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Welch Allyn Medical Diagnostic Equipment REF 29400 User's Manual

1. 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 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 The part and serial numbers are located on the bottom of the OAE Hearing Screener Before returning a product for repair you must obtain authorization from Welch Allyn Service personnel will give you a Service Notification number Please note this number on the outside of your shipping box Returns without a Service Notification number will not be accepted for delivery Warranty Welch Allyn warrants the OAE Hearing Screener when new to be free of defects in material and workmanship and to perform in accordance with manufacturer s specifications for a period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents Welch Allyn will either repair or replace any components found to be defective or at variance from manufacturer s specifications within this time at no cost to the customer It shall be the purchaser s responsibility to return the OAE Hearing Screener to Welch Allyn or an authorized distribut
2. Collapse is normal because bones If infant is lying on side reposition infant so that down ear haven t formed in ear yet faces up ask attending nurse or parent to keep infant in this position as much as possible wait a few hours before testing down ear Cochlear Outer Hair Cell Loss Hearing loss Problems include communication difficulties in noisy environments and speech and language development delays Refer on OAE and not on Pure Tone Audiometry Occurs most frequently in people exposed to high levels of sound energy noise or music or those treated with ototoxic medications OAE responses are often affected before evidence of hearing threshold change appears on a behavioral hearing test False Positives Refer criteria maximizes the detection of individuals with true hearing impairment A small percentage of people with normal hearing sometimes get a Refer result These are people whose OAE responses fall below the 10th percentile for the normal population Such low OAE responses warrant additional testing Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 18 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 t
3. The ON button is used to power on the Welch Allyn OAE Hearing Screener when it is turned off It also acts as a reset button if pressed when the screener is already on If the ON button is pressed during any operation it will function as a reset aborting the current process and returning to the beginning of the Power ON sequence flow chart The RESTART button returns the Welch Allyn OAE Hearing Screener to the PERFORM DPOAE message in preparation for performing another test or for viewing data from previous tests By pressing the RESTART button at any point during program operation the current operation will be aborted and the PERFORM DPOAE message will appear The DX SELECT button is used to initiate the procedure that is displayed on the LCD display For example if the PERFORM DPOAE message is displayed pressing the DX SELECT button initiates a test sequence Press the UP or DOWN arrow keys until the desired program function appears in the LCD display Then press the DX SELECT button Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 23 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
4. 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 Labels referring to the names of the connectors that are on the front label of the Welch Allyn OAE Hearing Screener are typed in bold text Help For additional assistance please contact Welch Allyn Technical Support at 1 800 535 6663 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 4 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 This software also can be used to update the Welch Allyn OAE Hearing Screener date time and default protocol COM communications port on a computer also known as serial port dB decibel a logarithmic measure of sound intensity DP Frequency the frequency at which the distortion product DP emission occurs DPOAE distortion product otoacoustic emission refers to the acoustic energy generated by the outer hair cells of the cochlea in response to stimulation with two
5. In the flow charts the boxes represent the display messages seen on the LCD of the screener The lines in between boxes show the software flow direction as indicated by the arrow The text beside the flow arrows indicates how the step is initiated For example the text may describe a button press or a condition that initiates an automatic progression to the next step The paragraphs below the flow chart provide information that is not covered in the flow chart format Power ON ON Welch Allyn VER DATE xx xx xx TIME xx xXx xx 2 sec delay NOTE At this stage the screener is ready to load software from the computer or from internal memory DX SELECT Welch Allyn DPOAE VER LOADING DP LOADING PLEASE WAIT 2 sec delay PERFORM DPOAE Log in logbook The operation of the ON button is the same for the following flow charts That is it will always return the user to the initial Welch Allyn message on the LCD It will not be depicted in the following charts Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 24 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
6. discharge ESD IEC 61000 4 2 kV contact 6 8 KV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds Mains power quality should be that of a typical commercial or hospital environment If the user of the REF 29400 Series OAE Hearing Screener requires continued operation during power mains interruptions it is recommended that the REF 29400 Series OAE Hearing Screener be powered from an uninterruptible power supply or battery Power frequency 50 60HZz magnetic field IEC 61000 4 8 3 A m 40A m Power frequency magnetic fields should be at levels charact
7. 52 Precautions During System Operation ccccccsceceseeeeeeeeeeeeeeeneeeeeeeeseeeeseeeeseeeseneeeseeeeeneeens 52 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 3 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 The system collects and averages data samples until specified measurement parameters are achieved For distortion product otoacoustic emissions DPOAEs the DP and noise floor amplitudes appear on the LCD A pass or refer result is assigned at the end of the test based on comparison of the patient s OAE response to normalized data Users can view and analyze the results The Welch Allyn OAE Hearing Screener is a medical device that produces information about the auditory system of a patient This information is then available for medical diagnosis or screening Therefore The Welch Allyn OAE Hearing Screener is intended for use by a health care professional or a technician who is trained and supervised by a health care professional or accredited organization 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
8. A a ae a aa AEDE ataa 25 Viewing DPOAE Test Details or Retesting an Ear with a Refer Result Immediately After a Test AE E E E A A E E E EA 27 Printing DPOAE Test Details Immediately After a Test ccccccceeceeeeeeeeeeeeeeeeeeeeaeeeeneeeeeeeeeaees 28 Viewing Previously Collected DPOAE Datta ccccccccceceeeeeeeeeeseeeseeeeeeeeseaeeseaeeeseaeeseuneeseaeeeeas 29 Chapter 9 Printing Previously Collected Data Single Ear ccccccccsscecesssseeeeeeseeeessseeeessaes 30 Chapter 10 Printing Previously Collected Data Both Ears on One Label ceceeseeeeeeees 32 Chapter 12 Primet aoirde once Os ag saad seated eed ea ts sath aaeain an E Dena AARAA Nena Aaaa aa N Eaa Aaaa a Ee 33 DIEA StS EE EA E E A A T 33 PACKING N Eel o E A T e A T E A AT ET 34 Chapter 12 System Default Protocol ccccccececeeeeeeeeeeeeeeeeeeeeeeeseaeeeeeeeseaeeeeeeeeseaeeseeeeseeeseeeess 35 DPOAE System Default Protocol cccccccceeeeeeeeeeeeeeeeeeeceaeeeceaeeseaeeseaaeeseaeeseeesseaeeseneeesseeseaees 35 Collection Parameters Stopping Parameters and Pass Refer Criteria ccccscceeseeeees 35 DPOAE Measurement Based Stopping Rules per TeSt c ccceceeeeseeeseeeeseneeeeeeeeseieeeeseeees 36 DPOAE Pass or Refer Criteria ccccccceececseeeeeeneeeeneeeeeeeeeeeeeeneeseaeeesaeeseaeeseeeeseaeeseneeeeeaeess 36 Changing the DPOAE Default Protocol to Continue through All Frequencies ceee 36 Chapter
9. 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 The cylindrical RS232 connector end of this cable should be aligned and plugged securely into the receptacle labeled IOIOI on the left side of the screener The other end of this cable is a RJ12 connector that is commonly seen on telephone cords It should be connected into the corresponding receptacle of the serial printer 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 VIEW DPOAE are am TEST RESULTS XXXX R L PASS REFER PRINT next previous ory Yes test DX SELECT DX SELECT PRINT ALL UNPRINTED DATA Printer detected TURN PRINTER ON TRY AGAIN Printing of selected test s Print All Unprinted Data prints all tests in memory that have not been printed previously The PRINT ALL UNPRINTED TESTS feature is intended for use when multiple tests are stored in mem
