GSI-AMTAS User Manual Rev C

Title: GSI AMTAS Pro™ User Manual Manufacturer Grason-Stadler, Inc. 10395 West 70th Street Eden Prairie, MN 55344 USA Copyright © 2018 Grason-Stadler. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Grason-Stadler. The information in this publication is proprietary to Grason-Stadler. This product incorporates software developed by others and redistributed according to license agreements. Copyright notices and licenses for these external libraries are provided in a supplementary document that is included with the other software applications distributed with this product. Compliance The CE 0086 mark identifies compliance with the Medical Device Directive 93/42/EEC. GrasonStadler is an ISO 13485 certified corporation.

European Authority Representative Grason-Stadler c/o Interacoustics A/S Audiometer Alle 1 5500 Middelfart Denmark

0086

Caution: US Federal law restricts this device to sale by or on the order of a physician or licensed hearing care professional.

Table of Contents Preface ... 5 Manual Conventions ... 5 Important Safety Instructions ... 5 Precautions ... 5 Regulatory Symbols ... 6 Introduction ... 7 Indication for Use of GSI AMTAS Pro ... 7 Intended Use of GSI AMTAS Pro ... 7 Installation and Setup ... 8 Precautions ... 8 Prerequisites ... 8 Installing on Windows® 7 and 10 ... 9 Uninstalling GSI AMTAS Pro ... 12 Connecting GSI Instruments ... 12 GSI AMTAS Pro License ... 12 Connecting the GSI Audiometer to the GSI AMTAS PRO PC ... 12 Patient Preparation ... 13 Bone Oscillator Placement ... 13 Headphone Placement ... 13 GSI AMTAS Pro Program ... 14 User Interface – Screen Layout and Controls ... 15 Welcome Screen ... 15 Patient Information Screen ... 16 Listen for a Tone Screen ... 17 Response to a Tone Screen ... 18 Listen for a Word Screen ... 19 Response to a Word Screen ... 20 Test Completed Screen ... 21 Settings and GSI AMTAS Pro Config App ... 22 Menu Bar ... 24 Configuration Options ... 28 Reports ... 28 General Options ... 29 Workflow ... 30

Demographics ... 32 Screening ... 33 Air/Bone Diagnostic ... 34 Speech Diagnostic... 35 GSI AMTAS Pro Reports ... 36 Audiometric Report ... 36 Patient Report... 40 Uploading GSI AMTAS Pro Results to GSI Suite ... 41 Error Messages... 42 GSI AMTAS Pro Testing Protocol ... 43 Psychophysical Method ... 43 Masking ... 43 Speech ... 43 Pure Tone Average Calculation ... 44 Non Responses ... 44 Config App Default Settings ... 45 AMTAS Publications and Patents... 46 AMTAS PUBLICATIONS ... 46 AMTAS PATENTS ... 46

Preface This user manual provides information about the GSI AMTAS Pro™ software program. This manual is intended for technically qualified personnel. Please note: This operating manual is not intended as a training manual for audiometry. The reader should consult standard audiology texts for the theory and application of the auditory tests provided by this software when connected to an instrument.

Manual Conventions In this manual the following label identifies conditions or practices that may present danger to the patient and/or user or damage to the equipment.

Important Safety Instructions The software program configuration and audiometer must be used only by practitioners qualified to perform audiometric tests. It is intended for transient use as a screening and diagnostic tool; however no surgical or medical procedure should be undertaken solely on the basis of results obtained from the program. Consult the audiometer manual for the important safety information regarding the audiometer. Ensure that all transducers are properly connected to the audiometer. Do not connect the transducers to the audiometer while attached to the patient. Consult the PC manual for the PC for the important safety information for the PC.

Precautions READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE SOFTWARE This software configuration and audiometer should only be used by a hearing health care professional such as an audiologist, otolaryngologist, researcher or a technician under the direct supervision by the aforementioned specialist. Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills. Appropriate placement of the transducers on the patient is required for accurate test results. Patient discomfort could lead to confusing results from the patient. Incorrect use could lead to wrong results.

Regulatory Symbols Symbol

IEC Pub.

Description

980 & 60601-1

Conforms to European Medical Device Directive 93/42/EEC.

980 & 60601-1

Symbol for "SERIAL NUMBER."

980

GSI Part Number.

980 & 60601-1

Return to Authorized Representative, Special disposal required.

980 & 60601-1

Medical Equipment Classified by Intertek Testing Services NA Inc. with respect to electric shock, fire, and mechanical hazards only, in accordance with UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class IIa device.

980 & 60601-1

Symbol for “European Representative.”

980 & 60601-1

Symbol for “Manufacturer.”

