Welch Allyn® OAE Hearing Screener Directions for use
© 2014 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. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
iii Contents Symbols ................................................................................................... 1 About warnings and cautions ................................................................ 3 Warnings and cautions ......................................................................................... 3 Customer responsibility ....................................................................................... 4 Safety precautions .............................................
iv Contents Welch Allyn® OAE Hearing Screener Start a test ......................................................................................................... 29 AutoStart probe check ....................................................................................... 29 Test results ............................................................................................. 31 Test phase .........................................................................................................
1 Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. CAUTION The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. This definition applies to both yellow and black and white symbols.
2 Welch Allyn® OAE Hearing Screener Symbols Symbol Description Symbol Description Regulatory Product Identifier (RPI) number Not made with natural latex rubber Global Trade Item Number Consult Operating Instructions
3 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.
4 Welch Allyn® OAE Hearing Screener About warnings and cautions Customer responsibility WARNING The screener and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this directions for use, accompanying labels, and inserts. A defective product should not be used. Make sure all connections to external accessories are tight and secured properly.
Directions for use About warnings and cautions 5 WARNING 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; in oxygen-enriched environments; or in any other potentially explosive environment.
6 Welch Allyn® OAE Hearing Screener About warnings and cautions 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. BT Device Not Found. The paired Bluetooth® device cannot be detected by the screener. The screener may be turned off or too far away. BT Error #xxx. There is an error condition with the Bluetooth® device. Check the status.
Directions for use About warnings and cautions 7 Indicator lights (LEDs) Message Definition NOISE/Orange The indicator labeled ‘NOISE’ displays an amber light when the noise level measured during the test exceeds a nominal threshold. It also is used to indicate some error conditions and when the outcome of test is REFER, NOISY, or NO SEAL. TEST/Yellow The indicator labeled ‘TEST’ displays a yellow light when the selected test is being performed.
8 About warnings and cautions Welch Allyn® OAE Hearing Screener
9 Introduction Introduction This directions for use describes the capabilities and operation of the Welch Allyn OAE Screener (screener). The purpose of the screener is to provide rapid screening of Distortion Product Otoacoustic Emissions (DPOAEs) at several frequencies. The screener is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). This device is suitable for use in all settings, including hospitals, schools, and physicians' offices.
Welch Allyn® OAE Hearing Screener 10 Introduction OAE functionality Item number Description 1 Probe connector 2 Test status indicators 3 Charge status indicator 4 Control panel 5 Micro-USB Connector 6 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.
Directions for use Introduction 11 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.
12 Introduction Welch Allyn® OAE Hearing Screener
13 Setup Unpack the system The following parts are shipped standard with each screener system: Number of items Description 1 Welch Allyn OAE Screener Unit 1 Welch Allyn OAE Screener Probe 1 Welch Allyn OAE Screener Data Manager Kit 1 OAE Screener Cradle 1 Single Use Eartip Kit 1 Communications Cable, USB A/Micro-B 1 Charging Cable, PSU 5V/Micro-B 1 Welch Allyn OAE Screener User Manual 1 Welch Allyn OAE Screener Data Manager Kit 1 Welch Allyn OAE Screener Quick Reference Guide 1 Calib
Welch Allyn® OAE Hearing Screener 14 Setup Cradle NOISE TEST READY 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.
Directions for use Setup • 15 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. This sequence is repeated until you place the battery in the charge mode.
Welch Allyn® OAE Hearing Screener 16 Setup 1. Insert a new probe tube into the probe head until it is fully seated. A properly inserted probe tube snaps securely into place when it is fully seated in the probe head. 2. To remove a probe tube, grasp the tube and pull gently away from the probe head with a slight twist. It is not necessary to replace the probe tube with each eartip; the tube is reusable as long as the probe tube is clear.
