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OAE Hearing Screener

Directions for Use
REF 29400

COPYRIGHT © 2009 Welch Allyn. All rights are reserved. No one is permitted to reproduce or
duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. Welch
Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the
product, that may result from failure to use this product in accordance with the instructions, cautions,
warnings, or statements of intended use published in this manual. Welch Allyn is a registered
trademark of Welch Allyn.
Software in this product is Copyright 2009 Welch Allyn or its vendors. All rights are reserved. The
software is protected by United States of America copyright laws and international treaty provisions
applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software
incorporated with this instrument as intended in the operation of the product in which it is embedded.
The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise
reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all
right, title and ownership of the software remain with Welch Allyn or its vendors.

For information about any Welch Allyn product, call Welch Allyn Technical Support:

USA

+1 315 685 4560 Australia
800 535 6663

Canada

800 561 8797 China

+61 29 638 3000
800 074 793
+86 216 327 9631

European Call Center +353 46 906 7790 France

+33 15 569 5849

Germany

+81 33 219 0071

Latin America
Singapore
United Kingdom

+49 747 792 7186 Japan
+1 305 669 9003 Netherlands

+31 15 750 5000

+65 6419 8100 South Africa

+27 11 777 7555

+44 207 365 6780 Sweden

Manual Part Number 705353 Rev E
Welch Allyn
4341 State Street Road
Skaneateles Falls, NY 13153 USA
http://www.welchallyn.com
Printed in USA

+46 85 853 6551

Distributed by Welch Allyn under agreement with
Natus Medical Incorporated
PROPERTY OF NATUS MEDICAL INCORPORATED
ALL RIGHTS RESERVED
U.S. Patents nos. 5,738,633 and 6,149,605

Bio-logic is a registered trademark of Natus Medical Incorporated
IBM is a registered trademark of the International Business Machines Corporation
Microsoft, Windows, is a registered trademark of Microsoft Corporation

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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 is
intended for use by a health care professional or
a technician who is trained and supervised by a
health care professional or accredited
organization.

About this manual
This manual gives step by step instructions on how to perform OAE tests and view results on the
Welch Allyn OAE Hearing Screener.

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.
DP - distortion product; used interchangeably with DPOAE. The DP that has
received the greatest interest and is most often measured clinically is the DP
that is calculated by the formula 2F1-F2.
DP-NF - the dB difference between the distortion product emission and the
noise floor amplitudes. To be sure that a response is present, the DP-NF
value must match or exceed a minimum. On the Welch Allyn OAE Hearing
Screener, this value is 6 dB or greater.
DX - a button on the front panel of the Welch Allyn OAE Hearing Screener
which is used to SELECT and implement functions described on the LCD.
F2 - the higher of the two stimulus frequencies used in a DPOAE test.
F1 - the lower of the two stimulus frequencies used in a DPOAE test.
F2/F1 ratio - the numeric relationship of the two stimulus frequencies to one
another. Most research has shown that an F2/F1 ratio of approximately 1.2
produces the most robust emissions.
Hz - Hertz; a unit of measurement of frequency; also known as cycles per
second.
LCD - liquid crystal display; refers to the message window on the upper
portion of the Welch Allyn OAE Hearing Screener front panel.
LED - light emitting diode; a light that illuminates to indicate a hardware
function. On the Welch Allyn OAE Hearing Screener, an illuminated green
LED at the bottom left of the front panel indicates that the AC adapter is
plugged in and AC power is flowing to the box.

Welch Allyn OAE Hearing 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

rWelch Allyn OAE Hearing Screener
Troubleshooting Quick Guide: Causes of Refer Results

Quick Guide: Causes of ‘Refer”

Noise
Problem
♦

Possible solutions

Noisy surroundings

♦

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.

♦

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.

— Other people in or near test site.
— Devices such as fans, air
conditioners, intercoms, and
public address systems.

♦

Patient noise
— Crying or struggling against the
probe

— Sucking a pacifier or bottle
— Excessive movement
— Talking

Middle Ear Involvement
Problem
♦

Possible solutions

Middle ear conditions that add
mass or stiffness to the middle ear
such as:

♦

Refer results caused by temporary conditions that cause middle
ear involvement will improve as the middle ear returns to normal.

— Otitis media
— Severe Eustachian tube
disfunction
— Otosclerosis

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

Obstructions
Problem
♦

Possible solutions

Cerumen, vernix, or other debris

♦

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.

