GSi AUDIOSTAR PRO User Manual

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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 952-278-4401 • e-mail info@grason-stadler.com
Part Number D-0100778 Rev. C
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Part Number 2012-0100 Rev. B
USER MANUAL
Title
: GSI AudioStar Pro™ Clinical Audiometer User Manual
Copyright © 2013-2014 Grason-Stadler. All rights reserved. No part of this publication may be
Compliance
The CE 0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason­Stadler is an ISO 13485 certified corporation.
European Authority Representative Grason-Stadler Kongebakken 9 2765 Smørum Denmark
0344
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GSI AudioStar Pro™ Clinical Audiometer
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
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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
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GSI AudioStar Pro™ Clinical Audiometer
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
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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
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GSI AudioStar Pro™ Clinical Audiometer
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
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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.
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 – supra­aural, 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 Grason­Stadler 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.
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.
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GSI AudioStar Pro™ Clinical Audiometer
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
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Warnings, Cautions, and Errors
The GSI AudioStar Pro Clinical Audiometer 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!
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 B requirements of IEC 60601-1.
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.
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.
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: Notes help identify areas of possible confusion and avoid potential problems during system operation.
The CAUTION label identifies conditions or practices that could result in damage to the equipment.
Status/Error Messages
Please try another selection: Indicates an incorrect selection. This could include actions such as incompatible transducers, incompatible routing, or no calibration data stored for the selected transducers.
No test data stored: Indicates that there is no test data available to be erased, printed or transferred.
Printer communication error: If communications problems occur during the course of printing, this error message will be displayed.
Error: If there are general system errors, a dialog box with “Error” in the title will be shown with the given error.
Record test result in comments: Test results of the ABLB and Tone Decay are not recorded directly on the report. This message indicates that the results should be documented in the comments.
The startup configuration for this test type is not fully calibrated; a search for a different configuration that is calibrated has found the currently displayed configuration: This message indicates that the selected transducers
have not been calibrated.
The session comments have been updated with the results of the SDT test:
This message indicates that the stored speech detection threshold results will appear in the comments section and will be printed directly or transferred electronically.
Not supported in speech: The selected action is not supported in the speech test type.
Speech data limit exceeded, speech tables limited to 6 test results per ear. Latest test result will not be saved: Up to six speech tests may be stored in each
ear. This message indicates that the maximum number of tests has been stored and the latest test has not been added.
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Customer Responsibility
Warning!
This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not be used. Make sure all connections to external accessories are snug and secured properly. Parts which may be broken or missing or are visibly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from GSI.
This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit should not be used until deemed safe by a GSI certified service technician.
Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases.
Do NOT use the AudioStar Pro in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc.
Periodically, have a service technician perform electrical safety checks on the unit in order to maintain continued compliance to IEC and UL 60601-1.
Equipment is not user repairable. Repairs and battery replacement must be performed by a qualified service representative only. GSI will make available any instructions and diagrams to repair devices that it deems appropriate to be repaired in the field.
Elimination of Ambient Noise
The GSI AudioStar Pro may be installed in a single room environment or as part of a two room suite.
Excessive noise in the test environment, such as that produced by conversation, office equipment, or printers, reduces test validity because it tends to mask the test signals. This is especially true at the lower frequencies where earphone cushions provide less effective attenuation. A room that attenuates sound may be
required if ambient noise at the patient’s ears reaches levels sufficient to cause
apparent hearing loss at the lower frequencies.
The following table shows the maximum background levels that can be present inside the room while a valid hearing test is being conducted. These values apply for hearing threshold measurements to 0 dB HL.
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GSI AudioStar Pro™ Clinical Audiometer
Test Tone Freq. (Hz)
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
Test Room level Max dB SPL,Ears covered
29.0
17.5
14.5
16.5
21.5
21.5
23.0
28.5
29.5
33.0
38.5
Max dB SPL, Ears not covered
23.0
13.5
9.5
7.5
9.0
5.5
3.5
3.5
4.0
9.0
5.5
NOTE: A room providing sound isolation from ambient noise is highly recommended so that hearing threshold values may be obtained. If a separate examination (sound) room is used, it is considered sufficiently quiet for the
purposes of these tests if a group of otologically “normal” listeners with their
ears occluded is unable to detect any ambient noise during the test period. See ANSI S3.1 (R2003) Criteria for Permissible Ambient Noise during Audiometric Testing for maximum allowable outside octave band noise levels with three prefabricated sound room types.
NOTE: Live voice testing requires a separate sound attenuated room for the patient in order to avoid feedback and direct transmission of the test stimuli.
Maximum Ambient Noise
Notes: Maximum permissible 1/3 octave band level. If the Hearing Level to be measured is -10 dB HL, then 10 dB should be subtracted from the levels listed in this table.
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Sound Attenuation for Earphones per ISO 4869-1
Frequency
(Hz)
Attenuation
TDH50/DD45 with
MX41/AR or PH51
Cushion (dB)
EAR-Tone 3A
(dB)
HDA 200
(dB)
125
3
33.5
14.5
160
4
200
5
250
5
34.5
16
315
5
400
6
500
7
34.5
22.5
630
9
750
-
800
11
1000
15
35.0
28.5
1250
18
1500
-
1600
21
2000
26
33.0
32
2500
28
3000
-
3150
31
4000
32
39.5
45.5
5000
29
6000
-
6300
26
8000
24
43.5
44
Sound Attenuation
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GSI AudioStar Pro™ Clinical Audiometer
Safety Precautions
The following safety precautions must be observed at all times. General Safety precautions must be followed when operating electrical equipment. Failure to observe these precautions could result in damage to the equipment and injury to the operator or patient.
The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists between the material contained in this manual and the rules of the organization using this instrument, the more stringent rules should take precedence.
This device should only be used by hearing health care professional such as an audiologist, otolaryngologist, researcher or a technician under the direct supervision by the aforementioned specialist. Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills. Incorrect use could lead to wrong results.
The maximum sound levels (over 100 dB HL) that can be generated by the system can cause serious injury to the ear. Before attaching the earphones to the patient, ensure that:
a. The system is running. b. The hearing levels in the test set to be used are appropriate. c. A biologic check of the stimulus has been performed by the operator.
The customer is responsible for maintaining all system software in a safe, secure location.
Do not use extension cords with this instrument or for the Isolation Box. If extension cords are used they can cause ground integrity and impedance problems.
In addition to electrical safety considerations, poorly earthed mains power outlets could cause inaccurate test results due to the introduction of electrical interference from the mains.
ANY EQUIPMENT CONNECTED TO THE GSI INSTRUMENT AND USED IN THE PATIENT VICINITY MUST BE POWERED BY AN ISOLATED POWER SOURCE TO MAINTAIN THE ELECTRICAL SAFETY OF THE OVERALL SYSTEM. The isolated power source can be purchased directly from GSI, or elsewhere when approved for use by GSI.
The operator should take care to not make contact with the computer or printer and the patient at the same time.
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NOTE: If the instrument is connected to a PC, power to the monitor and computer must be controlled by the isolation transformer. Always leave the monitor and computer power switches in the ON position and control power from the isolation transformer. Always turn OFF system power before connecting or disconnecting system components to help guard against personal injury.
Cautions - General
If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is tested and calibrated for proper functioning in accordance with Grason-Stadler published specifications.
Warning - Connecting Additional Equipment
Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (IEC 950 for data processing or IEC 60601-1 for medical equipment and/or appropriate European Directives). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everyone who connects additional equipment to the signal input or signal output port configures a medical system per the standard IEC 60601-1-1. If in doubt, consult the technical service department or a local GSI representative. Connect all nonmedical equipment to the GSI Isolated Power Supply.
The AC power outlets on the isolated transformer/power box are intended for use with GSI approved components only. Use of any other equipment may result in damage to the power unit. Follow all safety standards set by each place of employment.
Warning - Electric Shock Hazards
Do not open the case of the GSI Instrument. Do not remove any GSI instrument covers. Refer servicing to qualified personnel.
Warning - Electric Grounding
This device uses a three wire power cord with a hospital grade plug (for international applications, IEC 60601-1 approved plug). The chassis is earth grounded. For grounding reliability, connect the device to a hospital grade or hospital only receptacle (for non US applications, IEC 60601-1 approved receptacle). Inspect the power cord often for fraying or other damage. Do not operate the apparatus with a damaged power cord or plug. Improper grounding is a safety hazard. Periodically check the system ground integrity.
Warning - Explosion
This system is not explosion proof. Do not use in the presence of flammable anesthetics or other gases.
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GSI AudioStar Pro™ Clinical Audiometer
Warning - Line Voltage Brownout and Interruptions
There are four (4) UV detectors in the digital domain, two (2) over current detectors in the analog domain, one for USB and four (4) OV/UV detectors on the main supply lines. If just ONE fails, all output to the transducers will be muted.
Warning - Connections
Do not switch on any system power until all cables have been properly connected and verified. See this manual, which accompanies all deliveries of the system, for setup instructions,. Switch off the system power before connecting or disconnecting any system component(s) or accessories.
Warning - Battery Safety
This instrument contains a coin-type lithium battery for a real time clock. The life expectancy of the battery is 10 years. The battery is not intended to be changed by the user. Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures. Do not short-circuit.
Warning - General
Proper use of this device depends on careful reading of all instructions and labels. Follow all safety standards set by each place of employment.
Shutdown Procedure
To turn off the GSI AudioStar Pro, use the power switch on the right side of the device.
Recycling / Disposal
Many local laws and regulations require special procedures to recycle or dispose of electrical equipment and related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all local laws and regulations for the proper disposal of batteries and any other parts of this system.
Below is the contact address for proper return or disposal of electronic wastes relating to Grason-Stadler products in Europe and other localities.
The contact information for the WEEE in Europe:
Grason-Stadler Kongebakken 9 2765 Smørum Denmark
CRV. No. 21113379
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No.
Symbol
IEC Pub.
Description
1 980 & 60601-1
Conforms to European Medical Device Directive 93/94/EEC.
4 980 & 60601-1
Symbol for "SERIAL NUMBER."
6 980 & 60601-1
Return to Authorized Representative, Special disposal required.
7 980 & 60601-1
Medical Equipment Classified by Intertek Testing Services NA Inc. with respect to electric shock, fire, and mechanical hazards only, in accordance with UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class IIb device.
10 980 & 60601-1
Symbol for “European Representative.”
11 980 & 60601-1
Symbol for “Manufacturer.”
12 980 & 60601-1
Symbol for “Date of Manufacture.”
13 980 & 60601-1
Attention, consult accompanying documents.
14 60601-1
BF Patient Applied Part according to IEC 60601-1.
15 980 & 60601-1
Consult Operating Instructions.
16 60601-1
On/Off - Next to power mains.
17 60601-1
Keep Dry.
20 60601-1
This side up.
21 60601-1
Monitor.
Regulatory Symbols
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GSI AudioStar Pro™ Clinical Audiometer
No.
Symbol
IEC Pub.
Description
22 60601-1
Patient response switch.
23 ISO 7010-M002
Follow Instructions for Use.
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Audiometric Symbols
The AudioStar Pro can support different symbol sets to accommodate the conventions in different countries. The country symbol sets that are supported include:
Australia China Hong Kong UK USA
The AudioStar Pro Config App allows the selection of the desired symbol set. The symbol sets are shown in the following table. For symbols that are not specified in the reference documents for specific countries, the USA symbols are used.
Abbreviations used in the following symbol set table
AC: Air Conduction NR: No Response BC: Bone Conduction SF: Sound Field MCL: Most Comfortable Level UCL: Uncomfortable Level
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GSI AudioStar Pro™ Clinical Audiometer
USA
Australia
China
Hong Kong
UK
R L L/R R L
L/R R L
L/R R L
L/R R L
L/R
AC
or
or
(NR)
or
or
AC masked
(NR)
BC
(NR)
BC masked
(NR)
BC Forehead
(NR)
BC Forehead masked
(NR)
SF
(NR)
SF masked
(NR)
SF Aided
(NR)
SF Cochlear
(NR)
MCL
(NR)
UCL
(NR)
Tinnitus
(NR)
TEN
(NR)
AudioStar Pro Symbol Sets
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Chapter 1: Introduction
The GSI AudioStar Pro™ continues the tradition of excellence in clinical
audiometry by maintaining the Grason-Stadler legacy of fast, efficient, and familiar navigation. The one-button, one-function front panel of the AudioStar Pro is recognized worldwide as the Gold Standard of user-friendly design, allowing audiologists to test with confidence. From the extra large display that reduces eye strain, to the ergonomic housing that maximizes hand and wrist comfort, and the light pipes around selected test buttons allowing concentrated focus on the patient, the AudioStar Pro has every desired feature.
Audiologists appreciate the flexibility of a stand-alone audiometer that offers seamless data transfer to a computer. In the event of a network failure or computer lock-up, the examiner will not lose patient data or the ability to test. The stand alone configuration is optimized with direct connection to a wireless keyboard and mouse making it fast and easy to enter patient demographics, report comments, and expedite test administration. In addition, direct connection to a printer and the integrated print button make it possible to print a complete report for immediate review with the patient or physician. User login and password controls provide security for patient data in compliance with HIPAA. Complete audiometric results may be transferred to software such as GSI Suite and Noah, or integrated with your facility’s EMR/EHR system.
The AudioStar Pro addresses the needs of a broad patient population. This revolutionary audiometer introduces complete flexibility in signal routing by enabling the user to select either Channel 1 or Channel 2 as the recorded stimulus channel. The active microphone during tone presentation ensures there are no delays in reinforcing or coaching. The built-in auxiliary intercom allows direct communication between operator and assistant which eliminates the need for an external intercom system. The built-in monitor speaker allows third parties to participate in the patient evaluation. The built-in VRA controls facilitate fast and simple activation of VRA systems eliminating the need for an external control box. The pediatric centered signal options including pediatric noise provide unique, frequency specific stimuli for pediatric testing. The built-in sound field amplifier provides testing to 90 dB HL without the expense or space required for an external amplifier. High performance speakers and a high performance external amplifier are additional options for achieving 96 dB HL and 102 dB HL outputs in the sound field environment. The built-in selection of Special Tests including QuickSIN, BKB-SIN and TEN HL address special hearing evaluations. The direct calibration for all the transducers allows seamless transition between AC transducers without the need to plug and unplug saving time and eliminating the need for correction factors.
The AudioStar Pro comes standard with integrated word lists for repeatable and reliable recorded speech testing. Auto-advance, auto-play, auto-scoring and mouse control allows the examiner to present, pause, repeat, skip, and score with ultimate ease, removing the main objection for recorded speech testing. Other speech-in-noise tests and word lists can be loaded directly from a flash drive. Eight Test Type buttons allow access to protocols that are customized to facility preferences. Tests are pre-programmed to optimize efficiency and workflow.
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: Refer to the supplied accessories list below to ensure that all accessories and cables have been included in the shipment.
