GSi TYMPSTAR PRO User Manual
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GSi TYMPSTAR PRO User Manual

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GSI TYMPSTAR PRO
™
USER MANUAL
Part Number D-0105594 Rev G
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 952-278-4401 • e-mail info@grason-stadler.com

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  • Page 1 GSI TYMPSTAR PRO ™ USER MANUAL Part Number D-0105594 Rev G 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 952-278-4401 • e-mail info@grason-stadler.com...
  • Page 2 D-0105594 Rev. G...
  • Page 3 GSI TympStar Pro ™ Clinical Middle-Ear Analyzer Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual Manufacturer Grason-Stadler, Inc. 10395 West 70 Street Eden Prairie, MN 55344 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.

  • Page 4: Table Of Contents

    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 ........................
  • Page 5 GSI TympStar Pro ™ Clinical Middle-Ear Analyzer 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 ................................
  • Page 6 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 ..............................

  • Page 8: Preface

    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.
  • Page 9 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.”...
  • Page 10 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.

  • Page 11: Caution

    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...

  • Page 12: Warnings And Cautions

    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.

  • Page 13: Warning - General

    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.

  • Page 14: Warning - Explosion

    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.

  • Page 15: Recycling / Disposal

    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.

  • Page 16: Warranty

    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.

  • Page 17: Chapter 1: Introduction

    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.
  • Page 18 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.
  • Page 19 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: •...

  • Page 20: Chapter 2: Installation

    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.

  • Page 21: Initial Set Up

    On. If both green and yellow lamps are still illuminated and the probe is not occluded, contact a local service representative or the GSI service department for repair.

  • Page 22: Chapter 3: Connectors, Controls And Indicators

    Chapter 3: Connectors, Controls and Indicators Rear Panel The connectors on the rear panel of the TympStar Pro are shown in the following diagram. Connection Description Graphic Mains Power Input IEC 14 WARNING: To avoid the risk of electric shock, this equipment must only be...
  • Page 23 Connection Description Graphic USB A style port. Used to connect the USB Connectors TympStar Pro to a Printer or connect to USB flash drive External Monitor HDMI output - video only signals, no Output audio, 800 x 600 resolution. NOTE: Recommended specifications for external monitor are HDMI high definition monitor, 21.5 inch screen that...

  • Page 24: Right Side Panel

    A USB (A) port is also found on the right panel. The USB connection may be used for attaching a printer or a USB drive for upgrades. The TympStar Pro is equipped with four (4) USB ports – 3 ports on the back of USB Ports the instrument (2 USB Type A, 1 USB Type B) and one on the right side (USB Type A).

  • Page 25: Left Side Panel

    Left Side Panel 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 26: Bottom Panel Label

    Bottom Panel Label Graphic 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. Conforms to European Medical Device Directive 93/42/EEC.
  • Page 27 GSI Part number Return to authorized representative, special disposal required. Manufacturer.

  • Page 28: Probe Box

    Probe Box The probe box contains the connections for the probe and the contralateral probe. The buttons on the box allow the operator to change the ear being tested and to start and stop the test. The selected ear is indicated on the screen and on the probe box as the ear that has the light.

  • Page 29: Chapter 4: Front Panel Controls

    Chapter 4: Front Panel Controls The controls on the front panel of the TympStar Pro are shown below. Power 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 30: Test Type Buttons

    Test Type Buttons Screener The SCREENER key displays the screening screen. Tymp The TYMP key displays the tympanometry screen. Reflex The REFLEX key displays the reflex threshold screen. This buttons functions as a toggle to switch between reflex threshold/growth and reflex decay. The ETF key displays the Eustachian Tube Function Test screen.

  • Page 31: Tympanometry Controls

    Tympanometry Controls Manual 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. Hold 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 32: Reflex Stimulus Controls

    Configure screen. A compatible printer may be attached to the TympStar Pro to allow printing of the tympanometric test results directly. The printer must be HP PCL3, HP PCL5E, HP PCL3 GUI, or TSPL compatible. If a USB memory stick is inserted into an available USB port, print to PDF may also be selected.
  • Page 33 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. Some of the printer settings may be configured in the Configure screen, Print Settings menu and include printer protocol, paper size, and print button action.