— In the ear
— On the probe tip
— On the probe

♦

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

1)
2)
3)
4)
5)
6)
7)
8)

Properly plugs in equipment
_______
Properly turns on equipment
_______
Powers on label printer
_______
Demonstrates how to clean probe _______
Follows facility infection control
_______
Launches Screener program
_______
Records patient Log Number
_______
Swaddles baby and/or prepares
_______
patient for test
9) Selects patient's ear in software
_______
10) Selects proper sized probe tip
_______
11) Places probe into patient’s ear
_______
12) Troubleshoots probe fit if needed
_______
13) Knows how to View Details
_______
14) 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

Needed Training

Did Not
Observe

_______
_______
_______
_______
_______
_______
_______
_______

_______

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

DX Select
Button

Up & Down
Arrows

Restart
Button

ON
Button

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.
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
ON

Welch Allyn
VER #.##

DATE: xx/xx/xx
TIME: xx:xx:xx
2 sec delay
ON

Welch Allyn DPOAE
VER ##.##.##

NOTE: At this stage, the
screener is ready to load software
from the computer or from
internal memory.

DX SELECT

LOADING DP

LOADING #.##.##
PLEASE WAIT . . .
2 sec delay
ON

PERFORM DPOAE
Log # in logbook

The operation of the ON button is the same for the following flow charts. That is, it will always
return the user to the initial Welch Allyn message on the LCD. It will not be depicted in the
following charts.
Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.
PERFORM DPOAE
Log # in logbook
DX SELECT

Test R EAR
#### -R

^
Test L EAR
#### -L

DX SELECT

PROBE DETECT
IN PROGRESS . . .

No probe
detected

DX SELECT

NO PROBE FOUND
ATTACH PROBE

Probe detected

Calibrate
Channel A…
Calibration A
OK

Calibrate
Channel B…
Calibration B
OK
Test continues through
the frequencies.

####-R/L
PASS/REFER SEE
DETAIL

Calibration A
Unacceptable

PROBE IN EAR? or
OCCLUDED PROBE?
REFIT AND RETRY
Calibration B
Unacceptable

TESTING X KHZ
ART LVL ## / ##%
DX
SELECT
HELD
DOWN

High
Artifact

HIGH # ARTIFACT
REFIT AND RETRY

Artifact threshold
increased by 20

DX
SELECT

PLEASE RELEASE
BUTTON!

DX
SELECT

CONTINUE
DX SELECT

See note below about
CONTINUE option.

Re: CONTINUE option. When the DX SELECT button is chosen when the CONTINUE message is
displayed, the program will try to proceed to the next step in the test process, but possibly with poor
calibration results or test conditions, so it is not recommended on a routine basis.

Each test is assigned a unique test number that is displayed in the Test R/L EAR box. Since the
Welch Allyn OAE Hearing Screener holds 10 tests in memory, this unique number can assist you
in associating a test with a particular patient. To keep track of the patient test numbers, the
patient’s name, test numbers and details of the test (if desired) should be recorded in a logbook or
patient file.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

####-R/L
PASS/REFER SEE DETAIL V

^
Refer result?

REFER RESULT
RETEST

Yes

DX SELECT

No
X KHZ DP ##
PASS/REFER NOISE ##

####-R/L
PASS/REFER PRINT
See more printing
details in next
section.

^ or v
Next/Previous
Frequency

PROBE DETECT
IN PROGRESS . . .
New test performed
with new test ID
number assigned.

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)1. 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.

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” selfadhesive 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.
If result is a Refer, then pressing the down arrow 2 times will display
the Print message; Retest LCD message displays in between.

####-R/L
PASS/REFER SEE DETAIL

####-R/L
PASS/REFER PRINT
DX SELECT

DX (SELECT)

^ or v
Next
Frequency

X KHZ DP ##
PASS/REFER NOISE ##

Yes
Printing of this test
occurs.

DX SELECT

Printer detected?

PRINT TEST
RESULTS

TURN PRINTER ON
TRY AGAIN

DX SELECT

As can be seen from the flow chart above, printing of the test just completed can be performed in
two different ways. From the SEE DETAIL screen, the user can press the down arrow button to
access the PRINT message and press DX SELECT. Or, from the SEE DETAIL screen, the user
can elect to first see the details on the LCD by pressing the DX SELECT button and use the
up/down arrow buttons to move through the test frequencies. Pressing the DX SELECT button
from any one of the frequency details displays will access the PRINT TEST RESULTS screen.
Pressing the DX SELECT button implements the printing of this test.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

DX SELECT

Viewing Previously Collected DPOAE Data
This flow chart begins at the point where the PERFORM DPOAE message is displayed and
shows the program flow for instances in which you wish to view data that is saved in memory.
PERFORM DPOAE
Log # in logbook

VIEW DPOAE
RESULTS
DX SELECT

NOTE: The first test displayed
is the last test performed.

