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Medical Background Information

and Application Hints for


Echo-Screen Plus
(T, D, A, TD, TA, DA, TDA)

REFERENCE GUIDE

P/N 051591E January 2010


© 2010 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 is strictly
prohibited.

AABR, Natus, and Echo-Screen are registered trademarks of Natus Medical Incorporated.
NuPrep is a trademark of D.O. Weaver & Co.
Windows is a registered trademark of Microsoft Corporation.

Manufactured by:
Natus Europe GmbH
Bärmannstrasse 38
D-81245 Munich, Germany

Distributed and Supported by:


Natus Medical Incorporated
1 Bio-logic Plaza
Mundelein, IL 60060
USA
Phone: +1 (650) 802-0400
Fax: +1 (650) 802-0401
Email: Customer_Service @natus.com

www.natus.com

CONFIDENTIAL
PROPERTY OF NATUS MEDICAL INCORPORATED
ALL RIGHTS RESERVED
Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Explanation of Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Precautionary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Documentation Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Example Data and Screen Shots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Buttons, Menus, and Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Overview of Screening Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5


About Otoacoustic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Types of OAEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Transient Evoked Otoacoustic Emissions (TEOAEs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Distortion Product Otoacoustic Emissions (DPOAEs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Working with OAEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Recording OAEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
OAE Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
About AABR® Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Echo-Screen Device Technology Configurations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Screening Device & Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9


Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Display & Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Keys, Terms, Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Data Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Top View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Ear Probe Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Test cavity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Y Probe Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ABR Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Screening Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Echo Couplers & Snap Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Ear Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

© 2010 Natus Medical Incorporated P/N 051591E i


Echo-Screen User’s Guide

Setting Up the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


Initial Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Unpacking the Echo-Screen device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Storing the Echo-Screen Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Charging the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Removing the Battery Pack and Connecting the Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Monitoring the Battery Charge Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Battery Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Battery Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Increasing Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Battery Replacement & Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Language, Date/Time, Testing Alert & Background Light Settings . . . . . . . . . . . . . . . . . . . . . . . . 20
Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Date / Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Date / Time Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Background Lighting (display). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Default Test Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Data Input, User Access, & Patient Data Display Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Edit Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
User Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Setting User Login Names and IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Patient List Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ABR Configuration Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
ABR Notch Filter Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
ABR Stimulus Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Storing Default Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Preparing for Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29


TEOAE & DPOAE Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
AABR Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Connecting the ABR Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Connecting the Ear Probe Cable or Y Probe Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Checking the Test Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Screening Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Screening Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Step 1: Power on the Echo-Screen device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Step 2: Enter Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Step 3: Prepare Patient and Attach Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Skin Prepping Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Applying Echo Couplers (Y probe cable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Step 4: Start Screening/Monitor Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
TEOAE Screening Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
DPOAE Screening Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

ii P/N 051591E © 2010 Natus Medical Incorporated


Echo-Screen User’s Guide

AABR Screening Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41


Using the ear probe cable (ear tips) for AABR tests: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Using the Y probe cable (Echo Couplers) for AABR tests: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Monitoring the AABR test progress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Status messages during AABR test: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Screening Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Viewing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Understanding PASS & REFER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
TEOAE results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
DPOAE Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
AABR Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Printing Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Transfer & Deletion of Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53


Data Transfer Using Wireless (Infrared) or Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Installing EchoLinkII Software on the PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Transferring Test Records from the Echo-Screen Device to a PC . . . . . . . . . . . . . . . . . . . . . . . . 53
Transferring Test Records from the PC to the Echo-Screen Device . . . . . . . . . . . . . . . . . . . . . . 55
Deleting Screening Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Quick Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Equipment Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Performing Self tests/Equipment Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Probe Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Discharge Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Codec Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
LCD Display Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Keypad Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Memory Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Software and Hardware Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Error Messages & Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Echo-Screen Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Cleaning the Echo-Screen Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Maintenance of the Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Cleaning, Disinfection, & Sterilization of the Probe Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Probe Tip Cleaning Procedure:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Wet Cleaning and Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Changing the Acoustic Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Cleaning, Disinfection and Sterilization of Ear Tips and Cleaning Wire . . . . . . . . . . . . . . . . . . . . 70

© 2010 Natus Medical Incorporated P/N 051591E iii


Echo-Screen User’s Guide

Cleaning of the Y Probe Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70


Maintenance of the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Echo-Screen® Hearing Screener Limited Product Warranty . . . . . . . . . . . . . . . . . . . . . . . . 73

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
TEOAE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
DPOAE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
AABR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Y Probe Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Device Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Applied Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Manufactured by . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

List of Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

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Introduction
Intended Use

The Echo-Screen® Hearing Screener is a fast, reliable, portable device


designed to screen for hearing loss in newborns, infants, children, and adults.
During screening, the patient should be asleep or in a quiet state.

