be
inadequate to make the screening decision according to the criteria pre-set in the
protocol. In this case try the following:
 Check the OAE Probe fit in the ear and reinsert probe. It may be partly
blocked by the ear canal wall or it may have become loose in the ear canal
during the rest run. The probe fit checks to ensure the position of the OAE
Probe in the ear canal, with the ear tip installed on the probe is fit correctly for
the patient. This will ensure there is no leakage of sound from the ear canal
and that the probe‟s acoustic outlets and inlets are not blocked by ear wax or
the ear canal wall.
If the probe is inserted properly the ear tip end will be positioned approximately
at the end of the cartilaginous part of the ear canal.
 Choose another ear tip. If an ear tip is too small it can let excessive noise in
the occluded ear canal and cause an increase of the noise floor. If the tip is too
big, it may get wrinkled and also let excessive noise in the occluded ear canal.
 Reduce ambient noise or change the test location for a quieter place if
possible.
 Use ear muffs. The OAE Probe design allows using various types of ear
muffs. The deeper the ear muff cups, the better. Ear muffs can significantly
reduce the ambient noise and make OAE testing possible in otherwise
excessively noisy places, such as noisier general offices, schools, and
occupational settings. To use ear muffs, first insert the OAE Probe, then place
the ear muffs on the patient‟s head over the probe as described by the
manufacturer. Make sure the probe is not misplaced by the ear muffs.
6. Press Save to save the test results to the database.
Press Discard/Clear Graph to clear the Test Waveform Window. If the graph is
cleared before the results are saved, the data will be lost.
Press Print to print the test results.

CAUTION
To ensure that the data is saved in the correct patient’s file you must ensure that
the patient’s name and ID are both correct as they appear in the dialog box. If the
name or the ID is incorrect press Cancel and select the correct patient from the
patient list or enter a new patient in the Patient screen.

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7. Slowly remove the probe from the ear. Gently pull the ear tip from the ear canal.
While removing the ear tip, slightly push it sidewise to open some gap between the
ear tip and the wall of the ear canal. This allows air to enter the ear canal occluded
by the ear tip.

CAUTION
Removing the ear tip from the ear canal too quickly may cause negative air
pressure in the occluded ear canal and may hurt the eardrum. There is a pressure
release vent in the Probe, but it may not be sufficient to equalize air pressure in the
occluded ear canal if the Probe is removed too quickly.
8. Repeat the above procedure to test the other ear.
9. Remove the VivoLink from the patient.

Post Test Procedures

1. Remove ear tip from the OAE Probe.
WARNING
To avoid accidental swallowing of inhalation of an ear tip, do not leave ear tip(s)
within reach of a child. Patients should be attended during preparation and testing.
2. Properly dispose of the used ear tip.

CAUTION
The ear tips are single patient use only and should be disposed of immediately
after use. To avoid transfer of disease, do not re-use the ear tips on other patients.
3. If the grooves on the OAE Probe are congested with earwax, clean them using the
cleaning tools provided (brush, pick, and loop).
4. Disinfect the OAE Probe using disinfecting wipes.

CAUTION
To prevent damage to the probe:
While wiping the probe, hold the sound canals in the tapered tip down to avoid
wipe fluid from entering the sound canals and saturating the acoustic dampers.
The acoustic dampers are the red pieces in the two microphone sound canals.
Damaging the acoustic dampers will cause the probe to malfunction.
If wipe fluid has entered the sound canals, perform a Check Cavity test on the
probe. If a Probe Error is reported allow the probe to dry for an hour and repeat
the cavity test. If the problem persists, contact Customer Support.

Storing the Integrity System

1. Insert the Probe into the Probe Holder on the VivoLink.
2. If no other tests are planned in this test session press Exit in the right top corner of
the screen.
3. Shut down the computer.
4. Pack the VivoLink and accessories and place them back into their storage cases.

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Integrity System Care Integrity™ V500 Chapter 10:

Chapter 10: Integrity System Care

This instrument is designed to provide minimum maintenance with its unique easy-clean
Probe, calibration data storage and automatic retrieval, and in-the-cavity-check. However, it
is still recommended that a trained technician check the instrument every 12 months.

Caring for the Probes

Amplitrode and Electrode Clips
The Amplitrode and the electrode clips should be wiped with disinfecting wipes and placed
on the parking snaps on the VivoLink after use.

ABR Transducer and electrodes

ER-3A
The ear tips of the ER-3A earphones, and the snap electrode pads are both disposable and
should be properly disposed of after each use.

B-71 Bone Conductor

The B-71 and the headband should be disinfected with sanitizing wipes after each use.

Cleaning the OAE Probe

The Probe must be kept clean for sanitary reasons and to maintain acoustic performance.
To mechanically clean the Probe:
1. Inspect the Probe carefully for any visible particles, such as earwax, dead skin, and
any other debris.

CAUTION
During mechanical cleaning of the probe, hold the probe tip down to avoid
pushing the debris deeper into the sound canals of the Probe.
2. Brush off any visible debris from the probe surface with the mini-brush.
3. Remove remaining particles from the probe ditches with the all-purpose pick.
4. Remove particles from the sound canals and vent with the wax removal tool. The
vent (a tiny hole above the cable at the back of the Probe) is to ensure the release
excessive pressure from the occluded ear canal.

Disinfecting the OAE Probe

Refer to the sanitizing wipe manufacturer‟s general directions for use, storage and disposal
instructions, and caution statements.
1. Clean the Probe with a sanitizing wipe, and dispose of the wipe after use.
2. Insert the Probe tightly into the tapered hole of the Probe Holder (in the Probe
Adapter).

CAUTION
Do not apply excessive force to the Probe to avoid damaging it.
Hold the Probe tip down to avoid any ear wax or sanitizing liquid from entering the
microphone sound canals (indicated by red dots in the Probe tip). Wipe off any excess
liquid, and allow the Probe to dry for about an hour.

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Perform a Probe Cavity Check. If a problem is detected, contact Customer Support. The
problem may be due to residual ear wax on the microphone sound canals.

ECochG Gold Electrode Ear Tip

The gold electrode (TIPtrode) ear tips should be properly disposed of after each use.

Caring for the VivoLink

Recharging Batteries
VivoLink
Check that your batteries are fully charged before using the VivoLink. Refer to the
manufacturer‟s User Manual for details on rechargeable Nickel-Metal Hydride (NiMH)
batteries.

Computer
When the computer is running on battery power only, it can typically provide over an hour
of testing without re-charging. Refer to the manufacturer‟s User Manual for instructions on
how to monitor the status of the battery, and how to recharge the battery.

Replacing Batteries
The VivoLink requires NiMH batteries with a minimum capacity of 2200 mAh. To ensure
proper system function, check that your replacement batteries have this minimum capacity.
It is recommended that you order the proper set of batteries from Customer Support.
To replace the batteries of the VivoLink:
1. Press down lightly on the battery compartment cover and slide the cover off.
2. Remove the old batteries and dispose of them according to local regulations.
3. Insert four new AA batteries. Ensure that the polarity is correct by aligning the “+”
signs on the batteries with the “+” signs on the bottom of each of the four battery
compartment cells.

CAUTION
Injury to the patient or operator and damage to the VivoLink may occur.
If the batteries are left in the VivoLink for a prolonged period of time they may discharge
and leak battery acid into the battery compartment, which can burn skin and may
permanently damage the device.
 When the VivoLink will not be used for some time, remove the batteries and store
them in a cool, safe place.
 To avoid accelerated discharge and leakage, always ensure that batteries are installed
with the correct polarity.

Caring for the Computer

See the computer manufacturer‟s User Manual.
DISPOSAL OF ELECTRONIC EQUIPMENT (WEEE)
The equipment shall not be disposed of as unsorted municipal waste and
shall be collected as electrical and electronic equipment as specified by
Waste Electrical and Electronic Equipment (WEEE).

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Chapter 11: Integrity™ V500 Troubleshooting

Chapter 11: Troubleshooting

This chapter covers problems, possible causes, and some solutions.

ATTENTION
Do not attempt to repair any component of the system; this may cause it to function
improperly.
The Integrity System is not a field-repairable instrument. Call your distributor of Vivosonic
Customer Support for all repairs.

Table 9. Troubleshooting Problems, Causes, and Solutions

Problem Observed Possible Causes Possible Solutions
The computer does not The battery is dead and the  Charge the battery.
start up. computer is not plugged in.
 Try plugging the computer
The power outlet is not working.
into a power outlet that is
The computer is not turned on. known to work.
 Switch the computer on.
Check your computer‟s User
Manual for the location of
the switch.

The system starts and Printer drivers (or other non-  Please contact Customer
operates, but displays Integrity System peripheral Support.
error messages. drivers) installed on the system
by the operator may not be  Only printer drivers that
compatible with the Integrity have been tested and
System. validated by Vivosonic Inc.
to work with the Integrity
System may be used.

There is no signal from The wrong ear has been chosen.  Verify that the appropriate
the transducer (ER-3A) The earphone is not inserted ear tip is chosen.
(For ABR and ECochG properly.  Verify that the foam
only) The stimulus level has been set earphone has been placed
to 0 dB nHL or another low in the ear canal properly.
value.
 Verify the B-71 is affixed
The gold electrode ear tip in not
properly to the patient.
making good connection with the
ear canal wall. (ECochG only)  Check that the walls of ear
canal are clean and clear of
obstructions.

There is no signal from The B-71 transducer is not  Verify that the appropriate
the transducer (B-71). placed correctly. ear is chosen.
(For ABR only) The wrong ear has been chosen  Verify the B-71 is affixed
The stimulus level has been set properly to the patient.
to 0 dB nHL or another low
value.
®
The Bluetooth wireless The VivoLink has not been  Make sure that VivoLink is
connection fails. turned on. switched on.
The VivoLink batteries are low or  Check the battery voltage
dead. indicator to make sure the
The VivoLink is out of range. VivoLink batteries are
The software is out of sync. charged.

User‟s Manual Rev. 5.7 164

Chapter 11: Integrity™ V500 Troubleshooting

 Make sure that the distance

between VivoLink and the
computer does not exceed
30 ft (10 m).
 Press RETRY
CONNECTION button.
 Switch the VivoLink off and
on.
 Restart the Integrity.
 Refer to the Bluetooth®
Troubleshooting section of
Appendix P: Bluetooth®
Troubleshooting.

The EEG signal is above The electrodes may be poorly  Readjust the electrodes and
±40 µV and is not coming placed. start again.
down.
(For ABR and ECochG
only)
Cannot change the The old password is being typed  Check the Num Lock is set if
password. incorrectly. using the number pad.
 Check that the Caps Lock is
not set.
 Verify the password has not
been changed already.
 Contact Customer Support.

There is no response for The ear is not getting the  Check that the transducer is
either ear while testing. stimulus sent from the VivoLink. producing a sound. Listen to
the earphone using a
reasonably audible stimulus
setting such as 60 dB nHL.
 For OAE tests change the
OAE probe using the cavity
check function.
 For AEP tests perform a test
using the “Amplitrode Test”
protocol with the Amplitrode
connected to the snaps on
the VivoLink
 If there is still no response,
call Customer Support to
determine if the problem is
the connection on the
VivoLink.

OAE Probe does not The probe may be damaged.  Check the probe for obvious
produce any sound The probe is not connected damage
properly.  Check the OAE probe for
ear wax and clean it if
The OAE probe is blocked by ear necessary.
wax or another substance.
 Perform a Cavity Check
 Test with another „good‟
probe. If it does not produce

User‟s Manual Rev. 5.7 165

Troubleshooting Integrity™ V500 Chapter 11:

sound contact Vivosonic Inc.

 Check the connection of all
cables and connections

OAE Probe produces The probe may be damaged  Check the probe using the
poor quality sound There may be a loose or Cavity Check procedure
damaged cable found on page.
 Test with another „good‟
probe. If it does not produce
sound contact Vivosonic Inc.
 Check the connection of all
cables and connections
 Check the battery level on
the VivoLink

Bluetooth disconnect The Bluetooth connection may Disable Wireless Network

frequently be interrupted by a local wireless connection
network that is seeking to auto-  Press „Start‟ > „Control
connect to the computer. Panel‟ > „Network
Connections‟
Disabling the wireless network  Disable any activated
may improve reliability of the wireless network connection
Bluetooth driver. by right clicking on „Wireless
Network Connections‟, and
* Do not disable the wireless selecting „Disable‟.
network if it is required on this
computer
Some graphical elements The Integrity software uses the  Press Start > Control Panel
of the Integrity software Windows XP style or “theme” to > Display. Select “Windows
are not visible display its screens, dialog boxes, XP” as your theme.
buttons and other graphical
elements that you see.
You may be using another theme
that is not supported by the
Integrity software.

166 User‟s Manual Rev. 5.7

Technical Specifications Integrity™ V500 Appendix A:

Appendix A: Technical Specifications

Intended use The Integrity System with the ABR and ECochG test options are
indicated for Auditory Evoked Potential (AEP) testing as an aid in
detecting hearing loss and lesions in the auditory pathway.
The Integrity System with the TEOAE and DPOAE test options are
indicated for measuring whether or not the cochlear outer hair cells are
functioning.
This device does not measure hearing per se, but helps to determine
whether or not a hearing loss may be present, requiring further
evaluation.
The system does not determine hearing levels, but allows the operator
to establish specific pass or refer criteria.

Digital Signal The Kalman Weighted method, a patented method using a Linear
Processing (DSP) Minimum Mean-Square Error Filter, also called the Kalman Filter (US
method Patents 6,463,411 and 6,778,955), is used to estimate ABR, ECochG,
and TEOAE response signals recording and a time-averaging method.
(Li 2002)
Test procedure Non-invasive.
Patient Not required – ABR, ECochG, TEOAE, and DPOAE are objective.
participation/response
Diagnostic environment VivoLink will perform in a variety of environments (hospital,
ambulatory, or home). A soundproof room is typically not required.

