GSi TYMPSTAR PRO User manual

Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 10395 West 70th Street, Eden Prairie, MN, USA 55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]
GSI TYMPSTAR PRO™
USER MANUAL
Part Number D-0105594 Rev G

D-0105594 Rev. G i

GSI TympStar Pro ™ Clinical Middle-Ear Analyzer
ii D-0105594 Rev. G
Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2018 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 incorporates 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 Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
0123

D-0105594 Rev. G iii
Table of Contents
Preface ..........................................................................................................................................................1
Manual Conventions..................................................................................................................................1
Regulatory Symbols..................................................................................................................................1
Caution......................................................................................................................................................4
Safety Precautions.....................................................................................................................................4
Warnings and Cautions .............................................................................................................................5
Warning - General.....................................................................................................................................6
Warning - Connecting Additional Equipment...........................................................................................6
Warning - Electric Shock Hazards............................................................................................................6
Warning - Electric Grounding...................................................................................................................6
Warning - Explosion .................................................................................................................................7
Warning - Line Voltage Brownout and Interruptions ...............................................................................7
Warning - Connections..............................................................................................................................7
Warning - Battery Safety...........................................................................................................................7
Cautions - General.....................................................................................................................................7
Shutdown Procedure..................................................................................................................................7
Recycling / Disposal..................................................................................................................................8
Customer Responsibility ...........................................................................................................................8
Warranty....................................................................................................................................................9
Chapter 1: Introduction...............................................................................................................................10
Indication for Use....................................................................................................................................10
Intended Use............................................................................................................................................10
Contraindications ....................................................................................................................................10
Description and Operating Principles......................................................................................................10
Chapter 2: Installation.................................................................................................................................13
External Inspection..................................................................................................................................13
Unpacking ...............................................................................................................................................13
Initial Set Up ...........................................................................................................................................14
Chapter 3: Connectors, Controls and Indicators.........................................................................................15
Rear Panel ...............................................................................................................................................15
Right Side Panel......................................................................................................................................17
Left Side Panel ........................................................................................................................................18
Bottom Panel Label.................................................................................................................................19
Probe Box................................................................................................................................................21

GSI TympStar Pro ™ Clinical Middle-Ear Analyzer
iv D-0105594 Rev. G
Chapter 4: Front Panel Controls..................................................................................................................22
Power.......................................................................................................................................................22
Examiner .................................................................................................................................................22
Patient......................................................................................................................................................22
Data Erase ...............................................................................................................................................22
Test Type Buttons ...................................................................................................................................23
Screener...................................................................................................................................................23
Tymp .......................................................................................................................................................23
Reflex......................................................................................................................................................23
ETF..........................................................................................................................................................23
More........................................................................................................................................................23
Tympanometry Controls..........................................................................................................................24
Manual.....................................................................................................................................................24
Hold.........................................................................................................................................................24
Stop..........................................................................................................................................................24
Start .........................................................................................................................................................24
Pressure Control......................................................................................................................................24
Reflex Stimulus Controls........................................................................................................................25
Stimulus...................................................................................................................................................25
Intensity...................................................................................................................................................25
Present.....................................................................................................................................................25
Print.........................................................................................................................................................25
Data Transfer...........................................................................................................................................27
Configure.................................................................................................................................................27
Chapter 5: Test Type Displays....................................................................................................................29
Display Monitor ......................................................................................................................................29
Test Type Screens ...................................................................................................................................29
Screener Tests .........................................................................................................................................32
Tympanometry ........................................................................................................................................38
Reflex Test ..............................................................................................................................................46
Reflex Decay...........................................................................................................................................54
Acoustic Reflex Latency Test (ARLT) ...................................................................................................60
Eustachian Tube Function (ETF) - Intact................................................................................................67
Eustachian Tube Function (ETF) - Perforated........................................................................................74
Patulous Eustachian Tube Test (ETF).....................................................................................................77
Chapter 6: Operation...................................................................................................................................92

