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Summary of Contents for Welch Allyn 39500
- Page 1 ® Welch Allyn OAE Hearing Screener Directions for use...
- Page 2 © 2018 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn.
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Page 3: Table Of Contents
Contents Symbols and indicators ................1 About warnings and cautions ..............3 Warnings and cautions ..................3 Introduction ..................... 7 OAE functionality ....................8 Distortion product otoacoustic emissions ............9 Transient evoked otoacoustic emissions ............. 9 Frequency Range tested ..................9 Results storage and reporting ................ - Page 4 ® iv Contents Welch Allyn OAE Hearing Screener Test results ..................... 27 Test phase ......................27 Graph styles ....................... 27 Test techniques ....................29 Noise sources ....................29 View results ....................... 30 Manage results ..................31 Results storage and reporting ................31 Save/Store test results mode ................
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Page 5: Symbols And Indicators
Consult directions for use (DFU). Representative, special disposal A copy of the DFU is available on required this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. Reorder number Single use, do not reuse... - Page 6 ® 2 Symbols and indicators Welch Allyn OAE Hearing Screener Symbol Description Symbol Description Regulatory Product Identifier Not made with natural rubber (RPI) number latex Global Trade Item Number Direct current (DC) Federal Communications Non-ionizing electromagnetic Commission mark radiation UL Testing Services, Inc., with...
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Page 7: About Warnings And Cautions
About warnings and cautions Warning and caution statements can appear on the Welch Allyn OAE screener (screener), on the packaging, on the shipping container, or in this directions for use. The screener is safe for patients and clinicians when used in accordance with the instructions and the warning and caution statements presented in this directions for use. - Page 8 WARNING Safety hazard. This screener contains a rechargeable lithium- ion battery. The battery is not user-replaceable and must be returned to an authorized Welch Allyn service location for repair. WARNING Fire and explosion hazard. Do not operate the screener in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide;...
- Page 9 Directions for use About warnings and cautions 5 CAUTION Do not open the case of the screener. Only Welch Allyn service personnel or an authorized repair center are authorized to perform warranty service. Performing unauthorized service on a screener that is within warranty may void the warranty.
- Page 10 ® 6 About warnings and cautions Welch Allyn OAE Hearing Screener...
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Page 11: Introduction
Introduction This directions for use describes the capabilities and operation of the Welch Allyn OAE Screener. The purpose of the screener is to provide rapid screening of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies. -
Page 12: Oae Functionality
® 8 Introduction Welch Allyn OAE Hearing Screener OAE functionality Item number Description Probe connector Test status indicators Charge status indicator Control panel Micro-USB Connector Display The system consists of the screener, probe, printer, single-use eartips, replaceable probe tubes, and other accessories. The screener contains the hardware and software for generating the test stimuli, measuring and displaying the OAEs, and storing the results until they are printed. -
Page 13: Distortion Product Otoacoustic Emissions
Directions for use Introduction 9 Distortion product otoacoustic emissions Distortion product otoacoustic emissions (DPOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at the frequency 2f1-f2. - Page 14 ® 10 Introduction Welch Allyn OAE Hearing Screener...
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Page 15: Setup
Calibration Certificate OAE Hearing Screen software CD includes: Quick Start Guide, Data Manager software DFU, and Data Manager software If any part is missing, contact Welch Allyn Technical Support: www.welchallyn.com/ about/company/locations.htm. We recommend that you save the shipping box and... -
Page 16: Cradle
You can place the screener in the cradle to charge the device or to connect to a computer for communication with the Welch Allyn Data Manager (data manager). You can also charge the device or connect to a computer directly from the screener. The remainder of this directions for use assumes that you are charging the device or communicating with a computer from the screener. -
Page 17: Install The Probe
Directions for use Setup 13 • Fast blink: a fault condition. Return the screener to Welch Allyn for service or repair. For information about returning any device to Welch Allyn, see "Repairs" and "Returning products." When you use the screener, you are warned that the battery charge is low by two fast blinks followed by a pause and then two fast blinks. -
Page 18: Attach The Probe Tube
® 14 Setup Welch Allyn OAE Hearing Screener Attach the probe tube A clear probe tube must be attached to the probe head before an eartip is applied. 1. Insert a new probe tube into the probe head until it is fully seated. -
Page 19: Probe Holder
Placing the probe into the probe holder protects the probe head. Welch Allyn recommends that you insert the probe into the probe holder when the screener is not in use, such as when it is on a counter top or table, or when... -
Page 20: Clock Settings
® 16 Setup Welch Allyn OAE Hearing Screener Attach the probe holder 1. Place the probe holder near the end of the probe cable at the HDMI connector end. 2. Gently press the probe cable into the probe holder close to the point of the probe head. - Page 21 Directions for use Setup 17 Change the clock mode The Clock Mode menu enables you to change the clock from a 24 hour mode to a 12 hour mode. 1. See "Access menus" for how to access menus. 2. On the control panel, press the DOWN button to advance to the CLOCK MODE menu.