DP Stimulus primary 16 customizable frequencies: 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.2, 3.5, 4,
tone F2 frequencies (+/- 4.5, 5, 5.5, 6, 7, and 8 kHz.
0.1%)

DP f2/f1 ratio of 2 customizable ratios: 1.2 and 1.22 (f2 > f1).
stimulus primary tone
frequencies (+/- 0.1%)

Compliant transducers Compliant with the requirements of EN60601-1-2:2001 Sections

and cables 36.201, 36.202
 ER-3A earphones attached to 55.5 ± 2.5 cm cable
 B-71 Bone Conductor attached to 183±2.5 cm
cable
 OAE probe attached to 80 ±2.5 cm cable
Compliant accessories Compliant with the requirements of EN60601-1-2:2001, Sections
36.201, 36.202
Amplitrode cable length:
 between VivoLink and ground clip – 1 meter
 between ground clip and “+” clip – 25±2.5 cm
 between ground clip and “-”clip – 40±2.5 cm
VivoLink - wireless interface module
ABR Electrode type Single-use Neuroline 720-00-S snap electrodes or equivalent.
ECochG Electrode type Etymotic Research - Gold Electrode Ear Tip ER3-26A, ER3-26B

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Appendix A: Integrity™ V500 Technical Specifications

OAE Probe Type: External, with 2 microphones and 1 receiver used for OAE.
Dual-microphone design improves the signal-to- noise ratio.
Calibration data are stored in EEPROM in the Probe connector.
Cleaning: Similar to hearing-aid care – with mini-brush, wax remover,
all-purpose pick, single-use sanitizing wipes (starter tool kit and 10
wipes included).
Amplitrode filters For ABR: 30± 10 Hz – 3 kHz ± 300 Hz
Slope: 12 dB/octave.
Frequency bands and The receiver operates in 79 bands separated by 1MHz, centered at
bandwidth of reception 2402 MHz through 2480 MHz with a bandwidth of +/- 20 parts per
million.
Frequency For all frequencies:
characteristics of the Modulation Type:
modulation and the IQ Modulation
effective radiated
power of transmission Frequency Characteristics (where center frequency F0 = 2F1-F2):
Average delta F1 Modulation = 165 kHz (+10/-25 kHz)
Maximum delta F2 Modulation = 125 kHz
Effective Radiated Power:
+1 dBm (+/- 3dB)
ABR Numeric Latencies Peaks I, II, III, IV, and V, within an accuracy of 0.026 ms.
Peak Accuracy of
Labeled Peaks
3
Amplitrode gain For ABR and ECochG: 15 × 10
VivoLink gain Selectable: 0 dB, 10 dB, 20 dB, and 40 dB.
VivoLink filters Selectable notch filter settings: 50 Hz, 60 Hz, and “no filter”.
VivoLink resolution Analog-to-digital (A/D) conversion (in recording channels): 24 bit.
Digital-to-analog (D/A) conversion (in stimulation channels): 16 bit.
Automatic pre-testing The measurement of the electrode contact.
procedures
AEP ear tips Type: Disposable, foam
OAE ear tips Type: Disposable, soft PVC plastic, sizes 3-5 taper-shaped, sizes 6-16
mushroom-shaped.
Sizes: 13 with 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 16 mm
Diameter (supplied in 100-packs).
Starter Ear Tip Set: 156 ear tips, 3 to 13 mm Diameter, in a 9-
compartment box with lid.

Power source The VivoLink is powered by four AA batteries. The system ships with
eight Nickel-Metal Hydride (NiMH) rechargeable batteries, a charger
and 4 AA Alkaline batteries.
Pre-testing procedures OAE Probe check, system Transient Response, system Noise Floor
check, Probe “fit-in-ear” check – prior to each test.

Electrical path to the In ABR test: from the VivoLink through the Amplitrode and electrodes.
patient There is no electrical hazard to the patient, as the VivoLink is battery-
operated.

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Technical Specifications Integrity™ V500 Appendix A:

Safety standards The products gained the following regulatory clearances and
compliance approvals:
USA: FDA clearance under 510(k) K043396.
Canada: Health Canada Medical Device License No. 67609.
European Union: CE Registration No. DE/CA09/0170/1207 to 1212.
CB Test Certificate CA/023/ITS (testing to standards for safety of
electrical equipment)
Independent testing and audits verified that the product adheres to the
following standards:
CB Scheme certificate (Compliance to national deviations for 67
countries)
CSA C22.2 NO 601.1 (R2001) (Medical electrical equipment – general
requirements for safety)
EN 980:2003 (Graphical symbols for use in the labeling of medical
devices)
EN 55011:1998 (Limits and methods of measurement of radio
disturbance characteristics of industrial, scientific and medical radio-
frequency equipment)
EN 60601-1-1 (2001) (Collateral standard: safety requirements for
medical electrical systems (Part 1))
EN 60601-1-2:2003 (Collateral standard: electromagnetic compatibility
requirements and tests)
EN 60601-2-40 (Medical electrical equipment- Particular requirements
for the safety of electromyographs and evoked response equipment
(IEC 60601-2-40:1998))
FCC Part 518 (Title 47 CFR Part 518, Radio frequency devices)
IEC 60601-1-4:2000 (General requirements for safety – collateral
standard for programmable electrical medical systems)
ISO 13485:2003 (Medical devices - Quality management systems)
ISO 14971:2000 (Medical devices - Risk management for medical
devices)
UL 60601-1:2003 UL (Standard for safety - Medical electrical
equipment)
Environmental Ambient temperature of -40C to +70C
conditions for transport Relative humidity of 10% to 100%
and storage Atmospheric pressure range of 500 hPa to 1060 hPa
Potential There are no special measures that need to be taken to protect the
electromagnetic or instrument from interference. However, the instrument may interfere
other interference with other equipment, even if this equipment complies with CISPR
emission requirements.
® ®
Minimum computer Microsoft Windows XP Home or Professional
requirements Service Pack 1 or above
CPU clock speed >= 1GHz
RAM = 256 MB
Available free hard drive space after installation of operating system =
500 MB
Display resolution = 1024 pixels x 768 pixels or greater with a 4:3
aspect ratio
Computer mouse
CD-ROM drive
At least 3 USB ports

User‟s Manual Rev. 5.7 169

Appendix A: Integrity™ V500 Technical Specifications

Radio frequency related RF Output Power rating: 4 dB mW maximum

specifications software Operating frequency range: 2.400 – 2.4835 GHz
Modulation Types: GFSK Integrity control software
Printers (optional) Any printer connected to the network shared by the Integrity System or
any computer configured to run from the Integrity System.
Accuracy of Acoustic +/- 3dB
Measurements (DP, TE,
and Noise)
Transient Click 6 dB maximum deviation from the peak frequency in 1-4 kHz range
Spectrum
Transient Click 80 or 120 μs measured from 50% of rising edge to 50% of falling edge
Duration (+/- 10%)
Transient Inter-Click 10-1000 ms
Interval (+/- 5%)
Transient Stimulus 60-85 dB peak equivalent SPL measured by OAE microphone in the
Level (+/- 3B SPL) ear
A/D resolution 24 bits.
User interface Portable computer, color Graphic User Interface (GUI)

Test protocols Customizable, multiple, storable, selectable, password-protected.

Test time at one 1.0 – 2.0 seconds typical, depending on Noise Floor level and DPOAE
frequency level

Modes of operation Automatic Screening, Manual Screening, and Assessment.

Screening criteria in Customizable: SNR, number of test frequency bands for pass-refer
Screening Mode decision out of total number of frequency bands tested.
Screening decision- Pass-Refer-Test insufficient: Automatic as per pass-refer criteria, or
making Manual.
System DP and System < -9 dB SPL at primaries with up to L1 = L2 = 70 dB SPL in Occluded
Noise Floor levels Ear Simulator (Zwislocki Coupler).

170 User‟s Manual Rev. 5.7

Items Tracked by the Integrity Database Integrity™ V500 Appendix B:

Appendix B: Items Tracked by the Integrity

Database
The following items can be entered by the user and tracked by the database. Some of
these items may only be visible depending on the mode selected.

General Data for All Test Types

1. Patient‟s family name
2. Patient‟s given name
3. Hospital ID number
4. Insurance number
5. Mother's family name
6. Mother's given name
7. Gender
8. Ear (Right, Left)
9. Ethnicity
10. Address
11. State/Province
12. Zip/Postal code
13. Country
14. Telephone number
15. Date of birth
16. Time of birth
17. Age (calculated at time of test)
18. Birth weight (Grams or Pounds and Ounces)
19. High risk registry
20. Patient comment 1
21. Patient comment 2
22. Referring Physician
23. Location of test
24. Mother‟s ID number
25. Examiner
26. Date of test
27. Time of test
28. Test Outcome
29. Ear Tested
30. Protocol name and its parameters.
31. Test Type: ABR, ECochG, TEOAE, or DPOAE
32. Test comment 1
33. Test comment 2
34. Used equipment ID (VivoLink, Amplitrode, or OAE Probe depends on the type of
the test)

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Appendix B: Integrity™ V500 Items Tracked by the Integrity Database

ABR Test Type Data per Waveform

1. Stimulus parameters (Types of stimuli and levels)
2. Test Parameters
a. Applied algorithm
b. Transducer type
c. Ear Tip Used and electrode type
d. Polarity
e. Masking
f. Electrode Montage and recording side.
g. Patient Status
h. Notch Filter
3. ABR response waveforms
4. Latency values of the ABR peaks
5. I peak latency (positive peak)
6. I‟ peak latency (negative peak)
7. II peak latency
8. III peak latency
9. IV peak latency
10. V peak latency (positive)
11. V‟ peak latency (negative)
12. I - III inter-peak latency
13. III - V inter-peak latency
14. I – I‟ peak-to-peak amplitude
15. V – V‟ peak-to-peak amplitude
16. ABR wave V Input/Output function
17. Statistical Start (Stat-S or SS)
18. Statistical End (Stat-E or SE)
19. Correlation Coefficient
20. Equivalent Sweeps
21. Callout

ECochG Test Type Data per Waveform

1. Stimulus parameters (Types of stimuli and levels)
2. Test Parameters
3. Applied algorithm
4. Transducer type
5. Ear Tip Used, Electrode Type
6. Polarity
7. Masking
8. Electrode Montage, Recording Side
9. Patient Status
10. Notch Filter
11. ECochG response waveforms

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Items Tracked by the Integrity Database Integrity™ V500 Appendix B:

12. SP – Summating Potential

13. AP – Action Potential
14. Statistical Start (Stat-S or SS)
15. Statistical End (Stat-E or SE)
16. Baseline Location (BL)
17. Correlation Coefficient
18. Equivalent Sweeps
19. Callout

TEOAE Test Type Data

1. Stimulus parameters (Tone frequencies and levels)
2. Test Parameters (Applied Algorithm, and Ear Tip Used)
3. TEOAE response waveform
4. TEOAE levels in user-defined frequency bands
5. TEOAE noise floor in user-defined frequency bands
6. Number of Clicks, Rejected Clicks
7. Duration of the test
8. Artifact Rejection Rate, Whole Wave Reproducibility Ratio
9. Stimulus Stability Score Percentage
10. TE Level

DPOAE Test Type Data

1. Stimulus parameters (Modulated frequencies and levels)
2. Test Parameters (Ear Tip Used, Maximum Effective Duration per Frequency)
3. Test Duration
4. DPOAE Levels for every tested frequency
5. Noise Floor Levels for every tested frequency
6. Signal to Noise Ratio for every selected frequency

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Appendix C: Integrity™ V500 Automatic TEOAE Screening Algorithm

Appendix C: Automatic TEOAE Screening

Algorithm
The following automatic decision-making algorithms are employed for TEOAE Automatic
Screening test modes.
Terminology used in TEOAE screening algorithm described below
AR Artifact rejection rate in the test
ARC User-selected Artifact Rejection Rate Criterion
NF Measured Noise Floor in a frequency band in dB SPL
"PASS" Interim decision: PASS
PASS Final decision: PASS
"REFER" Interim decision: REFER
REFER Final decision: REFER
SNRC User-selected Signal-to-Noise Ratio Criterion in a frequency band in dB
TE Measured TEOAE level in dB SPL in a frequency band
MRLC User-selected TEOAE Minimum Response Level Criterion in a
frequency band in dB SPL
"Test Insufficient" Interim decision: Test Insufficient
Test Insufficient Final decision: Test Insufficient
TEST INVALID Test did not pass TEOAE validity check, automatic TEOAE screening
decision cannot be made
TEST VALID Test passed TEOAE validity check, automatic TEOAE screening
decision can be made
WWR Whole wave reproducibility in the test
WWRC User-selected Whole Wave Reproducibility criterion

Step-by-step decision-making algorithm on TEOAE screening test outcome

1. Evaluate TEOAE test validity:
IF AR > ARC then "Test Insufficient"
2. In each user-selected frequency band, evaluate TE and SNR to MRLC, SNRC:
IF TE ≥ MRLC AND SNR ≥ SNRC THEN "PASS"
IF TE < MRLC OR SNR < SNRC THEN "REFER"
3. Evaluate the test results across the frequency bands:
IF "PASS" at No. of Frequency bands to Pass (or more) AND WWR ≥ WWRC
THEN Final decision: PASS
IF "REFER" at No. of Frequencies to Pass (or more) OR WWR < WWRC THEN
Final decision: REFER
ELSE Final decision: Test Insufficient

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Automatic DPOAE Screening Algorithm Integrity™ V500 Appendix D:

Appendix D: Automatic DPOAE Screening

Algorithm
The following automatic decision-making algorithms are employed in this device in
DPOAE Automatic Screening test mode.