  • Page 34: Data Transfer

    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.
  • Page 35 USB drive in PDF format. Printer Paper The TympStar Pro supports letter and A4 paper sizes, 3” roll paper for the Sanibel printer and the LPQ-80 and 3” labels for the LPQ-80. Print Button Action o Screen Print –...

  • Page 36: Chapter 5: Test Type Displays

    Chapter 5: Test Type Displays Display Monitor The TympStar Pro comes standard with an LCD touch screen display. The LCD is used to display all of 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 37 However, if the device is attached to a PC, then the GSI Instrument Services software can automatically update the device from the PC.
  • Page 38 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. Comments Icon The comments icon (pencil) opens a comments window.

  • Page 39: 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.
  • Page 40 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: Indicator Lights Status...
  • Page 41 The Set Type option displays a dialog with the tympanogram types that are available to be selected. The choices for the tympanogram type are defined in the PC configuration application (TympStar Pro Config App). Reflex Parameter Buttons Up to four reflexes may be recorded on the Screener display and there are two parameter buttons for each reflex.
  • Page 42 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 43 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. The + and - magnifier buttons increase and decrease the magnification.
  • Page 44 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. Comments The comments icon opens a comments window.

  • Page 45: Tympanometry

    Individual tympanogram results are stored as tabs on the left side of the tympanogram graph. 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 46 sweep goes from negative pressure to positive pressure). The peak of the tympanogram may be indicated by the arrow and line if the Peak Indicator is selected in Settings. The peak may be manually set by the user using the Zoom function.
  • Page 47 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).
  • Page 48 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. The marked tab is indicated by the check mark in the tab area. The last test is...
  • Page 49 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. The + and - magnifier buttons increase and decrease the magnification.
  • Page 50 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. The device default settings may be found in the Appendix.
  • Page 51 Sweep Quantity The Sweep Quantity Test Options button is used to select the number of tympanograms that may be collected on a single tympanogram test tab. When the button is selected, a dropdown list is presented. A quantity of 1, 2 or 3 may be selected.
  • Page 52 When the button is pressed the list of available protocols is presented. 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.

  • Page 53: Reflex Test

    Reflex Test 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. The reflex screen is show below.
  • Page 54 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 55 The pressure meter displays the real time pressure as it is being recorded from the probe in the ear canal. The units are decapascals (daPa). The current value is displayed at the top left of the meter. Reflex Stimulus Information The reflex stimulus information displays the eliciting stimulus information.
  • Page 56 Threshold Seek The Threshold Seek menu option selects if the instrument automatically collects reflexes and increases the level until a threshold is found. This button toggles to turn on/off the threshold seek. The start level, stop level and level increase step size are all configured in the reflex settings dialog.
  • Page 57 Zoom The Zoom menu option displays the zoom dialog. The zoom dialog provides a magnified view of the reflex data and displays the time and admittance values for the selected point. All reflex data may be reviewed by selecting the desired test frequency.
  • Page 58 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 59 dB Step The dB Step Threshold Seek Option button is used to select the level (dB) step size between the start and stop level for the reflex threshold testing when the threshold seek protocol is selected from the reflex menu. When the button is selected, it toggles between the options (1, 2, 5 dB).
  • Page 60 for as long as the Present button on the instrument front panel is pressed down with a fixed off time of 1.5 seconds. Stimulus Stimulus Type The Stimulus Type button selects the characteristics of the stimulus used for the reflex testing. The button toggles between the Pulsed and Steady. The Pulsed stimulus presents multiple tones in the time window of the reflex.

  • Page 61: Reflex Decay

    Reflex Decay 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 62 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: Indicator Lights Status...
  • Page 63 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).
  • Page 64 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 65 Settings The Settings menu option may be used to define the parameters used to collect the reflex decay. A Settings dialog is presented with the reflex decay parameters that are available. The reflex decay default settings are defined in the PC Config App.
  • Page 66 Scaling - 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 Component The Immittance button selects the immittance component that is displayed on the graph.