####-R/L
PASS/REFER SEE DETAIL

^ or v
next/previous
test

next/previous test

DX (SELECT)

X KHZ DP ##
PASS/REFER NOISE ##
Next Frequency

^ or v

^ or v
PRINT TEST
RESULTS

DX SELECT

Recall that only the last 10 tests are retained in memory for retrieval and review. Tests collected
prior to the last 10 are sequentially overwritten with each new test performed. There is no way to
retrieve them after they have been overwritten.
The PASS/REFER indicator displayed in the first SEE DETAIL box is for the overall test. The
PASS/REFER indicator in the second X KHZ DP ## box is for the individual frequency being
displayed. The displayed PASS/REFER indicator is based on research published by Gorga et al
(1997). For more information about the criteria needed for a PASS or REFER indicator to appear,
see Chapter 12 System Default Protocol.
In the X KHZ DP ## message box, the number after the DP abbreviation is the amplitude of the
distortion product emission. In the second line, the number following the word NOISE is the
amplitude of the noise floor.
Remember that RESTART will return to the PERFORM DPOAE message at any time.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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.

PERFORM DPOAE
Log # in logbook

VIEW DPOAE
RESULTS

PRINT TEST
RESULTS

DX SELECT

DX SELECT
PRINT ALL
UNPRINTED DATA
V

XXXX-R/L
PASS/REFER PRINT
next/previous
test

DX SELECT

Printer
Yes

^ or V

Printing of selected
test(s). Print All
Unprinted Data
prints all tests in
memory that have
not been printed
previously.

detected?
No

DX SELECT

TURN PRINTER ON
TRY AGAIN

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
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

NO RESULTS FOR
BOTH EARS

DX SELECT

Database does not
contain both right and
left ear tests.

Final Test #/Ear

Database contains
####-L ####-R
right ear and left ear
DX SELECT
tests; R and L tests
V
with highest number
are displayed.
Automatically

Choose Test #1
####-R/L PASS/REFER

^ or V
DX SELECT

next/previous test
Automatically displays
test with the highest test
ID for the opposite ear.

Choose Test #2
####-R/L PASS/REFER

^ or V

displays test with
highest test ID
number.
Printer

Yes

DX SELECT

Printing of selected TURN PRINTER ON
TRY AGAIN
test(s). Both ears’
tests will print on a
single label.

DX SELECT

next/previous test

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

detected?

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.

Label Feed
Button

On Button

For additional questions, please make contact with Welch Allyn Technical Support at 1-800-5356663.
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,
1
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.

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 reinstalling 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 1800-535-6663.
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
Date and time (day-month-year-hourminute-second)
DDMMYYYYHHMMSS
ID Number of protocol used for test
ID number of patient/Orphan
Ear
Pass/Refer/No Result

Printed/Not printed
Number of frequencies in test
Frequency (F2 for DP)
Frequency Pass/Refer/Noisy

DP Result
DP-NF Result
Noise Result
AuDX Test ID (1000-9999); prefix
10= DP
AuDX Serial Number
Reproducibility %

Example Data
10052005134513

3
Orphan (i.e. no patient ID available)
AB123456789A01
Right
Left
OverAll_PASS
OverAll_REFER
OverAll_NOT_RESULT
Printed
Not_Printed
3
5000
PASS
REFER
NOISY
DP=7
DP-NF=18
Noise=-21
102001 (DP)
05369
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
LOW BATTERY!!!
CONNECT CHARGER
This message appears when the battery charge is completely depleted. The
message will flash for 10 seconds after which the unit will power off.
Connecting the AC adapter/charger unit will allow continued data collection
and will charge the unit between tests. Complete charging of the Welch Allyn
OAE Hearing Screener takes about 3 hours.

NO LOADER
RELOAD SOFTWARE
This message appears when the initialization software is not found either
because it was not installed on the Welch Allyn OAE Hearing Screener or
because it has become corrupted. Press the ON button to reset the device.
If the problem persists call Welch Allyn Technical Support at 1-800-535-6663
for further instruction.

CHECK SUM ERROR
This message appears when the software protocols are not found either
because it was not installed on the Welch Allyn OAE Hearing Screener or
because it has become corrupted. Reload the WA OAE Firmware using the
WA OAE Load program. If the problem persists call Welch Allyn Technical
Support at 1-800-535-6663 for further instruction.