- Page 22 ® 18 Setup Welch Allyn OAE Hearing Screener...
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Page 23: Device Overview
Device overview Control panel The screener uses four (4) buttons to control all functions. The arrows on the keypad (LEFT, RIGHT, UP, and DOWN) correspond to the arrows on the screen. Push the button that corresponds to the highlighted arrow on the screen in order to move through tasks. Note The UP key always brings the screener back to either the previous menu or the main menu. -
Page 24: Device Settings
® 20 Device overview Welch Allyn OAE Hearing Screener When you release the down button, the WIRELESS DEVICE screen appears and the menus are accessible. 5. Press the down control panel button to advance to other device settings. Device settings The screener menus enable you to change many of the screener settings or functions. -
Page 25: Clear Test Results
Directions for use Device overview 21 The message "Add a device" appears on the computer. 5. Select this notice, and then enter PIN 1234. 6. The first time the data manager software is launched, select Detect Com Port to finalize the screener and computer connection. 7. -
Page 26: Minimum Amplitude
® 22 Device overview Welch Allyn OAE Hearing Screener Minimum amplitude The Minimum Amplitude setting enables you to set the screening device to include minimum amplitude values in the PASS/REFER criterion. The minimum Distortion Product (DP) OAE amplitude is –5 dB SPL. The minimum Transient Evoked (TE) OAE amplitude selections are –5 dB or –10 dB SPL. -
Page 27: Operating Instructions
Operating instructions Turn on the screener Press the DOWN control panel button located below the display screen. A yellow TEST light appears briefly above the display. The green READY light remains constant, indicating that the screener is ready to use. A Flash Screen appears briefly, displaying the software version, serial number, calibration date, and type of instrument, such as SCR Screener with DP or TE. -
Page 28: Main Menu
® 24 Operating instructions Welch Allyn OAE Hearing Screener 3. Press either the LEFT or RIGHT control panel button to change to the desired interval. 4. Press the UP control panel button repeatedly to return to the MAIN menu. Main menu The main menu has seven regions. -
Page 29: Select The Test Protocol
Directions for use Operating instructions 25 Select the test protocol The DPOAE screener provides two (2) protocol options: DP 4s testing at a maximum time of 4 seconds per frequency and DP 2s testing at a maximum time of 2 seconds per frequency. - Page 30 ® 26 Operating instructions Welch Allyn OAE Hearing Screener Ear canal volume Explanation Blue The ear canal volume is too large for the test to begin. The probe is not in the ear or there is a large leak. Green The ear canal volume is in the target range for testing.
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Page 31: Test Results
Test results Test phase The screener automatically performs a calibration at the start of each test. During calibration a series of tones are sent to the ear canal to calibrate the levels of the frequencies to be tested. Following calibration of the test tones, the test phase begins automatically. - Page 32 ® 28 Test results Welch Allyn OAE Hearing Screener Value graph view The value graph view uses different colors and symbols to differentiate the DP test frequency or TE frequency band for the left and right ear tests: • Left ear: Dark blue line with “x” symbols indicate the DP test frequencies or TE frequency bands.
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Page 33: Test Techniques
Directions for use Test results 29 Test techniques As with other OAE test instruments, there are techniques to learn when using the screener, especially when screening infants. Experience with existing OAE systems suggests that it may take up to three (3) months to become completely proficient in screening infants. -
Page 34: View Results
See “Manage test results” for more information on managing results and how to print or transfer those results to the Welch Allyn Data Manager. See “Save results” for more information on the screener save mode options. Repeat an inconclusive test A conclusive test has a PASS or REFER result. -
Page 35: Manage Results
This allows you to retest a patient after a REFER result and to print or transfer only the most recent test result for each ear. Welch Allyn recommends that you print the results after each patient when using the default mode. SAVE 250 mode When operating in the SAVE 250 mode, the screener can save up to 250 tests. - Page 36 OAE Hearing Screener • When not used with the Welch Allyn Data Manager (data manager), the screener automatically numbers each test from 1 to 250. When using the SAVE 250 test mode for numbered tests, keep a record of the test number for each patient in order to synchronize the numbered test with the correct patient.
