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OAE Hearing Screener

Directions for Use

REF 29400

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 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

Canada

European Call Center

Germany

Latin America

Singapore

United Kingdom

+1 315 685 4560

800 535 6663

800 561 8797

+353 46 906 7790

+49 747 792 7186

+1 305 669 9003

+65 6419 8100

+44 207 365 6780

Australia

China

France

Japan

Netherlands

South Africa

Sweden

+61 29 638 3000

800 074 793

+86 216 327 9631

+33 15 569 5849

+81 33 219 0071

+31 15 750 5000

+27 11 777 7555

+46 85 853 6551

Manual Part Number 705353 Rev E

Welch Allyn

4341 State Street Road

Skaneateles Falls, NY 13153 USA

http://www.welchallyn.com

Printed in USA

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Distributed by Welch Allyn under agreement with

Natus Medical Incorporated

PROPERTY OF NATUS MEDICAL INCORPORATED

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

Contents

Chapter 1: Introduction .................................................................................................................... 4

About this manual ........................................................................................................................ 4

Chapter 2: Welch Allyn OAE Hearing Screener Components and Hardware Setup....................... 7

Cable Connections....................................................................................................................... 7

Battery.......................................................................................................................................... 9

Chapter 3: Environment and Patient Preparation .......................................................................... 10

Patient Preparation..................................................................................................................... 10

Patient Instructions..................................................................................................................... 11

Chapter 4: Care and Maintenance of the Probe ............................................................................ 12

Chapter 5: Quick Guides and Instructional Videos........................................................................ 12

Chapter 5: Quick Guides and Instructional Videos........................................................................ 13

Chapter 5: Quick Guides and Instructional Videos........................................................................ 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

Letters............................................................................................................................................ 19

Chapter 7: System Operation ........................................................................................................ 23

Buttons and Their Function ........................................................................................................ 23

Program Flow Chart ................................................................................................................... 24

Chapter 8: Distortion Product Otoacoustic Emissions................................................................... 25

Performing a DPOAE Test......................................................................................................... 25

Viewing DPOAE Test Details or Retesting an Ear with a Refer Result Immediately 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 Previously Collected Data – Both Ears on One Label ................................. 32

Chapter 11: Printer ........................................................................................................................ 33

Operating Steps ......................................................................................................................... 33

Ordering Labels.......................................................................................................................... 34

Chapter 12: System Default Protocol ............................................................................................ 35

DPOAE System Default Protocol ............................................................................................... 35

Collection Parameters, Stopping Parameters and Pass/Refer Criteria.................................. 35

DPOAE Measurement-Based Stopping Rules per Test......................................................... 36

DPOAE Pass or Refer Criteria ............................................................................................... 36

Changing the DPOAE Default Protocol to Continue through All Frequencies ........................... 36

Chapter 13: Reloading WA OAE Firmware (WA OAE Load software).......................................... 37

Chapter 14: Exporting using ASCII Link ....................................................................................... 40

Chapter 15: Troubleshooting, Service and Warranty .................................................................... 41

Error Messages.......................................................................................................................... 41

Service ....................................................................................................................................... 43

Technical Assistance ................................................................................................................. 43

Warranty..................................................................................................................................... 43

Appendix A..................................................................................................................................... 44

Precautions and Safety Instructions........................................................................................... 44

Equipment Identification Labels and Markings....................................................................... 44

Electrical Installation Requirements ....................................................................................... 45

Environmental Specifications ................................................................................................. 46

Installation Precautions .......................................................................................................... 50

System Hookups .................................................................................................................... 51

Installation Verification............................................................................................................ 52

Signal Output and Input.......................................................................................................... 52

Precautions During System Operation ................................................................................... 52

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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

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.

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

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 pure tone stimuli.

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 Screener Directions for Use 705353 Rev E

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 connector

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

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.

Welch Allyn OAE Hearing Screener Box with Cable Connections Indicated

Probe Cable Assembly

1. Align the 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 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

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 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

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 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

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

parameters 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 patient’s 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 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

Patient 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

Chapter 4: Care and Maintenance of the Probe

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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:

•

List the steps required for performing an OAE test and for reviewing OAE data.

•

Present suggestions 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 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 Hearing Screener Directions for Use 705353 Rev E

Quick Guide: Causes of ‘Refer”

rWelch Allyn 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 fans, air

conditioners, intercoms, and

public address systems.

♦ Eliminate or reduce noise

— Isolate and completely sound-proof the test site (optimal).