  • Page 67: Acoustic Reflex Latency Test (Arlt)

    Acoustic Reflex Latency Test (ARLT) Pressing the More button displays a menu that includes the ARLT option. Selecting the ARLT option displays the reflex latency screen. The reflex latency screen presents information for conducting acoustic stapedial reflex latency tests. The reflex collection data are displayed as graphs with different probe tones stored as tabs on the left side of the reflex graph.
  • Page 68 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: Indicator Lights Status...
  • Page 69 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 70 per stimulus may be stored. If you try to store a new reflex latency when a similar 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 71 Update point allows for changing the marked point to a different location on the tracing. Select the point to change by touching the marker on the tracing or the column in the table. Use the pressure knob to change the location of the cursor. Find points uses the built in algorithm of the device to locate each of the marked points.
  • Page 72 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 73 (Y) and the two components of Admittance, Susceptance (B) and Conductance (G). 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 74: Eustachian Tube Function (Etf) - Intact

    Eustachian Tube Function (ETF) - Intact 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 75 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: Indicator Lights Status...
  • Page 76 ETF Intact Test Results The lower right side of the ETF Intact screen displays the tympanogram results in a table. The header of the table indicates the test number and the probe tone frequency. The Tymp column displays the tympanogram number (up to 3 per test), the direction of the pressure sweep and the component that is being shown on the tympanogram.
  • Page 77 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...
  • Page 78 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. The + and - magnifier buttons increase and decrease the magnification.
  • Page 79 Settings The Settings menu option may be used to define the parameters used to collect the tympanogram for the ETF Intact test. A Settings dialog is presented with the tympanogram parameters that are available to be selected. The tympanogram default settings are defined in the Config App. Start Pressure The Start Pressure Test Options button is used to select the starting pressure (daPa) for collecting a tympanogram.
  • Page 80 Baseline Configuration The baseline configuration button may be used to select the point at which ear canal volume (Vea) is calculated. When the button is selected, a drop-down list is presented. When set to Auto, Vea for a 226 Hz probe tone tympanogram is calculated at the positive tail and for a 1000 Hz probe tone tympanogram, Vea is calculated from the negative tail.

  • Page 81: Eustachian Tube Function (Etf) - Perforated

    Eustachian Tube Function (ETF) - Perforated 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 82 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: Indicator Lights Status...
  • Page 83 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 84: Patulous Eustachian Tube Test (Etf)

    Patulous Eustachian Tube Test (ETF) 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 85 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: Indicator Lights Status...
  • Page 86 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. Probe The Probe button controls the probe tone frequency used for recording. The button indicates the current setting.
  • Page 87 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 88 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 89 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 be calibrated to perform Multi-Hz Tympanometry. Contact your GSI service representative if an error message occurs when accessing this test.
  • Page 90 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. Once completed, the TSP calculates and displays the 226 Hz Y tympanogram (Tab 1/Tymp 226 Hz), difference between the B components at the Start pressure (+200 daPa), and the Peak pressure (Tab 2 Delta Peak-Start), and the resonant frequency tympanogram (Tab 3/Tymp XX Hz).
  • Page 91 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 92 automatically identified by the cursor on the graphic displays where ΔB crosses 0 mmhos. Resonance of the ear is reached when stiffness and mass components are equal in magnitude. The Delta Peak-Start table contains the numerical values for the graphical results obtained at resonant frequency.
  • Page 93 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. Repeat for Tab 5 and 6 if desired.
  • Page 94 Multi-Hz Test Menu Auto Start The Auto Start check box determines if the test starts automatically upon obtaining a seal. When the box is checked, the data collection begins as soon as a seal is obtained. When the box is not checked, the start button on the device or probe shoulder box is used to start a test.
  • Page 95 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 Δ and phase Ø B graphs. he resonant frequency, admittance Ø, and admittance values display for the selected point.
  • Page 96 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. The device default settings may be found in the Appendix.
  • Page 97 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. Range The Pressure Range Test Options button controls the minimum and maximum pressure that is displayed on the tympanogram graphs.

