natus Echo-Screen III Pro User manual

© 2020 Natus Medical Incorporated 026057 RevE Revision Date 05/31/2020
Echo-Screen®III Pro
Instructions for Use
TEOAE, DPOAE, ABR
Version 1.1

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly
licensed practitioner).
© 2020 Natus Medical Incorporated. All rights reserved. Distribution of contents to persons other than
customers of Natus is strictly prohibited. Reproduction of any part of this document without the expressed
written consent of Natus Medical Incorporated is strictly prohibited.
The content of this manual may change without notice.
AOAE®, Natus®, and Echo-Screen®are registered trademarks of Natus Medical Incorporated.
NuPrep®is a registered trademark of D.O. Weaver & Co.
Windows®is a registered trademark of Microsoft Corporation.
Bluetooth®s a registered trademark of the Bluetooth SIG.
Natus Medical Incorporated
5900 First Avenue South
Seattle, WA 98108 USA
Toll-free: [phone]
Telephone: [phone]
Fax: [phone]
E-mail: technical_[email protected]
www.natus.com
Natus Manufacturing Limited
IDA Business Park
Gort, Co. Galway, Ireland
Tel.: [phone]
Website: natus.com
Natus...Where Babies Come First.™

© 2020 Natus Medical Incorporated 026057 RevE i
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Echo-Screen III Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Echo-Screen III Pro Device and Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Echo-Screen III Pro Device and Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Device Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Navigating the Echo-Screen III Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Entering Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Powering On and Off and Logging In and Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Working with Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Preparing for Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Prepare the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Check the Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Assess the Patient for Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Prepare the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Performing a TEOAE, DPOAE, or DPOAE+ Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Performing an ABR Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cleaning Cables After Each Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Reviewing Screening Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Printing Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Performing a Quick Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Testing Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
OAE Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
ATA Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
PCA Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
LCD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Touch Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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Echo-Screen III Pro Instructions for Use
Maintaining the Device and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Storing the Device and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Cleaning the Device and Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Replacing the OAE Probe Nozzle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Maintaining the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Inspecting Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Accessories and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Appendix A: Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

© 2020 Natus Medical Incorporated 1 026057 RevE
Introduction Echo-Screen III Pro Instructions for Use
Introduction
This document provides the instructions that screeners need for the proper and safe use of the
Echo-Screen III®Pro hearing screener. Administrators should refer to the Echo-Screen III Pro
Reference Guide for instructions about setting up, configuring, and managing Echo-Screen III
Pro hearing screening devices.
Echo-Screen III®Pro devices come with audble software. If you install audble, you can transfer
patient and test data from the device to audble for reviewing and reporting. You can also use
audble to upload patients into worklists on the Echo-Screen III device. In addition, administrators
can use audble to configure and maintain settings and users on the device. For more information
about using the Echo-Screen III device with audble software, see the Echo-Screen III Pro
Reference Guide and the audble/Desktop User Guide.
Note: You can install the Echo-Screen III Pro Reference Guide on the
computer by using the Device Management Tools installation program. Look for
the guide under All Programs, Natus Medical, Echo-Screen III.
Intended Use
The Echo-Screen III hearing screener models are based upon otoacoustic emission (OAE) and
auditory brainstem response (ABR) technology.
The device is intended to screen hearing for newborns through adults, including geriatric
patients. The device does not measure hearing per se, but helps to determine whether or not a
hearing loss may be present.
The Echo-Screen III product family consists of handheld, automated OAE and ABR based
hearing screening systems which are easy to use. The measurement flow is menu guided and
the evaluation is based upon signal statistics. The Echo-Screen III devices are intended to be
used by trained personnel in a medical or school environment. The Echo-Screen III models are
not intended for fitting assistive listening devices such as hearing aids or cochlear implants.
Echo-Screen III Product Information
The Echo-Screen III hearing screener is a portable device for detecting hearing loss in patients
of all stages of life, including newborns of at least 34 weeks gestational age, infants, children,
adults, and geriatric adults.
The Echo-Screen III device detects hearing loss by using Automated Otoacoustic Emissions
(AOAE®) technology, which includes both Transient Evoked Otoacoustic Emissions (TEOAE),
Distortion Product Otoacoustic Emissions (DPOAE), and Auditory Brainstem Response (ABR)
technology.
Echo-Screen III devices are designed for use in medical environments, such as the well-baby
nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office, and in
school environments. Echo-Screen III devices are intended for use by audiologists, physicians,
nurses, and technicians, and any other personnel who are trained to operate the device. Basic
training with the device is sufficient for performing screening of patients in good health.
The otoacoustic emissions test is especially indicated for use in testing individuals who are
unable to respond reliably to verbal instructions, such as infants, young children, and
cognitive-impaired adults.