Chapter 2: Installation
External Inspection
Although this GSI AudioStar Pro Clinical Audiometer was carefully tested, inspected, and packed for shipping, it is good practice after receiving the instrument to immediately examine the outside of the container for any signs of damage. Notify the carrier if any damage is observed.
Unpacking
Carefully remove the GSI AudioStar Pro from its shipping container. If the instrument appears to have suffered any damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing material so that the claim adjuster can inspect it as well. As soon as the carrier has completed the inspection, notify a Grason-Stadler representative.
If the instrument must be returned to the factory, repack it carefully in the original container, (if possible) and return it prepaid to the factory for the necessary adjustments.
Check that all accessories are received in good condition. If any accessories are missing, a Grason-Stadler representative should be notified immediately.
Page 24
Product Descriptions
Part Number
AudioStar Pro™ Clinical Two-Channel Audiometer
Subject Response Hand switch
8004365
Headset, Operator/Monitor
8030462
Headphones, Assistant (Aux Intercom)
8030463
Extension cable - Assistant headphones, 3.5 meters
8121801
Talk Back Microphone with mounting bracket
8101853
Instruction Manual (AudioStar Pro™), English, paper
8030496
Quick Guide, English, paper
8100770
GSI Suite - Audiometric Data Management
8013063
Cable, USB A/B, 2 meters
8122259
CD, Applications (Config App)
8101169
CD, User manuals & Quick Guides
8101156
Calibration Certificate
8122375
Dust Cover
8013226
Country Kit, USA hospital grade power
8100120
Consists of: power cord and wireless mouse and keyboard
AudioStar Pro with Internal Display
Part Number
TDH
50
B71
EAR
3A
HDA 200
Red
Patch
Cord
Blue Patch
Cord
Grey
Patch
Cord
Black Patch
Cord
8100230
1 ea.
1 ea.
1 ea.
1 ea.
8100107
3 ea.
3 ea.
1 ea.
1 ea.
8100671
2 ea.
2 ea.
1 ea.
1 ea.
8101369
2 ea.
2 ea.
1 ea.
1 ea.
AudioStar Pro without Internal Display
TDH
50
B71
EAR
3A
HDA
200
Red Patch
Cord
Blue Patch
Cord
Grey
Patch
Cord
Black Patch
Cord
8102055
1 ea.
1 ea.
1 ea.
1 ea.
8121622
3 ea.
3 ea.
1 ea.
1 ea.
8121624
2 ea.
2 ea.
1 ea.
1 ea.
8121626
2 ea.
2 ea.
1 ea.
1 ea.
Accessories
NOTE: Part numbers may change periodically. Please see the current GSI price/parts list for current part numbers.
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GSI AudioStar Pro™ Clinical Audiometer
Part Number
Country Description
8100120
United States Power Cord, English
8120249
United States Power Cord, Spanish
8120250
United States Power Cord, Portuguese
8120251
United States Power Cord, French
8100623
European Power Cord, French
8120252
European Power Cord, German
8100624
European Power Cord, Spanish
8120253
European Power Cord, Portuguese
8102218
European Power Cord, Russian
8100448
European Power Cord, English
8100672
United Kingdom Power Cord, English
8120254
Italian Power Cord, Italian
8120255
Italian Power Cord, Spanish
8120256
Swiss Power Cord, German
8120257
Swiss Power Cord, French
8120258
Swiss Power Cord, English
8120259
Danish Power Cord, English
8102037
Israel Power Cord, English
8100625
South African Power Cord, English
8100449
Australian Power Cord, English
8101076
Chinese Power Cord, Chinese
8102713
European Power Cord, Korean
8120260
United States Power Cord, Japanese
8120261
Brazilian Power Cord, Portuguese
Country Kits
GSI Country Kits include a power cord specific to a region of the world and a user manual in the language for the specific country.
Page 26
Connection
Description
Graphic
R1
Mains Power Input
IEC 14
R2
USB Computer Connection
USB B style connector
R3
LAN Connections
Ethernet Connection RJ45 Currently not supported
R4
USB Connectors
USB A style plug
R5
External Monitor Output
HDMI Video only signals, no audio, 600 x 800 resolution
R6
FF Speaker DIN Connection Output
SFS - Sound Field Speaker
5 pin DIN connector Provides connection between the internal amplifier to left and right loudspeakers within a sound room
NOTE:
Free Field Speaker Outputs 1 and 2 are
25 Watts per channel into 8 ohm.
R7
R7
FF Speaker RCA Connections Output
FF Speaker RCA
4 RCA jacks Optionally connect to 4 speakers through an external amplifier using jacks 1 -4 (contact a GSI Representative for more information)
NOTE:
Free Field Line Outputs 1 and 2 are 5
VRMS into a 2000 ohm load.
NOTE:
Cannot use internally amplified
Chapter 3: Connectors, Controls and Indicators
Rear Panel
The connectors on the rear panel of the GSI AudioStar Pro are shown in the following diagram. The label and jacks are visible by turning the instrument around on a flat, stable surface.
R1 R3 R6 R7 R8 R11 R13 R16
R2 R4 R5 R9 R10 R12 R14 R15
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GSI AudioStar Pro™ Clinical Audiometer
Connection
Description
Graphic
Connections Output, cont.
speaker connection and externally amplified speaker connections at the same time.
NOTE:
The CTL connection is for future use –
not currently supported.
R8
Left and Right Headphone Outputs
6.35 mm stereo jack Left (blue) and Right (red)
R9
Patient Response Inputs
6.35 mm mono jack 1 or 2 handswitches may be used
R10
AUX Intercom Output
3.5mm stereo jack Assistant monitor headset connector
R11
Left and Right Insert phone Outputs
6.35 mm stereo jack Left (blue) and Right (red)
R12
VRA Connection Output
3.5 mm stereo jack to activate a left or right VRA system (contact a GSI service representative for details)
R13
Left and Right High Frequency Headset Output
6.35 mm stereo jack Left (blue) and Right (red)
R14
Talkback Microphone Input
3.5 mm stereo jack
NOTE:
Microphone inputs are between .25 mV and 5 mV for a 0 dB reading on a VU indicator; the input impedance is 3,200 ohm.
R15
Ext. A and B
3.5 mm stereo jack Input jacks for optional digital music player or CD player input
NOTE:
External A and B inputs are between 15 mV and 500 mV for a 0 dB reading on a VU indicator; the input impedance is 50,000 ohm.
R16
Bone Vibrator
6.35 mm phone stereo jack
Page 28
NOTE: Do not block access to the power switch.
Connection
Description
Graphic
USB Ports
2 USB ports (A style)
Monitor Headset
3.5 mm stereo jack Monitor microphone
Headphones
3.5 mm stereo jack Monitor speaker
Gooseneck Microphone
6.35 mm stereo jack (optional)
Right Side Panel
Monitor Speaker
Left Side Panel
The power switch is located on the right side panel.
The monitor speaker is located on the right side panel. If there is not anything plugged into the headset jack of the mic/monitor headset, the monitor speaker will be active. The intensity of the Channel 1 and Channel 2 stimuli may be adjusted using the monitor knob on the front panel of the instrument.
The following connectors will be visible on the left side panel of the GSI AudioStar Pro:
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: Scan files on a USB drive for viruses prior to installing the drive into the instrument.
NOTE: It is recommended to always have the USB ports enabled on the PC. Disable the “suspend USB” option on the PC.
USB Port The AudioStar Pro is equipped with four (4) USB ports. It is possible to connect
external devices such as mouse, keyboard, or external printer to be used with the audiometer. Additionally, a memory stick may be inserted into a USB port for updating software, adding additional sound files, or exporting diagnostic log files.
A/B Cable Remote connection to an external computer is achieved through the use of a
standard A/B USB cable.
Page 30
Description
Graphic
Medical Equipment Classified by Intertek Testing Services NA Inc. with respect to electric shock, fire, and mechanical hazards only, in accordance with UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class IIb device.
Caution, consult accompanying documents.
Conforms to European Medical Device Directive 93/94/EEC.
Manufacture Date (year will be inserted below).
China RoHS symbol for products with a 50 year life cycle.
B Patient Applied Part according to IEC 60601-1.
Serial Number and GSI Part Number.
Return to authorized representative, special disposal required.
Manufacturer.
Bottom Panel Label
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GSI AudioStar Pro™ Clinical Audiometer
Chapter 4: Front Panel Controls
The controls on the front panel of the GSI AudioStar Pro are shown below.
Power
The green LED, located in the upper right portion of the front panel, is illuminated when mains power is supplied to the GSI AudioStar Pro. This indicates that the power switch is in the on position.
Stimulus Intensity Level(s)
Test Mic, Input A and Input B Level Controls — To calibrate the test signal for the test microphone or the external devices, use the Select button to activate the LED associated with the device. Then use the rotary knob to adjust the signal intensity until an indication of 0 dB on average is obtained on the selected channel VU meter.
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Note: The talk forward mic may be calibrated using the mic level select
Talk Forward
This rotary control allows the operator to adjust the microphone intensity in a continuous range of 45 to 90 dB HL when communicating through Talk Forward.
The Talk Forward Button allows the operator to speak directly to the patient using the Mic/Monitor headset or optional gooseneck microphone. Pressing and holding the Talk Forward button interrupts the stimulus that is being presented and activates the microphone in all selected transducers on Channel 1 and Channel 2. The GSI AudioStar Pro resumes the test status when the pushbutton is released. The light pipe around the Talk Forward button will be illuminated when enabled.
Left & Right VRA
When an external Visual Reinforcement Audiometry (VRA) remote box is plugged into the VRA jack, and the Left or Right VRA button is pressed and held, it will activate the VRA toy in the corresponding position. Pressing both Right and Left VRA together will activate the Center position on compatible VRA systems.
Interlock
The Interlock pushbutton locks the presentation function of the two channels together so that stimulating one channel will also stimulate the other, according to the status of the Interrupt button. When the Interlock is active, an icon is displayed on the LCD and the light pipe around the button is illuminated.
Tracking
The Tracking pushbutton allows the Channel 2 hearing level to track the Channel 1 hearing level. When in Tracking, any dB change to the Channel 1 HL causes the Channel 2 HL to change by the same amount, until the limit of the Channel 1 transducer is reached. If the dB HL limit is reached in Channel 2 before Channel 1, the Channel 2 dB HL display will temporarily flash and remain at this level. Tracking remains on. When the Channel 1 dB returns to a level at which the selected difference between the two channels can resume, Channel 2 again tracks Channel 1. When tracking is selected, an icon will appear on the screen and the light pipe will be illuminated. It is possible to manually change the intensity of Channel 2 to alter the dB difference between the two channels without deselecting Tracking.
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GSI AudioStar Pro™ Clinical Audiometer
Status / Audiogram Button
The Status / Audiogram button is used to select the format for the screen display. Pressing it will switch the screen between displaying the Status screen and the Audiogram screen for the Tone, High Frequency, TEN and Speech Test Types. On the Tone and High Frequency test types, this button allows access to the Fine Frequency Resolution option for detailed frequency testing.
Data Transfer
When the Data Transfer button is pressed, a data record containing the stored test data is transmitted to an external computer. Data is transferred as a complete battery of all saved test results. The data transfer format is configurable – see details regarding the data format options in the GSI Instrument Services manual.
Printing
If the appropriate printer is connected to the AudioStar Pro and the printer has been configured properly using the Configuration Application Software, the current stored test information is sent directly to the printer when the Print pushbutton is pressed.
An HP color printer may be attached to the GSI AudioStar Pro to allow printing of the audiometric test results directly from the AudioStar Pro. The HP Printer must be PCL 5E, PCL 3, or PCL 3 GUI compatible.
Instrument Operation While Printing
The GSI AudioStar Pro remains operational while printing with the following exceptions: pressing the Data Erase, Store or Data Transfer pushbuttons while printing will result in the error message Please try another selection.
Print Messages
Printing A status bar will indicate the printing progress after the print button has
been pressed.
Check Printer Connection and Paper If there is an error detected during printing, it is also recommended that the printer protocol in the configuration application is verified.
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Printer Output Formats
The printout formats are shown in the following figures.
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GSI AudioStar Pro™ Clinical Audiometer
Page 36
NOTE: The selection of Tone on Channel 1 and Mic on Channel 2 is a valid combination. This setting allows the operator to have contact with the patient, especially a young child, without the need to select Talk Forward.
NOTE: When using a digital music player, select the level using the calibration track. First adjust the volume on the device until the VU meter reads nearly 0 dB, then fine tune the intensity using the level selection.
Stimulus Channel 1 and Channel 2
Tone — The Tone pushbutton allows the selection of a pure tone stimulus for air/bone conduction testing with the choice of five transducer types.
Mic — The Mic pushbutton provides input capability from the test microphone for monitored live-voice testing with the choice of five transducer types.
Int./Ext. A, Int./Ext. B — Internal A and Internal B provide access to internal .Wav files that may be used for recorded speech testing. External A and External B accept recorded audiometric material from an optional digital music player or compact disc player.
Narrow Band Noise — The NB Noise pushbutton selects a noise which is geometrically centered at the selected test frequency and contains a 3 dB down bandwidth of a 1/3 octave at a minimum and ½ octave at a maximum.
Speech Noise — The Speech Noise pushbutton selects speech noise that is calibrated in effective masking level and contains a spectrum of equal energy per frequency from 100 to 1,000 Hz with a 12 dB/octave roll-off from 1,000 to 6,000 Hz.
White Noise — The White pushbutton selects White Noise which is a broad band signal containing acoustic energy at all frequencies between 125 Hz and 12,000 Hz. White noise is calibrated for pure tone effective masking if a tone type signal is selected on the opposite channel and for speech effective masking if a speech type signal is selected on the opposite channel.
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GSI AudioStar Pro™ Clinical Audiometer
Channel 1 Stimulus
Tone
Mic
Ext. A
Ext. B
NB
Noise
S Noise
White Noise
Channel 2
Stimulus
Tone
Valid
Valid
Valid
Valid
Valid
Invalid
Valid
Mic
Valid
Valid
Valid
Valid
Invalid
Valid
Valid
Ext. A
Valid
Valid
Valid
Valid
Invalid
Valid
Valid
Ext. B
Valid
Valid
Valid
Valid
Invalid
Valid
Valid
NBNoise
Valid
Invalid
Invalid
Invalid
Valid
Invalid
Invalid
S Noise
Invalid
Valid
Valid
Valid
Invalid
Valid
Invalid
W Noise*
Valid
Valid
Valid
Valid
Invalid
Invalid
Valid
NOTE: If White Noise is selected on both channels, then calibration is set to speech effective masking levels. If White Noise is selected on one channel only, calibration will be set to mask the stimulus type on the opposite channel.
Channel 1
Phone
Bone
Speaker
Insert
High
Freq.
