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Welch Allyn REF 29400, Directions For Use Manual

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Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 

 

 

 

35 

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.   

 

 

 

Summary of Contents for REF 29400

Page 1: ...OAE Hearing Screener Directions for Use REF 29400...

Page 2: ...f 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 otherw...

Page 3: ...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 t...

Page 4: ...y After a Test 27 Printing DPOAE Test Details Immediately After a Test 28 Viewing Previously Collected DPOAE Data 29 Chapter 9 Printing Previously Collected Data Single Ear 30 Chapter 10 Printing Prev...

Page 5: ...n 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 Al...

Page 6: ...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...

Page 7: ...t 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 S...

Page 8: ...e pins in the connector end of the probe cable to the holes in the jack on the top of the Welch Allyn OAE Hearing Screener box An arrow on the connector shows the correct orientation of the probe conn...

Page 9: ...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...

Page 10: ...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 He...

Page 11: ...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 lo...

Page 12: ...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...

Page 13: ...Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 12 Chapter 4 Care and Maintenance of the Probe...

Page 14: ...Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 13...

Page 15: ...gestions to help you use otoacoustic emissions to test infants toddlers and preschoolers Explain conditions that could cause a Refer result for a Welch Allyn OAE Hearing Screener One laminated copy of...

Page 16: ...Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 15...

Page 17: ...Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 16...

Page 18: ...e Use larger probe tip if possible Patient noise Crying or struggling against the probe Sucking a pacifier or bottle Excessive movement Talking FOR NEWBORNS OR INFANTS Swaddle child in blanket and tes...

Page 19: ...ormed in ear yet Manipulate the ear in a gentle circular motion before inserting the ear tip Make sure to have a good probe fit If infant is lying on side reposition infant so that down ear faces up a...

Page 20: ...tion can be used to ensure that new screeners are competent in using the Welch Allyn OAE Hearing Screener This evaluation can also be used to document that training occurred and use of the Welch Allyn...

Page 21: ...aunches Screener program _______ _______ _______ 7 Records patient Log Number _______ _______ _______ 8 Swaddles baby and or prepares _______ _______ _______ patient for test 9 Selects patient s ear i...

Page 22: ...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 concern...

Page 23: ...evelopment 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 c...

Page 24: ...f 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 t...

Page 25: ...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 t...

Page 26: ...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...

Page 27: ...ay 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 t...

Page 28: ...d 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...

Page 29: ...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 W...

Page 30: ...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 n...

Page 31: ...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 The PRINT ALL UNPRINT...

Page 32: ...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...

Page 33: ...ESULTS Choose Test 1 R L PASS REFER DX SELECT V Final Test Ear L R NO RESULTS FOR BOTH EARS Database does not contain both right and left ear tests DX SELECT V Database contains right ear and left ear...

Page 34: ...nected 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 Loa...

Page 35: ...Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E 34 Ordering Labels To order labels call Welch Allyn at 1 800 535 6663...

Page 36: ...omes 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...

Page 37: ...ers 1997 1 In Gorga et al s study hearing impairment was defined as a behavioral pure tone audiometric threshold of 25 dB HL or greater at a particular frequency The interested reader is referred to t...

Page 38: ...vered 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...

Page 39: ...that the screener is connected to the PC using the cable provided with the system 3 It is advisable to plug the screener charger power supply into the screener during this operation so that a low batt...

Page 40: ...te 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 I will check to make sure...

Page 41: ...formed This application automatically transfers the data from the Welch Allyn OAE Hearing Screener to the computer and converts it to an ASCII file 4 The ASCII file can be found in the directory C Pro...

Page 42: ...lch 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 instr...

Page 43: ...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...

Page 44: ...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 specificati...

Page 45: ...ctrical shock Warning Labels and Symbols Symbols are often used on equipment in preference to words in order to simplify language differences and to provide instant comprehension of warnings and marki...

Page 46: ...ify the wall receptacle is correctly grounded before inserting the 3 pin power plug A 2 pin 3 pin adapter for connecting 3 pin power supply plugs to a 2 pin wall socket The grounding terminal on the a...

Page 47: ...t 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...

Page 48: ...ical 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 o...

Page 49: ...mitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compli...

Page 50: ...according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Max Output Power of Transmitter W 150 kHz to 80 MHz d 1 17 P 80...

Page 51: ...are stored or where there is a potential for gas leakage Avoid moisture or contact with water extreme atmospheric pressure excessive humidity and temperatures poorly ventilated areas and dusty saline...

Page 52: ...does not exceed the safety limit 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...

Page 53: ...owing conditions are met 1 The system computer and all other peripheral devices are plugged into an approved isolation transformer 2 The portable computer is powered by batteries not plugged into a wa...

Page 54: ...Equipment Identification Labels and Markings 44 Error messages 41 H Hardware 7 I Increase Artifact Reject Level 26 Instructional Videos 14 L Label Printer 33 P Patient Instructions 11 Patient Preparat...

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