Terminology used in DPOAE screening algorithm

DP Measured DPOAE level in dB SPL
|∆DDP| Absolute value of the difference in DPOAE levels measured in the 1st
and 2nd repetitions of the test
DPCL User-selected DPOAE Criterion Level in dB SPL
NF Measured Noise Floor in dB SPL at the DPOAE frequency
"PASS" Interim decision: PASS
PASS Final decision: PASS
RC User-selected Repeatability Criterion in dB
REFER Final decision: REFER
“REFER” Interim decision: REFER
SNRC User-selected Signal-to-Noise Ratio Criterion in dB
Test Insufficient Final decision: Test Insufficient
“Test Insufficient” Interim decision: Test Insufficient

Step-by-step decision-making algorithm on DPOAE screening test outcome

1. At each frequency point (in each of the two runs of the test), evaluate DP and NF
relative to DPCL and SNRC:
 IF DP ≥ DPCL AND (DP – SNRC) > NF THEN "PASS"
 IF DP ≥ DPCL AND (DP – SNRC) ≤ NF THEN "Test Insufficient"
 IF DP < DPCL AND (DPCL – SNRC) > NF THEN "REFER"
 IF DP < DPCL AND (DPCL – SNRC) ≤ NF THEN "Test Insufficient"
2. At each frequency point, combine the results from the two repetitions of the test
(note that the order of the two repetitions in the statements below is not
important):
 IF "PASS" AND "PASS" THEN "PASS"
 IF "REFER" AND "REFER" THEN "REFER"
 IF "Test Insufficient" AND "Test Insufficient" THEN "Test Insufficient"
 IF "PASS" AND "Test Insufficient" THEN "PASS"
 IF "REFER" AND "Test Insufficient" THEN "REFER"
 IF "PASS" AND "REFER" THEN "Test Insufficient"
3. At each frequency point, evaluate the repeatability of the DP in the two repetitions
of the test relative to RC:
 IF |∆DDP| ≤ RC THEN Repeatable
 IF |∆DDP| > RC THEN NOT Repeatable

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Appendix D: Integrity™ V500 Automatic DPOAE Screening Algorithm

4. Combine the results of Steps 2 and 3 at each frequency point:

 IF "PASS" AND Repeatable THEN "PASS"
 IF "PASS" AND NOT Repeatable THEN "Test Insufficient"
 IF "REFER" AND (Repeatable OR NOT Repeatable) THEN "REFER"
 IF "Test Insufficient" AND (Repeatable OR NOT Repeatable) THEN
"Test Insufficient"
5. Evaluate the results across the frequency points:
 IF "PASS" at No. of Frequencies to Decide (or more) THEN Final
decision: PASS
 IF "REFER" at No. of Frequencies to Decide (or more) THEN Final
decision: REFER
 ELSE Final decision: Test Insufficient

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Preset Protocols and Test Settings Integrity™ V500 Appendix E:

Appendix E: Preset Protocols and Test Settings

The following protocols are pre-installed on Integrity for ABR, ECochG, TEOAE, and
DPOAE tests. They contain protocol names, test parameters for Protocol Screen and
Test Screen, and their predefined settings.

NOTE
Pre-installed protocols are provided as samples and may not necessarily be used. The
user is encouraged to review the sample protocols and create new protocols fine-tuned to
the user‟s specific clinical needs, specific patient population, local regulations, or hospital-
approved protocols.

ABR Preset Protocols

ABR Air-Conducted Default Protocols
The following default protocols are defined for ABR:
 ABR air-conducted click 37.7
 ABR air-conducted 500 Hz tone-burst 37.7
 ABR air-conducted 1000 Hz tone-burst 37.7
 ABR air-conducted 2000 Hz tone-burst 37.7
 ABR air-conducted 3000 Hz tone-burst 37.7
 ABR air-conducted 4000 Hz tone-burst 37.7
 ABR air-conducted click 27.5
 ABR air-conducted 500 Hz tone-burst 27.5
 ABR air-conducted 1000 Hz tone-burst 27.5
 ABR air-conducted 2000 Hz tone-burst 27.5
 ABR air-conducted 3000 Hz tone-burst 27.5
 ABR air-conducted 4000 Hz tone-burst 27.5

Protocol: ABR air-conducted click 37.7

Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 to 137
Selected Stimulus Level (dB nHL) 0 to 95 (by steps of 5), and 99

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Appendix E: Integrity™ V500 Preset Protocols and Test Settings

Protocol: ABR air-conducted 500 Hz tone-burst 37.7

Stimulus Type 500 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 25 to 130
Selected Stimulus Level (dB nHL) 0 to 105 (by steps of 5)

Protocol: ABR air-conducted 1000 Hz tone-burst 37.7

Stimulus Type 1000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 26 to 130
Selected Stimulus Level (dB nHL) 0 to 100 (by steps of 5), and 104

Protocol: ABR air-conducted 2000 Hz tone-burst 37.7

Stimulus Type 2000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 31 to 130
Selected Stimulus Level (dB nHL) 0 to 95 (by steps of 5), and 99

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Preset Protocols and Test Settings Integrity™ V500 Appendix E:

Protocol: ABR air-conducted 3000 Hz tone-burst 37.7

Stimulus Type 3000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 33 to 130
Selected Stimulus Level (dB nHL) 0 to 95 (by steps of 5), and 97

Protocol: ABR air-conducted 4000 Hz tone-burst 37.7

Stimulus Type 4000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 35 to 130
Selected Stimulus Level (dB nHL) 0 to 95 (by steps of 5)

Protocol: ABR air-conducted click 27.5

Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 - 137
Selected Stimulus Level (dB nHL) 0 - 95 (by steps of 5), and 99

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Protocol: ABR air-conducted 500 Hz tone-burst 27.5

Stimulus Type 500 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 25 - 130
Selected Stimulus Level (dB nHL) 0 - 105, step of 5

Protocol: ABR air-conducted 1000 Hz tone-burst 27.5

Stimulus Type 1000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 26 - 130
Selected Stimulus Level (dB nHL) 0 - 100 (step of 5), and 104

Protocol: ABR air-conducted 2000 Hz tone-burst 27.5

Stimulus Type 2000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 31 - 130
Selected Stimulus Level (dB nHL) 0 - 95 (step of 5), and 99

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Protocol: ABR air-conducted 3000 Hz tone-burst 27.5

Stimulus Type 3000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 33 - 130
Selected Stimulus Level (dB nHL) 0 - 95(step of 5), and 97

Protocol: ABR air-conducted 4000 Hz tone-burst 27.5

Stimulus Type 4000 Hz
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 27.5/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 35 - 130
Selected Stimulus Level (dB nHL) 0 - 95, step of 5

Test Screen Settings for All Air-Conducted Protocols

This table contains the default Test Screen settings for all air-conducted protocols.
Algorithm Kalman Weighted
Status Awake
Polarity Rarefaction
Ear Tip Not specified
Masker None
Masking Level Disabled
Notch Filter Off
Electrode Used Neuroline 720 000-S
Level (dB nHL) Minimum allowable value
Initial Test Screen Settings
Selected Ear Right
Non-inverting (+) Fz - Frontal Upper Forehead
Inverting (-) A2 - Ear Lobe Right
Recording Side Ipsilateral

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Appendix E: Integrity™ V500 Preset Protocols and Test Settings

ABR Bone Conductor Default Protocols

 ABR bone-conducted click 7.6
 ABR bone-conducted 500 Hz tone-burst 7.6
 ABR bone-conducted 1000 Hz tone-burst 7.6
 ABR bone-conducted 2000 Hz tone-burst 7.6
 ABR bone-conducted 3000 Hz tone-burst 7.6
 ABR bone-conducted 4000 Hz tone-burst 7.6
 ABR bone-conducted click 37.7
 ABR bone-conducted 500 Hz tone-burst 37.7
 ABR bone-conducted 1000 Hz tone-burst 37.7
 ABR bone-conducted 2000 Hz tone-burst 37.7
 ABR bone-conducted 300 Hz tone-burst 37.7
 ABR bone-conducted 4000 Hz tone-burst 37.7

Protocol: ABR bone-conducted click 7.6

Protocol screen settings
Stimulus Type Click
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 51 to 111
Selected Stimulus Level (dB nHL) -10 to 50 (by steps of 5)

Protocol: ABR bone-conducted 500 Hz tone-burst 7.6

Protocol screen settings
Stimulus Type 500 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 66 to 117
Selected Stimulus Level (dB nHL) -1 To 50 (-1, and from 5 to 50 by steps of 5)

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Protocol: ABR bone-conducted 1000 Hz tone-burst 7.6

Stimulus Type 1000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 60 to 114
Selected Stimulus Level (dB nHL) 6 to 60 (6, from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 2000 Hz tone-burst 7.6

Protocol screen settings
Stimulus Type 2000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 56 to 109
Selected Stimulus Level (dB nHL) 7 to 60 (7, and from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 3000 Hz tone-burst 7.6

Protocol screen settings
Stimulus Type 3000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled

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Stimulus Levels Range (dB pe FL) 50 to 106

Selected Stimulus Level (dB nHL) 4 to 60 (4, and from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 4000 Hz tone-burst 7.6

Stimulus Type 4000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 7.6/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 48 to 101
Selected Stimulus Level (dB nHL) 7 to 60 (7, and from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted click 37.7

Stimulus Type Click
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 51 to 111
Selected Stimulus Level (dB nHL) -10 to 50 (by steps of 5)

Protocol: ABR bone-conducted 500 Hz tone-burst 37.7

Stimulus Type 500 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled

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Stimulus Levels Range (dB pe FL) 66 to 117

Selected Stimulus Level (dB nHL) -1 To 50 (-1, and from 5 to 50 by steps of 5)

Protocol: ABR bone-conducted 1000 Hz tone-burst 37.7

Stimulus Type 1000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 60 to 114
Selected Stimulus Level (dB nHL) 6 to 60 (6, from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 2000 Hz tone-burst 37.7

Stimulus Type 2000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 56 to 109
Selected Stimulus Level (dB nHL) 7 to 60 (7, and from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 3000 Hz tone-burst 37.7

Stimulus Type 3000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled

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Appendix E: Integrity™ V500 Preset Protocols and Test Settings

Stimulus Levels Range (dB pe FL) 50 to 106

Selected Stimulus Level (dB nHL) 4 to 60 (4, and from 10 to 60 by steps of 5)

Protocol: ABR bone-conducted 4000 Hz tone-burst 37.7

Stimulus Type 4000 Hz
Transducer Type B-71
Stimulus Rate (Stimuli/s) 37.7/sec
Maximum Number of Stimuli Maximum
Windowing Blackman
Ramp Number of Cycles 2-0-2
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe FL) 48 to 101
Selected Stimulus Level (dB nHL) 7 to 60 (7, and from 10 to 60 by steps of 5)

Test Screen Settings for All Bone Conductor Protocols

This table contains the default Test Screen settings for all bone conductor protocols.
Algorithm Kalman Weighted
Status Awake
Polarity Alternating Split
Ear Tip Not specified
Masker None
Masking Level Disabled
Notch Filter Off
Electrode Used Neuroline 720 000-S
Level (dB nHL) Minimum allowable value
Initial Test Screen Settings
Selected Ear Right
Non-inverting (+) Fz
Inverting (-) A2 - Ear Lobe Right
Recording Side Ipsilateral

Other ABR Default Protocols

 Amplitrode Test
 Neurologic

Protocol: Amplitrode Test

Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 37.5/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 1500 Hz
High Pass Filter Rolloff 12 dB/oct

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Low Pass Filter Rolloff 12 dB/oct

Amplifier Gain 0
Recording Window 25 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 to 137
Selected Stimulus Level (dB nHL) 0

Protocol: Neurologic
Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 17.7/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 2400 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 20 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 to 137
Selected Stimulus Level (dB nHL) 60 to 95 (by steps of 5), and 99

Test Screen Settings for other ABR Protocols

This table contains the default Test Screen settings for “Other ABR Protocols.”
Algorithm Kalman Weighted
Status Awake
Polarity Rarefaction
Ear Tip Not specified
Masker None
Masking Level Disabled
Notch Filter Off
Electrode Used Neuroline 720 000-S
Level (dB nHL) Minimum allowable value
Initial Test Screen Settings
Selected Ear Right
Non-inverting (+) Fz - Frontal Upper Forehead
Inverting (-) A2 - Ear Lobe Right
Recording Side Ipsilateral

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Appendix E: Integrity™ V500 Preset Protocols and Test Settings

ECochG Preset Protocols

ECochG Default Protocols
The following default protocols are defined for ECochG:
 ECochG – 11.3 – SP/AP
 ECochG – 95.7 – SP

Protocol: ECochG – 11.3 – SP/AP

Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 11.3/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 2400 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 7.0 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 to 137
Selected Stimulus Level (dB nHL) 60 to 95 (by steps of 5 dB), 96, 97, 99

Protocol: ECochG – 95.7 – SP

Stimulus Type Click
Transducer Type ER-3A insert earphones
Stimulus Rate (Stimuli/s) 95.7/sec
Maximum Number of Stimuli Maximum
Windowing Disabled
Ramp Number of Cycles Disabled
High Pass Filter Cutoff Frequency 30 Hz
Low Pass Filter Cutoff Frequency 2400 Hz
High Pass Filter Rolloff 12 dB/oct
Low Pass Filter Rolloff 24 dB/oct
Amplifier Gain 0
Recording Window 7.0 ms
Artifact Rejection Disabled
Artifact Rejection Threshold Disabled
Stimulus Levels Range (dB pe SPL) 38 to 137
Selected Stimulus Level (dB nHL) 60 to 95 (by steps of 5 dB), 96, 97, 99

Test Screen Settings for ECochG Protocols

This table contains the default Test Screen settings for all ECochG protocols.
Algorithm Kalman
Status Awake
Polarity Alternating - Split
Ear Tip Not specified
Masker None

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Masking Level Disabled

Notch Filter Off
Electrode Used Neuroline 720 000-S
Level (dB nHL) Minimum allowable value
Initial Test Screen settings
Selected Ear Right
Non-inverting (+) EAC1
Inverting EAC2
Recording Side Horizontal

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Appendix E: Integrity™ V500 Preset Protocols and Test Settings

TEOAE Preset Protocols

TEOAE Default Protocols
The following default protocols are defined for TEOAE:
 TEOAE Assessment
 TEOAE Screening
 TEOAE Screening Kemp et.al.