Directions for use Setup 17 1. Select the appropriate-sized eartip. 2. Push and slightly twist the eartip onto the probe tube. Ensure that the eartip is fully seated on the probe. There should be no gaps between the eartip and the collar of the probe head. 3. To remove the eartip, grasp the probe tube gently at the base and slightly twist it while pulling the eartip off of the probe tube.
18 Welch Allyn® OAE Hearing Screener Setup Clock settings Set the date and time before using the screener. The clock should be set prior to testing because changing the date and time after tests are saved will not change the date on the printout. Seasonal time changes, such as Daylight Saving Time, also require resetting the clock.
Directions for use Setup 19 3. Press either the LEFT or RIGHT control panel button to change from the 12 to 24 hour mode or from the 24 to 12 hour mode. 4. Press the UP control panel button repeatedly to return to the MAIN menu. Change the date and time 1. If the date and time are correct, press the UP control panel button to return to the main menu. If either the date or time are not correct, go to Step 2. 2.
20 Setup Welch Allyn® OAE Hearing Screener
21 Device settings Control panel Note The UP key always brings the screener back to either the previous menu or the main menu. The UP key will also access the print command from the Main menu. The screener uses four (4) buttons to control all functions. These buttons are arranged in a clock face configuration, with arrows at 12:00, 3:00, 6:00, and 9:00. The arrows on the keypad (LEFT, RIGHT, UP, and DOWN) correspond to the arrows that are used on the screen.
Welch Allyn® OAE Hearing Screener 22 Device settings The Clock menu appears with the current date and time. 3. While viewing the CLOCK menu, press the down control panel button on the control panel until the green LED READY light on the screener turns off. 4. Release the down control panel button. When you release the down button, the New BT Device screen appears and the menus are accessible. 5. Press the down control panel button to advance to other device settings.
Directions for use Device settings 23 Bluetooth® device pairing The Bluetooth pairing menu enables you to pair the screener with a Bluetooth device, such as a thermal printer or computer, for printing test results and data transfer. However, you can only pair one device with the screener at any given time. Pair the screener and Bluetooth device Note When pairing to a computer for use with the data manager, confirm the computer has Bluetooth availability or a Bluetooth dongle will be required.
24 Welch Allyn® OAE Hearing Screener Device settings Clear test results The Test Results menu enables you to clear the test results stored in the screener without printing them. 1. See "Access menus" for how to access menus. 2. Press the DOWN control panel button to advance to the TEST RESULTS menu. 3. Press the LEFT or RIGHT control panel button to clear the results. 4. Press the LEFT or RIGHT control panel button to select Yes or No to clear the results. 5.
Directions for use Device settings 25 4. Press the UP control panel button repeatedly to return to the MAIN menu. Reset to default The RESET TO DEFAULT menu returns all screener settings to its original factory defaults. Reset to default settings 1. See "Access menus" for how to access menus. 2. Press the DOWN control panel button and advance to the RESET TO DEFAULT menu. 3. Press the LEFT or RIGHT control panel button. 4.
26 Device settings Welch Allyn® OAE Hearing Screener
27 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.
28 Welch Allyn® OAE Hearing Screener Operating instructions 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 six regions.
Directions for use Operating instructions 29 Select the test protocol The OAE 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. The last protocol that was used is shown on the Main menu. 1. Press the LEFT or RIGHT control panel button on the Main menu. The Change Protocol menu appears. 2. Press the LEFT or RIGHT contorl panel button to select the desired protocol. 3.
Welch Allyn® OAE Hearing Screener 30 Operating instructions 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. The test will begin automatically if the probe fit is stable. Orange The ear canal volume is too small for the test begin. The eartip may be pressed against the ear canal wall or the probe tube may be completely clogged.
31 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. Note Press the UP control panel button to abort a test in progress. No record of an aborted test is saved in memory. Graph styles The results of a test are displayed as a graph.
