grason stadler inc
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grason stadler inc
Part Number 2205-0100 Rev B 2205-0100 Rev B Page 1 Preface Title: GSI AUDIOscreener+ User Manual Copyright © 2008 Grason-Stadler Inc. 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 Inc. The information in this publication is proprietary to Grason-Stadler. Compliance The CE0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-Stadler is an ISO 9001-certifed corporation. European Authority Representative Grason-Stadler Kongebakken 9 2765 Smorum Denmark 0344 2205-0100 Rev B Page 2 Warranty Grason-Stadler (hereinafter referred to as GSI) warrants that each GSI AUDIOscreener+ will be free from defects in materials and workmanship under normal use and service for a period of one year from the date of delivery by GSI to the first purchaser. If any such defect occurs during the warranty period, the aforesaid purchaser should communicate directly with GSI. If returned to GSI, GSI will arrange for repairs or replacement within the terms of the warranty. The defective device should be properly packaged and promptly returned, postage prepaid. Loss or damage to device in return shipment to GSI shall be at purchaser’s risk. In no event shall GSI be liable for any incidental, indirect or consequential damages in connection with the purchase or use of the GSI AUDIOscreener+. This warranty shall not apply to, and GSI shall not be responsible for, any loss arising in connection the purchase or use of any such device that has been repaired by anyone other than an authorized GSI representative or altered in any way so as, in GSI’s judgment, to affect its stability or reliability or which has been subject to misuse, negligence or accident, or which has had the serial or lot number altered, defaced or removed, or which has been used otherwise than in accordance with the instructions furnished by GSI. GSI neither assumes nor authorizes any representative or other person to assume for it any other liability in connection with the sale of such devices. GSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OTHER THAN THOSE EXPRESSLY SET FORTH IN THE APPROPRIATE PRODUCT LABELING OR USER INFORMATION MANUAL. IN NO EVENT WILL GRASON-STADLER BE LIABLE FOR ANY INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THE PURCHASE OR USE OF ITS PRODUCTS, NOR FOR LOSS, DAMAGE OR INJURY TO OTHERS. THIS LIMITED WARRANTY SHALL NOT EXTEND TO ANYONE OTHER THAN THE ORIGINAL PURCHASER OF THE PRODUCT AND STATES YOUR EXCLUSIVE REMEDY. 2205-0100 Rev B Page 3 Specifications DPOAE Operating Specifications Frequency Range: Frequency Resolution: Frequency Accuracy: Level Measurement Accuracy: Dynamic Range: Transducer THD: TEOAE Operating Specification Analysis Frequency Range: Stimulus Center Frequency: Frequency Accuracy: Level Measurement Accuracy: Dynamic Range: Transducer THD: ABR Operating Specifications Stimulus Types: Stimulus Polarity: Level Measurement Accuracy: Input Frequency Range: Waveform Latency Accuracy: Common Mode Rejection: Gain: Patient Leakage Current: Differential Input Impedance: Long Term Average System Noise: Transducer THD: Alarms Low Battery, Dead Battery 2205-0100 Rev B 2000 Hz – 6000 Hz 50 Hz ± 5% of displayed value ± 1 dB SPL (configurable to wider ranges) 96 dB 3% 500 Hz - 5000 Hz (resolution 50 Hz) 1000 Hz - 6000 Hz (resolution 1000 Hz) ± 5% of displayed value ± 1 dB SPL (configurable to wider range) 96 dB 3% Click 100 µsec width, Blackman Windowed tone pips, (500 Hz, 1000 Hz, 2000, Hz, 4000 Hz) Rarefaction, condensation, alternating ± 1 dB SPL (measured peak-peak equivalent per IEC 60645-3, configurable to wider ranges) 30 Hz - 3000 Hz (3rd order low-pass, 2nd order high-pass analog filter) ±0.2 msec 108 dB 43 dB < 100 µA AC, <10µA DC Normal Condition <500 µA AC, <50 µA DC Single Fault Condition 1 GOhm <0.05µV P-P 3% Page 4 Database Error Internal Circuit Error Battery NiMH 2150 mAh Battery operating life – approximately 24 hours Recharge time – approximately 2 hours Device Dimensions 19.7 cm L x 10.2 cm W x 4.5 cm H Weight 0.57 kg Case Material ABS UL94-V0 Fire Retardant IR Window Lexan UL94-V0 Fire Retardant AC Adapter Power Requirements 100-240 VAC, 50-60 HZ, 1.25A (GSI PN: 8000-0265) Operating Conditions 10 degrees - 40 degrees C (50 degrees - 104 degrees F) 95% Relative humidity non-condensing 500-1060 hPa atmospheric pressure Storage Conditions 0 degrees - 50 degrees C (32 degrees - 122 degrees F) 95% Relative humidity non-condensing for 72 hours 500-1060 hPa atmospheric pressure Type of Protection Against Electric Shock Class II Mode of Operation Continuous Degree of Protection Against Ingress of Fluids IPX0 – Ordinary Equipment Degree of Mobility Portable Degree of Protection Against Electric Shock Type BF 2205-0100 Rev B Page 5 Degree of Protection Against Flammable Anesthetic Mixtures Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Degree of Electrical Connection Between Equipment and Patient Equipment with an applied part not designed for conductive connection to the patient Medical and Electrical Safety Compliance UL60601-1, CAN/CSA C22.2 NO. 601.1 IEC60601-1-2 CISPR 11 (EN55011) IEC 1000-4-2 IEC 1000-4-3 IEC 1000-4-4 IEC 1000-4-5 EN 61000-4-11 IEC 1000-4-8 ANSI S3.6-1996 IEC 60601-2-26 IEC 60601-2-40 IEC 60645-3 Electrode Wires Connectors to the GSI AUDIOscreener+ are compliant to “Safety DIN” standard (DIN 42-802) with snap connectors for electrodes 2205-0100 Rev B Page 6 Electromagnetic Compatibility 2205-0100 Rev B Page 7 Table of Contents Preface .............................................................................................................................................. 2 Title: ............................................................................................................................................ 2 Warranty ..................................................................................................................................... 3 Specifications .............................................................................................................................. 4 Electromagnetic Compatibility...................................................................................................... 7 Chapter 1 Introduction ....................................................................................................................10 Chapter 2 Installation .....................................................................................................................12 Introduction ............................................................................................................................... 12 AC Adapter ............................................................................................................................... 12 Probe Module ............................................................................................................................ 14 External Devices ....................................................................................................................... 14 External Computer .................................................................................................................... 15 Chapter 3 Basic Operation ..............................................................................................................17 Introduction ............................................................................................................................... 17 The Front Panel ........................................................................................................................ 17 The Main Screen ....................................................................................................................... 18 The Patient Database Section ................................................................................................... 19 OAE Section ............................................................................................................................. 23 ABR Section.............................................................................................................................. 23 Prepare to Test ......................................................................................................................... 24 Testing With the Probe .............................................................................................................. 25 The Probe Module ......................................................................................................................25 Select a Disposable Ear Tip .......................................................................................................25 Attach the Disposable Ear Tip ....................................................................................................26 Couple the Probe to the Ear .......................................................................................................27 The Use of Comfort Cups™ .......................................................................................................27 Testing With Electrodes ............................................................................................................. 28 The Electrodes ...........................................................................................................................28 Select Three Disposable Electrodes ...........................................................................................28 Attach Disposable Electrodes to Wires .......................................................................................28 Prepare Skin ..............................................................................................................................29 Attach Electrodes .......................................................................................................................29 Select Patient Record ................................................................................................................ 30 Perform Test ............................................................................................................................. 31 View Overall Results ................................................................................................................. 33 View Detailed Results ............................................................................................................... 34 Overall Operation ...................................................................................................................... 34 Chapter 4 OAE Advanced Operation ..............................................................................................35 Introduction ............................................................................................................................... 35 Advanced DPOAE Operation .................................................................................................... 35 Advanced TEOAE Operation ..................................................................................................... 40 Chapter 5 ABR Advanced Operation ..............................................................................................45 Introduction ............................................................................................................................... 45 View Detailed Results ............................................................................................................... 48 Chapter 6 Configuration..................................................................................................................52 2205-0100 Rev B Page 8 Introduction ............................................................................................................................... 52 DPOAE Configuration ............................................................................................................... 54 DP Global Parameters................................................................................................................55 DP Test Frequency Parameters .................................................................................................56 TEOAE Configuration ................................................................................................................ 58 TE Global Parameters ................................................................................................................59 TE Data Acquisition Parameters .................................................................................................60 TE Frequency Bands ..................................................................................................................61 ABR Configuration..................................................................................................................... 63 ABR Global Parameters .............................................................................................................64 ABR Filter Parameters................................................................................................................66 ABR Signal Parameters ..............................................................................................................66 Database Configuration ..............................................................................................................67 Time / Date Configuration .......................................................................................................... 68 Printing Configuration ................................................................................................................ 68 Device Configuration ................................................................................................................. 69 Power Down Screen .................................................................................................................. 70 Chapter 7 Maintenance ...................................................................................................................71 Cleaning.................................................................................................................................... 71 General Maintenance ................................................................................................................ 72 Preventive Maintenance ............................................................................................................ 72 Manufacturer ............................................................................................................................. 72 Service ...................................................................................................................................... 72 Chapter 8 Troubleshooting .............................................................................................................73 Alarms ...................................................................................................................................... 73 Troubleshooting ........................................................................................................................ 