10. 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 That means no talking minimal movement and the patient should not respond to the sounds in any way Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 11 Chapter 4 Care and Maintenance of the Probe Place the clear tube slightly onto Using your fingertip continue pushing The end of the clear tube of the ear Do not pinch foam while attaching the nozzle of the probe body on the top of the foam until the clear tip should cover the nozzle completely ear tip onto the nozzle tube covers the entire nozzle leaving no gap at the base To remove foam tips hold the probe body Do not pull on the foam This will cause suction You may end up pulling the foam off of the clear with your fingertips on top of the nozzle clips of the tube around grooves in the nozzle and will tube while the tube remains on the nozzle Then with the other hand place your fingemails actually impede the removal behind the clear tube at the base of the nozzle and slide the tube toward the end Slide ear tip onto the probe nozzle until
11. button to turn the system on again If the battery becomes depleted the LCD display will briefly flash a LOW BATTERY message before the Welch Allyn OAE Hearing Screener automatically turns off To recharge the battery plug the charger unit into the 6V DC connector on the left side of the Welch Allyn OAE Hearing Screener box and the power cord into an AC outlet A green LED on the front of the Welch Allyn OAE Hearing Screener illuminates when the charger is plugged in The AC charger can fully recharge the system battery in approximately three hours The system can be used to perform tests while it is plugged into the charger While the charger is plugged in it will recharge the batteries between tests and the LCD will display a message continuously Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 9 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 It is necessary however that the patient cooperate by allowing for insertion of the ear tip into the ear canal and by leaving the ear tip in place for the duration of the test Depending on the test pa
12. may increase the current amount of leakage and exceed the safety limit e Do not interconnect multiple pieces of equipment without verifying that the sum of all leakage currents does not exceed the safety limit e Do not connect any non medical electrical equipment directly to a wall outlet if the Welch Allyn OAE Hearing Screener is using a multiple portable socket outlet with a separating iso transformer The additional equipment may increase the current amount of leakage and exceed the safety limit e Do not connect equipment which can potentially provide electromagnetic or other types of interference This may cause the Welch Allyn OAE Hearing Screener equipment to function incorrectly e Verify the equipment is connected to a power line source with the following frequency voltage and current capacity Frequency 50 60 Hz Voltage 100 240 VAC Current Capacity 1 60 1 20A Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 51 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 Verify all syst
13. message so that function is not represented in the flow chart PERFORM DPOAE Log in logbook DX SELECT Test R EAR detected Calibrate Channel A Calibration A Calibration A Unacceptable PROBE IN EAR or OCCLUDED PROBE REFIT AND RETRY Test continues through the frequencies HHH R L PASS REFER SEE i DX DETAIL increased by 20 PLEASE RELEASE BUTTON See note below about CONTINUE option Re CONTINUE option When the DX SELECT button is chosen when the CONTINUE message is displayed the program will try to proceed to the next step in the test process but possibly with poor calibration results or test conditions so it is not recommended on a routine basis Each test is assigned a unique test number that is displayed in the Test R L EAR box Since the Welch Allyn OAE Hearing Screener holds 10 tests in memory this unique number can assist you in associating a test with a particular patient To keep track of the patient test numbers the patient s name test numbers and details of the test if desired should be recorded in a logbook or patient file Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 25 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 w
14. on the OAE Hearing Screener 2 When the Welch Allyn DPOAE software message appears in the display area Press the DX SELECT button to continue 3 When message PERFORM DPOAE appears in the display area Press DX SELECT to initiate test 4 When message TEST R EAR appears in the display area Record unique test number assigned to the test if necessary 5 If the ear to be tested is the left ear e Press the DOWN arrow to display the message TEST L EAR 6 When the correct ear is displayed e Press the DX SELECT button to initiate the automated check fit calibration and test Test continues until completion e When the test is complete the test number and PASS or REFER result appears on the display along with the message SEE DETAILS 7 To see test results for individual frequencies Press DX SELECT 8 Use the DOWN and UP arrows to move through the test frequencies 9 To print test results use the UP or DOWN arrow until PRINT appears on the display Press DX SELECT to print RE FERENCE G Ul D E Data Review 1 Press the ON button on the OAE Hearing Screener 2 When the Welch Allyn DPOAE software message appears in the display area Press the DX SELECT button to continue When message PERFORM DPOAE appears in the display area Press DOWN arrow e The message changes to VIEW DPOAE RESULTS Press DX SELECT The last test performe
15. pure tone stimuli DP distortion product used interchangeably with DPOAE The DP that has received the greatest interest and is most often measured clinically is the DP that is calculated by the formula 2F1 F2 DP NF the dB difference between the distortion product emission and the noise floor amplitudes To be sure that a response is present the DP NF value must match or exceed a minimum On the Welch Allyn OAE Hearing Screener this value is 6 dB or greater DX a button on the front panel of the Welch Allyn OAE Hearing Screener which is used to SELECT and implement functions described on the LCD F2 the higher of the two stimulus frequencies used in a DPOAE test 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 LED light emitting diode a light that illuminates to indicate a hardware function On the Welch Allyn OAE Hearing Screener an illuminated green LED at the bottom left of the front panel indicates that the AC adapter is plugged in and AC power is flowing to the box Welch Allyn OAE Hearing Screene
16. the Welch Allyn OAE Hearing Screener or because it has become corrupted Press the ON button to reset the device If the problem persists call Welch Allyn Technical Support at 1 800 535 6663 for further instruction CHECK SUM ERROR This message appears when the software protocols are not found either because it was not installed on the Welch Allyn OAE Hearing Screener or because it has become corrupted Reload the WA OAE Firmware using the WA OAE Load program If the problem persists call Welch Allyn Technical Support at 1 800 535 6663 for further instruction MEMORY ERROR RELOAD SOFTWARE This message appears when the initialization software is not found either because it was not installed on the Welch Allyn OAE Hearing Screener or because it has become corrupted Press the ON button to reset the device If the problem persists call Welch Allyn Technical Support at 1 800 535 6663 for further instruction Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 41 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 When a new software version is uploaded from
17. the connector end of the probe cable to the holes in the jack on the top of the Welch Allyn OAE Hearing Screener box An arrow on the connector shows the correct orientation of the probe connector to the Welch Allyn OAE Hearing Screener 2 After verifying the connector is properly aligned slide the probe connector end securely into its matching connector CAUTION No other probes are compatible with the Welch Allyn OAE Hearing Screener blue hardware 29400 29401 The connectors do not match and attempting to force the connectors together may damage pins in the connector Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 7 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 Connect the detachable power cord to the charger unit 3 Plug the grounded power cord into an AC outlet WARNING AC ADAPTER UNITS ARE NOT INTERCHANGEABLE Use only the 6 volt AC adapter 520 PS6VDC supplied for the Welch Allyn OAE Hearing Screener blue hardware 29400 29401 Using an AC adapter charger supplied for
