Page 1 RELIABLE CLINICAL TYMPANOMETER TYMPSTAR PRO USER MANUAL...
Page 2 Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual Manufacturer Grason-Stadler 10395 West 70 Street Eden Prairie, MN 55344 Copyright © 2022 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.
Page 3: Table Of Contents
GSI TympStar Pro User Manual ABLE OF ONTENTS Table of Contents .......................... 1 Preface ............................12 Manual Conventions ........................ 12 Regulatory and Device Symbols ....................13 Warnings and Cautions ....................... 16 Important Safety Instructions ....................16 Safety Precautions........................16 Fluids ..............................17 Damage ...............................
Page 4 USB Ports ............................. 28 USB A/B Cable ............................. 29 Left Side Panel .......................... 29 Monitor ............................. 30 Operating the TympStar Pro ....................... 31 Preliminary Checks ........................31 Prepare to Test ......................... 31 Helpful hints ..........................31 Data Collection ......................... 32 Instructing the Patient ........................
Page 5 GSI TympStar Pro User Manual Reflex Stimulus Controls......................37 Stimulus ............................ 37 Level ............................37 Present ............................37 Print ............................37 Instrument Operation While Printing ....................37 Print Messages ............................ 37 Printout ............................... 38 Data Transfer ..........................38 Configure ..........................39 Print Settings Menu ..........................
Page 6 GSI TympStar Pro User Manual Tympanometry ......................... 50 Probe Status Indicator ........................51 Admittance and Pressure Meters ....................... 51 Manual ..............................51 Tympanometry Test Results ....................... 52 Set Type ............................... 52 Tympanometry Test Menu ......................... 53 Reflex Test ..........................58 Probe Status Indicator ........................
Page 7 GSI TympStar Pro User Manual Stored Reflex Decay Information ......................68 Reflex Decay Test Menu ........................68 Auto Zero ............................68 Probe ..............................68 Stimulus Ear ............................68 Zoom ..............................69 Store ..............................69 Settings ..............................69 Level ..............................70 Timing ..............................
Page 8 GSI TympStar Pro User Manual Eustachian Tube Function (ETF) - Intact ................. 78 Probe Status Indicator ........................78 Admittance and Pressure Meters ....................... 79 Instructions box ..........................79 ETF Intact Test Results ........................79 ETF Intact Test Menu .......................... 80 Continue ..............................
Page 9 GSI TympStar Pro User Manual Patulous ETF Test Menu ........................89 Auto Zero ............................89 Probe ..............................89 Store ..............................89 Zoom ..............................89 Settings ..............................90 Scaling ..............................91 Immittance ............................91 Comments ............................91 Multiple Frequency Tympanometry Test (Multi Hz) [Licensed Option] ........92 Probe Status Indicator ........................
Page 10 Test Type Buttons ........................115 Tympanometry ........................115 Acoustic Reflex........................116 Application Software & Integration ..................118 TympStar Pro Config App ...................... 118 Installing the Configuration Software ....................118 Customizing the Configuration ......................118 Menu ..............................118 Instrument ............................119 Diagnostic Protocols .........................
Page 11 GSI TympStar Pro User Manual Cleaning and Disinfecting Agents ..................126 LCD Touch Screen..........................127 Cleaning patient contact devices ..................127 Probe care ..........................127 Use of the cleaning tool ......................129 Error Messages .......................... 131 Error - Invalid Start Direction ....................131 Error –...
Page 12 GSI TympStar Pro User Manual Temporal Characteristics ........................144 Pneumatic System ........................144 Acoustic Reflex Activating Stimulus System ................. 145 Pure Tone Stimulus Signals ....................... 145 Pure Tone Harmonic Distortion ......................146 Broad Band Noise Stimulus Signals ....................146 Noise Bandwidths ..........................146 Click Stimulus Signals ........................
Page 13 GSI TympStar Pro User Manual Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the TympStar Pro ..................156 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ......157 Appendix E - Warranty and Repair ................... 160 Warranty ..........................160 Repair ............................
Page 14: Preface
This user manual provides information about the GSI TympStar Pro. This manual is intended for technically qualified personnel. This manual contains information pertinent to the use of the TympStar 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.
Page 15: Regulatory And Device Symbols
GSI TympStar Pro User Manual EGULATORY AND EVICE YMBOLS Symbol Description Conforms to European Medical Device Directive 93/42/EEC. Indicates that the device is a Medical Device Symbol for "SERIAL NUMBER." GSI Part Number. Return to Authorized Representative, Special disposal required.
Page 16 GSI TympStar Pro User Manual Symbol Description On/Off Keep Dry This side up. Class II medical equipment 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;...
Page 17 This icon indicates that the GSI TympStar Pro is Type B, Class 1 according to the international standard IEC 60601-1. The applied parts are the probe assembly, probe clip, wrist strap, shoulder strap, contralateral insert earphone or headphone, and the ear tips.
Page 18: Warnings And Cautions
GSI TympStar Pro User Manual ARNINGS AND AUTIONS MPORTANT AFETY NSTRUCTIONS 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.
Page 19: Fluids
See Warranty and Repair in the Appendix. Electrical Warnings The TympStar Pro is designed to be used with a hospital grade outlet. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
Page 20: Line Voltage Brownout And Interruptions
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. 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.
Page 21: Battery Safety
GSI TympStar Pro User Manual 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.
Page 22: Introduction
The device is intended to be used on patients of any age. NTENDED 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.
Page 23: Description And Operating Principles
PERATING RINCIPLES 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.
Page 24 The TympStar Pro can 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.
Page 25: Installation
Notify the carrier if any damage is observed.  It is recommended that you unpack your TympStar Pro carefully to make sure that all components are removed from the packing materials.