980 & 60601-1

Symbol for “Date of Manufacture.”

980 & 60601-1

Attention, consult accompanying documents.

60601-1

B Patient Applied Part according to IEC 60601-1.

980 & 60601-1

Consult Operating Instructions.

ISO 7010-M002

Follow Instructions for Use.

Introduction GSI AMTAS Pro™ is a software program that provides an automated method for obtaining a diagnostic hearing test including air and bone conduction thresholds with masking applied to the non-test ear. GSI AMTAS Pro also provides automated tests of speech reception. Both Speech Recognition Threshold (SRT) and Word Recognition Scores (WRS) may be obtained. AMTAS was developed through a partnership between Audiology Incorporated and three research institutions, the University of Minnesota, the University of Utah, and the James H. Quillen Veterans Administration Medical Center. The development was funded by the National Institutes of Health Small Business Technology Transfer (STTR) Program. AMTAS Pro is based on a psychophysical procedure that uses the patient’s responses to determine signal levels needed to find auditory thresholds. Once the transducers are placed on the patient, the test is self-administered. The test is selfpaced so that patients proceed at the rate that is comfortable for them. Feedback is provided to the patient that helps them distinguish between test tones and other auditory sensations. GSI AMTAS Pro was designed to provide the same test results that would be obtained by an expert audiologist with a psychophysical procedure that has advantages over the commonly used clinical (“HughsonWestlake”) method. Quality indicators provide information about the validity of results. Air conduction audiograms are classified based on configuration, severity, and symmetry. The program generates a report and interfaces with GSI Suite and the data may be transferred to other software programs. The software performs these tests by controlling a GSI audiometer connected to the PC running the software.

Indication for Use of GSI AMTAS Pro GSI audiometers are intended to be used for the identification and etiology of hearing loss in patients of any age. It is intended to be used by an audiologist, ENT, hearing healthcare professional, or trained technician in a hospital, clinic, healthcare facility or other suitable quiet environment.

Intended Use of GSI AMTAS Pro GSI AMTAS PRO is intended to be used to obtain diagnostic audiometric data through a GSI audiometer. It is intended to be used for routine clinical testing in any environment in which pure-tone audiometry and speech recognition testing is performed. Anyone who can follow the instructions used for manual audiometry may be tested by GSI AMTAS Pro. Patients unable to cooperate because of young age or other conditions that cannot undergo pure tone audiometry and may need to have the auditory system tested by other methods.

Installation and Setup Precautions The following precautions will aid in the secure collection and storage of patient data: • Disable the “suspend USB” power option to ensure proper communication between instrument and PC. • To avoid unwanted data transfer from PC to the network, ensure that an appropriate virus & spyware scanner is installed, updated, and effective. Please contact a local administrator for help and guidance. • All users should have a unique login to the PC. NOTE: To ensure proper sound presentation all speaker enhancements in Windows should be disabled. The Sound Playback - Speaker Properties dialog, Enhancements tab has the option to disable all enhancements.

Prerequisites GSI AMTAS PRO PC Minimum Requirements • • • • • • • • •

CPU: 2.0 GHz, Intel i5 (dual or quad core) or better RAM: 4 GB Hard Disk: 128 GB or larger USB Ports: 1 Display: 19” or larger Resolution: 1280 x 800 minimum Touch screen or mouse/trackball CD-ROM Drive or USB for software installation Network LAN Card (if connecting to database via a network)

GSI AMTAS PRO Supported Operating Systems • •

Microsoft Windows® 10 Pro Microsoft Windows® 7 Professional

GSI AMTAS PRO Software Requirements The following will be installed automatically with the GSI Suite installation, if they are not already present on the PC. • Microsoft .NET Framework version 4.6.2 • Driver for the GSI audiometer

GSI AMTAS PRO Audiometer Requirements • • •

GSI AMTAS Pro License Bone conduction Oscillator: B71, B81 Headphones: HDA200, DD450

Installing on Windows® 7 and 10 Initiating GSI AMTAS Pro Insert the GSI AMTAS Pro CD into the CD-ROM drive. If the program is delivered on a USB drive, insert the drive into a USB port on the PC. If auto-run is disabled, browse the CD or USB drive and double click on the Setup_GSI_AMTAS_Pro.exe file. NOTE: In order to install this application, the user must either be an Administrator or know the Administrator password.