Phones
Channel 2
Phone
Valid
Valid
Valid
Invalid
Invalid
Bone
Valid
Valid
Valid
Valid
Valid
Speaker
Valid
Valid
Valid
Valid
Valid
Insert
Invalid
Valid
Valid
Valid
Invalid
High Freq.
Phones
Invalid
Valid
Valid
Invalid
Valid
The selection of any stimulus will deselect a previously selected stimulus on the opposite channel if the stimuli are not compatible. Refer to the following table for the stimuli compatibilities listing:
Valid Stimuli Combinations
Transducer Output Selector
The Transducer pushbuttons allow the easy selection of the transducer for each stimulus available for Channel 1 and Channel 2. A transducer selection may be changed at anytime.
Valid Transducer Combinations
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Note: When using four speakers a single channel can have a maximum of three speakers. The total of all channels cannot exceed four
Routing Output
The Routing pushbuttons determine the routing for the stimulus to the output transducer selected for Channel 1 and Channel 2. Left/Right delivers the stimuli from the selected channel to both the left and right transducers with the combined signal. Both the Channel 1 and Channel 2 maximum dB HL limits are appropriately decreased from the non-mixed maximum dB HL limits.
The AudioStar Pro can support four speakers. Using a four speaker configuration requires the instrument to be calibrated to accommodate all speakers. Additionally, the speaker defaults and descriptions must be defined in the Config App. When using four speakers a speaker routing dialog is displayed when the Left/Right routing is selected and the transducer is speaker.
Attenuators (HL Controls)
Channel 1 and Channel 2
The GSI AudioStar Pro contains two independent HL rotary controls for test
signal and masking intensity level control with a range of -10 dB HL to 120 dB. HL Maximum dB HL values apply to the mid-frequencies with earphones only. Refer to the specific transducer for dB HL limits in the Table in Appendix 1.
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GSI AudioStar Pro™ Clinical Audiometer
Present Bar / Interrupt
The function of the present bar in each channel is determined by the status of its Interrupt button. When the interrupt button is in the off position, pressing the present bar presents the stimulus to the selected transducer(s) for as long as the present bar is depressed. The channel turns off immediately when the bar is released. When the Interrupt button is in the on position, the corresponding channel is deactivated by pressing the present bar and activated by releasing the bar. Both the Interrupt buttons and present bars in each channel operate independently of the other. Note that in the ABLB test mode, the Interrupt pushbuttons do not operate independently of each other.
Frequency Up / Down
The Frequency pushbuttons allow the selection of twelve standard audiometric frequencies and nine high frequencies with the High Frequency option. When at the lower limit of the frequency selection, pressing the (<) pushbutton will cause the display to roll over to the highest frequency limit, and vice versa. If a transducer with a narrower range is selected, only the valid frequencies for that transducer are available. The frequency order is configurable by using the Configuration Application software.
Data Store
The Store pushbutton, when pressed, saves the current dB HL level representing the current data point (threshold level, MCL, UCL, tinnitus,aided sound field, cochlear implant and effective masking level if selected, as well as transducers and routing. Pressing Store in the Speech testing mode will save the current test type, word list, score and other applicable speech data. In the Display Audiogram format, the appropriate symbol appears each time the Store button is pressed.
Navigation Controls
The four navigation buttons and the middle select button may be used to make selections from the on-screen menus as well as navigate through the internal .Wav files for speech testing.
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NOTE: The timer may also be started by pressing the patient response button in the Tone Decay test. The timer will be active as long as the patient response button is depressed. When the patient response button is released, the timer will be paused and may be resumed by pressing and holding the patient response button again.
Icon
Description
Front Panel
Configuratio n
Examiner, Ch1 and Ch2 sounds can be heard by the assistant
On
Checked
Ch1 and Ch2 sounds can be heard by the assistant
Off
Checked
No sound goes the assistant monitor headphones
On/Off
Unchecked
Scorer / Timer
The Correct, Clear and Incorrect pushbuttons are used for scoring results in Speech, QuickSIN, BKB-SIN and SISI tests. The scorer is displayed in the test status area of the Status screen. When Speech, QuickSIN, BKB-SIN or SISI is selected, the scorer initializes to 0/0 = 0%. The operator presses the Correct or Incorrect pushbutton after each presentation to score the evaluation. The display clears with the pressing of the Clear pushbutton.
During Tone Decay tests, the Scorer/Timer pushbuttons may be used to start, pause, stop and clear the timer. The timer is displayed in the test status area of the Status screen. The timer may be set to stop at 1, 2, 3 or 4 minutes. The timer may be paused and resumed at any point by pressing the Pause pushbutton. Pressing Stop will stop the timer, but leave the current time displayed. Pressing Start will reset the timer to 0:00 and restart the timer.
Aux Intercom
In Pure Tone testing, if the Incorrect/Stop button is pressed instead of the Store button the No Response (NR) symbol is stored and displayed on the current frequency and intensity on the audiogram.
When the AUX Intercom button is pressed, there may be direct communication between the Operator and an Assistant. The assistant monitor headset allows the assistant to monitor signals being delivered to the patient with the same settings as the operator’s Microphone / Monitor headset. The Aux Intercom can be configured as a toggle with the Configuration Application software. The button may also be disabled from the Configure button on the device.
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GSI AudioStar Pro™ Clinical Audiometer
Monitoring
Channel 1 (CH 1), Channel 2 (CH 2), AUX Intercom, Talkback Controls
The Monitor Headset or Internal Speaker allows the operator to listen to the
stimuli as they are presented and to listen to the patient’s comments through the
talk-back system. The Assistant monitor headphones allow an assistant to listen to the stimuli as they are presented and to listen to operator via the AUX intercom. Adjust the Channel 1 (CH 1) and Channel 2 (CH 2) signals by using the select button to choose the appropriate signal to be adjusted and then rotating the knob to the desired intensity for the operator (and assistant). Select Talkback
to adjust the intensity of the patient’s voice for the operator. Select the AUX
Intercom to adjust the intensity of the operator’s voice for the Assistant
When Mic is selected, or when the Talk Forward is operated, that channel’s input
to the monitor speaker is disabled to reduce acoustic feedback.
Test Type Buttons
Test Type buttons allow the operator transition between audiometric evaluation components with a single button press. Pressing a test type button loads all stimuli, routing and transducer preferences from default settings or from customized protocols determined in the Config App. Test types are pre­programmed to optimize efficiency and workflow.
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Function Buttons
Examiner - This button displays a list of examiners that may be assigned to each test session. Additional examiner names and security options are defined in the configuration application.
Patient - This button displays a screen that allows the examiner to create a new session, enter patient demographics, select a patient from the patient list, import a patient list, transfer a session and delete a session.
Data Erase - This button erases user defined data from the internal memory. The user may select to erase a single data point, the last curve or all session data.
Configure - From this screen, it is possible to view the instrument information such as serial number, software version and the custom logo. This button displays setup options to update the AudioStar Pro software, set the date and time, configure bone conduction symbol settings, set the print format, enable/disable the Aux Intercom and adjust the screen brightness.
Update - Place a USB drive with the appropriate update loaded into one
Date and Time - Select to change the date format and update the time
Bone - Select the symbol scheme for bone conduction testing. Choose
Print - Select to change the printing format for the current session. When
Aux Intercom - Select to turn off the Aux Intercom. When the box is
Brightness - Select to change the brightness of the screen.
of the four USB ports. Select Update and then select from device or sound files to update the instrument. Software and Sound File updates must be obtained from GSI or an authorized GSI representative.
displayed on the AudioStar Pro. It is necessary to use a keyboard to update the date and time from the stand-alone instrument.
between Mastoid and Forehead. This selection will be active throughout the current session. When a new session is started, the symbol scheme will revert to the configured preference.
a new session is started, the print format will revert to the configured preference.
checked the Aux Intercom is enabled. If the box is not checked the Aux Intercom is disabled.
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GSI AudioStar Pro™ Clinical Audiometer
Keyboard Key
Instrument Function
B
Routing - Left/Right
F
Transducer - Speaker
H
Transducer – High Frequency Phone
I
Transducer - Insert
K
Interlock
L
Routing – Ch 1 Left Ch 2 Right
M
Masking
N
Tone No Response
P
Transducer - Phone
R
Routing – Ch 1 Right Ch 2 Left
S
Store
T
Tracking
V
Transducer - Bone
Space Bar
Ch 1 Present
Up Arrow
Ch 1 Increase Intensity
Down Arrow
Ch 1 Decrease Intensity
Right Arrow
Ch 1 Increase Frequency
Left Arrow
Ch 1 Decrease Frequency
Page Up
Ch 2 Increase Intensity
Page Down
Ch 2 Decrease Intensity
+ or =
Correct/Start
-
Incorrect/Stop
NOTE: channel 1 is always the stimulus and channel 2 is always masking when using remote functionality
Keyboard
The AudioStar Pro works with a keyboard and many of the operations of the front panel keys on the instrument may be performed using the keyboard. The following table shows the mapping of the keyboard keys to the instrument.
Page 44
NOTE: Recommended specifications for external monitor are as follows: HDMI high definition monitor, 21.5 inch screen that supports 800 x 600 resolution in order to maintain the aspect ratio of the audiogram.
NOTE: The time does not change automatically for daylight savings time. The operator must manually change the time using the configure button on the front panel of the instrument or the configuration application.
Chapter 5: Test Type Displays
Monitor
The AudioStar Pro comes standard with an LCD display. The LCD is hinged to the GSI AudioStar Pro and is used to display all of the testing information from the instrument. When the LCD is in the lowered position, easy access to the rear connector panel is provided. It is possible to order the AudioStar Pro without the LCD display and connect it to an external HDMI compatible monitor.
Test Type Screens
The information displayed on the AudioStar Pro LCD varies depending on the Test Type. There are common elements found on all screens such as the Channel 1 and 2 intensity settings, the Navigation menu and the Title Bar.
Title Bar
The title bar is located at the top of the display. The title bar displays the test type in the middle. The patient name will appear on the left side of the title bar if a patient name has been entered (or selected from an imported patient list). The right side of the title bar displays the examiner name if examiners have been entered. The examiners can be entered from the Configuration application.
Test Type Information
Under the title bar test specific information will be displayed. On the left and right side, the current output in dB HL for Channel 1 and Channel 2 will be displayed. The other information displayed will depend on the test type and is described as part of the individual test type displays.
Navigation Menu
This menu is located at the bottom of the display. It utilizes the on-board navigation buttons or an external mouse to access the menu options. The menu is specific to the test type selected.
Time and Date
The date and time are displayed in the bottom right corner of the screen. Using the Configuration Application, the Time can be configured in a 12 or 24 hour format and the Date can be configured in any order (dd/mm/yyyy, etc.). It is also possible to set the format on the configuration screen of the instrument. It is necessary to use an external keyboard to change the date and time from the configure screen of the instrument.
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GSI AudioStar Pro™ Clinical Audiometer
BVRA
Common Icons
These icons are found in the test information area and common to the different test types
Talk Forward When pressed, a head with a headset icon will appear. This icon will remain active as long as the talk forward button is depressed.
Store When either of the store buttons is pressed, a floppy disc icon flashes and the result is then displayed.
Interlock – When interlock is active, a padlock icon will appear.
Tracking – When tracking is selected, a railroad track icon will appear. Aux Intercom – When pressed, the Aux intercom icon indicates direct
communication between the operator and the Aux headset.
Data Transfer When there is an active connection between the AudioStar Pro and an external computer, communication will be indicated by the blue arrows.
Left and Right VRA A two-toy VRA system may be connected to the AudioStar Pro. The LVRA and RVRA icons will appear on the display when the front panel buttons have been pressed to activate the VRA system. Pressing both buttons will send the signal to the center toy in GSI compatible VRA systems. Pressing both buttons will display a BVRA icon.
Pencil Icon
This icon opens a comments window (must use external keyboard to utilize comment section). Comments may be entered from any test screen and it is possible to review and edit comments from any test screen.
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Tone Test Type - Audiogram
Tone Test - Audiogram Display
Title Bar
On the left side of the title bar, the patient name, if entered, will be displayed. In the center of the title bar, the test type (Pure Tone) will be displayed. On the right side of the title bar, the examiner name will be displayed. An underline on any item on the display indicates that a choice may be made using the mouse. In the title bar it is possible to select a patient, test type or examiner using the mouse to display a drop down menu of the selection choices.
Channel 1 and Channel 2 Windows
The Channel 1 and 2 windows display the current output for each channel. The sound wave symbol indicates that a stimulus is being presented. This sound wave will be present as long as the present bar is depressed, will flash to indicate a pulsed stimulus, and will be steady if “interrupt” is in the on position. The intensity of the stimulus will be displayed in the color of the ear that has been
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GSI AudioStar Pro™ Clinical Audiometer
selected for each channel. If Left/Right routing is selected, the Channel color will be black. At extreme intensity levels, the intensity value will be highlighted in yellow. When the attenuator has reached its upper limit (per transducer and frequency), an NR label will be displayed (and highlighted in yellow if the intensity is 100 dB or more), indicating No Response. The signal type (pulsed, FM, pulsed/FM, steady), ear selected and transducer selected are displayed at the bottom of the channel windows. The signal type, ear and transducer may be selected with the mouse to display a drop down list of options for selection.
Frequency Window
This window will display the test frequency. When a patient response switch is used, a bar will flash below the frequency when the patient depresses the button. This bar will be gray if only one response switch is used. If two response switches are used, then the bar will be blue for a left response and red for a right response.
On Screen Data Logging
The Pure Tone Average (PTA) for air and bone conduction is automatically calculated as the threshold data is collected. The frequencies used for the PTA may be defined in the Configuration application.
The Speech Intelligibility Index (SII) is automatically calculated as the threshold data is collected. The perception of speech information that is audible and usable for each patient based on pure tone thresholds can be quickly calculated. There is a high correlation between SII and word recognition scores.
Reliability may be reported as good, fair, or poor at any time throughout the evaluation to indicate the validity of the results of the tests. None indicates that the reliability was not labeled. Additional labels may be defined in the configuration application. The reliability may be assigned by using the navigation buttons in the comments window of the instrument. By clicking on the reliability underline with the mouse a menu of reliability items defined by the Configuration application will be displayed.
Audiogram View
Selecting the Audiogram viewing mode displays the audiometric data in graphic format. The user may determine the layout of the audiogram graphs (Right/Left, Left/Right, or combined into a single graph). Press and hold the Test Type Tone button for two seconds to change the graph view.
Black crosshairs on the graph indicate position of the attenuator and oscillator. The appropriate symbols will be displayed on the audiogram after either of the Store buttons has been pressed. The effective masking levels for air conduction and bone conduction will be displayed below the audiogram graphs.
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NOTE: When HA or CI is selected the transducer will automatically change to speakers as the selected transducer and FM as the signal type.
Navigation Menu
Signal Menu
Decibel (dB) Step
Threshold Test Type
Aided
The navigation menu contains the options for the Tone test type. The options may be selected by using the navigation keys on the instrument or by using a mouse. The right side of the menu displays the current date and time.
