Welch Allyn REF 29400 Directions For Use Manual
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Welch Allyn REF 29400 Directions For Use Manual

Welch Allyn REF 29400 Directions For Use Manual

Oae hearing screener
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OAE Hearing Screener
Directions for Use
REF 29400

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Summary of Contents for Welch Allyn REF 29400

  • Page 1 OAE Hearing Screener Directions for Use REF 29400...
  • Page 2 COPYRIGHT © 2009 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.
  • Page 3 Distributed by Welch Allyn under agreement with Natus Medical Incorporated PROPERTY OF NATUS MEDICAL INCORPORATED ALL RIGHTS RESERVED U.S. Patents nos. 5,738,633 and 6,149,605 Bio-logic is a registered trademark of Natus Medical Incorporated IBM is a registered trademark of the International Business Machines Corporation Microsoft, Windows, is a registered trademark of Microsoft Corporation Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...

  • Page 4: Table Of Contents

    Chapter 1: Introduction ... 4 About this manual ... 4 Chapter 2: Welch Allyn OAE Hearing Screener Components and Hardware Setup... 7 Cable Connections ... 7 Battery ... 9 Chapter 3: Environment and Patient Preparation ... 10 Patient Preparation... 10 Patient Instructions...

  • Page 5: Chapter 1: Introduction

    Chapter 1: Introduction The Welch Allyn OAE Hearing Screener measurement system 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.
  • Page 6 Abbreviations ART LVL - artifact level; refers to the threshold at which samples of data coming into the Welch Allyn OAE Hearing Screener for processing are rejected before averaging in order to keep noise from averaging into the response. Artifact level is reported in pressure units, milliPascals (mPa). WA OAE Load Software - loads the firmware that resides on the memory chip inside the Welch Allyn OAE Hearing Screener.
  • Page 7 L1 - level or intensity of F1; the lower of the stimulus frequencies expressed in dB SPL. L2 - level or intensity of F2; the higher of the stimulus frequencies expressed in dB SPL. NF - noise floor; refers to the average amplitude of the background noise measured at frequencies surrounding the DP frequency during the DPOAE test.

  • Page 8: Chapter 2: Welch Allyn Oae Hearing Screener Components And Hardware Setup

    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.
  • Page 9 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.

  • Page 10: Battery

    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.

  • Page 11: Chapter 3: Environment And Patient Preparation

    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.

  • Page 12: Patient Instructions

    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.

  • Page 13: Chapter 4: Care And Maintenance Of The Probe

    Chapter 4: Care and Maintenance of the Probe Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...

  • Page 14: Chapter 5: Quick Guides And Instructional Videos

    Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...

  • Page 15: Chapter 5: Quick Guides And Instructional Videos

    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. •...
  • Page 16 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...
  • Page 17 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...
  • Page 18 Quick Guide: Causes of ‘Refer” Troubleshooting Quick Guide: Causes of Refer Results Problem Noisy surroundings ♦ — Other people in or near test site. — Devices such as fans, air conditioners, intercoms, and public address systems. Patient noise ♦ — Crying or struggling against the probe —...
  • Page 19 Problem Cerumen, vernix, or other debris ♦ — In the ear — On the probe tip — On the probe Temporary collapse of the ear canal ♦ — Occurs often with "down ear" when infant is lying on side. — Collapse is normal because bones haven't formed in ear yet.

  • Page 20: Chapter 6: Welch Allyn Oae Hearing Screener Clinical Competency Evaluation And Result Letters

    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.
  • Page 21 Welch Allyn OAE 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. TASK 1) Properly plugs in equipment 2) Properly turns on equipment...
  • Page 22 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.
  • Page 23 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.

  • Page 24: Chapter 7: System Operation

    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.

  • Page 25: Program Flow Chart

    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.

  • Page 26: Chapter 8: Distortion Product Otoacoustic Emissions

    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.
  • Page 27 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.

  • Page 28: Viewing Dpoae Test Details Or Retesting An Ear With A Refer Result Immediately After A Test

    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 DX SELECT X KHZ DP...

  • Page 29: Printing Dpoae Test Details Immediately After A Test

    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” self- adhesive label showing the test details immediately after it is performed or to print it out later by retrieving it from memory.

  • Page 30: Viewing Previously Collected Dpoae Data

    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 VIEW DPOAE RESULTS...

  • Page 31: Chapter 9: Printing Previously Collected Data - Single Ear

    Chapter 9: Printing Previously Collected Data – Single 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.
  • Page 32 displayed will be the last test performed. When the desired test numbers have been chosen, press the DX SELECT button to print out a label for that particular patient. 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.

  • Page 33: Chapter 10: Printing Previously Collected Data - Both Ears On One Label

    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. DX SELECT NO RESULTS FOR Database does not...

  • Page 34: Chapter 11: Printer

    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.

  • Page 35: Ordering Labels

    Ordering Labels To order labels call Welch Allyn at 1-800-535-6663. Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E...

  • Page 36: Chapter 12: System Default Protocol

    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.

  • Page 37: Dpoae Measurement-Based Stopping Rules Per Test

    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.

  • Page 38: Chapter 13: Reloading Wa Oae Firmware (Wa Oae Load Software)

    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.
  • Page 39 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 Install WA OAE Load button. 6.
  • Page 40 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 1- 800-535-6663. The table below provides more details about the various buttons and options on the WA OAE Load application screen.

  • Page 41: Chapter 14: Exporting Using Ascii Link

    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.

  • Page 42: Chapter 15: Troubleshooting, Service And Warranty

    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 This message appears when the battery charge is completely depleted. The message will flash for 10 seconds after which the unit will power off.
  • Page 43 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...

  • Page 44: Service

    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.

  • Page 45: Appendix A

    Appendix A Precautions and Safety Instructions 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 Identification Labels and Markings Classification...

  • Page 46: Electrical Installation Requirements

    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).

  • Page 47: Environmental Specifications

    UL94 HB EMC Guidance and Manufacturer’s Specifications 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.
  • Page 48 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...
  • Page 49 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the REF 29400 Series OAE Hearing Screener is used exceeds the applicable RF compliance level above, the OAE Hearing Screener should be observed to verify normal operation.
  • Page 50 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. The customer or user of the REF...

  • Page 51: Installation Precautions

    Installation Precautions Observe the following precautions when using the Welch Allyn OAE Hearing Screener and related equipment. Environmental Conditions Select a room with properly grounded power sources (when using in AC-powered • configuration). Do not use or store the Welch Allyn OAE Hearing Screener and equipment in •...

  • Page 52: System Hookups

    System Hookups Only use the Battery Charger Power Supply Models Verify the maximum load for any multiple portable socket-outlet (if used) does not • exceed 750 VA. Do NOT place any multiple portable socket-outlets (if used) on the floor. • If multiple portable socket-outlets are used, DO NOT use the multiple socket-outlets •...

  • Page 53: Installation Verification

    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 •...
  • Page 54 Abbreviations ...5, 6 ASCII Link ...40 AuDX Buttons ...23 AuDX Load...37 Auto OFF ...9 Battery ...9 Changing the Default Protocol to Continue through All Frequencies ...36 Charger Unit ...8 Clinical Competency Evaluation ...19, 20 Communication Cable ...9 Default Protocols ...35 DPOAE Protocol ...35 Environmental Specifications...46 Equipment Identification Labels and Markings .44...

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