18. 1 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA p 800 535 6663 f 315 685 2174 www welchallyn com 2008 Welch Allyn SM2930 Rev B WelchAllyn Advancing Frontline Care Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 16 Welch Allyn OAE Hearing Screener Troubleshooting Quick Guide Causes of Refer Results Problem Possible solutions Noisy surroundings Eliminate or reduce noise Isolate and completely sound proof the test site optimal seer Pe Open OF eal test elle Ask others in or near test site to refrain from talking or other Devices such as fans air activity conditioners intercoms and Ask noisy people to move to another location ask parents to public address systems move noisy children to another location Deactivate or remove any device that is a potential source of noise Use larger probe tip if possible Patient noise FOR NEWBORNS OR INFANTS Swaddle child in blanket and test while child is asleep Ask parent to hold child comfortably and to prevent child from pulling probe or cable Sucking a pacifier or bottle FOR TODDLERS Distract fussy toddlers with a quiet toy or book i Ask parent to help by holding the toddler comfortably on lap or Talking shoulder FOR OLDER CHILDREN Explain that being quiet will speed up the test and reduce the possibility of retesting Crying or struggl
19. 13 Reloading WA OAE Firmware WA OAE Load softwar e ccccseeseeeseteeeeeeeees 37 Chapter 14 Exporting using ASCII Link ccccecceeceeeeeeeeeeneeeeeeeeeeaeeeeaeeeseaeeeeeeeseaeeseeeeseeeseeeees 40 Chapter 15 Troubleshooting Service and Warranty cccccccceeeeeeeeeeeeeseneeeeeeeeeeaeeseteeeseneeseneeess 41 Error MOSSAQ S aae aheraine ta eee isl tee en ee a a h 41 ELTENO E E T E A A A E E A E 43 Technical Assistante eee a 43 AE RIE A EE T E E N E E tes ott E T Sea as AE E E AT E E E A 43 JAP OMOIG a TEE L N O A ET AE AT OE A E A EE ETE 44 Precautions and Safety INStrUctiOns cccccceceececeeeeeeeeeeeeeeeceeeeseaeeeeeaeeseaeeseeesseaeeseueeeseeessaees 44 Equipment Identification Labels and Markings ceseseeeeeeeneeeeeeeneeeeeeeneeeeseeneeeeeeeaeeeeeeaes 44 Electrical Installation Requirements 00 0 0 cece eects eeneeeeeeeeeeeeeeeaeeeeeeaaeeeeeenaeeeeeenaeeeeeesaeeeeeeaas 45 Environmental Specifications ccccccececeeceeeeeeeeeeceeeeeeneeeeeaeeeeeeeeseaeeseaeeeseaeeseaeeseneeeseeeseeeeess 46 Installation PreCautions cecccceesenceeeeseeceeeeseneeeenseneeeensaeseesaaenenseseneeseanensensaneesensaneeseneaes 50 SYySteM HOOKUPS ieei veers hein eat gah coarite nee ee erie oe eae ae ieee ea 51 Installation Verification eeeceeeeeeeceeeeeeeneeeeeeeaeeeeeeeaeeeeeeeaeeeeeecaeeeeeeeaeeeeeeeaeeeesseeeeeseeeeeeenaes 52 Signal Output and INOut ses esen e a a a a iaa i a Taa a Eaa a
20. 5 And 6 5 Yes 3000 E And 6 5 Yes 2000 7 And 6 5 Yes Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 35 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 This has the advantage of shortening the test time If you would like the system to continue through all of the test frequencies rather than stopping when conditions for an overall Pass or Refer are achieved refer to the section entitled Changing the Default Protocol to Continue through All Frequencies DPOAE Pass or Refer Criteria For an overall PASS result to display on the LCD at the completion of a DPOAE test when using the DPOAE system default protocol three of the four test F2 frequencies must meet the response conditions defined for a PASS The PASS REFER criteria incorporated into the screener are based on published data by Gorga Neely Ohlrich Hoover Redner and Peters 1997 In Gorga et al s study hearing impairment was defined as a behavioral pure tone audiometric threshold of 25 dB HL
21. 53 Rev E 37 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 gt 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 To install the WA OAE Firmware to your screener 1 Verify that the tests in the screener can be deleted safely The process of re installing the firmware into the screener will delete all tests N Verify that the screener is connected to the PC using the cable provided with the system 3 Itis advisable to plug the screener charger power supply into the screener during this operation so that a low battery charge does not cause interruption of the download of firmware into the screener Launch the WA OAE Load application using the shortcut icon on your PC desktop and the following screen will appear Welch Allyn OAE Load Ver 4 3 1 o J This program will update Welch Allyn DAE Hearing Screener internal software Start and will load the default screening protocol During this process all test data will be erased From Disk Set Date Note The full update process requires 2 3 minutes Load Fonts About Select Option Se
22. China 86 216 327 9631 European Call Center 353 46 906 7790 France 33 15 569 5849 Germany 49 747 792 7186 Japan 81 33 219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Manual Part Number 705353 Rev E Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 USA http Awww welchallyn com Printed in USA 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 2 Contents Chapter 14 Intr ductioMi esaa atten Seated aiseeck Sane ates Saati eaa cena aeiaai 4 About this manual ascetic E R titre setts pete eutectic tei ation dees 4 Chapter 2 Welch Allyn OAE Hearing Screener Components and Hardware Setup 0008 7 Gable Connects s e a sade ceozecwestd deans chic cstteth Saueenste cued eaate eal E E ENESA 7 Battery casi divcisicgceas tet te sll cevuststistvessl ieeveuds ueshest ite wtside dpveshide eae eesidpeesdi les silted ove so ien cence N tives 9 Chapter 3 Environme
23. OAE Hearing Screener Directions for Use REF 29400 WelchAllyn Advancing Frontline Care 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 Welch Allyn is a registered trademark of Welch Allyn Software in this product is Copyright 2009 Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remain with Welch Allyn or its vendors For information about any Welch Allyn product call Welch Allyn Technical Support USA 1 315 685 4560 Australia 61 29 638 3000 800 535 6663 800 074 793 Canada 800 561 8797
24. St csesceseseeseeeseeeeseeeenees 27 View Previously Collected DPOAE Data 29 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 53
25. Use 705353 Rev E 28 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 NOTE The first test displayed DX SELECT is the last test performed HAHH R L PASS REFER SEE DETAIL next previous test Recall that only the last 10 tests are retained in memory for retrieval and review Tests collected prior to the last 10 are sequentially overwritten with each new test performed There is no way to retrieve them after they have been overwritten The PASS REFER indicator displayed in the first SEE DETAIL box is for the overall test The PASS REFER indicator in the second X KHZ DP box is for the individual frequency being displayed The displayed PASS REFER indicator is based on research published by Gorga et al 1997 For more information about the criteria needed for a PASS or REFER indicator to appear see Chapter 12 System Default Protocol In the X KHZ DP message box the number after the DP abbreviation is the amplitude of the distortion product emission In the second line the number following the word NOISE is the amplitude of the noise floor Remember that RESTART will return to the PERFORM DPOAE message at any time Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 29 Chapter 9 Printing Previously
26. Use 705353 Rev E 31 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 PRINT TEST RESULTS TE PRINT BOTH EARS DX SELECT RESULTS DX SELECT NO RESULTS FOR Final Test Ear BOTH EARS Database does not Database contains HHHH L HH R contain both right and right ear and left ear left ear tests tests R and L tests V DX SELECT with highest number are displayed Automatically displays test with highest test ID Choose Test 1 number R L PASS REFER Printer detected ory No next previous test DX SELECT Yes DX SELECT Automatically displays Printing of Selected TE A An ON test with the highest test test s Both ears ID for the opposite ear tests will print ona Choose Test 2 single label HHH R L PASS REFER next previous test Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 32 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