026057 RevE 2 © 2020 Natus Medical Incorporated
Safety Information Echo-Screen III Pro Instructions for Use
Safety Information
Definitions
This manual describes three types of precautionary information, all of which are equally
important to the safe and effective use of the device. These types of information are identified
and used in this manual as follows:
IMPORTANT: An instruction provided to help ensure correct clinical results and provide quality
assurance to screening procedures.
Precautions
The following warnings and cautions pertain to the use of the Echo-Screen III Pro hearing
screener. Additional warnings and cautions are provided throughout this manual as they apply
to specific content.
WARNING A condition or practice that might present danger or possible injury to the patient and/or
user. Refer to accompanying documentation.
CAUTION An instruction that, if not followed, can result in damage to the device or loss of data.
WARNING Do not use the screener if you suspect it is not functioning properly or if any parts
appear damaged or missing. Contact Natus Technical Service or your authorized
service provider for assistance.
Do not use the Echo-Screen III Pro device for screening while it is docked in the
docking station or plugged into external power.
Do not connect external power or a USB cable from the device to a computer while
the device is connected to a patient.
Single-use screening supplies (ear couplers, sensors/electrodes, ear tips/inserts)
and their packaging materials, as well as parts of the screening system that may
come into contact with the bassinet, contain small parts that may present a choking
hazard. Supplies and packaging should be placed away from the baby’s head and
hands while preparing to screen. When screening is completed, screening supplies
and all packaging materials should be accounted for and disposed of properly.
The OAE/ATA port is intended to connect the OAE cable or ATA cable to the
Echo-Screen III Pro device. No other cable should be connected to this port.
The PCA cable port is intended to connect the PCA electrode cable to the
Echo-Screen III Pro device. No other cable should be connected to this port.
Make sure that any platform, table, cart, or other surface used during the operation,
transport, or temporary or permanent storage of the system and its components is
adequate, sturdy, and safe. Natus is not responsible for any injury or damage that
may result from inadequate, poorly constructed, or unapproved transports, carts, or
operating surfaces.
Any use of the earphones or the ATA earphone cable other than that described in this
manual may result in screening at unknown and uncontrolled decibel levels.
AC adapter units are not interchangeable. Use only the AC adapter supplied with the
Echo-Screen III Pro device. Using an AC adapter supplied for other devices, such as
notebook computers or printers, can cause damage to the Echo-Screen III Pro
device.
A communications failure or data coupling error between the Echo-Screen III Pro
device and the external PC can create a loss of data and delay in diagnosis

© 2020 Natus Medical Incorporated 3 026057 RevE
Echo-Screen III Pro Device and Components Echo-Screen III Pro Instructions for Use
Echo-Screen III Pro Device and Components
IMPORTANT: Hearing screening program administrators should refer to the Echo-Screen III
Pro Reference Guide for details about how to set up and configure Echo-Screen III devices.
Echo-Screen III Pro Device and Docking Station
IMPORTANT: The docking station must be kept outside the patient environment. It is
recommended that you keep the docking station near the computer where you view and manage
your screening data.
Device Symbols
CAUTION Connection of the Echo-Screen III Pro to a networked environment can present addi-
tional risk. The responsible organization should have in place a network security pro-
cedure to ensure the integrity of the network and Echo-Screen III Pro device.
The responsible organization should reevaluate the integrity of the Echo-Screen III
Pro each time an update, upgrade or additional change is made within a networked
environment.
Use only Natus screening supplies and accessories with the Echo-Screen III Pro
device (see Accessories and Supplies on page 38). Use of non-Natus supplies
may damage the Echo-Screen III Pro device or affect the accuracy of screening
results, and may void the warranty.
ATA and OAE cables are fragile. Handle with care.
Although the Echo-Screen III Pro fulfills the relevant EMC requirements, precautions
should be taken to avoid unnecessary exposure to electromagnetic fields, e.g., from
mobile phones, etc. If the device is used adjacent to other equipment it must be
observed that no mutual disturbance appears. Please refer to appendix A for more
information regarding EMC.
Symbol Description
Attention, consult product documentation
Consult instructions for use
ATA transducer test
fixtures
Barcode scanner
(optional)
Touch screen
Keyboard
Barcode button
Spare battery charging
status LED
Power LED
Spare battery
Device connection
On/Off
Battery charging
status LED Color-coded PCA
test fixtures

