GSi AUDIOSTAR PRO User manual

Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 7625 Golden Triangle Drive, Suite F, Eden Prairie MN 55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]
GSI AUDIOSTAR PRO™
USER MANUAL
Part Number D-0100778 Rev. C

D-0100778 Rev C 1
Title : GSI AudioStar Pro™ Clinical Audiometer User Manual
Copyright © 2013-2014 Grason-Stadler. All rights reserved . No part of this publication may be
reproduced or transmitted in any form or by any means without the prior written permission of
Grason-Stadler . The information in this publication is proprietary to Grason-Stadler.
Compliance
The CE 0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
Kongebakken 9
2765 Smørum
Denmark
0344
Part Number 2012-0100 Rev. B
USER MANUAL

GSI AudioStar Pro™ Clinical Audiometer
2 D-0100778 Rev C
Table of Contents
Intended Use .................................................................................................................................................7
Warranty....................................................................................................................................................7
Audiometric Standards..................................................................................................................................8
Warnings, Cautions, and Errors....................................................................................................................9
Status/Error Messages.............................................................................................................................10
Customer Responsibility .........................................................................................................................11
Elimination of Ambient Noise ................................................................................................................11
Safety Precautions.......................................................................................................................................14
Cautions - General...................................................................................................................................15
Warning - Connecting Additional Equipment.........................................................................................15
Warning - Electric Shock Hazards..........................................................................................................15
Warning - Electric Grounding.................................................................................................................15
Warning - Explosion ...............................................................................................................................15
Warning - Line Voltage Brownout and Interruptions .............................................................................16
Warning - Connections............................................................................................................................16
Warning - Battery Safety.........................................................................................................................16
Warning - General...................................................................................................................................16
Shutdown Procedure................................................................................................................................16
Recycling / Disposal................................................................................................................................16
Regulatory Symbols....................................................................................................................................17
Audiometric Symbols .................................................................................................................................19
Chapter 1: Introduction...............................................................................................................................21
Chapter 2: Installation.................................................................................................................................22
External Inspection..................................................................................................................................22
Unpacking ...............................................................................................................................................22
Accessories..............................................................................................................................................23
Country Kits............................................................................................................................................24
Chapter 3: Connectors, Controls and Indicators.........................................................................................25
Rear Panel ...............................................................................................................................................25
Right Side Panel......................................................................................................................................27
Left Side Panel........................................................................................................................................27
Bottom Panel Label.................................................................................................................................29
Chapter 4: Front Panel Controls..................................................................................................................30
Power.......................................................................................................................................................30

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

GSI AudioStar Pro™ Clinical Audiometer
4 D-0100778 Rev C
QuickSIN.................................................................................................................................................64
SISI..........................................................................................................................................................67
TEN.........................................................................................................................................................68
Tone Decay .............................................................................................................................................69
Chapter 6: Operation...................................................................................................................................70
Preliminary Checks .................................................................................................................................70
Typical Evaluations.................................................................................................................................71
Test Type Buttons ...................................................................................................................................71
More Test Type button............................................................................................................................73
Routine Test Procedures..........................................................................................................................73
Patient Instructions..................................................................................................................................73
Patient Familiarization ............................................................................................................................73
Threshold Determination (Pure Tone): Modified Hughson-Westlake....................................................74
Spondaic Speech Testing, Speech Reception Threshold (SRT)..............................................................75
Speech Discrimination (PB Words) ........................................................................................................75
Special Test Procedures - More Test Type button ..................................................................................76
Alternate Binaural Loudness Balance (ABLB) or Fowler Test ..............................................................76
BKB-SIN.................................................................................................................................................77
QuickSIN.................................................................................................................................................78
SISI (Short Increment Sensitivity Index) Test ........................................................................................80
TEN Test.................................................................................................................................................81
Tone Decay Test......................................................................................................................................82
Chapter 7: Application Software & Integration..........................................................................................83
Config App..............................................................................................................................................83
GSI Instrument Services..........................................................................................................................85
GSI Suite.................................................................................................................................................86
OtoAccess™............................................................................................................................................86
Noah 4.....................................................................................................................................................86
Noah 3.....................................................................................................................................................86
AudBase..................................................................................................................................................86
Chapter 8: Routine Maintenance.................................................................................................................87
Biological Calibration Check..................................................................................................................87
Periodic Checks.......................................................................................................................................87
Earphone and Bone Vibrator Cords ........................................................................................................87
Hum and Noise........................................................................................................................................87
Distortion and Frequency Shift ...............................................................................................................87