Protocol: TEOAE Assessment

Stimulation Mode Non-linear
Click Duration 80 µs
Click Interval 21.12 ms
Click Level 80 dB pe SPL
Number of Clicks Enable Enabled
Number of Clicks 99 999
Recording Window Start 2.8 ms
Recording Window End 12 ms
High Pass Filter Cutoff 750 Hz
Low Pass Filter Cutoff 6000 Hz
Artifact Rejection Threshold Enabled
Artifact Rejection Threshold value 55 dB SPL
Description
Comments
Operating Mode TEOAE Assessment
Artifact Rejection Rate Enabled Disabled
Artifact Rejection Rate 0%
Auto Stop Disabled
Bands to Pass 0
1 kHz Band Enabled Unchecked
2 kHz Band Enabled Unchecked
3 kHz Band Enabled Unchecked
4 kHz Band Enabled Unchecked
Whole Wave Reproducibility Enabled Disabled
Whole Wave Reproducibility 0%
SNR Criteria Enabled Disabled
1 kHz Band SNR Level 0 dB
2 kHz Band SNR Level 0 dB
3 kHz Band SNR Level 0 dB
4 kHz Band SNR Level 0 dB
Response Level Criteria Enabled Disabled
1 kHz Band Minimum Response Level 0 dB SPL
2 kHz Band Minimum Response Level 0 dB SPL
3 kHz Band Minimum Response Level 0 dB SPL
4 kHz Band Minimum Response Level 0 dB SPL

Protocol: TEOAE Screening

Stimulation Mode Non-linear
Click Duration 80 µs
Click Interval 10.16 ms
Click Level 80 dB pe SPL
Number of Clicks Enable Enabled

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Number of Clicks 4096

Recording Window Start 4 ms
Recording Window End 9 ms
High Pass Filter Cutoff 1600 Hz
Low Pass Filter Cutoff 2800 Hz
Artifact Rejection Threshold Enabled
Artifact Rejection Threshold value 55 dB SPL (If Artifact Rejection Threshold
is Enabled)
Description
Comments
Operating Mode TEOAE Automatic Screening
Artifact Rejection Rate Enabled Disabled
Artifact Rejection Rate 0%
Auto Stop Unchecked
Bands to Pass 3
1 kHz Band Enabled Unchecked
2 kHz Band Enabled Unchecked
3 kHz Band Enabled Unchecked
4 kHz Band Enabled Unchecked
Whole Wave Reproducibility Enabled Checked
Whole Wave Reproducibility 75%
SNR Criteria Enabled Checked
1 kHz Band SNR Level 6 dB
2 kHz Band SNR Level 6 dB
3 kHz Band SNR Level 6 dB
4 kHz Band SNR Level 6 dB
Response Levels Criteria Enabled Unchecked
1 kHz Band MRL Level 0 dB SPL
2 kHz Band MRL Level 0 dB SPL
3 kHz Band MRL Level 0 dB SPL
4 kHz Band MRL Level 0 dB SPL

Protocol: TEOAE Screening Kemp et.al.

Stimulation Mode Non-linear
Click Duration 80 µs
Click Interval 10.16 ms
Click Level 80 dB pe SPL
Number of Clicks Enable Checked
Number of Clicks 36000
Recording Window Start 4 ms
Recording Window End 9 ms
High Pass Filter Cutoff 1200 Hz
Low Pass Filter Cutoff 2800 Hz
Artifact Rejection Threshold Enabled
Artifact Rejection Threshold value 55 dB SPL
Description Modified UK Newborn Hearing Screening
Pilot Recommended Test Protocol
Comments Contributors: David Kemp, et.al.
Operating Mode TEOAE Automatic Screening
Artifact Rejection Rate Enabled Enabled
Artifact Rejection Rate 75%
Auto Stop Unchecked
Bands to Pass 2
1 kHz Band Enabled Unchecked

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2 kHz Band Enabled Unchecked

3 kHz Band Enabled Unchecked
4 kHz Band Enabled Unchecked
Whole Wave Reproducibility Enabled Unchecked
Whole Wave Reproducibility N/A
SNR Criteria Enabled Checked
1 kHz Band SNR Level 6 dB
2 kHz Band SNR Level 6 dB
3 kHz Band SNR Level 6 dB
4 kHz Band SNR Level 6 dB
Response Levels Criteria Enabled Checked
1 kHz Band MRL Level 0 dB SPL
2 kHz Band MRL Level 0 dB SPL
3 kHz Band MRL Level 0 dB SPL
4 kHz Band MRL Level 0 dB SPL

Test Screen Settings for TEOAE Protocols

This table contains the default Test Screen settings for all TEOAE protocols.
Ear Tip Grason - Size 3
Algorithm Averaging
Display A+B
Bands 1 kHz Band Width

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DPOAE Preset Protocols

DPOAE Default Protocols
 DPOAE Assessment All Frequencies
 DPOAE Assessment All Audiometric Frequencies
 DPOAE Assessment Basic Audiometric
 DPOAE Assessment High Frequencies
 DPOAE Screening 5 Frequencies
 DPOAE Screening 3 Frequencies
Protocol: DPOAE Assessment All Frequencies
f2/f1 ratio 1.22
Frequency order Descending
f2 frequency 500, 750, 1000, 1500, 2000, 2500, 3000,
3200, 3500, 4000, 4500, 5000, 5500, 6000,
7000, 8000 Hz.
Stimulus Levels L1 = 65 dB SPL; L2 = 55 dB SPL
Number of Runs 2
DPOAE DSP Stability Accurate
Description Assessment at all test frequencies
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Assessment
Criterion Levels Disabled
No. of Frequencies to Decide Disabled
Minimum No. of Frequency Disabled
Maximum No. of Frequency Disabled
SNR Criterion Disabled
SNR Level Disabled
Repeatability Criterion Disabled
Repeatability Level Disabled
Response Level Disabled

Protocol: DPOAE Assessment All Audiometric Frequencies

f2/f1 ratio 1.22
Frequency order Descending
f2 frequency 500, 750, 1000, 1500, 2000, 3000, 4000,
6000, 8000 Hz.
Stimulus Levels L1 = 65 dB SPL; L2 = 55 dB SPL
Number of Runs 2
DPOAE DSP Stability Accurate
Description Assessment at audiometric frequencies
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Assessment
Criterion Levels Disabled
No. of Frequencies to Decide Disabled
Minimum No. of Frequency Disabled
Maximum No. of Frequency Disabled
SNR Criterion Disabled
SNR Level Disabled
Repeatability Criterion Disabled
Repeatability Level Disabled
Response Level Disabled

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Protocol: DPOAE Assessment Basic Audiometric

f2/f1 ratio 1.22
Frequency order Descending
f2 frequency 1000, 2000, 4000, 8000 Hz.
Stimulus Levels L1 = 65 dB SPL; L2 = 55 dB SPL
Number of Runs 2
DPOAE DSP Stability Accurate
Description Assessment at basic audiometric
frequencies
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Assessment
Criterion Levels Disabled
No. of Frequencies to Decide Disabled
Minimum No. of Frequency Disabled
Maximum No. of Frequency Disabled
SNR Criterion Disabled
SNR Level Disabled
Repeatability Criterion Disabled
Repeatability Level Disabled
Response Level Disabled

Protocol: DPOAE Assessment High Frequencies

f2/f1 ratio 1.22
Frequency order Descending
1500, 2000, 3000, 3500, 4000, 4500, 5000,
f2 frequency
5500, 6000, 7000, 8000 Hz.
Stimulus Levels L1 = 65 dB SPL; L2 = 55 dB SPL
Number of Runs 2
DPOAE DSP Stability Accurate
Description Assessment at high frequencies
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Assessment
Criterion Levels Disabled
No. of Frequencies to Decide Disabled
Minimum No. of Frequency Disabled
Maximum No. of Frequency Disabled
SNR Criterion Disabled
SNR Level Disabled
Repeatability Criterion Disabled
Repeatability Level Disabled
Response Level Disabled

Protocol: DPOAE Screening 5 Frequencies

f2/f1 ratio 1.2
Frequency order Descending
f2 frequency 2000, 2500, 3200, 4000, 5000 Hz
Stimulus Levels L1 = 60 dB SPL; L2 = 50 dB SPL
Number of Runs 2
DPOAE DSP Stability Accurate
Description Screening at 2, 2.5, 3.2, 4, 5 kHz 60/50 dB
SPL 3/5
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Automatic Screening

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Criterion Levels Checked

No. of Frequencies to Decide Checked
Minimum No. of Frequency 3
Maximum No. of Frequency 5
SNR Criterion Checked
SNR Level 5 dB
Repeatability Criterion Checked
Repeatability Level 3 dB
Response Level - 5 dB SPL at all selected f2 Frequencies

Protocol: DPOAE Screening 3 Frequencies

f2/f1 ratio 1.22
Frequency order Descending
f2 frequency 2000, 3000, 4000 Hz
Stimulus Levels L1 = 65 dB SPL; L2 = 55 dB SPL
Number of Runs 1
DPOAE DSP Stability Accurate
Description DPOAE screening at 2, 3, 4 kHz 65/55 dB
SPL 3/3
Comments Suggested by Vivosonic Inc.
Operating Mode DPOAE Automatic Screening
Criterion Levels Checked
No. of Frequencies to Decide Checked
Minimum No. of Frequency 3
Maximum No. of Frequency 3
SNR Criterion Checked
SNR Level 6 dB
Repeatability Criterion Disabled
Repeatability Level Disabled
Response Level -5 dB SPL at all selected f2 Frequencies

Test Screen Settings for DPOAE Protocols

This table contains the default Test Screen settings for all DPOAE protocols.
Maximum effective duration per frequency 12
(sec)
Ear Tip Grason - Size 3

User‟s Manual Rev. 5.7 195

Appendix F: Integrity™ V500 Guidance and Manufacturer‟s Declaration

Appendix F: Guidance and Manufacturer’s

Declaration
Emissions
The Integrity System is intended for use in the electromagnetic environment specified
below. The customer or user of the Integrity should ensure that it is used in such an
environment.
All equipment and systems
Emission Test Compliance Electromagnetic Environment – Guidance
RF Emissions Group 1 The Integrity uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions Class B The Integrity is suitable for use in all establishments,
CISPR 11 including domestic, and those directly connected to the
public low-voltage power supply network that supplies
Harmonics IEC Class N/A buildings used for domestic purpose.
61000-3-2
Flicker IEC 61000- N/A
3-3

Immunity
The Integrity System is intended for use in the electromagnetic environment specified
below. The customer or user of the Integrity should ensure that it is used in such an
environment.
Equipment and systems that are NOT life-supporting
Immunity Test IEC 60601 Test Compliance Electromagnetic
Level Level Environment-
Guidance
Portable and mobile communications
equipment should be separated from
the Integrity by no less than the
distances calculated, listed below.
Conducted RF 3 Vrms V1=3 Vrms D=(3.5/V1)(Sqrt P)
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m E1=3 V/m D=(3.5/V1)(Sqrt P)
IEC 80 MHz to 2.5 MHz 80 to 800 MHz
61000-4-3
D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
Where P is the max. power (watts)
and D is the recommended
separation distance (meters).
Field strength from fixed transmitters,
as determined by an electromagnetic
site survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the vicinity
of equipment containing a
transmitter.

196 User‟s Manual Rev. 5.7

Guidance and Manufacturer‟s Declaration Integrity™ V500 Appendix F:

Immunity for all equipment and systems

Immunity Test IEC 60601 Compliance Electromagnetic Environment-
Test Level Level Guidance
ESD ±6kV Contact ±6kV Contact Floors should be wood, concrete or
IEC 61000-4-2 ±8kV Air ±8kV Air ceramic tile. If floors are synthetic,
the r/h should be at least 30%.
EFT ±2kV Mains N/A Battery N/A
IEC 61000-4-4 ±1kV I/Os Operated
Device
Surge ±1kV Differential N/A Battery N/A
IEC 61000-4-5 ±2kV Common Operated
Device
Voltage >95% Dip for 0.5 N/A Battery N/A
Dips/Dropout Cycle Operated
IEC 61000-4-11 Device
60% Dip for
5 cycles

30% Dip for

25 Cycles

>95% Dip for

5 Seconds
Power Frequency 3A/m 3A/m Power frequency magnetic fields
50/60 Hz should be that of a typical
Magnetic Field commercial or hospital environment.
IEC 61000-4-8

Note: ESD compliance is dependent on a single layer of heat shrink applied over the
insert earphone connector. If this is not installed, the connector shell should not be
touched during operation.

Radio Transmissions
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause harmful interference to
radio communications. However, there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one of more of the following
measures:
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
 Consult the dealer or an experienced radio/TV technician for help.

User‟s Manual Rev. 5.7 197

Appendix F: Integrity™ V500 Guidance and Manufacturer‟s Declaration

This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference and (2) this device
must accept any interference received, including interference that may cause undesired
operation.

WARNING
Changes or modifications not expressly approved by Vivosonic Inc. could void
the user‟s authority to operate the equipment.

198 User‟s Manual Rev. 5.7

Recommended Separation Distance Integrity™ V500 Appendix G:

Appendix G: Recommended Separation Distance

This Appendix covers the recommended separation distance between portable and
mobile radio frequency devices and the Integrity System.
The Integrity System is intended for use in electromagnetic environments in which
radiation disturbances are controlled. The customer or user of the Integrity can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile Radio Frequency Communication Equipment and the Integrity
System as recommended below, according to the maximum output power of the
communication equipment.
Equipment and systems that are NOT life-supporting
Max. Output Power Separation (m) Separation (m) Separation (m)
(Watts) 150 kHz to 80 MHz 80 to 800 MHz 800 MHz to 2.5GHz

D= 1.1667(Sqrt P) D=1.1667(Sqrt P) D=2.3333(Sqrt P)

0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.333

User‟s Manual Rev. 5.7 199

Appendix H: Integrity™ V500 Symbols Used on the Instrument

Appendix H: Symbols Used on the Instrument

Label Symbol Description
Read accompanying documentation

On (power)

Off (power)

Wireless communication established

Standby

Electrode Contact Indicator

REF: Reference or Model Number

SN: Serial Number

Date of Manufacture

Type BF equipment

CE Mark with notified body number

0120
UL 2601 Entela certification
CSA 601.1
® EN 60601-1
7644

Input voltage

Cell (battery)

AA Cell size

Alkaline Alkaline battery

NiMH Nickel Metal Hydride battery (NiMH)

Connector for Amplitrode

Connector for OAE Probe (not implemented)

Connectors for ER-3A earphones (black – the right

ear, white – the left ear)

200 User‟s Manual Rev. 5.7

Symbols Used on the Instrument Integrity™ V500 Appendix H:

Connector for B-71 Bone Conductor

Probe Holder

Parking Snaps for the Amplitrode and its clips on the

VivoLink

Caution. Fragile. Sensitive to mechanical shock.

