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Welch Allyn REF 29400 manual

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Table of contents for the manual

  • Page 1

    OAE Hearing Screener Directions for Use REF 29400[...]

  • Page 2

    COPYRIGH T © 2009 Welch Allyn. Al l rights are reserved. No one is perm itted to reproduce or duplicate, in any form, this m anual or any part thereof without permission f rom W elch Ally n. W elch Ally n assumes no responsibility for any i njury to any one, or for any illega l or improper use of the product, that m ay result from f ailure to use [...]

  • Page 3

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 2 Distributed by W elch Ally n under agreem ent with Natus Medical Incorporated PROPERTY OF NAT US MEDICAL INCORPORAT ED ALL RIGHTS RESERVED U.S. Patents nos. 5,738,633 and 6,149,605 Bio-logic is a registered tradem ark of Natus Medical Incorpor ated IBM is a registered tradem ark [...]

  • Page 4

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 3 Contents Chapter 1: Introduction ....................................................................... ............................................. 4 About this manual .................................. ..........................................................................[...]

  • Page 5

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 4 Chapter 1: Introduction The W elch Ally n OAE Hearing Screener m easurem ent system perf orm s otoacoustic em iss ions tests. Using a com bination of hardware and sof tware, the W elc h Ally n OAE Hearing Screener produces a controlled acoustic signal in the ear canal and measure[...]

  • Page 6

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 5 A bbreviations A RT LVL - ar tifact level; refers to the thres hold at which samples of data com ing into the W elch Allyn OAE Hearing Screener for process ing are rejected bef ore averaging in order to keep noise fr om averaging into the response. Artifac t level is reported in [...]

  • Page 7

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 6 L1 - level or intensity of F 1; the lower of the stimulus f requencies ex pressed in dB SPL. L2 - level or intensity of F 2; the higher of the stim ulus frequenc ies express ed in dB SPL. NF - noise floor; r efers to the average am plitude of the back ground noise meas ured at fr[...]

  • Page 8

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 7 Chapter 2: Welch A lly n OA E Hearing Scre ener Component s and Hardw are Setup Cable Connections The cable connec tions to the W elch Ally n OAE Hearing Screener box are desc ribed in the figure and the instructions below. Welch Ally n O A E Hearing Screener Box w ith Cable Conn[...]

  • Page 9

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 8 Probe part #29402 is compatible o nly with Welch Ally n O A E Hearing Screener (b lue) hardware 29400/29401. Charger Unit Assembly The charger unit is not required for norm al operation. The unit is attached to the W elch Ally n OAE Hearing Screener f or the purpose of rec hargin[...]

  • Page 10

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 9 Communicat ion Cable Assembly The com m unication cable is provided only f or loading the W elch All y n OAE Hearing Screener internal firm ware or for downloading data to a computer. Com m unication tak es place through a serial port or USB port and requires connection to a com [...]

  • Page 11

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 10 Chapter 3: Environment and Patient Prep aration There is m inim al patient preparation required for an OAE test. Since the test m easures a phy s iologic event, no behavi or al response is required f rom the patient. Therefor e, OAEs can be recorded on sleeping individuals or on[...]

  • Page 12

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 11 Patient Instr uctions For patients who can understand instructions, the f ollowing i nf orm ation will hel p prepare them for the test. Inform them that: 1. You w ill insert the ear tip into the ear canal. 2. He/She will hear a series of s ounds for a f ew seconds, up to a m inu[...]

  • Page 13

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 12 Chapter 4: Care and M aintenance of the Probe[...]

  • Page 14

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 13[...]

  • Page 15

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 14 Chapter 5: Quick Guides and Instructional Videos This sec tion of the docum ent presents Q uick Guides, step-by step test procedures and other useful inform ation. T he Quick Guides: • List the steps required for perform ing an OAE test and f or reviewing OAE data. • Present[...]

  • Page 16

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 15[...]

  • Page 17

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 16[...]

  • Page 18

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 17 Quick Guide: Causes of ‘Refer” r Welch A l ly n OAE Hearing Screener Troubleshooting Quick Guide: Causes of Refer Results Noise Problem Possible solutions ♦ Noisy surroundings — Other people in or near test site. — Devices such as f ans, air conditioners, intercom s, a[...]

  • Page 19

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 18 Obstructions Problem Possible solutions ♦ Cerum en, vernix, or other debris — In the ear — On the probe tip — On the probe ♦ IN THE EAR: — Make sur e that a properly tr ained technician examines the ear canal for obstr uctions BEFORE inserting the probe. — Delay te[...]

  • Page 20

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 19 Chapter 6: Welch A lly n OA E Hearing Scr eener Clinical Competency E v alua tion and Result Letters The W elch Ally n OAE Hearing Screener Clinical Competency Evalua tion is used for the T rain the Trainer approac h to learning the W elch Allyn OAE Hearing Screener. This evalua[...]