The signal menu displays a sub menu with the choices of signal type.
Steady – Indicates a steady pure tone or noise signal. FM – Applies a frequency modulation (warble) to a pure tone stimulus. Pulsed – Any signal or masking signal may be pulsed including narrow
band noise for a pediatric-focused stimulus.
FM/Pulsed – Applies both a warble and a pulse to the test signal Ped Noise – Pediatric noise – a steeply filtered noise providing a
frequency specific signal and presented in HL
PN/Pulsed – Pulsed pediatric noise Lock Menu – Locks the signal dialog box - the dialog box will remain on
the screen for efficient changing of signal types.
The dB Step button toggles the choices for the decibel steps. Each time this option is selected with the navigation button or a mouse, the step size moves to the next option. The options for dB step size are
1 dB 2 dB 5 dB
The Test Type button display a sub menu with the choices for the test type level.
HTL – Hearing Threshold Level. The appropriate threshold symbols will
be stored on the audiogram when HTL is selected.
 MCL – Most Comfortable Level. An “M” symbol will be displayed.  UCL – Uncomfortable Level. A “U” symbol will be displayed.  Tinn – Tinnitus level. A “t” symbol will be displayed.
The Aided menu has 3 options that toggle each time the button is selected.
Blank Aided (HA) Cochlear Implant (CI)
When the box is HA or CI, the aided or cochlear implant symbol will appear on the audiogram.
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: Only the frequencies appropriate for the test type are presented. If a high frequency is included in the frequency list and the test type is standard, only the standard frequencies are presented.
Auto Hz
The Auto Hz button controls whether or not the frequency automatically advances to the next frequency to be tested when the store button is pressed. The frequency presentation order is defined in the Configuration application. When the Auto Hz option is checked, each time a threshold is stored (pressing Store) the frequency will advance to the next test frequency automatically. If the option is not checked, the frequency must be changed using the frequency buttons on the front panel of the instrument.
Comments
This pencil icon opens a comments window (must use external keyboard to utilize comment section). Comments may be entered from any test screen and it is possible to review and edit comments from any test screen.
Stenger Test Results
In addition to entering comments, the dialog has the options for recording Stenger test results (both pure tone and speech). The Stenger buttons on the comments dialog may be toggled to indicate a positive or negative test result. Off indicates that the test was not performed.
Reliability
The comments dialog also contains the option to record the patient test reliability. Selecting the Reliability button from the comments dialog displays the options for reliability. The options for the reliability label are defined in the Configuration application.
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High Frequency Test Type - Audiogram
The display for the High Frequency and the Tone tests are similar except for the “range” option on the navigation menu. The High Frequency Range display does not have the data calculations for the PTA or SII and only displays frequencies from 8 kHz to 20 kHz.
The high frequency headphones (Sennheiser HDA 200/300) may be calibrated from 125 Hz to 20 kHz. The display view may be configured as high frequencies only from 8 kHz to 20 kHz or full frequency range from 125 Hz to 20 kHz. Use the Range Selection button on the Navigation Menu to select the high frequency range or the full frequency range.
High Frequency - Audiogram Display
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GSI AudioStar Pro™ Clinical Audiometer
Full Frequency Test Type - Audiogram
The display for the Full Frequency and the Tone tests are identical except for the “range” option on the navigation menu and the additional high frequencies displayed in the audiogram.
The high frequency headphones (Sennheiser HDA 200/300) may be calibrated from 125 Hz to 20 kHz. The display view may be configured as high frequencies only from 8 kHz to 20 kHz or full frequency range from 125 Hz to 20 kHz. Use the Range Selection button on the Navigation Menu to select the high frequency range or the full frequency range.
Full Frequency Audiogram Display
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Tone Test Type - Status
Tone Test Status Display
The Status display for the Tone Test Type presents the data in a tabular format. The columns indicate the frequency, dB HL level and the effective masking level (dB EM). The display contains the same elements as the audiogram display. You may navigate the list of frequencies using the mouse or the frequency keys. The Navigation Menu is similar to the audiogram Navigation Menu but has one additional button – Fine Hz.
Fine Frequency Resolution
The Fine Hz button allows the user to select from a sub menu of different octave band frequency resolutions and single hertz resolution. When an octave band or single hertz resolution is selected the table is updated with the available
frequencies. Navigation keys on the right and left of the table provide ‘page’
movement in the list. If the resolution is 1 Hz then there are additional movement icons that move the table in 1000 Hz increments.
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GSI AudioStar Pro™ Clinical Audiometer
Tone Test Status Display – Single Hz Resolution
The right and left outlined areas show the list navigation icons. The top (darker icon) moves +/- 1000 Hz and the other arrow moves to the next/previous page.
High Frequency Test Type – Status Full Frequency Test Type - Status
The display for the High Frequency and Full Frequency Status and the Tone Test Status are identical except for the “range” option on the Navigation Menu. Use the Range Selection button on the Navigation Menu to select the high frequency range or the full frequency range.
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Speech Test Type - Status
Speech Test Status Display
Title Bar
On the left side of the title bar, the patient name, if entered, will be displayed. In the center of the title bar, the test type (Speech) will be displayed. On the right side of the title bar, the examiner name will be displayed. An underline on any item on the display indicates that a choice may be made using the mouse. In the title bar, it is possible to select a patient, test type or examiner using the mouse to display a drop down menu of the selection choices.
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: When using internal .Wav files, the Correct, Incorrect and Clear buttons are inactive while the stimulus is being presented.
Channel 1 and Channel 2 Windows
The sound wave icon and the VU meter indicate when a stimulus is being presented. The sound wave icon and VU meter will remain active through the duration of the stimulus.
The intensity of the stimulus will be displayed in the color of the ear that has been selected for each channel (red for right, blue for left and black for binaural). At extreme intensity levels, the intensity value will be highlighted in yellow. When the attenuator has reached its upper limit (per transducer) the level will flash and the NR symbol will appear.
The stimulus source (Microphone, INT/EXT A or INT/EXT B), ear selected, and transducer selected are displayed at the bottom of the channel windows. The signal type, ear and transducer may be selected with the mouse to display a drop down list of choices for selection.
Scoring Window
This scoring window displays the speech scores in a percentage value. The scores are populated using the Correct/Incorrect buttons on the front panel of the instrument. The left side indicates the number of correct responses over the total presented. The right side converts this into a percentage. The lower part indicates the current word being presented.
On Screen Data Logging
Pure Tone Average (PTA) for air and bone conduction is automatically populated from the tone test screen if the data is available. The audiologist may
quickly compare the results of the PTA with the results of the Speech Reception Threshold (SRT) or Speech Detection Threshold (SDT) to rule out the possibility of pseudohypoacousis.
Speech Intelligibility Index (SII) is automatically populated from the tone test screen if the data is available. The audiologist may quickly quantify the speech information that is audible to the patient and compare to the word recognition score (WRS). There is a high correlation between SII and WRS.
Speech Test Results
The Speech Test Results Table displays the speech information for the tests that
have been stored. To store a speech test result the Store button is pressed on the
instrument. The results table stores the ear, test type speech source, the word list
presented, if an aid (hearing aid or cochlear implant) was used by the patient, the
percentage correct, the HL level and the masking level. There are two tables and
each table can hold up to 6 tests.
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Words/Sentences for Presentation
Navigation Menu
Test Type
Word Lists
Word Nav
The lower part of the Speech display shows the words from the selected word list. The words on the list may be presented by selecting the word with the mouse or by using the navigation buttons on the device (and the Word Nav option from the Navigation Menu) to highlight the word and pressing the present button. When a word is being presented, the background of the selected word will be highlighted in yellow. As the words are scored by pressing the correct or incorrect button, the correct word cells are colored green and the incorrect word cells are colored red. If more words are on the list than can be displayed, additional pages are used. This is indicated in the top right area of the word list title bar. There are up/down arrows that allow movement between pages using the mouse. When the last word on the list is presented the next page will be displayed. Using the navigation buttons on the instrument you can move to the next page by pressing the down or right navigation key on the last word in the list.
Select SRT (Speech Reception Threshold), SDT (Speech Detection Threshold), WRS (Word Recognition Score), SRS (Speech/Sentence Recognition Score), MCL (Most Comfortable Level) or UCL (Uncomfortable Level); this will determine how the record is scored and labeled.
Using the on-board navigation keys or an external mouse, selecting this button will pull up a menu of available word list options. The operator may select the source (internal or external), the CD name (protocol of assorted word lists such as Adult Basic Evaluation or Child Basic Evaluation) and the word list. When the word list has been selected by pressing Save, the dialog box will disappear and the words will appear in the bottom half of the display screen. There is a favorite list at the top of the word list dialog. This favorite list is specific to the test type and is set up in the Configuration application. The favorite list is automatically populated when the test type is selected.
When selected, this option presents a sub menu of options. The Manual option moves the cursor control to the word lists and allows the operator to use the navigation buttons to scroll to specific words in the internal word lists. To return
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: In Manual mode, highlight the desired word and press the presentation bar to present the word. When the word is presented, it will be highlighted yellow. When the yellow highlight disappears, score the word and move to the next test word using the navigation keys. If a score is indicated before the highlight disappears it might not be accepted as a score.
NOTE: When scoring phonemes (CVC, etc), it is necessary to deselect the Auto Advance option to ensure that three “scores” may be entered per word
NOTE: When HA or CI is selected the transducer will automatically change to speakers as the selected transducer.
to the Navigation Menu, deselect Word Nav (by pressing the select key of the navigation controls). The Auto Advance check box determines the word movement behavior that is set up in the Configuration application. The Auto Advance moves to the next word in the list after a score key (Correct/Incorrect) is pressed. The Auto Play option has a box indicating the time (in seconds) and up/down arrows to adjust the time. The Auto Play option will automatically present the word and the time is how long between the word presentations. Auto Play is activated by pressing the interrupt button. The Configuration application defines the behavior of the Auto Play option. The auto play option may be defined to do one of the following; wait for a score, score as correct, incorrect or no score when the time expires.
Aided
Select this box to indicate if the word list was presented in an aided condition. The Aided menu has 3 options that toggle each time the button is selected.
Decibel (dB) Step
The dB Step button toggles the choices for the decibel steps. Each time this option is selected with the navigation button or a mouse, the step size moves to the next option. The options for dB step size are
Display PT Audiogram
The audiogram checkbox displays the pure tone air conduction audiogram in place of half of the Speech test Results table. This button acts as a toggle to display the audiogram or speech results table. The audiogram that is displayed is for the ear being tested.
Blank Aided (HA) Cochlear Implant (CI)
1 dB 2 dB 5 dB
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Speech Test Status Display – Pure Tone AC Audiogram
Comments
This pencil icon opens a comments window (must use external keyboard to utilize comment section). Comments may be entered from any test screen and it is possible to review and edit comments from any test screen.
Stenger Test Results
In addition to entering comments, the dialog has the options for recording Stenger test results (both pure tone and speech). The Stenger buttons on the comments dialog may be toggled to indicate a positive or negative test result. Off indicates that the test was not performed.
Reliability
The comments dialog also contains the option to record the patient test reliability. Selecting the Reliability button from the comments dialog displays the options for reliability. The options for the reliability label are defined in the Configuration application.
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GSI AudioStar Pro™ Clinical Audiometer
Speech Test Type - Audiogram
Speech Test Audiogram Display
This Speech Test Audiogram displays speech results in a graphic format and has the Rollover Index Table. The display for the Speech Test Audiogram is identical to the Speech Test Status display except for middle section of the display. The Speech Test Results tables are replaced with the Speech Audiogram and Speech Rollover Results Table. One new menu option, New Curve, is added to the Navigation Menu.
The SRT score will be plotted on the Speech Audiogram at 50% on the corresponding intensity. Word recognition scores will be plotted on the Speech Audiogram based on the intensity at which the test was performed and the score that was achieved. As additional WRS are plotted, the AudioStar Pro will determine PIPB (Performance Intensity Function for Phonetically Balanced Words) function. PIPB function is tested by comparing two (2) or more WRS results performed at different intensities. It will automatically calculate and display in the table the Rollover index when enough data is available.
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NOTE: Only curves with PIPB Rollover will be displayed in the rollover results table.
Navigation Menu
The Navigation menu has the same functionality and selections as the Speech Status display and the addition of the New Curve menu item.
New Curve
The new curve button on the Navigation Menu starts a new curve on the speech audiogram. The current data is maintained and you can start a new test collecting SRT and WRS data that will be plotted on the graph and resulted displayed in the Speech Rollover Results table.
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More Test Type ABLB
In ABLB (Alternate Binaural Loudness Balance) test the tone is presented alternately between the two ears. The level of the tone stays the same in one ear (i.e. fixed ear) and is varied up / down in the other ear (i.e. variable ear).
The top section ABLB test display has common elements found on the previously described screens. The Navigation Menu has a single option for the dB Step in addition to the comment icon. The results should be stored as a comment.
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Note: In order to obtain a SNR loss the age range must be indicated in the Age box of the Navigation Menu.
BKB-SIN
The BKB-SIN is a speech-in-noise test that uses BKB (Bamford-Kowal-Bench) sentences, recorded in four-talker babble. The BKB-SIN can be used to estimate SNR loss in children and adults for whom the QuickSIN test is too difficult.
The BKB-SIN display has the Title bar and the Channel 1 and 2 Output sections that are similar to what has been described for the speech displays.
Scoring Window
There are two scoring windows in the middle of the top section of the display. The scoring windows show the calculated average of the individual list test scores. The scores are separated for the ear and group and reported as the SNR loss. There can be two groups for comparison.
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BKB-SIN Test Results
The BKB-SIN Test Results Table displays the information for the tests that have
been stored. The data is separated by ear and group. The results include the
SNR 50 and the SNR Loss. For details on the scoring see the BKB-SIN manual.
The SNR Loss can only be calculated if the age range is indicated in the Age
button on the Navigation menu.
BKB-SIN Sentences and Score
The lower section of the display contains the BKB-SIN sentences. The capitalized words indicate the target words to be scored. Next to the sentence is the score box for the sentence with an indication of the Signal to Noise (S/N) ratio for the sentence.
The sentence on the list may be chosen for presentation by selecting with the mouse or by using the navigation buttons on the device (and the Word Nav option from the Navigation Menu) to highlight the sentence and pressing the present button. When a sentence is being presented the background will be highlighted yellow. The sentences are scored by pressing the correct or incorrect button, the appropriate number of times. If more sentences are on the list than can be displayed, additional pages are used. This is indicated in the top right area of the sentence list title bar. There are up/down arrows that allow movement between pages using the mouse. When the last sentence on the list is presented the next page will be displayed. Using the navigation buttons on the instrument, move to the next page by pressing the down or right navigation key on the last sentence in the list.
