OAE Hearing Screener Directions for Use REF 29400
COPYRIGHT © 2013 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statements of intended use published in this manual.
Distributed by Welch Allyn under agreement with Natus Medical Incorporated PROPERTY OF NATUS MEDICAL INCORPORATED ALL RIGHTS RESERVED Bio-logic is a registered trademark of Natus Medical Incorporated Microsoft Windows is a registered trademark of Microsoft Corporation Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev F
Contents Chapter 1: Introduction................................................................................................................................... 5 Indications for use ...................................................................................................................................... 5 About this manual .......................................................................................................................................
Electrical Standards .................................................................................................................................. 48 Performance Specifications ...................................................................................................................... 48 EMC Guidance and Manufacturer’s Specifications .................................................................................. 49 Installation Precautions...................................................
Chapter 1: Introduction The Welch Allyn OAE Hearing Screener performs otoacoustic emissions tests. Using a combination of hardware and software, the Welch Allyn OAE Hearing Screener produces a controlled acoustic signal in the ear canal and measures the resulting evoked emission that is generated by outer hair cells in the cochlea. The system collects and averages data samples until specified measurement parameters are achieved.
About this manual This manual gives step by step instructions on how to perform OAE tests and view results on the Welch Allyn OAE Hearing Screener. Conventions The Welch Allyn OAE Hearing Screener manual uses specific font styles to identify aspects of the system operation. References to the buttons on the front label of the Welch Allyn OAE Hearing Screener are always typed in all caps.
F1 - the lower of the two stimulus frequencies used in a DPOAE test. F2/F1 ratio - the numeric relationship of the two stimulus frequencies to one another. Most research has shown that an F2/F1 ratio of approximately 1.2 produces the most robust emissions. Hz - Hertz; a unit of measurement of frequency; also known as cycles per second. LCD - liquid crystal display; refers to the message window on the upper portion of the Welch Allyn OAE Hearing Screener front panel.
Chapter 2: Welch Allyn OAE Hearing Screener Components and Hardware Setup Cable Connections The cable connections to the Welch Allyn OAE Hearing Screener box are described in the figure and the instructions below. Welch Allyn OAE Hearing Screener Box with Cable Connections Indicated Probe Cable Assembly 1. Align the pins in the connector end of the probe cable to the holes in the jack on the top of the Welch Allyn OAE Hearing Screener box.
Probe part #29402 is compatible only with Welch Allyn OAE Hearing Screener (blue) hardware 29400/29401. Charger Unit Assembly The charger unit is not required for normal operation. The unit is attached to the Welch Allyn OAE Hearing Screener for the purpose of recharging the battery or to perform tests when the battery charge is low. 1. Plug the charger unit into the connector labeled +6V DC on the left side of the Welch Allyn OAE Hearing Screener box. 2.
Communication Cable Assembly The communication cable is provided only for loading the Welch Allyn OAE Hearing Screener internal firmware or for downloading data to a computer. Communication takes place through a serial port or USB port and requires connection to a computer. To connect the communication cable, align the connector on the communication cable to the connector on the left side of the Welch Allyn OAE Hearing Screener box. 1.
Chapter 3: Environment and Patient Preparation There is minimal patient preparation required for an OAE test. Since the test measures a physiologic event, no behavioral response is required from the patient. Therefore, OAEs can be recorded on sleeping individuals or on patients who cannot reliably perform a pure tone audiometric test of hearing either because of illness, language barrier, developmental delays or cognitive deficits.
Patient Instructions For patients who can understand instructions, the following information will help prepare them for the test. Inform them that: 1. You will insert the ear tip into the ear canal. 2. He/She will hear a series of sounds for a few seconds, up to a minute or so. 3. The test will be fastest and most accurate if the patient remains quiet throughout the entire test which will be brief, no more than a minute.
Chapter 4: Care and Maintenance of the Probe Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev F 13
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Chapter 5: Quick Guides and Instructional Videos This section of the document presents Quick Guides, step-by step test procedures and other useful information. The Quick Guides: • List the steps required for performing an OAE test and for reviewing OAE data. • Present suggestions to help you use otoacoustic emissions to test infants, toddlers and preschoolers. • Explain conditions that could cause a Refer result for a Welch Allyn OAE Hearing Screener.
Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev F 16
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Welch Allyn OAE Hearing Screener Troubleshooting Quick Guide: Causes of Refer Results Quick Guide: Causes of ‘Refer” Noise Problem ♦ Noisy surroundings Possible solutions ♦ Eliminate or reduce noise — Isolate and completely sound-proof the test site (optimal). — Ask others in or near test site to refrain from talking or other activity. — Ask noisy people to move to another location; ask parents to move noisy children to another location.
Obstructions Problem ♦ Possible solutions Cerumen, vernix, or other debris ♦ IN THE EAR: — Make sure that a properly trained technician examines the ear canal for obstructions BEFORE inserting the probe. — Delay testing newborns until 11 hours after birth, if possible. (Note: 'Refer' results caused by vernix decrease with each hour after birth.) ♦ ON THE PROBE TIP: — Remove, discard, and replace the probe tip before each test (optimal).
Chapter 6: Welch Allyn OAE Hearing Screener Clinical Competency Evaluation and Result Letters The Welch Allyn OAE Hearing Screener Clinical Competency Evaluation is used for the Train the Trainer approach to learning the Welch Allyn OAE Hearing Screener. This evaluation can be used to ensure that new screeners are competent in using the Welch Allyn OAE Hearing Screener. This evaluation can also be used to document that training occurred and use of the Welch Allyn OAE Hearing Screener has been mastered.
Welch Allyn Hearing Screener Clinical Competency Evaluation Purpose: This evaluation certifies that _________________ has met Welch Allyn’s requirements for utilizing the OAE Hearing Screener. The training involved hands-on exercises. Although further training may be needed, this individual has demonstrated competency in the following areas at this time.
Pediatric Hearing Screening Results Date of Exam: ________________________ Patient’s Name: ________________________ Date of Birth: ________________________ This patient's hearing was screened using otoacoustic emissions. The patient passed the hearing screening in both ears, which indicates that hearing is adequate for normal speech and language development. No further testing is recommended at this time.
Pediatric Hearing Screening Results Date of Exam: ________________________ Patient’s Name: ________________________ Date of Birth: ________________________ This patient's hearing was screened using otoacoustic emissions. The patient referred on the hearing screening in one or both ears. The purpose of this screening is to detect any hearing loss that could be detrimental to normal speech and language development.
Chapter 7: System Operation The front label of the Welch Allyn OAE Hearing Screener incorporates five buttons that the user presses to turn on or reset the box and move through the possible program operations. Refer to the figure and the instructions that follow it to understand the functions of each button. Other sections of this chapter provide flow charts of the software.
The UP and DOWN arrow buttons move through the list of program choices and data files. Press the UP or DOWN arrow keys until the desired program function appears in the LCD. Then press the DX SELECT button. Program Flow Chart In this section the Program Flow Chart is broken down into four sections: Power ON, Performing a Test, Viewing Test Details, and Viewing Previously Collected Data. In the flow charts, the boxes represent the display messages seen on the LCD of the screener.
Chapter 8: Distortion Product Otoacoustic Emissions Performing a DPOAE Test This flow chart begins at the point where the Power ON flow chart ended. The steps shown here are specific for performing the pre-programmed DPOAE test procedure. Note: Selection of the RESTART button from any point in the program flow chart returns to the PERFORM DPOAE message so that function is not represented in the flow chart.
After 10 tests have been performed, the next test (test 11) will overwrite the first test. This proceeds in a continuous loop so that only the last 10 tests performed are saved and accessible in memory. Once overwritten, a test cannot be retrieved. If you wish to record or print the details of a test, it is important that you do so before it is overwritten.
Viewing DPOAE Test Details or Retesting an Ear with a Refer Result Immediately After a Test This flow chart begins at the point immediately after the DPOAE test has been successfully completed and the SEE DETAILS message is displayed. ####-R/L PASS/REFER SEE DETAIL V ^ Refer result? REFER RESULT RETEST Yes DX SELECT V DX SELECT No X kHZ DP ## PASS/REFER NOISE ## ^ or v Next/Previous Frequency ####-R/L PASS/REFER PRINT See more printing details in next section. PROBE DETECT IN PROGRESS . . .
Printing DPOAE Test Details Immediately After a Test The Welch Allyn OAE Hearing Screener with the serial label printer prints out a 2” x 4” selfadhesive label showing the test details immediately after it is performed or to print it out later by retrieving it from memory. The AC power supply must be connected to the back of the printer and plugged into an outlet. The printer must be powered ON using the ON/OFF switch on the printer.