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

GSI AudioStar Pro™ Clinical Audiometer
6 D-0100778 Rev C
Electrical Safety, EMC and Associated Standards................................................................................114
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions.............................................115
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and
the GSI AudioStar Pro...........................................................................................................................115
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................116
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................117
Appendix 4: Reference Materials .............................................................................................................118

D-0100778 Rev C 7
Intended Use
The AudioStar Pro is intended to be used for the identification and etiology of
hearing loss in patients of any age. It is intended to be used by an audiologist,
ENT, hearing healthcare professional, or trained technician in a hospital, clinic,
healthcare facility or other suitable quiet environment as defined in ANSI S3.1 or
equivalent.
Description This instrument is a two-channel clinical audiometer. This instrument has
advanced functionality that makes it ideal for testing in every clinical setting,
including Ear, Nose and Throat (ENT) physicians’ offices, hospitals, clinics and
audiology private practices. The tests are administered via headphones –supra-
aural, circum-aural, or insert phones –or through a bone vibrator or sound field
speakers. User defined test protocols allow for basic audiometric testing as well
as detailed evaluations to assist in diagnosis of audiologic pathologies. Careful
handling of instrument transducers and testing performed by a properly trained
instrument operator should be of high priority. The patient is to remain relaxed
and still while testing is being performed for optimal accuracy.
Warranty
We, Grason-Stadler, warrant that this product is free from defects in material and
workmanship and, when properly installed and used, will perform in accordance
with applicable specifications. If within one year after original shipment, it is
found not to meet this standard; it will be repaired, or at our option, replaced at
no charge except for transportation costs, when returned to an authorized Grason-
Stadler facility. If field service is requested, there will be no charge for labor or
material; however, there will be a charge for travel expense at the service center’s
current rate.
NOTE: Changes in the product not approved in writing by Grason-Stadler shall
void this warranty. Grason-Stadler shall not be responsible for any indirect,
special or consequential damages, even if notice has been given in advance of the
possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.

GSI AudioStar Pro™ Clinical Audiometer
8 D-0100778 Rev C
Audiometric Standards
The AudioStar Pro is designed to meet or exceed the following standards:
Audiometer Standard Requirements - Type 1
1. ANSI S3.6 (2010) Specification for Audiometers (Type 1)
2. IEC 60645-1 Electroacoustics - Audiological Equipment - Pure-Tone
Audiometers Type 1
3. IEC 60645-2 Electroacoustics - Audiological Equipment - Equipment for
Speech Audiometry
4. ISO 389-1 Reference Equivalent Threshold SPLS for Pure Tones and
Supra-Aural Earphones
5. ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and
Insert Earphones
6. ISO 389-3 Reference Equivalent Threshold Force Levels for Pure Tones
and Bone Vibrator
7. ISO 389-4 Reference Levels for Narrow-Band Masking Noise
8. ISO 389-5 Reference Equivalent Threshold SPLS for Pure Tones in the
Frequency Range 8 kHz to 16 kHz
9. ISO 389-7 Reference zero for the calibration of audiometric equipment
10. ISO 389-8 Reference zero for the calibration of audiometric equipment

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

GSI AudioStar Pro™ Clinical Audiometer
10 D-0100778 Rev C
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTE: Notes help identify areas of possible confusion and avoid potential
problems during system operation.
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.

D-0100778 Rev C 11
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
12 D-0100778 Rev C
Maximum Ambient Noise
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
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.
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.

D-0100778 Rev C 13
Sound Attenuation
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

GSI AudioStar Pro™ Clinical Audiometer
14 D-0100778 Rev C
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.

D-0100778 Rev C 15
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.
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.
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
16 D-0100778 Rev C
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

D-0100778 Rev C 17
Regulatory Symbols
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.

GSI AudioStar Pro™ Clinical Audiometer
18 D-0100778 Rev C
No.
Symbol
IEC Pub.
Description
22
60601-1
Patient response switch.
23
ISO 7010-M002
Follow Instructions for Use.

D-0100778 Rev C 19
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