Page 26: Standard Components
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. GSI TympStar Pro desktop unit including GSI TympStar Pro Probe Assembly * • Contralateral Insert phone * •...
Page 27: System Assembly
3. Connect power cable from base unit to outlet or isolation transformer ANEL Connections The connectors on the rear panel of the GSI TympStar Pro are shown below. The label and jacks are visible by turning the instrument around on a flat, stable surface. Connection...
Page 28 USB Computer USB B style connector. Used to Connection connect the TympStar Pro to the PC LAN Connection Ethernet Connection RJ45 Not supported USB Connectors USB A style port. Used to connect...
Page 29 GSI TympStar Pro User Manual Connection Description Graphic DC output DC connection 2.1 mm – only for use with the 4” Sanibel printer Left and Right 6.35 mm stereo jack Headphone Right (red) use for optional contra Outputs headset. Left (blue) currently not supported.
Page 30: Right Side Panel
USB Ports The TympStar Pro is equipped with four (4) USB ports – 3 ports on the back of the instrument (2 USB Type A, 1 USB Type B) and one on the right side (USB Type A). It is possible to connect external devices such as mouse, keyboard, or external printer to be used with the instrument.
Page 31: Usb A/B Cable
“suspend USB” power option on the PC. ANEL The connector to the probe box assembly is on the left side panel of the TympStar Pro. The connection has a tube for the delivery of the air pressure and an electronic connection for the microphone and receivers.
Page 32: Monitor
Select Button ONITOR The TympStar Pro comes standard with an LCD touch screen display. The LCD is used to display all the testing information from the instrument. The touch screen provides the input method to make selections. An optional keyboard and mouse may also be used.
Page 33: Operating The Tympstar Pro
It is good practice to perform a test on a normal ear each day to make certain that the instrument is functioning properly. See Routine Maintenance for details. Before starting any procedures using the GSI TympStar Pro, ensure that the power cord is plugged into a properly grounded receptacle.
Page 34: Data Collection
It is a good idea upon first receiving the instrument to practice on a cooperative patient to gain confidence in its use. A GSI provided Probe Tip must be used. Using the probe without the Probe Tip could result in injury to the subject.
Page 35: Positioning The Probe Box
GSI TympStar Pro User Manual Positioning the Probe Box Position the shoulder mount for the probe box over the patient’s shoulder on the same side as the ear to be tested. The Velcro strip should be facing away from the body. The probe box is then positioned on front of the Velcro strip.
Page 36: Front Panel Controls
RONT ANEL ONTROLS The controls on the front panel of the TympStar Pro are shown below. OWER The green LED, located in the upper right portion of the front panel, is illuminated when mains power is supplied to the TympStar Pro. This indicates that the power switch is in the on position.
Page 37: Data Erase
GSI TympStar Pro User Manual RASE The DATA ERASE button presents a dialog to choose the data to erase from the current session. The entire session, a specific test tab or selected waveform may be erased. UTTONS CREENER The SCREENER key displays the screening screen.
Page 38: Tympanometry Controls
GSI TympStar Pro User Manual YMPANOMETRY ONTROLS ANUAL The Manual button changes the test to use the pressure control knob instead of the predefined pressure rate and direction from the protocol for tympanometry. The Hold button holds the current pressure in the ear canal. The test remains in the hold condition until Start or Stop is pressed.
Page 39: Reflex Stimulus Controls
Print button action may be changed from the Configure screen on the instrument. Instrument Operation While Printing The TympStar Pro does not remain operational while printing. Wait until the printer status indicates that the printing is complete before attempting to initiate any actions on the instrument.
Page 40: Printout
A single ear or both ears may be selected. Printout The printout settings may be configured using the configuration software (GSI TympStar Pro Config App). The settings available for the printout include the print button action, the printer protocol, page size, color or grayscale and the format of the facility information and logo.
Page 41: Configure
This button displays setup options to update the TympStar Pro software, set the date and time, configure the cursor, adjust the screen brightness, set altitude, set print settings, and export log files. Pressing the CONFIGURE button a second time returns to the previous screen.
Page 42: Print Settings Menu
TSPL protocol is used for the LPQ-80 printer. The PDF protocol will send the printout to an attached USB drive in PDF format. Printer Paper The TympStar Pro supports letter, A4 paper sizes, and 3” roll paper and labels for the LPQ- Print Button Action Screen Print – prints the data displayed on the screen.
Page 43: Test Type Displays
GSI TympStar Pro User Manual ISPLAYS The information displayed on the TympStar Pro LCD varies depending on the Test Type. There are common elements found on all screens such as the Ear Tab, Probe Status indicator, Admittance meter, Pressure meter, the Test menu, and the Title Bar.
Page 44: Test Type Information
“marked.” The marked tab indicates the test that will be exported to GSI Suite or printed directly from the device. When you are reviewing data, there are some parameters that may be changed in analysis.
Page 45: Common Icons
GSI TympStar Pro User Manual Common Icons These icons are found in the test menu area and common to the different test types. Settings Icon The settings icon opens the settings dialog. The settings dialog displays the user selectable parameters for the specific test type.
Page 46: Screener Tests
A check mark indicates the ‘marked’ screening result. The marked screening results are those that will be transferred to GSI Suite or printed directly from the device. Only a single screening result per probe tone frequency may be marked. A total of four screening results per ear can be displayed on the screen.
Page 47: Probe Status Indicator
GSI TympStar Pro User Manual The area to the right of the graphic area displays the admittance and pressure meters along with the results of the tympanogram displayed in a table. The area under the tympanogram has the parameter buttons for the acoustic reflexes. Up to four acoustic reflexes may be collected for each screening test.