— Ask others in or near test site to refrain from talking or other

activity.

— Ask noisy people to move to another location; ask parents to

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

— Crying or struggling against the

probe

—

Sucking a pacifier or bottle

—

Excessive movement

—

Talking

♦ 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.

♦ FOR TODDLERS:

— Distract fussy toddlers with a quiet toy or book.

— Ask parent to help by holding the toddler comfortably on lap or

shoulder.

♦ FOR OLDER CHILDREN:

— Explain that being quiet will speed up the test and reduce the

possibility of retesting.

Middle Ear Involvement

Problem Possible solutions

♦ Middle ear conditions that add

mass or stiffness to the middle ear

such as:

— Otitis media

— Severe Eustachian tube

disfunction

— Otosclerosis

♦ Refer results caused by temporary conditions that cause middle

ear involvement will improve as the middle ear returns to normal.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Obstructions

Problem Possible solutions

♦ Cerumen, vernix, or other debris

— In the ear

— On the probe tip

— On the probe

♦ IN THE EAR:

— Make sure that a properly trained technician examines

the ear canal for obstructions BEFORE inserting the

probe.

— Delay testing newborns until 11 hours after birth, if

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

— Occurs often with "down ear" when infant

is lying on side.

— Collapse is normal because bones

haven't formed 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; 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

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 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 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

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

1) Properly plugs in equipment _______ _______ _______

2) Properly turns on equipment _______ _______ _______

3) Powers on label printer _______ _______ _______

4) Demonstrates how to clean probe _______ _______ _______

5) Follows facility infection control _______ _______ _______

6) Launches Screener program _______ _______ _______

7) Records patient Log Number _______ _______ _______

8) 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) Prints results from label printer _______ _______ _______

15) Restarts for next patient _______ _______ _______

16) 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

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

PEDIATRIC HEARING SCREENING RESULTS

Date of Exam:________________________

Patient’s Name:________________________

Date of Birth:________________________

This patient's hearing was screened using otoacoustic 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. If 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

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

Welch Allyn OAE Hearing Screener and Buttons

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.

Restart

Button

Up & Down

Arrows

DX Select

Button

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

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

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

VER #.##

Welch Allyn DPOAE

VER ##.##.##

2 sec delay

LOADING #.##.##

PLEASE WAIT . . .

DX SELECT

PERFORM DPOAE

Log # in logbook

2 sec delay

NOTE: At this stage, the

screener i

s ready to load software

from the computer or from

internal memory.

LOADING DP

DATE: xx/xx/xx

TIME: xx:xx:xx

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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

message so that function is not represented in the flow chart.

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.

TESTING X KHZ

ART LVL ## / ##%

Test R EAR

#### -R

DX SELECT

PROBE DETECT

IN PROGRESS . . .

Test L EAR

#### -L

DX SELECT

Calibrate

Channel B…

PROBE IN EAR? or

OCCLUDED PROBE?

REFIT AND RETRY

SELECT

Calibration B

Calibration A

Unacceptable

####-

R/L

PASS/REFER SEE

DETAIL

HIGH # ARTIFACT

REFIT AND RETRY

SELECT

PERFORM DPOAE

Log # in logbook

Calibrate

Channel A…

Calibration B

Unacceptable

High

Artifact

Calibration A

CONTINUE

PLEASE RELEASE

BUTTON!

SELECT

HELD

DOWN

Probe detected

No probe

detected

NO PROBE FOUND

ATTACH PROBE

DX SELECT

Test continues through

the frequencies.

See note below about

CONTINUE option.

DX SELECT

Artifact threshold

increased by 20

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 wish 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

Viewing DPOAE Test Details or Retesting an Ear with a Refer

Result Immediately After 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.

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 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 & Hearing. 18: 6,

440-455.

####-R/L

PASS/REFER SEE DETAIL

DX SELECT

X KHZ

DP ##

PASS/REFER NOISE ##

or v

Next/Previous

Frequency

REFER RESULT

RETEST

Refer result?

Yes

####-R/L

PASS/REFER PRINT

DX SELECT

PROBE DETECT

IN PROGRESS . . .

See more printing

details in next

section.

New test performed

with new test ID

number assigned.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 printer 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.

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.

####-R/L

PASS/REFER SEE DETAIL

X KHZ DP ##

PASS/REFER NOISE ##

or v

Frequency

DX SELECT

PRINT TEST

RESULTS

DX (SELECT)

####-R/L

PASS/REFER PRINT

DX SELECT

Printing of this test

occurs.