Made in Canada

FCC mark

The equipment shall not be disposed of as unsorted

municipal waste and shall be collected as electrical
and electronic equipment, as applicable, separately
as specified by Waste Electrical and Electronic
Equipment (WEEE)

User‟s Manual Rev. 5.7 201

Appendix I: Integrity™ V500 Clinical Applications for AEP

Appendix I: Clinical Applications for AEP

This is a brief overview of the clinical applications for AEP procedures. Refer to
Appendix N: References for information sources.
What is ABR?
Auditory brainstem response (ABR) is an objective electrophysiological test of the
function and integrity of the auditory system from the inner ear to the brainstem.
ABR is an electrical response starting in the inner ear that travels through the
auditory nerve and balance nerve, to the brainstem.
What are the clinical applications of ABR?
 Hearing screening in newborns.
 Estimating hearing levels in difficult to test patients, i.e., mentally disabled,
autistic, developmentally delayed, infants, and small children.
 Evaluating patients with suspected retro-cochlear pathology.
 Evaluating patients with Meniere's disease or similar disorders.
 Diagnostics of Auditory Neuropathy/Dissynchrony.

202 User‟s Manual Rev. 5.7

Clinical Application for Electrocochleography Integrity™ V500 Appendix J:

Appendix J: Clinical Application for

Electrocochleography
The most popular applications for Electrocochleography (ECochG) are as follows:
 Assessment of hearing pathology associated with increased inner ear fluid
pressure (Meniere‟s disease, endolymphatic hydrops)
 Enhancement of wave I in ABR recording
ECochG is intended to diagnose Meniere's disease in particular. ECochG responses may
also be abnormal in perilymph fistula and in sudden hearing loss. The cochlear
microphonic of ECochG may be normal in auditory neuropathy as well as other disorders
in which the cochlea is preserved but the auditory nerve is damaged. ECochG has also
been used as an indicator of the temporary threshold shift that may follow noise injury.
ECochG techniques can be used to enhance wave I in ABR recording.

User‟s Manual Rev. 5.7 203

Appendix K: Integrity™ V500 Clinical Application for Otoacoustic emissions

Appendix K: Clinical Application for Otoacoustic

emissions
This is a brief overview of the clinical applications for Otoacoustic emissions (OAE). Refer
to Appendix N: References for information sources.

OAE Specifics
What is OAE?
Otoacoustic emissions (OAE) are the faint sounds produced by the Cochlea either
spontaneously or in response to acoustic stimulation as a part of normal hearing process.
They have important clinical applications for identifying the cochlear component of a
hearing disorder and for monitoring small changes in the cochlear status undetectable by
other audiometric methods.
How is OAE generated in the ear?
The Outer Hair Cells (OHC) are considered the source of OAE generation. OAE
waveforms are thought to be generated by the active cochlear process associated with
the OHC electromotility responsible for enhancing basilar membrane vibration and
increasing frequency selectivity of the cochlear. Generated in the cochlea, OAE then
propagate in the reverse direction through the cochlear fluids, the middle ear, tympanic
membrane and into the external ear canal
Advantages of OAE testing (TEOAE and DPOAE)
Site specificity: OAE is known to be a selective indicator of Outer Hair Cells (OHC)
function.
High specificity and sensitivity to cochlear impairment: The presence or absence of
OAE waveforms correlates well with normal and abnormal hearing thresholds. Typically
the OAE waveform cannot be detected in ears with sensory hearing loss ≥ 30 dB HL or
with signs of the middle ear abnormalities.
Objective: Only minimal cooperation, of the patient is required to obtain the reliable
result. No response from the patient is required.
Noninvasive: No parts, fluids, electromagnetic fields, rays, or particles of the measuring
system are penetrating the patient‟s body.
Safety: The only parts in contact with the patient‟s body are the probe and the ear tip
which are both made of plastic, with no metal parts. The stimuli are sound waveforms of
normal-speech level.
Time: OAE recording is fast and easy; typically a test requires 10 – 60 seconds.
Detection: OAE is sensitive to minor changes in the cochlear function, which are typically
not detected by behavior audiometry. This is valuable for ototoxicity and noise-induced
hearing loss monitoring.
Cost: OAE is cost effective. The equipment and disposable items are less expensive
than Evoked Potential equipment.

TEOAE Specifics
What is Transient Evoked Otoacoustic Emission (TEOAE)?
TEOAE is the low-level acoustic signal, also known as Kemp‟s echoes, emitted by the
cochlea in response to a click or transient auditory stimulus. They appear shortly after the
stimulating click and appear as echoes of the stimulus.

204 User‟s Manual Rev. 5.7

Clinical Application for Otoacoustic emissions Integrity™ V500 Appendix K:

DPOAE Specifics
What are the Distortion Product Otoacoustic emissions (DPOAEs)?
DPOAEs are the intermodulation distortions generated within the cochlea when two pure
tones (primaries) are presented simultaneously to the cochlea. These pure tones are
labeled f1 and f2, with f2 slightly higher than f1. In humans with normal auditory function,
a ratio between f2 and f1 of 1.2-1.22 tends to produce the largest DPOAEs. Numerous
intermodulation distortion products could be generated by the human cochlea, but the
largest DPOAE occurs at a frequency equal to 2f1-f2, which is known as cubic distortion
product.

Conditions for DPOAEs measurements

DPOAEs can be recorded in the audible frequency range. The levels of primaries are
typically L1=65 dB, L2=55 dB SPL. Typically OAEs can be recorded in an office
environment, but recording at f2 = 1500 Hz and lower requires a soundproof booth. In
general, OAE testing is more reliable when ambient noise is lower. The subject‟s
behavior is also important: crying, coughing, sneezing, excessive movement, talking
during examination affect test results. Hermetic seal of the Ear Canal is less crucial than
in tympanometry, but the better the seal the better OAE recording. Proper position of the
Probe is important: it should not be blocked by the Ear Canal walls and ear wax. There is
no reported influence of the subject‟s pose or position on OAEs. No patient response is
required.

DPOAE Properties
The level of DPOAEs in normal ears (hearing thresholds ≤15 dB HL) is usually within the
range of 0 to 20-25 dB SPL at L1/L2=65/55 dB SPL and f2/f1=1.22, although in some
rare cases they can be up to 50-70 dB SPL; DPOAEs decrease with sensory hearing
loss; and DPOAEs are not recordable below 30-40 dB HL. However, there is an overlap
in distributions of both DPOAEs‟ amplitudes and SNR in normal and impaired ears.

Advantages of DPOAE testing

Frequency specificity: can be recorded in a wide frequency range, as opposed to
Transient Evoked Otoacoustic Emissions (TEOAEs) recordable only up to about 4000
Hz.

Minor changes in a specific frequency range, like in ototoxic or noise-induced hearing

loss, are more easily detectable with DPOAE than with TEOAE.

User‟s Manual Rev. 5.7 205

Appendix L: Integrity™ V500 ABR Latency Norms Data

Appendix L: ABR Latency Norms Data

UCLA School of Medicine Norms for Infants
Wave V Mean Latency as Function of Click
Table 10. UCLA School of Medicine norms for infants
Age in weeks 25 dB 35 dB 45 dB 55 dB 65 dB 75 dB
Newborn Mean 8.92 8.53 8.05 7.76 7.50 7.24
SD 0.58 0.68 0.63 0.51 0.50 0.47
2 wk Mean 8.50 8.05 7.70 7.37 7.10 6.89
SD 0.51 0.42 0.40 0.34 0.37 0.36
4 wk Mean 8.41 7.98 7.60 7.32 7.07 6.87
SD 0.45 0.38 0.35 0.35 0.35 0.35
6 wk Mean 8.25 7.80 7.46 7.18 6.93 6.73
SD 0.32 0.32 0.30 0.31 0.28 0.28
9 wk Mean 8.13 7.69 7.32 7.04 6.78 6.61
SD 0.40 0.34 0.32 0.31 0.28 0.26
12 wk Mean 8.04 7.63 7.24 6.96 6.76 6.59
SD 0.36 0.30 0.29 0.29 0.26 0.24
26 wk Mean 7.80 7.44 7.10 6.83 6.58 6.38
SD 0.37 0.46 0.42 0.38 0.31 0.29
Adult Mean 7.32 6.82 6.46 6.10 5.89 5.75
SD 0.40 0.30 0.25 0.23 0.23 0.23

Data collected for a click rate of 33.3 clicks/s. Infants were categorized by chronological
age (weeks after birth).
Source: Zimmerman, M.C., Morgan, D.E., Dubno J.R. (1987). Auditory Brain Stem
Evoked Response Characteristics in Developing Infants. Annals of Otology, Rhinology,
Laryngology, 96, 291-299. Used with permission from the publisher.

Boys Town Norms for Newborns

ABR Latency and Amplitude Values as a Function of Intensity Level in Newborns
Table 11. Boys Town norms for newborns
Conception age in weeks Wave V latency (msec)
20 dB 40 dB 60 dB 80 dB
33 – 34 wk Mean 9.72 8.48 7.62 7.05
SD 0.56 0.49 0.41 0.39
35 – 36 wk Mean 9.61 8.42 7.58 7.02
SD 0.67 0.54 0.43 0.38
37 – 38 wk Mean 9.57 8.29 7.45 6.94
SD 0.74 0.51 0.44 0.42
39 – 40 wk Mean 9.36 8.11 7.30 6.82
SD 0.57 0.49 0.40 0.38
41 – 42 wk Mean 9.31 8.08 7.20 6.69
SD 0.54 0.35 0.29 0.29
43 – 44 wk Mean 9.16 7.94 7.08 6.53
SD 0.53 0.51 0.33 0.32

206 User‟s Manual Rev. 5.7

ABR Latency Norms Data Integrity™ V500 Appendix L:

Data collected under the following measurement parameters: stimulus – click, 0.1 ms,
13/sec, monaural, Beyer DT48 earphones; acquisition – filters, 100 – 3000 Hz;
amplification, 100,000; sweeps, 1,024; analysis time, 15 ms; electrodes, Cz-Mi.
Infants were categorized by conceptional age in weeks (gestational age at birth plus
number of weeks since birth).
Source: Gorga, M.P., Reiland, J.K., Beauchaine, K.A., Worthington, D.W, Jesteadt, W.
(1987), Auditory brainstem responses from graduates of an intensive care nursery:
normal patterns of response. Journal of Speech and Hearing Research, 30, 311-318.
Used with permission from ASHA and M. Gorga.

Boys Town Norms for Infants

ABR Latency Values as a Function of Intensity Levels in Children Aged 3 Months to 3
Years
Table 12. Boys Town norms for infants
Latency (ms)
Age in Wave V Wave I
months
20 dB 40 dB 60 dB 80 dB
3 – 6 mt Mean 8.72 7.43 6.73 6.25 1.59
SD 0.53 0.36 0.33 0.32 0.17
6 – 9 mt Mean 8.59 7.28 6.56 6.10 1.59
SD 0.61 0.38 0.29 0.26 0.16
9 -12 mt Mean 8.31 7.05 6.31 5.90 1.59
SD 0.54 0.37 0.29 0.27 0.18
12 – 15 mt Mean 8.28 7.10 6.30 5.91 1.59
SD 0.60 0.45 0.33 0.27 0.17
15 – 18 mt Mean 8.33 7.00 6.24 5.84 1.58
SD 0.61 0.38 0.24 0.27 0.14
18 – 21 mt Mean 8.22 6.95 6.19 5.74 1.55
SD 0.62 0.36 0.18 0.19 0.12
21 – 24 mt Mean 8.05 6.79 6.14 5.71 1.57
SD 0.58 0.33 0.29 0.26 0.17
24 – 27 mt Mean 8.30 6.89 6.09 5.71 1.53
SD 0.46 0.29 0.22 0.19 0.14
27 – 30 mt Mean 7.98 6.75 6.08 5.60 1.59
SD 0.42 0.33 0.28 0.22 0.19
30 – 33 mt Mean 8.12 6.79 6.07 5.68 1.56
SD 0.53 0.32 0.31 0.27 0.16
33 – 36 mt Mean 8.10 6.82 6.06 5.68 1.56
SD 0.68 0.38 0.31 0.27 0.15

Data collected under the following measurement parameters: stimulus – click, 0.1 ms,
13/sec, monaural, Beyer DT48 earphones, 0 dB = 30 dB peSPL; acquisition – filters, 100
– 3000 Hz; amplification, 100,000; sweeps, 1,024; analysis time, 15 ms; electrodes, Cz-
Mi.

User‟s Manual Rev. 5.7 207

Appendix L: Integrity™ V500 ABR Latency Norms Data

Gorga, M.P., Kaminski, J.R., Beauchaine, K.L., Jesteadt, W., Neely, S.T. (1989). Auditory
brainstem responses from children three months to three years of age: normal patterns of
response. Journal of Speech and Hearing Research, 32, 281-288. Used with permission
from ASHA and M. Gorga.

Absolute and Interwave Latency Values

These latency values are for the primary components of the ABR.
Table 13. Absolute and interwave latency values
Stimulus
Intensity I II III IV V I – III III – V I-V
dB nHL
90 Mean 1.53 2.53 3.58 4.56 5.37 2.05 1.79 3.84
SD 0.11 0.09 0.09 0.17 0.12 0.14 0.14 0.16
80 Mean 1.62 2.68 3.68 4.68 5.47 2.06 1.79 3.85
SD 0.12 0.11 0.08 0.22 0.12 0.11 0.09 0.14
70 Mean 1.82 2.79 3.85 4.92 5.64 2.03 1.79 3.82
SD 0.17 0.12 0.13 0.24 0.16 0.11 0.12 0.11
60 Mean 2.04 2.98 4.06 5.11 5.88 2.02 1.72 3.75
SD 0.20 0.15 0.21 0.31 0.25 0.12 0.10 0.11
50 Mean 2.43 3.69 4.60 5.43 6.19 2.02 1.56 3.64
SD 0.17 0.10 0.23 0.25 0.32 0.19 0.18 0.19
40 Mean 3.01 4.05 4.94 5.65 6.65 1.85 1.71 3.60
SD 0.25 0.18 0.25 0.49 0.32 1.85 1.71 3.60
30 Mean - - 5.45 - 7.24 - 1.74 -
SD - - 0.30 - 0.42 - 0.26 -
20 Mean - - 5.56 - 7.52 - 1.88 -
SD - - 0.57 - 0.63 - 0.23 -

Source: Linda J. Hood. Clinical Applications of the Auditory Brainstem Response.