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Page 37: Delete Test Results
Directions for use Manage results 33 Delete test results The screener holds data in non-volatile memory. The data stays in the memory even after data is printed on the thermal printer or downloaded to the data manager. The save mode determines how data is deleted. Delete results in SAVE L/R mode The most recent test for the left ear and the most recent test for the right ear are held in memory. -
Page 38: Connect The Screener Cradle To A Computer
USB-B port. Use the micro-USB port on the bottom of the screener for both data transfer and recharging. Connect the screener to a computer using wireless 1. Welch Allyn OAE ScreenerDFU1.0Power on the screener and ensure that the screener is charged. 2. Power on the computer, and then launch the data manager. -
Page 39: Print To A Thermal Printer
Directions for use Manage results 35 4. When the correct computer appears on the screen, press the DOWN control panel button to pair the screener and computer. The message "Add a device" appears on the computer. 5. Select this notice, and then enter PIN 1234. 6. - Page 40 ® 36 Manage results Welch Allyn OAE Hearing Screener...
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Page 41: Understand Printed Results
Understand printed results DPOAE printout The following information is provided for each test: • The time and date of the test, based on the setting of the internal clock; if the clock is set correctly, this time and date will be correct •... -
Page 42: Rounding Results
® 38 Understand printed results Welch Allyn OAE Hearing Screener • The noise floor (NF) in dB SPL • The emission level (TE) in dB SPL • The signal-to-noise ratio (SNR)—DP level minus the NF—in dB • The Value or SNR graph as selected on the screener •... -
Page 43: Maintenance
Welch Allyn. Failure to do so may cause infection. The screener requires no regular maintenance beyond routine cleaning and annual calibration. -
Page 44: Calibrate The Screener
® 40 Maintenance Welch Allyn OAE Hearing Screener CAUTION Do not put excessive pressure on the clear display window or allow any utensil to puncture the display window or control panel. Putting excessive pressure on the clear display window or puncturing the display window or control panel with any utensil may affect the stability of the device. -
Page 45: Repairs
Qualified service personnel or a Welch Allyn Service Center should repair products out of warranty. If you are advised to return a product to Welch Allyn for repair or routine maintenance, schedule the repair with the service center nearest you. - Page 46 ® 42 Maintenance Welch Allyn OAE Hearing Screener...
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Page 47: Troubleshooting
Check that the instrument will start in your own ear using the proper eartip for your ear. If the test will not start or if the AutoStart tones sound unusual, replace the probe tube. • If the problem persists across several patients, contact Welch Allyn Technical Support: www.welchallyn.com/about/company/locations.htm. The results will not print •... - Page 48 Wireless Not • Printing has been attempted, but no wireless device is paired with the Welch Allyn OAE Configured Screener. Establish wireless pairing. Device Not Responding • The printer is not responding to queries from the instrument. Check printer status.
- Page 49 Troubleshooting 45 Message Solutions • If the problem persists across several patients, contact Welch Allyn Technical Support: www.welchallyn.com/about/company/locations.htm. Fit Error Too Low • The level of the calibration tone is too low. User should refit the probe and retry the test.
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Page 50: Status/Error Messages
® 46 Troubleshooting Welch Allyn OAE Hearing Screener Status/Error messages Display messages Message Definition Attach Probe No probe is detected at the start of a test. Device not Responding The printer is not responding to queries from the instrument. Wireless Device Not Found The paired wireless device cannot be detected by the screener. -
Page 51: Standards And Compliance
Standards and compliance General compliance and standards The Welch Allyn OAE screener complies with the following standards: Standard Issue Date Title ANSI/ASA 3.6 2010 Specification for Audiometers IEC 60601-1 2005 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance, Ed. -
Page 52: Emc Compliance
Electromagnetic emissions The Welch Allyn® OAE Hearing Screeneris intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn® OAE Hearing Screenershould assure that it is used in such an environment. Emissions test Compliance... - Page 53 Electromagnetic immunity The Welch Allyn® OAE Hearing Screeneris intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn® OAE Hearing Screenershould assure that it is used in such an environment. Immunity test...
- Page 54 Electromagnetic immunity The Welch Allyn® OAE Hearing Screeneris intended for use in the electromagnetic environment specified below. The customer or the user of the Welch Allyn® OAE Hearing Screenershould assure that it is used in such an environment. Immunity test...
- Page 55 Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn® OAE Hearing Screener equipment (transmitters) and the Welch Allyn® OAE Hearing Screeneras recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m)
- Page 56 ® 52 Standards and compliance Welch Allyn OAE Hearing Screener...
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Page 57: Warranty
Warranty Welch Allyn warrants that this product is free from defects in material and workmanship and, when properly installed and used, will perform in accordance with applicable specifications. If within one year after original shipment, it is found not to meet this standard;... - Page 58 ® 54 Warranty Welch Allyn OAE Hearing Screener...