27. a computer to the Welch Allyn OAE Hearing Screener the database of tests is erased from memory LOADING PLEASE WAIT This message routinely appears when the unit is powered on and the DX SELECT button is pressed It is only problematic if the message remains on the screen for a prolonged period more than 10 seconds and does not progress to the next message PERFORM DPOAE This may occur if the battery charge is marginal If this occurs plug in the charger unit press the ON button and the DX SELECT button and try again Once the battery is recharged the unit will return to the normal Power ON sequence TURN PRINTER ON TRY AGAIN This message appears when an attempt is made to print data on the label printer but the printer is not communicating with the Welch Allyn OAE Hearing Screener This can be due to poor connection of the printer serial cable to the printer or to the screener or lack of power to the printer NO PROTOCOLS EXIST This message appears when an error has occurred during the installation of the WA OAE Firmware into the unit or if the firmware has been corrupted causing the protocols database in the unit to become unreadable NOTE For error messages that do not appear here or if you are unable to correct a problem contact Welch Allyn Technical Support at 1 800 535 6663 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 42 Service Caution Unauthorized repairs will void the warranty
28. art command button to begin to download the firmware Note that the program requires 2 3 minutes to complete the installation process Make sure the time and date on your PC are accurate From Disk command button Select click on this command button to launch an Open dialog box This dialog box lets you run the WA OAE Load installation program from another disk Set Date command button Select click on this command button to update the time and date settings in screener The date and time will be taken from your PC Load Fonts Select click on this command button to load the fonts for the Label Printer will check to make sure this is still accurate Help command button This command button is inactive Exit command button Select click on the Exit command button to close the WA OAE Load Main Screen Select Option radio buttons This area of the Main Screen contains a set of radio buttons next to a list of the options that apply to the WA OAE Load process In most cases select click on the radio button next to Update internal software and default protocol Select click on the radio button next to Update only default protocol only if you have received a new test protocol file and you only want to update that part of the WA OAE Firmware Select ComPort field The setting in this field is only relevant if you are using a serial cable for communication between the PC and screener In tha
29. ccur in the vicinity of equipment marked with the following symbol gt Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people i Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed 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 If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the OAE Hearing Screener Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 48 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 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 disturbance
30. d appears on the display 4 Use the UP and DOWN arrow buttons to move through the tests that are stored in the OAE Hearing Screener memory 5 When the desired test number appears on the display e Press the DX SELECT button to review the details of this test 6 To print the results or view another test 7 Press the DX SELECT button 8 Use the UP and DOWN arrows to move through the tests that are stared in the OAE Hearing Screener memory oe Testing Hints for Newborns 1 Do not screen patient more than three times per ear Overscreening can result in a false negative result 2 Swaddle baby and position on side for best access to ear 3 Test at least 11 hours after birth if possible to prevent false positives due to vernix 4 If infant fails re test at least one more time before discharge 5 If one ear fails try to have baby lay so that the failed ear is facing up for a while to clear vernix before retesting 6 If infant is fussy or crying offer pacifier 7 OK to test while infant is nursing WelchAllyn Advancing Frontline Care Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 15 TF UO Bk E S ae 0 0 T CON G U L R E Welch Allyn OAE Hearing Screener Troubleshooting the Probe 29402 Semidisposable probe only Error Messages Problem Probe in Ear Refit and Retry Or Occluded Probe Empty Database Reset Date Time Memory Error Reload Software or No Loader R
31. eload Software or Error 000 Turn Printer On Try Again Printer Skipping Labels Using the Test Cavity 1 Place a Tree Tip on the probe 2 Insert the probe securely into the test cavity 3 Perform test on OAE Hearing Screener as usual 4 Test results should show a REFER 1 Clean probe and make sure ear tip is properly placed 2 Verify secure connections of all cables 3 Verify that no pins are bent or broken on the probe cable connector 4 Verify that there is no damage to probe connection on OAE Hearing Screener box 5 Reconnect probe cable into OAE Hearing Screener box 1 When a new software version is uploaded from a computer to OAE Hearing Screener the database of tests is erased from memory 1 Use WA OAE Load program 1 Detach printer cable or USB cable 2 Allow OAE Hearing Screener to power down Then press ON button and initiate internal software installation 3 If the above does not work use WA QAE Load program to reinstall software 1 Verify that printer power is on 2 Verify secure cable connection from printer to QAE Hearing Screener 3 Reload paper in printer if needed 1 Reload paper in printer 5 If error messages are obtained follow the troubleshooting suggestions above 6 A PASS result may be observed at individual test frequencies in a DPOAE test due to the resonance properties of a hard walled cavity But the overall test result should be a REFER 434
32. em or equipment batteries show the correct voltage and are in perfect working condition Signal Output and Input The system computer must NOT be used in a patient environment unless the following conditions are met 1 The system computer and all other peripheral devices are plugged into an approved isolation transformer The portable computer is powered by batteries not plugged into a wall outlet The system computer has an approved isolated power supply Precautions During System Operation Follow all safety procedures giving careful and constant attention to the patient and system equipment 1 Verify the patient cannot become either entangled or strangled by cables connecting the patient to the system hardware Avoid direct contact between the patient and system equipment at all times Do not add other equipment which is not protected against ingress of liquids This equipment is not suitable for use in areas of flammable or anesthetic mixtures This is a Class A product In a domestic environment this product may cause radio interference in which case the end user may be required to take adequate measures Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 52 A Abbreviations cccccccsssescceeeeeceeeseceeeeeeeneeens 5 6 ASCII LINK nessieira 40 AUDX Buttons 20 02 22 cece cece e eee eeeeeeeeeeeeeeeeeeenaees 23 AUDX LOG E E Stpessaiasehcas 37 AUTO ORF ii EEE E MIN elo coc anes 9 B Battery
33. eristic of a typical location ina typical commercial or hospital environment Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 47 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 IEC 60601 Test Compliance Electromagnetic Environment Guidance Test Level e Level Portable and mobile RF communications equipment should be used no closer to any part of the REF 29400 Series OAE Hearing Screener including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vrms 150 kHz to 3 Vrms d 1 17 RF IEC 80 MHz 61000 4 6 Radiated RF 3 V m 80 MHzto2 5 5 V m from d 1 17 80 MHz to 800 MHz IEC 61000 4 GHz 30MHz to 3 1GHz 7 d 2 33 800 MHz to 2 5 GHz V m for 1GHz to 2 5 where Pis the maximum output power rating of the GHz 1000 transmitter in watts W according to the transmitter Hz 80 manufacturer and d is the recommended separation Modulated distance in meters m Test Signal Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may o
34. facturer 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 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The REF 29400 Series OAE Hearing Screener uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The REF 29400 Series OAE Hearing Screener is suitable for CISPR 11 use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic Harmonic Class A emissions IEC purposes 61000 3 2 Voltage Complies fluctuations flicker emissions IEC 61000 3 3 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 46 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