Singular Publishing Group, Inc. 1998, San Diego, 285 pages. Used with permission from
publisher.

208 User‟s Manual Rev. 5.7

DPOAE Norms Data Integrity™ V500 Appendix M:

Appendix M: DPOAE Norms Data

The table below provides the 95th and 90th percentiles from the impaired distributions and
the 10th and 5th percentiles from the normal distributions as a function of frequency.

Frequency
750 1000 1500 2000 3000 4000 6000 8000
95th 5.95 7.65 3.83 -0.9 -2.3 0.18 -2.08 -9.97
(Impaired)
Percentile

90th 2.4 4.4 0.43 -3.5 -5.55 -4.42 -6.88 -12.85

(Impaired)
10th -10.4 -8.1 -6.73 -9.85 -11.5 -5.93 -7.84 -22.2
(Normal)
5th (Normal) -13.6 -12.05 -9.8 -13.9 -16.25 -9.23 -11.0 -26.0

Data collected under the following measurement parameters:

 L1 = 65 dB SPL
 L2 = 55 dB SPL
 F2/F1 Ratio = 1.22

Source:
Gorga, M., Neely, S., Ohlrich, B., Hoover, B., Redner, J, 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, V. 18, No. 6, pp.
440-455.

User‟s Manual Rev. 5.7 209

Appendix N: Integrity™ V500 References

Appendix N: References
This Appendix contains references for the ABR latency and amplitude values, terms,
abbreviations, the definitions for the Glossary of Terms, and a summary of clinical
applications of ABR found in Appendix I: Clinical Applications for AEP.
ASHA, (1987) Short Latency Auditory Evoked Potentials. Audiologic Evaluation Working
Group on Auditory Evoked Potentials.
Gorga, M.P., Reiland, J.K., Beauchaine, K.A., Worthington, D.W, Jesteadt, W. (1987)
Auditory brainstem responses from graduates of an intensive care nursery: normal
patterns of response. Journal of Speech and Hearing Research, 30, 311-318.
Gorga, M.P., Kaminski, J.R., Beauchaine, K.L., Jesteadt, W., Neely, S.T. (1989) Auditory
brainstem responses from children three months to three years of age: normal
patterns of response. Journal of Speech and Hearing Research, 32, 281-288.
Hall, J.W., III. (1990) Handbook of Auditory Evoked Responses. Allyn and Bacon
Hall, J., Mueller, G. (1997) Audiologists’ Desk Reference: Diagnostic Audiology Principles
and Procedures. Singular: San Diego, 1997.
Hood, L. (1998) Clinical Applications of the Auditory Brainstem Response. Singular: San
Diego, ISBN: 1-56593-200-5.
Li, X., Sokolov, Y., Kunov, H. (Oct. 8, 2002) System and method for processing low
signal-to-noise ratio signals.
Stevens, Ed. J., (26 November 2001) Neonatal Hearing Screening and Assessment.
Click Auditory Brainstem Response Testing in Babies. A recommended test protocol.
Source: www.unhs.org.uk
Stevens, Ed. J., (26 November 2001) Neonatal Hearing Screening and Assessment.
Auditory Brainstem Response Testing in Babies Using Tone Pip Stimulation. A
recommended test protocol. Source: www.unhs.org.uk
Stach, B.A. (1997) Comprehensive Dictionary of Audiology. Williams & Wilkins:
Baltimore, 1997. ISBN: 0-683-18075-4.
Stapells, D. (2001) Frequency-Specific Evoked Potential Audiometry in Infants. In R.
Seewald, (ed.) A Sound Foundation Through Early Amplification.
Basel, Switzerland, Phonak AG, (2002) Proceedings of the Second International
Conference., pp. 13-31.
Zimmerman, M.C., Morgan, D.E., Dubno J.R. (1987). Auditory Brain Stem Evoked
Response Characteristics in Developing Infants. Annals of Otology, Rhinology,
Laryngology, 96, 291-299.
Merriam-Webster‟s Medical Dictionary, (2005). Source: http://www2.merriam-
webster.com/cgi-bin/mwmednlm?book=Medical
Ed. C.I. Berlin, Otoacoustic Emissions. Basic Science and Clinical Applications. 1998.
ISBN: 1-56593-975-1.
Ed. C.I. Berlin (1999), The Efferent Auditory System. Basic Science and Clinical
Applications. Singular Publishing Group. ISBN: 0-7693-0013-8.
Culpepper, N.B. (1997) Neonatal screening via Evoked Otoacoustic Emissions. In:
Otoacoustic Emissions, Clinical Applications, Edited by Martin S. Robinette,
Theodore J. Glattke, pp. 233-269. ISBN: 0-86577-579-6.

210 User‟s Manual Rev. 5.7

References Integrity™ V500 Appendix N:

Eds. C.I. Berlin, L.J. Hood, A. Ricci. Thomson (2002) Hair Cells Micromechanics and
Otoacoustic Emissions.: Australia etc., ISBN: 0-7668-6190-2.
Hall, J.W., III. (1992) Handbook of Auditory Evoked Responses. Allyn and Bacon:
Boston et al., 1992. ISBN: 0-205-13566-8.
Hall, J.W., III. (2000) Handbook of Otoacoustic Emissions. Singular Publishing Group:
San Diego, 2000. ISBN: 1-56593-873-9.
Glattke, T.J., Robinnette, M.S. (2002) Transient Evoked Otoacoustic Emissions. In:
Otoacoustic Emissions, Clinical Applications, Second edition, Edited by Martin S.
Robinette, Theodore J. Glattke, pp. 95-115. ISBN: 3-13-103712-1.
Gorga, M., Neely, S., Ohlrich, B., Hoover, B., Redner, J, 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, V. 18, No. 6,
pp. 440-455.
Gorga, M., Neely, S., Dorn, P. (1999) Distortion Product Otoacoustic Emissions Test
Performance for a prior Criteria and for Multifrequency Audiometric Standards Ear &
Hearing, V. 20, No. 4, pp. 345-362.
James, A.L., Mount, R.J., Harrison, R.V. (2002) Contralateral suppression of DPOAEs
measured in real time. Clin. Otolaryngol., 27 (2), pp. 106-112.
Kemp, D.T., Ryan, S. (1993) The use of Transient Evoked Otoacoustic Emissions in
neonatal hearing screening programs. Seminars in Hearing, Vol. 14, No. 1, pp. 30-
44.
Kemp, D.T., Thornton, R., Kimm, L., Lutman, M., Watkin, P. (26 November 2001)
Neonatal hearing screening and assessment. Transient Evoked Otoacoustic
Emission (TEOAE) testing in babies. National UK newborn screening pilot
recommended test protocol. . Ed. John Stevens. Source: www.unhs.org.uk.
Li, X., Wodlinger, H., Sokolov, Y. (February 2003) A new method for measuring DPOAEs
and ASSRs. The Hearing Review, , pp. 43-47.
(2002) Otoacoustic Emissions, Clinical Applications, Second edition, Edited by Martin S.
Robinette, Theodore J. Glattke,ISBN: 3-13-103712-1.
Stach, B.A. (1997) Comprehensive Dictionary of Audiology. Williams & Wilkins:
Baltimore, ISBN: 0-683-18075-4.

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Appendix O: Integrity™ V500 Glossary of Terms

Appendix O: Glossary of Terms

The following definitions are used in this manual and can also be found in the Integrity
software instrument screens.
The terms shown here were defined using the information referenced in Appendix N:
References.
A-collected The cumulative response waveform obtained by averaging the successive
Waveform response waveforms in recording window collected in the odd numbers of
Response Collection Periods (RCP).
Acoustic Cavity of predetermined shape, volume, and acoustic impedance such as
coupler Occluded Ear Simulator (Zwislocki Coupler) that couples the Probe and a
measuring microphone of the sound level meter and is used for calibration of
stimuli.
Air conduction A mode of presenting auditory stimuli via earphones placed over the ear or
within the ear canal.
Algorithm The algorithm field allows selection of the signal processing algorithm used to
combine successive ABR responses. The Integrity System offers the
standard Averaging method and the Kalman Weighted averaging method.
Alternating Alternating presentation of rarefaction and condensation polarity stimuli.
Stimulus
Polarity
Ambient noise Sound level of the acoustic noise that is present in the surrounding
level environment and produced by acoustical sources other than the sources of
interest, i.e. the Probe and the Ear.
Amplitrode An integrated pre-amplifier and electrode in a combined unit for attaching or
affixing to a subject.
Artifact Unwanted signal that may interfere with the measurement of desired signals.
Artifact A process to discard the Response Collection Period (RCP) in which an
Rejection (AR) artifact is detected.
Artifact The number of rejected response collection periods (RCP) expressed as a
Rejection Rate percentage of the total number of cumulative response collection periods.
(ARR)
Artifact The sound pressure level in µV above which the detected acoustic signal is
Rejection considered an artifact.
Threshold (ART)
Assessment A user-selectable test procedure that performs tests without automatic
qualification of results.
Auditory Auditory evoked potential originating from the cranial nerve VIII and auditory
Brainstem brainstem structures.
Response (ABR)
Authorization Permission to access protected features or data.
Automatic A user-selectable test procedure that automatically qualifies a test result
Screening using user-defined pass-refer criteria.
Averaging ABR and TEOAE processing algorithm, which uses a standard time
averaging technique when equivalent weighting is given to each collected
response. Sweeps contaminated with artifacts above a certain artifact-
rejection threshold (ART) are excluded from the averaging.
B-collected The cumulative response waveform obtained by averaging the successive
waveform response waveforms in recording window collected in the even numbers of
Response Collection Periods (RCP).
Bone Vibrator A transducer that is used to present sounds to the skull that reaches the
cochlea through the head tissues and bones, i.e., bypassing the middle ear.

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Cavity Check Procedure performed to ensure the OAE probe is working and is in good
condition, i.e. no acoustical change has occurred since the probe
programming. The procedure is performed with the probe inserted in the
Probe Holder on the VivoLink. The test includes checking System NF, probe
calibration, and System TR in case of TEOAE test, or System DP in case of
DPOAE test.
Channel A single set of inputs into an Auditory Evoked Potential system (e.g., from
one pair of electrodes) or a single output from a stimulus generator (e.g., to
the right earphone).
Click Short-duration, broadband sound produced by applying a short electric pulse
to the receiver of the probe, typically around 100 μs for ABR and 80-120 μs
for TEOAE.
Click Bandwidth The frequency range of the click spectrum within 6 dB from its maximum.
Click Duration Duration of an electric pulse driving the receiver to elicit a click, in
(CD) microseconds (μs).
Click Interval The time interval between the onsets of two successive clicks.
(CI)
Click Level (CL) Sound pressure level of clicks in dB peSPL (peak-equivalent SPL).
Common Mode A noise reduction technique implemented by the differential amplifier where
Rejection (CMR) an identical (common) noise measured at two electrodes is subtracted from
the electrophysiological response.
Component A peak or wave in the response waveform.

Condensation The initial displacement of the stimulus, produced with an outward movement
(Positive) of the acoustic transducer.
Stimulus
Polarity
Contralateral TEOAE response changes caused by stimuli presented to the ear opposite to
TEOAE the one where TEOAE is recorded.
Suppression
Customizable Settings that can be changed by the user.
Database An organized collection of data.
dB HL A decibel scale referenced to acceptable standards for normal hearing (0 dB
is averaged normal hearing for each audiometric test frequency).
dB nHL A decibel scale used in auditory brainstem response measurement
referenced to average behavioral thresholds for click or tone-burst stimuli
collected on a small group of normal hearing patients.
dB peSPL The decibel level of a 1000 Hz tone at an amplitude equivalent to the peak of
a transient signal such as a click.
dB SPL The logarithmic ratio of the RMS sound pressure of an acoustic signal, Prms
to the reference sound pressure, P0 = 20 μPa = 2 * 10-5 Pa, calculated as:
SPL (dB) = 20 * log (Prms/P0).

DP level Sound Pressure Level of Distortion Product Otoacoustic Emissions

measured at the probe acoustic inlet.

DP-gram A graph that presents DP level and Noise Floor as functions of stimulus
frequency, typically f2.

DPOAE Distortion Product Otoacoustic Emissions.

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Appendix O: Integrity™ V500 Glossary of Terms

DPOAE Stability User-selectable criterion of Vivosonic DPOAE Algorithm stability:

 Accurate (default): DPOAE Algorithm will stop processing when it
finds the DP amplitude variation at a point in current frequency
range is less than ±1 dB SPL within 0.4 seconds.
 Medium: DPOAE Algorithm will stop processing when it finds the DP
amplitude variation at a point in current frequency range is less than
±2 dB SPL within 0.3 seconds.
 Fast: DPOAE Algorithm will stop processing when it finds the DP
amplitude variation at a point in current frequency range is less than
±3 dB SPL within 0.2 seconds.

DSP Digital Signal Processing.

