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 D-0100778 Rev. C

D-0100778 Rev C 1
Title : GSI AudioStar Pro™ Clinical Audiometer User Manual
Copyright © 2013-2014 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.
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Part Number 2012-0100 Rev. B
USER MANUAL

GSI AudioStar Pro™ Clinical Audiometer
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Table of Contents
Intended Use .................................................................................................................................................7
Warranty....................................................................................................................................................7
Audiometric Standards..................................................................................................................................8
Warnings, Cautions, and Errors....................................................................................................................9
Status/Error Messages.............................................................................................................................10
Customer Responsibility .........................................................................................................................11
Elimination of Ambient Noise ................................................................................................................11
Safety Precautions.......................................................................................................................................14
Cautions - General...................................................................................................................................15
Warning - Connecting Additional Equipment.........................................................................................15
Warning - Electric Shock Hazards..........................................................................................................15
Warning - Electric Grounding.................................................................................................................15
Warning - Explosion ...............................................................................................................................15
Warning - Line Voltage Brownout and Interruptions .............................................................................16
Warning - Connections............................................................................................................................16
Warning - Battery Safety.........................................................................................................................16
Warning - General...................................................................................................................................16
Shutdown Procedure................................................................................................................................16
Recycling / Disposal................................................................................................................................16
Regulatory Symbols....................................................................................................................................17
Audiometric Symbols .................................................................................................................................19
Chapter 1: Introduction...............................................................................................................................21
Chapter 2: Installation.................................................................................................................................22
External Inspection..................................................................................................................................22
Unpacking ...............................................................................................................................................22
Accessories..............................................................................................................................................23
Country Kits............................................................................................................................................24
Chapter 3: Connectors, Controls and Indicators.........................................................................................25
Rear Panel ...............................................................................................................................................25
Right Side Panel......................................................................................................................................27
Left Side Panel........................................................................................................................................27
Bottom Panel Label.................................................................................................................................29
Chapter 4: Front Panel Controls..................................................................................................................30
Power.......................................................................................................................................................30

D-0100778 Rev C 3
Stimulus Intensity Level(s) .....................................................................................................................30
Talk Forward...........................................................................................................................................31
Left & Right VRA...................................................................................................................................31
Interlock ..................................................................................................................................................31
Tracking ..................................................................................................................................................31
Status / Audiogram Button......................................................................................................................32
Data Transfer...........................................................................................................................................32
Printing....................................................................................................................................................32
Stimulus Channel 1 and Channel 2 .........................................................................................................35
Transducer Output Selector.....................................................................................................................36
Routing Output Selector..........................................................................................................................37
Attenuators (HL Controls).......................................................................................................................37
Tone Bar / Interrupt.................................................................................................................................38
Frequency Up / Down .............................................................................................................................38
Data Store................................................................................................................................................38
Navigation Controls ................................................................................................................................38
Scorer / Timer..........................................................................................................................................39
Aux Intercom...........................................................................................................................................39
Monitoring...............................................................................................................................................40
Test Type Buttons ...................................................................................................................................40
Function Buttons.....................................................................................................................................41
Keyboard.................................................................................................................................................42
Chapter 5: Test Type Displays....................................................................................................................43
Monitor....................................................................................................................................................43
Test Type Screens ...................................................................................................................................43
Tone Test Type - Audiogram..................................................................................................................45
High Frequency Test Type - Audiogram.................................................................................................49
Full Frequency Test Type - Audiogram..................................................................................................50
Tone Test Type - Status...........................................................................................................................51
High Frequency Test Type –Status........................................................................................................52
Full Frequency Test Type - Status ..........................................................................................................52
Speech Test Type - Status.......................................................................................................................53
Speech Test Type - Audiogram...............................................................................................................58
More Test Type.......................................................................................................................................60
ABLB......................................................................................................................................................60
BKB-SIN.................................................................................................................................................61

GSI AudioStar Pro™ Clinical Audiometer
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QuickSIN.................................................................................................................................................64
SISI..........................................................................................................................................................67
TEN.........................................................................................................................................................68
Tone Decay .............................................................................................................................................69
Chapter 6: Operation...................................................................................................................................70
Preliminary Checks .................................................................................................................................70
Typical Evaluations.................................................................................................................................71
Test Type Buttons ...................................................................................................................................71
More Test Type button............................................................................................................................73
Routine Test Procedures..........................................................................................................................73
Patient Instructions..................................................................................................................................73
Patient Familiarization ............................................................................................................................73
Threshold Determination (Pure Tone): Modified Hughson-Westlake....................................................74
Spondaic Speech Testing, Speech Reception Threshold (SRT)..............................................................75
Speech Discrimination (PB Words) ........................................................................................................75
Special Test Procedures - More Test Type button ..................................................................................76
Alternate Binaural Loudness Balance (ABLB) or Fowler Test ..............................................................76
BKB-SIN.................................................................................................................................................77
QuickSIN.................................................................................................................................................78
SISI (Short Increment Sensitivity Index) Test ........................................................................................80
TEN Test.................................................................................................................................................81
Tone Decay Test......................................................................................................................................82
Chapter 7: Application Software & Integration..........................................................................................83
Config App..............................................................................................................................................83
GSI Instrument Services..........................................................................................................................85
GSI Suite.................................................................................................................................................86
OtoAccess™............................................................................................................................................86
Noah 4.....................................................................................................................................................86
Noah 3.....................................................................................................................................................86
AudBase..................................................................................................................................................86
Chapter 8: Routine Maintenance.................................................................................................................87
Biological Calibration Check..................................................................................................................87
Periodic Checks.......................................................................................................................................87
Earphone and Bone Vibrator Cords ........................................................................................................87
Hum and Noise........................................................................................................................................87
Distortion and Frequency Shift ...............................................................................................................87