74 Appendix A Screening Methods and Criteria .................................................................................75 Appendix B Probe Handling Guide.................................................................................................76 Appendix C Probe Cleaning Guide .................................................................................................76 2205-0100 Rev B Page 9 Chapter 1 Introduction The GSI AUDIOscreener+ is an advanced, precision, handheld medical instrument designed for hearing screening. It measures both otoacoustic emissions (OAE) and auditory brainstem responses (ABR) in either an automated mode or an advanced mode. It can implement all screening protocols including the multi-stage protocols recommended by the National Institutes of Health. Though the self-contained device can be operated and configured with no external equipment, built-in wireless communication allows patient records to be transferred to and from patient records to be transferred to and from an external computer. It has the ability to test a patient with only one click – right out of the box. The GSI AUDIOscreener+ is designed for patients of all ages, from newborn infants through adulthood. It screens auditory function in any individual for whom traditional behavioral audiometric responses are unreliable including newborns, infants, young children, and uncooperative or cognitively-impaired individuals. The GSI AUDIOscreener+ is particularly well suited for all Universal Neonatal Hearing Screening programs. The OAE section evokes and measures either distortion product otoacoustic emissions (DPOAE) or transient evoked otoacoustic emissions (TEOAE). A distortion product otoacoustic emission is a tone generated by the normal ear (fdp) in response to the simultaneous presentation of two external tones (f1 and f2). The GSI AUDIOscreener+ presents two tones, f1, f2, simultaneously and measures the distortion product otoacoustic emission, fdp, in the ear canal, all through a single small probe module coupled to the external ear canal with a disposable probe tip. The measured level of the distortion product (Ldp) provides information concerning the outer hair cell function of the cochlea which in turn is correlated to hearing sensitivity. An otoacoustic emission at an expected level strongly suggests that outer hair cell function in the cochlea is normal and that hearing sensitivity is normal and leads to a “Pass” test result. Because a measure of outer hair cell function does not measure the entire auditory system, a “Pass” result should not override other clinical indications that hearing may not be normal. In contrast, the absence of an otoacoustic emission, or an emission that is lower than the expected level, suggests that outer hair cell function may be abnormal and that hearing sensitivity may not be normal. A transient evoked otoacoustic emission is a broad band sound generated by the normal ear in response to transients (also called clicks) presented to the ear. The same probe is used to present the clicks and measure the sounds. Similar to the DPOAE, the measured 2205-0100 Rev B Page 10 level and frequency content of the sound emitted by the ear also provides information about the outer hair cell function of the cochlea which in turn is correlated to hearing sensitivity. A transient evoked otoacoustic emission at an expected level strongly suggests that outer hair cell function is normal and that hearing sensitivity is normal and leads to a "Pass" test result. Because a measure of outer hair cell function does not measure the entire auditory system, a "Pass" result should not override other clinical indications that hearing may not be normal. In contrast, the absence of a TEOAE or an emission that is lower than the expected level suggests that outer hair cell function is abnormal and that hearing sensitivity may not be normal. The ABR section evokes and measures auditory brainstem responses. An auditory brainstem response is a characteristic electrical waveform made in response to an auditory signal that is measured by electrodes that are placed on the skin. The GSI AUDIOscreener+ presents acoustic signals (clicks, or very short tones called “pips”) through the same small probe module used for OAE that is coupled to the external ear canal or through a Comfort Cup™ that is placed over the ear. The device measures electrical signals from the brain through disposable electrodes that are placed on the surface of the skin. The presence of electrical signals provides correlated information concerning the integrity of the auditory system from the external ear canal up through the level of the brain stem. The occurrence of these signals strong-ly suggests that hearing sensitivity is normal. Whether or not the signals are present can be determined automatically by the device in the automated mode or manually by a trained professional in the advanced mode. The combination of an OAE device and ABR device in a single, handheld unit allows easy implementation of the widely-recommended multi-stage screening procedures, all with a single device. The GSI AUDIOscreener+ is shipped with default software settings; one for DPOAE (QuickDPOAE), one for TEOAE (QuickTEOAE), and two for ABR (QuickABRCups, QuickABRProbe), that are permanently stored in memory so no software setup is required. However, the device is very advanced and can be controlled well beyond the default parameters. Custom sets of test parameters can be defined by the operator, named, saved and recalled for future tests. The Configuration section of this Operating Manual provides information on how to view or change software settings allowing for a large amount of operator control. This Operating Manual describes the features and operations of the GSI AUDIOscreener+. Please review the Set Up section before proceeding with the Operation section of this manual. 2205-0100 Rev B Page 11 Chapter 2 Installation Introduction A new GSI AUDIOscreener+ requires only minimal set-up upon delivery. The Set-Up section provides information for preparing a new device for the first time. It also can be a reference when setting up the device later. AC Adapter The GSI AUDIOscreener+ is powered by a permanent internal nickel metal-hydride (NiMH) rechargeable battery. A separate AC adapter is provided for charging the battery and for operating the device during charging. However, for optimal results it is not recommended to use the GSI AUDIOscreener+ while is it plugged into a wall outlet. Insert the appropriate AC outlet plug prior to use. Use only the supplied AC adapter. Another may cause damage to the unit and increase the risk of electrical shock. Using the device adapter on other devices could cause damage to those other devices. AC Adapter WARNING: AC ADAPTERS ARE NOT ALWAYS INTERCHANGEABLE! High voltage is inside the AC adapter. DO NOT REMOVE THE COVER! 2205-0100 Rev B Page 12 Your new GSI AUDIOscreener+ is shipped with a discharged battery. To charge the battery, insert the hospital-grade plug on the AC adapter into an AC wall outlet (either 110 volts or 220 volts, 60 Hz or 50 Hz). Plug the cable on the other end of the adapter into the receptacle on the bottom of the GSI AUDIOscreener+. The battery charge indicator light on the front panel blinks while the battery is charging and glows steadily when the battery is fully charged. The battery will charge continuously whenever the device is plugged into a wall outlet, even when the OFF button has been pressed. To be certain that power to all circuits has been disconnected, the power cord must be unplugged from the outlet. Unplugging the AC adapter from the device or from the AC wall outlet automatically switches the device to battery mode. A new, fully charged battery will operate the instrument for approximately 24 hours of continuous use and for many days under typical use. Approximately 10 minutes prior to battery discharge, AC Adapter connects to the bottom of device the battery alarm will appear on the display (see Chapter 8). When complete discharge occurs, the device will automatically turn itself off. Reconnect the AC adapter each time the battery is discharged. The battery must be charged for two hours before using the device on battery power. Though the GSI AUDIOscreener+ can be used to test patients with the AC adapter connected to the wall outlet, for optimal performance, it is recommended that the device not be operated while the battery is charging. The GSI AUDIOscreener+ should be connected to the AC adapter at least once every two weeks for a minimum of two hours to prevent battery self-discharge and possible damage. The battery should last over several years under normal usage. The GSI AUDIOscreener+ will have to be returned for service should the battery need replacement. The device should never be opened by the user. (See warranty section). 2205-0100 Rev B Page 13 Probe Module The GSI AUDIOscreener+ probe module has a circular connector on the cable designed to be inserted into the device only one way. Line up the indicator mark on the probe with the indicator mark on the device and insert probe into device. Care should always be Line up indicator mark on probe and device taken with the probe module to ensure that the delicate internal loudspeakers and microphones are not damaged. Also, always use care when handling the probe and avoid dropping it or bumping it against hard surfaces. A probe holder on the side of the case is designed to protect the probe when not in use. Each probe module has an ID number and unique calibration data. A probe module cannot be switched with another probe module without also changing the calibration data. To ensure that the probe module and the internal calibration data match, the ID number of the probe module and the date the internal calibration data were entered can be viewed on the display (described in the Basic Operation section). External Devices The GSI AUDIOscreener+ is a self-contained, stand-alone unit that can be used without any other equipment. However, the base of the device contains an infrared port that allows convenient wireless connection to other devices such as a printer or a personal computer. 2205-0100 Rev B Page 14 External Computer The GSI AUDIOscreener+ ships with a computer application on a CD-ROM called AUDIOtrac™. AUDIOtrac™ allows communication between GSI AUDIOscreener+ and an external computer. If the external computer is a laptop computer, there is a good chance that it already has an infrared port. If the external computer is a desktop model or a laptop without a built-in infrared port, an external infrared port (supplied) can be attached. The AUDIOtrac™ application allows the entry of patient records with a full-sized screen and keyboard. This is convenient for entering large numbers of patient records. It also can be used to store and print all patient data and results after the records have been deleted from the GSI AUDIOscreener+. The AUDIOtrac™ application allows further communication with tracking software from other manufacturers such as Oz™ and HiTrack™, as well as the generation of files in other formats that can be sent by e-mail and read by other computer applications including conventional web browsers or spreadsheet applications. Please refer to the separate AUDIOtrac™ user manual for details concerning interaction between the GSI AUDIOscreener+ and an external computer. 2205-0100 Rev B Page 15 2205-0100 Rev B Page 16 Chapter 3 Basic Operation Introduction This section of the Operating Manual describes the basic operation of the GSI AUDIOscreener+ and provides sufficient information to begin using the device immediately. The remaining sections are intended for administrators or advanced operators. The basic operation of the GSI AUDIOscreener+ is easy to understand. No external computer is needed to operate the device. Further, complete instructions and detailed help screens are available on the large display. The GSI AUDIOscreener+ is a battery-operated, handheld device with a single probe module. For OAE testing, the probe is coupled directly to the ear with a disposable ear tip. The probe module delivers test sounds and measures the sounds in the ear canal generated by the ear. For ABR testing, the same probe delivers the test sounds either directly to the ear or through a Comfort Cup™ that fits over the ear. Three electrode wires, attached to the skin with disposable electrodes, are used to pick up electrical signals from the brain during ABR testing. The device operates solely with the buttons on the front of the device for both OAE and ABR testing. The Front Panel The front panel has several sealed membrane buttons, two indicator lights and a large display. The buttons are used to operate the device. The indicator lights indicate the patient test results and the battery charging status. The large display shows screens that change as the device is operated and has a bright backlight that makes it easy to view in low light environments. The front panel is impervious to moisture and most liquids and can be kept clean by occasionally wiping it with a soft, damp cloth. The four blue buttons located directly below the display are COMMAND buttons. The functions for the COMMAND buttons change depending on the screen being displayed but are always clearly labeled with text at the bottom of the display just above each button. If a COMMAND button does not have a function for a particular screen, there will be no label. The operator operates the GSI AUDIOscreener+ by observing the selected text on the screen, then pressing a labeled blue COMMAND button to start the selected operation. 2205-0100 Rev B Page 17 The UP, DOWN, LEFT and RIGHT arrow buttons surrounding the large HELP button on the front panel are ARROW buttons. The ARROW buttons move a selection box on the display. The selection box is a small black box surrounding white text and functions like a cursor on a conventional computer. The ARROW buttons also activate new screens, similar to turning pages in a book. The HELP button can be pressed at any time for further information. The front panel also has an AC indicator light and a PA SS/REFER indicator light. The AC indicator light is off if the AC adapter is not plugged in. If the AC adapter is plugged in, the light blinks green while the battery is charging and glows steady green when the battery is fully charged. The PA SS/REFER indicator light indicates the status of the test results being displayed. The PA SS/REFER light is off if no testing has been done and glows amber if the testing was started but is incomplete. When testing is complete, the light glows green for a PA SS result and orange for a REFER result. The ON/OFF button located at the bottom left of the front panel is used to turn on and turn off the GSI AUDIOscreener+. If the display does not light up when turning on the device, connect the external AC adapter. After the battery has charged for a few minutes, the device can then be turned on. You also can turn off the device manually by pressing the ON/OFF button. When turning off the device, text on the display will ask to confirm that you wish to turn it off. To conserve the battery charge, an auto-shutoff feature automatically turns off the device after 10 minutes have passed since the last button push. The auto-off setting can be configured for both shorter and longer durations. Turn on the GSI AUDIOscreener+. An Introductory screen briefly appears and after a few seconds, the Main screen appears. The Main Screen The multipurpose Main screen is used for scrolling through patient records in the internal database, selecting the ear and type of test (OAE or ABR), selecting the operator’s name, initiating the test, viewing test results. The very bottom of the display is divided into four sections that label each of the blue COMMAND buttons below the display. To operate the device, it is only necessary that you understand the information on the Main screen. 2205-0100 Rev B Page 18 A selection box initially appears for the right ear in the OAE section. The DOWN ARROW button can be used to move this selection down to the left ear in the OAE section, down further to the right or left ear in the ABR section, and down further to the operator’s name. The up arrow can be used to move the selection box up to the otoacoustic emissions header that will show either DPOAE or TEOAE. Once the header is selected, the left or right arrows can be used to change the type of OAE test. If the header shows TEOAE, pressing either the left or right arrow will change it to DPOAE and vice versa. The UP ARROW button can be used to move the selection box up to the Patient Database section. The selection box wraps around from the bottom of the display to the top, or vice versa depending on which arrow key is pressed. Main Screen The Patient Database Section The Patient Database section at the top of the Main screen always displays a single patient record from the internal patient database identified with a unique patient ID number. Each patient record must contain a unique ID number but may also contain the patient’s first and last name, and other patient data including gender and birth date. This information is shown below the ID number if present. Each patient record holds all OAE and ABR test results including all relevant test settings. Up to twelve separate tests can be saved in each individual patient record, three OAE tests for each ear (up to 5 frequencies per test) and three ABR tests for each ear (up to 8 waveforms per test). The internal patient database can hold up to 300 patient records that are preserved even if the battery is entirely discharged. 