  • Page 21

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 20 Welch A llyn OA E Hearing Sc reene r Clinica l Competenc y E valuation Purpose: This evaluation certifie s that ____ ____ _____ ____ has m et W elch Allyn’s requiremen ts fo r utilizing the OA E Hearing Scre ener. The training involved hand s-on exercises. Althou gh fu rther t[...]

  • Page 22

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 21 PEDIATRIC HEA RING SCREENI NG RESULTS Date of Exam :____ ____ ____ _____ ____ ___ Patient ’s Name :____ ____ ____ ____ _____ ___ Date of Birth :____ ____ _____ ____ ____ ___ This p atient's hearing was scree ned u sing otoa coustic e missions. Th e patien t passed the he [...]

  • Page 23

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 22 PEDIATRIC HEA RING SCREENI NG RESULTS Date of Exam :____ ____ ____ _____ ____ ___ Patient ’s Name :____ ____ ____ ____ _____ ___ Date of Birth :____ ____ _____ ____ ____ ___ This p atient's hearing was scree ned u sing otoa coustic e missions. Th e patien t referre d on t[...]

  • Page 24

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 23 Chapter 7: System Operation The f ront label of the W elch Ally n OAE Hearing Screener incorporates five buttons that the user presses to tur n on or reset the box and m ove through the possible program operations. Refer to the figure and the instructions that follow it to under[...]

  • Page 25

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 24 The UP and DOW N arrow buttons m ove through the list of program choic es and data files. Press the UP or DOW N arrow keys until the desired program f unction appears in the LCD. Then pres s the DX SELECT button. Program Flow Chart In this section the Program Flow Chart is brok [...]

  • Page 26

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 25 Chapter 8: Distortion Product Otoacoustic Emis sions Performing a DPOAE Test This flow c hart begins at the point where the Pow er ON flow c hart ended. The s teps shown here are specif ic for per form ing the pre-pr ogram m ed DPOAE test procedure. Note: Selection of the RESTAR[...]

  • Page 27

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 26 After 10 tests have been perf orm ed, the next test (test 11) will overwrite the first test. This proceeds in a continuous loop so that only the last 10 tests perfor m ed are saved and access ible in mem or y . O nce overwritten, a test cannot be retrieved. If you w ish to rec o[...]

  • Page 28

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 27 Viewing DPOAE Test Detai ls or Retesting an Ear with a Refer Result Immediate ly After a Test This f low chart begins at the point imm ediately af ter the DPOAE test has been succ essf ully com pleted and the SEE DETAILS mess age is display ed. The PASS/REFER indicator display e[...]

  • Page 29

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 28 Printing DPOAE Test Detai ls I mmediately After a Test The W elch Ally n OAE Hearing Screener with the serial label pr inter prints out a 2” x 4” self - adhesive label showi ng the test details imm ediately af ter it is perfor m ed or to print it out later by retrieving it f[...]

  • Page 30

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 29 Viewing Previ ously Collected DPOAE Data This f low chart begins at the point where the P ERFORM DPOAE m essage is dis play ed and shows the program flow for instances in which y ou wish to view data that is saved in mem ory. Recall that only the last 10 tests ar e retained in m[...]

  • Page 31

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 30 Chapter 9: Printing Pr ev iously Collected Dat a – Single Ear The AC power supply must be connected to the back of the printer and plugged into an outlet. The printer m ust be powered ON using the ON/OFF switch. W hen using the serial label printer, be sure to have it plugged [...]

  • Page 32

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 31 display ed will be the last test perf orm ed. W hen the des ired test num bers have been chos en, press the DX SELECT button to print out a label for that particular patient. If the printer is not connec ted to the scr eener or is not powered O N when an attem pt is made to prin[...]

  • Page 33

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 32 Chapter 10: Printing Pr ev iousl y Colle cted Dat a – Both Ears on One Label This flow c hart begins at the point where the PERFORM DPOAE m es sage is display ed and shows the program flow for instances in which y ou wish to print data that is stored in mem ory. PERFORM DPOAE [...]

  • Page 34

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 33 Label Feed Button On Button Chapter 1 1 : Printer See Chapters 8, 9 and 10 for instruc tions about how to print out tests from the W elch Ally n OAE Hearing Screener. The W elch Ally n OAE Hearing Screener 29400/29401 (blue label) is only com patible with the Seiko label printer[...]

  • Page 35

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 34 Ordering Labels To order labels c all W elch Allyn at 1-800-535-6663.[...]

  • Page 36

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 35 Chapter 12: System Default Protocol The W elch Ally n OAE Hearing Screener com es pre-progr am med with a DPOAE default scr eening protocol. The system default protocol is: DPOAE System Default Protocol Collection P aramete rs, Stopping Parame ters and Pass/ Refer Criter ia The [...]

  • Page 37

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 36 DPOA E Measur ement-Base d Stopping Rules per Tes t The system def ault DPOAE protocol stops the test when the conditions for an overall test Pass or Refer occ ur. For exam ple, if the f irst 3 fr equencies “Pass” , then the final frequency wi ll not be tested since the over[...]