IMPORTANT: Newborns must be at least 34 weeks gestational age to be


tested with the Echo-Screen device.

IMPORTANT: Before setting up the Echo-Screen device or screening


patients, read all sections of this manual carefully.

The Echo-Screen is designed as a completely modular system. According to


the current scientific standard, three important methods are suitable for the
screening of hearing loss. These methods are distinguished by features that
qualify them for specific situations, target groups, and screening protocols.
Depending on your situation, you might have a choice of a single method or a
combination of methods. The Echo-Screen system is available as a single or
multi-step hearing screener. An advantage of an Echo-Screen that incorporates
multiple methods is that different methods can be applied successively without
requiring follow-up procedures.
The Echo-Screen device incorporates the following three types of technologies
for the screening of hearing loss:
• Transient Evoked Otoacoustic Emissions (TEOAE) technology
• Distortion Product Otoacoustic Emissions (DPOAE) technology
• AABR® technology
With this combination of technologies, the Echo-Screen is flexible in both
handling and application, and is suitable for all stages of life.
Otoacoustic Emissions (OAE) technology measures the acoustic response of
the outer hair cells within the inner ear and indicates whether the cochlea is
functioning properly. TEOAE technology is optimized for use with newborn and
pediatric populations, while DPOAE technology is appropriate for patients of all
ages. The DPOAE technology has the advantage of providing a
frequency-specific test. Both technologies can be used as a first stage
screening test within a multi-stage screening program.
AABR technology measures the electrical response of the auditory nerves and
the brain to brief click stimuli. It is optimized for use with newborn patients. This
technology is appropriate as a second screening step for children at risk of
hearing loss.
After you start the Echo-Screen measurements, all the methods and the
interpretation of the measurements proceed automatically. By providing
automatic PASS and REFER results, the Echo-Screen device does not require

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Echo-Screen User’s Guide
Safety Information

special technical skills or interpretation of results. Basic training with the


equipment is sufficient to learn how to screen correctly.
The Echo-Screen is designed for every measurement modality so that the tests
meet the needs of various groups and hearing loss can be detected with a high
degree of validity.
The simple and reliable technology ensures that hearing loss can be detected
objectively, even at an early age or in non-cooperative persons. Numerous
investigations show that, because of the early maturation of the brain in
children, it is beneficial to assess hearing loss within the first six months of life.
With early technical and therapeutic intervention, hearing-impaired children
have the potential to develop considerable speech and language skills, which
are essential for their mental and social development.

Safety Information

Explanation of
Terminology This manual presents three types of precautionary information. The three types
of statements carry equal weight; that is, they are of equal importance to the
safe and effective use of the device. Each statement is categorized by using an
introductory word in boldface as follows:

WARNING: Identifies conditions or practices that might present danger or


possible injury to the patient and/or user.

IMPORTANT: An instruction provided to help ensure correct clinical results


and provide quality assurance to the screening procedures.

CAUTION: An instruction that, if not followed, can result in a condition that


could damage the device.

Other explanatory information is highlighted with the word "Note". Information


in this category is not considered precautionary.

Note: Background information provided to clarify a particular step or


procedure.

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Echo-Screen User’s Guide
Documentation Conventions

Precautionary
Information The following precautionary information pertains to the use of the Echo-Screen
Hearing Screener.

WARNING: Do not use the screener if you suspect it is not functioning


properly or if any parts appear damaged. Contact Natus Technical Service or
your authorized service provider for assistance.

WARNING: Do not attempt to plug the ear probe, ABR, or Y probe cable
into any other equipment, as unspecified damage to either component may
occur. The ear probe, ABR, and Y probe cables are patient connected cables
and must only be plugged into the Echo-Screen device.

WARNING: Print or export data to a PC outside of the immediate patient


care area.

WARNING: When the device battery requires replacement, always charge


batteries outside of the immediate patient care area.