1. Read the license agreement carefully. Select the “I Agree” check box to accept the agreement and press “Install” to continue or select “Close” to avoid acceptance of the license agreement and exit Setup. 2. Windows may present a User Account Control dialog that asks if you want to allow the program to make changes to the computer. Answer “Yes” to continue the installation. 3. In order to use the GSI-AMTAS Pro, it is necessary to have .NET and Adobe Reader installed on the computer. Before the GSI AMTAS Pro application is installed, the setup will evaluate the computer for these programs. If they are not currently installed, GSI AMTAS Pro will display a dialog box indicating that it is necessary to install these programs. Press “Install” to install the prerequisite software. This may take several minutes. Follow the on-screen instructions to complete the installation of these programs.

4. The type of security that is used with the program is setup during the installation. A security selection dialog is presented with three (3) security options. Select the appropriate security type for your facility. •

Windows – Domain Integration Security When the program requires authentication, it will verify the user identity and password based on Windows authentication. The software will automatically add this installation user to the AMTAS administrator group. Additional AMTAS administrators may be added by running the GSI AMTAS Pro Config app as an administrator with this user account.

•

Single Password Security There is one administrator account which will have the user identity of “admin” and initial password of “admin”. You will be able to set the password using the GSI AMTAS Pro Config App. This account will have no connection to the Window authentication. When the program requires authentication, it will verify the identity and password based on this one admin account.

•

No Security The program will not restrict access based on the user (i.e., it will never prompt for identification or password).

5. A message will be displayed to indicate that the software has been successfully installed. Select “Close”. NOTE: Installing GSI AMTAS Pro will also install the GSI Instrument Service software package and any drivers needed for the audiometer. The installation may require a restart of the computer to continue.

Uninstalling GSI AMTAS Pro 1. 2. 3. 4. 5.

Open the Windows Control Panel Select Programs and features Select GSI-AMTAS Pro Select Remove or Uninstall Follow the onscreen instructions

Connecting GSI Instruments To configure GSI AMTAS Pro to a specific GSI audiometer you need to make the connection between the instrument and the PC running the GSI AMTAS Pro software.

GSI AMTAS Pro License GSI AMTAS Pro requires a license on the audiometer in order for the program to connect to the audiometer. The licensing is specific to the audiometer and not the PC running the GSI AMTAS Pro software. Existing license information for an audiometer is found in the Configuration screen of the audiometer. A license to run GSI AMTAS Pro is obtained from your authorized GSI distributor.

Connecting the GSI Audiometer to the GSI AMTAS PRO PC 1. 2. 3. 4.

Use a standard A/B USB Cable. Plug the hexagon connector (B plug) into the USB port on the GSI audiometer. Plug the USB connector (A plug) into a USB port on the computer. Connect the audio out port on the PC to the external in port (EXT A+B) on the audiometer using the supplied audio cable. 5. Power on both the audiometer and the PC. 6. Launch GSI AMTAS Pro. 7. GSI AMTAS Pro will automatically detect the audiometer.

AudioStar Pro rear panel – USB and External Input ports

Pello rear panel – USB and External Input ports

Patient Preparation Although the GSI AMTAS Pro is a self-administered test, it is recommended that the transducers be placed on the patient by trained health care personnel. It is also appropriate to provide general instructions to the patient about the test and how to interact with the computer. The patient should be seated comfortably in front of the PC with the GSI AMTAS Pro program running.

Bone Oscillator Placement The bone oscillator should be placed prior to the placement of the headphones. The AMBAND headband should be used to couple the bone conduction vibrator to the head in the forehead position. A Velcro dot (provided with the headband) can be attached to the back of the bone vibrator to stabilize it under the headband. Follow the AMBAND instructions and use the appropriate attachment point based on the age and head size.

Headphone Placement • • • • •

•

Take the headphones and pull both sides out while placing the headband on the very top middle part of the patient’s head. Make sure that the ears are in the center part of the headphone cups. Ensure the headband remains in the middle of the very top of the head The ears should be in the center and completely surrounded by the ear cups. If you need to change the height of the ear cups, take the headphones completely off and adjust by using your thumb and fingers on the yoke and block. Push the yoke and block closer together to reduce the overall ear cup height. Conversely, if you need to increase the height of your headphone ear cups, pull the yoke and blocks apart. Once adjusted, place the headphones back on the patient’s head.

GSI AMTAS Pro Program GSI AMTAS Pro and the GSI AMTAS Pro Config App are installed as part of the software installation. GSI AMTAS Pro is the program that the patient interacts with to obtain the audiometric data. The GSI AMTAS Pro Config App is used by the administrator to set the users of the GSI AMTAS Pro program and the parameters used for the test. The GSI AMTAS Pro Config App also manages the data obtained from the GSI AMTAS Pro program. The GSI AMTAS Pro program operates in full screen, kiosk mode (no other program can be run and the desktop is not available). In order to exit the program and return the computer to the desktop, a password may be required depending on the security type selected during installation. A password may also be required to enter the configuration from the GSI AMTAS Pro program.