026057 RevE 4 © 2020 Natus Medical Incorporated
Echo-Screen III Pro Device and Components Echo-Screen III Pro Instructions for Use
Type BF for patient-applied parts
Power
WEEE Directive (Waste from Electrical and Electronic Equipment Directive)
Symbol - Product should not be disposed of in normal waste
Manufacturer
Direct current
AC/DC adapter
USB port
Electrostatic sensitive device
Authorized representative
Catalog number
Serial number
Device is cleared for the US market as requiring a prescription.
Temperature Limit
Humidity Limitation
Atmospheric Pressure Limitation
Symbol Description

© 2020 Natus Medical Incorporated 5 026057 RevE
Echo-Screen III Pro Device and Components Echo-Screen III Pro Instructions for Use
Cables
Echo-Screen III Pro cables include:
OAE probe cable • Required for TEOAE, DPOAE, and DPOAE+
screening.
• Optional for ABR screening.
• Probe requires disposable ear tip and fits into
patient’s ear.
ATA cable • Optional for ABR screening. Cannot be used for
OAE screening.
• Attaches to disposable earphones that fit over
baby’s ears.
• Recommended for newborns to about 6 months.
• Supports screening ears sequentially without
requiring reconfiguration between screenings.
PCA cable • Required for ABR screening.
• Not used for OAE screening
• Attaches to three disposable Jelly Tab
electrodes.

026057 RevE 6 © 2020 Natus Medical Incorporated
Navigating the Echo-Screen III Interface Echo-Screen III Pro Instructions for Use
Navigating the Echo-Screen III Interface
• Starting at the Home screen, touch a button to start a task. (Some buttons may be
grayed out or dimmed, depending on how the administrator configured the device.)
• On screens that contain more data than can be viewed, drag the screen up and down,
or press the up and down arrow keys to see more data.
• Each screen on the device has a header that provides information and navigational
aids. Touch icons on the screen header to perform actions. Icons are grayed out or
dimmed on screens where the functions are not available.
Entering Data
Select options and enter data by using the touch screen, physical or touch-screen keyboard, or
optional barcode reader:
• Touch an option to select it.
• Touch a field and then type by using the physical or touch-screen keyboard. The device
might be configured to automatically show the touch-screen keyboard when you touch
a field that supports keyboard entry. If not, touch the keyboard icon in the screen header
to display the touch-screen keyboard.
• To move to the next field, touch the Enter key on either keyboard or press an arrow key
on the physical keyboard.
• To enter letters with diacritical marks, press and hold the related key on either keyboard
for about one second until the available letters are displayed. For capital letters, first
press the CAP key, and then press and hold the related letter key. On the displayed list
of available letters, touch the letter you need and then press Enter. To close the list
without selecting a letter, touch the small Xto the right of the list.
• Double-press the CAPS key to lock in capital letters. Double-press the 123 sym key to
lock in symbols and numbers. Press the key again to release the lock. The screen
header indicates CAPS or SYM when capital letters or symbols are locked on the
physical keyboard. The associated buttons turn red when capital letters or symbols are
locked on the touch-screen keyboard.
• To scan a barcode into a field if the device includes a barcode scanner, touch the field
to activate the barcode reader, aim the barcode scanner at the barcode, and press the
barcode button. The selected field is filled with the data from the barcode.
Go to Home Go back one
screen
View Help Open touch-screen
keyboard
Date and time
Battery charge status