35. fter 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 REFER RESULT RETEST V DX SELECT PROBE DETECT IN PROGRESS New test performed with new test ID number assigned HHH R L PASS REFER SEE DETAIL X KHZ DP PASS REFER NOISE A Orv yv Refer result No HHH R L PASS REFER PRINT See more printing details in next section Next Previous Frequency The PASS REFER indicator displayed in the first SEE DETAIL box is for the overall test The PASS REFER indicator in the second X KHZ DP box is for the individual frequency being displayed The displayed PASS REFER indicator is based on research published by Gorga Neely Ohlrich Hoover Redner and Peters 1997 For more information about the criteria needed for a PASS or REFER indicator to appear see Chapter 12 System Default Protocol In the X KHZ DP message box the number after the DP abbreviation is the amplitude of the distortion product emission In the second line the number following the word NOISE is the amplitude of the noise floor Remember that RESTART will return to the PERFORM DPOAE message at any time When a Refer result has occurred selection of the DOWN arrow key from the SEE DETAILS message will display a REFER RESULT RETEST message Selection of the DX SELECT button will then initiate another test and increment to the
36. hat 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 The Result Letters can be used to give to patients or their caregivers to provide additional documentation of the screening results The Welch Allyn OAE Hearing Screener Clinical Competency Evaluation and Result Letters are on separate pages so that they can be copied and used multiple times Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 19 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 Performed Task Needed Training Did Not Observe Properly plugs in equipment Properly turns on equipment Powers on label printer Demonstrates how to clean probe Follows facility infection control Launches Screener program Records patient Log Number Swaddles baby and or prepares patient for test 9 Selects patient s ear in software 10 Selects proper sized probe tip 11 Places probe into patient s ear 12 Troubleshoots probe fit if needed 13 Knows how to View Details 14 15 16 Rico Me Wicd ease Ne Pr
37. ic 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 The hearing screening result does not mean that the patient definitely has a hearing loss however it does mean that the patient needs further audiological evaluation to either rule out or confirm a hearing loss Further evaluation by an audiologist experienced with pediatric assessment is recommended Early detection of hearing loss is critical for language development and or school success lf you have additional questions do not hesitate to contact us An appointment has been made for further evaluation Date Time If you have any questions do not hesitate to contact us Insert OAE Screener Sticker Here Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 22 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 Buttons and Their Function Up amp Down DX Select Arrows Button Restart ON Button Button RESTART qo OAE Hearing Screener Welch Allyn OAE Hearing Screener and Buttons
38. iewing OAE data e Present suggestions to help you use otoacoustic emissions to test infants toddlers and preschoolers e Explain conditions that could cause a Refer result for a Welch Allyn OAE Hearing Screener One laminated copy of the Quick Guide is provided with the Welch Allyn OAE Hearing Screener Instructional Videos on the Welch Allyn OAE Hearing Screener Inservice Guide The Welch Allyn OAE Hearing Screener Inservice Guide supplied with your Welch Allyn OAE Hearing Screener contains Instructional Help Videos along with the Directions for Use document Welch Allyn OAE Software Welch Allyn ASCII Link View Instructional Help Video i E i Directions for Use 4 Browse CD Contents K Contact Us Exit Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 14 OQ ulc Kk System Setup 1 Connect the probe cable to the top of the QAE Hearing Screener box 2 Align the pins in the end of the cable with the holes in the jack e The arrow on the connector shows the correct orientation of the probe connector to the QAE Hearing Screener 3 Select appropriate ear tip 4 Slide probe tip all the way onto the probe body e Verify that no hard surfaces are exposed at the end of the ear tip that will be inserted into the ear canal e The tips are designed to extend beyond the plastic tip by approximately 1 16th inch e Dispose of probe tip after each patient Data Collection 1 Press the ON button
39. ing against the probe Excessive movement Middle Ear Involvement Problem Possible solutions Middle ear conditions that add Refer results caused by temporary conditions that cause middle mass or stiffness to the middle ear ear involvement will improve as the middle ear returns to normal such as Otitis media Severe Eustachian tube disfunction Otosclerosis Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 17 Obstructions Problem Possible solutions Cerumen vernix or other debris IN THE EAR Make sure that a properly trained technician examines Inthe ear the ear canal for obstructions BEFORE inserting the On the probe tip probe Delay testing newborns until 11 hours after birth if On the probe 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 Remove examine and wipe probe tip clean make sure that both the inside and outside of the tip are clean replace cleaned probe tip ON THE PROBE Clean the probe carefully by following the instuctions in the Directions for Use guide Temporary collapse of the ear canal Manipulate the ear in a gentle circular motion before inserting the ear tip Occurs often with down ear when infant is lying on side Make sure to have a good probe fit
40. ins the following information Example Data Date and time day month year hour 10052005134513 minute second DDMMYYYYHHMMSS ID Number of protocol used for test 3 Orphan i e no patient ID available AB123456789A01 Left Pass Refer No Result OverAll_ PASS OverAll_ REFER OverAll NOT RESULT Printed Not printed Printed Not_Printed Number of frequencies in test 3 Frequency F2 for DP 5000 Frequency Pass Refer Noisy PASS REFER NOISY DP Result DP 7 DP NF Result DP NF 18 Noise Result Noise 21 AuDX Test ID 1000 9999 prefix 102001 DP 10 DP AuDX Serial Number 05369 Reproducibility Reproducibility 85 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 40 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 Connecting the AC adapter charger unit will allow continued data collection and will charge the unit between tests Complete charging of the Welch Allyn OAE Hearing Screener takes about 3 hours NO LOADER RELOAD SOFTWARE This message appears when the initialization software is not found either because it was not installed on
41. ints results from label printer Restarts for next patient Provides appropriate counseling to patient or caregiver regarding results 17 Documents results according to facility s protocol The above evaluation was successfully completed on Name and Title of Person Supervising the Competency Evaluation Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 20 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 A delayed onset hearing loss can develop and this screening does not rule out the need for future evaluation if parental concerns regarding speech and language development arise or if future medical events place this child at risk for a hearing loss The Joint Committee on Infant Hearing advises that follow up hearing evaluations occur if this patient has a congenital infection or a family history of hearing loss If you have questions concerning the screening do not hesitate to contact us Insert OAE Screener Sticker Here Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 21 PEDIATRIC HEARING SCREENING RESULTS Date of Exam Patient s Name Date of Birth This patient s hearing was screened using otoacoust
42. is still compressed gently pull up and back on the patient s ear to straighten the ear canal and insert the ear tip deeply and securely into the canal Hold it in place for a few seconds while the foam expands in the canal If the ear tip stays in place without holding it it is in securely 4 When using the OAE Tree Ear Tip gently pull down and back on the patient s ear to straighten the ear canal and insert the ear tip deeply and securely into the canal If the ear tip stays in place without holding it it is in securely Do not hold the probe in place as this will create noise 5 Clip the probe cord to the patient s clothing infant carry all or bassinet with enough slack so that it is not pulling down on the probe This will reduce the chance that the weight of the probe cord will pull the probe out of the ear For young children clipping the probe cable on the back of the shirt could help prevent the child from grabbing the cable and pulling the probe out of the ear 6 When testing a newborn or young infant it may be helpful to swaddle the baby in a blanket to try to keep movement at a minimum Placing the infant on his her stomach or side with a rolled blanket behind the back to keep the baby from rolling onto his back can facilitate testing With the test ear facing up the probe is more likely to remain in the ear canal for the duration of the test Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 10 Patient
