GSi AUDIOSTAR PRO User manual

Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 7625 Golden Triangle Drive, Suite F, Eden Prairie MN 55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]
GSI AUDIOSTAR PRO™
USER MANUAL
Part Number 2012-0100 Rev. A

2012-0100 Rev. A 1
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GSI AudioStar Pro Clinical Audiometer
2 2012-0100 Rev. A
Title: GSI AudioStar Pro™ Clinical Audiometer User Manual
Copyright © 2012 Grason-Stadler. All rights reserved . No part of this publication may be
reproduced or transmitted in any form or by any means without the prior written permission of
Grason-Stadler . The information in this publication is proprietary to Grason-Stadler.
Compliance
The CE 0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
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2765 Smørum
Denmark
0344

2012-0100 Rev. A 3
Table of Contents
Intended Use .................................................................................................................................................8
Warranty....................................................................................................................................................8
Audiometric Standards..................................................................................................................................9
Warnings, Cautions, and Errors..................................................................................................................10
Status/Error Messages.............................................................................................................................11
Customer Responsibility .........................................................................................................................11
Safety Precautions.......................................................................................................................................13
Cautions - General...................................................................................................................................14
Warning - Connecting Additional Equipment.........................................................................................14
Warning - Electric Shock Hazards..........................................................................................................14
Warning - Electric Grounding.................................................................................................................14
Warning - Explosion ...............................................................................................................................14
Warning - Line Voltage Brownout and Interruptions .............................................................................15
Warning - Connections............................................................................................................................15
Warning - Battery Safety.........................................................................................................................15
Warning - General...................................................................................................................................15
Shutdown Procedure................................................................................................................................15
Recycling / Disposal................................................................................................................................15
Regulatory Symbols....................................................................................................................................16
Specifications..............................................................................................................................................18
Audiometric Symbols..............................................................................................................................20
Hearing Level and Frequency Limits - Hearing Level (dB HL).............................................................20
Frequency Limits.....................................................................................................................................21
Elimination of Ambient Noise ................................................................................................................22
Accessories .................................................................................................................................................26
Country Kits................................................................................................................................................27
Chapter 1: Introduction...........................................................................................................................28
Chapter 2: Installation .............................................................................................................................29
External Inspection..................................................................................................................................29
Unpacking ...............................................................................................................................................29
Connectors, Controls and Indicators...........................................................................................................30
Rear Panel ...............................................................................................................................................30
Right Side Panel......................................................................................................................................31
Left Side Panel........................................................................................................................................32

GSI AudioStar Pro Clinical Audiometer
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Monitor....................................................................................................................................................32
Bottom Panel Label.................................................................................................................................33
Front Panel Controls...................................................................................................................................34
Power.......................................................................................................................................................34
Stimulus Intensity Level(s) .....................................................................................................................34
Talk Forward...........................................................................................................................................35
Left & Right VRA...................................................................................................................................35
Interlock ..................................................................................................................................................35
Tracking ..................................................................................................................................................35
Status / Audiogram Button......................................................................................................................35
Data Transfer...........................................................................................................................................35
Printing....................................................................................................................................................36
Stimulus Channel 1 and Channel 2 .........................................................................................................36
Transducer Output Selector.....................................................................................................................37
Routing Output Selector..........................................................................................................................38
Attenuators (HL Controls).......................................................................................................................38
Tone Bar / Interrupt.................................................................................................................................38
Frequency Up / Down .............................................................................................................................38
Data Store................................................................................................................................................38
Navigation Controls ................................................................................................................................39
Scorer / Timer..........................................................................................................................................39
Aux Intercom...........................................................................................................................................39
Monitoring...............................................................................................................................................39
Test Type Buttons ...................................................................................................................................40
Function Buttons.....................................................................................................................................40
Chapter 3: Function Specific Display......................................................................................................41
Navigation Menu.....................................................................................................................................41
Tone Test Type Display..........................................................................................................................42
High Hz Test Type Display.....................................................................................................................46
Speech Test Type Display.......................................................................................................................47
Blue Navigation Menu ............................................................................................................................48
Speech Status Screen...............................................................................................................................49
Chapter 4: Operation ...............................................................................................................................51
Preliminary Checks .................................................................................................................................51
Typical Evaluations.................................................................................................................................52
Test Type Buttons ...................................................................................................................................52

2012-0100 Rev. A 5
More Test Type button............................................................................................................................53
Chapter 5: Test Procedures .....................................................................................................................54
Routine Test Procedures..........................................................................................................................54
Patient Instructions..................................................................................................................................54
Patient Familiarization ............................................................................................................................54
Threshold Determination (Pure Tone): Modified Hughson-Westlake....................................................54
Spondaic Speech Testing, Speech Reception Threshold (SRT)..............................................................55
Speech Discrimination (PB Words) ........................................................................................................55
Special Test Procedures..............................................................................................................................56
More Test Type button............................................................................................................................56
Alternate Binaural Loudness Balance (ABLB) or Fowler Test ..............................................................56
QuickSIN.................................................................................................................................................57
SISI (Short Increment Sensitivity Index) Test ........................................................................................58
TEN Test.................................................................................................................................................58
Tone Decay Test......................................................................................................................................59
Additional Special Tests..........................................................................................................................60
Chapter 6: Configuration Application Software....................................................................................61
Instrument................................................................................................................................................62
Word Lists Tab........................................................................................................................................62
Audiometry..............................................................................................................................................62
Pure tone Tab ..........................................................................................................................................62
High Hz Tab............................................................................................................................................62
Speech Tab..............................................................................................................................................63
Norm Values Tab....................................................................................................................................63
Chapter 7: Integration..............................................................................................................................64
GSI Instrument Services..........................................................................................................................64
Description..............................................................................................................................................64
Operation.................................................................................................................................................64
Public Interface (Direct)..........................................................................................................................64
Data Port (Direct)....................................................................................................................................64
GSI Suite.................................................................................................................................................64
NOAH 4 ..................................................................................................................................................65
NOAH 3 ..................................................................................................................................................65
AudBase..................................................................................................................................................65
Chapter 8: Routine Maintenance ............................................................................................................66
Biological Calibration Check..................................................................................................................66