Page 48: Set Type
GSI TympStar Pro User Manual direction of the pressure sweeps and the component that is being shown on the tympanogram. The Vea column displays the ear canal volume (in cm ). The Peak column displays the pressure (daPa) and admittance (mmho) value of the peak of the tympanogram.
Page 49: Reflex Result
The Mark Test menu option is used to indicate the screening tab that will be used when the data is transferred to GSI Suite or printed. The marked tab is indicated by the check mark in the tab area. The last test is automatically marked.
Page 50: Zoom
GSI TympStar Pro User Manual Zoom The Zoom (magnifying glass icon) menu option displays the zoom dialog. The zoom dialog provides a magnified view of the tympanogram and displays the pressure and admittance values for the selected point. The up, down, left, and right arrow buttons are used to scroll the waveform.
Page 51: Settings
GSI TympStar Pro User Manual Settings The Settings menu option displays the Settings dialog that shows the parameters used to collect the tympanogram. The Screener default settings may be defined in the PC Config App. The device default settings can be found in the Appendix.
Page 52: Tympanometry
A check mark indicates the ‘marked’ tympanogram. The marked tympanogram is the tympanogram that will be transferred to GSI Suite or printed directly from the device. The peak pressure of the marked tympanogram is used to set the pressure for conducting the acoustic reflex tests.
Page 53: Probe Status Indicator
GSI TympStar Pro User Manual Up to three tympanograms may be displayed per test. When running multiple tympanograms, the direction of the pressure sweep must alternate between sweeps (i.e. if the first sweep goes from positive pressure to negative pressure the second sweep goes from negative pressure to positive pressure).
Page 54: Tympanometry Test Results
The Set Type option displays a dialog with the tympanogram types that are available to be selected. Separate tympanogram types may be defined for Y and B/G components and are defined in the PC configuration software (TympStar Pro Config App). D-0129427 Rev. B...
Page 55: Tympanometry Test Menu
Mark Test The Mark Test menu option is used to indicate the tympanometry tab that will be used when the data is transferred to GSI Suite or printed directly from the device. D-0129427 Rev. B Page 53 of 162...
Page 56 GSI TympStar Pro User Manual The marked tab is indicated by the check mark in the tab area. The last test is automatically marked. Zoom The Zoom (magnifying glass icon) menu option displays the zoom dialog. The zoom dialog provides a magnified view of the tympanogram and displays the pressure and admittance values for the selected point.
Page 57 GSI TympStar Pro User Manual Settings The Settings menu option may be used to define the parameters used to collect the tympanogram. A Settings dialog is presented with the tympanogram parameters that are available to be selected. The tympanogram default settings may be defined in the PC Config App.
Page 58 GSI TympStar Pro User Manual Baseline Configuration The baseline configuration button may be used to select the point at which the compensated admittance is calculated. When the button is selected, a drop-down list is presented. When set to Auto, the baseline for a 226 Hz probe tone tympanogram is calculated at the positive tail and for a 1000 Hz probe tone tympanogram, the baseline is calculated from the negative tail.
Page 59 The tests included in the protocol are displayed to the right of the button. The auto sequence protocols are defined in the TympStar Pro Config App. Comments The comments icon opens a comments window. An external keyboard is used to enter comments.
Page 60: Reflex Test
GSI TympStar Pro User Manual EFLEX Pressing the Reflex button displays the reflex screen. Pressing the Reflex button, a second time displays the Reflex Decay screen. The reflex button acts as a toggle button switching between the reflex screen and the reflex decay screen.
Page 61: Probe Status Indicator
GSI TympStar Pro User Manual threshold is indicated by a box/line around the curve. If no threshold is found, the test will be marked as “no response” (NR). When Threshold Seek is not enabled, the data may be stored by the user by selecting the Store icon or the NR-Store icon. If Store is selected and a threshold is selected in the scratchpad, the threshold will be indicated in the stored reflex.
Page 62: Reflex Stimulus Information
GSI TympStar Pro User Manual Reflex Stimulus Information The reflex stimulus information displays the eliciting stimulus information. The level and the stimulus settings are displayed for all types of reflex measurements. The level and stimulus may be controlled from the buttons on the front panel or the +/- buttons at the edges of the display (when not using threshold seek).
Page 63: Nr Store
GSI TympStar Pro User Manual NR Store The NR Store button (NR disk icon) on the Reflex menu saves the selected reflex graph as a ‘No Response.’ The graph is copied from the collection area to the stored display area. Only a single reflex per stimulus may be stored. If you try to store a new reflex when a similar reflex has already been stored, you will be prompted with a confirmation dialog before the data is replaced.
Page 64: Settings
A Settings dialog is presented with the reflex parameters that are available to be selected. The default settings are defined in the PC configuration application software (TympStar Pro Config App). Threshold Seek The Threshold seek section is used to set the parameters when using the threshold seek function.
Page 65: Non-Threshold Seek
GSI TympStar Pro User Manual Start Level The Start Level Threshold Seek Option button is used to select the initial stimulus level (dB HL) for the reflex threshold testing when the threshold seek protocol is selected from the reflex menu. When the button is selected, a dropdown list of options is presented.
Page 66: Timing
GSI TympStar Pro User Manual Start Level The Start Level Non-Threshold Seek Option button is used to select the initial stimulus level (dB HL) for manual reflex threshold testing. When the button is selected, a dropdown list of options is presented.
Page 67: Immittance
GSI TympStar Pro User Manual Y-Axis Scale The Y-Axis Scale button selects the amplitude scale (mmho) for the reflex test. When the button is selected, a dropdown list of options is presented. Immittance Immittance Component The Immittance button selects the immittance component that is displayed on the graph.
Page 68: Reflex Decay
GSI TympStar Pro User Manual EFLEX ECAY Pressing the Reflex button displays the reflex screen or if the Reflex screen is already displayed, pressing the button will display the Reflex Decay screen. The reflex button acts as a toggle button switching between the reflex screen and the reflex decay screen.