Navigation Menu
The Navigation Menu contains options that are the same as those previously described for the speech displays. The Word List, Word Nav, Aided, dB Step and the comment icon items function the same as in the Speech display. The Navigation Menu also contains items unique to the BKB-SIN test.
Age
The age menu item is a toggle that provides a choice of age ranges for the patient. This information is necessary to score the results and provide an SNR loss calculation. The age range is automatically set if the patient date of birth has
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Note: When using Split Track I both Channel 1 and 2 outputs should be set to the same HL level. If the output HL is different for the channels then the S/N ratio will not be correctly maintained.
Group
Research
been entered in the demographic information. If the date of birth has not been entered, toggle the age button to choose the appropriate age range. The selections correspond to the BKB-SIN test norms.
The Group menu item acts as a toggle to indicate the ‘group’ for the testing. In
the BKB-SIN test, up to 2 groups may be used to compare different conditions. Such comparisons might be used to demonstrate the benefits of amplification (unaided vs. aided) or assess directional microphone performance (no directional mic vs. directional mic). The BKB-SIN Test is a flexible tool that may be applied clinically in a variety of ways by adjusting the presentation level or the presentation mode.
The Research menu item is a check box to indicate that the system is in Research mode. Research mode is designed for research and special applications. In the Research mode the Output for Channel 1 and 2 may be controlled independently. In the ‘Standard’ mode the Output for Channel 2 cannot be adjusted. The Split Track lists should be used for Research mode. The standard BKB-SIN sentences have the target talker and background babble recorded on the same channel and the S/N ratio integrated into the recording. The Split Track lists provide the ability to control the signal and noise in ways not available in the standard sentences.
Split Track I
In these recordings the target talker and background babble are recorded on separate channels (Channel 1 = target talker, Channel 2 = background babble) so the speech and babble may be presented through separate loudspeakers in the sound field. When the audiometer attenuators are set correctly (both attenuators set to identical presentation levels) these tracks maintain the same signal-to-noise ratios as on the standard recording; that is, the signal-to-noise ratio automatically changes by 3 dB for each sentence.
Split Track II
Both channels of these tracks (Channel 1 = target talker, Channel 2 = background babble) were recorded at a constant overall level. The signal-to-noise ratios do not change automatically after each sentence; the tester must manually adjust the level of the target talker and/or the background babble to change the signal-to­noise ratio.
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QuickSIN
The QuickSIN is a speech-in-noise test that quickly and easily measures the ability to understand speech in noise. The QuickSIN is comprised of sentences recorded in four-talker babble.
The QuickSIN display has the Title bar and the Channel 1 and 2 Output sections that are similar to what has been described for the speech displays.
Scoring Window
There are two scoring windows in the middle of the top section of the display. The scoring windows display the calculated average of the individual list test scores. The scores are separated for the ear, group, QuickSIN sentence type and are reported as the SNR loss. There can be two groups so that comparisons may be made.
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QuickSIN Test Results
QuickSIN Sentences and Score
The QuickSIN Test Results Table displays the information for the tests that have been stored. The data is separated by ear and group. The results include the SNR 50 and the SNR Loss. For details on the scoring see the QuickSIN manual.
Navigation Menu
The lower section of the display contains the QuickSIN sentences. The capitalized words indicate the target words to be scored. Next to the sentence is the score box for the sentence with an indication of the Signal to Noise (S/N) ratio for the sentence.
The sentence on the list may be chosen for presentation by selecting with the mouse or by using the navigation buttons on the device (and the Word Nav option from the Navigation Menu) to highlight the sentence and pressing the present button. When a sentence is being presented the background will be highlighted yellow. The sentences are scored by pressing the correct or incorrect button, the appropriate number of times. If more sentences are on the list than can be displayed, additional pages are used. This is indicated in the top right area of the sentence list title bar. There are up/down arrows that allow movement between pages using the mouse. When the last sentence on the list is presented the next page will be displayed. Using the navigation buttons on the instrument, move to the next page by pressing the down or right navigation key on the last sentence in the list.
The Navigation Menu contains options that are the same as those previously described for the speech displays. The Word List, Word Nav, Aided, dB Step and the comment icon items function the same as in the Speech display. The Navigation Menu also contains items unique to the QuickSIN test.
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Group
The Group menu item acts as a toggle to indicate the ‘group’ for the testing. In
the QuickSIN test, up to 2 groups may be used to compare different conditions. Such comparisons might be used to demonstrate the benefits of amplification (unaided vs. aided) or assess directional microphone performance (no directional mic vs. directional mic). The QuickSIN Test is a flexible tool that may be applied clinically in a variety of ways by adjusting the presentation level or the presentation mode.
Research
The Research menu item is a check box to indicate that the system is in Research mode. Research mode is designed for research and special applications. In the Research mode the Output for Channel 1 and 2 may be controlled independently. In the ‘Standard’ mode the Output for Channel 2 cannot be adjusted. The Separated Track lists should be used for Research mode. The standard QuickSIN sentences have the target talker and background babble recorded on the same channel and the S/N ratio integrated into the recording. The Separated Track lists provide the ability to control the signal and noise in ways not available in the standard sentences.
Separated Tracks
Both channels of these tracks (Channel 1 = target talker, Channel 2 = background babble) were recorded at a constant overall level. The signal-to-noise ratios do not change automatically after each sentence; the tester must manually adjust the level of the target talker and/or the background babble to change the signal-to­noise ratio.
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SISI
The SISI (Short Increment Sensitivity Index) test requires the generation of a continuous tone that increases in intensity a selected amount at a selected point in time. The SISI has intensity increments of 5 dB, 2 dB and 1 dB. An intensity increment is added to a tone in the selected channel for 200 msec, every 5 seconds.
The top section of the display has the common elements found on all the previously described screens. The center section displays the results of the testing. Using the Correct/Incorrect score buttons, obtain a percentage correct of the patient responses. The results are added to the table when the test is Stored. The Navigation Menu has an option for the dB Step (continuous HL level) and an option for the SISI step (intensity increment). The results are not transferred to GSI Suite via the data transfer and therefore should be entered as a comment.
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GSI AudioStar Pro™ Clinical Audiometer
TEN
The TEN test involves measuring the threshold for detecting a sinusoidal tone presented in a special background noise called “threshold-equalising noise” (TEN). The methods used to conduct the test are similar to those used for masking in conventional pure-tone audiometry, except that the signal threshold is measured in the presence of a continuous background noise and a 2-dB final step size is used to measure thresholds. The test was designed for detecting the presence of cochlear dead regions and defining their limits. The TEN Test defaults to a pulsed tone and 2 dB Step size.
The TEN test display is similar to the tone test type audiogram display. The Navigation Menu has a single option for the dB Step in addition to the comment icon. The data is stored by pressing the Store button and when stored a TEN symbol is displayed on the audiogram.
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Tone Decay
The Tone Decay test evaluates auditory fatigue. The general procedure is to measure the ability to perceive and maintain a pure tone presented continuously (usually for 1 minute).
The top section of the display has the common elements found on the previously described screens. The center section displays the timer. The timer is started when the patient presses the response button or may be started manually from the Correct/Start button on front panel. When the patient response button is released it pauses the timer and when pressed again resumes. The Navigation Menu has an option for the dB Step and an option to set the time in minutes (1-4). The time setting in the Navigation Menu will stop the timer after the defined number of minutes is reached on the timer. The results are not transferred to GSI Suite via the data transfer and therefore should be entered as a comment.
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Chapter 6: Operation
Preliminary Checks
Before starting any procedures using the GSI AudioStar Pro Clinical Audiometer, ensure that the power cord is plugged into a properly grounded receptacle.
WARNING! Check also that all cords from the transducers, patient response hand switch (if used), and printer fit securely in their connectors on the rear and side panels.
Inspect all cords for fraying and damage. If there is any damage to any cord, do not use the AudioStar Pro. If speech testing with recorded voice from an external source is to be performed, check that the CD or digital music player device is connected and operating properly.
1. Turn on the instrument and allow it to come to operating temperature
(approximately 10 minutes).
2. Check that the transducers and other system components are operating
properly.
3. Seat the patient comfortably in the test area.
4. Place the selected transducers on the patient.
CAUTION! Handle earphones, bone vibrator, and insert earphones with care. Do not drop them nor allow them to be banged together. Severe mechanical shock can alter their operating characteristics or change the output levels, which may require that the transducers be replaced.
CAUTION! It is recommended that all parts that come into direct contact with the patient (e.g. earphone cushions) are subjected to standard disinfecting procedures between patients. This includes physically cleaning and using a
recognized disinfectant. Individual manufacturer’s instructions should be
followed for use of any disinfecting agent to provide an appropriate level of sterilization.
Placement of the Earphones
Prior to positioning the earphones on the patient’s head, inspect the ear canals for
any blockage due to cerumen or foreign objects. Recognize that soft-walled ear canals may collapse under the earphones and this may lead to incorrect threshold levels. Insert phones might be used in these cases. Eliminate all obstructions, such as glasses, hair, or hearing aid, between the earphone and the patient.
Center the earphone over both ears and adjust the headband so that it rests solidly on the crown of the head and exerts pressure on both ears. Place the earphone
with the red connector over the patient’s right ear and the earphone with the blue
connector over the left ear.
Placement of the Insert Phone
WARNING! Push the correctly sized eartip onto the earphone and then place the
insert phone securely into the patient’s ear. Be sure there is an eartip attached to
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NOTE: Press “Store” after each threshold is obtained
the insert phone before inserting into the patient’s ear. Inserting the insert phone
without an eartip could cause harm to the patient. When using the paired insert phones, follow the manufacturer’s recommended procedure for eartip preparation, placement, and insertion.
WARNING! Insert eartips are single use only. Using disposable eartips ensures sanitary conditions for each patient.
Placement of the Bone Vibrator
The bone vibrator may be placed on the promontory of the mastoid process or on the forehead, whichever has been selected in the configuration application or modified in the Configure screen.
Placement of the High Frequency Transducer
Remove eyeglasses and earrings if possible and position the transducer directly on the head of the patient. Place the rubber cushions so that the earphone diaphragm is aimed directly at the opening into the ear canal. Adjust the headband for a tight fit. If the cushions are not tight to the ears, the test result will be false, especially at lower frequencies.
WARNING! Do not connect or disconnect Earphones, Insert Phones, Bone Vibrator, High Frequency Transducers or any other accessories while in contact with the patient.
Typical Evaluations
Test Type Buttons
Test Type buttons allow the operator to access protocols that are customized to facility preference with a single button press. Tests are pre-programmed to optimize efficiency and workflow. The options for the defaults for each test type are set up in the Configuration application.
Tone Test Type Button
Pressing the Tone Test Type button prepares the AudioStar Pro for pure tone air and bone conduction testing from 125 to 12,000 Hz. Each selection on the blue Navigation Menu is specific to Pure Tone Testing. It is possible to utilize headphones (TDH 50, DD45) insert earphones (ER3A, IP30) bone vibrators (B71, B81) and Sound Field speakers from this test type. Pressing this button will set the defaults from the configuration application to start the test.
Press the Tone Test Type Button. Verify that the transducers and signals are correct. Perform air conduction threshold testing.
When the pure tone evaluation is complete, move to the next test type in
the typical testing sequence.
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NOTE: Press “Store” after each threshold is obtained.
High Hz Test Type Button
Pressing the High Hz test type button prepares the AudioStar Pro for high frequency air and bone conduction testing from the high range (8,000 to 20,000 Hz) or the full range (125 to 20,000 Hz). Select full or high range from the blue navigation menu. It is possible to utilize the high frequency headphones (HDA 200/300), bone vibrator (B71, B81) and sound field speakers from this test type. Pressing this button will set the defaults from the configuration application to start the test.
Press the High Hz Test Type Button. Ensure that the Range is set to user preferences (High or Full). Verify that the transducers and signals are correct. Perform High Frequency Testing.
When the high frequency evaluation is complete, move to the next test
type in the typical testing sequence.
Speech Test Type Button
Pressing the Speech Test type button prepares the AudioStar Pro for Speech testing. The internal .Wav files may be presented by either using the auto play options, the present button or by a single click of a wireless mouse. The correct/incorrect/clear buttons may be used to score. It is critical that the test type be carefully selected as the reporting/storing is dependent upon test type. To perform a PIPB rollover evaluation, select the speech audiogram view.
Integrated Word Files
When Speech Test Type is selected, the AudioStar defaults to internal .Wav files. These may be presented for consistent recorded speech testing. For manual presentation:
Utilize the navigation menu or external mouse to select the test type and
the word list.
Select Word Nav and use the navigation buttons to highlight word
stimulus. Press the present bar to present the word.
- OR -
Utilize an external mouse to present the words (single click to present). When the speech stimulus is being presented, the word will be
highlighted yellow.
When the patient responds (and the yellow highlight disappears), the
stimulus word/sentence may be scored correct or incorrect.
The stimulus word/sentence will turn green for correct or amber for
incorrect. The center area of the display will indicate the % correct/#words presented.
After the completion of each speech test type, press store to save the
results in the speech results table.
When the speech evaluation is complete, move to the next test type in the
typical test sequence.
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NOTE: A total of six (6) individual speech test results may be stored for each ear. Right ear results will be stored in the left column, left ear results will be stored in the right column and binaural results will typically be stored in the left column.
NOTE: Discomfort of the patient could lead to inaccurate results. The operator is to evaluate the environment and physical conditions to determine whether these factors may affect the examination and give discomfort to the patient.
Using the Configuration application and the Auto Advance and Auto Play options, it is possible to configure the AudioStar to automatically move and present the internal word lists.
More Test Type button
Pressing the “More” test type button calls up a menu of the following special tests: ABLB, BKB-SIN, QuickSIN, SISI, TEN and Tone Decay. Use the on­board navigation buttons or an external mouse to select the special test.
Routine Test Procedures
The following procedures are in compliance with the current ANSI and ISO recommendations for Manual Pure Tone Threshold Audiometry.
Patient Instructions
Preparing the subject for test:
1. Put the subject at ease.
2. Make sure the subject understands the task.
3. Use the following instructions:
“I am going to place these earphones over your ears. You will hear tones or
beeping sounds which may be loud or soft. Whenever you hear, or think you hear, one of these tones, raise your hand. Lower your hand when you no longer hear the sound. Remember, raise your hand when you hear the tone and lower
your hand when you do not.”
Patient Familiarization
Familiarize the subject with the test and determine the start point. Start with the “better” or RIGHT ear. Demonstrate a tone for the subject using 1,000 Hz at 50 dB HL. If the subject responds, repeat at 40 dB. If the subject responds again, this is the “start” point.
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GSI AudioStar Pro™ Clinical Audiometer
NOTE: Threshold = minimum dial setting at which a response has occurred 2 times out of 3 on an ascending scale.
Threshold Determination (Pure Tone): Modified Hughson-Westlake
Present the tone at 50 dB. Present the tone for 1 or 2 seconds. The time between the tones should
vary, but should not be shorter than the test tone.