2205-0100 Rev B Page 19 Patient Data Entry The internal patient database contains a special patient record with a patient ID number of “0” and a patient name of “Trial Patient”. The Trial Patient record is a permanent patient record that cannot be deleted and is always displayed first after turning on the device. The Trial Patient record is very convenient because it can be used to collect test results from practice tests, from training tests, or from any other measurement situation including tests from an actual patient without first having to create an actual patient record. The Trial Patient record can contain only one test result for each ear for each type of test. Any test result obtained for the Trial Patient will be deleted if another test is performed or if the device is turned off. However, once a test result is obtained, the third COMMAND button is labeled SAVE which allows you to create a regular patient record and save the results from the Trial Patient record. Actual patient records can be added to the GSI AUDIOscreener internal patient database in two ways. Patient records can be added one at a time using only the buttons on the front of the device and without any other equipment. Patient records also can be entered into AUDIOtrac™ running on a conventional computer and transferred in large numbers to the device. Patient records originating in the device can be transferred back to AUDIOtrac™. For computer transfer of patient records, please see the booklet accompanying the AUDIOtrac™ software application. + To enter an individual patient record from the Main screen, use the UP or DOWN arrow keys to move the selection box to the patient ID line at the top of the display. The second COMMAND button will change to a NEW button. Press the NEW COMMAND button to create a new patient record and display a Patient Data Entry screen called Patient Information that contains six sections. ID: A patient ID number can be up to 11 characters long. It can include both letters and numbers in any combination. If you attempt to create a patient ID number that is identical to one already in the patient database, you are notified and asked to change it. This ensures that every ID number in the internal database is unique. 2205-0100 Rev B Page 20 First: The first name can be up to 14 characters and does not have to be unique. Last: The last name can be up to 14 characters and does not have to be unique. Gender: The gender can be MALE or FEMALE. Gestational Age: The gestational age can be 24 to 44 weeks and has a default value of 40 weeks. Gestational age is used only for determining normative ABR Peak V latency values for children under 3 months of age. It can be ignored if ABR measures do not consider this latency as in the default screening settings, or if the patient is older than 3 months. Birth date: The birth date can be from 1/1/1906 through 12/31/2099 and is used to calculate the age of the patient at the time of the test. Each section ends with a Data Entry Area indicated by brackets [ ]. Initially the selection box is shown on the ID Data Entry Area. The selection box can be moved up and down the screen to other Data Entry Areas using the UP and DOWN arrows surrounding the Help button below the display. After a Data Entry Area has been selected, press the Enter button to enter data in the Data Entry Area. Data are entered in two ways depending on the type of data. Open-ended data: If the data are open ended and from a large data set (such as a patient’s name) a Virtual Keyboard is shown. The Virtual Keyboard is Virtual Keyboard an image of a conventional keyboard with the numbers 0 through 9, the letters of the alphabet, a dash, an apostrophe, 2205-0100 Rev B Page 21 and a space character indicated b y an underscore located after the last character. The COMMAND buttons are labeled CANCL (cancel the data entry screen), TYPE (type the selected character to the top line), DEL (delete the last character from the top line) and DONE (finished entering all data). When the Virtual Keyboard is first opened, the “1” character is selected. The selection can be moved around the virtual keyboard using the four Arrow keys to select other characters. Once the desired character is selected, press the TYPE COMMAND button to place the character on the top line. Move the selection to the next desired character and TYPE it. A character on the top line can be deleted by pressing the DELETE COMMAND button. When all of the desired characters have been placed on the line, press the DONE COMMAND button to save the data and return to the Data Entry screen. Restricted data: If the data is a restricted data set (Male, Female, e.g.) a pop-up menu is shown listing the restricted set of data. The Up or Down arrows can be used to make a selection from the pop-up list. Long lists on pop-up menus will scroll. After the selection is made, press the DONE COMMAND button to save the selection to the data area, close the pop-up screen and return to the Data Entry screen. Only the patient ID is required to create a new patient record. Data in all other data areas are optional. After all data have been entered, press the DONE COMMAND button to save the patient record into the internal patient database and return to the Main screen. Test results obtained f or this patient on the Main screen can now be saved to this new patient record. Once individual patient records are in the database, they can be accessed by moving the selection box to the patient database section at the top of the Main screen and pressing the LEFT or RIGHT arrow keys to scroll through the records. The patient records display one at a time and scroll continuously if the arrow button is held down. The records wrap around to the beginning when the end of the list is reached, and vice versa. The sequential location of the patient record number in the database followed by a slash mark and the total n umber of patient records in the database are indicated in the patient database section. For example, “75/84” indicates that the patient record on the display is the 75th one of a total of 84 patient records. This information is useful when deter mining the direction to scroll the records. Note that as you scroll through the patient database, the PASS/REFER light below the display will indicate the status of the patient shown on the top line of the Main screen. 2205-0100 Rev B Page 22 OAE Section DPOAE or TEOAE test selection for testing or results re view may be preformed by using the up or down arrow keys to move the cursor to the OAE heading and using the left or right keys to switch to the alternate O AE test. The O AE Section below the patient database section contains a separate area f or each ear indicated by a large R for the right ear and a large L for the left ear. To the right of the R and the L is a Result Box that displays the test findings. An empty Result Box indicates that the ear has not been tested. A √ symbol indicates that the ear was tested and that a PASS result was obtained. A ? symbol indicates that the ear was tested and that a REFER Main Screen result was obtained. The text to the right of the Result Box indicates whether a test was performed and the time and date of the test. A Configuration that defines the test parameters will be indicated to the right of the Result Box if the test was performed. The number of the test followed by a slash mark and the total number of tests for that ear also are indicated. For example, “2/3” indicates that the test result shown on the display for that ear is the second one of a total of three tests f or that ear. Note that the tests are always sorted with the best result first, regardless of the order the tests were obtained. The results for the other tests for the selected ear can be viewed by using the LEFT or RIGHT arrow keys. A single DPOAE test can contain measures f or up to 5 frequencies. A single TEOAE test can show the spectral content of the result at up to 5 frequency bands. ABR Section The ABR section of the Main screen, below the OAE Section, also contains a separate area for each ear indicated by a large R for the right ear and a large L for the left ear. To the right of the R and the L is a Result Box used for displaying the test findings. An empty Result Box indicates that the ear has not been tested. A √ symbol indicates that the ear was tested and that a PASS result was obtained. A ? symbol indicates that the ear was tested and that a REFER result was obtained. The text to the right of the Result Box indicates whether or not a test was performed and if so, a Configuration that defines the test parameters and the time and date of the test. The number of the test for that ear followed by a “/” and the total number of tests for that 2205-0100 Rev B Page 23 ear are also indicated. For example, “2/3” indicates that the test result shown on the display for that ear is the second one of a total of three tests for that ear. Note that the tests are always sorted with the best result first, regardless of the order the tests were obtained. The results for the other tests for the selected ear can viewed by using the LEFT or RIGHT arrow keys. A single test can contain measures for up to 8 signals (e. g., waveforms for clicks at 8 different levels). Text Section The text section below the ABR section indicates the overall patient result of the test, the Operator’s name, an indication of the function of the operation of the ARROW buttons, an infrared transfer graphic and a battery status graphic. If the selection box is moved to the Tester section, the LEFT or RIGHT ARROW keys can be used to select an Operator’s name from a prepared list (see the Configuration Section for information on how to enter and change the names of the Operator). If the Operator’s name is not necessary, it may be left blank. The battery status graphic image represents a battery with black indicating the remaining charge. You may need to disconnect and then reconnect the AC adapter to the GSI AUDIOscreener+ to initiate battery charging if a low battery condition occurs when the GSI AUDIOscreener+ is already connected to the AC adapter. Prepare to Test The GSI AUDIOscreener+ can be operated effectively in typical environments without the need for a sound-treated booth because advanced digital signal processing reduces the effects of ambient noise. However, it is best to keep ambient noise as low as possible. Measures should be made in the quietest area available and the user and other individuals nearby should not be talking or otherwise making noise during the test. Any nearby devices (telephones, air conditioners, ice making machines, etc.) should be turned off if possible. If such devices cannot be turned off, measures should be made at times when these devices produce the least noise. Testing should be done away from electrical/electronic devices that may produce electrical interference. 2205-0100 Rev B Page 24 Testing With the Probe The Probe Module The GSI AUDIOscreener+ probe module is used separately for both OAE and ABR testing. The Probe Module houses two miniature loudspeakers that produce the test stimuli and a miniature, low-noise microphone that measures sounds in the ear canal. The miniature loudspeakers are connected to two small stainless steel tubes and the miniature microphone is connected to a single, larger stainless steel tube. The three stainless steel tubes exit the probe module and are designed to accept a disposable ear tip. The probe module has a one meter cable with a circular connector that connects to a receptacle at the top of the GSI AUDIOscreener+. (See Set Up Section for instructions concerning how to plug in the probe module if it is disconnected). Care always should be taken with the probe module to ensure that the delicate loudspeakers and microphone are not damaged. Please refer to Appendix E for maintenance and care of the probe module. Select a Disposable Ear Tip The probe module couples to the ear with a disposable ear tip intended for single-patientuse only. Use a new disposable ear tip for each ear and dispose of the used ear tips in a manner compliant with applicable medical waste disposal procedures. WARNING: Never insert the probe into any ear or test cavity at any time without a disposable ear tip properly attached. The disposable ear tip serves three functions: 1. To form an acoustic seal to the ear. Disposable ear tips are designed to form a tight acoustic seal between the probe module and the ear canal to reduce external noise. Soft disposable ear tips come in several sizes for use with neonates, children, or adults. Select a size that is just larger than the diameter of 2205-0100 Rev B Page 25 2. 3. the external ear canal so that when it is placed into the ear a tight seal is formed. To hold the probe in the ear. The probe should be coupled to the ear without having to hold it in place with your hand. The fit of the probe tip should be sufficient to keep the probe in the ear without having to hold it. The probe module can be held in the ear with your hand during the test, though this will increase ambient noise due to unavoidable hand movements. To direct sound to and from the ear. The disposable probe tip directs sound from the two small stainless steel tubes into the external ear and from the external ear back to the larger stainless steel tube that connects to the microphones. The disposable probe tip allows a firm connection to the Comfort Cup™ for ABR testing. Attach the Disposable Ear Tip The probe tip should be placed on the probe module and sealed all the way. Attaching ear tip & inserting probe 2205-0100 Rev B Page 26 Couple the Probe to the Ear First make sure that the probe module cable is straight. Then insert the probe tip into the ear canal while pulling the ear slightly upward and backward to insure that the ear canal is not collapsed. Finally, relieve any pressure on the probe cable. The GSI AUDIOscreener+ will perform checks prior the testing process to ensure that the probe has been coupled properly. With practice, the operator (without holding the probe in place) should be able to couple the probe module to the ear with the sound tubes open, thus ensuring proper communication with the ear canal. Care should be taken to ensure that the sound opening in the disposable tip is directed into the ear canal and not against the canal wall. To become familiar with probe placement, practice using your own ear or the ear of a volunteer. Once the probe is coupled to the patient, OAE testing can begin. The Use of Comfort Cups™ Comfort Cups™ are also available for neonate ABR testing. These ear cups are a soft foam with an opening that covers the ear. The probe module is coupled to the ear cup with a disposable ear tip (Green 6 mm). The ear cup is held in place with an adhesive. Couple the probe to the ear cup, ensuring that the flange is visible on the inside rim of the cup. Remove the backing from the ear cup and position it over the ear to be tested. If ABR testing is to be performed, electrodes must be attached. The location of the electrodes may differ depending on whether a Comfort Cup™ is being used Attaching Comfort cups 2205-0100 Rev B Page 27 Testing With Electrodes The Electrodes The GSI AUDIOscreener+ picks up electrical signals from the brain with disposable electrodes on the surface of the skin and delivers them over wires that connect to receptacles at the top of the GSI AUDIOscreener+ with Touch-Proof connectors. Match the color of the electrode wire with the color of the receptacle and insert the connector for each electrode wire until it is firmly seated. Care always should be taken with the electrodes and wires to ensure that they are not damaged. Select Three Disposable Electrodes The disposable electrodes are intended for single-patient-use only. Each is mounted on a small protective sheet of plastic. Use new disposable electrodes for each patient and dispose of the used electrodes and backing in a manner compliant with applicable medical waste disposal procedures. The electrodes themselves are small metallic circular disks. One side of the electrode has a flat, smooth surface coated with an electricallyconductive gel and is designed to be applied to the surface of the skin using an integral piece of adhesive gauze surrounding the electrode to hold it in place. The other side of the electrode has a small protuberance that accepts a snap connector on the electrode wire. Attach Disposable Electrodes to Wires Snap an individual electrode onto the snap connector on each electrode wire prior to placing on head. Make sure that the electrodes remain attached to the plastic protective sheet. 