43. ish to record or print the details of a test it is important that you do so before it is overwritten Increase Artifact Reject Level During a test you can increase the artifact rejection threshold in small increments by pressing and holding down the DX SELECT button until the message PLEASE RELEASE BUTTON flashes on the LCD It may take a few seconds to see the change on the LCD since the display only updates every few seconds The default artifact rejection threshold is 30 mPa Each press of the DX SELECT button increases the artifact rejection level by 20 mPa and this will be displayed on the LCD This feature can be used when a high percentage of data samples are being rejected from averaging caused by a noisy environment or patient resulting in prolonged test time However increasing the artifact rejection threshold allows more noise into the average and that may confound interpretation of the data If possible try to control the environmental or patient noise instead of increasing the artifact rejection threshold However newborns and infants often produce high levels of internal noise just due to breathing and the artifact rejection threshold may have to be increased in order to collect any data successfully This procedure will have to be repeated for each test frequency in the DPOAE test Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 26 Viewing DPOAE Test Details or Retesting an Ear with a Refer Result Immediately A
44. lect Com Port Exit WelchAllyn Update internal software and default protocol coM1 z C Update only default protocol Select language English v Status Serial Number Loader Version DP Screener Version DP Default Protocol TE Screener Version TE Default Protocol Status 5 If you are using a serial cable between the screener and the PC verify that the setting in the Select Com Port field is set correctly for your hardware If you are using USB connection then this setting is irrelevant 6 Select the Start button in the upper right corner of the screen Note If you only want to reset the Date and Time in screener select the Set Date button 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 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 38 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 Component Description Information area This area of the Main Screen displays information about the WA OAE Load program Start command button Select click on the St
45. ls are often used on equipment in preference to words in order to simplify language differences and to provide instant comprehension of warnings and markings in a restricted space The following symbols appear on the Welch Allyn OAE Hearing Screener equipment or in the Welch Allyn OAE Hearing Screener Directions for Use Attention consult accompanying documents R Type B equipment Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 44 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 The grounded terminal shall be connected to the steel skeleton or under the main reinforcing steel with any multiple grounding wires grounded at the same point One point grounding The shield room or bed must also be grounded at the same grounding terminal as the installation site Power Plug Requirements Use only the following power plug configurations e A 3 pin power plug requires a 3 pin wall socket with a properly installed grounding pole Verify the wall receptacle is correctly grounded before inserting the 3 pin power plug e A 2 pin 3 pin adapter for connecting 3 pin power supply plugs to a 2 pi
46. n wall socket The grounding terminal on the adapter must be fixed with the free end secured to the ground terminal e A 2 pin power plug with a grounding terminal for a 2 pin wall socket The grounding terminal on the power plug must be secured to the ground terminal Types of Hospital Facility Groundings Use the following information to verify the installation site has the appropriate grounding Grounding Resistance The ground resistance of grounding poles connected to medical equipment must be 10 ohms or less Protective Grounding Protective grounding must be provided for patient safety to let the leak current flow into the ground Functional Grounding This type of grounding is not a requirement for patient safety but will help to eliminate hums Hazards of Improper Electrical Installations Improper electrical installation can cause electrical shock to either the patient or user It can also damage system equipment under a fault condition Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 45 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 HB EMC Guidance and Manu
47. nd related equipment Environmental Conditions e Select a room with properly grounded power sources when using in AC powered configuration e Do not use or store the Welch Allyn OAE Hearing Screener and equipment in places where chemicals are stored or where there is a potential for gas leakage e Avoid moisture or contact with water extreme atmospheric pressure excessive humidity and temperatures poorly ventilated areas and dusty saline or sulfuric air e Verify the selected site maintains a relative humidity between 25 and 95 without condensation e 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 Avoid the potential for mechanical shock or possible vibrations during setup system operation or when relocating the equipment Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 50 System Hookups WARNING Only use the Battery Charger Power Supply Models Number 520 PS6VDC with the Welch Allyn OAE Hearing Screener e Verify the maximum load for any multiple portable socket outlet if used does not exceed 750 VA e Do NOT place any multiple portable socket outlets if used on the floor e f multiple portable socket outlets are used DO NOT use the multiple socket outlets to power any equipment that isn t a part of the Welch Allyn OAE Hearing Screener Adding other equipment
48. next test ID number so that all tests performed in this way will be present in memory until the tests begin to be overwritten once the capacity of the memory is achieved 1 Gorga MP Neely ST Ohlrich B Hoover B Redner J Peters J 1997 From laboratory to clinic a large scale study of distortion product otoacoustic emissions in ears with normal hearing and ears with hearing loss Ear amp Hearing 18 6 440 455 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 27 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 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 To print out the results immediately after a test is performed using the serial printer it must be connected to the screener before the test is begun using the special cable provided with the printer The cylindrical RS232 connector end of this cable should be aligned and plugged securely into the receptacle labeled IOIOI on the left side of the screener The other end of this cable is a RJ12 connector that is commonly seen on telephone cords It should be connected into the bottom of the serial printer If the serial p
49. nt and Patient Preparation cccccccccceseeeeeeeeeeeeeeeeeeeseeeeeseaeeseieeeseieeeeeeess 10 Patient Preparation isuri eriin e an iaa etae ARAA EEan ERA aE EEEN REE E A tar R A 10 Pati6nt Instruciion S anea e a a a 11 Chapter 4 Care and Maintenance of the Probe cc cccecceeeeeeeeeneeeeneeeeeaeeeeeeeeeeaeeseeeeseeeseeeess 12 Chapter 5 Quick Guides and Instructional Videos ccccceeeseeeeeeeeeeeee tees scene eeeaeeteeeeteaeeeeneeess 12 Chapter 5 Quick Guides and Instructional Videos cceccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeteeeeteaeeseneeee 13 Chapter 5 Quick Guides and Instructional Videos ccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeaeeseeeeseaeeseneeess 14 Instructional Videos on the Welch Allyn OAE Hearing Screener Inservice Guide 14 Chapter 6 Welch Allyn OAE Hearing Screener Clinical Competency Evaluation and Result LOLS NS cenana zi febe cus o La a ee Lea aa eda ee Rt gS ee ate 19 Chapter 7 System Operation cccccecceeeeeeceneeeeeeeeseaeeeeeeeceaeeeeeaeeseaeeseaneeseaeesseeeeseaeetsaeeessaeeseaeeees 23 Buttons and Their Function iniri aa eee a atheist en glen anes 23 Program Flow Chart ecccccccceeeceeceeeeeeeeeeseeeeeeeeeeceaeeseaeeeseaeeceaeeeseaeeseaeeseaaeescaeeseeeeseaeessueeesseessaees 24 Chapter 8 Distortion Product Otoacoustic EMISSIONS ccccccccesseeeessceeeessneeeeessnseeeeesnaeeeeseaes 25 Pertormingza DROAE TOS tis sissies e aaaea r aaa a a aaa