With each response, decrease the tone 10 dB until the first “No
Response” occurs.
When the subject does not respond to a tone, increase the intensity by 5
dB until a response occurs.
Continue with DOWN 10 dB, UP 5 dB until the threshold is reached.
The threshold is considered to be the minimum intensity setting at which
a response has occurred two out of three times at lowest db HL. Record this setting by pressing Store.
Repeat the sections on Patient Familiarization and Threshold
Determination for each tone setting in the following order: 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz. Retest 1,000 Hz followed by 500 Hz and 250 Hz. If there is a difference of 20 dB or greater between octaves, test the inter-octave frequencies, i.e. 750 Hz, 1,500 Hz, 3,000 Hz, and 6,000 Hz. Record these settings by pressing the Store pushbutton with each threshold level.
Repeat this procedure with the other ear. Determine if masking should be used. If necessary, repeat the testing
with masking and again record the testing process.
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NOTE: It is appropriate to familiarize the patient with the entire spondee word list.
Spondaic Speech Testing, Speech Reception Threshold (SRT)
Speech Reception Thresholds (SRT) refer to the intensity level at which a patient can repeat 50% of the presented words correctly. Use the following instructions to prepare the patient:
“You will now hear some two syllable words such as hotdog, ice-cream, baseball, mushroom or toothbrush. Some of the words will be loud enough to hear easily but others will be softer and more difficult to understand. Repeat the words until you can no longer hearing them. It is okay to guess.”
Using live voice or recorded speech (internal .Wav files or external file
played through a digital device), present the standardized spondee word lists, testing the better ear first. Start 20 dB above the 1,000 Hz pure tone threshold level. Present one word on the list and, if the response is correct, lower the level by 10 dB. Continue to decrease the intensity until the patient can no longer repeat the word. Increase the intensity 5 dB and present another word. Continue in the down 10 dB, up 5 dB method until the patient responds correctly to 50 % of the words presented.
Speech Discrimination (PB Words)
Instruct the patient that he or she is to repeat the words presented. Using live voice or recorded speech (internal .Wav files or external file
played through a digital device), present the selected standardized PB word list. Present the words at a level comfortable to the patient; at least 30 dB and generally 35 to 50 dB above the 1,000 Hz pure tone threshold.
Using the scorer buttons on the front panel, press the “Correct” button each time the right response is given and the “Incorrect” button each time
a wrong response is given.
The Discrimination Score is the percentage of words repeated correctly: Discrimination % at HL = 100 x Number of Correct Responses/Number of
Trials.
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Special Test Procedures - More Test Type button
The AudioStar Pro may be configured to perform many audiologic evaluations for further diagnosis, to rule out the presence of malingering and for research purposes. This section describes special test procedures that have been optimized for use with the GSI AudioStar Pro audiometer.
Pressing the “More” test type button calls up a menu of special tests. Use the on­board navigation buttons or an external mouse to select the desired special test.
Alternate Binaural Loudness Balance (ABLB) or Fowler Test
The perceived growth of loudness of a supra-threshold tone in an impaired ear may differ from the compared growth of loudness of a tone of identical frequency in the normal ear. Recruitment, if present, may be found.
Determine the threshold level for each ear at all frequencies being tested. Select the ear to serve as the reference ear, typically the ear with the
better hearing sensitivity. This ear will receive the tone at a fixed intensity.
Select ABLB from the More Test Menu. Set the intensity of the tone for each channel to 20 dB above the
threshold of each corresponding ear.
The tone will automatically alternate from Channel 1 when the interrupt
function in channel 1 is in the on position or manually, by pressing and holding the presentation bar in channel 1.
The tone alternates at the rate of 400 msec on, 400 msec off followed by
Channel 2 at 400 msec on, 400 msec off.
Keeping the intensity fixed in the reference ear, vary the intensity level
of the tone presented to the test ear. Record the level at which the patient judges both of the signals to be of equal loudness.
Repeat the above procedure increasing the intensity of the reference ear
by 20 dB each time until an intensity of 80 or 90 dB is reached. Identify
the dB HL of the tone necessary to “balance” in loudness the tone in the
reference ear at each level. This procedure is followed for the each frequency to be balance tested.
To increase the test reliability, the patient should be given several trials
to judge whether a variable tone is “softer,” “equal to,” or “louder” than
the tone in the reference ear.
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BKB-SIN
For a detailed description of the BKB-SIN test the user is referred to the BKB­SIN manual provided on the AudioStar Pro CD. The BKB-SIN Test uses the Bamford-Kowal-Bench sentences (Bench and Bamford, 1979; Bench, Kowal and Bamford, 1979) spoken by a male talker in four-talker babble (Auditec of St.
Louis, 1971). The QuickSIN™ Test (Etymotic Research, 2001; Killion et al.,
2004) was designed to provide a quick estimate of SNR Loss and is appropriate for use with most adults. The sentences used in the QuickSIN are at approximately a high school language level, making the test too difficult for use with young children. The BKB-SIN test was developed as speech-in-noise test that could be used as part of the test protocol for a binaural cochlear implant study on adults and children. The BKB-SIN Test is a flexible tool that can be applied clinically in a variety of ways.
BKB-SIN Methodology
The BKB-SIN contains 18 List Pairs. Each List Pair consists of two lists of eight to ten sentences each. The first sentence in each list has four key words, and the
remaining sentences each have three. A verbal “ready” cue precedes each
sentence. The key words in each sentence are scored as correct or incorrect. The sentences are presented at prerecorded signal-to-noise ratios that decrease in 3­dB steps.
Presentation Level
The choice of presentation level depends on the purpose of testing. For standard SNR Loss testing the BKB-SIN Test should be presented at a relatively high level (loud, but below discomfort). Normative data on normal-hearing adults and normal-hearing children were collected using binaural presentation via insert earphones, at a presentation level of 70 dB HL (83 dB SPL). Normative data on adult cochlear implant users were collected using a 65 dB SPL presentation level in sound field (equivalent to 50 dB HL at 0 degrees azimuth).
Test Instructions
Child
“You will hear a man talking to you through the earphones (or loudspeaker). He is going to say “Ready” and then he'll say a sentence. Repeat the sentence the
man says. You will hear other talkers in the background. Don't pay any attention to them; just repeat what the man says. The background talkers will get louder, and then it will be hard for you to hear the man's voice. When that happens, it is OK to guess; repeat anything you think you heard the man say.”
Adult
“Imagine that you are at a party. There will be a woman talking and several
other talkers in the background. The woman’s voice is easy to hear at first,
because her voice is louder than the others. Repeat each sentence the woman says. The background talkers will gradually become louder, making it difficult to
understand the woman’s voice, but please guess and repeat as much of each
sentence as possible.”
Test Procedure
Select BKB-SIN from the More Tests Menu.
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NOTE: Scoring preference options may be setup as defaults from the Config App.
Select the proper transducer and intensity levels for each channel. Select the appropriate age from the Navigation Menu Using the Word Nav and front panel navigation buttons or an external
mouse, select the first sentence.
Press the present bar or click the first sentence. Score the four/three key words highlighted in each sentence by pressing
the CORRECT or INCORRECT button for each word repeated by the patient.
The SNR Loss score will appear in the SCORE/WORD window. Select additional list pairs for testing if necessary Interpreting test results for children should be done on a case-by-case
basis. For adults the table presented in the QuickSIN section that follows can be used.
QuickSIN
The primary complaint of hearing-impaired persons is difficulty in background noise. The measurement of SNR loss (signal-to-noise ratio loss) is important because speech understanding in noise cannot be reliably predicted from the pure tone audiogram (Killion & Niquette, 2000). For detailed information on the QuickSIN, please see the QuickSIN manual.
QuickSIN Methodology
A list of six (6) sentences with five (5) key words per sentence is presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to­noise ratios which decrease in 5 dB steps from 25 (very easy) to 0 (extremely difficult). The SNR’s used are 25, 20, 15, 10, 5, and 0, encompassing normal to severely impaired performance in noise.
Presentation Level
For pure-tone average (PTA) less than or equal to 45 dB HL, set the attenuators in Channel 1 and Channel 2 to 70 dB HL. For PTA of 50 dB HL or greater, set the attenuators to a level that is judged to be “loud, but okay.” The sound should be perceived as loud, but not uncomfortably loud.
Test Instructions
“Imagine that you are at a party. There will be a woman talking and several
other talkers in the background. The woman’s voice is easy to hear at first,
because her voice is louder than the others. Repeat each sentence the woman says. The background talkers will gradually become louder, making it difficult to
understand the woman’s voice, but please guess and repeat as much of each
sentence as possible.”
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NOTE: Scoring preference options may be setup as defaults from the Config App.
SNR LOSS
DEGREE OF SNR LOSS
EXPECTED IMPROVEMENT WITH DIRECTIONAL MIC
0-3 dB
Normal / near normal
May hear better than normals hear in noise
3-7 dB
Mild SNR loss
May hear almost as well as normals hear in noise
7-15 dB
Moderate SNR loss
Directional microphones help; consider array mic
>15 dB
Severe SNR loss
Maximum SNR improvement is needed; consider FM system
Test Procedure
Select QuickSIN from the More Tests Menu. Select the proper transducer and intensity levels for each channel. Using the Word Nav and front panel navigation buttons or an external
mouse, select the first sentence.
Press the present bar or click the first sentence. Score the five key words highlighted in each sentence by pressing the
CORRECT or INCORRECT button for each word repeated by the patient.
The SNR Loss score will appear in the SCORE/WORD window. Select additional lists for testing if necessary To interpret the SNR loss score see table below.
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GSI AudioStar Pro™ Clinical Audiometer
SISI (Short Increment Sensitivity Index) Test
The SISI test is used to detect small intensity changes in a steady-state signal in patients with disorders of the cochlea. The SISI tests a patient’s ability to detect 1 dB change of intensity in a pure tone stimulus at 20 dB SL. A SISI consists of 20 target intensity increments (200 msec at 1, 2, or 5 dB) presented every 5 seconds and can be completed for a number of frequencies. The SISI test is scored in terms of the percentage of correctly identified 1 dB increments out of a possible
20. Scores of higher than 70% indicate cochlear involvement equals Positive SISI. Scores of less than 70% indicate auditory disorders not in the cochlea or normal hearing equals Negative SISI.
Presentation Level
Increase the attenuator to 20 dB SL.
Test Instructions
“You will hear a steady tone in your left or right ear. There may be an increase in loudness. Each time you hear the increase in loudness, press the patient response button.”
Test Procedure
Familiarize patient by presenting an easily heard (5 dB) SISI step. To do
this, press the presentation bar one time per presentation of the SISI increment.
Select dB Step (1 dB) for the test. To begin, press the “Interrupt” button to automatically present the
intensity increment change every 5 seconds.
Observe the patient responses – Record them using the
correct/incorrect” counter.
Press Store to record the SISI score for each frequency. Results are
displayed on the results table.
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NOTE: The test should not be conducted for frequencies below 500 or above 4,000 Hz.
NOTE: The TEN threshold symbol will be the word “TEN.”
TEN Test
Presentation Level
Test Instructions
Test Procedure
Purpose of the TEN Test is to identify cochlear dead regions. This is useful for several purposes including the following:
Counseling about the benefit of hearing aids. Assisting in hearing aid selection or cochlear implant candidacy. Fitting hearing aids appropriately.
The accepted rule is that a dead region is present when the TEN-masked threshold is at least 10 dB above the absolute threshold.
Channel 1 and Channel 2 will be routed to the same ear (default is the
Right ear).
Channel 1 stimulus will be tone. Channel 2 stimulus will be TEN Noise. The step size will default to 2 dB. To perform the test, use the following guide.
If the hearing loss is 60 dB or less, start the TEN noise level at 70 dB. If the hearing loss is 70 dB or greater, start the TEN level 10 dB higher
than the threshold.
If the TEN is reported to be too loud, start the TEN level at the same
level as the threshold.
When the starting level has been determined, instruct the patient in the same manner as when measuring pure tone thresholds with masking.
The procedure for determining thresholds in the TEN is identical to the manual pure tone audiometry except that a 2 dB final step size should be used for maximum accuracy. The TEN will take approximately 4 minutes per ear (to complete all test frequencies).
Press the Store button to store the TEN threshold and advance to the next frequency or ear.
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GSI AudioStar Pro™ Clinical Audiometer
Tone Decay Test
Carhart Tone Decay Test (1957)
Patients with retrocochlear pathology of the eighth nerve exhibit a rapid
“abnormal auditory adaption” or “temporary threshold drift” in response to a
continuous pure tone presentation.
Presentation Level
Establish the patient’s hearing threshold for the test ear using earphones
or insert phones using a pulsed tone.
Set the intensity for the selected channel to 0 dB SL (or 20 dB SL to
present an easier listening task). The Interrupt pushbutton may be selected or the Tone bar may be manually depressed for the duration of the test.
Test Instructions
Instruct the patient to depress the hand switch as soon as a tone is heard,
and to release the hand switch only when the tone becomes inaudible.
Test Procedure
Select Tone Decay from the More Tests Menu. Present the continuous tone at the selected intensity. When the patient responds by pressing the patient response button, the
timer will start. The timer may be manually started by pressing the Start pushbutton of the scorer/timer.
When the patient releases the patient response button, the timer will
pause. If the patient pushes the response button again, the timer will resume.
Record the number of seconds the tone sustains audibility. If the tone becomes inaudible before the minute criteria is met, without
interrupting the tone presentation, raise the intensity in 5 dB steps until the tone is heard for a full minute.
Reset the time at each increase in intensity level. Continue this procedure
until the tone is heard for a full minute, or until an intensity of 40 dB SL is reached.
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NOTE: Administrator or Power User Rights on the computer are required to load the software.
NOTE: Close all other applications before attempting to up/download from the AudioStar Pro Config. App.
NOTE: The AudioStar Pro must be powered down and restarted after downloading Config. App. changes in order for them to take effect.
Chapter 7: Application Software & Integration
The AudioStar Pro uses configuration application software to define the instrument and test settings defaults. These settings are downloaded from the application software on the PC to the AudioStar Pro. It is recommended that a copy of the custom configuration is saved as a back-up. This will allow the custom configuration to be loaded quickly onto multiple AudioStar Pros. A separate manual describes in detail the AudioStar Pro Config App program.
Config App
Installing the Configuration Software
Insert the CD into the computer and ensure the computer is connected to the AudioStar Pro via USB cable. The AudioStar Pro should be powered on. Follow the on-screen installation prompts to load the configuration application to the computer.
The AudioStar Pro Config App will be listed in the Windows start menu.
Customizing the Configuration
The configuration application is separated into two sections. The first section, Instrument, determines global settings of the instrument. The second section, Audiometry, dictates default settings for audiometric evaluations. Each section will be described briefly in the following section. For a more detailed explanation of the configuration application, review the AudioStar Pro Config App User Manual.