Page 69: Probe Status Indicator
GSI TympStar Pro User Manual Probe Status Indicator The probe status indicator indicates the state of the probe and displays messages regarding the current test. On the left side of the indicator, the two circles will be colored to match the LED lights on the probe box. The probe may be in the following states:...
Page 70: Stored Reflex Decay Information
GSI TympStar Pro User Manual Stored Reflex Decay Information The reflex decay results section displays the stored reflex decay tests. The information from the collection data scratchpad is selected and then stored (by selecting the store icon from the reflex decay menu bar or changing the stimulus frequency). Vertical lines indicate the 5 and 10 second points on the time axis (x).
Page 71: Zoom
GSI TympStar Pro User Manual Zoom The Zoom menu option displays the zoom dialog. The zoom dialog provides a magnified view of the reflex decay data and displays the time and admittance values for the selected point. The dialog has selections to scroll the waveform and change the magnification.
Page 72: Level
GSI TympStar Pro User Manual Level Max Level The Max Level Option button is used to select the maximum level (dB) for the eliciting stimulus when the front panel button is pressed. When the button is selected, a dropdown menu of options is presented.
Page 73: Acoustic Reflex Latency Test (Arlt) [Licensed Option]
On the right of the stimulus information is the information on the reflex threshold. Note: The TympStar Pro must have the Advanced Clinical Tympanometry license and calibrated to perform the Acoustic Reflex Latency Test.
Page 74: Probe Status Indicator
GSI TympStar Pro User Manual The individual reflex latency curve is stored to the reflex latency results area under the data collection graphs when the store icon is pressed. The reflex latency menu bar is under the results area. Probe Status Indicator...
Page 75: Stored Reflex Latency Information
GSI TympStar Pro User Manual Stored Reflex Latency Information The reflex latency results section displays the stored reflex latency tests. The information from the scratchpad is selected and then stored (by selecting the store icon from the reflex latency menu bar). Under the graph is the information on the marked points on the latency graph.
Page 76: Zoom
GSI TympStar Pro User Manual reflex latency has already been stored, you will be prompted with a confirmation dialog before the data is replaced. Zoom The Zoom menu option displays the zoom dialog. The zoom dialog provides a magnified view of the averaged reflex latency data and displays the time and admittance values for the selected point.
Page 77: Settings
When the button is selected, it toggles between the options (1, 2, 5 dB). Measurement Method The TympStar Pro supports different methods for the acoustic reflex latency measurements. Interest has focused on latency characteristics, rise and fall times of the reflex response, amplitude, and recovery characteristics. The definitions of these parameters are variable among investigators.
Page 78: Timing
There are two measurement methods supported. TympStar – this method uses the calculations that were used by the GSI TympStar. Four data points are marked that correspond to the 10% and 90% of the maximum amplitude from the stimulus onset and the 10% and 90% response decay from the stimulus offset.
Page 79: Comments
GSI TympStar Pro User Manual Comments The comments icon opens a comments window (you must use external keyboard to enter comments). Comments may be entered from any test screen and it is possible to review and edit comments from any test screen.
Page 80: Eustachian Tube Function (Etf) - Intact
GSI TympStar Pro User Manual (ETF) - I USTACHIAN UNCTION NTACT The ETF key displays the Eustachian Tube Function Test screen and loads the default ETF protocol. This button functions as a toggle to switch between the Intact, Perforated, and Patulous Eustachian Tube Function tests. The intact ETF screen is show below.
Page 81: Admittance And Pressure Meters
GSI TympStar Pro User Manual regarding the current test. On the left side of the indicator, the two circles will be colored to match the LED lights on the probe box. The probe may be in the following states: Indicator Lights...
Page 82: Etf Intact Test Menu
The Mark Test menu option is used to indicate the tympanometry tab that will be used when the data is transferred to GSI Suite. The marked tab is indicated by the check mark in the tab area. The last test is automatically marked unless the tympanogram peak is not detected.
Page 83: Zoom
GSI TympStar Pro User Manual Zoom The Zoom (magnifying glass icon) menu option displays the zoom dialog. The zoom dialog provides a magnified view of the tympanograms and displays the pressure and admittance values for the selected point. The up, down, left and right arrow buttons are used to scroll the waveform.
Page 84: Test Options
GSI TympStar Pro User Manual tympanogram parameters that are available to be selected. The tympanogram default settings are defined in the Config App. Test Options Start Pressure The Start Pressure Test Options button is used to select the starting pressure (daPa) for collecting a tympanogram.
Page 85: Display Options
GSI TympStar Pro User Manual calculated from the negative tail. When Positive Tail is selected, the baseline for all probe tones is calculated at the positive tail. When Negative Tail is selected, baseline for all probe tones is calculated at the negative tail.
Page 86: Eustachian Tube Function (Etf) - Perforated
GSI TympStar Pro User Manual (ETF) - P USTACHIAN UNCTION ERFORATED The ETF key displays the Eustachian Tube Function Test screen and loads the default ETF protocol. This button functions as a toggle to switch between the Intact, Perforated, and Patulous Eustachian Tube Function tests. The ETF Perforated screen is show below.
Page 87: Probe Status Indicator
GSI TympStar Pro User Manual Probe Status Indicator The probe status indicator indicates the state of the probe and displays messages regarding the current test. On the left side of the indicator, the two circles will be colored to match the LED lights on the probe box. The probe may be in the following states:...
Page 88: Etf Perforated Test Results
Mark Test The Mark Test menu option is used to indicate the ETF perforated tab that will be used when the data is transferred to GSI Suite. The marked tab is indicated by the check mark in the tab area.