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Page 59: Appendices
Appendices Appendix A: Specifications Probe specifications Item Specification Measurement type Distortion Product Otoacoustic Emissions (DPOAE) Transient Evoked Otoacoustic Emissions (TEOAE) Frequency range DPOAE: 2.0 to 5.0 kHz TEOAE: 1.5 to 4.0 kHz Stimulus intensity DPOAE: 40 to 70 dB SPL TEOAE: 80 dB SPL peak equivalent (±3 dB) Microphone system noise •... - Page 60 ® 56 Appendices Welch Allyn OAE Hearing Screener Item Specification • 4-button keypad to control instrument functions Connectors/Communications • Integrated USB communication capability for battery charging and communication with PC-based database programs or an optional PC printer • HDMI Connector for connection to the Probe •...
- Page 61 Directions for use Appendices 57 Category Feature Implementation Antenna Internal, chip antenna Max. gain 0.5dBi Environmental Operating temperature -40 °C to +85 °C Operating voltage 2.7V to 3.6V Approvals FCC/IC/CE/MIC/KC/TRA Qualified This device is a 2.4 GHz wideband transmission system (transceiver), intended for use in all EU member states and EFTA countries, except in France and Italy where restrictive use applies.
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Page 62: Appendix B: Flowchart - Measurement
® 58 Appendices Welch Allyn OAE Hearing Screener Appendix B: Flowchart – Measurement... -
Page 63: Appendix C: Test Sequence
Directions for use Appendices 59 Appendix C: Test sequence A complete test sequence consists of the following phases: • AutoStart • Calibration • Test AutoStart phase The AutoStart phase determines when the calibration phase should proceed. Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts. - Page 64 ® 60 Appendices Welch Allyn OAE Hearing Screener frequency bands is obtained in real time and displayed once per second. The average peak pressure of the stimulus is calculated after completion of the test. Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts by the use of an adaptive rejection threshold.
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Page 65: Appendix D: Pass/Refer Criteria
SNR value for a PASS with the two methods would be quite similar. The Welch Allyn OAE screener uses a patented noise-rejection algorithm that permits accurate DPOAE and TEOAE measurements in background noise and babble as high as 55 to 65 dB SPL (A-weighted). Briefly explained, use of available memory in the OAE... - Page 66 ® 62 Appendices Welch Allyn OAE Hearing Screener whose retention would improve the overall accuracy. Those samples are included in the final analysis; the noisier samples are rejected. The improved operation in noise with the new algorithm was so substantial that a complete replica of the original validation tests in "fully impaired ear"...
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Page 67: Appendix E: Configurations And Test Protocols
Directions for use Appendices 63 Appendix E: Configurations and test protocols DPOAE screener The protocols included are DP 4s (default) and DP 2s. Note Protocol # of F2 Frequency L1/L2 Averaging Time Pass # Passing Name Frequencies (max) Frequency for Test Pass DP 4s 2.0, 3.0, 4.0, 5.0... -
Page 68: Appendix F: Approved Accessories
® 64 Appendices Welch Allyn OAE Hearing Screener Appendix F: Approved accessories The following table lists approved accessories for 39500, 39500-NP, 39500-TE and 35900-NP-TE. Part Number Description 39402 OAE HEARING SCREENER PROBE ASSEMBLY 39405 OAE HEARING SCREENER POWER SUPPLY 39410... - Page 69 Directions for use Appendices 65 particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: •...
- Page 70 ® 66 Appendices Welch Allyn OAE Hearing Screener German Hiermit erklärt Grason-Stadler, dass dieser Niedrigleistungssender den grundlegenden Anforderungen und anderen relevanten Bestimmungen der Richtlinie 2014/53/EG entspricht Greek Με αυτό τον τρόπο, η Grason-Stadler δηλώνει ότι αυτός ο πομπός χαμηλής ισχύος είναι...
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Questions and answers
While using the WelchAllyn hearing screener it would not make it past the probe check part. The white bar would either be in the blue (start line) or orange line, it never went green. It continued to jump back and forth. I attempted this on multiple people and it continued to not make it past the probe section. How do I fix this?
To fix the probe check issue on the Welch Allyn 39500 hearing screener, follow these steps:
1. Select a different sized eartip to ensure a proper fit.
2. Reposition the probe in the ear to achieve a better seal.
3. Secure the probe cable using the shirt clip.
4. Change the probe tube if needed.
5. Verify the eartip seal during the probe check in AUTOSTART mode.
6. Test the instrument on your own ear with the correct eartip to confirm functionality.
7. Replace the probe tube if the AutoStart tones sound unusual.
8. If the problem persists across multiple patients, contact Welch Allyn Technical Support.
These steps help ensure proper probe function and accurate hearing screening results.
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