Menu
Download: Download default settings from the Configuration application to the AudioStar Pro (always restart the AudioStar Pro after download).
Upload: Upload current settings from an AudioStar Pro audiometer to the Configuration application on a connected computer.
Default: Loads all factory default settings into the configuration application. Changes will not be reflected on the AudioStar Pro until they are downloaded to the unit.
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GSI AudioStar Pro™ Clinical Audiometer
Load: Allows the operator to select a specific protocol from a list of saved configurations. This may include back-up configurations or site-specific configurations.
Save: Saves selections and settings from the configuration application to a specific location. This saved configuration may be downloaded at a different time or to multiple AudioStar Pro audiometers.
Instrument
Security Tab A list of examiner names and examiner passwords may be entered under the
Instrument/Security tabs of the Config App software. Examiner Passwords are user defined and may contain any combination of lower or upper case letters and numbers.
Facility Tab
Facility name, address and logo may be configured from this tab. Date format and calibration reminders may also be customized. The device regional settings and the information for 4 speakers, if used, may also be defined in this section. Please see the AudioStar Pro Config App manual for further information.
Printout Tab
Report preferences are determined by the selections made in this tab. The high frequency print format, graph orientation, printer protocol, speech printing and facility logo are customizable items on the printout.
Word Lists Tab
When uploaded from the AudioStar Pro, this window displays the existing word lists. External CD names may also be added. Word lists may be deleted from the instrument and Favorites for the word lists are defined in this tab.
Log Tab
In the event of a repeatable error, the log window allows the examiner to upload or email a file from the AudioStar Pro to the computer. This file retraces your steps (button pushes) for the purposes of troubleshooting.
Audiometry
General Tab
Select the frequencies used for PTA calculations, indicate the start-up test mode, and graph orientation from the general tab. Additionally, the patient response switch and bone conduction protocol strategies may be determined from this tab. The routing behavior, reliability label text, auto Hz advance frequency order and the aux intercom button behavior may also be customized.
Pure tone Tab
Pure Tone Channel 1 and Channel 2 defaults for the start-up stimulus, transducer, starting intensity and routing defaults are defined in this tab. It is also possible to assign signal format and dB step size from this tab.
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High Hz Tab
Channel 1 and Channel 2 defaults may be set for the start-up stimulus, transducer, and starting intensity. It is also possible to assign the signal format and dB step size from this tab. It is also possible to select the desired frequency as a start-up setting for both high range and full range.
Speech Tab
Default Speech settings for Channel 1 and Channel 2 may be defined for the start-up stimulus, transducer and starting intensity. It is also possible to assign signal format and dB step size and filter settings for the free-field speakers from this tab. Select the desired speech testing display and stimulus source for speech testing. Additionally, define the Auto advance and Auto play settings and scoring methods for the BKB-SIN and QuickSIN tests.
Norm Values Tab
The GSI factory does not include sample norm values to be used on the Speech Audiogram screen. Each facility should enter its own values, if desired.
If Display on the AudioStar Pro box is checked, the normative curves will appear on the Speech Audiogram screen based on the transducer being used.
GSI Instrument Services
Description
The GSI Instrument Services allows electronic transmission of test parameter information from the AudioStar Pro to an external computer with a single push of the Data Transfer button. See the GSI Instrument Services user manual for detail on how to utilize its functionality.
Operation
Data capture occurs when the Store pushbutton is pressed. When there are test results, comments or patient demographics saved in the AudioStar Pro, data may be electronically transferred to a software solution on an external computer using the Data Transfer button.
Public Interface (Direct)
The Public Interface option, provided through the GSI Instrument Service, transfers the audiometric data from the AudioStar Pro in an XML format which may be directly incorporated into an Electronic Medical Record. The GSI Suite utilizes this format. Alternatively, independent software programming engineers may implement the XML schema provided by GSI into their proprietary software in order to manage patient data directly. The direct transfer of data gives the physician immediate access to the audiometric data in the electronic record. More information can be found on the Instrument Services CD that was included in the original shipment of the AudioStar Pro or contact your GSI representative.
Data Port (Direct)
The Data Port provides backwards compatibility with the GSI 61 (serial) data stream. This will require the selection of an available COM port. Using the Data
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NOTE: It may be necessary to also install GSI Instrument Services.
Port interface makes it possible to transfer audiometric data from the AudioStar Pro directly into existing Electronic Medical Record solutions. Independent software programming engineers may implement the data stream protocol provided by GSI into their proprietary software in order to manage patient data directly. The direct transfer of data gives the physician immediate access to the audiometric data in the electronic record. More information can be found on the Instrument Services CD that was included in the original shipment of the AudioStar Pro or contact your GSI representative.
GSI Suite
GSI Suite Audiometric Data Management software (Rev. 2.0 and higher) is compatible with the GSI AudioStar Pro as well as legacy products. GSI Suite imports, saves, and stores audiometric data from the AudioStar Pro and allows the addition of comments into a report. The report data is saved in a PDF or other format that may be saved to the local PC, a remote location or attached with electronic medical data records (EMR). GSI Suite may be used as a stand­alone software solution or in combination with Noah 4 or OtoAccess.
OtoAccess™
OtoAccess is a SQL database that is used to network multiple audiometric systems, creating one master database. The robust database provides security and detailed patient search function for intuitive patient review. When combined, GSI Suite and OtoAccess increase the efficiency of the contemporary audiology practice.
Noah 4
GSI Suite may be installed in Noah 4 as a measurement module providing seamless integration between the audiometric evaluation and the hearing instrument fitting. Noah 4 may be installed as standalone software or on a network. Data transfer and storage utilizes the Noah database for data management.
Noah 3
The GSI Instrument Service and the GSI Audio Tymp module provide compatibility with Noah 3. This solution provides a seamless integration between the audiometric evaluation and the hearing instrument fitting.
AudBase
AudBase software saves audiometric data from the AudioStar Pro and other legacy GSI products into multiple report formats (single page, tabular and graphic, as well as sequential test results and custom options). Multiple data formats – PDF, TIF, GIF, JPEG, etc. – are available for compatibility with EMR/EHR systems. Patient data is maintained via a 4D database.
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Chapter 8: Routine Maintenance
Biological Calibration Check
The design of the GSI AudioStar Pro audiometer should provide trouble-free service for a long time period. It is recommended to routinely make and file the audiogram of one person for the purpose of biologic calibration. This person (or group of persons) should have a known stable audiometric curve that does not exceed 25 dB HL at any frequency. This procedure should start when the GSI AudioStar Pro is first installed and then be continued. Remember that individual thresholds can shift by as much as 5 dB from day to day; however variations that exceed this range may point to difficulties which require attention.
Periodic Checks
The routine maintenance checks described below may point to the source of some instrument problems. If they do not, the instrument should receive technical service before further use. The checks should be made at periodic intervals, even if biologic checks reveal no problems.
Earphone and Bone Vibrator Cords
With extended use, all transducer cords tend to fray internally at the connectors. To evaluate the cord status, turn on the GSI AudioStar Pro. Set the HL to a comfortably audible level. Place the transducer on your head. Activate both Interrupt buttons. Bend the cord next to the plug at both ends of each earphone. Listen for an intermittent signal, abrupt changes in the signal level, or a scratchy sound that coincides with the flexing of the cord. The presence of any of these conditions signifies that the cord should be replaced. Repeat this check for all transducers.
Hum and Noise
Set the GSI AudioStar Pro to Tone test type with the standard earphones selected and the Channel 1 Interrupt button in the ON mode. Turn the Channel 1 Hearing Level control from 0 to 60 dB HL. Listen for low frequency hum (60 or 120 Hz) and any other noise (hiss or low rushing sound) at all attenuator levels through the earphone. Some audible noise at levels above 70 dB is permissible. If these noises are detected below 70 dB, the audiometer should be scheduled for maintenance. Repeat for Channel 2.
Distortion and Frequency Shift
Check for distortion and frequency shift by listening to the GSI AudioStar Pro’s output through the earphones at each frequency (in the 125 Hz to 12,000 Hz range) at a loud, but not uncomfortable level (70 to 80 dB HL for normal ears). Listen also to ensure that the signal frequencies change appropriately when the Frequency up arrow (>) and down arrow (<) pushbuttons are operated. If distortion is heard in one earphone but not the other, the chances are high that the
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earphones are at fault and should be replaced. In any case, the audiometer should be scheduled for immediate maintenance.
Speech Level Check
To check the speech level with recorded speech, select the Speech test type button. Place the earphones on a person with normal hearing and present a word list at 40 dB. If intelligible speech is not heard, with the Channel 1 Hearing Level control set at 40 dB or less, the audiometer should be scheduled for technical service.
Internal Controls Check
Should the front panel controls lock into one state and it is not possible to change any of the parameters, turn off the power. Wait one minute and then power on.
Bone Vibrator Check
This check must be performed in a quiet environment or in a sound room. With the frequency set to 2,000 Hz, the Channel 1 intensity set at 40 dB HL and the bone vibrator positioned properly, the tone should be clearly audible to a person with normal hearing – less than 25 dB. When a bone vibrator fails this test, the calibration should be verified.
Masking Level Check
Select the Tone test type. Ensure the stimulus is narrow band noise on Channel 2. Activate the Channel 2 Interrupt button and listen for a smooth, even hiss.
Talk Forward Check
Speech should be clearly audible (in the earphones) when spoken in a normal tone with the Talk Forward dB HL control set at 45 dB HL.
Cleaning the System
Turn OFF the system and disconnect power before cleaning the instrument. Use a soft cloth lightly dampened with cleaning solution to clean all exposed surfaces. Take care to not allow liquid to come in contact with the metal parts inside the transducers (e.g., earphones / headphone). Do not permit solutions or Disinfecting agents to seep into the electronic portions of the system. Take special care around controls, connectors and panel edges. Remove any dust from the exterior of the system with a soft brush or cloth. Use a brush to dislodge any dirt on or around the connectors and panel edges. Remove stubborn dirt with a soft cloth slightly dampened with mild detergent and water. Wipe surfaces dry afterward. Do not use instrument or transducers until they are completely dry.
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Cleaning and Disinfecting Agents
According to the recommendations from the CDC, audiometric equipment is considered to be non-critical medical equipment and typically requires cleansing followed by low to intermediate level disinfecting, depending on the nature of the contamination. Cleaning should be done with a mild soapy detergent (such as dishwashing liquid) and a damp cloth or an Endozime Sponge followed by an application of EPA-registered hospital disinfectant. Do not use any abrasive cleaners.
Use of a non-alcohol based disinfectant is recommended for larger areas and headphones. Non-alcohol based products contain the active ingredient referred to as quaternary ammonia compound or hydrogen peroxide based cleaner such as Oxivir Disinfectant Wipes to clean the ear cushions, headset, and to wipe down the machine. The quaternary ammonia compound and hydrogen peroxide are specifically designed to disinfect rubber, plastic, silicone and acrylic products which are commonly used in hearing evaluation instruments.
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Appendix 1: Specifications
Dimensions and W x D x H: 20.1 inches x 14.6 inches x 13.2 inches (LCD raised) Weight 51.0 cm x 37.0 cm x 33.5 cm
Height with LCD lowered: 5.5 inches 14.0 cm Weight: 17 pounds 7.7 kg Shipping Weight: 27 pounds 12.25 kg
Power Specifications Power Consumption: 90 Watts
Voltage & Amperage: 100 Vac 1.0 A and 240 Vac 0.6 A Frequency: 50 Hz and 60 Hz
Channels Two independent Channels
Pure Tone - Channel 1 and Channel 2 Frequency Range
Air Conduction: 125 Hz to 12,000*** Hz High Frequency:* 8,000 Hz to 20,000 Hz (8 kHz, 9 kHz, 10 kHz, 11.2 kHz, 12.5
kHz, 14 kHz, 16 kHz, 18 kHz*** and 20 kHz***) Full Frequency Range:* 125 Hz to 20,000 Hz Bone Conduction: 250 Hz to 8,000 Hz Sound Field:* 125 Hz to 8,000 Hz Paired Inserts:* 125 Hz to 8,000 Hz Frequency Accuracy: ± 1 % Total Harmonic Distortion: < 2% (earphones and paired insert phones*)
< 5% (bone vibrator)
Intensity Range **
Air Conduction (TDH): -10 dB HL to 120 dB HL High Frequency:* -20 dB HL to 100 dB HL (with Sennheiser HDA 200
Phones) Bone Conduction: -10 dB HL to 75 dB HL (mastoid)
-10 dB HL to 65 dB HL (forehead)
Sound Field:* -10 dB HL to 90 dB HL (basic speakers)
-10 dB HL to 96 dB HL (high performance speakers)
-10 dB HL to 102 dB HL (high performance speakers and
external booster amplifier) Paired Inserts:* -10 dB HL to 120 dB HL
Masking Intensity Range (Calibrated in effective masking)
Narrow Band Noise: Maximum dB HL is 15 dB below tone
Signal Format Steady: Tone continuously present. Pulsed: Tone pulsed 200 msec ON, 200 msec OFF.
FM: Modulation Rate: 5 Hz
Modulation depth +/- 5% Pediatric Noise Continuously presented or pulsed
Speech - Channel 1 and Channel 2 Microphone: For live voice testing and communications
INT/EXT A & INT/EXT B: Can be utilized for internal wave files or recorded speech
material from an external digital device
Intensity Range: Air Conduction: -10 dB HL to 100 dB HL for TDH 50 (Linear Type A)
Speech - Channel 1 Bone Conduction: -10 dB HL to 55 dB HL (mastoid) and Channel 2 -10 dB HL to 35 dB HL (forehead)
Sound Field:* -10 dB HL to 90 dB HL (basic speakers)
Page 92
Paired Inserts:* -10 dB HL to 95 dB HL
Masking Intensity Range
Speech Noise:
Air Conduction -10 dB HL to 95 dB HL (TDH 50P) Bone Conduction -10 dB HL to 50 dB HL (mastoid)
-10 dB HL to 35 dB HL (forehead)
Sound Field: -10 dB HL to 80 dB HL
White Noise:
Air Conduction -10 dB HL to 95 dB HL (TDH50) Bone Conduction -10 dB HL to 50 dB HL (mastoid)
-10 dB HL to 35 dB HL (forehead)
Sound Field -10 dB HL to 80 dB HL
Special Tests ALT (ABLB): Tone alternating between Channel 1 and Channel 2: Channel 1 is 400
msec ON, 400 msec OFF followed by Channel 2, 400 msec ON, 400 msec OFF.
SISI: An intensity increment is added to a tone in the selected channel for
200 msec, every 5 seconds. The HL increments are in 1, 2 or 5 dB.
High Frequency:* Pure tone testing in the frequency range of 8,000 Hz to 20,000 Hz
using circum-aural headphones
TEN: TEN masking noise will be presented to the test ear. Pure tone stimuli
between 500 and 4000 Hz may be used at 1, 2, or 5 dB increments to obtain TEN thresholds.