Page 89: Patulous Eustachian Tube Test (Etf)
GSI TympStar Pro User Manual (ETF) ATULOUS USTACHIAN The ETF key displays the Patulous Eustachian Tube Test screen and loads the default protocol. This button functions as a toggle to switch between the Intact, Perforated, and Patulous Eustachian Tube Function tests. The Patulous ET test screen is show below.
Page 90: Probe Status Indicator
GSI TympStar Pro User Manual Probe Status Indicator The probe status indicator indicates the state of the probe and displays messages regarding the current test. On the left side of the indicator, the two circles will be colored to match the LED lights on the probe box. The probe may be in the following states:...
Page 91: Patulous Etf Test Menu
GSI TympStar Pro User Manual Patulous ETF Test Menu Auto Zero The Auto Zero menu option automatically sets the admittance to zero when the key is pressed. The system automatically sets the admittance to zero when the test is started.
Page 92: Settings
GSI TympStar Pro User Manual Settings The Settings menu option may be used to define the parameters used to collect the Patulous ETF test results. A Settings dialog is presented with the parameters that are available. The Patulous ETF default settings are defined in the PC Config App.
Page 93: Scaling
GSI TympStar Pro User Manual Scaling Time Base The Time Base button selects the time scale in seconds for X-Axis for the Patulous ETF test. When the button is selected, a dropdown list of options is presented. Y-Axis Scale The Y-Axis Scale button selects the amplitude scale (mmho) for the Patulous ETF test.
Page 94: Multiple Frequency Tympanometry Test (Multi Hz) [Licensed Option]
Multi-Hz screen may also be selected from the Title Bar test type drop down menu. Selecting Multi-Hz displays the Multi-Hz screen and is shown below. Note: The TympStar Pro must have the Advanced Clinical Tympanometry license and calibrated to perform Multi-Hz Tympanometry. If a device is started without calibration for Multi-Hz it will present the Config screen and display a calibration error message.
Page 95: Probe Status Indicator
GSI TympStar Pro User Manual test data. Three tabs are available to display tympanograms at other probe tone frequencies. The Multi-Hz test consists of an automatic sequence of measurement and data calculation. The sequence begins by presenting a wide-band stimulus while completing a pressure sweep (+200 to -400 by default) in 50 Hz steps in the sealed ear canal.
Page 96: Multi-Hz Test Results
GSI TympStar Pro User Manual Multi-Hz Test Results Tab 1-Tymp 226 Hz The 226 Hz tympanogram displays on the graph and the numerical results display in a table on the lower right side of the display. The Tymp column displays the direction of the pressure sweep and the component that is being shown on the tympanogram.
Page 97 GSI TympStar Pro User Manual The Delta Peak-Start table contains the numerical values for the graphical results obtained at resonant frequency. The table includes the resonant frequency (Hz), ΔB (mmho) and ØB (degrees). The starting pressure and peak in daPa are also displayed.
Page 98: Multi-Hz Test Menu
GSI TympStar Pro User Manual Tabs 4-6 It is possible to display additional tympanograms at any probe tone between 250 and 2000 Hz in 50 Hz increments. Select Tymp Tab 4 and press the +/ – buttons or drag the slider bar until the desired tympanogram appears.
Page 99: Immittance
GSI TympStar Pro User Manual Immittance The Immittance button selects the tympanometry component(s) that is displayed on the graph. The button label indicates the current setting. When the button is pressed a submenu is displayed where the user may choose between the Admittance (Y) and the two components of Admittance, Susceptance (B), and Conductance (G) and the combined graph showing both B and G (B/G).
Page 100: Zoom-Delta Peak-Start
GSI TympStar Pro User Manual Zoom-Delta Peak-Start Zoom allows the user to review or override the Delta Peak data. When Delta Peak tab is selected, the Zoom (magnifying glass icon) menu option displays a magnified view of the ΔB and B graphs.
Page 101: Settings
GSI TympStar Pro User Manual Settings The Settings menu option may be used to define the parameters used to collect the Multi-Hz test data. A Settings dialog is presented with the available parameters. The Multi-Hz default settings may be defined in the PC Config App.
Page 102: Test Options
GSI TympStar Pro User Manual Test Options Start Pressure The Start Pressure Test Options button is used to select the starting pressure (daPa) for collecting Multi-Hz tympanometry. When the button is selected, a dropdown list of starting pressures is presented.
Page 103: Comments
GSI TympStar Pro User Manual Comments The comments icon opens a comments window. An external keyboard is used to enter comments. Comments may be entered, edited and reviewed from any test screen. D-0129427 Rev. B Page 101 of 162...
Page 104: Wideband Tympanometry Test (Wbt) [Licensed Option]
Title Bar test type drop down menu. Selecting WideBand Tympanometry displays the WideBand Tympanometry screen. Note: The TympStar Pro must have the Advanced Clinical Tympanometry license and calibrated to perform WideBand Tympanometry. If a device is started without calibration for wideband it will present the Config screen and display a calibration error message.
Page 105: Wideband Tympanometry Test Menu
The sequence begins by presenting a wideband click stimulus while completing a pressure sweep (+200 to -400 by default) in the sealed ear canal. Once completed, the TympStar Pro calculates and displays three tabs. 226 Hz Y tympanogram (or 678, 800, or 1000 Hz Y tympanogram) •...
Page 106 GSI TympStar Pro User Manual showing both B and G (B/G). The default setting for the immittance for data collection is set in the Config App but may be changed on the analysis. Baseline The Baseline checkbox button is used to select if the tympanogram is baseline adjusted.
Page 107 GSI TympStar Pro User Manual Start Pressure The Start Pressure Test Options button is used to select the starting pressure (daPa) for collecting a tympanogram. When the button is selected, a dropdown list of starting pressures is presented. Range The Pressure Range Test Options button controls the minimum and maximum pressure that is displayed on the tympanogram.