MEMORY ERROR
RELOAD SOFTWARE
This message appears when the initialization software is not found either
because it was not installed on the Welch Allyn OAE Hearing Screener or
because it has become corrupted. Press the ON button to reset the device.
If the problem persists call Welch Allyn Technical Support at 1-800-535-6663
for further instruction.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

PLEASE RELEASE
BUTTON!
This message appears when one of the buttons on the Welch Allyn OAE
Hearing Screener label is depressed for more than .3 sec. Releasing the
button returns the system to normal operation. If depressed during data
collection the artifact rejection threshold level will be increased by 20mPa.
EMPTY
DATABASE
This message appears when an attempt is made to view data when no tests
are stored in memory. When a new software version is uploaded from a
computer to the Welch Allyn OAE Hearing Screener, the database of tests is
erased from memory.

LOADING #.##.##
PLEASE WAIT. . .
This message routinely appears when the unit is powered on and the DX
SELECT button is pressed. It is only problematic if the message remains on
the screen for a prolonged period (more than 10 seconds) and does not
progress to the next message, PERFORM DPOAE. This may occur if the
battery charge is marginal. If this occurs, plug in the charger unit, press the
ON button and the DX SELECT button and try again. Once the battery is
recharged, the unit will return to the normal Power ON sequence.

TURN PRINTER ON
TRY AGAIN
This message appears when an attempt is made to print data on the label
printer but the printer is not communicating with the Welch Allyn OAE Hearing
Screener. This can be due to poor connection of the printer serial cable to
the printer or to the screener, or lack of power to the printer.

NO PROTOCOLS
EXIST
This message appears when an error has occurred during the installation of
the WA OAE Firmware into the unit or if the firmware has been corrupted
causing the protocols database in the unit to become unreadable.

NOTE: For error messages that do not appear
here, or if you are unable to correct a
problem, contact Welch Allyn Technical
Support at 1-800-535-6663.

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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
IMPORTANT
This device is intended for use by qualified personnel only. Please read
this section and the Welch Allyn OAE Hearing Screener Directions for
Use before installing any of the hardware, then retain this section as a
reference while operating, transporting, storing or re-installing
equipment.

Equipment Identification Labels and Markings
Classification
The International Electrotechnical Commission classifies electro-medical equipment
according to its power source (external or internal) and the degree of protection it
provides against shock. The Welch Allyn OAE Hearing Screener is classified as Type B
which means it qualifies as externally powered equipment capable of protecting a
patient from electrical shock.
Warning Labels and Symbols
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

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
patient

Protective grounding must be provided for
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

RF emissions
CISPR 11

Class B

Harmonic
emissions IEC
61000-3-2

Class A

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.
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.

Voltage
fluctuations/
flicker emissions
IEC 61000-3-3

Complies

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

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 610004-5

±1 kV differential
mode
±2 kV common
mode
>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.

3 A/m

40A/m

Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines. IEC
61000-4-11
Power frequency
(50/60Hz)
magnetic field IEC
61000-4-8

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 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

Immunity
Test

IEC 60601 Test
Level

Complianc
e Level

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment
should be used no closer to any part of the REF 29400
Series OAE Hearing Screener, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted
RF IEC
61000-4-6

3 Vrms 150 kHz to
80 MHz

3 Vrms

d = (1.17)

Radiated RF
IEC 61000-43

3 V/m 80 MHz to 2.5
GHz

5 V/m from
30MHz to
1GHz, 7
V/m for
1GHz to 2.5
GHz; (1000
Hz. 80%
Modulated
Test Signal)

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,a should be less than
the compliance level in each frequency range.b
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.
a

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

0.233

0.1

0.37

0.74

1.17

2.33

3.70

7.37

100

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
WARNING!
Only use the Battery Charger Power Supply Models
Number 520-PS6VDC with the
Welch Allyn OAE Hearing Screener.

•
•
•

•
•

•

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:
Voltage:
Current Capacity:

50 / 60 Hz
100 - 240 VAC
1.60 – 1.20A

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

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

Abbreviations ..................................................5, 6
ASCII Link .........................................................40
AuDX Buttons ...................................................23
AuDX Load........................................................37
Auto OFF ............................................................9

L
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 Ears 32
Printing Previously Collected Data – Single Ear
..................................................................... 30
Probe
--care and maintenance ............................... 14
Program Flow Chart ......................................... 24

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

C
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

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

Environmental Specifications............................46
Equipment Identification Labels and Markings .44
Error messages ................................................41

System Components.......................................... 7
System Operation ............................................ 23

T
H

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

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

V
I

View DPOAE Test............................................ 27
View Previously Collected DPOAE Data.......... 29

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

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev E

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