Duration of The sum of clicks intervals presented to record a TEOAE response less one
stimulation click interval, plus the time between the onset of the last click and the end of
(DOS) recording window. Practically, it can be approximated by the multiple of the
number of all clicks presented and the click interval, for example 1000 x 20
ms = 2000 ms.
Ear Tip A part of the ER-3A earphone, typically made of soft plastic, that is inserted
into the ear canal and used to test for acoustic isolation of the ear canal from
the environment.
Earphone A device for presenting a sound stimulus to the ear, consisting of an acoustic
transducer for converting an electrical signal into sound and a cushion that
couples the transducer to the ear.
Electro- A method of diagnosis that uses low potential electrodes (e.g. gold electrode
cochleography ear tip (sometimes known as TIPtrode), transtympanic, and tympanic
(ECochG) membrane electrodes) to measure the inner ear‟s Auditory Evoked Potential
(AEP) response to stimulation. This method of analysis is used for the
diagnoses of conditions like Meniere‟s disease.
Electroence- An instrument used to study and record brain activity.
phalograph
(EEG)
Envelope The shape of the overall waveform of an acoustic stimulus that follows the
(Window) rise, plateau, and fall portions of the stimulus.
Epoch A time period, such as the analysis time in evoked response measurement.
f1, f2 Frequencies of stimuli for DPOAE test. They are also called primaries (f1<f2,
usually f2/f1=1.20 or 1.22 and
Selected f2 : 500 Hz, 750 Hz, 1000 Hz, 1500 Hz, 2000 Hz, 2500 Hz, 3000
Hz, 3200 Hz, 3500 Hz, 4000 Hz, 4500 Hz, 5000 Hz, 5500 Hz, 6000 Hz, 7000
Hz, 8000 Hz
FDP The frequency of DPOAE, in this device fDP=2f1-f2.

Fall time The time from the maximum amplitude of the stimulus, or the end of the
plateau, to some measure of baseline (zero voltage).
Filter An electronic device for eliminating electrical energy in a specific frequency
region while allowing other frequencies to pass.
Gain Increase in amplitude or energy of an electrical signal amplification. Gain is
the difference between the input signal and the output signal.
Ground A connection from a piece of electronic equipment, or a person to the actual
ground or a relatively large metal structure that will provide an electrical
ground. The ground electrode from a person is connected to the grounding
circuit on an evoked response system. A good ground connection reduces
electrical interference in evoked response recording.
GUI Graphic User Interface
Hearing Hearing testing in a certain population in order to identify persons with
Screening hearing loss based on a certain definition of hearing loss and screening
criteria.

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High-Pass Filter A filter that passes electrical energy above a specific cutoff frequency to
eliminate (filters out) energy below that frequency.
In situ In the natural position or place on the patient.
In situ Pre- Pre-amplifies the AEP signal at the scalp with the Amplitrode, which is
Amplification positioned on the ground electrode.
Inter-Peak The difference in milliseconds between two peaks of ABR waveform, such as
Latency the difference between the latencies of ABR Wave I and III.
Inverting An electrode that is attached to the negative voltage input (inverts the input
electrode by 180º) of a differential amplifier. This electrode is typically placed on the
earlobe, mastoid, or nape of the neck in ABR recording.
Kalman This signal processing algorithm combines successive ABR responses
Weighted through the assignment of weights to each response. A higher weight is
assigned to "better" responses (i.e., those with less noise contamination).
The weights are optimally selected through the use of the Kalman filter,
which acts as a linear minimum mean-square error filter. As such, Kalman
Weighted signal processing (a) gives less weight to the noise-contaminated
responses and (b) emphasizes less noisy responses. In addition, this method
processes signals in real time without rejecting any time segments (even
those containing significant artifacts).
L1, L2 Levels (dB SPL) of DPOAE primaries, where L1 are the level of f1 and L2 are
the level of f2.

Latency A time interval between two events (e.g., the stimulus and response).
Linear TEOAE stimulation when all clicks in a test are of the same polarity and level.
Stimulation
Mode
Low-Pass Filter A filter that passes electrical energy below a specific cutoff frequency and
eliminates (filters out) energy above that frequency.
Masking The constant level of the background noise presented to the non-tested ear
(Masker) in an audiometric procedure or ABR measurement.
Mastoid A portion of the temporal bone located behind the external ear.
Microsecond One millionth of a second.
(μs)
Microvolt (μV) One millionth of a volt.
Millisecond (ms) One thousandth of a second.
nHL Normalized hearing level. The decibel level of sound that lacks a
standardized reference, as opposed to standardized pure-tone audiometry
levels. It is referred to behaviorally determined normative levels, obtained
from a group of normally hearing listeners and expressed in dB nHL.
Noise floor (NF) Minimum noise level achievable with a measurement system.
Noise level Sound Pressure Level of noise measured at the probe acoustic inlet.
Non-Inverting The electrode that is attached to the positive voltage (non-inverting) input of a
Electrode differential amplifier. This electrode is typically placed on the high forehead in
ABR recording.
Nonlinear TEOAE stimulation when four clicks are presented in series, the first three (a,
Stimulation b, and c) of the same polarity and level, and the forth (d) click, also called
Mode balancing click, of the opposite polarity and the amplitude is three times
greater than that of the preceding three clicks, i.e. the Click level is 9.54 dB
higher, for example 70.45 and 80 dB peSPL.
Notch Filter A type of filter used in evoked response measurement, designated to reduce
interference from power line noise – 50 Hz or 60 Hz depending on the region
of the world. Notch filter may introduce filter distortion in AEP, and is
recommended to be switched off in most tests unless a strong electrical
interference is present.

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Appendix O: Integrity™ V500 Glossary of Terms

Number of The total number of clicks presented to record a TEOAE response, including
Clicks (NOC) accepted, with artifacts below Artifact Rejection Threshold, and rejected due
to excessive artifacts.
Occluded Ear Occluded ear simulator for the measurement of earphones coupled to the ear
Simulator with ear inserts, as per IEC 711-1981, ANSI S3.25-1979 (R 1986), for
example Brüel & Kjær Ear Simulator Type 4157.
Octave Frequency range in which the higher frequency limit is two times higher than
the lower limit, for example between 1 kHz and 2 kHz.
Otoacoustic Stimulated and non-stimulated faint sounds produced by oscillations of the
Emissions Outer Hair Cells in the Cochlea that can be measured in the occluded Ear
Canal.
Pass Screening test outcome when screening „pass‟ criteria are met.
Pass – Auto PASS screening outcome obtained by automatic screening procedure when
screening criteria have been met.
Pass – Manual PASS screening outcome when the user considers that the test results have
met the user‟s screening criteria.
Pass – Refer Criteria for qualification of screening-test results as Pass or Refer.
Criteria
Peak The maximum or minimum amplitude value of an evoked response
waveform.
Peak Equivalent The numeric value of the sound pressure vibratory force level of a long
Force Level duration sinusoidal signal which, when fed to the same transducer under the
(pe FL) same test conditions, has the same peak-to-peak sound pressure of a
vibratory force amplitude as the transient signal .
Peak Equivalent The decibel level of a 1000 Hz tone at an amplitude equivalent to the peak of
Sound Pressure a transient signal such as a click.
Level (pe SPL)
Polarity The sign of the voltage of the stimulus or waveform response (positive or
negative. Response polarity depends on the location of the electrode plugged
into the positive input versus the electrode plugged into the negative voltage
input of the differential physiological amplifier relative to the neural generator.
Pre-amplifier An electronic device that receives an electrical signal, such as an evoked
potential, directly from the electrodes, and increases the amplitude of the
signal before it is sent on for further processing such as amplification,
filtering, and averaging.
Probe Electro-acoustic device for presentation of acoustic stimuli into the occluded
ear canal and recording acoustic responses from the occluded ear canal. The
Probe contains receivers and microphone(s).
Probe Fit Check The probe fit checks to ensure the position of the OAE Probe in the ear canal,
with the ear tip installed on the probe is fit correctly for the patient. This will
ensure there is no leakage of sound from the ear canal and the probes
acoustic outlets and inlets are not blocked.
Probe Procedure performed by Vivosonic Production Utility Software on each
Programming individual Probe to program the built-in EEPROM of the probe to record the
Probe ID, and Probe calibration data.
Probe, General- Probe designed for testing all ages, from infants through adults.
use (GP)
Protocol A set of parameters, typically user-defined, that instructs the system how to
automatically perform and analyze a test. It covers stimulus settings, DSP
settings, etc.
Rarefaction The initial displacement of the stimulus, produced with an inward movement of
(negative) the acoustic transducer.
Stimulus
Polarity

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Rate The number of stimulus repetitions per unit of time, usually 1 second.
Recording Time period over which a response waveform is recorded, particularly in
Window (RW) TEOAE tests. Typically it is within the click interval.
Recording Time between the click onset and the beginning of recording window.
Window
Beginning
Recording Time between the click onset and the end of recording window.
Window End
Refer Screening test outcome when screening „pass‟ criteria are not met.
Refer – Auto REFER screening outcome obtained by automatic screening procedure when
screening criteria have not been met.
Refer – Manual REFER screening outcome when by the user considers that the test results
have not met the user‟s screening criteria.
Repetitions The number of single reoccurring events, such as a waveform, that is
(Sweeps) presented in a set period of time.
Response Time period over which a TEOAE response waveform is collected. In linear
Collection mode, it is the same as the recording window. In non-linear mode, it is the
Period aggregate of four recording windows.
(RCP)
Response Amplitude spectrum of the response waveform.
Spectrum
Response Time-averaged waveforms sampled during Response Collection Period.
Waveform
RMS Root-mean-square value.
Screening A user-selectable test procedure that qualifies a screening test result using
user-defined pass-refer criteria.
Screening Screening-test result qualification, typically Pass or Refer. If a test result
outcome cannot be qualified by Pass or Refer, it is insufficient (invalid).

Signal-to-Noise The difference in dB between the levels of DPOAE and the Noise Floor at
Ratio (SNR) each DPOAE frequency.
SNR Criterion User-defined minimum SNR that the user considers suggesting the presence
(SNRC) of physiological response, for example DPOAE or TEOAE.
Sound Level Sound pressure level indicated by a sound level meter, with dynamic response
and weighting characteristics conforming to the requirements of IEC 651 or
ANSI S.1.4. When not otherwise qualified, the term denotes a weighted sound
level.
Stimulus Sound energy presented to the patients through the transducer.
Stimulus Level The sound level of an acoustic stimulus as measured in an acoustic coupler,
usually an Occluded Ear Simulator (Zwislocki Coupler). In DPOAE tests, the
levels of primaries are typically presented in the L1/L2 format, for example
65/55 dB SPL.
Stimulus Rate Number of stimuli presented per second.
Stimulus The ratio (in % rather than dB, while 1 dB is approximately 10%) between The
Stability Score first click level and the final click level over the duration of stimulation, as
(%) (SSS) measured by the system.
Stimulus The waveform of acoustic signal produced by the probe, as recorded by the
Waveform system.
Sweep A single stimulus repetition (particularly, a single click in either linear or non-
linear TEOAE mode), and recording response to this single stimulus.

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Appendix O: Integrity™ V500 Glossary of Terms

System DP Distortion Product produced by system hardware. As an index scaling the

system quality, it contains the DP levels at all DP frequency points
corresponding to the reference frequencies (f2).

System NF Noise Floor of system hardware in the absence of physiological response.

System TR The procedure performed by the system when the probe is placed in probe
Check holder to make sure the system transient response is ignorable according to
the designed bottom line.
System Transient Response of system hardware. As an index scaling the system
Transient quality, it contains the averaged response waveform as the reaction of the
Response system hardware to the specified stimuli.
(System TR)
TE Level Root Mean Square of the TE response waveform, expressed in dB SPL.
TEOAE Transient Evoked Otoacoustic Emissions.
TEOAE high- High-pass filtering of TEOAE-response signal to improve response quality in
pass filtering TEOAE screening, especially neonatal screening, by removing low-frequency
noise; recommended with cut-off frequency 1.2 kHz with ≥12 dB per octave
slope [Kemp et al., 2001].
TEOAE stimulus A process to compensate for the difference between the click levels in the real
adjustment ear and the occluded ear simulator where the OAE Probe is calibrated.
in situ This is accomplished by creating the same click level, as measured at the
probe‟s acoustic inlet, both in the occluded ear simulator and in situ. The
measure of the in situ click level is its peak equivalent SPL, as measured by
Integrity, when equal to the peak equivalent SPL measured by Integrity when
the click level in the occluded ear simulator is equal to nominal values. For
example the system will measure the same peSPL both in the occluded ear
simulator and in situ when the occluded ear simulator measures a click level of
80 dB peSPL.
TEOAE Test TEOAE automatic screening test result that does not allow making a Pass-
Invalid Refer decision.
TEOAE Test The TEOAE automatic screening test conditions that make a Pass-Refer
Valid screening-outcome decision,
TEOAE test Condition of a TEOAE test result that allows making a Pass-Refer decision.
validity
Test A complete sequence of stimuli presentation and response recording
performed according to a protocol within one test session.
Test Insufficient Screening test outcome when the ambient noise does not allow the system to
make a definite „pass‟ or „refer‟ decision.
Test Insufficient Screening outcome obtained by automatic screening procedure when the
– auto system cannot decide whether or not the screening criteria have been met.
Test Insufficient Screening outcome decided by the user when the user cannot decide whether
– manual screening outcome is Pass or Refer.
Test outcome A decision in a screening test: Pass, Refer, or Test Insufficient.
Test result A result of complete sequence of stimuli presentation and response recording
performed according to a protocol obtained in a single test, for example a
single DP-gram or a single TEOAE record.
Test Type The type of test measurements performed by a device.
Tone Burst A brief pure tone stimulus having a rapid rise and fall time with a duration
sufficient enough to be perceived as having tonality (usually less than 1 sec).
Transducer An electroacoustic device for converting one form of energy into another.
Tympanic The thin membrane that separates the liquid-filled inner ear from the air-filled
membrane middle ear. Also known as the eardrum.

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VivoLink The world‟s first wireless interface module used in auditory electrophysiology.
It has a universal platform: it can perform ABR, ASSR, DPOAE, and TEOAE
tests, and has the potential to add other testing modalities on the same
platform. (Note - not all modalities are released yet, only ABR is currently
available.) It is operated by a microprocessor, controlled from a remote
computer through Bluetooth®, and powered by batteries.
Wave The rise and fall of a voltage. A wave component is usually attributed to neural
activity (action potential or dendritic activity) of a generator or several
generators of a response.
Wave The degree to which a recorded waveform can be reproduced in another
Reproducibility similar recording event.
Waveform A form or shape of a wave, represented graphically as magnitude in a function
of time.
Whole Wave Also called Whole A, B Waveform Reproducibility, or simply Repro. Cross-
Reproducibility correlation between A- and B- collected waveforms in recording window,
expressed in percentage format.

