Grason-Stadler gsi AUDIOSTAR PRO User manual
TWO CHANNEL
CLINICAL
AUDIOMETER
AUDIOSTAR PRO
INSTRUCTIONS FOR USE
GSI TympStar Pro Instructions for Use
D-0131088 Rev. C, 2022-07
TWO CHANNEL
CLINICAL
AUDIOMETER
AUDIOSTAR PRO
INSTRUCTIONS FOR USE
Title:
GSI AudioStar Pro Instructions for Use
Manufacturer
Grason-Stadler
10395 West 70th Street
Eden Prairie, MN 55344
USA
Copyright © 2021 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.
This product may incorporate software developed by others and redistributed according to
license agreements. Copyright notices and licenses for these external libraries are
provided in a supplementary document that is included with the other software
applications distributed with this product.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Regulation (EU)
2017/745. Grason-Stadler is an ISO 13485 certified corporation.
European Authorized Representative
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
0123
Caution: US Federal law restricts this device to sale by or on the order of a physician or licensed
hearing care professional.
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TABLE OF CONTENTS
Table of Contents .......................................................................................................................... 1
Preface............................................................................................................................................ 7
Manual Conventions.................................................................................................................. 7
Regulatory Symbols ................................................................................................................... 8
Device Symbols .......................................................................................................................... 9
Warnings and Cautions............................................................................................................... 11
Important Safety Instructions................................................................................................. 11
Safety Precautions ................................................................................................................... 11
Fluids ..................................................................................................................................... 12
Damage................................................................................................................................. 12
Connecting Additional Equipment...................................................................................... 12
EXPLOSION ........................................................................................................................... 13
ENVIRONMENTAL FACTORS.................................................................................................... 13
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS........................................... 13
Introduction ................................................................................................................................. 14
Indications for Use................................................................................................................... 14
Intended Use............................................................................................................................ 14
Contraindications..................................................................................................................... 14
Essential Performance............................................................................................................. 14
Unpacking the system................................................................................................................. 15
Standard Components ............................................................................................................ 16
Getting Started............................................................................................................................. 17
System Assembly ..................................................................................................................... 17
Base Unit Rear Panel ............................................................................................................... 17
Connections.......................................................................................................................... 17
Right Side Panel ....................................................................................................................... 20
Power Switch ........................................................................................................................ 20
Monitor Speaker................................................................................................................... 20
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Left Side Panel.......................................................................................................................... 20
USB Port ................................................................................................................................ 21
A/B Cable............................................................................................................................... 21
Front Panel ............................................................................................................................... 22
Monitor ..................................................................................................................................... 22
Elimination of Ambient Noise ................................................................................................. 23
Maximum Ambient Noise (dB re: 20 µPa to the nearest 0.5 dB) ..................................... 23
Operating the AudioStar Pro ...................................................................................................... 24
Preliminary Checks .................................................................................................................. 24
Prepare to Test......................................................................................................................... 24
Placement of the Earphones............................................................................................... 25
Placement of the Insert Phone ........................................................................................... 25
Placement of the High Frequency Transducer .................................................................. 25
Placement of the Bone Vibrator.......................................................................................... 25
Loud Auditory Output.......................................................................................................... 25
Test Type Screens .................................................................................................................... 26
Title Bar ................................................................................................................................. 26
Test Type Information.......................................................................................................... 26
Navigation Menu .................................................................................................................. 27
Time and Date ...................................................................................................................... 27
Common Icons ..................................................................................................................... 27
Tone Test Type ......................................................................................................................... 28
High Frequency Testing........................................................................................................... 29
TEN Test Type........................................................................................................................... 29
Presentation Level................................................................................................................ 29
Test Instructions................................................................................................................... 30
Test Procedure ..................................................................................................................... 30
Interpretation ....................................................................................................................... 30
Speech Test Type Button......................................................................................................... 30
Integrated Word Files........................................................................................................... 31
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More Test Type button............................................................................................................ 32
BKB-SIN..................................................................................................................................... 33
Presentation Level................................................................................................................ 33
Test Instructions................................................................................................................... 33
Test Procedure ..................................................................................................................... 34
QuickSIN ................................................................................................................................... 35
Presentation Level................................................................................................................ 35
Test Instructions................................................................................................................... 35
Test Procedure ..................................................................................................................... 36
Configuration and Update ...................................................................................................... 37
Update................................................................................................................................... 37
Bone ...................................................................................................................................... 37