QuickSIN: Six (6) sentences with five (5) key words per sentence are presented
in four-talker babble noise. The sentences are presented at pre­recorded signal-to-noise ratios. The SNR’s used are 25, 20, 15, 10, 5, and 0.
BKB-SIN: 18 List Pairs. The sentences are presented at prerecorded signal-to-
noise ratios that decrease in 3-dB steps. Each list in the pair is individually scored, and the results of the two lists are averages to obtain the List Pair score. Results are compared to normative data to obtain the SNR Loss.
Special Tests MLB (User Defined) Lombard test
Pure Tone Stenger Speech Stenger SAL
Communications and Talk Forward: Permits the tester to speak through the test microphone into the Monitoring selected transducer at approximately the intensity level set by the
front panel controls.
Talk Back: Allows the tester to listen to comments from the patient in the testing
booth.
Monitor: The monitor headset or monitor speaker built into the instrument
housing can be used by the tester to listen to Channel 1, Channel 2, Aux intercom, and/or Talk Back signals.
Aux Intercom: The built-in Auxiliary Intercom and Assistant headset allows the
tester to speak directly to an Assistant without the patient hearing the conversation and allows the assistant to hear what is being presented to the patient.
Environmental Temperature: +15ºC to 40ºC (59 to 104ºF) Requirements Relative Humidity: 10% to 95% (non-condensing)
Ambient Pressure Range: 98 kPa to 104 kPa Background Sound Level: <35 dB(A) Storage Temperature: 0ºC to + 50ºC (32ºF to 122ºF) Transport Temperature: -20ºC to + 50ºC (-4ºF to 122ºF)
Page 93
GSI AudioStar Pro™ Clinical Audiometer
Notes: * Optional configuration ** The maximum HL values are applicable to the middle frequencies only ***RETSPL values interpolated
Quality System Manufactured, designed, developed and marketed under ISO 13485 certified quality systems
Compliance/Regulatory Designed, tested and manufactured to meet the following domestic (USA), Canadian, European and Standards International Standards:
ANSI S3.6, IEC 60645-1, IEC 60645-2, ISO 389 UL 60601-1 American Standards for Medical Electrical Equipment IEC/EN 60601-1 International Standards for Medical Electrical Equipment CSA C22.2 # 601-1-M90 Medical Device Directive (MDD) to comply with EC Directive 93/42/EEC
Page 94
Appendix 2: Calibration Reference & Maximum Levels
The AudioStar Pro is supplied from the factory calibrated for the transducers that were purchased with it. The exception is the speakers, as those must be calibrated in the environment where they will be used. The calibration data supplied from the factory is only valid for GSI supplied transducers and cannot be applied to non-GSI supplied transducers.
It is recommended that calibration of the instrument and transducers be performed annually by authorized GSI Representatives using appropriate calibration instrumentation. If periodic checks are also desired, the tables in this section provide the SPL values per frequency for each transducer. If the measured values are not within ± 5 dB at 125, 6,000, 8,000 and 12,000 Hz in the earphones, the GSI AudioStar Pro should be scheduled for immediate maintenance.
It is not possible to select a dB HL value outside the limits for a particular transducer/ frequency combination. An attempt to change or select a hearing level control that is outside of the limit will cause the dB HL display to flash momentarily and then the test channel value will be replaced with NR (No Response). If an audiogram is displayed and the limits for a frequency/transducer are reached, the symbol for no response is displayed in the audiogram.
It is not possible to select a test frequency that is invalid for a particular transducer.
The hearing levels listed in the Max HL tables are maximum levels. These levels are achievable only if ANSI, ISO or GSI reference threshold levels, and not customized calibration values, are used. At no time will the hearing level limit exceed 120 dB HL
Page 95
GSI AudioStar Pro™ Clinical Audiometer
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
125 Hz
47.5
45
47.5
45
30.5
27
160 Hz
40.5
38.5
40
38.5
26
24.5
200 Hz
33.5
32.5
33.5
32.5
22
22.5
250 Hz
27
27
26.5
27
18
20
315 Hz
22.5
22
22
22
15.5
16
400 Hz
17.5
17
17.5
17
13.5
12
500 Hz
13
13.5
13.5
13.5
11
8
630 Hz
9
10.5
10.5
10.5 8 6
750 Hz
6.5 9 8.5 9 6
4.5
800 Hz
6.5
8.5
8.5
8.5 6 4
1000 Hz
6
7.5
7.5
7.5
5.5
2
1250 Hz
7
7.5
7.5
7.5 6 2.5
1500 Hz
8
7.5
7.5
7.5
5.5
3
1600 Hz
8 8 8.5 8 5.5
2.5
2000 Hz
8 9 11 9 4.5
0
2500 Hz
8
10.5
10
10.5 3 -2
3000 Hz
8
11.5
9.5
11.5
2.5
-3
3150 Hz
8
11.5
9.5
11.5 4 -2.5
4000 Hz
9
12
10.5
12
9.5
-0.5
5000 Hz
13
11
12
11
14
10.5
6000 Hz
20.5
16
13.5
16
17
21
6300 Hz
19
21
13.5
21
17.5
21.5
8000 Hz
12
15.5
13
15.5
17.5
23
9000 Hz
19
27.5
10000 Hz
22
18
11200 Hz
23
22
12000 Hz
17.5
11 0
12500 Hz
27.5
27
14000 Hz
35
33.5
16000 Hz
56
45.5
18000 Hz
83
83
20000 Hz
105
105
Earphones - Pure Tone RETSPL
DD45 6ccm uses IEC60318-3 or NBS 9A coupler and RETSPL comes from PTB – DTU report 2009-2010.
Force 4.5N ±0.5N
DD45 Artificial ear uses IEC60318-1 coupler and RETSPL comes from ANSI S3.6 2010 and ISO 389-1 1998.
Force 4.5N ±0.5N
TDH50 6ccm uses IEC60318-3 or NBS 9A coupler and RETSPL comes from ANSI S3.6 2010. Force 4.5N
±0.5N
TDH50 Artificial ear uses IEC60318-1 coupler and RETSPL comes from ANSI S3.6 2010 and ISO 389-1 1998
Force 4.5N ±0.5N
HDA200 Artificial ear uses IEC60318-1 coupler with type 1 adaptor and RETSPL comes from ANSI S3.6 2010
and ISO 389-8 2004. Force 9N ±0.5N
HDA300 Artificial ear uses IEC60318-1 coupler with type 1 adaptor and RETSPL comes from PTB report
2012. Force 8.8N ±0.5N
Page 96
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
Speech
18.5
20
20
20
19
14.5
Speech Equ.FF.
18.5
19.5
17
18
18.5
16
Speech Non­linear
6
7.5
7.5
7.5
5.5
2
Speech noise
18.5
20
20
20
19
14.5
Speech noise Equ.FF.
18.5
19.5
17
18
18.5
16
Speech noise Non-linear
6
7.5
7.5
7.5
5.5
2
White noise in speech
21
22.5
22.5
22.5
21.5
17
Earphones - ANSI Speech RETSPL
DD45 (GF-GC) PTB-DTU report 2009-2010.  TDH50 (GF-GC) ANSI S3.6 2010.  HDA200 (GF-GC) ANSI S3.6 2010 and ISO 389-8 2004.  HDA300 (GF-GC) PTB report 2013.  ANSI Speech level 12.5 dB + 1 kHz RETSPL ANSI S3.6 2010 (acoustical linear weighting) ANSI Speech Equivalent free field level 12.5 dB + 1 kHz RETSPL – (GF-GC) from ANSI S3.6
2010(acoustical equivalent sensitivity weighting)
ANSI Speech Not linear level 1 kHz RETSPL ANSI S3.6 2010 (DD45-TDH50-HDA200-HDA300)
and EAR 3A –IP30- B71-B81 12.5 dB + 1 kHz RETSPL ANSI S3.6 2010 (no weighting)
Page 97
GSI AudioStar Pro™ Clinical Audiometer
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
RETSPL
Speech
20
20
20
20
20
20
Speech Equ.FF.
3.5
4.5 2 3
3.5
1
Speech Non­linear
6
7.5
7.5
7.5
5.5
2
Speech noise
20
20
20
20
20
20
Speech noise Equ.FF.
3.5
4.5 2 3
3.5
1
Speech noise Non-linear
6
7.5
7.5
7.5
5.5
2
White noise in speech
22.5
22.5
22.5
22.5
22.5
22.5
Earphones - IEC Speech RETSPL
DD45 (GF-GC) PTB-DTU report 2009-2010.  TDH50 (GF-GC) ANSI S3.6 2010.  HDA200 (GF-GC) ANSI S3.6 2010 and ISO 389-8 2004.  HDA300 (GF-GC) PTB report 2013.  IEC Speech level IEC60645-2 1997 (acoustical linear weighting) IEC Speech Equivalent free field level (GF-GC) from IEC60645-2 1997 (acoustical equivalent
sensitivity weighting)
IEC Speech Not linear level 1 kHz RETSPL (DD45-TDH50-HDA200-HDA300) and EAR 3A – IP30
- B71- B81 IEC60645-2 1997 (no weighting)
Page 98
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
Signal
Max HL
Max HL
Max HL
Max HL
Max HL
Max HL
Tone 125 Hz
90
90
85
85
100
115.0
Tone 160 Hz
95
95
90
90
105
120
Tone 200 Hz
100
100
95
95
105
120
Tone 250 Hz
110
110
105
105
110
120
Tone 315 Hz
115
115
110
110
115
120
Tone 400 Hz
120
120
115
115
115
120
Tone 500 Hz
120
120
120
120
115
120
Tone 630 Hz
120
120
120
120
120
120
Tone 750 Hz
120
120
120
120
120
120
Tone 800 Hz
120
120
120
120
120
120
Tone 1000 Hz
120
120
120
120
120
120
Tone 1250 Hz
120
120
120
120
110
120
Tone 1500 Hz
120
120
120
120
115
120
Tone 1600 Hz
120
120
120
120
115
120
Tone 2000 Hz
120
120
120
120
115
120
Tone 2500 Hz
120
120
120
120
115
120
Tone 3000 Hz
120
120
120
120
115
120
Tone 3150 Hz
120
120
120
120
115
120
Tone 4000 Hz
120
120
120
120
115
120
Tone 5000 Hz
120
120
115
115
105
120
Tone 6000 Hz
115
115
115
110
105
110
Tone 6300 Hz
115
110
110
105
105
110
Tone 8000 Hz
110
110
100
100
105
110
Tone 9000 Hz
100
100
Tone 10000 Hz
100
105
Tone 11200 Hz
95
105
Tone 12000 Hz
90
90
Tone 12500 Hz
90
100
Tone 14000 Hz
80
90
Tone 16000 Hz
60
75
Tone 18000 Hz
30
35
Tone 20000 Hz
15
10
Earphones - Pure Tone max HL
Page 99
GSI AudioStar Pro™ Clinical Audiometer
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
EM
EM
EM
EM
EM
EM
NB 125 Hz
51.5
49
51.5
49
34.5
31.0
NB 160 Hz
44.5
42.5
44
42.5
30
28.5
NB 200 Hz
37.5
36.5
37.5
36.5
26
26.5
NB 250 Hz
31
31
30.5
31
22
24
NB 315 Hz
26.5
26
26
26
19.5
20
NB 400 Hz
21.5
21
21.5
21
17.5
16
NB 500 Hz
17
17.5
17.5
17.5
15
12
NB 630 Hz
14
15.5
15.5
15.5
13
11
NB 750 Hz
11.5
14
13.5
14
11
9.5
NB 800 Hz
11.5
13.5
13.5
13.5
11
9
NB 1000 Hz
12
13.5
13.5
13.5
11.5
8
NB 1250 Hz
13
13.5
13.5
13.5
12
8.5
NB 1500 Hz
14
13.5
13.5
13.5
11.5
9
NB 1600 Hz
14
14
14.5
14
11.5
8.5
NB 2000 Hz
14
15
17
15
10.5
6
NB 2500 Hz
14
16.5
16
16.5 9 4
NB 3000 Hz
14
17.5
15.5
17.5
8.5
3
NB 3150 Hz
14
17.5
15.5
17.5
10
3.5
NB 4000 Hz
14
17
15.5
17
14.5
4.5
NB 5000 Hz
18
16
17
16
19
15.5
NB 6000 Hz
25.5
21
18.5
21
22
26
NB 6300 Hz
24
26
18.5
26
22.5
26.5
NB 8000 Hz
17
20.5
18
20.5
22.5
28
NB 9000 Hz
24
32.5
NB 10000 Hz
27
23
NB 11200 Hz
28
27
NB 12000 Hz
22.5
16
NB 12500 Hz
32.5
32
NB 14000 Hz
40
38.5
NB 16000 Hz
61
50.5
NB 18000 Hz
88
88
NB 20000 Hz
110
110
White noise
0 0 0 0 0
0
TEN noise
25
25
24.5
24.5
Earphones - NB noise effective masking level
Page 100
Transducer
DD45
DD45
TDH50
TDH50
HDA200
HDA300
Impedance
10 Ω
10 Ω
60 Ω
60 Ω
23 Ω
23 Ω
Coupler
318-3
318-1
318-3
318-1
318-1
318-1
Max HL
Max HL
Max HL
Max HL
Max HL
Max HL
NB 125 Hz
75
75
65
65
75
80.0
NB 160 Hz
80
80
70
70
80
85
NB 200 Hz
90
90
80
80
80
85
NB 250 Hz
95
95
85
85
85
90
NB 315 Hz
100
100
90
90
90
90
NB 400 Hz
105
105
95
95
95
95
NB 500 Hz
110
110
100
100
95
100
NB 630 Hz
110
110
100
100
95
100
NB 750 Hz
110
110
105
105
100
100
NB 800 Hz
110
110
105
105
100
105
NB 1000 Hz
110
110
105
105
100
105
NB 1250 Hz
110
110
105
105
95
105
NB 1500 Hz
110
110
105
105
100
105
NB 1600 Hz
110
110
105
105
100
105
NB 2000 Hz
110
110
100
100
100
105
NB 2500 Hz
110
110
100
100
100
110
NB 3000 Hz
110
110
100
100
100
110
NB 3150 Hz
110
110
100
100
100
110
NB 4000 Hz
110
110
100
100
100
110
NB 5000 Hz
110
110
100
100
95
100
NB 6000 Hz
105
105
95
95
90
95
NB 6300 Hz
105
100
95
90
90
95
NB 8000 Hz
100
100
90
85
90
95
NB 9000 Hz
85
90
NB 10000 Hz
85
95
NB 11200 Hz
80
90
NB 12000 Hz
75
75
NB 12500 Hz
75
85
NB 14000 Hz
70
75
NB 16000 Hz
50
60
NB 18000 Hz
20
20
NB 20000 Hz
0
0
White noise
120
120
120
120
115
115
TEN noise
110
110
100
100
Earphones - NB noise max HL
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