50. or agent or service representative This warranty does not include breakage or failure due to tampering misuse neglect accidents modification or shipping This warranty is also void if the instrument is not used in accordance with manufacturer s recommendations or if repaired by other than Welch Allyn or an authorized agent Purchase date determines warranty requirements No other express warranty is given Remember to submit the instrument registration warranty card for warranty validation Complete the information and mail the pre addressed card to Welch Allyn Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 43 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 Equipment Identification Labels and Markings Classification The International Electrotechnical Commission classifies electro medical equipment according to its power source external or internal and the degree of protection it provides against shock The Welch Allyn OAE Hearing Screener is classified as Type B which means it qualifies as externally powered equipment capable of protecting a patient from electrical shock Warning Labels and Symbols Symbo
51. or greater ata particular frequency The interested reader is referred to this study for more detailed information Changing the DPOAE Default Protocol to Continue through All Frequencies If you would like the system default DPOAE protocol to test all of the frequencies even after conditions for an overall Pass or overall Refer are met you can load a new default protocol into your Welch Allyn OAE Hearing Screener 1 Using Windows Explorer open the directory C Program Files Welch Allyn OAE Hearing Screener WA OAE Load Software 2 Delete the file named default adx 3 Locate the folder named AA and open it 4 Select and copy the file named default adx contained in the AA folder 5 Return up one level to the WA OAE Load directory 6 Paste the copied default adx file into the WA OAE Load directory 7 Exit Windows Explorer 8 Connect the screener to the PC using the provided communication cable 9 Launch the WA OAE Load program 10 Select Start to load the firmware into the screener See Chapter 13 if you need additional instructions about how to install the WA OAE Firmware onto the screener 1 Gorga MP Neely ST Ohlrich B Hoover B Redner J Peters J 1997 From laboratory to clinic a large scale study of distortion product otoacoustic emissions in ears with normal hearing and ears with hearing loss Ear amp Hearing 18 6 440 455 Welch Allyn OAE Hearing Screener Directions for Use 705353 Re
52. ory and the user wishes to print out all of them at one time Every test that is stored in memory that has not been printed before will be printed if the DX SELECT button is pressed when the PRINT ALL UNPRINTED TESTS message is displayed If the intent is only to print individual tests bypass the PRINT ALL UNPRINTED TESTS message by pressing the DOWN arrow button until the PRINT BOTH EARS RESULTS is displayed on the LCD The first individual test Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 30 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 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 This is an indication that all of the tests currently stored in memory were previously printed out However if the user wishes to print a test result again this can be accomplished by printing out the desired test s individually Welch Allyn OAE Hearing Screener Directions for
53. other devices such as notebook computers or printers may cause damage to the Welch Allyn OAE Hearing Screener unit Likewise using the Welch Allyn OAE Hearing Screener adapter charger on other devices may cause damage to that device Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 8 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 After verifying the connectors are properly aligned slide the communication cable connector end securely into its matching connector on the Welch Allyn OAE Hearing Screener box 2 Insert the opposite end of the communication cable into the appropriate port USB or Serial on the computer Battery Welch Allyn OAE Hearing Screener 29400 29401 uses either a lithium ion battery or an AC charger as a power source When fully charged the battery will last for approximately three hours of continuous testing The auto OFF feature conserves battery life by turning the Welch Allyn OAE Hearing Screener off after approximately 180 seconds of dormancy When the system turns off automatically the user presses the ON
54. posable nozzle will have to be replaced The nozzle has two clips that secure it to the prabe hady The hottam clip is flat and smooth to the touch The tap clip has a ridge of additional plastic on its surface Locate the smooth flat clip Use your fingernail Locate the clip with the ridge and use your After both clips are unlocked gently to lift up on the end of the clip to unlock it fingernail to lift up and unlock it pull nozzle off of the prabe body To install a new nozzle onto the probe body Once the two pieces are aligned to match Make sure that the nozzle component is align the clips on the probe nozzle with the slide the nozzle clips down the slots until they securely attached to the probe body corresponding slots in the probe body Be sure lock into the small indentations at the back of that the probe nozzle component is oriented the probe body so that the shape of the cavity matches the shape of the probe body WelchAllyn 4341 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA p 800 535 6663 f 315 685 2174 www welchallyn com Advancing Frontline Care 2006 Welch Allyn M2931 Rev B Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 13 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 e List the steps required for performing an OAE test and for rev
55. printer USB printing from the screener to the label printer is not possible Some models of Seiko label printers are only compatible with a newer version of the firmware that is installed on the OAE Hearing Screener using the WA OAE Load Software This means that the Seiko printer provided with a new system purchase may not print when connected to a previously purchased Welch Allyn OAE Hearing Screener system To resolve this issue the user can update the firmware version installed on the older OAE Hearing Screener using the WA OAE Load Software provided with the new system or printer Refer to Chapter 13 for instructions about how to install the firmware Operating Steps 1 Connect the white power supply to the back of the Seiko label printer and plug into wall outlet 2 Turn Seiko label printer on by pressing white button green light should display 3 Place white cylinder thru roll of labels Labels should be facing downward Feed label thru into slot behind and below the label roll container Press the white Label feed button to start the label roll 4 Connect the serial cable to the printer telephone jack and to the OAE Hearing Screener red connector 5 See chapter 8 9 and 10 regarding how to print data Label Feed Button On Button For additional questions please make contact with Welch Allyn Technical Support at 1 800 535 6663 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 33 Ordering Label
56. r Directions for Use 705353 Rev E 5 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 This value is expressed in dB SPL RS232 a cylindrical hardware connector with pins that must be aligned to the corresponding holes in the connector to which it attaches the Welch Allyn OAE Hearing Screener to a serial printer Serial connector an external peripheral interface standard for communication to a label printer USB connecior An external peripheral interface standard for communication between a computer and the Welch Allyn OAE Hearing Screener box for updating the software in the Welch Allyn OAE Hearing Screener setting the time and date or to download data to the PC Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 6 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 EAR PROBE BLACK SERIAL CONNECTOR TO LABEL PRINTER RED POWER SUPPLY NO COLOR Welch Allyn OAE Hearing Screener Box with Cable Connections Indicated Probe Cable Assembly 1 Align the pins in