Assistant Headset................................................................................................................. 38
Export Logs ........................................................................................................................... 38
License................................................................................................................................... 38
Settings.................................................................................................................................. 38
Cleaning and Maintenance ......................................................................................................... 39
Routine Maintenance .............................................................................................................. 39
Biological Calibration Check ................................................................................................ 39
Periodic Checks .................................................................................................................... 39
Earphone and Bone Vibrator Cords ................................................................................... 39
Hum and Noise..................................................................................................................... 39
Distortion and Frequency Shift ........................................................................................... 39
Speech Level Check.............................................................................................................. 40
Internal Controls Check ....................................................................................................... 40
Bone Vibrator Check ............................................................................................................ 40
Masking Level Check............................................................................................................ 40
Talk Forward Check.............................................................................................................. 40
Calibration ................................................................................................................................ 40
Cleaning the System ................................................................................................................ 41
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Cleaning and Disinfecting Agents ....................................................................................... 41
Single-use Accessories......................................................................................................... 41
Status and Error Messages ......................................................................................................... 42
Error Messages ........................................................................................................................ 42
Please try another selection................................................................................................ 42
Error ...................................................................................................................................... 42
Error ...................................................................................................................................... 42
Supplies and Accessories............................................................................................................ 43
Appendix A – Technical Data ...................................................................................................... 44
Appendix B – Specification of Input/output Connections ........................................................ 50
Mains Cable .............................................................................................................................. 50
Headphones/Inserts (2 connectors, R, L)............................................................................... 50
Bone Oscillator......................................................................................................................... 50
Gooseneck Mic ......................................................................................................................... 50
Patient Response x2 ................................................................................................................ 51
Talk Forward, Talk Back Mic .................................................................................................... 51
Monitor Headset ...................................................................................................................... 51
Aux Headset ............................................................................................................................. 51
External A+B ............................................................................................................................. 52
VRA ............................................................................................................................................ 52
Monitor ..................................................................................................................................... 52
Speakers (FF1, FF2, FF3, FF4) ................................................................................................... 53
USB A (Host) x4 ........................................................................................................................ 53
USB B (device) .......................................................................................................................... 54
Speaker 1 &2 (5 pole DIN) ....................................................................................................... 54
LAN Ethernet ............................................................................................................................ 54
Appendix C - Calibration Reference & Maximum Levels.......................................................... 55
Earphones - Pure Tone RETSPL............................................................................................... 56
Earphones - ANSI Speech RETSPL........................................................................................... 57
Earphones - IEC Speech RETSPL ............................................................................................. 58
GSI AudioStar Pro Instructions for Use
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Earphones - Pure Tone max HL .............................................................................................. 59
Earphones - NB noise effective masking level....................................................................... 60
Earphones - NB noise max HL ................................................................................................ 61
Earphones - ANSI Speech max HL .......................................................................................... 62
Earphones - IEC Speech max HL............................................................................................. 62
Insert Earphones - Pure Tone RETSPL.................................................................................... 63
Insert Earphones - ANSI Speech RETSPL................................................................................ 64
Insert Earphones - IEC Speech RETSPL .................................................................................. 64
Insert Earphones - Pure Tone max HL ................................................................................... 65
Insert Earphones - NB noise effective masking level............................................................ 66
Insert Earphones - NB noise max HL ..................................................................................... 67
Insert Earphones - ANSI Speech max HL ............................................................................... 68
Insert Earphones - IEC Speech max HL .................................................................................. 68
Bone Vibrator - Pure Tone RETFL ........................................................................................... 69
Bone Vibrator - ANSI Speech RETSPL ..................................................................................... 70
Bone Vibrator - IEC Speech RETSPL........................................................................................ 70
Bone Vibrator - Pure Tone max HL......................................................................................... 71
Bone Vibrator - NB noise effective masking level ................................................................. 72
Bone Vibrator - NB noise max HL........................................................................................... 73
Bone Vibrator - ANSI Speech max HL..................................................................................... 74
Bone Vibrator - IEC Speech max HL ....................................................................................... 74
Free Field Speakers – ANSI RETSPL and Max HL ................................................................... 75
Appendix D - Warranty and Repair ............................................................................................ 76
Appendix E – Recycling and Disposal......................................................................................... 77
Appendix F – Electromagnetic Compatibility (EMC).................................................................. 78
Cautions regarding EMC.......................................................................................................... 78
Guidance and manufacturer’s declaration Electromagnetic emissions.............................. 79
Recommended separation distances between portable and mobile RF communications
equipment ................................................................................................................................ 80
Guidance and Manufacturer’s Declaration Electromagnetic Immunity.............................. 81
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GSI AudioStar Pro Instructions for Use
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PREFACE
This user manual provides information about the GSI AudioStar Pro. This manual is
intended for technically qualified personnel. This manual contains information pertinent to
the use of the AudioStar Pro system including safety information as well as maintenance
and cleaning recommendations. Proper use of this device depends on careful reading of all
instructions and labeling. Also be sure to follow all safety standards set by your facility.