Printer detected?

TURN PRINTER ON

TRY AGAIN

DX SELECT

Yes

If result is a Refer, then pressing the down arrow 2 times will display

the Print message; Retest LCD message displays in between.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

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.

PERFORM DPOAE

Log # in logbook

VIEW DPOAE

RESULTS

DX SELECT

next/previous

test

####-R/L

PASS/REFER SEE DETAIL

NOTE: The first test displayed

is the last test performed.

DX (SELECT)

X KHZ DP ##

PASS/REFER NOISE ##

or v

Next Frequency DX SELECT

next/previous test

PRINT TEST

RESULTS

or v

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Chapter 9: Printing Previously 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.

The PRINT ALL UNPRINTED TESTS feature is intended for use when multiple tests are stored in

memory 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

PERFORM DPOAE

Log # in logbook

VIEW DPOAE

RESULTS

PRINT TEST

RESULTS

PRINT ALL

UNPRINTED DATA

DX SELECT

Printing of selected

test(s). Print All

Unprinted Data

prints all tests in

memory that have

not been printed

previously.

Printer detected?

TURN PRINTER ON

TRY AGAIN

DX SELECT

XXXX-R/L

PASS/REFER PRINT

DX SELECT

or V

next/previous

test

Yes

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 Use 705353 Rev E

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

VIEW DPOAE

RESULTS

PRINT TEST

RESULTS

DX SELECT

PRINT BOTH EARS

RESULTS

Choose Test #1

####-R/L PASS/REFER

DX SELECT

Final Test #/Ear

####-L ####-R

NO RESULTS FOR

BOTH EARS

Database does not

contain both right and

left ear tests.

DX SELECT

Database contains

right ear and left ear

tests; R and L tests

with highest number

are displayed.

Printing of selected

test(s). Both ears’

tests will print on a

single label.

Printer detected?

TURN PRINTER ON

TRY AGAIN

DX SELECT

Yes

Automatically

displays test with

highest test ID

number.

DX SELECT

Choose Test #2

####-R/L PASS/REFER

Automatically displays

test with the highest test

ID for the opposite ear.

DX SELECT

or V

next/previous test

or V

next/previous test

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Label Feed

Button

On Button

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 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.

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

Ordering Labels

To order labels call Welch Allyn at 1-800-535-6663.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 or greater at a

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 & Hearing. 18: 6,

440-455.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

• 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.

6. 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.

2. Verify 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 battery charge does not cause interruption of the download of

firmware into the screener.

4. Launch the WA OAE Load application using the shortcut icon on your PC desktop and the

following screen will appear.

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

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 Start 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. I 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 that 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

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. Install the ASCII Link program from the Welch Allyn OAE Inservice Guide CD.

2. Attach the Welch Allyn OAE Hearing Screener unit to the computer using the USB cable

provided with the system.

3. 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.

4. The ASCII file can be found in the directory C:\Program Files\Welch Allyn\OAE Hearing

Screener\ASCII Link. The filename and extension is “asciilink.axo”.

5. The AXO file is a space delimited ASCII file. Each line contains the following information:

Description Example Data

Date and time (day-month-year-hour-

minute-second)

DDMMYYYYHHMMSS

10052005134513

ID Number of protocol used for test 3

ID number of patient/Orphan Orphan (i.e. no patient ID available)

AB123456789A01

Ear Right

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

10= DP

102001 (DP)

AuDX Serial Number 05369

Reproducibility % Reproducibility=85

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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

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.

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.

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.

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.

LOW BATTERY!!!

CONNECT CHARGER

NO LOADER

RELOAD SOFTWARE

MEMORY ERROR

RELOAD SOFTWARE

CHECK SUM ERROR

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

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 a

computer to the Welch Allyn OAE Hearing Screener, the database of tests is

erased from memory.

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.

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.

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.

EMPTY

DATABASE

TURN PRINTER ON

TRY AGAIN

LOADING #.##.##

PLEASE WAIT. . .

PLEASE RELEASE

BUTTON!

NO PROTOCOLS

EXIST

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Service

Caution Unauthorized repairs will void the warranty.

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 distributor, 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

Appendix A

Precautions and Safety Instructions

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

Symbols 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

Type B equipment

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.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

• 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.

• A 2-pin/3-pin adapter for connecting 3-pin power supply plugs to a 2-pin wall socket.

The grounding terminal on the adapter must be fixed with the free end secured to

the ground terminal.