NOTE: The GSI AMTAS Pro program runs in kiosk mode preventing most keystrokes from being recognized and preventing the user from leaving the program. However, the Ctrl+Alt+Del key combination is a special sequence that is not trapped by the program. Pressing Ctrl+Alt+Del invokes Windows Security with an interface that allows the user to lock the system, switch user, log off, change password or invoke the Windows Task Manager. The IT administrator should adjust the Window user’s security to deny or allow the options accessible with this key combination.

Launching and running GSI AMTAS Pro After installation of the program, a shortcut icon appears on the desktop. Doubleclick the desktop icon to open GSI AMTAS Pro. It is also possible to open this application from Start > All Programs > Grason-Stadler > GSI AMTAS Pro.

User Interface – Screen Layout and Controls Welcome Screen Once the GSI AMTAS Pro is started, the program presents the Welcome screen in full screen, kiosk mode. The Welcome screen contains a menu icon in the top right corner and a Get Started arrow in the bottom right corner.

Menu Icon

Menu When the menu icon is selected on the opening screen, a list of 3 menu items is presented. When the Settings or Exit menu item is selected, a prompt for a password will appear if security has been enabled. The password should be the Windows password of the user who is currently logged into the PC or the GSI AMTAS admin password depending on the type of security selected at the installation of the software. Once the password has been authenticated, the Settings menu option displays the parameters used for the GSI AMTAS program. Once the password has been authenticated for the Exit menu option, the user is returned to the PC desktop. The About selection will display the version, copyright, patent and trademark information of the GSI AMTAS program.

Get Started Arrow The Get Started arrow is pressed to proceed with the GSI AMTAS Pro testing. The program takes the user to the next screen - the patient registration screen.

Patient Information Screen The patient information screen provides fields for patient information. Required fields are indicated by an ‘*’. The required fields may be set in the configuration program or via the settings menu option. The First Name, Last Name and ID fields have a maximum character limit of 50.

Once the required fields have been entered, the Continue button will become selectable to indicate the test is ready to begin. Pressing the Continue button will move to the next screen. The next screen that is displayed depends on the configuration settings. Options include a headphone check and/or the instructional video or text (see the Setup and GSI AMTAS Pro Config App section of this manual for details). The configuration Test Options also determines the exams that will be performed. Available tests include any combination of air thresholds, bone thresholds, speech recognition threshold and word recognition.

NOTE: The GSI AMTAS Pro Config App provides an option to skip the patient information screen.

Listen for a Tone Screen The “Listen for a TONE” screen is presented to alert the patient that they should pay attention and listen to see if they hear a tone. GSI AMTAS Pro uses this screen for air and bone diagnostic threshold testing as well as screening. There is a progress bar at the bottom of the screen to indicate the percentage of the test that has been completed. Masking is always presented to the non-test ear.

Once the tone has been presented, a new the screen is displayed to allow the patient to respond.

NOTE: Because of the psychophysical procedure that is employed by the program, there may be times in which no stimulus is presented. In addition, if the patient does not respond in a timely fashion, a warning message will be presented. The fourth non-response will result in the application ending the test and proceeding to the Finish screen

Response to a Tone Screen The response screen prompts the user with the question about hearing the tone and presents two icons. The patient indicates that they heard the tone by choosing the icon on the left and to indicate that they did not hear the tone by choosing the icon on the right.

The “Listen for a TONE” and “Did you hear the TONE” screens repeat to test the different levels and frequencies as needed to determine the patient’s threshold. The air conduction threshold test is followed by the bone conduction threshold test (if both tests have been selected in the settings). The screens are the same for the two tests and there is no indication to the patient that the air threshold test has completed and the bone threshold test has started.

Listen for a Word Screen The “Listen for a WORD” screen is presented to alert the patient that they should pay attention and listen to see if they hear a word. GSI AMTAS Pro uses this screen for speech recognition threshold and word recognition scoring. There is a progress bar at the bottom of the screen to indicate the percentage of the test that has been completed. Masking is always presented to the non-test ear.

Once the word has been presented, a new the screen is displayed to allow the patient to respond.

Response to a Word Screen The response to a word screen prompts the user with the question about hearing the word and presents a list of four words from which to choose. The patient indicates that they heard the word by choosing the matching word.

The “Listen for a Word” and “What word did you hear?” screens repeat to test the different levels as need to determine the patient’s threshold. The speech recognition threshold test is followed by the word recognition test (if both tests have been selected in the settings). The screens are the same for the two tests and there is no indication to the patient that the speech recognition threshold test has completed and the word recognition test has started.