Please note: This User Manual is not intended as a training manual. The reader should
consult standard audiology texts for the theory and application of the tests provided by
this instrument.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
MANUAL CONVENTIONS
Throughout this manual, the following meaning of warnings, cautions and notices are used.
WARNING
The WARNING symbol identifies conditions or practices that may present
danger to the patient and/or user.
CAUTION
The CAUTION Symbol identifies conditions or practices that could result in
damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation.
GSI AudioStar Pro Instructions for Use
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REGULATORY SYMBOLS
Symbol
Description
Conforms to European
Medical Device
Regulation (EU) 2017/745
.
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special
disposal required.
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
Regulation (EU) 2017/745
as a Class IIa
device.
China RoHS symbol for product compliance
Symbol for “European Authorized
Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
On/Off
Keep Dry
GSI AudioStar Pro Instructions for Use
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Symbol
Description
This side up.
Consult the operating instructions/directions
for use. A copy of the operating manual is
available on this website: www.grason-
stadler.com
A printed copy of the operating instructions
can be ordered from Grason-Stadler for
shipment within 7 days; or you can contact
your local representative.
Consult the operating instructions/directions
for use. A copy of the operating manual is
available on this website: www.grason-
stadler.com
A printed copy of the operating instructions
can be ordered from Grason-Stadler for
shipment within 7 days; or you can contact
your local representative.
DEVICE SYMBOLS
The following symbols appear on the instrument.
Definition: Type B applied part – IEC 60601-1 uses the term applied part to
refer to the part of the medical device which comes into physical contact with
the patient for the device to carry out its intended function. This icon
indicates that the GSI AudioStar Pro is Type B according to the international
standard IEC 60601-1. The applied parts are the headphones, insert earphones, and the
bone oscillator.
GSI AudioStar Pro Instructions for Use
D-0131088 Rev C, 2022-07 Page 10 of 84
Symbol
Description
Consult Operating Instructions.
Follow Instructions for Use.
Connection for headphones. The red markings
around the connector indicate the right ear and the
blue marking indicate the left connector.
Connection for the insert earphones. The red
markings around the connector indicate the right
ear and the blue marking indicate the left connector.
Connection for the bone conductor transducer.
Connection for the sound field speakers. The red
markings around the connector indicate the right
ear and the blue marking indicate the left connector.
Monitor
Patient response switch
On/Off - Next to power mains.
GSI AudioStar Pro Instructions for Use
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WARNINGS AND CAUTIONS
IMPORTANT SAFETY INSTRUCTIONS
The following safety precautions must always be observed. 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 instrument must only be used by hearing health care professionals qualified to
perform hearing threshold and auditory tests such as an audiologist, otolaryngologist,
researcher, or a technician under direct supervision by the 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 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.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Grason-Stadler and the local national competent authority.
SAFETY PRECAUTIONS
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 instrument is suitable in hospital environments except for near active high frequency
(HF) surgical equipment and radio frequency (RF) shielded rooms of systems for magnetic
resonance imaging, where the intensity of electromagnetic disturbance is high.
In case of emergency, disconnect the instrument from the supply mains by pulling the plug
out of the power socket.
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Before the first use of the instrument each day, or if suspect or inconsistent results are
apparent, the checks specified in the Routine Maintenance section should be carried out. 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.
No parts of the equipment can be serviced or maintained while in use with the patient.
Latex is not used anywhere in the manufacturing process. The base material for the
earphone cushions is made from natural and synthetic rubber.