© 2020 Natus Medical Incorporated 7 026057 RevE
Powering On and Off and Logging In and Off Echo-Screen III Pro Instructions for Use
IMPORTANT: Scan only barcodes supported by the device. If the barcode is too long, the
scanner cannot read it. Contact your administrator about supported barcodes.
Note: Data that is encoded in the barcode with uppercase letters appears in
the field as lowercase letters.
Powering On and Off and Logging In and Off
• To power on, briefly press the power button, and wait for the startup and splash screens.
The device starts in about a minute. Log in, if configured by your administrator. You may
need to enter a combination of user name, password, or location to log in.
• When powered on, press the power button briefly to go into or out of standby mode.
• To log off (if device is configured for logins), on the Home screen touch Log Off, or press
the power button to enter standby mode.
• To power down, press and hold the power button for several seconds. At the power off
prompt, touch OK.
• To force the device to shut down, press and hold the power button for about ten
seconds.
WARNING Although the barcode scanner uses an LED light and not a laser beam, do not direct
the barcode scanner light toward anyone’s eyes.

026057 RevE 8 © 2020 Natus Medical Incorporated
Working with Patient Information Echo-Screen III Pro Instructions for Use
Working with Patient Information
Except for Quick Tests, patient information must be entered on the device before you can start
to screen. Quick Tests do not allow you to enter patient information and do not save any test
data.
Two lists store patient information on the device:
• The To-Do List contains all the patients who need to be screened.
• The Patient List contains every patient on the device, whether or not the patients have
been screened.
Enter patient information in either of two ways:
• Enter the information in the audble Desktop data manager and upload it to the device.
Uploaded patients are added to the To-Do List. See the audble Desktop User Guide
for details.
Note: When you upload patients with risk factors, you do not see the risk
factors on the device. However, any risk factors you add for the patient on the
device are merged with the risk factors in the audble database when you
transfer the patient and test records back to the audble software.
• Enter the information directly on the device and screen immediately or save the
information for later screening. Saved patients are added to the To-Do List and the
Patient List. Patients who are screened (that is, both ears screened to completion with
a Pass or Refer result during this session) are saved only in the Patient List.
Add new patient to the device:
1On the Home screen, touch Add Patient.
— OR —
On the Home screen, touch To-Do List. In the To-Do List, touch Add.

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Working with Patient Information Echo-Screen III Pro Instructions for Use
2Enter the patient’s information.
Fields highlighted in blue are required. Patient ID is always required. Other required fields
are configured by the administrator. For details about the fields, see Echo-Screen III Help.
3Touch Save to screen later, or touch Screen to start screening immediately.
Edit a patient:
1On the Home screen, touch To-Do List.
— OR —
On the Home screen, touch Patient List.
2In the list of patients, select the patient to be edited.
3Touch Edit.
4Change patient information as needed.
5Touch Save to screen later, or touch Screen to start screening immediately.
Enter risk factors (if configured on your device):
1Add risk factors when adding or editing patient information, or before starting to screen:
• On the Patient Info screen, touch Risks.
• On the test selection screen, touch Risks.
2On the Risk Factors screen, specify the appropriate risk factors:
• Touch Yes to specify a condition as a known risk factor.
• Touch No to specify a condition known to not be a risk factor.
• Touch ?to specify a risk factor as unknown.
• Touch Set All To No to reset all risk factors to No.
• Touch Set All To ? to set all risk factors to Unknown.
3Touch Done.

