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AUDIOSTAR PRO
User Manual
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User Manual
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GSi AUDIOSTAR PRO User Manual

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
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
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
Stimulus Intensity Level(s) ..................................................................................................................... 30
Talk Forward ........................................................................................................................................... 31
Left & Right VRA ................................................................................................................................... 31
Interlock .................................................................................................................................................. 31
Tracking .................................................................................................................................................. 31
Status / Audiogram Button ...................................................................................................................... 32
Data Transfer ........................................................................................................................................... 32
Printing .................................................................................................................................................... 32
Stimulus Channel 1 and Channel 2 ......................................................................................................... 35
Transducer Output Selector ..................................................................................................................... 36
Routing Output Selector .......................................................................................................................... 37
Attenuators (HL Controls)....................................................................................................................... 37
Tone Bar / Interrupt ................................................................................................................................. 38
Frequency Up / Down ............................................................................................................................. 38
Data Store ................................................................................................................................................ 38
Navigation Controls ................................................................................................................................ 38
Scorer / Timer .......................................................................................................................................... 39
Aux Intercom ........................................................................................................................................... 39
Monitoring ............................................................................................................................................... 40
Test Type Buttons ................................................................................................................................... 40
Function Buttons ..................................................................................................................................... 41
Keyboard ................................................................................................................................................. 42
Chapter 5: Test Type Displays .................................................................................................................... 43
Monitor .................................................................................................................................................... 43
Test Type Screens ................................................................................................................................... 43
Tone Test Type - Audiogram .................................................................................................................. 45
High Frequency Test Type - Audiogram................................................................................................. 49
Full Frequency Test Type - Audiogram .................................................................................................. 50
Tone Test Type - Status........................................................................................................................... 51
High Frequency Test Type – Status ........................................................................................................ 52
Full Frequency Test Type - Status .......................................................................................................... 52
Speech Test Type - Status ....................................................................................................................... 53
Speech Test Type - Audiogram ............................................................................................................... 58
More Test Type ....................................................................................................................................... 60
ABLB ...................................................................................................................................................... 60
BKB-SIN ................................................................................................................................................. 61
GSI AudioStar Pro™ Clinical Audiometer
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
Speech Level Check ................................................................................................................................ 88
Internal Controls Check........................................................................................................................... 88
Bone Vibrator Check ............................................................................................................................... 88
Masking Level Check .............................................................................................................................. 88
Talk Forward Check ................................................................................................................................ 88
Cleaning the System ................................................................................................................................ 88
Cleaning and Disinfecting Agents ........................................................................................................... 89
Appendix 1: Specifications ......................................................................................................................... 90
Appendix 2: Calibration Reference & Maximum Levels ........................................................................... 93
Earphones - Pure Tone RETSPL ............................................................................................................. 94
Earphones - ANSI Speech RETSPL ....................................................................................................... 95
Earphones - IEC Speech RETSPL .......................................................................................................... 96
Earphones - Pure Tone max HL .............................................................................................................. 97
Earphones - NB noise effective masking level ........................................................................................ 98
Earphones - NB noise max HL ................................................................................................................ 99
Earphones - ANSI Speech max HL ....................................................................................................... 100
Earphones - IEC Speech max HL .......................................................................................................... 100
Insert Earphones - Pure Tone RETSPL ................................................................................................. 101
Insert Earphones - ANSI Speech RETSPL ........................................................................................... 102
Insert Earphones - IEC Speech RETSPL .............................................................................................. 102
Insert Earphones - Pure Tone max HL .................................................................................................. 103
Insert Earphones - NB noise effective masking level ........................................................................... 104
Insert Earphones - NB noise max HL ................................................................................................... 105
Insert Earphones - ANSI Speech max HL ............................................................................................. 106
Insert Earphones - IEC Speech max HL................................................................................................ 106
Bone Vibrators - Pure Tone RETFL ..................................................................................................... 107
Bone Vibrators - ANSI Speech RETSPL .............................................................................................. 108
Bone Vibrators - IEC Speech RETSPL ................................................................................................. 108
Bone Vibrators - Pure Tone max HL .................................................................................................... 109
Bone Vibrators - NB noise effective masking level .............................................................................. 110
Bone Vibrators - NB noise max HL ...................................................................................................... 111
Bone Vibrators - ANSI Speech max HL ............................................................................................... 112
Bone Vibrators - IEC Speech max HL .................................................................................................. 112
Free Field Speakers – ANSI RETSPL and Max HL ............................................................................. 113
Appendix 3: EMC Compatibility .............................................................................................................. 114
Electromagnetic Compatibility .............................................................................................................. 114
GSI AudioStar Pro™ Clinical Audiometer
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
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.
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
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.
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.
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.
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.
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
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.
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.
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
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
GSI AudioStar Pro™ Clinical Audiometer
No.
Symbol
IEC Pub.
Description
22 60601-1
Patient response switch.
23 ISO 7010-M002
Follow Instructions for Use.
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
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
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.
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.
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.
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.
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
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
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:
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.
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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