Viewing Previously Collected DPOAE Data This flow chart begins at the point where the PERFORM DPOAE message is displayed and shows the program flow for instances in which you wish to view data that is saved in memory. PERFORM DPOAE Log # in logbook ^ V VIEW DPOAE RESULTS DX SELECT NOTE: The first test displayed is the last test performed.
Chapter 9: Printing Previously Collected Data – Single Ear The AC power supply must be connected to the back of the printer and plugged into an outlet. The printer must be powered ON using the ON/OFF switch. When using the serial label printer, be sure to have it plugged into the screener serial port before you print. To print out the results on a serial printer, it must be connected to the screener using the special cable provided with the printer before you select the test for printing.
If the printer is not connected to the screener or is not powered ON when an attempt is made to print, the message TURN PRINTER ON, TRY AGAIN will display on the LCD. Verify that the cable is securely attached to both the screener and the printer and that the printer power is ON. Then press the DX SELECT button again to attempt to print. If PRINT ALL UNPRINTED TESTS is selected when no remaining unprinted tests are stored in memory, the LCD will return automatically to the PERFORM DPOAE message.
Chapter 10: Printing Previously Collected Data – Both Ears on One Label This flow chart begins at the point where the PERFORM DPOAE message is displayed and shows the program flow for instances in which you wish to print data that is stored in memory. PERFORM DPOAE Log # in logbook ^ V VIEW DPOAE RESULTS ^ V PRINT TEST RESULTS ^ DX SELECT V PRINT BOTH EARS RESULTS ^ NO RESULTS FOR BOTH EARS DX SELECT Database does not contain both right and left ear tests.
Chapter 11: Printer See Chapters 8, 9 and 10 for instructions about how to print out tests from the Welch Allyn OAE Hearing Screener. The Welch Allyn OAE Hearing Screener 29400/29401 (blue label) is only compatible with the Seiko label printer supplied by Welch Allyn. The screener uses serial communication to print test results using the label printer. USB printing from the screener to the label printer is not possible.
Chapter 12: System Default Protocol The Welch Allyn OAE Hearing Screener comes pre-programmed with a DPOAE default screening protocol. The system default protocol is: DPOAE System Default Protocol Collection Parameters, Stopping Parameters and Pass/Refer Criteria The DP system default protocol is set with the following stimulus parameters, response parameters, measurement-based stopping rules, and Pass/Refer criteria.
DPOAE Measurement-Based Stopping Rules per Test The system default DPOAE protocol stops the test when the conditions for an overall test Pass or Refer occur. For example, if the first 3 frequencies “Pass”, then the final frequency will not be tested since the overall pass criterion is that 3 out of 4 frequencies must pass. Likewise, if the first 2 frequencies “Refer” then the final two frequencies will not be tested since there is no chance for an overall Pass result even if the final two frequencies Pass.
Note: Normal hearing is defined as pure tone audiometric threshold of 20 dB HL or better at each test frequency. Frequency Specific Performance Estimates Frequency (Hz) Sensitivity Specificity 2000 0.8 0.85 3000 0.87 0.83 4000 0.89 0.88 5000 0.9 0.
Chapter 13: Reloading WA OAE Firmware (WA OAE Load software) The Welch Allyn OAE Hearing Screener runs on firmware that resides on a memory chip inside the unit. Each Welch Allyn OAE Hearing Screener comes with this firmware pre-installed so that the device is fully functional upon delivery. Users can, however, reprogram this memory chip with a PC-based application called WA OAE Load. This application comes with every new system.
• If your PC does not support the automatic running of the installation software on the CD you will need to browse to the CD drive using Windows Explorer and open the file named “install.exe” to view this screen. 5. Select the “Welch Allyn OAE Software” button. 6. Follow the on-screen prompts to complete the installation of WA OAE Load onto your PC. A WA OAE Load shortcut icon will be placed on the PC’s desktop. 7. Select the Exit button on the WA OAE Load installation screen.
7. The “Status:” area toward the bottom of the screen will show the progress of the download of firmware into the screener. The complete process takes 2-3 minutes. 8. Exit the application when the WA OAE Firmware download is complete. Note: If you need assistance installing the WA OAE Load software on your PC or downloading WA OAE Firmware, please contact Welch Allyn Technical Support at 1800-535-6663.