D-0105594 Rev. G v
Preliminary Checks .................................................................................................................................92
Typical Evaluations.................................................................................................................................94
Test Type Buttons ...................................................................................................................................94
Tympanometry ........................................................................................................................................94
Acoustic Reflex.......................................................................................................................................95
Chapter 7: Application Software & Integration..........................................................................................97
TympStar Pro Config App ......................................................................................................................97
GSI Instrument Services........................................................................................................................101
GSI Suite ...............................................................................................................................................101
OtoAccess™..........................................................................................................................................102
Noah 4 ...................................................................................................................................................102
AudBase................................................................................................................................................102
Chapter 8: Routine Maintenance...............................................................................................................103
Pretest Tympanometry Checks..............................................................................................................103
Calibration Quick Check for Probe.......................................................................................................103
Biological Calibration Check................................................................................................................105
Preventive Maintenance........................................................................................................................105
Cleaning the System..............................................................................................................................105
Cleaning and Disinfecting Agents.........................................................................................................106
Cleaning patient contact devices...........................................................................................................107
Probe care..............................................................................................................................................107
Appendix 1: System Defaults ...................................................................................................................112
Instrument Settings................................................................................................................................112
Screener Settings...................................................................................................................................112
Tympanometry Settings ........................................................................................................................113
Reflex Settings ......................................................................................................................................113
ETF Settings..........................................................................................................................................114
Auto Sequence Settings.........................................................................................................................114
Appendix 2: Specifications.......................................................................................................................116
Appendix 3: Error Messages.....................................................................................................................121
Appendix 4: Safety, EMC and Associated Standards...............................................................................122
Appendix 5: Audiometric Standards.........................................................................................................127

Preface This user manual provides information about the GSI TympStar Pro ™middle
ear analyzer. This manual is intended for technically qualified personnel.
Manual Conventions
In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures.
WARNING
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
CAUTION
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.
Regulatory Symbols
Symbol
Description
Conforms to European Medical Device Directive 93/42/EEC.
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special disposal required.

Symbol
Description
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.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
Attention, consult accompanying documents.
China RoHS symbol for products with a 50 year life cycle.
B Patient Applied Part according to IEC 60601-1.
On/Off - Next to power mains.
Keep Dry.
This side up.
Monitor.
Patient response switch.
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.

Symbol
Description
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.

Caution
US Federal law restricts this device to sale by or on the order of a physician or
licensed hearing care professional.
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 may cause serious injury to the ear. Before attaching the probe 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 Transformer
(if supplied). 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 may 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.
Warnings and Cautions
The TympStar Pro 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 TympStar Pro power plug and an AC outlet or
extension cord.
Do not block access to the power switch.
Instruments 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.
This icon indicates that the TympStar Pro is in compliance with Class 1, Type B
requirementsof IEC60601-1.
The TympStar 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 as a warning
indictor (IEC 60645-1 and ANSI S3.6).
Any program aimed at obtaining reliable records of middle ear measurements
should be staffed and supervised by appropriately trained individuals.
Latex is not used anywhere in the manufacturing process. The base material for
the ear tips is made from silicone rubber.
Always use ear tips on the insert earphones. Use of the insert earphone without
the tips mounted on insert phone could result in scratches to the ear canal.
A probe tip must be always used on the probe. Using the probe without the probe
tip could result in injury to the subject.
Eartips are single use only. Using disposable eartips ensures sanitary conditions
for each patient.

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.
No modifications of the equipment are allowed by anyone other than a qualified
GSI representative.
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
To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protective earth.
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.
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.
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.
Shutdown Procedure
To turn off the TympStar 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
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
Customer Responsibility
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 may 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 TympStar 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.

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.

Chapter 1: Introduction
Indication for Use
The TympStar Pro is intended to be used for the measurement of acoustic
impedance/admittance and otoacoustic emissions within the human external ear
canal. These measures are useful in the evaluation, identification, documentation
and diagnosis of ear disorders. The device is intended to be used on patients of
any age.
Intended Use
The TympStar Pro is intended to be used by an audiologist, ear nose and throat
physician (ENT), hearing healthcare professional, or trained technician. The
TympStar Pro is intended to be used in a hospital, clinic, or other healthcare
facility with a suitable quiet testing environment.
Contraindications
Ear canal examination with an illuminated otoscope is an essential prerequisite
to successful middle-ear testing. Make sure that the canal is free of any
obstruction. If the canal is completely plugged at the entrance or if fluid is
running from the ear canal, tympanometry should not be attempted until the
condition is cleared. Testing should not be performed on patients with conditions
listed below without a medical doctor’s approval.
•Recent stapedectomy or other middle ear surgery
•Discharging ear
•Acute external auditory canal trauma
•Discomfort (e.g. severe otitis externa)
•Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may
contraindicate testing when high intensity level stimuli are used
Description and Operating Principles
The TympStar Pro Middle-Ear Analyzer is a clinical aural acoustic
impedance/admittance instrument (Type 1). The TympStar Pro is a technically
advanced, computer-based instrument that builds on the sophistication,
functionality and flexibility of the GSI TympStar.
The main components of TympStar Pro instrument consist of a desktop unit with
an LCD and a probe assembly that has a probe and probe box connected to the
device. A contralateral insert phone, eartips and test cavity are included with the
system.