Page 108 This dialog allows data to be imported, exported, or deleted from the device. The normative data is provided from GSI with the system. If you wish to create and import you own norms, contact GSI for the technical information on the supported file structure.
Page 109: Probe Status Indicator
GSI TympStar Pro User Manual Comments The comments icon opens a comments window. An external keyboard is used to enter comments. Comments may be entered, edited, and reviewed from any test screen. Probe Status Indicator The probe status indicator indicates the state of the probe and displays messages regarding the current test.
Page 110 GSI TympStar Pro User Manual The tympanogram displays on the graph and the numerical results display in a table on the right side of the display. The Tymp column displays the direction of the pressure sweep and the immittance component that is being shown on the tympanogram.
Page 111 GSI TympStar Pro User Manual Tab 2-WideBand Tymp (WBT AVG) The WideBand Tymp tab displays the average WideBand Tympanogram in which the percent absorbance vs. pressure is plotted. The range of frequencies used to obtain the average curve depends on the selected age range. For ages less than 6 months, the frequencies from 800 to 2000 Hz are averaged to produce a single curve.
Page 112 GSI TympStar Pro User Manual Tab 3-WideBand Absorbance (Absorb % 0 daPa) The Absorb % tab displays the wideband absorbance graph in which the percent absorbance vs. frequency is plotted. Absorbance is defined as the fraction of acoustic energy that is absorbed by the middle ear. The wideband absorbance graph is displayed at ambient pressure when the test tab is initially presented.
Page 113 GSI TympStar Pro User Manual Normative Data checkbox and Settings – the settings icon displays a dialog that lists the normative data files on the device and is used to select the normative data that you wish to load. The list of the available normative files is presented on the left side of the dialog. The right side of the dialog shows the details for the highlighted file.
Page 114 GSI TympStar Pro User Manual The slider along the bottom of the graph provides a means to select a specific pressure and displays the absorbance curve at the selected pressure. Tab 4-6-User Defined (Blank) Three additional tabs are available to display data from the wideband testing. When a user defined tab is selected, the choice of display type is chosen from the buttons.
Page 115 GSI TympStar Pro User Manual The Diff button provides options where you can display the difference between two absorbance curves. The table to the right of the graph contains the information for the wideband tympanogram. Below the table are the settings that determine which two absorbance curves are used to plot the difference curve.
Page 116 GSI TympStar Pro User Manual The Curve 1 and Curve 2 buttons have options that pop up when the button is selected. These options include Ambient, Peak, Stored daPa, Current daPa, and Norm. The graph that is displayed is the difference between the two selected curves. The Stored daPa button has an icon to the left side of the button that allows the absorbance curve represented by value from the slider to be saved and used in the calculation (Stored daPa).
Page 117: Typical Evaluations
Tests are pre-programmed to optimize efficiency and workflow. The options for the defaults for each test type are set up in the PC configuration software (TympStar Pro Config App). YMPANOMETRY 1. Select the Tympanometry mode by pressing TYMP button on the front panel. The display will show the screen for the tympanogram along with the summary information.
Page 118: Acoustic Reflex
GSI TympStar Pro User Manual been defined in the settings. The HOLD button may be pressed prior to completion of the sweep. The user may abandon automatic testing by pressing the STOP button at any point for difficult to test patients.
Page 119 GSI TympStar Pro User Manual 9. View ongoing test results on the graphic display area, and on the pressure and admittance meters. After presentation of the stimulus, the system is paused and waits for the next presentation (if threshold seek is off).
Page 120: Application Software & Integration
These settings are downloaded from the application software on the PC to the TympStar Pro. It is recommended that a copy of the custom configuration is saved as a back-up. This will allow the custom configuration to be loaded quickly onto multiple TympStar Pros.
Page 121: Instrument
Revert: Ignores the changes since the last Save and reverts to the previous settings. Changes will not be reflected on the TympStar Pro until they are downloaded to the unit. Load: Allows the operator to select a specific protocol from a list of saved configurations.
Page 122: Diagnostic Protocols
GSI TympStar Pro User Manual Printing Direct printing preferences are determined by the selections made in this section. The preferred print button action, printer protocol, page size and color/gray scale logo are customizable items in this section. General The General section defines the default new session test and ear, contralateral ear side and contralateral transducer.
Page 123: Screener Protocols
The GSI Instrument Service allows electronic transmission of test parameter information from the TympStar Pro to an external computer with a single push of the Data Transfer button. See the GSI Instrument Service user manual for detail on how to utilize its functionality.
Page 124: Data Port (Direct)
GSI Suite Audiometric Data Management software (Rev. 2.8 and higher) is compatible with the TympStar Pro as well as legacy products. GSI Suite imports, saves, and stores data from the TympStar Pro and allows the addition of comments into a report. The report data is saved in a PDF or other format that may be saved to the local PC, a remote location or attached with electronic medical data records (EMR).
Page 125: Routine Maintenance
HECKS A test cavity is provided with this instrument. This test cavity enables the ability to quickly verify the proper calibration of the unit. GSI strongly recommends that this quick check is a part of the daily routine. Test Cavity...
Page 126: 678 Hz And 1000 Hz
GSI TympStar Pro User Manual counter as the instrument or any moving object during this check as mechanical noise may be picked up by the probe and interfere with the calibration check. The calibration check will start automatically after the Start button has been pressed if the probe has been inserted into the cavity properly.
Page 127: Biological Calibration Check
The routine maintenance checks described in this chapter may suggest the source and solution to the problem. If they do not, the instrument should receive technical service by a GSI certified technician before further use.