  • Page 38

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 37 Chapter 13: Reloading W A OA E Firmw are (W A OA E Load sof tw ar e) The W elch Ally n OAE Hearing Screener runs on firm ware that resides on a m em ory chip inside the unit. Each W elc h Ally n OAE Hearing Screener c omes with this firm ware pre-installed so that the device is [...]

  • Page 39

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 38 • If y our PC does not support the autom atic running of the installation software on the CD y ou will need to browse to the CD drive using W indows Explorer and open the file nam ed “install.exe” to view this screen. 5. Select the Install WA OA E Load button. 6. Follow th[...]

  • Page 40

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 39 8. Exit the application w hen the W A OAE Firmware download is complete. Note: If you need assist ance installing th e WA OA E Load softw are on your PC or dow nloading W A OA E Firmware, please con tact Welch Ally n Tech nical Support at 1- 800-535-6663. The table below provide[...]

  • Page 41

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 40 Chapter 14: Exporting using A SC II Link ASCII Link is a utility program that lets you downl oad data f rom the W elch Ally n OAE Hearing Screener unit's m em ory to a PC and convert it to an ASCII file. This tool lets you save W elch Ally n OAE Hearing Screener data in y o[...]

  • Page 42

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 41 Chapter 15: T r oubleshooting, Service and W arranty Error m essages usually appear on the LCD when the sy s tem is unable to perform a des ired function. T his section lists som e of the mor e com m on error m ess ages and possible solutions. Error Messages This mes sage appear[...]

  • Page 43

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 42 This m essage appears when one of the buttons on the W elch Ally n O AE Hearing Screener label is depressed f or mor e than .3 sec . R eleasing the button returns the s y s tem to norm al operation. If depressed during data collection the artifact rejec tion threshold level w il[...]

  • Page 44

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 43 Service Caution Unauthorized repairs will voi d the warranty . A W elch Ally n Service Center mus t perform all repairs on produc ts under warranty. Quali fied electronics personnel or a W elch Ally n Service Center s hould repair products out of warranty. Technical Assistance I[...]

  • Page 45

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 44 A ppendix A Precautions and Safety Instructions Equipment Ide ntification Lab els and Markings Classification The International Electrotechnical Com m ission classif ies electro-m edical equipm ent according to its power source (ex ternal or internal) and the degree of protectio[...]

  • Page 46

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 45 Electric al Insta llation Requi rements The f ollowin g requirem ents are necess ary onl y when using the W elch Ally n O AE Hearing Screener in an AC-powered configuration. Grounding is not necess ary i n nor m al battery -powered use. Groundin g Requirement s The desired insta[...]

  • Page 47

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 46 Environmental Spec ifications Temperature Operating: 15 to 40 degrees C Storage: -20 to 70 degrees C Humidity Operating: 15% to 95% @ 40 degrees C non-condens ing Storage: 90% @ 65 degrees C Note: These are maximums and shou ld not be co nsidered 'normal' operating or [...]

  • Page 48

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 47 Electromagnetic Imm unity The REF 29400 Series OAE Hearing Screener is intended f or use in the electrom agnetic environment specified below. The custom er or user of the REF 29400 Series OAE Hearing Screener should assur e that it is used in such an environment. Immunity Test I[...]

  • Page 49

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 48 Electromagnetic Imm unity The REF 29400 Series OAE Hearing Screener is intended f or use in the electrom agnetic environment specified below. The custom er or user of the REF 29400 Series OAE Hearing Screener should assur e that it is used in such an environment. Immunity Test I[...]

  • Page 50

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 49 b Over the frequency range 150 kHz to 80 MHz, field strengths s hould be less than 3 V /m. Recommended Separation Distances Betw een Portab le and M obile RF Co mmunicatio ns Equipment an d the REF 29400 Series OAE Hearing Screener The REF 29400 Series OAE Hearing Scr eener is i[...]

  • Page 51

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 50 Installatio n Preca utions Observe the following precautions when using the W elch Allyn OAE Hearing S creener and related equipment. Environmental Co nditions • Select a room with properly gr ounded power sources (when using in AC-powered configuration). • Do not use or sto[...]

  • Page 52

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 51 System Hookups • Verify the maxim um load for any multiple portable sock et-outlet (if used) does not exceed 750 VA. • Do NO T place any multiple portable socket- outlets (if used) on the f loor. • If m ultiple portable socket-outlets are used, DO NOT use the m ultiple soc[...]

  • Page 53

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 52 Installatio n Verific ation Use the following list to verify all equipment is c orrectly install ed before use. • Verify all equipment and cables are undam aged and in perfect working c ondition. • Verify all equipment and cables are connected acc ording to the instructions [...]

  • Page 54

    W elch All yn OAE Hearing Screener Directions for Us e 705353 Rev E 53 INDEX A Abbreviations .................................................. 5, 6 ASCII Link ......................................................... 40 AuDX Buttons ...................................................23 AuDX Load.....................................................[...]