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Appendix P: Integrity™ V500 Bluetooth® Troubleshooting

Appendix P: Bluetooth® Troubleshooting

®
This section has been written to describe the process of troubleshooting the Bluetooth
installation. Please read the instructions in their entirety and follow the suggestions
before calling for technical support.
I connect the USB Adapter to my computer and nothing happens.
®
If no activity takes place after inserting the Bluetooth USB Adapter to the computer it is
®
because the Bluetooth driver has not been installed.
®
Please follow the Bluetooth driver installation instructions (P/N 11106), shipped with
your Integrity System, to install the drivers and configure the services and security for
®
Bluetooth .
I insert the USB Adapter to the back of the computer and the Bluetooth icon in the
system tray remains off.
®
If your Bluetooth icon ( ), which is found in the system tray, in the lower right corner of
the screen is turned off it could be for the following reasons:
®
1. The Bluetooth driver is not properly installed.
®
Action - Re-install the Bluetooth driver and ensure that the settings have been
configured correctly.
®
2. The Bluetooth USB Adapter is not plugged into the proper USB connection.
®
Ensure that the Bluetooth driver is installed and that the USB Adapter is
connected to the same port as it was during the driver installation.
®
3. The Bluetooth USB Adapter may not be connected properly.
To ensure that the USB Adapter is properly connected, check that the LED on
the USB Adapter is lit. If the LED is NOT lit, remove the USB Adapter and then
connect it again.
®
I have installed the Bluetooth driver and made the proper connection to the
VivoLink but the connection is not recognized after a system shutdown.
® ®
This problem is usually caused by incorrectly configured Windows Bluetooth
®
settings. If the Bluetooth driver does not recognize the previous settings, do the
following:
Please follow the Installation Instructions (P/N 11106) shipped with this manual.
I am getting the error "Cannot initialize COM port 0" or PIN Code required
1. Turn on the VivoLink and start the Integrity System computer.
2. Make sure the Bluetooth USB Adapter is connected to the correct USB port.
3. Exit the VivoLink software if it is already running.
4. Double-click on the "My Bluetooth Places" icon on the desktop.
5. On the menu bar select Bluetooth | Search for Devices.
6. The system will now show a list of all Bluetooth devices in range.
7. Right-click on the VivoLink icon. Select Unpair Device if it is shown and search
for devices again by repeating the previous step.
8. After right-clicking on the VivoLink icon Pair Device will be an option.

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9. Select Pair Device.

10. Enter the Bluetooth PIN Code “0000.” If your VivoLink has not been updated
since its purchase, enter the Bluetooth PIN Code “5150.”
11. The VivoLink icon will now show a red checkmark.
12. Double-click the VivoLink icon.
13. It will now show "COM1 on …, Not Connected". Double-click the icon to connect.
14. Two green arrows will be displayed and the status as will show as Connected.
15. Right-click the VivoLink icon and select Disconnect Bluetooth Serial Port.
16. Select Yes when asked to close the connection.
17. Close the "My Bluetooth Places" window.
18. Launch the Integrity V500 software from the Windows Desktop.
19. The error message should now be gone and the VivoLink should connect
correctly through Bluetooth.

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 User's Manual Integrity™ V500

Index
% Rejected ............................ 74, 102 Clear
AB data ................................. 74, 102 window..................................... See
display ............................... 79, 106 Click ..................................... 73, 101
ABR ............................................ 1, 3 ABR ............................................ 3
ABR test ................................ 87, 125 Clinic information ......................... 56
Accurate ................................... 147 Clinical Applications .................. 202
Activate Clinical benefits ............................ 18
protocol ..................................... 48 Comment ..................................... 106
software ..................................... 50 Condensation........................... 70, 98
Algorithms ..................................... 5 Configuration ................................ 10
Alternating .............................. 70, 98 Configure
Alternating split ................ 70, 98, 99 system ....................................... 50
Amplifier Gain ........................ 68, 96 Connection
Amplitrode .................................... 16 failed ......................................... 35
electrodes ............................ 71, 99 Connectors
Applications ................................ 202 accessory ................................... 15
Apply Contact quality
electrode ............................ 60, 118 poor ......................................... 103
Archive Test screen ........................ 61, 120
data ............................................ 46 VivoLink LED .................. 61, 120
Artifact Rejection .................... 68, 96 Contact Quality . 69, 75, 97, 103, 123
Artifact Rejection Threshold... 68, 97 LED ................................... 88, 125
Assessment ..................... 148, 154 contraindication............................... 8
Audible levels Contralateral ....................... 72, 100
discomfort ................................... 8 Criterion Levels .............. 133, 148
Automatic ......................... 148, 154 Current Day/Time
Averaging ................................ 70, 98 Display ...................................... 34
Backup Data
records ....................................... 55 AB buffered ...................... 74, 102
Baseline ....................................... 106 archive ....................................... 46
Batteries backing up ................................. 55
recharging ............................... 163 customize .......................... 85, 111
replacing .................................. 163 Discard ...................................... 32
Battery export ........................................ 45
indicator .................................... 35 lost ............................................. 32
birth weight merge......................................... 56
units ........................................... 51 Pause ......................................... 31
Blockage ....................................... 8 report ......................................... 43
Bluetooth results ........................................ 40
LED ..................................... 28, 35 save ..................................... 31, 55
troubleshoot............................. 220 select results .............................. 39
Calibration....................................... 9 view ........................................... 37
units ........................................... 51 waveforms ................................. 77
Cavity Check ..................... 146, 156 Database .......................................... 7

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expand ..................................... 110 EarTip ......................................... 152

tracked items ........................... 171 ECochG ............................. 1, 13, 214
waveform window .................... 40 EEG Window ................ 76, 103, 124
Database screen ............................. 37 Electrode
define password ........................ 53 application ......................... 60, 118
expanded view .................. 86, 112 brand ................................. 72, 101
latency vs intesity graph............ 86 inverting (-) ......................... 71, 99
patient list .................................. 38 non-inverting (+) ................. 71, 99
query ................................... 39, 40 placement .......................... 71, 100
Database Screen Electromagnetic Compatibility ....... 2
preview (ECochG) ................. 110 EMC ................................................ 2
Date Emissions .................................... 196
display ....................................... 34 Environment .................................... 2
incorrect .................................... 34 Eq. Sweeps ............................ 74, 102
Date of Birth ................................. 26 ER-3A Earphones ......................... 62
Deactivate ERA .............................................. 16
protocol ..................................... 48 Error
Define measurment ................................. 9
battery information.................... 51 Expand ....................................... 110
birth weight units ...................... 51 Expanded view ...................... 86, 112
password ................................... 53 Export............................................ 45
transducer .................................. 51 F2147
Delete Fast ............................................ 148
protocol ..................................... 49 Filter
records ....................................... 46 high and low pass ................ 68, 96
waveform .......................... 80, 107 notch.................... 72, 76, 100, 104
Discard Rolloff ................................. 68, 96
data ...................... 32, 84, 109, 124 Filters ............................................ 18
Display Gold Electrode Eartip ..... 10, 91, 163
AB ..................................... 79, 106 Graph
dongle .......................................... 220 Latency vs Intensity ............ 74, 86
DP-Gram ..................................... 150 Y-axis scale ....................... 82, 108
DPOAE ............................... 2, 6, 144 Ground placement ................. 59, 117
DPOAE Database Screen ............ 157 High-Pass filter ....................... 68, 96
DPOAE Protocol ......................... 146 Horizontal ............................ 72, 100
DPOAE Test Screen ................... 149 Immunity ..................................... 196
Driver Inflammation................................ 8
Bluetooth ................................. 220 Installation
DSP ............................................. 167 separation distance .................. 199
Ear Insufficient ................................. 154
discharge.................................. 8 Integrity
right and left button ....... 33, 69, 97 Intended use ................................ 1
Ear tips .................................... 71, 99 Integrity system
Earlobe placement ......................... 59 features ........................................ 6
Eartip setup .......................................... 20
Gold Electrode ........................ 167 unpackaging .............................. 20

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Integrity™ system Num of Stim.......................... 74, 102

General Configuration .............. 10 Number of Stimuli ................ 74, 102
Interference Operating mode ...................... 148
notch filter ......................... 72, 100 Operation
Ipsilateral ............................. 71, 100 general procedures .................... 57
Kalman filter ........................... 70, 98 PASS ........................................... 154
Label Pass/Refer Criteria.................... 148
ABR Buttons ............................. 78 Password
peaks ........................... 77, 78, 105 define......................................... 53
Lanyard ......................................... 16 Patient
Latency date/time of birth ....................... 26
labels ........................... 77, 78, 105 enter information ....................... 26
normative data ................. 206, 209 infant ......................................... 13
norms................................. 80, 107 print ........................................... 34
peak-to-peak data ...................... 83 selecting .................................... 27
Latency intensity ........................... 74 status ................................... 70, 98
Latency norms ............................... 81 Patient screen
international standards ............. 82 layout......................................... 47
LED indicator................................ 13 Patients
Level .......................... 67, 73, 96, 101 contraindications ................... 8
List selectable ................................... 30
protocol ..................................... 47 sorting ....................................... 26
Low-Pass filter ........................ 68, 96 Patients screen ............................... 25
Manual ....................................... 148 customizing look ....................... 26
Masker..................................... 71, 99 Pause and Resume......................... 31
Masking level .......................... 71, 99 Performing a DPOAE Test ......... 159
Mastoid placement ........................ 59 Polarity .................................... 70, 98
Medial................................... 72, 100 Poor contact quality .................. 103
Medium ..................................... 148 Power ............................................ 15
Merge low battery ................................ 35
records ....................................... 56 Print
Message and Assessment Window waveform .................................. 33
................................................. 154 Probe
Nape placement ..................... 59, 117 Gold Electrode Eartip ............... 91
NeuroLine .................................... 11 Probe Fit .......................... 6, 146, 153
No. of Frequencies to Decide Probe ID ..................................... 152
................................................. 148 Protocol
Noise applied ....................................... 30
artifacts ...................................... 18 define......................................... 48
Contact Quality .... 69, 75, 97, 103, parameters ............. 29, 48, 64, 121
123 preset ....................................... 177
masker ................................. 71, 99 settings ...................................... 93
masking level ...................... 71, 99 Protocol screen ........................ 47, 69
Source of ..................................... 4 define password ........................ 53
Noise floor..................................... 89 Query
Notch Filter ........................... 72, 100 database entries ................... 39, 40

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protocol ..................................... 48 System screen................................ 50

Range ............................................ 13 TEOAE ....................................... 2, 5
Rarefaction .............................. 70, 98 Test
Recording Window ................. 68, 96 type ...................................... 28, 30
Records Test Control Buttons ................... 155
archive ....................................... 46 Test Duration ............................. 152
delete ......................................... 46 Test Parameters
REFER ....................................... 154 define......................................... 47
References ................................... 210 Test screen
Report............................................ 43 % rejected.......................... 74, 102
Response Levels ............ 133, 148 algorithm ............................. 70, 98
Restore averaging ............................. 70, 98
database ..................................... 55 clear ........................................... 32
Review contact quality 69, 75, 97, 103, 123
data ............................................ 37 current day/time ........................ 34
Save Discard ...................................... 32
data ............................................ 31 ear tips ................................. 71, 99
records ....................................... 55 EEG ........................... 76, 103, 124
Screening .................................... 154 Kalman filter ............... 70, 98, 138
Screens latency intensity ........................ 74
General ...................................... 25 leave .......................... 84, 109, 124
Test screen ................................ 28 level ....................... 67, 73, 96, 101
Select masker ................................. 71, 99
data ............................................ 39 masking level ...................... 71, 99
Separation Distance .................... 199 number of stimuli .............. 74, 102
Shipping .......................................... 9 Patients ...................................... 30
Signal Information ........................ 73 pause ......................................... 31
Skin damage ................................ 8 polarity ................................ 70, 98
SNR Criterion .................. 133, 148 print ........................................... 33
Sort recording side .................... 71, 100
database information ................. 39 Resume ...................................... 31
Sound Level indicators ........ 151 right ear and left ear ..... 33, 69, 97
Stability ..................................... 147 Save ........................................... 31
Start/stop ....................................... 31 Start/stop ................................... 31
Stimulation status ................................... 70, 98
polarity ................................ 70, 98 Stimulus type .................... 73, 101
Stimulation level ....... 67, 73, 96, 101 Test type .............................. 28, 30
Stimulus Parameters ................. 147 Y-axis scale ....................... 82, 108
Stimulus Settings ................... 65, 93 Test Settings ............... 65, 68, 93, 96
Stimulus Type ....................... 73, 101 Tone-burst ..................................... 73
Storing ........................... 90, 115, 127 Transducer
Symbols................................. 14, 200 define......................................... 51
System selection .................................... 62
care .......................................... 163 Transducer Type ................... 73, 102
preparation ................................ 57 Troubleshooting .......................... 164
storage ....................... 90, 115, 127 Bluetooth ................................. 220

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Unit ID .......................................... 53 Clear .......................................... 32

Units data ............................................ 83
birth weight ............................... 51 delete ................................. 80, 107
calibration ................................. 51 expanded view .................. 86, 112
Values functions of ....................... 85, 111
latency ....................................... 74 handles .............................. 77, 105
View label ............................. 77, 78, 105
data ............................................ 37 markup ...................................... 83
VivoLink Pause ......................................... 31
Contact Quality ................. 88, 125 window...................................... 77
VivoLink™ Y-axis scale ....................... 82, 108
connector panel.................... 15 Waves I and V ............................... 81
front panel ................................. 14 Wireless connection ...................... 35
placement .................................. 13 Y-axis scale ........................... 82, 108
Waveform

Check (dB pe SPL)/ (dB nHL) (dB pe SPL)/ (dB nHL) (dB pe SPL)/ (dB nHL)
(dB pe SPL)/ (dB nHL) Check

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