The probe contains one microphone, two receivers and an air channel. One of the
receivers is used for probe tone signal. The second receiver is used for the
acoustic reflex stimulus signal. The microphone measures the response. The air
channel is connected to the pump system which makes it possible to supply the
eardrum with air pressure. Acoustic energy, commonly referred to as the probe
tone, is introduced into a hermetically sealed ear canal. The decibel level of this
tone is monitored via a microphone with measurements taken at fixed time
intervals.
As pressure within the ear canal is varied, the eardrum is subjected to varying
degrees of stress which alters mobility of the eardrum. Maximum mobility will
occur when the pressure on both sides of the eardrum are equal. Changes in
mobility of the eardrum tend to produce changes in the probe tone level within
theearcanal. Probetonedecibel levelchangesindicatetheamountofsound energy
entering the middle ear.
The acoustic reflex consists of a response by one or more middle-ear muscles to
suprathreshold acoustic stimulation of the auditory pathway. To elicit an
acoustic reflex, an acoustic stimulus (pure-tone, noise, or click) is presented to the
ear canal by a probe or earphone. Contraction of the stapedius muscle and/or
the tensor tympani stiffens the eardrum and the ossicular chain; thereby,
decreasing the ease with which sound enters the auditorypathway.

The TympStar Pro is able to perform complete, manual or automatic diagnostic
testing for analysis of middle ear function. This diagnostic testing includes
measurement-plane and compensated static immittance and tympanometry under
manual and automatic control of air pressure. Admittance (Y), and its
components Susceptance (B) and Conductance (G), may be measured with
probe tone frequencies of 226, 678, and 1000 Hz. The TympStar Pro is capable
of generating noise and pure-tone acoustic reflex-activating signals for the
measurement of ipsilateral and contralateral acoustic reflexes. The extensive
battery of tests includes :
•Diagnostic Tympanometry
•Screening Tympanometry and Reflex
•Acoustic Reflex Threshold
•Acoustic Reflex Decay
•Eustachian-Tube Function Testing
•Acoustic Reflex Latency Test
•Multiple Frequency Tympanometry (250 Hz to 2000 Hz)
Operators have a choice of using GSI preprogrammed test parameters, or
programming customized test criteria. A large, touch-enabled liquid crystal
display (LCD) clearly displays test parameter choices and the possible
alternatives. Admittance and pressure indications are shown on the LCD along
with a continuous digital readout and test status. The tympanometric
measurement results are automatically scaled. All “Y”, “B” and “G”
measurements performed at probe tone frequencies of 226 Hz, 678 Hz and 1000
Hz are expressed in mmhos. Reflex test stimuli may be input from an external
source and presented via external control. A cursor is available in all test modes
for defining numeric positions on the X and Y axes. Test results are displayed in
real time so the user mayview the results as they are being measured. Data may be
saved, printed or sent to a PC for reporting and importing into an electronic
medical record.

Chapter 2: Installation
External Inspection
Although this TympStar Pro 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 TympStar 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.
NOTE: Keep the original packing material and shipping container so the
instrument can be well packaged if it needs to be returned to the local service
center for repair or calibration.
Check that all accessories listed in the table are received in good condition. If any
accessories are missing, a Grason-Stadler representative should be notified
immediately.
Part Number
Description
8108266
GSI TympStar Pro desktop unit including
GSI TympStar Pro Probe Assembly *
Contralateral Insert phone *
8109427
Sample box of Probe Eartips (3-18.5 mm)*
8515033
Shoulder Strap, Silicone *
8013166
Wrist Strap*
8006690
Probe Clip*
8108913
Probe House Mount Kit
8108227
Test Cavity
8108329
TympStar Pro Flash Drive Bundle
8109060
GSI Suite Flash Drive Bundle
8108100
Probe Tube Replacement Kit
8109405
Probe Tip Replacement Kit
8108944
Probe Cleaning Kit
8107449
Cleaning Cloth (LCD)