D-0100778 Rev C 5
Speech Level Check................................................................................................................................88
Internal Controls Check...........................................................................................................................88
Bone Vibrator Check...............................................................................................................................88
Masking Level Check..............................................................................................................................88
Talk Forward Check................................................................................................................................88
Cleaning the System................................................................................................................................88
Cleaning and Disinfecting Agents...........................................................................................................89
Appendix 1: Specifications.........................................................................................................................90
Appendix 2: Calibration Reference & Maximum Levels ...........................................................................93
Earphones - Pure Tone RETSPL.............................................................................................................94
Earphones - ANSI Speech RETSPL .......................................................................................................95
Earphones - IEC Speech RETSPL ..........................................................................................................96
Earphones - Pure Tone max HL..............................................................................................................97
Earphones - NB noise effective masking level........................................................................................98
Earphones - NB noise max HL................................................................................................................99
Earphones - ANSI Speech max HL.......................................................................................................100
Earphones - IEC Speech max HL..........................................................................................................100
Insert Earphones - Pure Tone RETSPL.................................................................................................101
Insert Earphones - ANSI Speech RETSPL ...........................................................................................102
Insert Earphones - IEC Speech RETSPL ..............................................................................................102
Insert Earphones - Pure Tone max HL..................................................................................................103
Insert Earphones - NB noise effective masking level ...........................................................................104
Insert Earphones - NB noise max HL ...................................................................................................105
Insert Earphones - ANSI Speech max HL.............................................................................................106
Insert Earphones - IEC Speech max HL................................................................................................106
Bone Vibrators - Pure Tone RETFL .....................................................................................................107
Bone Vibrators - ANSI Speech RETSPL..............................................................................................108
Bone Vibrators - IEC Speech RETSPL.................................................................................................108
Bone Vibrators - Pure Tone max HL ....................................................................................................109
Bone Vibrators - NB noise effective masking level..............................................................................110
Bone Vibrators - NB noise max HL......................................................................................................111
Bone Vibrators - ANSI Speech max HL...............................................................................................112
Bone Vibrators - IEC Speech max HL..................................................................................................112
Free Field Speakers –ANSI RETSPL and Max HL.............................................................................113
Appendix 3: EMC Compatibility..............................................................................................................114
Electromagnetic Compatibility..............................................................................................................114

GSI AudioStar Pro™ Clinical Audiometer
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Electrical Safety, EMC and Associated Standards................................................................................114
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions.............................................115
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and
the GSI AudioStar Pro...........................................................................................................................115
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................116
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................117
Appendix 4: Reference Materials .............................................................................................................118

D-0100778 Rev C 7
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, circum-aural, or insert phones –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.

GSI AudioStar Pro™ Clinical Audiometer
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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. ISO 389-1 Reference Equivalent Threshold SPLS for Pure Tones and
Supra-Aural Earphones
5. ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and
Insert Earphones
6. ISO 389-3 Reference Equivalent Threshold Force Levels for Pure Tones
and Bone Vibrator
7. ISO 389-4 Reference Levels for Narrow-Band Masking Noise
8. ISO 389-5 Reference Equivalent Threshold SPLS for Pure Tones in the
Frequency Range 8 kHz to 16 kHz
9. ISO 389-7 Reference zero for the calibration of audiometric equipment
10. ISO 389-8 Reference zero for the calibration of audiometric equipment

D-0100778 Rev C 9
Warnings, Cautions, and Errors
The GSI AudioStar Pro ClinicalAudiometer is designed to be used with a hospital
grade outlet. Injury to personnel or damage to equipment can result when a
three-prong to two-prong adaptor is connected between the GSI AudioStar Pro
power plug and an AC outlet or extension cord.
Warning! To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Do not block access to the power switch.
Audiometers which bear the Underwriters Laboratories, Inc . label should be
interconnected with accessories that have the proper electrical compatibility and
are listed as meeting the requirements of the UL Medical and Dental Equipment
Standard. Connection of accessories not meeting these requirements may result
in electrical leakage currents in excess of those allowed by the standard and
present a potential electrical shock hazard to the person being tested.
When testing with the High Frequency earphones, do not allow the
presentation of the signal at the maximum dB HL to exceed 10 minutes. The
buildup of increased temperature can cause harm to the earphones. This caution
label refers the user to the accompanying literature and manuals.
This icon indicates that the GSI AudioStar Pro is in compliance with Class 1,
Type BrequirementsofIEC60601-1.
The GSI AudioStar Pro is designed for compliance to IEC and UL 60601-1 when
used in the patient vicinity.
In the presence of high intensities, a yellow light will appear per channel as a
warning indictor (IEC 60645-1 and ANSI S3.6).
Any program aimed at obtaining reliable records of hearing thresholds should be
staffed and supervised by appropriately trained individuals.
Latex is not used anywhere in the manufacturing process. The base material for
the earphone cushions is made from natural and synthetic rubber.
Warning! No modifications of the equipment are allowed by anyone other than a qualified
GSI representative.
In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures.
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.