2205-0100 Rev B Page 28 Prepare Skin Preparation of the skin surface is recommended prior to attaching electrodes. Adequate electrical conductivity is assured if skin oils, lotions, etc. are removed by gently rubbing the surface of the skin with the abrasive skin prepping gel (NuPrep) or skin prep tape provided. Apply a small amount of the gel to a cotton swab or gauze and lightly rub the electrode site. To ensure good adhesion, dry the site with a dry portion of the swab or gauze before attaching the electrode. Or, alternatively, tear off approximately 1" of prep tape and using a brushing action, lightly abrade the skin at the electrode site, before attaching the electrode. Preparation time is minimal, but the low, balanced impedance values obtained will reduce noise in the ABR acquisition, which in turn will lead to shorter test times. NOTE: Prepping with Isopropyl Alcohol (alcohol wipes) alone is not recommended. The GSI AUDIOscreener+ performs electrical impedance tests to determine the adequacy of the electrical connection. Attach Electrodes The electrodes are attached at different locations depending on whether you use a Comfort Cup™. Small graphics on the back of the device near the electrode wire connectors indicate these locations. The test results will be similar regardless of which method is used. Midline Electrode Configuration (Must be used with Comfort Cups™) 1)The midline of the forehead just below the hair line (Black wire) 2)The nape of the neck (Blue wire) 3)The shoulder (Red wire) The midline electrode configuration prevents interference between the ear cup and the electrodes but uses locations that may not be convenient due to clothing or blankets. Mastoid Electrode Configuration 1)The midline of the forehead just below the hair line( Black wire) 2)The right mastoid process, the bone behind the right ear (Red wire) 3)The left mastoid process, the bone behind the left ear (Blue wire) In neonates, the mastoid electrode configuration is convenient because clothing or blankets do not have to be loosened. 2205-0100 Rev B Page 29 Main Screen DPOAE Test Progress Select Patient Record All test results are stored in a single patient record. When first turning on the device, the Trial Patient record, ID 0, is automatically displayed. The Trial Patient record allows testing to proceed without having to select a particular patient record. A particular patient record can be selected if patient records have been entered into the internal patient database (see page 16).If no test has been performed for the selected patient record, “No Test Data” is shown to the right of the Result box. The second blue COMMAND button is labeled TEST, which initiates the selected test on the selected ear. At this point the test can either be initiated or the test and ear selection can be changed. 2205-0100 Rev B Page 30 Main Screen TEOAE Test Progress Perform Test Press the TEST button to initiate the test. During the O AE test, a Test Progress screen appears that shows the ID number, patient name, type of test and ear being tested. Graphic bars move to indicate the percentage of the test completed. The test progress screen will be either the DPO AE test progress screen or the TEOAE test progress screen 2205-0100 Rev B Page 31 During both the DPOAE and the TEOAE tests, a brief calibration sequence determines whether the probe is adequately coupled to the ear. If the probe is not adequately coupled to the ear, the device will instruct you to readjust the probe before proceeding. Next, test signals are presented and measured in the ear canal. If the levels of the test signals are not the values specified in the Configuration, a compensation procedure automatically adjusts them. The test will not proceed if the levels of the stimuli cannot be achieved due to blocked sound tubes, excess ear wax (cerumen) or amniotic fluid, or from placement of the sound opening against the canal wall. After the automatic level adjustments have been made, the test automatically starts with the test frequencies specified in the Configuration. ABR Impedence Check ABR Test Progress During the ABR test, the Test Progress Screen first provides information on the electrical impedance of the electrodes. If the electrodes are not adequately coupled to the skin, the device will inform you to readjust them before proceeding. A brief sequence then determines whether the probe is adequately coupled to the ear and calibrates the level of the stimulus. The probe fit and calibration sequence will be skipped if using the 2205-0100 Rev B Page 32 Comfort Cups and the default ABR configuration. When this sequence is complete, a second ABR Test Progress screen appears showing the progress of the ABR test. Under most conditions, the OAE test will take only a few seconds and the ABR test will take only a few minutes. Use the UP arrow or DOWN arrow to move the selection box in preparation for the next test. Note that it is just as easy to select the next type of test as it is to select the opposite ear so any order of the tests and ears can be performed at anytime. If the ear is different from the last test, couple the probe to the opposite ear. For ABR testing, there is no need to switch the electrodes. When any test is complete, the device will return to the Main screen and show the results. View Overall Results The overall status of testing for a particular patient is never ambiguous. First, all test results on the Main screen are accessible f or the patient listed in the Database Section at the top of the display. Second, the best individual test results, both OAE and ABR for each ear, are displayed on the Main screen. An empty Result Box for an ear indicates that the ear has not yet been tested. If the test Result Box for an ear contains a PASS or REFER symbol, the ear has been tested at least once. If multiple tests for that ear have been performed, the best test results are shown. Third, the OAE and ABR results are integrated into an overall result for the patient. The PASS/REFER light below the display and text on the Main screen indicate the overall result f or the patient based on the combination of all of the test results f or both ears. If multiple tests are made on an ear, the device will sort and display the best result first. The best results for each ear are then combined based on the criteria specified in the Configuration. The PASS/REFER light is off if no tests have been performed and glows amber if testing has started but is yet incomplete, green for a patient PASS, or orange for a patient REFER. When either ear is selected on the Main screen, the second COMMAND button will be labeled TEST. If at least one test has been performed on the selected ear, the first COMMAND button will be labeled VIEW. After a test has been performed, the results can be viewed on the display or printed for the patient’s permanent file. 2205-0100 Rev B Page 33 View Detailed Results The first COMMAND button on the Main screen is labeled VIEW if at least one test has been performed. This button activates the view mode where details of the selected test results can be viewed on the display. The detailed view functions differ for OAE and ABR tests and are discussed in their respective sections of the advanced operation portions of the Operating Manual. Actual patients can be screened using the Trial Patient record. Simply conduct the tests while using the Trial Patient record, view the overall result on the PASS/REFER light and manually record the overall result in the patient’s hospital chart or on the supplied blank labels. The Trial Patient record can contain only one test result for each ear. Any test result for the Trial Patient will be deleted if another test is performed or if the device is turned off. Overall Operation The GSI AUDIOscreener+ is easy to understand and use. Because no external equipment ever is required to operate the device and because the device has a large display with complete instructions and detailed help screens, a trained operator can learn quickly how to use it, and remember how to use it even if he or she does not use the device frequently. The GSI AUDIOscreener+ has much more capability than these basic screening operations. The remainder of this manual has complete information concerning the advanced capabilities of the GSI AUDIOscreener+. 2205-0100 Rev B Page 34 Chapter 4 OAE Advanced Operation Introduction This section of the operating manual describes the advanced OAE operations of the GSI AUDIOscreener+ and is intended for administrators, supervisors or advanced operators. Generally, an administrator or supervisor need only use the Basic Operation section of the operating manual to train a new operator regarding aspects of the device common to both OAE and ABR screening including issues concerning the probe, electrodes and the patient database. This section of the operating manual will cover in detail what happens when an OAE test is initiated as well as advanced OAE testing capability. Refer to the Configuration section for information on how to set the test parameters. The up arrow can be used to move the selection box up to the otoacoustic emissions header that will show either DPOAE or TEOAE. Once the header is selected, the left or right arrows can be used to change the type of OAE test. If the header shows TEOAE, pressing either the left or right arrow will change it to DPOAE and vice versa. The advanced operations of DPOAE and the TEOAE will be explained separately. Advanced DPOAE Operation With the selection box set to the DPOAE selection set, the TEST button displays a DPOAE Test Progress screen and initiates a sequence of events based on a selectable Configuration that determines all test parameters and other test requirements. The DPOAE sequence begins with a short, low frequency test signal that determines if the probe is adequately coupled to the ear. If the probe is not adequately coupled to the ear, a message instructs you to readjust the probe before proceeding. Next, the two test tones are presented and measured in the ear canal. If the levels of the tones (L1 and L2) are not the values specified in the DPOAE Configuration, a compensation procedure automatically adjusts them. The test will not proceed if the levels of the tones cannot be achieved due to blocked sound tubes, excess ear wax (cerumen) or amniotic fluid in the canal, or from placing the sound opening against the canal wall. After the automatic tone level adjustment is made, the OAE test sequence automatically presents the test signals sequentially. When all testing in the sequence is complete, the device returns to the Main screen. A choice of two test progress screens is available, the default Simple DPOAE Test Progress screen or a Graph DPOAE Test Progress screen. The Simple DPOAE Test Progress screen is the default test progress screen and is described in the Test Patient 2205-0100 Rev B Page 35 section of the Operation chapter of this operating manual. The Simple DPOAE Test Progress screen is the default test progress screen and is described in the Test Patient section of the Operation chapter of this operating manual. The Simple DPOAE Test Progress screen displays progress bars during the test, one for each test frequency. A progress bar is an empty horizontal bar that fills as the test progresses. The approximate percentage of the maxim um test time for that frequency is displayed in the bar. After each test frequency is completed, the result for that frequency, either a PASS or REFER, is displayed and the test proceeds automatically to the next test frequency. The sequence of test frequencies progresses from the first to last frequency (Up) or from the last to first frequency (Down) according to the direction parameter set in the DPO AE configuration section. At any time Simple DPOAE Test Progress during the test, the fourth COMMAND button, labeled STOP, can be used to stop the testing and return to the Main screen. Note that the Stop button must be held down for a few seconds until the test stops. This Simple Test Progress screen is best used f or operators who have minimal training. Operators with more advanced training may wish to use the Graph DPOAE Test Progress screen that displays the measurements during the test as a graph. The Graph DPOAE Test Progress screen displays the patient ID, name, ear, and the test frequency number at the top of the display along with the time and date. As the test progresses, results are shown in a graph of dB SPL as a function of frequency in Hz. Two vertical lines indicate the test frequencies in Hz, f1 and f2. The heights of these lines indicate the respective levels of the test frequencies in dB SPL in the ear canal, L1 and L2. Because the two test frequencies are displayed continuously, their levels can be monitored to make sure that the tones remain at the proper levels during the test. Also during the test, the n umbers of frames accepted and tested (96/128, e.g.) are shown as well as the current signal to noise ratio (S/N) in dB. 2205-0100 Rev B Page 36 The DPOAE frequency, fdp, is indicated to the left of f1 and if present, is shown as a thin vertical line. The height of this line indicates the level of the distortion product, Ldp in dB SPL. Surrounding the thin Ldp line is a wide bar that indicates the level of the noise (Ndp) at fdp. The effect of noise reduction digital signal processing can be observed during the test. As the test progresses, the level of the noise decreases. If a distortion product is present, the level of the noise bar will decrease sufficiently to reveal the level of the distortion product. When the test f or that frequency is complete, the f1 and f2 bars are eliminated leaving only the fdp bar and the Ndp bar. The difference in level between Ldp and Ndp is the signal to noise ratio, S/N, in dB. Graph DPOAE Test Progress During the test, one of two letters may flash in the upper right portion of the display. The letter "C" (Clipping) indicates that the level of sound exceeds the limits of the microphone system and the measure is discarded. The letter "N" (Noisy) indicates that the level of noise for a frame exceeded the Frame Reject setting in the DPO AE Configuration and the measure is discarded. The test proceeds until a reliable result is obtained or until a maxim um test time occurs. In noisy environments, the test may stop at a particular frequency and indicate that too much noise is present. If this occurs, the testing is stopped and a choice is given to start testing again or stop all testing. While the testing is stopped, the operator should attempt to reduce the amount of noise (turn off other devices, ask people to stop talking, etc.) or wait until the noise subsides (a phone stops ringing, the baby stops crying, etc.) and then start testing again by pressing the TEST button. The current results for the previous test frequencies will be saved and the test will continue with the test frequency at the point you were informed of the noisy condition. The STOP button will stop the entire test, discard the results for the previous frequencies and return to the Main screen. 