026057 RevE 10 © 2020 Natus Medical Incorporated
Preparing for Testing Echo-Screen III Pro Instructions for Use
Create To-Do Lists for later screenings:
• Add a patient to the To-Do List:
• On the Home screen, touch To-Do List. Touch Add, enter the patient information, and
touch Save.
• On the Home screen, touch Patient List. Select a patient already on the device, and
then touch To-Do.
• Remove a patient from the To-Do list:
• On the Home screen, touch To-Do List. Select a patient in the list, and then touch
Remove.
Note: The patient is removed from the To-Do List but remains in the Patient
List.
Preparing for Testing
IMPORTANT: Do not operate the Echo-Screen III Pro device close to display monitors or other
electrical equipment. Before you begin, check the calibration date displayed on the Home
screen. You cannot perform a screening when the probe is out of calibration.
WARNING Do not use the Echo-Screen III device to screen or connect to a patient while it is
docked in the docking station or plugged into external power.
Do not turn off medical equipment suspected of causing interference unless under
the direct supervision of a physician or appropriate medical practitioner.
If you are permitted to use the Echo-Screen III Pro integrated hooks on a bassinet,
hang the device at the foot of the bassinet, well away from the baby.
Never leave a patient unattended while the patient is connected to the device.
Do not suspend the Echo-Screen III device or the wireless printer over the infant’s
head.
WARNING If using the wireless printer with the shoulder strap, remove or secure the printer
prior to preparing the patient.
CAUTION Do not operate the Echo-Screen III Pro device in an environment where it continu-
ously displays interference. Such interference may slow down or stop the screening
and compromise the device’s performance or accuracy.
Do not operate the Echo-Screen III Pro device if cardiac monitors or incubator fans
(or other equipment required for monitoring a very sick infant) in the near vicinity
cause interference.

© 2020 Natus Medical Incorporated 11 026057 RevE
Preparing for Testing Echo-Screen III Pro Instructions for Use
Prepare the Device
1Power on the device and log in, if required.
2Change the language for this session, if necessary. At the Home screen, touch Select
Language, select the language, and then touch Done.
3Adjust backlight and sound settings to suit the screening environment, if necessary. Touch
Device Settings:
aTouch Backlight Settings, move the slider to brighten or dim the display, and then touch
Done.
bTouch Sound Settings. Do any of the following and then touch Done:
• To turn off all sounds, touch Mute All.
• To make key clicks softer or louder, touch Soft or Loud. To turn off key click sound,
touch Off.
• To make chimes louder or softer, move the slider. To turn chimes off, touch Mute.
4Select the patient to be screened. At the Home screen, do one of the following:
• Touch To-Do List, and select a patient already on the device.
• Touch Patient List, select a patient already on the device, and touch To-Do to add the
patient to the To-Do List. In the To-Do List select the patient.
• Touch Add Patient to add a new patient to the device.
Check the Environment
During screening, it is important to control noise in the environment as much as possible.
Screening is faster when background noise and patient generated noise is low. Take measures
to control such noise, or find a quieter room, if possible.
Assess the Patient for Screening
Patients with the following characteristics are appropriate for screening:
• Term, healthy newborns
• Infants 34 weeks gestational age or older
• Infants who are ready for discharge or scheduled to go home within a few days
• Infants who are sleeping or in a relaxed state (usually after a recent feeding)
• Infants in an open crib
• Patients with normal outer ear anatomy and no obvious deformities of the head or neck
• Patients who are receiving no central nervous system (CNS) stimulants
Screening a patient in a less optimal state, such as when a baby is awake or a patient is
medically unstable, is not recommended and may increase screening time. Qualified medical,
nursing, or audiological personnel need to conduct the screening in less than optimal situations