Welch Allyn® OAE Hearing Screener 32 Test results Value graph view The value graph view uses different colors and symbols to differentiate the DP test frequency for the left and right ear tests: • Left ear: Dark blue line with “x” symbols indicate the DP test frequencies. • Right ear: Red line with circles indicate the DP test frequencies. On both the left and right ear value graphs, inverted triangles on a light blue line represent the NF at each DP test frequency.
Directions for use Test results 33 1. Use a pacifier to calm the infant; however, sucking adds noise to the test and decreases the likelihood of a PASS result. 2. Press either the LEFT or RIGHT control panel button to select which ear is tested. 3. Pull gently down and back on the pinna to straighten the ear canal. 4. Gently insert the eartip into the ear canal. It should fit snuggly and comfortably. 5. Repeat steps 2–4 to test the opposite ear.
Welch Allyn® OAE Hearing Screener 34 Test results The possible test results are: • PASS: The ear tested passed screening. • REFER: The ear tested did not pass screening. • NOISY: Excessive noise was present during the test. • NO SEAL: A seal was not maintained throughout the test. • FIT ERR: Inadequate probe placement in the ear canal to produce target stimulus intensities.
35 Manage results Results storage and reporting When the screener is set in its default settings, the instrument stores the results from one patient (left and right ears) in its non-volatile memory for subsequent printing. The screener is capable of storing up to 250 test results. The results are displayed on the LCD on the front of the device and are stored in the device’s internal memory. After testing is complete, results can be printed using the printer or exported to a computer.
Welch Allyn® OAE Hearing Screener 36 Manage results • 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. • When used with the data manager, the data manager transfers patient names to the screener and the screener displays the names.
Directions for use Manage results 37 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 is held in memory. Data is deleted when a new test for the left or right ear is completed. 1.
Welch Allyn® OAE Hearing Screener 38 Manage results 5. Begin data or name transfers. Connect the screener cradle to a computer Use a standard USB to micro-USB cable to connect the screener cradle to a computer: 1. Power on the screener and ensure that the screener is charged. 2. Plug the micro-USB connector into the port on the bottom of the screener cradle. The cradle does not need to be connected to a mains outlet for data transfer. 3. Plug the USB connector into a USB port on the computer. 4.
Directions for use Manage results 39 6. The first time the data manager software is launched, select Detect Com Port to finalize the screener and computer connection. 7. To cancel the pairing process, press the CANCEL control panel button. The screener returns to the Main menu. Print to a thermal printer You must have an optional Bluetooth-enabled thermal printer to print from the screener. See “Pair the screener and Bluetooth device” for directions.
40 Manage results Welch Allyn® OAE Hearing Screener
41 Understand printed results DPOE 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 • The test number (if operating in SAVE 250 mode) • The protocol selected (for example, DP 2S) • The averaging time used for this test (for example, 2 sec avg) • Instrument/Probe serial number (SN) • The software version number (for example, V101.
42 Understand printed results Welch Allyn® OAE Hearing Screener
43 Clean and disinfect Clean and disinfect WARNING Eartips are for single patient use only. WARNING Use a new eartip for each patient. External parts of the screener and probe can be cleaned to remove visible particulate contamination. CAUTION Do not insert any object into probe. CAUTION Do not immerse the instrument or probe in fluids or attempt to sterilize the instrument or any of its accessories. CAUTION Do not allow any fluid to enter the device. CAUTION Do not use autoclave sterilization.
44 Clean and disinfect Welch Allyn® OAE Hearing Screener probe can be cleaned to remove visible particulate contamination. Wiping the housing and probe exterior with a mild non-alcohol based disinfecting solution, using a clean cloth or towel, provides a suitable form of cleaning and low-level disinfecting. Perform this process weekly, or as often as conditions warrant, to prevent a build-up of dirt from normal handling and use.
45 Maintenance General maintenance CAUTION A defective screener should not be used. Confirm that all connections to external accessories are seated and secured properly. Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from Welch Allyn. The screener requires no regular maintenance beyond routine cleaning and annual calibration. Replace the probe tube if it becomes clogged.