2205-0100 Rev B Page 37 The program administrator has a choice of sophisticated noise processing methods that are described in detail in the Device configuration section of this manual. In general, the processing methods differ in speed of testing. More test time is needed in noisy environments to maintain reliable results. If the letters "C" or "N" never appear, a f aster processing method ma y be used. If these letters appear often, a slower, but more reliable processing method can be selected. After testing at all frequencies is finished, the device automatically returns to the Main screen to show the overall result for the ear. Because up to three tests can be saved for each ear, the result for the best of the tests for that ear will be displayed. In other words, even if the third test (3/3) was just preformed, the device may return to the second test (2/3) if the second test is the best of the three. Only Simple DPOAE Test Result the last three tests for that ear are saved. If more than three tests have been performed for that ear, all earlier results are discarded. When testing for the first ear is complete, remove the probe from the ear and couple it to the opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the selection box from first ear to the opposite ear (or to the ABR section). Press the TEST button to obtain results for the ear that has not been tested. When the test for the opposite ear is complete, the device returns to the Main screen and shows the results for both ears. View Detailed DPOAE Results To view the DPOAE test results in detail, first use the UP or DOWN arrow keys to select the desired ear in the DPOAE section. If more than one DPOAE test was obtained for this ear, use the left or right arrow keys to select the desired test, (1/2 or 2/3, e.g.) and press the VIEW COMMAND button. A Simple DPOAE Test Result screen similar to the Simple DPOAE Test Progress screen displays the results in text form with a PASS or a REFER for each frequency tested and the overall result for the ear. 2205-0100 Rev B Page 38 From the Simple DPOAE Test Result screen the results can be viewed as a graph. Press the UP arrow as indicated on the screen to activate the Graph DPOAE Test Result screen. The complete test results f or each test frequency for the selected ear are shown in the form of a graph similar to the Graph DPOAE Test Progress screen. From the Graph DPOAE Test Result screen the complete test results at each frequency can be viewed in numeric form. Press the UP arrow to display the complete data including all of the test signal parameters and the test result values for the first nominal test frequency. Each value is clearly labeled. The complete results for the other test frequencies can be accessed b y pressing the RIGHT or LEFT arrow keys as indicated on the screen. When finished viewing the detailed test results, press the DONE COMMAND button to return to the Main screen. Numeric DPOAE Test Result 2205-0100 Rev B Page 39 Advanced TEOAE Operation With the selection box set to the TEOAE selection set, the TEST button displays a TEOAE Test Progress screen and initiates a sequence of events based on a selectable Configuration that determines all test parameters and other test requirements. The TEOAE sequence begins with a short, low frequency test signal that determines if the probe is adequately coupled to the ear. If the probe is not adequately coupled to the ear, a message instructs you to readjust the probe before proceeding. Next, the test clicks are presented and measured in the ear canal. If the level of the test clicks (Lt) is not the value specified in the TEOAE Configuration, a compensation procedure automatically adjusts it. The test will not proceed if the level of the clicks cannot be achieved due to blocked sound tubes, excess ear wax (cerumen) or amniotic fluid in the canal, or from placing the sound opening against the Simple TEOAE Test Progress canal wall. After the automatic level adjustment is made, the TEOAE test sequence automatically presents the test signals. When testing is complete, the device returns to the Main screen. A choice of two test progress screens is available, the default Simple TEOAE Test Progress screen or a Graph TEOAE Test Progress screen. The Simple TEOAE Test Progress screen is the default test progress screen and is described in the Test Patient section of the Operation chapter of this operating manual. The Simple TEOAE Test Progress screen displays a progress bar during the test. A progress bar is an empty horizontal bar that fills as the test progresses. The approximate percentage of the maximum test time is displayed in the bar. At any time during the test, the fourth COMMAND button, labeled STOP, can be used to stop the testing and return to the Main screen. Note that the Stop button must be held down for a few seconds until the test stops. After the test is completed, the device returns to the main screen. The Simple TEOAE Test Progress screen is best used f or operators who have minimal training. Operators with more advanced training may wish to use the Graph TEOAE Test Progress screen that displays the measurements during the test as graphs. 2205-0100 Rev B Page 40 The Graph TEOAE Test Progress screen displays the patient ID, name and ear at the top of the display along with the time and date. As the test progresses, results are shown in a graph form. At the top of the screen is a graph of the averaged waveform of the response in dB SPL as a function of time. The lower part of the screen shows the spectral content of the waveform in dB SPL as a function of frequency in Hz. The frequency range is divided into a number of frequency bands depending on the setting in the configuration (See configuration section). Each frequency band is shown by vertical bars. The height of the thin bar indicates the level of the transient evoked emission, Lte in dB SPL in that band. Surrounding each thin Lte bar is a wider bar that indicates the level of the noise in the Graph TEOAE Test Progress band, Nte. The effect of noise reduction digital signal processing can be observed during the test. As the test progresses, the level of the noise decreases. If a TEOAE is present, the level of the noise bar will decrease sufficiently to reveal the level of the TEOAE. The difference in level between Lte and Nte is the signal to noise ratio, S/N, in dB. Above each bar will be a letter "P" or a letter "R" to indicate if the response exceeded the pass criterion. During the test, one of two letters may flash in the upper right portion of the display. The letter "C" (Clipping) indicates that the level of sound exceeds the limits of the microphone system and the measure is discarded. The letter "N" (Noisy) indicates that the level of noise for a frame exceeded the Frame Reject setting in the TEOAE Configuration and the measure is discarded. The test proceeds until a reliable result is obtained or until a maximum test time occurs. Also during the test, the numbers of frames accepted and tested (96/128, e.g.) are shown as well as the current signal to noise ratio (S/N) in dB for each frequency band. 2205-0100 Rev B Page 41 In noisy environments, the test may stop at a particular point and indicate that too much noise is present. If this occurs, the testing is stopped and a choice is given to start testing again or stop all testing. While the testing is stopped the operator should attempt to reduce the amount of noise (turn off other devices, ask people to stop talking, etc.) or wait until the noise subsides (a phone stops ringing, the baby stops crying, etc.) and then start testing again b y pressing the TEST button. The current results for the previous test frequencies will be saved and the test will continue at the point you were informed of the noisy condition. The STOP button will stop the entire test, discard the results for the previous frequencies and return to the Main screen. The program administrator has a choice of sophisticated noise processing methods that are described in detail in the Device configuration section of this manual. In general, the processing methods differ in speed of testing. More test time is needed in noisy environments to maintain reliable results. If the letters "C" or "N" never appear, a faster processing method may be used. If these letters appear often, a slower, but more reliable processing method can be selected. After testing is finished, the device automatically returns to the Main screen to show the overall result for the ear. Because up to three tests can be saved for each ear, the result for the best of the tests for that ear will be displayed. In other words, even if the third test (3/3) w as just preformed, the de vice may return to the second test (2/3) if the second test is the best of the three. Only the last three tests for that ear are saved. If more than three tests have been performed for that ear, all earlier results are discarded. When testing for the first ear is complete, remove the probe from the ear and couple it to the opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the selection box from first ear to the opposite ear (or to the ABR section). Press the TEST button to obtain results for the ear that has not been tested. When the test for the opposite ear is complete, the device returns to the Main screen and shows the results for both ears. 2205-0100 Rev B Page 42 View Detailed TEOAE Results To view the TEOAE test results in detail, first use the UP or DO WN arrow keys to select the desired ear in the TEOAE section. If more than one TEOAE test was obtained for this ear, use the left or right arrow keys to select the desired test (1/2 or 2/3, e .g.) and press the VIEW COMMAND button. A Simple TEOAE Test Result screen similar to the Simple TEOAE Test Progress screen displays the results in text form with a PASS or a REFER for each frequency band and the overall result for the ear. From the Simple TEOAE Test Result (see page 42) screen the results can be viewed as a graph. Press the UP arrow as indicated on the screen to activate the Graph TEOAE Test Result screen. The complete test results for each test frequency band for the selected ear are shown in the form of a graph similar to the Graph TEOAE Test Progress screen. From the Graph TEOAE Test Result (see page 42) screen the complete test results at each frequency band can be viewed in numeric form. Press the UP arrow to display the complete data including all of the test signal parameters and the test result values for the first nominal test frequency band. Each value is clearly labeled. The complete results for the other test frequency bands can be accessed by pressing the RIGHT or LEFT arrow keys as indicated on the screen. When finished viewing the detailed test results, press the DONE COMMAND button to return to the Main screen. Simple TEOAE Test Result 2205-0100 Rev B Page 43 Numeric TEOAE Test Result Graph TEOAE Test Result 2205-0100 Rev B Page 44 Chapter 5 ABR Advanced Operation Introduction This section of the operating manual describes the advanced ABR operations of the GSI AUDIOscreener+ and is intended for administrators, supervisors or advanced operators. Generally, an administrator or supervisor need only use the Basic Operation section of the operating manual to train a new user regarding aspects of the device common to both OAE and ABR screening including issues concerning the probe, electrodes and the patient database. This section of the operating manual will cover in detail what happens when an ABR test is initiated as well as advanced ABR testing capability. Refer to the Configuration section for information on how to set the test parameters. With the selection box in the ABR section, the TEST button initiates a selectable Configuration that defines all test parameters and other test requirements. The device measures the electrode impedances individually between two electrodes and displays the values in kOhms. If these impedance values are less than values specified by the configuration including the maximum allowed, 12 kOhms (default), or the maximum impedance difference allowed between two electrodes, < 5 kOhms (default), the test sequence proceeds automatically. If the electrode impedance criteria are not met, the sequence pauses to give the opportunity to reapply the electrodes and continue with the RETRY button or alternatively to continue with the present impedance values with the TEST button. The measured impedance values are saved as part of the patient test record. The ABR test sequence begins with a check of electrode impedances. The default ABR configuration uses Comfort Cups and is set to skip probe fit and calibration sequences. However, these sequences can be enabled (see configuration section) and are useful when using only the probe. 2205-0100 Rev B Page 45 ABR Impedance Check Simple ABR Test Progress If enabled, a short, low frequency test signal determines if the probe is adequately coupled to the ear. If the probe is not adequately coupled to the ear, a message suggests an adjustment of the probe before proceeding. Next, a 1000 Hz sinusoid test tone at 65 dB SPL is presented and measured in the ear canal using the microphone in the probe module. If the measured level of this tone is incorrect (dB peps or dB nil), a compensation procedure automatically adjusts it. The test will not proceed if the level of the test tone cannot be achieved due to blocked sound tubes, excess ear wax (cerumen) or amniotic fluid in the canal, or from placing the sound opening against the canal wall. After the automatic tone level adjustment is made, the ABR test sequence automatically presents the test signals sequentially and displays an ABR Test Progress screen. When all testing in the sequence is complete, the device returns to the Main screen. A choice of two test progress screens is available, the default Simple ABR Test Progress screen or the Graph ABR Test Progress screen The Simple ABR Test Progress screen displays progress bars during the test, one for each test signal. A progress bar is an empty horizontal bar that fills as the test progresses. The approximate percentage of the maximum test time for that test signal is displayed in the bar. After each test signal is completed, the result f or that waveform, either a PASS or REFER, is displayed and the test proceeds to the next test signal. During the test, the first COMMAND button is labeled PAUSE to allow the user (tester) to pause testing and hold the results collected so far. The PAUSE changes to CONT to allow the testing to continue. The fourth COMMAND button labeled STOP, can be used to stop the testing and return to the Main screen. 2205-0100 Rev B Page 46 Note that you have to continuously hold the PAUSE or the STOP button down for a few seconds until the command is initiated. The Graph ABR Test Progress screen displays the ongoing averaged waveform, that is, the voltage coming from the electrodes as a function of time over a 15 msec period. The test parameters determined by the Configuration are listed at the top of the screen including the date of the test, the number of the test in the sequence (1 to 8), the level of the stimulus, the number of frames collected and the number of frames measured (512/1000, e.g.). During the test with the Graph ABR Test Progress screen the first COMMAND button is labeled P AUSE to allow the operator to Simple ABR Test Progress pause testing and hold the results collected so far. The PAUSE changes to CONT to allow the testing to continue. If enabled, the second COMMAND button is labeled DONE which stops the entire test sequence, discards the test measurements and returns to the Main screen. The fourth COMMAND button is labeled STOP which stops data collection for the displayed stimulus, saves the result and proceeds to the next test stimulus if more than one stimulus is configured. Note that you have to continuously hold these buttons down for a few seconds until the command is initiated. After testing at all levels is complete, the device automatically returns to the Main screen. Up to three ABR tests can be saved for each ear with the best result for the tests for that ear displayed first. In other words, even if the third test (3/3) for this ear was just performed, the device may return to the second test (2/3) if the second test is the best of the three. Only the last three tests for that ear are saved. If more than three tests have been performed for that ear, the earlier results are discarded. 