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Preparing for Testing Echo-Screen III Pro Instructions for Use
because professional assessment skills may be needed for troubleshooting during the
screening.
When evaluating a patient for screening, consider the following:
• Screening an infant in an incubator may result in increased interference and may make
the screening take longer.
• Do not screen patients while they exhibit excessive movement, because such activity
can lead to high myogenic interference.
• Do not screen patients with known absence or malformation of external, middle, or
internal ear structures. The device is not designed for these conditions.
• The device is not intended for patients with known or suspected neurological conditions.
Screen a patient with known neurological conditions only with well-informed medical
and/or audiological supervision.
Prepare the Patient
ABR tests require a PCA cable and either an OAE cable or an ATA cable. The ATA cable is
recommended for newborns. ATA supports sequential testing of ears without requiring you to
prepare the patient between tests and provides a better fit for newborns.
TEOAE and DPOAE (including DPOAE+) screenings require only an OAE cable.
Connect the cables:
1Select the cables for the test:
• OAE cable for TEOAE or DPOAE tests
• ATA or OAE cable plus PCA cable for ABR tests
2For ATA or OAE cables, align the double ridges on the connector (blue on both cables) with
the slots in the ATA/OAE port, and press the cable in until it clicks into place.
3For PCA cables, align the single ridge of the connector (purple) with the slot in the PCA port,
and press the cable in until it clicks into place.
IMPORTANT: When you disconnect the cables, grasp the sleeve of the connector and pull the
connector out of the port. Do not pull the connector by the cable or the strain relief.
CAUTION Carefully align the ridges on the plug to the slots in the port to reduce the chance of
bending the metal pins inside the male plug. You must insert the plugs completely
into the corresponding ports for the device to operate properly. Never twist the con-
nectors during insertion or removal. Twisting the connector in the port can damage
the metal pins and cause system malfunctions involving stimulus delivery or system
recording.
Do not allow ATA transducers to dangle from the screening device. Never swing the
earphone cable or strike the transducers against a hard surface. Shock to the trans-
ducers can result in damage to their sensitive acoustic components.
ATA/OAE port PCA port
WARNING Natus recommends that you test the Echo-Screen III Pro cables once a day before
beginning to screen or any time you suspect that a cable or probe may have an issue.

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Preparing for Testing Echo-Screen III Pro Instructions for Use
Apply the electrodes for ABR screenings:
1If the patient's skin is dry or oily, prepare the skin for the electrodes by using saline or
NuPrep®gel. Skin preparation reduces electrical impedance, allowing for better
conductivity of the ABR electrical signals.
• Oily skin responds well when cleaned with mild soap and water, followed by an
application of NuPrep®gel (gel for neonates).
• Dry skin responds well to an application of saline or NuPrep®gel, or a drop of saline
under each electrode.
Note: Alcohol dries the skin. If alcohol use is permitted, follow it with a wet
gauze wash or apply NuPrep gel to rehydrate the skin.
IMPORTANT: If the electrodes appear discolored or hard, or are not sticky when removed from
the foil pouch, dispose of the electrodes and use new ones. Do not use damaged or expired
electrodes.
2Attach the clips of the PCA cable to a triplet of disposable Jelly Tab electrodes: Squeeze
each clip open and place it on the tab of the electrode. Keep the cable side of the clip and
the gel side of the electrode on the same side. Attach the clips to the electrodes before
removing the electrodes from the adhesive liner card.
3Hold the electrodes by the tabs. One at a time remove the liner card from each electrode
and attach the electrode to the patient, orienting all the electrodes in the same general
direction:
•Black clip: Vertex (center forehead, as high as possible, nearest to the hairline and
away from eyebrow and eye area. Avoid the forehead muscles to increase screening
efficiency.)
•White clip: Nape (centered on back of the neck, not on the skull or back.)
•Green clip: Common (back of either shoulder, not touching the nape sensor.)
IMPORTANT: Failure to place electrodes in the recommended locations can result in
significantly slower screening and increased Refer rates.
WARNING Do not use soap or alcohol on an infant’s skin unless permitted by your facility’s
standard protocol.
Do not prepare skin or apply electrodes to damaged or compromised tissue or to
babies with marked jaundice.
Do not leave electrodes on a baby for prolonged periods. If the baby perspires under
an electrode that has not been removed, irritation may develop.
CAUTION Connect the PCA cable clips only to the purple colored tab section of the electrode. Do
not allow the PCA clip to come in contact with the hydrogel portion of the electrode.
Myogenic readings may be affected.
Correct
Incorrect