CAUTION: Use only Natus screening supplies with the Echo-Screen


device. Use of non-Natus supplies may damage the Echo-Screen device, may
affect the accuracy of screening results, and will void the warranty.

CAUTION: Never use any type of sharp instrument on the plastic keypad.
Reliable operation of Echo-Screen device can no longer be guaranteed if sharp
instruments are used.

CAUTION: Use only the Natus approved battery charger (REF 900729)
delivered with the Echo-Screen device. Battery chargers not approved by
Natus may not meet electrical and safety standards. Use of other chargers may
cause damage to the device and Natus is not liable for damages caused in their
use.

CAUTION: Incorrect use of the Echo-Screen device and its accessories,


or the use of parts and accessories not supplied by Natus Medical
Incorporated, can lead to incorrect results.

Documentation Conventions

Example Data and


Screen Shots Example Data
Throughout this manual, you will find screen shots that illustrate the windows
you see when using the data management software or screening devices. In

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Echo-Screen User’s Guide
Documentation Conventions

some cases, these screen shots appear to contain patient data. This data is
fictional, having been created for illustration purposes only.

Screen Shots
The screens shown in the following pages may look different than the screens
on your particular system. Not all command buttons or on-screen choices may
be available, as software configuration allows for some features to be
assignable to custom profiles and the administrator of your system may have
configured your system differently than depicted.

Buttons,
Menus, and Fields In this document, the names of toolbar icons, buttons, and menu options are
displayed in teal. These items are selections you can make to execute the
described functions.
Field names, checkboxes, and radio buttons are displayed in bold. These
items represent places where you can enter data or choose an option.

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Overview of Screening Technology

About Otoacoustic Emissions

Congenital hearing impairment can lead to serious consequences for speech


and language acquisition, as well as for emotional and intellectual
development. Recent research has confirmed that these consequences can be
minimized if identification and intervention occur before the hearing-impaired
child reaches six months of age. In addition, technological advances make it
possible for a wide range of caregivers to perform automated screening of
infants’ hearing. One of these automated screening methods uses the
presence of otoacoustic emissions.
Otoacoustic emissions (OAEs) are sounds found in the ear canal that originate
from activity in the cochlea. These sounds are weak, but potentially audible,
sometimes amounting to as much as 30 dB SPL. They are created by motion
of the eardrum driven by vibrations in the cochlea, which are transmitted
through the middle ear chain. Consequently, they can be detected only when
the middle ear is operating normally. OAEs are generated only when the Organ
of Corti is in normal or near normal condition. They can emerge spontaneously,
but more commonly follow acoustic stimulation.
Note that otoacoustic emissions do not contribute to hearing, but are
by-products of an active process in the cochlea, in which motility of the outer
hair cells tunes the basilar membrane and amplifies weak sounds. They are
clinically significant in that they provide an indication of the integrity of the
cochlear amplifier (outer hair cells).

Types of OAEs

Transient Evoked
Otoacoustic
Emissions TEOAEs are elicited by brief stimuli such as clicks or tone bursts. They can be
(TEOAEs) recorded in nearly all persons with normal hearing. TEOAEs are highly
non-linear. Their pattern of growth is consistent with the operation of the
cochlear amplifier, which provides most gain for the low level inputs, and lends
support to the notion that OAEs arise from outer hair cell activity.
TEOAEs do not correlate with behavioral audiometric thresholds. Thus it is not
possible to predict hearing thresholds based upon TEOAE thresholds.
However, since the presence of TEOAEs correlates strongly with normal
hearing, the most common clinical application involves click stimulation at
moderate intensity levels for the purpose of hearing screening or differential
diagnosis.
The Echo-Screen system uses a binomial statistical test to give either a PASS
or REFER result. In contrast to the signal averaging technique with two buffers,
typically applied in most TEOAE instruments, the Echo-Screen device