2205-0100 Rev B Page 47 When testing for the first ear is complete, remove the probe from the ear and couple it to the opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the selection box from the first ear to the opposite ear. Press the TEST button to obtain results for the ear that has not been tested. The test sequence automatically selects the correct electrode pair for the ear being tested. When the test for the opposite ear is complete, the device returns to the Main screen. Because the ABR measures are collected automatically under the Configuration, personnel with minimal training easily can collect reliable ABR data. In the automated mode, the interpretation of the ABR test results are made based on criteria in the Configuration. The GSI AUDIOscreener also allows manual analysis of the waveforms after they have been collected. In the manual mode, the ABR test results are stored automatically and the Test Result box contains a “U” for “Unevaluated”. The test results may then be analyzed manually directly on the device in a manner similar to that of desktop diagnostic ABR devices (cursor control, order of waveforms, determination of the latency of Wave V, etc.) or transferred to an external computer application called AUDIOtrac™ for evaluation later. If the test has been evaluated directly on the device, the Test Result box will contain either a symbol for a PASS or a ? symbol for a REFER. View Detailed Results The ABR waveforms and test results are automatically saved in internal memory and can be viewed in detail. Use the UP or DOWN arrow keys to select the desired ear in the ABR section. If more than one ABR test was obtained for this ear, use the LEFT or RIGHT arrow keys to select the desired test, (1/2 or 2/3, e.g.) and press the VIEW COMMAND button to display an ABR Multiple Waveform screen with up to 4 individual waveforms. Each waveform is numbered on the left with the stimulus level indicated on the right. Multiple ABR Waveform 2205-0100 Rev B Page 48 Additional waveforms for the test sequence, if collected, can be viewed by scrolling the window using the first or second COMMAND keys (not the UP or DOWN ARROW keys). From the Multiple ABR Waveform screen, individual waveforms can be viewed in more detail by pressing the RIGHT arrow key sequentially to display a Single Waveform screen, one for each stimulus in the sequence. Each Single ABR Waveform screen is similar to the Multiple ABR Waveform screen but with additional information. The top of the Single ABR Waveform screen displays the date of the test, the number of the test stimulus in the sequence, and the level of the test stimulus using a reference stipulated by the Single ABR Waveform Configuration. A thin vertical bar is placed on the graph that functions as a cursor set at the latency indicated in msec at the top of the display. The vertical cursor, which can be turned off and on with the third COMMAND button, can be moved to the left with the first COMMAND button or to the right with the second COMMAND button. The latency value is updated numerically at the top of the display as the cursor is moved. The GSI AUDIOscreener+ can be used to identify and measure the latency of a peak in an averaged waveform. If the identified peak is Wave V, GSI AUDIOscreener+ also can determine if the measured latency is in the normal range. The normative latency value of Wave V is indicated by a small black horizontal bar at the top of the graph. The center of the bar represents the normative mean latency and takes into account both the level of the stimulus and the age of the patient. The width of the bar along the time axis represents the normative range of latency values. The latency of the identified peak falls within the normative latency range if the vertical line falls on the normative latency bar. 2205-0100 Rev B Page 49 The mean latency values of Wave V systematically decrease with increasing signal level and increasing subject age. Published mean values (Gorga et al 1987) are incorporated into GSI AUDIOscreener+ and set the location of the normative latency indicator bar. The default normative latency values can be changed easily. The mean normative latency values can be offset in 0.1 msec steps (Normative Latency Offset value) which increases the normative mean values and moves the normative range latency bar to the right on the graph. The normative of latencies (Latency Peak V Range value) Single ABR Waveform can be increased in ±0.25 msec steps which widens the normative latency bar. From the Multiple ABR Waveform screen or Single ABR Waveform screen, relevant data can be viewed numerically by pressing the UP NAVIGATION button. The Multiple ABR Numeric screen lists the latency values taken from the cursor positions on the Single ABR Waveform screens so they can be assessed systematically and easily in numeric form. The Single ABR Numeric screen includes other numeric data for each waveform. From each numeric screen, the corresponding waveform screen can be recalled by pressing the DOWN NAVIGATION button. Multiple ABR Numeric 2205-0100 Rev B Page 50 After the latencies of Wave V for each waveform have been determined, the trained professional can view the results of the test sequence as a whole and determine if the test sequence should be marked as a PASS or a REFER. This assessment can be based on conventional diagnostic principles that usually involve a determination if the latency of Wave V is within the normal range for each test stimulus level and if this latency lengthens systematically as the level of the stimulus is reduced. The latencies of Wave V across stimulus levels can be viewed graphically from the Multiple Waveform screen or numerically from the Multiple Tabular Data screen. If desired, the trained professional also can estimate the average hearing level in dB HL, though this level cannot be entered into the database from the GSI AUDIOscreener. In the manual mode only, the test sequence can be marked as a PASS or a REFER from the Multiple Waveform screen. Pressing the third blue COMMAND button labeled “EVAL” displays a pull down menu with UNEVALUATED, PASS, or REFER as options. Select an option and press the DONE button to mark the test and return to the Main screen. Note that an evaluation decision can be changed at anytime, including changing it back to an UNEVALUATED result. Gorga, M. P., Reiland, J. K., Beauchaine, K. A., Worthington, D. W, & Jesteadt, W. (1987). Auditory brainstem responses from graduates of an intensive care nursery: normal patterns of response. J Speech Hear Res, 30(3), 311-8 2205-0100 Rev B Page 51 Chapter 6 Configuration Introduction The Configuration option for the GSI AUDIOscreener+ gives the operator great flexibility and ease of use and allows complete control of the device. Many functions can be configured, adjusted, and manipulated using only the buttons on the front panel. Test signals can be selected and adjusted, digital signal processing methods can be altered, and PASS/REFER methods and criteria can be changed. Patient records in the internal patient database can be deleted or printed as a group. The time and the date can be set and the name of your hospital or institution and the names of the testers can be entered into permanent memory. The Configuration option also allows you to view important device settings. This section describes how to use the Configuration options. Configuration Selection The Configuration option is accessed from the Main screen by pressing the fourth unlabeled COMMAND button and holding it down for several seconds. This access is intentionally obscure to limit the ability of the daily operator to change test parameters or accidentally delete patient records. Only authorized administrators should be taught how to access the Configuration option. From the Main screen, press and hold the fourth unlabeled COMMAND button for at least 4 seconds. The Configuration selection screen appears with the following Configuration options DPOAE configuration TEOAE configuration ABR configuration Database configuration Time/Date configuration 2205-0100 Rev B Page 52 Printing configuration Device configuration Tester IDs configuration Performance configuration Battery configuration Use the UP and DOWN arrows to select a configuration option and press the Enter COMMAND button. Data are entered in Data Entry screens that contain one or more lines that end with a colon. Following the colon is a Data Entry Area that is indicated with brackets [ ], if the data can be changed, or without brackets, if the data cannot be changed. New data are entered, or existing data are edited, by either typing characters or by selecting from a list of options. The selection box, shown on the first Data Entry Area, is moved up and down the screen to other Data Entry Areas using the UP and DOWN buttons. After a Data Entry Area has been selected, press the ENTER On Edit Button. Example Data Entry Data are entered into the Data Entry Area in two ways depending on the type of data. Open-ended data: If the data are from a large data set and open ended (such as a Configuration name) a Virtual Keyboard appears (see Basic Operation chapter). The Virtual Keyboard is an image of a conventional keyboard with keys for the numbers 0 through 9, the letters of the alphabet and additional characters located after the M letter. The COMMAND buttons are labeled CANCL (cancel the virtual keyboard), TYPE (type the selected character to the top line), DEL (delete the last character from the top line) and DONE (finished entering all data). When the Virtual Keyboard is first opened, the “1” character is selected. The selection is moved around the virtual keyboard using the four arrow keys to select other characters. Once the desired character is selected, press the TYPE COMMAND button to type the character on the top line. Move the selection to the next desired character and TYPE it. 2205-0100 Rev B Page 53 The last character on the top line can be deleted by pressing the DELete COMMAND button. When all of the desired characters have been placed on the line, press the DONE COMMAND button. Restricted data: If the data are from a small restricted data set (a list of test frequencies, e. g.) a pop-up menu is shown listing the restricted set of data. The Up or DOWN arrows are used to make a selection from the pop-up list. After the selection is made, press the DONE COMMAND button to save the selection to the data area, close the popup screen and return to the Data Entry screen. DPOAE Configuration The methods and criteria for determining whether a patient receives a PASS or REFER when using DPOAE measures are listed in Appendix D. Each individual DPOAE measure has a very large number of independent test parameters that can be varied, each of which can DPOAE Configurations affect the PASS/REFER decision. To obtain repeatable PASS/REFER decisions, each of these many test parameters must be specified and recorded in the Configuration and the same Configuration must be used for each screening measure. To facilitate the setting and recording of these test parameters, the DPOAE Configuration option stores a complete set of DPOAE test settings under a single Configuration. Up to 10 Configurations can be stored, each with different test parameters and criteria. The Configuration for each test always is shown with the test results on the Main screen and on all printed reports. With this arrangement, the simple act of selecting a Configuration automatically sets all of the test parameters at once and records the settings as well. The GSI AUDIOscreener has a default DPOAE Configuration named QuickDPOAE. QuickDPOAE is not modifiable but its settings can be viewed. This arrangement ensures that all test parameters are set to known values for every test performed with QuickDPOAE. 2205-0100 Rev B Page 54 New Configurations can be added to the Configuration list. Press the NEW COMMAND button to open the Virtual Keyboard and enter a new Configuration name. The new Configuration name can be up to 19 characters long but cannot be the name of an existing Configuration. The new Configuration initially contains the test parameters in the last selected Configuration. Each of the individual test parameters in the new Configuration can then be adjusted. The process of creating a new Configuration by duplicating an existing Configuration and editing its values, is much faster than entering a new value for every test parameter. Press DONE to see the new name in the list of Configurations. A Configuration also can be deleted by selecting it and pressing the DEL COMMAND button. Global Parameters The DPOAE Configuration screen also is used to select a Configuration for testing. After a Configuration is selected, press DONE to return to the Main screen. The device then uses the test settings of the selected Configuration. The DPOAE Configuration screen also is used to view or adjust the test parameters of a Configuration. After a Configuration is selected, press the ENTER COMMAND button to open the Configure DPOAE screen for the selected Configuration. The Configure DPOAE screen allows adjustment of all of the individual test parameters. The test parameters and ranges of settings are listed below. DP Global Parameters The DP Global Parameters section is used for setting test parameters that apply to all DPOAE test operations. The following numbered sections are used for setting test parameters for each test frequency individually. Number TF: 1, 2, 3, 4, 5 (number of test frequencies for each ear) Number T Pass: 1, 2, 3, 4, 5 (number of test frequencies that "Pass" for the ear to receive a "Pass") Direction: Up, Down (proceed from high to low or low to high) Min S/N: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, (minimum signal to noise ratio in 2205-0100 Rev B Page 55 Note: The QuickScan default values are shown in bold. dB for a valid Ldp) Calib tol: Environment: Time/freq: Time/ear: Max time/ft: Display mode: 1, 2, 3, 4, 5 (calibration tolerance level of L1 and L2 in dB) Quiet, Normal, Noisy (Advanced signal processing based on an estimate of the acoustic noise level in the environment including noise made by the patient. The Quiet setting is very fast and intended for use in quiet environments. The Normal setting is average and intended for use in environments with average noise levels. The Noisy setting is the slowest and intended for the noisiest environments. The maximum time at each test frequency should be extended for the Noisy condition). Estimated test time at each frequency computed by the GSI AUDIOscreener+ OAE+ABR. Cannot be changed. Estimated test time for each ear computed by the GSI AUDIOscreener+ OAE+ABR. Cannot be changed. 