Chapter 14: Exporting using ASCII Link ASCII Link is a utility program that lets you download data from the Welch Allyn OAE Hearing Screener unit's memory to a PC and convert it to an ASCII file. This tool lets you save Welch Allyn OAE Hearing Screener data in your own spreadsheet where you can use it for research. To use the ASCII Link program: 1. Install the ASCII Link program from the Welch Allyn OAE Inservice Guide CD. 2.
OAE Test ID (1000-9999); prefix 10= DP 102001 (DP) OAE Serial Number Reproducibility % 05369 Reproducibility=85 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev F 42
Chapter 15: Troubleshooting, Service and Warranty Error messages usually appear on the LCD when the system is unable to perform a desired function. This section lists some of the more common error messages and possible solutions. Error Messages LOW BATTERY!!! CONNECT CHARGER This message appears when the battery charge is completely depleted. The message will flash for 10 seconds after which the unit will power off.
PLEASE RELEASE BUTTON! This message appears when one of the buttons on the Welch Allyn OAE Hearing Screener label is depressed for more than .3 sec. Releasing the button returns the system to normal operation. If depressed during data collection the artifact rejection threshold level will be increased by 20mPa. EMPTY DATABASE This message appears when an attempt is made to view data when no tests are stored in memory.
Service Caution Unauthorized repairs will void the warranty. A Welch Allyn Service Center must perform all repairs on products under warranty. Qualified electronics personnel or a Welch Allyn Service Center should repair products out of warranty. Technical Assistance If you have an equipment problem that you cannot resolve call the Welch Allyn Technical Support center nearest you (page ii) on normal business days.
Appendix A - Precautions and Safety Instructions IMPORTANT This device is intended for use by qualified personnel only. Please read this section and the Welch Allyn OAE Hearing Screener Directions for Use before installing any of the hardware, then retain this section as a reference while operating, transporting, storing or re-installing equipment.
Electrical Installation Requirements The following requirements are necessary only when using the Welch Allyn OAE Hearing Screener in an AC-powered configuration. Grounding is not necessary in normal battery-powered use. Grounding Requirements The desired installation site must have a grounding wire for electrically connecting the system equipment to a properly grounded terminal (Earth).
Environmental Specifications Temperature Operating: 15 to 40 degrees C Storage: -20 to 70 degrees C Humidity Operating: 15% to 95% @ 40 degrees C non-condensing Storage: 90% @ 65 degrees C Note: These are maximums and should not be considered 'normal' operating or storage environments. Condensation Recovery Time after condensation to operational specification: 24 Hours Flammability UL94 V-0 Electrical Standards Safety: IEC 60601-1 Ed. 3.0 b:2005 Collateral Standard: IEC 60601-1-2 Ed 3.
EMC Guidance and Manufacturer’s Specifications Electromagnetic Emissions The REF 29400 Series OAE Hearing Screener is intended for use in the electromagnetic environment specified below. The customer or user of the REF 29400 Series OAE Hearing Screener should assure that it is used in such an environment.
Electromagnetic Immunity The REF 29400 Series OAE Hearing Screener is intended for use in the electromagnetic environment specified below. The customer or user of the REF 29400 Series OAE Hearing Screener should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete, or ceramic tile.
Electromagnetic Immunity The REF 29400 Series OAE Hearing Screener is intended for use in the electromagnetic environment specified below. The customer or user of the REF 29400 Series OAE Hearing Screener should assure that it is used in such an environment.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the REF 29400 Series OAE Hearing Screener The REF 29400 Series OAE Hearing Screener is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
• Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas and dusty, saline or sulfuric air. • Verify the selected site maintains a relative humidity between 25% and 95% (without condensation). • Verify all conditions meet the requirements listed in the Environmental Specifications section of this manual. Room Topography Place all equipment on an even, level surface.
Installation Verification Use the following list to verify all equipment is correctly installed before use. • Verify all equipment and cables are undamaged and in perfect working condition. • Verify all equipment and cables are connected according to the instructions in this manual. • Verify unauthorized equipment is not connected to the system. • Verify the equipment is properly grounded. • Verify all circuitry with a direct connection to the patient has been checked twice.
Index Instructional Videos .................................. 15 A L Abbreviations .......................................... 6, 7 ASCII Link ...................................................41 Auto OFF ....................................................10 Label Printer ............................................. 34 Load .......................................................... 38 B P Battery .......................................................10 Buttons .......................................