Page 128: Cleaning And Disinfecting Agents
GSI TympStar Pro User Manual electrostatically adhered dust particles. Use the supplied microfiber cleaning cloth to wipe the fingerprints from the LCD screen. Clean with a slow and light touch moving in as broad a motion as possible either left to right or up and down across the screen. Although the...
Page 129: Lcd Touch Screen
GSI TympStar Pro User Manual LCD Touch Screen It is safe to use a disinfecting wipe containing up to 0.5% hydrogen peroxide or a commercial product that has been specifically formulated for LCD screens (i.e., CareWipes Antibacterial Force Item #: 2XL-400). Gently wipe the screen thoroughly, being careful to ensure no liquid drips into the bezel.
Page 130 GSI TympStar Pro User Manual 3: Thread the stiff end of the cleaning brush into one of the tubes from inside 4: Pull the cleaning brush completely through the probe tip tube. Clean each of the four tubes. Discard floss after NOTE: Only insert the thread from the inside →...
Page 131: Use Of The Cleaning Tool
GSI TympStar Pro User Manual NOTE: Never clean inside the probe holes 5: Assemble the probe again (step 2+1) SE OF THE CLEANING TOOL The cleaning kit also provides a 3-in-1 cleaning tool. At one end of the tool is a metal loop and the other end of the tool may be removed to expose a wire and brush.
Page 132 GSI TympStar Pro User Manual 3: Use the wire end to push the cerumen from the inside to the outside for each the four tubes of the probe tip. Do not use the brush end of this tool to clean the probe tip;...
Page 133: Error Messages
Both the Probe (IPSI) and Contra transducers are required to be calibrated. If this error appears, it is recommended to contact your GSI Service Representative. ALIBRATION RROR The system has not been calibrated for WideBand testing. Contact your GSI service representative to calibrate. LTITUDE HANGE RROR Changing the altitude requires a new wideband calibration at the new altitude.
Page 134: Error
GSI TympStar Pro User Manual RROR If there are general system errors, a dialog box with “Error” in the title will be shown with the given error. D-0129427 Rev. B Page 132 of 162...
Page 135: Appendix A: System Defaults
GSI TympStar Pro User Manual A: S PPENDIX YSTEM EFAULTS The instrument is shipped with the default settings shown below. These settings may be changed by connecting the instrument to a PC and running the configuration application software (TympStar Pro Config App).
Page 136: Screener Settings
GSI TympStar Pro User Manual CREENER ETTINGS Auto Start Probe Tone 226 Hz Immittance Component Baseline Tymp Measure Width Sweep Rate 600/200 daPa/s Pressure Range Normal Start Pressure +200 daPa Normative Data Sweep Quantity Peak Indicator Reflex Ear Ipsi Reflex Frequency...
Page 137: Tympanometry Settings
GSI TympStar Pro User Manual YMPANOMETRY ETTINGS Auto Start Probe Tone 226 Hz Immittance Component Baseline Tymp Measure Sweep Rate 600/200 daPa/s Pressure Range Normal Start Pressure +200 daPa Normative Data Sweep Quantity Peak Indicator D-0129427 Rev. B Page 135 of 162...
Page 138: Reflex Settings
GSI TympStar Pro User Manual EFLEX ETTINGS Probe Tone 226 Hz Immittance Component Reflex Ear Ipsi Reflex Frequency 500 Hz Reflex Stimulus Type Pulsed Reflex Averages Reflex Stimulus Quantity Time Base 15 sec Stimulus Timing Auto On Time 1.5 sec Off Time 1.5 sec...
Page 139: Etf Settings
GSI TympStar Pro User Manual ETF S ETTINGS Intact Probe Tone 226 Hz Immittance Component Baseline Sweep Rate 50 daPa/s Pressure Range Normal Start Pressure +200 daPa Perforated Max Pressure + 400 daPa Time Base 50 sec Patulous Probe Tone...
Page 140: Multi-Hz Settings
GSI TympStar Pro User Manual ULTI ETTINGS Probe Tone 226 Hz (Tab 1) Immittance Y (Tab 1) AutoStart Baseline Sweep Rate 50 daPa/sec Adult Normative Data (226 Hz, Tab 1) Peak Indicator Pressure Range Normal Start Pressure +200 daPa Immittance B (Delta Peak-Start;...
Page 141: Wideband Settings
GSI TympStar Pro User Manual ETTINGS Probe Tone 226 Hz (Tymp Tab) Immittance Y (Tymp Tab) AutoStart Baseline Sweep Rate 50 daPa/sec ≥ 6 months Normative Data (226 Hz, Tymp Tab) Peak Indicator Pressure Range Normal Start Pressure +200 daPa D-0129427 Rev.
Page 142: Auto Sequence Settings
GSI TympStar Pro User Manual EQUENCE ETTINGS Factory [System] Sequence Test Freq Type Decay Tymp Probe 226 Reflex- Ipsi Pulsed Reflex- Ipsi 1000 Pulsed Reflex- Ipsi 2000 Pulsed Reflex- Ipsi 4000 Pulsed Reflex- Contra Pulsed Reflex- Contra 1000 Pulsed Reflex- Contra...
Page 143: Appendix B - Technical Data
B – T PPENDIX ECHNICAL The TympStar Pro is an active, diagnostic medical product. The device is classified as a class IIa device according to the EU medical directive 93/42/EEC and a class II device according to the US FDA.
Page 144 GSI TympStar Pro User Manual Vibration and Shock Not Applicable Warm up Time At room temperature +15° C to +35° C 10 minutes At room temperature; < +15° C 1 hour Expected Service Life 7 years POWER Power Supply (internal) Input Voltage: 100 –...