GSI AudioStar Pro Clinical Audiometer
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Periodic Checks.......................................................................................................................................66
Earphone and Bone Vibrator Cords ........................................................................................................66
Hum and Noise........................................................................................................................................66
Distortion and Frequency Shift ...............................................................................................................66
Speech Level Check................................................................................................................................67
Internal Controls Check...........................................................................................................................67
Bone Vibrator Check...............................................................................................................................67
Masking Level Check..............................................................................................................................67
Talk Forward Check................................................................................................................................67
Cleaning the System................................................................................................................................67
Cleaning and Disinfecting Agents...........................................................................................................68
Calibration Reference Levels......................................................................................................................69
Appendix 1: QuickSIN™ User Manual ..................................................................................................73
Quick Start...............................................................................................................................................73
Purpose of the QuickSIN.........................................................................................................................73
QuickSIN Methodology..........................................................................................................................74
Included with QuickSIN..........................................................................................................................74
How to Use the QuickSIN.......................................................................................................................75
Practice Lists...........................................................................................................................................76
What is SNR Loss? .................................................................................................................................77
Scoring ....................................................................................................................................................77
Where Does the Number 25.5 Come From?...........................................................................................78
The Formula for SNR Loss.....................................................................................................................78
Guilt-Free QuickSIN Test: for Ski-Slope Loss.......................................................................................78
Separated Speech and Noise Channels....................................................................................................79
Directional Comparison ..........................................................................................................................79
Test Development ...................................................................................................................................81
QuickSIN Search for Sentence Equivalence...........................................................................................83
Reliability (Statistics Made Useful) ........................................................................................................85
Appendix A.............................................................................................................................................87
Appendix B .............................................................................................................................................87
References...............................................................................................................................................88
Appendix 2: EMC Compatibility ............................................................................................................89
Electromagnetic Compatibility................................................................................................................89
Electrical Safety, EMC and Associated Standards..................................................................................89
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions...............................................90

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Recommended Separation Distances between Portable and Mobile RF Communications Equipment and
the GSI AudioStar Pro.............................................................................................................................90
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ...............................................91
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ...............................................92
Appendix 3: Reference Materials............................................................................................................93

GSI AudioStar Pro Clinical Audiometer
8 2012-0100 Rev. A
Intended Use
The AudioStar Pro is intended to be used for the identification and etiology of
hearing loss in patients of any age. It is intended to be used by an audiologist,
ENT, hearing healthcare professional, or trained technician in a hospital, clinic,
healthcare facility or other suitable quiet environment as defined in ANSI S3.1 or
equivalent.
Description This instrument is a two-channel clinical audiometer. This instrument has
advanced functionality that makes it ideal for testing in every clinical setting,
including Ear, Nose and Throat (ENT) physicians’ offices, hospitals, clinics and
audiology private practices. The tests are administered via headphones –supra-
aural, insert phones or circum-aural headphones –or through a bone vibrator or
sound field speakers. User defined test protocols allow for basic audiometric
testing as well as detailed evaluations to assist in diagnosis of audiologic
pathologies. Careful handling of instrument transducers and testing performed
by a properly trained instrument operator should be of high priority. The patient
is to remain relaxed and still while testing is being performed for optimal
accuracy.
Warranty
We, Grason-Stadler, warrant that this product is free from defects in material and
workmanship and, when properly installed and used, will perform in accordance
with applicable specifications. If within one year after original shipment, it is
found not to meet this standard; it will be repaired, or at our option, replaced at
no charge except for transportation costs, when returned to an authorized Grason-
Stadler facility. If field service is requested, there will be no charge for labor or
material; however, there will be a charge for travel expense at the service center’s
current rate.
NOTE: Changes in the product not approved in writing by Grason-Stadler shall
void this warranty. Grason-Stadler shall not be responsible for any indirect,
special or consequential damages, even if notice has been given in advance of the
possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.

2012-0100 Rev. A 9
Audiometric Standards
The AudioStar Pro is designed to meet or exceed the following standards:
Audiometer Standard Requirements - Type 1
1. ANSI S3.6 (2010) Specification for Audiometers (Type 1)
2. IEC 60645-1 Electroacoustics - Audiological Equipment - Pure-Tone
Audiometers Type 1
3. IEC 60645-2 Electroacoustics - Audiological Equipment - Equipment for
Speech Audiometry
4. IEC 60645-4 Electroacoustics - Audiological Equipment - Equipment for
Extended High-Frequency Audiometry
5. ISO 389-1 Reference Equivalent Threshold SPLS for Pure Tones and
Supra-Aural Earphones
6. ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and
Insert Earphones
7. ISO 389-3 Reference Equivalent Threshold Force Levels for Pure Tones
and Bone Vibrator
8. ISO 389-4 Reference Levels for Narrow-Band Masking Noise
9. ISO 389-5 Reference Equivalent Threshold SPLS for Pure Tones in the
Frequency Range 8 kHz to 16 kHz
10. ISO 389-7 Reference zero for the calibration of audiometric equipment
11. ISO 389-8 Reference zero for the calibration of audiometric equipment