46 Welch Allyn® OAE Hearing Screener Maintenance Troubleshooting Problem Solutions Instrument does not turn on • • • The test will not start The results will not print Press the DOWN arrow until the Yellow LED light appears. Connect the charger. Confirm that blue "Charging" LED is illuminating in a slow blink pattern. Wait at least 10 minutes and then attempt to turn on the screener If the problem persists, contact Welch Allyn Technical Support: www.welchallyn.com/about/company/locations.htm.
Directions for use Maintenance 47 Message Solutions • BT Device Not Found • Cycle instrument power. Paired to Printer: Check that the printer is turned on. Move closer to the printer. Try again. Paired to PC Computer or Bluetooth dongle: ○ Check that the serial port is open. Establishing the serial port is handled by the PC and/or the software, not by the Welch Allyn OAE Screener. ○ ○ ○ • BT Error #xxx • • • Check BT device (printer or PC) status. Attempt to connect to BT device again.
Welch Allyn® OAE Hearing Screener 48 Maintenance Message Solutions Power Low! • The battery charge level is too low for operation. Charge the battery in order to perform additional tests. Printer Error • • • Indicates a problem with the printer. Check the printer status. Reset the printer or cycle the printer power. Printer Paper Out! • Replace the paper roll. Time/Date Error • The clock is checked during power on to ensure it has not lost time and been reset.
49 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.
50 Standards and compliance Welch Allyn® OAE Hearing Screener Directive 2002/96/EC-WEEE: Disposal of noncontaminated electrical and electronic equipment Many local laws and regulations require special procedures to recycle or dispose of electrical equipment-related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices.
51 Appendices Appendix A: Specifications Probe specificiations Item Specification Measurement type Distortion Product Otoacoustic Emissions (DPOAE) Frequency range 2.0 to 5.0 kHz Stimulus intensity 65/55 dB SPL Microphone system noise • • -20 dB SPL @ 2 kHz (1 Hz bandwidth) -13 dB SPL @ 1 kHz (1 Hz bandwidth) Dimensions and weight • • Length: 40 in. (1.0 meter) Weight: 1.00 oz.
52 Welch Allyn® OAE Hearing Screener Appendices Item Specification • • HDMI Connector for connection to the Probe Integrated Bluetooth Class 2 + EDR with SPP Protocol for communication with printer Power supply specifications CAUTION Use only approved power supply Item Specification Model No. UE08WCP-050160SPA Output 5.0V DC, 1.
Directions for use Appendix B: Flowchart: Measurement Appendices 53
Welch Allyn® OAE Hearing Screener 54 Appendices Appendix C: Test sequence A complete test sequence consists of an: • AutoStart • Calibration • Test phase 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. Immediately after you press the test button, the AutoStart phase begins.
Directions for use Appendices 55 Appendix D: Pass/Refer criteria The decision that a DPOAE exists is based on detecting a signal whose level is significantly above the background noise level. This requires a statistical decision, since the random noise level in the DPOAE filter channel can be expected to exceed the average of the random noise levels in the four adjacent filter channels — used as the reference for comparison — roughly 50% of the time.
Welch Allyn® OAE Hearing Screener 56 Appendices Appendix E: Configurations and test protocols The protocols Included are DP 4s (default) and DP 2s. Note Name No. of F2 Frequency Frequenci es DP 4s 4 DP 2s 4 Note L1/L2 Maximum Average Pass Time SNR # Passing Frequency for Test Pass 2.0, 3.0, 4.0, 5.0 kHz 65/55 4 seconds 6 dB 3 65/55 2 seconds 6 dB 3 The DPOAE protocols differ in the amount of averaging time per frequency. The DP 4s protocol is the default.
Directions for use Appendices Appendix F: Approved options Item Wireless Thermal Printer Kit 57