  • Page 99: Chapter 6: Operation

    If there is any damage to any cord, do not use the TympStar Pro. If reflex testing with stimuli from an external source is to be performed, check that the CD or digital music player device is connected and operating properly.
  • Page 100 Different size eartips are provided with this instrument. The size of eartip will vary with size of the individual patient. Generally speaking, the following criteria apply: • Preemie - < 8 mm • Newborn - 8 mm, 11 mm • Pre-school -11 mm, 13 mm •...

  • Page 101: 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). Tympanometry 1. Select the Tympanometry mode by pressing TYMP button on the front panel.

  • Page 102: Acoustic Reflex

    positive pressure to a negative ending pressure. The right arrow indicates that the pressure will sweep from a negative starting pressure to a positive ending pressure. The choice of which start button to select depends on the starting pressure for the test. The starting pressure is set in the Settings dialog from the Settings button on the menu.
  • Page 103 4. Examine the ear canal to determine the appropriate size eartip for the test and position the eartip on the probe. Be certain that the eartip is pushed as far down the probe tip as possible so that the eartip is flush with the tip of the probe.

  • Page 104: Chapter 7: Application Software & Integration

    The TympStar Pro uses configuration application software to define the instrument and test settings defaults. 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 105 Revert: Ignores the changes since the last Save and reverts back 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 106 Diagnostic Protocols Default [SYSTEM] Test settings are saved as a protocol. There is one protocol that contains the default settings for the system and the protocol is name SYSTEM. This protocol may be copied and edited but cannot be deleted. Multiple protocols may exist on the system.
  • Page 107 A set of tests that may be run in a sequence are setup in the Auto Sequence protocol. The tests in the protocol may include diagnostic tests.

  • Page 108: Gsi Instrument Services

    Description The GSI Instrument Services 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 Services user manual for detail on how to utilize its functionality.

  • Page 109: Otoaccess

    Noah 4 GSI Suite may be installed in Noah 4 as a measurement module providing seamless integration between the audiometric evaluation and the hearing instrument fitting. Noah 4 may be installed as standalone software or on a network.

  • Page 110: Chapter 8: Routine Maintenance

    A test cavity is provided with this instrument. This test cavity enables the ability to quickly verify, on a daily basis, the proper calibration of the unit. GSI strongly recommends that this quick check is a part of the daily routine.
  • Page 111 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. This is confirmed by the green lamp changing from blinking to a steady condition.

  • Page 112: Biological Calibration Check

    Grason-Stadler, upon request, will provide circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist qualified service personnel to repair the instrument. The TympStar Pro Service manual contains this information. Cleaning the System Turn the system OFF and disconnect power before cleaning the instrument.

  • Page 113: Cleaning And Disinfecting Agents

    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 microfiber should pose little to no risk to the screen, by avoiding cleaning in small circular motions you avoid the risk of creating buffed out spots or spiral marks on the surface of the screen.

  • Page 114: Cleaning Patient Contact Devices

    As an alternative to disinfecting wipes, an ultraviolet (UV) light source could be used to disinfect touch screen surfaces. Cleaning patient contact devices Patient contact parts should be cleaned prior to each use. The probe and contralateral earphone and probe box may be wiped with a slightly damp cloth containing soap and water ammonia based cleaners or bleach based cleaners.
  • Page 115 2: Take off the probe tip. Note the gasket inside the tip. 3: Thread the stiff end of the cleaning brush into one of the tubes from inside.
  • Page 116 4: Pull the cleaning brush completely through the probe tip tube. Clean each of the four tubes. Discard floss after use. NOTE: Only insert the thread from the inside → out, this will insure that the dirt is pushed out of the probe instead of into the probe and as well protect the gasket from being damaged.
  • Page 117 5: Assemble the probe again (step 2+1) Use 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 118 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; instead, use the cleaning floss. 3: After the cerumen has been removed, reassemble the probe as described above.