Fluids
The device is not intended to be used in environments exposed to fluid spills.
No means is specified for fluid protection (not IP classed). Do not use the
device in the presence of fluid that can contact 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 an
authorized service technician. Do not immerse the unit in any fluids. See the Routine
Maintenance Section of this manual for the proper cleaning procedure for the instrument
and its accessories and the function of single-use parts.
Damage
Do not drop or otherwise impact this instrument. If the instrument is dropped
or damaged, return it to the manufacturer for repair and/or calibration. Do
not use the instrument if any damage is suspected.
Do not attempt to open, modify or service the instrument. Return the instrument to the
manufacturer or distributor for all repair and servicing requirements. Opening the
instrument will void the warranty. See Warranty and Repair in the Appendix
Connecting Additional Equipment
This equipment is intended to be connected to other equipment thus forming
a Medical Electrical System. External equipment intended for connection to
signal input, signal output or other connectors shall comply with the relevant
product standard e.g., IEC 60950-1 for IT equipment and the IEC 60601-series
for medical electrical equipment. In addition, all such combinations – Medical Electrical
Systems – shall comply with the safety requirements stated in the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment i.e., at least 1.5
m from the patient support or shall be supplied via a separation transformer to reduce the
leakage currents.
GSI AudioStar Pro Instructions for Use
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Any person who connects external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical technician
or your local representative. If the instrument is connected to a PC (IT equipment forming
a system) ensure not to touch the patient while operating the PC. If the instrument is
connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.
EXPLOSION
This system is not explosion proof.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device near
flammable anesthetic gases.
Do NOT use the system in a highly oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the
instrument be operated within an ambient temperature range of 15 °C / 59 °F
to 35 °C / 95 °F and in relative humidity between 30 % and 90 % (non-
condensing).
Transport the instrument in temperatures between 20 °C / -4 °F to +50 °C / +122 °F and
store the instrument in temperatures between 0 °C / 32 °F to 50 °C / 122 °F.
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in the Appendix. Although
the instrument fulfills the relevant EMC requirements, precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g., from mobile phones etc. This
appendix provides guidance on the electromagnetic environment in which to operate the
instrument.
Portable and mobile radio frequency (RF) communications equipment can affect medical
electrical equipment. Use of this instrument adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is necessary,
this instrument and the other equipment should be observed to verify that they are
operating normally.
GSI AudioStar Pro Instructions for Use
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INTRODUCTION
Thank you for purchasing the GSI AudioStar Pro™ system. The GSI AudioStar Pro is a stand-
alone, two channel, advanced clinical\research audiometer. It supports data transfer to a
computer but does not rely on the computer to perform tests and will not lose data if the
computer connection fails. User login and password controls provide security for patient
data. Test data can be transferred to software such as GSI Suite and Noah and can be
integrated into your EMR/EHR system.
INDICATIONS FOR USE
The AudioStar Pro is intended to be used for the identification 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.
INTENDED USE
The GSI AudioStar Pro is intended to be used for the purposes of determining patient
hearing sensitivity. It is intended to quantify the patient's level of hearing by presenting
pure tones stimuli through specific transducers at different frequencies and at different
sound pressure levels.
CONTRAINDICATIONS
There a no known contraindications for use.
ESSENTIAL PERFORMANCE
Essential Performance for this instrument as per IEC 60601-1 is defined by the
manufacturer as:
This instrument does not have an Essential Performance.
Absence or loss of Essential Performance cannot lead to any unacceptable immediate risk.
Final diagnosis shall always be based on clinical knowledge.
GSI AudioStar Pro Instructions for Use
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UNPACKING THE SYSTEM
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.
It is recommended that you unpack your AudioStar Pro carefully to make sure that
all components are removed from the packing materials.
Verify that all components are included as shown on the packing slip included with
your shipment.
If any component is missing, contact your distributor immediately to report the
shortage.
If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Please check that all accessories listed below have been received in good condition.
All standard components are part of the medical device and suitable for operation
in a patient environment.
Notify the carrier immediately if any mechanical damage is noted. This will ensure that a
proper claim is made. Save all packing material so the claim adjuster can inspect it as well.
Notify your dealer or GSI when the adjuster has completed the inspection.
Save all the original packing material and the shipping container so the instrument can
be properly packed if it needs to be returned for service or calibration.
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