• 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

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 Manufacturer’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

CISPR 11

Group 1 The REF 29400 Series OAE Hearing Screener uses RF energy

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

CISPR 11

Class B

Harmonic

emissions IEC

61000-3-2

Class A

Voltage

fluctuations/

flicker emissions

IEC 61000-3-3

Complies

The REF 29400 Series OAE Hearing Screener is suitable for

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

purposes.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 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

>95% dip in 0.5

cycle 60% dip in 5

cycles 30% dip for

25 cycles >95%

dip in 5 seconds

>95% dip in 0.5

cycle 60% dip in 5

cycles 30% dip for

25 cycles >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

(50/60Hz)

magnetic field IEC

61000-4-8

3 A/m 40A/m Power frequency magnetic fields should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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

Complianc

e Level

Electromagnetic Environment - Guidance

Conducted

RF IEC

61000-4-6

Radiated RF

IEC 61000-4-

3 Vrms 150 kHz to

80 MHz

3 V/m 80 MHz to 2.5

GHz

3 Vrms

5 V/m from

30MHz to

1GHz, 7

V/m for

1GHz to 2.5

GHz; (1000

Hz. 80%

Modulated

Test Signal)

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

d = (1.17)

d = (1.17) 80 MHz to 800 MHz

d = (2.33) 800 MHz to 2.5 GHz

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

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 occur in the vicinity of equipment marked

with the following symbol:

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.

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

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 disturbances 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.

Output Power of

Transmitter (W)

150 kHz to 80 MHz d =

(1.17) P

80 MHz to 800 MHz d =

(1.17) P

800 MHz to 2.5 GHz d =

(2.33) P

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 d in 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

Installation Precautions

Observe the following precautions when using the Welch Allyn OAE Hearing Screener and related

equipment.

Environmental Conditions

• Select a room with properly grounded power sources (when using in AC-powered

configuration).

• 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.

• Avoid moisture or contact with water, extreme atmospheric pressure, excessive

humidity and temperatures, poorly ventilated areas and dusty, saline or sulfuric air.

• Verify the selected site maintains a relative humidity between 25% and 95%

(without condensation).

• 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

System Hookups

• Verify the maximum load for any multiple portable socket-outlet (if used) does not

exceed 750 VA.

• Do NOT place any multiple portable socket-outlets (if used) on the floor.

• If 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 may increase the current amount of leakage and exceed the

safety limit.)

• Do not interconnect multiple pieces of equipment without verifying that the sum of all

leakage currents 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 a

separating iso-transformer. (The additional equipment may increase the current

amount of leakage and exceed the safety limit.)

• 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.

• 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

WARNING!

Only use the Battery Charger Power Supply Models

Number 520-PS6VDC with the

Welch Allyn OAE Hearing Screener.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 system 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.

2. The portable computer is powered by batteries, not plugged into a wall outlet.

3. 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.

2. Avoid direct contact between the patient and system equipment at all times.

3. Do not add other equipment which is not protected against ingress of liquids.

4. This equipment is not suitable for use in areas of flammable or anesthetic mixtures.

5. 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

INDEX

Abbreviations ..................................................5, 6

ASCII Link.........................................................40

AuDX Buttons ...................................................23

AuDX Load........................................................37

Auto OFF ............................................................9

Battery ................................................................9

Changing the Default Protocol to Continue

through All Frequencies................................36

Charger Unit .......................................................8

Clinical Competency Evaluation .................19, 20

Communication Cable ........................................9

Default Protocols ..............................................35

DPOAE Protocol ...............................................35

Environmental Specifications............................46

Equipment Identification Labels and Markings .44

Error messages ................................................41

Hardware ............................................................7

Increase Artifact Reject Level: ..........................26

Instructional Videos.......................................... 14

Label Printer..................................................... 33

Patient Instructions .......................................... 11

Patient Preparation .......................................... 10

Performing a DPOAE Test............................... 25

Precautions and Safety Instructions ................ 44

Printing DPOAE ............................................... 28

Printing Previously Collected Data – Both Ears32

Printing Previously Collected Data – Single Ear

..................................................................... 30

Probe

--care and maintenance ............................... 14

Program Flow Chart......................................... 24

Quick Guide ..................................................... 17

System Components.......................................... 7

System Operation ............................................ 23

Troubleshooting ............................................... 41

View DPOAE Test............................................ 27

View Previously Collected DPOAE Data.......... 29

Welch Allyn Medical Diagnostic Equipment Ref 29400 Users Manual Revised OAE DFU Cover Page 2 27 06

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