Page 145: Measuring System
GSI TympStar Pro User Manual Width 1.3 cm (0.5 in.) Depth 3.76 cm (1.5 in.) Weight Isolation Transformer (optional) Electrical Switchable 120 VAC, 600 VA, 5.0 A Outlets 4 NEMA Height 8.9 cm (3.5 in.) Width 26.7 cm (10.5 in.) Depth 16.5 cm (6.5 in.)
Page 146: Measurement Range
GSI TympStar Pro User Manual Measurement Range Frequency Measurement Range 226 Hz -10 to +10 mmho 678 Hz -21 to +21 mmho 1000 Hz -32 to +32 mmho Accuracy of Measurement Mode Measurement Range Tymp mode at 226 Hz Probe Tone 0.1 mmho or 5% whichever is greater...
Page 147: Acoustic Reflex Activating Stimulus System
GSI TympStar Pro User Manual COUSTIC EFLEX CTIVATING TIMULUS YSTEM Pure Tone Stimulus Signals Frequency (Hz) Min Level Max Level Max Level Max Level Frequency (dB HL) (dB HL) (dB HL) (dB HL) Accuracy Ipsi Contra- Contra- Insert Headset +/- 3%...
Page 148: Pure Tone Harmonic Distortion
GSI TympStar Pro User Manual Zero level reference values (250 Hz-4000 Hz) are a GSI Standard and come from an internal study performed according to ISO 389-9. BBN, LBN and HBN reference values were determined by GSI using the “Threshold Determination Method”.
Page 149: Click Stimulus Signals
GSI TympStar Pro User Manual Click Stimulus Signals Output Minimum 35 dB SPL Output Maximum Ipsi Output Maximum Contra 120 dB SPL Rate 50-300/sec, +/- 1/sec Stimulus Interval and Minimum Range 1, 2 and 5 dB step size Stimulus Level Control Accuracy +/- 0.5 dB...
Page 150: External Stimulus Signals
GSI TympStar Pro User Manual For 1000 Hz and above Period 115 ms Stimulus on time 46 ms Stimulus off time 69 ms Rise and fall time 6 ms External Stimulus Signals Peak Voltage 3 VAC Input Impedance 15 k Ohms At 0.5VRMS 1kHz Maximum...
Page 151: Appendix C - Specification Of Input/Output Connections
GSI TympStar Pro User Manual C – S PPENDIX PECIFICATION OF NPUT OUTPUT ONNECTIONS AINS ABLE Description Live Neutral Earth USB C OMPUTER ONNECTION Description + 5 V DC Data - Data + LAN C ONNECTION Description SGND SGND D-0129427 Rev. B...
Page 152: Usb Connectors
GSI TympStar Pro User Manual USB C ONNECTORS Description + 5 V DC Data - Data + ATIENT ESPONSE NPUT Description Ground Signal , R, L) EADPHONES CONNECTORS Description Ground Signal (7Vrms at 10 Ohm; 60-20,000Hz -3dB) OUTPUT 4” S...
Page 153: External Monitor Output
GSI TympStar Pro User Manual XTERNAL ONITOR UTPUT Description TMDS Data 2+ TMDS Data 2 shield TMDS Data 2- TMDS Data 1+ HDMI Type A TMDS Data 1 shield TMDS Data 1- TMDS Data 0+ TMDS Data 0 shield TMDS Data 0-...
Page 154: External Input
GSI TympStar Pro User Manual XTERNAL NPUT Description Ground Signal (External input is between 15 mV and 3.5 mm 500 mV for a 0 dB reading on a VU indicator; the input impedance is 50,000 ohm.) ROBE BOX Description INTERRUPT...
Page 155: Appendix D - Safety, Emc, And Associated Standards
TympStar Pro according to the EMC information presented on this appendix. The TympStar Pro has been tested for EMC emissions and immunity as a standalone instrument. Do not use the TympStar Pro adjacent to or stacked with other electronic equipment.
Page 156: Electromagnetic Compatibility
GSI TympStar Pro User Manual LECTROMAGNETIC OMPATIBILITY Although the instrument fulfils the relevant EMC requirements, precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones, etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears.
Page 157: Guidance And Manufacturer's Declaration Electromagnetic Emissions
ECLARATION LECTROMAGNETIC MISSIONS The TympStar Pro is intended for use in the electromagnetic environment specified below. The customer or the user of the TympStar Pro should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment -...
Page 158: Equipment And The Tympstar Pro
QUIPMENT AND THE The TympStar Pro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TympStar Pro can help prevent electromagnetic interferences by maintaining a minimum distance between...
Page 159: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
GSI TympStar Pro User Manual ’ UIDANCE AND ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY Immunity Test IEC 60601 Test Compliance Electromagnetic level Environment- Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, Discharge (ESD) concrete or ceramic tile. If ±2 kV, ±4 kV, ±8 kV,...
Page 160 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TympStar Pro is used exceeds the applicable RF compliance level above, the TympStar Pro should be observed to verify normal operation. If abnormal D-0129427 Rev.
Page 161 GSI TympStar Pro User Manual performance is observed, additional measures may be necessary, such as re-orienting or relocating the TympStar Pro. (b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. NOTICE: There are no deviations from the collateral standard and allowances uses.
Page 162: Appendixe - Warranty And Repair
This warranty is extended to the original purchaser of the instrument by GSI through the distributor from whom it was purchased and covers defects in material and workmanship for a period of one year from date of delivery of the instrument to the original purchaser.
Page 163: Repair
Grason-Stadler will provide circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist service personnel in parts repair. This information is found in the Service Manual which may be ordered from GSI or the GSI distributor. D-0129427 Rev. B...
Page 164: Appendixf - Recycling And Disposal
GSI TympStar Pro User Manual F – R PPENDIX ECYCLING AND ISPOSAL 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.

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