  • Page 119: Appendix 1: System Defaults

    Appendix 1: System Defaults 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). Instrument Settings Date Format: mm/dd/yyyy...

  • Page 120: Tympanometry Settings

    Presentation # (db HL) (db HL) (db HL) (db HL) (db HL) Ipsi Contra 1 Tympanometry Settings Auto Start: Off Probe Tone: 226 Hz Immittance Component: Y Baseline: On Tymp Measure: Off Sweep Rate: 600/200 daPa/s Pressure Range: Normal Start Pressure: +200 daPa Normative Data: On Sweep Quantity: 1 Peak Indicator: Off...

  • Page 121: Etf Settings

    ETF Settings Intact Probe Tone: 226 Hz Immittance Component: Y Baseline: On Sweep Rate: 50 daPa/s Pressure Range: Normal Start Pressure: +200 daPa Perforated Max Pressure: + 400 daPa Time Base: 50 sec Patulous Probe Tone: 226 Hz Immittance Component: Y Y axis Scale: -.32 mmho Time Base: 30 sec Multi-Hz Settings...
  • Page 122 Auto Sequence 1: T+RT-I/C+RD-C [I/C+RD] 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 2000 Pulsed Reflex- Contra 4000 Pulsed...

  • Page 123: Appendix 2: Specifications

    Appendix 2: Specifications Measuring System Probe Signals Frequency Frequency Accuracy Total Harmonic Distortion 226 Hz +/- 1% < 1% 678 Hz +/- 1% < 1% 1000 Hz +/- 1% < 1% Probe Signal Level Probe Frequency Level 226 Hz 85 dB SPL, 69 dB HL 678 Hz 72 dB SPL, 69 dB HL 1000 Hz...
  • Page 124 Low Band Noise High Band Noise 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 125 Broad Band Noise Stimulus Signals Output Minimum: 35 dB HL Output Maximum: 108 dB HL Noise Bandwidths Low Band: 400 -1600 Hz High Band: 1600 - 4000 Hz Broad Band: 400 - 4000 Hz Spectrum response +/- 10 dB relative to 1 KHz Band-edges accurate to within ±15% Roll off rate: >...
  • Page 126 Stimulus Presentation Control On-Off and Signal-to-Noise Ratios Signal On/Off Ratio: > 70 dB Signal to Noise Ratio: > 60 dB Pulsed Stimulus Signal For 250 and 500 Hz: Period: 124msec Stimulus on time: 51 msec Stimulus off time: 73 msec Rise and fall time: 6 msec For 1000 Hz and above: Period: 115 msec...
  • Page 127 Isolation Transformer Switchable 120 VAC, 600 VA, 5.0 A 4 NEMA outlets Height: 8.9 cm (3.5 in) Width: 26.7 cm (10.5 in) Depth: 16.5 cm (6.5 in) Weight: 5.7 kg (12.6 lb) Physical Instrument Height: 37 cm (14.5 in) Width: 41 cm (16 in) Depth: 28 cm (11 in) Weight: 5.5 kg (12 lb) Probe...

  • Page 128: Appendix 3: Error Messages

    Calibration Error: 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. Multi-Hz Calibration Error -- The system has not been calibrated for Multi-Hz testing.

  • Page 129: Appendix 4: Safety, Emc And Associated Standards

    Pro. Install and operate the 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 130 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions 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...
  • Page 131 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity 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. Immunity Test...
  • Page 132 To assess the electromagnetic environment due to fixed 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 performance is observed, additional measures may be necessary, such as re-orienting or relocating the TympStar Pro.
  • Page 133 To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories: Item Manufacturer Item # TympStar Pro Probe Grason-Stadler 8104117 IP30 Contra earphone RadioEar 8101894 DD45 Contra earphone...

  • Page 134: Appendix 5: Audiometric Standards

    Appendix 5: Audiometric Standards The TympStar Pro is designed to meet or exceed the following standards: Aural Impedance/Admittance Instrument Standard Requirements - Type 1 1. ANSI S3.39 (1987) Specification for Instruments to measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) 2.

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