10, 20, 30, 40, 50, 60 (Desired maximum test time at each test frequency, in seconds) Simple, Graph DP Test Frequency Parameters A list of DP Test Frequency Parameters, for each test frequency, is displayed below Global Parameters. The total number of DP Test Frequencies in the is set in the Global Parameters configuration. The name of each DP Test Frequency in the list contains the test number, test frequency, level of L1, in dB SPL, and level of L2 in dB SPL. The DP Test Frequency configuration on the right contains three test frequencies 2000 Hz, 3000 Hz and 4000 Hz each with L1 equal 65 dB SPL and L2 equal to 55 dB SPL. one list to DP Test frequencies 2205-0100 Rev B Page 56 Each DP Test Frequency configuration can be selected individually. Pressing ENTER will then open the DP FT Parameters configuration screen. Centering: On F2 (the nominal test frequency is centered on F2) TF: Nominal test frequency (2000, 3000, 4000, 5000, 6000 Hz) F2/F1: 1.2 (ratio of F2/F1) F1: Frequency of F1 in Hz (based on TF) F2: Frequency of F2 in Hz (based on TF) L1: 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70 (level of F1 in dB SPL) L2: 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70 (level of F2 in dB SPL) Test Parameters Test Pass Criterion Min Ldp: -10, -9, -8, -7, -6, -5, -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, (minimum level of Ldp in dB SPL to be considered a PASS. The default criterion levels are -7, -8, -5, -7 and -7 dB SPL for 2000, 3000, 4000, 5000 and 6000 Hz, respectively. See Appendix C) Max Ndp: -2, 0, 2, 4, 6, 8, 10 (maximum allowable noise level) Default level is 4 for 2000Hz, 0 for all others. Frame Reject if Ndp>28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50 (level of Ndp in dB SPL for frame rejection. The default Ndp levels are 42, 34, 32, 30 and 30 dB SPL for 2000, 3000, 4000, 5000 and 6000 Hz, respectively) 2205-0100 Rev B Page 57 TEOAE Configuration The methods and criteria for determining whether a patient receives a PASS or REFER when using TEOAE measures are listed in Appendix D. Each individual TEOAE measure has a very large number of independent test parameters that can be varied, each of which can affect the PASS/REFER decision. To obtain repeat-able PASS/REFER decisions, each of these many test parameters must be specified and recorded in the Configuration and the same Configuration must be used for each screening measure. To facilitate the setting and recording of these test parameters, the TEOAE Configuration option stores a complete set of TEOAE test settings under a single Configuration. Up to 10 Configurations can be stored, each with different test parameters and criteria. The Configuration for each test always is shown with TEOAE Configurations the test results on the Main screen and on all printed reports. With this arrangement, the simple act of selecting a Configuration automatically sets all of the test parameters at once and records the settings as well. The GSI AUDIOscreener+ has a default TEOAE Configuration named QuickTEOAE. QuickTEOAE is not modifiable but its settings can be viewed. This arrangement ensures that all test parameters are set to known values for every test performed with QuickTEOAE. New Configurations can be added to the Configuration list. Press the NEW COMMAND button to open the Virtual Keyboard and enter a new Configuration name. The new Configuration name can be up to 19 characters long but cannot be the name of an existing Configuration. The new Configuration initially contains the test parameters in the last selected Configuration. Each of the individual test parameters 2205-0100 Rev B Page 58 in the new Configuration can then be adjusted. The process of creating a new Configuration by duplicating an existing Configuration and editing its values, is much faster than entering a new value for every test parameter. Press DONE to see the new name in the list of Configurations. A Configuration also can be deleted by selecting it and pressing the DEL COMMAND button. The TEOAE Configuration screen also is used to select a Configuration for testing. After a Configuration is selected, press DONE to return to the Main screen. The device then uses the test settings of the selected Configuration. The TEOAE Configuration screen also is used to view or adjust the test parameters of a Configuration. After a Configuration is selected, press the ENTER COMMAND TEOAE Global Parameters button to open the Configure TEOAE screen for the selected Configuration. The Configure TEOAE screen allows adjustment of all of the individual test parameters. The test parameters and ranges of settings are listed below. TE Global Parameters The TE Global Parameters section is used for setting test parameters that apply to all DPOAE test operations. The following numbered sections are used for setting test parameters for each test frequency individually. Number bands: 1, 2, 3, 4, 5 (number of test frequency bands for each ear) Number bands Pass: 1, 2, 3, 4, 5 (number of test frequency bands that "Pass" for the ear to receive a "Pass") Calib tol: 1, 2, 3, 4, 5 (Calibration tolerance level of transients in dB) Environment: Normal, 2205-0100 Rev B Page 59 Display Mode: Max time: Repro Type: Rate: Level: Simple, Graph 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 (Desired maximum test time in seconds) Band, Global Calculated — read only. 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90 TE Data Acquisition Parameters The TE Data Acquisition Parameters section is used for setting data acquisition parameters that apply to all TEOAE test operations. Post Stim Delay: Sample Time: Min Frames: Max Frames: Max Noisy Frames: Max Quiet Frames: Repro Pass: 3.5 (Delay after stimulus that data acquisition begins, in msec). 10.0 (Duration of sample time, in msec) 64, 128, 256, 512 (Minimum number of good frames) 128, 256, 512, 1024, 2048, 4096, 8192, 16,384, 32,768 (Maximum total number of frames, including rejected frames) 128, 256, 512, 1024, 2048, 3072, 4096 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 0, 60, 70, 80 (percent) TEOAE Test Parameters 2205-0100 Rev B Page 60 Max Rejection Level: Max Noise Rejection: Max Signal Rejection: 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, (Level of signal above which frame will be rejected, in dB pSPL) 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90 TE Frequency Bands A list of TE analysis frequency bands, one for each frequency band, is displayed below TE Data Acquisition Parameters. The total number of frequency bands in the list is set in the Global Parameters configuration. The name of each TE Analysis Frequency Band in the list contains the band number and the center frequency of the band. The example TEOAE configuration screen contains five frequency bands. Each TE Analysis Frequency Band configuration can be selected individually. Pressing ENTER will then open the TE Analysis Frequency Band configuration screen. TEOAE Test Frequencies 2205-0100 Rev B Page 61 Low Cutoff Defaults are: 3500, 2500, 1500 High Cutoff Defaults are: 4500, 3500, 2500 Decision Cnt: Defaults are: Min SNR: Defaults are: Defaults are: 3 3, 3, 3, 3, 3, for 4000, 3000, 2000, 1500, and 1000 Hz bands 2, 3, 4, 5, 6, 7, 8, 9, 10 (Minimum signal to noise ratio for the band response to be considered a "PASS", in dB) 10, 10, 8, 6, 6 for 4000, 3000, 2000, 1500, and 1000 Hz bands Repro Pass: 0, 60, 70, 80 (Reproducibility value required for the band response to be considered PASS, in percent) 70, 70, 70, 70 and 70 for 4000, 3000, 2000, 1500, and 1,000 Hz bands CAUTION: Setting the reproducibility value to 0 (per band or global) may result in an increase in false negative tests unless the Min SNR for each band is set higher than 6 dB. This is especially true for frequency bands that have centers less than 2000 Hz or Low Cutoff frequencies less than 1500 Hz. Clinical evaluation of the GSI AUDIOscreener TEOAE operation indicates that the default TEOAE configuration may be copied and the 3 default bands’ reproducibility set to 0 in environments with considerable acoustic noise. ABR Configuration 2205-0100 Rev B Page 62 ABR Configuration The methods and criteria for determining whether a patient receives a PASS or a REFER when using ABR measures are listed in Appendix D. Each individual ABR measure has a very large number of independent test parameters that can be varied, each of which can affect the PASS/REFER decision. To obtain repeat-able PASS/REFER decisions, each of these many test parameters must be specified and recorded in the Configuration and the same Configuration must be used for each screening measure. To facilitate setting and recording these test parameters, the ABR configuration option stores a complete set of ABR test settings under a single Configuration. Up to 10 Configurations can be stored, each with different test parameters and criteria. The Configuration for each test always is shown ABR Global Parameters with the test results on the Main screen and on all printed reports. With this arrangement, the simple act of selecting a Configuration automatically sets all of the test parameters at once and records the settings as well. The GSI AUDIOscreener+ has two default ABR Configurations named QuickABRCups and QuickABRProbe. These two configurations are not modifiable but their settings can be viewed. This arrangement ensures that all test parameters are set to known values for every test performed with QuickABRCups or QuickABRProbe. New Configurations can be added to the Configuration list. Press the NEW COMMAND button to open the Virtual Keyboard (see Basic operation) and enter a new Configuration name. The new Configuration name can be up to 19 characters long but cannot be the same name as an existing ABR Configuration. The new Configuration name initially contains the test parameters in the last selected Note: default values are shown in bold. 2205-0100 Rev B Page 63 Configuration. Each of the individual test parameters in the new Configuration can then be adjusted. The process of creating a new Configuration by duplicating an existing Configuration and editing its values is much faster than entering new values for all test parameters. Press DONE to see the new name in the list of Configurations. A Configuration also can be deleted by selecting it and pressing the DEL button. The ABR configuration screen also is used to select a Configuration for testing. After a Configuration is selected, press DONE to return to the Main screen. The device will then use the test settings of the selected Configuration. The ABR configuration screen also is used to view or adjust the test parameters of an existing Configuration. After a Configuration is selected, press the ENTER COMMAND button to open the Configure ABR screen for the selected Configuration. The Configure ABR screen allows the operator to adjust all of the individual test parameters. The test parameters and ranges of settings are listed below for QuickABRCups. ABR Global Parameters The ABR Global Parameters section and the ABR Filter Configuration section are used for setting test parameters that apply to all ABR test operations. The following numbered sections are used for setting test parameters for individual test waveforms. The number of test waveforms is set in the ABR Global Parameters section. Transducer: Cups, Probe (allows indication on reports which transducer was used) (Probe for QuickABRProbe) Fit Test: Mandatory, Report, Ignore (Mandatory requires that a tight fit be established between transducer and ear, Report allows proceeding with the test if transducer fit test fails but reports the result, and Ignore skips transducer fit testing.) (Report for QuickABRProbe) Num stimulus: 1, 2, 3, 4, 5, 6, 7, 8 (number of test waveforms) Num stim for Pass: 1, 2, 3, 4, 5, 6, 7, 8 (number of test waveforms that receive a PASS for the ear to receive a PASS) Stim. Cal: Mandatory, Report, Ignore (Mandatory requires that real ear calibration be established, Report allows proceeding with the test if real ear calibration fails but reports the result, and Ignore skips real ear calibration.) (Report for QuickABRProbe) Lev Tol: 3, 4, 5 (stimulus level tolerance in dB) Lev Ref: dB nHL, dB peSPL (stimulus level reference) 2205-0100 Rev B Page 64 Electrodes: Max Imp: Max Imp DIF: Allow Override: Environment: Midline or Mastoid (Midline uses black for forehead, blue for nape of neck, and red for shoulder, and maintains these settings when testing either ear. Mastoid uses black for forehead, red for right mastoid process, and blue for left mastoid process, and switches electrodes for each ear setting. For right ear testing the active electrodes are black and red and the reference electrode is blue. For left ear testing the active electrodes are black and blue and the reference electrode is red.) (Mastoid for QuickABRProbe) 1000, 1500, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 11000, 12000, 15000, 20000 (Maximum allowable electrode impedance in Ohms per channel) 1000, 2000, 5000, 10000 (Maximum allowance difference in electrode impedance in Ohms between channels) yes, no (allows test to continue if the electrode impedance criteria are not met) Quiet, Normal, Noisy (Advanced signal processing based on an estimate of the electrical noise level in the environment including myogenic noise made by the patient. The Quiet setting is very fast and intended for use in environments with little electrical interference. The Normal setting is slower and intended for use in environments with average electrical interference. The Noisy setting is the slowest and intended for use in environments with more than normal electrical interference.) Display Mode: Progress display) Simple, Graph (Type of Test Allow Done: averaging process) yes, no (Allows user to stop Scoring Mode: Manual, waveform analysis) Auto (Type of ABR Filter Configuration 2205-0100 Rev B Page 65 ABR Filter Parameters Low Cutoff: 30, 100, 300 (Low frequency cut off in Hz) Hi Cutoff: 1000, 1500, 3000 (High frequency cut off in Hz) Artifact Reject Lev: 10,20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 (Maximum allowable input level in µV) Max % Reject: 10, 20, 30, 40, 50, Frame Processing: Method: Linear, Scaled Low Cutoff: 30,100,300 High Cutoff: 1000, 1500, 3000 CAUTION: The default Artifact Reject Level and Maximum % Reject settings are set for optimal noise rejection. Changing these values may result in an increase in false negative or false positive responses, depending upon your electrical noise environment ABR Signal Configuration ABR Signal Parameters Signal: Click, 2000 HZ Pip, 4000 Hz Pip (type of signal) Polarity: Rate: Number: Condens., Rarefact., Alternat. (polarity of signal) 32, 37, 42, 47, 52, 57, 62 (rate of stimuli per second) 1000, 2000, 3000, 4000, 6000, 8000,12000, 1600, (maximum number of frames per test waveform) 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 (level of stimulus in dB re level reference) 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 (difference in dB between SPL and nHL) NONE, 0.25, 0.50, 0.75, 1.0 (± normative range in msec. Level: dB nHL: Lat Pk V Range: 2205-0100 Rev B Page 66 Fsp Threshold: 3.0, 3.2, 3.4, 3.6, 3.8, 4.0, (minimum value of Fsp for ABR waveform to be considered valid) Database Configuration The Database configuration option is used for managing the internal database. The initial Database configuration screen has four options. Select an option and press the ENTER COMMAND button to initiate the selected Configuration. The option Print Record Summary prints a report of all patient records in the database with one patient record per line and approximately 50 lines per page. Each line contains the patient ID, patient name, test Configuration, result for the right ear, Database Configuration result for the left ear and overall result for the patient. Make sure that the printer (if equipped) has been set up and that it has at least 7 sheets of paper. The option Print All Records prints a report (Simple or Detailed, depending on the setting in Printing configuration option described below) for each patient record in the database. Be sure to have sufficient paper available and to add paper to the printer as necessary. This option can produce a maximum of 300 printed reports depending on how many patient records are in the internal database. Time/Date Configuration 2205-0100 Rev B Page 67 The option Delete One Record opens the Select Patient screen that displays a list of the patient ID numbers in the patient database. The first patient record is selected. Other individual patient records can be selected by using the UP or DOWN arrow keys. The RIGHT or LEFT arrow buttons scroll through the patient records one full screen at a time. Continuously holding down an arrow key scrolls through the database continuously. Press the DEL COMMAND button to delete the selected patient record including all test results associated with it. Press the CANCL COMMAND button cancel the screen and return to the Database screen. The option Delete All Records deletes all patient records in the internal patient database. You will be asked to confirm your decision to delete all records before the records are actually deleted. Time / Date Configuration The Time/Date configuration option is used for setting the date format, the time format, the time and date. Use the UP or DOWN arrow keys to move the small arrow on the left of the display to the desired section. Use the LEFT or RIGHT arrow keys to select the items on the selected line. For the date and time sections, a + COMMAND key or — COMMAND key is used to change values. Press the DONE key to save the settings. Printing Configuration This section does not apply to AUDIOscreener+. Printing to be done using AUDIOtrac software. Device Configuration 2205-0100 Rev B Page 68 Device Configuration The Device configuration option is used for setting parameters that apply to the overall operation of the device. The Device configuration option also is used for viewing internal information unique to the device. Institution: (name of your institution, 19 characters maximum) Patient Pass: 1, 2 (number of ears tested for the patient to be labeled a PASS) AutoOff: 0, 1, 2, 5, 10, 15, 30, 45, 60 (number of minutes of key pad inactivity before device turns off automatically, a value of 0 disables the auto shutoff feature) Power Freq: 50, 60 (local power line frequency) Firmware: (version number of firmware, read only) (date firmware built, read only) (time firmware built, read only) Probe: (serial number of probe, read only) S/N: (serial number of device, read only) Lang: Eng X.Y-ZZZZZZ (identifies language module, revision and check sum, read only) Operator IDs The Operator ID configuration creates a list for 20 Operator IDs. The ID is usually the operator’s name but can also be a number (17 characters for each ID). This list of Operator IDs can be scrolled on the Main screen under Operator: to allow a tester to bring up his or her ID. It may be useful to create a blank Operator ID using the last character on the virtual keyboard (underscore) to indicate that no tester was named. The Operator ID selected on the main screen is stored with each test. Performance For use only by GSI. Battery For use only by GSI. Operator ID 2205-0100 Rev B Page 69 Power Down Screen When shutting down the device, it will prompt the tester to a power down screen. This screen will ask if the tester wants to shut down and will display the number of tests completed for the last session and the total number of test in the device lifetime. DPOAE Tests: TEOAE Tests: ABR Tests: Patients: Number of DPOAE tests, read only (Number of DPOAE tests in device lifetime, read only) Number of TEOAE tests, read only (Number of TEOAE tests in device lifetime, read only) Number of ABR tests, read only (Number of ABR tests in device lifetime, read only) Number of patients tested, read only. (Number of patients tested in device lifetime, read only). 