57. rameters used the patient s emissions and the level of background noise test time can vary from as little as 10 seconds to several minutes During the OAE test very soft sounds are measured by the probe in the patient s ear canal Because sound measurements are being performed it is important that the noise in the environment be controlled as much as possible OAE tests are fastest when the background noise and patient generated noise is low Be aware of sources of noise in the room Take measures to control them or find a quieter room if possible Patient Preparation 1 If you are trained and equipped to perform an examination of the ear canal with an otoscope it is highly recommended that you do so prior to insertion of the ear tip into the patient s ear Verify that the ear canal is clear of cerumen earwax that can interfere with the OAE test Performing an OAE test on an ear draining fluid is not recommended 2 Select a disposable ear tip that seems appropriate for the size of the patient s ear canal and install it on the probe Use the largest ear tip that will fit into the patient s ear canal An ear tip that is too small will result in low stimulus intensity and may cause a refer result See Chapter 4 for proper ear tip instructions 3 Insert the ear tip into the patients ear canal When using the larger size foam tips be sure to compress the tip with your fingers until it is a small diameter cylinder Quickly while it
58. rinter was not attached to the screener during collection of the data see the section entitled Printing Previously Collected Data for the details on printing test results This flow chart begins at the point immediately after the DPOAE test has been successfully completed With the serial label printer the assumption is that the printer is already powered ON and is connected to the screener If result is a Refer then pressing the down arrow 2 times will display the Print message Retest LCD message displays in between HHH R L HHH R L PASS REFER SEE DETAIL A PASS REFER PRINT DX SELECT X KHZ DP PASS REFER NOISE ai detected Printer Yes No DX SELECT a SELECT Printing of this test TURN PRINTER ON O TEST occurs TRY AGAIN RESULTS SELECT As can be seen from the flow chart above printing of the test just completed can be performed in two different ways From the SEE DETAIL screen the user can press the down arrow button to access the PRINT message and press DX SELECT Or from the SEE DETAIL screen the user can elect to first see the details on the LCD by pressing the DX SELECT button and use the up down arrow buttons to move through the test frequencies Pressing the DX SELECT button from any one of the frequency details displays will access the PRINT TEST RESULTS screen Pressing the DX SELECT button implements the printing of this test Welch Allyn OAE Hearing Screener Directions for
59. s To order labels call Welch Allyn at 1 800 535 6663 Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 34 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 Creation Date gaang Power down tine 3 Number of frequencies for overall pass 3 Mumber of samples per set 60 Checkfit trials 10 Calibration trials 10 Humber of successes to pass 1 Huriber of calibration successes to pass 1 Number of checkfit failures until refit 7 Muruber of calibration failures until refit 7 Checkfit Calbration Artifact Rejection 250 Checkfit is not done during test Lower frequency shift On Higher frequency shift OF The action taken when an overall refer is achieved is to stop the test The action taken when an overall pass is achieved is to stop the test Collection Parameters L2 S000 fia 55 1 22 30 4000 65 55 1 22 30 3000 65 55 1 22 30 2000 a5 55 1 22 30 5000 5 nd a 17 12 4000 5 Amel 8 17 12 3000 5 nd a 17 12 2000 5 nd a 17 12 Pass Refer Criteria DP And Or DP NF Noisy Message Include in PR 5000 And 6 5 Yes 4000
60. s ceftssscictistecieiais fase A 9 Cc Changing the Default Protocol to Continue through All Frequencies sece 36 Charger Unit sccectjechelectiea tein ideesteathe ec 8 Clinical Competency Evaluation 19 20 Communication Cable ccccseeeeeteeeeeneees 9 D Default Protocols cccecceeeeeeeeeeeteeeeeeeeeees 35 DPOAE Protocol cccccccceeseeeeeeeeeeeeeeeneeeeess 35 E Environmental Specifications ccceeeee 46 Equipment Identification Labels and Markings 44 Error messages seceeeeeseeeeeseeeeeeeseeeneetnneeteee 41 H Hardware sisinio nae inten 7 l Increase Artifact Reject Level ee 26 INDEX Instructional Videos 14 L Label Printer 2 cceseeceeeeseeeeeeeseeeteseneeeessees 33 P Patient Instructions s e 11 Patient Preparation seeren 10 Performing a DPOAE Test 25 Precautions and Safety Instructions 44 Printing DPOAE ecceesceeeseeeeeeeeeeeeteeeteeeeee 28 Printing Previously Collected Data Both Ears32 Printing Previously Collected Data Single Ear i Ses uaslemtiedvinialesied SieYulladea tel 30 Probe Care and Maintenance e 14 Program Flow Chatt eeccesceseceeseeeeeeeesrens 24 Q Quik Guide eaa 17 S System COMPOnents ccceeeceeeeeeeeeeeeteeeeeeetees 7 System Operation cceceeeeeeeseeeeeeteneeeeeens 23 T Troubleshooting e ee eeeeeeeeneeeeeeteeeeeenneeeeennees 41 V View DPOAE Te
61. s are controlled The customer or user of the REF 29400 Series OAE Hearing Screener can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the REF 29400 Series OAE Hearing Screener as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Max 150 kHz to 80 MHz d 80 MHz to 800 MHz d 800 MHz to 2 5 GHz d Output Power of 1 17 P 1 17 P 2 33 P Transmitter W 0 01 0 117 0 117 0 233 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 49 Installation Precautions Observe the following precautions when using the Welch Allyn OAE Hearing Screener a
62. t case select click on the arrow to display a list of the Communication ports available Click on the communication port to which the screener is connected Status area This area displays information about the progress of the WA OAE Firmware download Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 39 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 2 Install the ASCII Link program from the Welch Allyn OAE Inservice Guide CD Attach the Welch Allyn OAE Hearing Screener unit to the computer using the USB cable provided with the system Launch the ASCII Link program Be aware that this application will automatically delete all tests from the Welch Allyn OAE Hearing Screener memory after the conversion to ASCII format has been performed This application automatically transfers the data from the Welch Allyn OAE Hearing Screener to the computer and converts it to an ASCII file The ASCII file can be found in the directory C Program Files Welch Allyn OAE Hearing Screener ASCIl Link The filename and extension is asciilink axo The AXO file is a space delimited ASCII file Each line conta
63. v E 36 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 You can use this application if the delivered firmware becomes corrupted and must be reinstalled to update the date and time on the Welch Allyn OAE Hearing Screener or to upgrade the system if you receive new firmware To install the WA OAE Load application on your computer 1 Turn on your computer 2 Make sure the system date and time settings on your computer are correct During the WA OAE Load process the date and time set on the PC will be used to set the clock inside of the screener 3 Locate the Welch Allyn OAE Hearing Screener Inservice Guide CD provided with your Welch Allyn OAE Hearing Screener 4 Insert the CD into the computer s CD drive If your PC supports automatic opening of the installation program you will see the following screen when the CD is opened j ide Welch Allyn OAE Software Welch Allyn ASCII Link View Instructional Help Video Directions for Use E a E TE CD Contents Contact Us Exit Welch Allyn OAE Hearing Screener Directions for Use 7053
64. you meet with resistance Then place your fingernails behind the thickened ring around the base of the tip and slide the tip on until it is all the way on the nozzle Base end of the ear tip is not flush against base of nozzle To remove the silicone ear tips hold the probe body with your fingers on top of the nozzle clips With the other hand place your fingernails at the base of the ear tip and slide it off the nozzle WelchAllyn Advancing Frontline Care Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 12 After removing the disposable ear tip inspect the probe nozzle for debris in any of the three grooves Note At the base of two of the groves a short protrusion of nylon filament may be visible This is part of the design and should not be removed If debris is present clean the grooves with a tissue or gauze pad A hearing aid wax removal tool may be useful for this as well if one is available Be sure to clean the grooves from the base to the tip to avoid pushing debris back into the closed channels at the base of the grooves You may use an alcohol pad to clean the nozzle Do not let excess alcohol drip down the grooves into the closed channels at the base That portion of the probe cannot be cleaned The probe nozzle should only be removed to troubleshoot data collection problems After a few times being removed the clips will no longer hold the nozzle securely in place on the body and the semidis

Welch Allyn Medical Diagnostic Equipment REF 29400 User's Manual

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