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Preparing for Testing Echo-Screen III Pro Instructions for Use
4Press gently and firmly to adhere the hydrogel surface to the skin, and hold in place for a
few seconds to create a good adhesion to the patient's skin.
Note: To help reduce interference during testing, make sure that the ATA cable
does not touch the electrodes during testing.
IMPORTANT: Always handle the electrodes only by the non-adhesive tab. The adhesive
surface is conductive and may become unusable with excessive or improper handling.
Apply disposable earphones if using ATA cable for ABR screenings:
1Open the earphone pouch by tearing the notch in the corner. Leaving the earphones on the
liner, attach the earphones to the earphone connectors on the transducer housings.
IMPORTANT: Flexicoupler earphones are designed for single-patient use. Do not reuse.
Note: Flexicoupler earphones are designed only for use with newborn patients.
Note: Flexicoupler earphones are intended only for use with the ATA cable. Do
not attempt to use Flexicoupler earphones with the OAE cable.
2One at a time, remove an earphone from the liner and place it over the patient's ear:
Blue transducer — left ear Red transducer — right ear
Position the earphone tab at the back of the ear with the cable emerging either toward the
top of the head or toward the patient's body. Roll the earphone from the back of the ear to
the front as you attach it to the patient.
Black
White
Green
WARNING Any use of the earphones or the earphone cable other than described here may
result in screening at unknown and uncontrolled decibel levels.
Never apply pressure to the ear canal or compress the tragus (the prominence in
front of the external opening of the ear).
Never insert the acoustic transducers directly into an ear.
Earphone
connector
Earphone tab
Earphone liner

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Preparing for Testing Echo-Screen III Pro Instructions for Use
The earphone must completely enclose the external ear and form a good seal all the way
around. Avoid applying earphones to hair if possible. Ensure that the colored transducer is
in front of the patient’s ears.
Apply probe for TEOAE or DPOAE, or for ABR with OAE cable:
1Select a disposable ear tip to fit the patient’s ear canal, and slide it onto the probe nozzle.
IMPORTANT: Only use ear tips designed for your Echo-Screen III probe and provided by
Natus Medical Incorporated.
IMPORTANT: When attaching and removing the ear tip, hold the housing of the probe and not
the probe cable.
IMPORTANT: For foam tips, do not pinch the foam while attaching the foam tip to the probe
nozzle.
2Gently insert the probe into the patient’s ear canal, ensuring a snug, secure fit:
• If necessary, pull the external ear slightly backwards, similar to preparing for an
otoscopy.
• Compensate for spontaneous head movements by reducing the strain on the probe
cable: either form a big loop that is loosely held with one hand close to the head of the
patient, or use the cable clip and attach the clip to a surface close to the patient’s head
(such as to the patient’s clothing or to a baby’s blanket).
• Avoid possible contact of the cable with any vibrating or gliding surfaces during
measurement.
Note: You can use the same ear tip for both ears. However, if you suspect an infection in
the external auditory canal, change the ear tip before testing the other ear.
Note: If a probe error occurs, ensure that the probe nozzle grooves are free of debris and
that the probe is properly connected.
Example of foam tip placement
Example of tree tip placement
WARNING The probe nozzle must not be placed into the ear canal at any time without using a
proper ear tip.
Never apply pressure to the ear canal or compress the tragus (the prominence in
front of the external opening of the ear).
If a probe with an unsuitably sized ear tip is used, or if excessive force is applied, the
ear canal bay become irritated.

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Performing a TEOAE, DPOAE, or DPOAE+ Screening Echo-Screen III Pro Instructions for Use
3To remove an ear tip after screening, hold the probe body with your fingers pressing on the
probe nozzle clips. Position the fingernails of your other hand behind the clear tube of a
foam tip or at the base of a tree tip and slide the ear tip off the nozzle. For foam tips, do not
pull on the foam.
Performing a TEOAE, DPOAE, or DPOAE+ Screening
Note: DPOAE+ is available only if your administrator configured your device
for it. DPOAE+ test results are not included in aggregated test results. This
option is used only by certain hearing screening programs.
TEOAE, DPOAE, and DPOAE+ screenings use only the OAE probe cable.
IMPORTANT: Before you begin, check the calibration date displayed on the Home screen.
You cannot perform a screening when the probe is out of calibration.
IMPORTANT: Natus and the Joint Committee on Infant Hearing (JCIH) recommend always
screening both ears during each screening session.
Start screening:
1With the patient selected in the To-Do List or on the Patient Info screen (after adding or
editing the patient information), touch Screen, and then on the test selection screen, select
the type of screening to be performed: TEOAE, DPOAE, or DPOAE+ (if configured for your
device).
CAUTION Make sure that the cables are not wrapped around any part of the device and that the
cables are separated and untangled while performing a screening. These conditions
might result in inaccurate screening results.