2205-0100 Rev B Power Down Page 70 Chapter 7 Maintenance Cleaning CAUTION: Disconnect device from AC power source before cleaning. Upon completion of cleaning, do not connect to AC power source until the device is thoroughly dry. Cleaning of the GSI AUDIOscreener+ must be performed as follows: A mild detergent may be used for general cleaning. If necessary, the GSI AUDIOscreener+ may be cleaned with a 10:1 water/hypochlorite solution; however, repeated cleaning with this solution can damage the plastic case. Isopropyl alcohol applied with a damp (not wet) cotton swab may be used for cleaning difficult to reach areas such as the DPOAE probe connector; however, it should be used sparingly because repeat cleaning may damage the case. See Appendix B: Probe Handling Guide. See Appendix C: Cleaning the Probe. DO NOT USE strong cleaners such as Spray-Nine, Phisohex, Hibiclens, or Vesta-Syde because damage to the case can result. Clean the outside surface with a damp (not wet) cloth or sponge. Avoid excess moisture. When cleaning around connector receptacles, do not let cleaning solution get inside. Unless soiling is observed, the charger should not be cleaned. If cleaning the charger is necessary, wipe the exterior surfaces with a cloth dampened with isopropyl alcohol. 2205-0100 Rev B Page 71 CAUTION: Avoid exposing charger to excess moisture, as this can lead to an electric shock or fire hazard General Maintenance There are no user-serviceable parts contained within the GSI AUDIOscreener+, probe module, or the AC Adapter. Do not attempt to open or service these units. Return the device and accessories to the manufacturer for all service. Opening the instrument, probe module, or AC adapter case will void the warranty. Do not drop or otherwise cause undue impact to the probe module. Return the GSI AUDIOscreener+ and the probe to the manufacturer if the probe or the device is dropped or otherwise damaged. Preventive Maintenance This device must be periodically recertified to assure proper functioning. The recommended service interval is 12 months, but in no case less than once each 24 months. Manufacturer Grason-Stadler Service To arrange for service, contact: Grason-Stadler 7625 Golden Triangle Drive Suite F Eden Prairie, MN 55433 USA Tel: +1-800-700-2282 e-mail: [email protected] 2205-0100 Rev B Page 72 Chapter 8 Troubleshooting Alarms + The GSI AUDIOscreener provides visible alarms on the display. Alarms are of five types: 1. Confirmation of Certain User Commands (Perform the requested command) Are you sure you want to shutdown? Are you sure you want to delete all of the records in the database? Are you sure you want to delete this record? Are you sure you want to delete this configuration? 2. Notification of Internal Processing (Wait until processing is completed) Deleting record... 3. Conditions That Require Intervention (Perform the requested intervention) The probe is not completely sealed. Please adjust probe. TEST again or STOP? The test environment is too noisy. TEST again or STOP? One or both of the test frequencies cannot be calibrated. Please check probe tip, probe module, probe placement, or ear canal. TEST again or STOP? The battery is too low to begin testing. Please charge the battery before continuing. + The GSI AUDIOscreener battery is critically low. Please discontinue operation and apply the battery charger immediately. + The GSI AUDIOscreener battery is too low to continue operation. Shutting Down... Conditions That Do Not Require Intervention (Explanation of an invalid user request) No patient records in database. 4. There are no records in the database. The test was stopped by the operator. You may not delete the default configuration. The data cannot be saved because the storage capacity for this device has been exceeded. Configuration name is invalid. Please choose a unique name for the new configuration. You have reached the maximum number of configurations. Blank Patient IDs are not allowed. The specified ID is already in use. Internal Error Conditions (Call technical support) A startup error has occurred. There is not enough memory to initialize this device. 5. A startup error has occurred. The patient database has been corrupted. It will be cleared. A startup error has occurred. The configuration has been corrupted. All settings will be reset to factory defaults. Unrecoverable Error. Cannot initialize the configuration. The device will now power off. Unrecoverable Error. Cannot initialize the database. The device will now power off. A database error has occurred. WARNING: This device has not been calibrated for use with a probe. There is not enough free memory to perform the operation. + WARNING: The GSI AUDIOscreener was not previously shut down properly. Patient data may have been lost or corrupt. Please examine all records. IrDA Communications Failure. Clock Battery is Low. Please contact factory for replacement. 2205-0100 Rev B Page 73 Troubleshooting Condition Probable Cause Corrections Device does not turn on Dead battery Connect charger for at least 2 hours Battery will not charge - No AC indicator operation Defective charger Return charger for service - AC indicator never blinks to show charge cycle in progress Defective battery Return GSI AUDIOscreener+ for service - L1 or L2 tones are too weak Inadequate coupling between probe & ear Refit ear tip or select different size ear tip Bad probe Return GSI AUDIOscreener+ and probe for service Cannot download patient data to PC Bad infrared link Verify that the GSI AUDIOscreener+ IRDA port is pointed directly at IRDA port of PC Database Error Memory full Delete patient files that are no longer needed Probe fit error Probe not completely sealed Readjust probe to obtain seal Too noisy error The noise level is too high Reduce source of noise or set configurations in Global parameters to “Noisy” Exceed maximum configurations Attempt to create more than 10 Delete existing configurations - L1 or L2 tones not present 2205-0100 Rev B Page 74 Appendix A Screening Methods and Criteria DP Otoacoustic Emission Screening Methods Presence/Absence Method A “Pass” or a “Refer” result for each test frequency is based on the presence or absence of a distortion product otoacoustic emission defined by the signal to noise ratio. The signal to noise ratio is the level of the emission minus the level of noise in dB. In ears with normal hearing, signal to noise ratios are zero with no averaging and increase with the amount of averaging. (Gorga et al., 2000) Level Method A “Pass” or a “Refer” result for each test frequency is based first on the presence or absence of a distortion product otoacoustic emission and second, on the absolute level of the distortion product otoacoustic emission in dB SPL. In ears with normal hearing, average emissions levels vary with test frequency parameters but do not change with the amount of averaging. (Gorga et al., 2000) TEOAE Screening Methods Presence/Absence Method The TEOAE test does not use a presence/absence method. Level Method A "Pass" or "Refer" result for each frequency band is based first on the presence or absence of a transient evoked response and second on the absolute level of the transient evoked emission in dB SPL. In ears with normal hearing, average emissions levels vary with frequency band but do not change with the amount of averaging. Auditory Brainstem Response Screening Methods Presence/Absence Method A “Pass” or a “Refer” result for each test signal is based on the presence or absence of an auditory brainstem response. The presence of a response is determined in some devices by matching the response to a template. More commonly, the determination of the presence of a response is made from an estimate of the signal to noise ratio. The most common estimate of the signal to noise a value called Fsp. The Fsp value is the ratio obtained by the variance of a portion of the values in the averaged ABR waveform divided by the variance of either a single point (original definition) or the average of two points to cancel line frequency effects (current definition), in each frame for the number of frames that made up the averaged result. In ears that are unable to hear 2205-0100 Rev B Page 75 the clicks because of hearing loss, the Fsp values are ~1.0. In ears that are able to hear the clicks, the Fsp values increase with the amount of averaging. (Sininger et al., 2000) Latency Method A “Pass” or a “Refer” result is based first on the presence or absence of an auditory brain-stem response and second, on the latency of a peak in the auditory brainstem response in msec. In ears with normal hearing, the average latencies of Peak V vary with test parameters and patient age but do not change with the amount of averaging. Identification of the location of a peak, either manually or with an automated procedure, is compromised if the responses are noisy or atypical. (Hall, 1992) Analysis of Methods Screening methods and criteria are not well standardized. Additional screening criteria include consideration of the number of tests that receive a Pass for the individual ear to receive a Pass, and the number of ears that receive Pass for the patient to receive a Pass overall. The most comprehensive and scientific data concerning screening methods and criteria were provided by a large multicenter study of 7179 neonates sponsored by the National Institutes of Health (NIH) (Norton et al., 2000). This study reported that an OAE screen (Presence/Absence Method with 3 dB criterion) followed by an ABR screen (Presence/Absence Method with a 3.1 Fsp criterion) will result in a refer rate of only 2% in well baby nurseries and only 2.7% in neonatal intensive care units. GSI AUDIOscreener+ Default Methods and Criteria The GSI AUDIOscreener+ can implement all methods with a large range of selectable criteria for each method. To ensure optimal performance and minimal errors, permanent default configurations are provided based on the NIH multi-center study - one for DPOAE, one for TEOAE and one for ABR. A pass result in at least one of these three types of tests is necessary for the ear to receive a "Pass". For example, if one ear was tested with DPOAE, TEOAE and ABR and received a "Refer" for DPOAE and ABR but a "Pass" for TEOAE, the ear would receive a "Pass". Patient Criteria A Pass result must be obtained in both ears for the patient to receive a Pass overall. GSI AUDIOscreener+ DPOAE Default Configuration The default DPOAE screening configuration is called QuickDPOAE. It is based on the Level Method with the following criteria: 2205-0100 Rev B Page 76 Individual Frequency Test Criteria DPOAE Presence: Signal to Noise ratio 6 dB DPOAE Level at 2000 Hz: -7 dB SPL (L1=65 dB SPL, L2=55 dB SPL) DPOAE Level at 3000 Hz: -8 dB SPL (L1=65 dB SPL, L2=55 dB SPL) DPOAE Level at 4000 Hz: -5 dB SPL (L1=65 dB SPL, L2=55 dB SPL) Individual Ear Criteria A Pass result must be obtained at any two of the three test frequencies for the ear to receive a Pass. GSI AUDIOscreener+ TEOAE Default Configuration The default TEOAE screening configuration is called QuickTEOAE. It is based on the level method with the following criteria: Individual Frequency Test Criteria TEOAE Presence: Signal to Noise ratio TEOAE Reproducibility: 70% Consecutive Decision Count: 3 6 dB GSI AUDIOscreener+ ABR Default Configuration The two default ABR screening configurations are called QuickABRCups and QuickABRProbe. They are based on the Presence/Absence method with the following criteria: Individual Test Criteria ABR Presence: Fsp 3.2 (rarefaction clicks, 35 dB nHL, one test) Summary The two stage NIH recommendation can be implemented with the default configurations. The NIH recommendation also can be improved with the addition of a single retest. Alternative methods and criteria can be easily implemented if and when new research produces different recommendations. Other configurations that are patterned after diagnostic functions such as systematic changes to stimulus levels or other stimulus parameters can easily be programmed into the GSI AUDIOscreener+. Hall, J. Handbook of Auditory Evoked Responses. Boston, Allyn and Bacon, 1992 Don, M, Elberling, C, and Waring M. Objective Detection of Averaged Auditory Brainstem Responses. Scandinavian Audiology, 13, pp 219-228, 1984 Norton, SJ, Gorga M P, Widen, JE, Folsom, RC, Sininger, YS, Cone-Wesson, B, Vohr, BR and Fletcher, KA. Identification of Neonatal Hearing Impairment: Summary and Recommendations, Ear & Hearing, 21:5, pp 529-535, 2000 Sininger, YS, Cone-Wesson, B, Folsom, RC, Gorga M P, Vohr, Widen, JE, Ekelid, M and Norton, SJ. Identification of Neonatal Hearing Impairment: Auditory Brainstem Responses in the Perinatal Period, Ear & Hearing, 21:5, pp 383-399, 2000 2205-0100 Rev B Page 77 Appendix B Probe Handling Guide Failure to follow these instructions will void your warranty. STOP: Please read ALL instructions before handling the GSI Probe. 1 2 3 4 5 The probe is ONLY to be used for hearing screening purposes. Store probe in its proper packaging when not in use. Handle the probe wire with care. Do not excessively twist, bend or stretch the probe wire. DO NOT insert ANY object(s) into the probe head. This can cause permanent damage to the probe. Only use the cleaning floss to clean the probe tip. Do not clean the probe tip when it is attached to the probe wire. 6 7 8 9 10 Do not use water or any kind of liquid to clean the probe. For instructions on cleaning the probe, please refer to "Cleaning the GSI Probe" on the reverse of this card. NEVER use the probe without an ear tip in place. Do not drop or cause undue impact to the probe. DO NOT attempt to service the probe. Return the probe to the manufacturer for all service. Phone: 2205-0100 Rev B 800-700-2282 Page 78 Appendix C Probe Cleaning Guide 2205-0100 Rev B Page 79