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Echo-Screen User’s Guide
Types of OAEs

calculates the statistical probability that an emission has been recorded, at a


succession of sampling points ranging from 6 to 12 ms after the stimulus.
The Echo-Screen device considers every data point individually. The
assumption is that for each point no time locked signal is present. This point is
then compared to the distribution of random signal which is well defined by
binomial statistics. If the assumption that each single point is random can be
rejected with 99.7% confidence, then the point is considered to be a signal (or
emission).
Each recorded sweep is assigned to one of eight quality buffers, according to
its amplitude. The statistical analysis is carried out simultaneously in each
quality buffer, and the test result will be OK if the criterion for this outcome is
met, in any of the quality buffers. A PASS result is indicated by the presence of
4 alternating peak pairs of the statistical OAE trace exceeding the 99.9%
confidence limit.
The advantage of this method over the usual averaging techniques is that the
measures are more robust in noise and measurement time can be reduced.
Because the Echo-Screen device can automatically identify and exclude
artifacts, measurement time can be dramatically shortened, a distinct
advantage especially in the case of restless infants. In addition, the statistical
criterion reduces the probability for a false negative result to less than 0.3%.

Distortion Product
Otoacoustic
Emissions DPOAEs are tones produced by the ear in response to two simultaneous
(DPOAEs) pure-tone stimuli denoted as primary tones. These emissions are distortion
products (DPs) in that they are not present in the pure-tone stimuli that elicits
them. The lower frequency pure-tone stimulus is represented by f1 and the
higher frequency pure-tone stimulus is represented by f2. The most frequently
measured DPOAE is at the 2f1 - f2 frequency, although the cochlea also
produces DPOAEs at other frequencies. This measurement is typically the only
one used for clinical applications.
The crucial task of the DPOAE evaluation is to discriminate the sound of the
environment — the noise — from the cochlear sound response — the DP.
Although the distinction can never be absolutely certain, a properly designed
statistical algorithm can reduce the probability of incorrectly classifying noise as
a cochlear signal to a known probability. With the Echo-Screen device, this
probability is 0.3% for each frequency applied. Conventional criteria commonly
used in this type of device show a false pass rate that is considerably higher (up
to 10% with the frequently used 6dB SNR criterion).
The Echo-Screen device utilizes a statistical solution that makes it possible to
evaluate the spectrum specifically at the frequency of the expected DP. Thus,
no comparison with adjacent spectral lines is necessary.
During a specific time, the acoustic activity at the expected DP frequency fDP =
2f1 - f2 is analyzed by reducing the spectral component to a unit vector. Its
phase is determined mathematically. By repeating this procedure, a set of unit
vectors with different phases is obtained. These vectors can be added using the
laws of vector addition in the polar coordinate system.

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Echo-Screen User’s Guide
Working with OAEs

The evaluation is based upon the laws of statistical distributions: It can be


shown mathematically that the vector of randomly distributed unit vectors will
not exceed a certain value with a probability of 99.7%. Spectral components of
random noise with phases that are independent of the primary tones behave
similarly. A DP with fixed phase relative to the primary phases will add a
constant value to this sum. Therefore, if the vector sum exceeds this limit, the
presence of a response can be claimed on a 99.7% confidence level.
This criterion is set up for each of four f2 frequencies applied: 2 kHz, 2.5 kHz,
3.2 kHz and 4 kHz. An overall PASS result requires 3 passes out of 4
frequencies.

Working with OAEs

Recording OAEs Recording OAEs requires a sensitive, low-noise microphone to be sealed in the
external ear canal. Recording of OAEs elicited by an acoustic stimulus also
requires that two transducers deliver the stimuli. The microphone records the
sound present in the external ear canal. The type of signal analysis applied
depends on the type of emissions to be recorded.

OAE Applications TEOAEs are well suited and widely accepted for the purpose of hearing
screening. The presence of TEOAEs is a strong indicator that a portion of the
audiogram has hearing threshold levels better than 25 db HL, and correlates
best with good hearing in the mid-frequency range. It is not possible to rely on
the TEOAE spectrum to predict threshold levels by frequency.
Although DPOAEs do not allow clinicians to predict behavioral thresholds,
there is a correspondence between DP-gram configurations and audiograms.
That is, in ears having sensory hearing loss, DPOAEs are reduced or
eliminated only for the f2 stimulus frequency region that coincides with the
impaired region. Therefore, DPOAEs can give a better frequency-specific
impression of cochlear integrity than TEOAEs, and they are well suited to
monitoring cochlear function.
Although OAEs have not proven to be good predictors of auditory nerve tumors,
they can provide an opportunity to document normal or near-normal cochlear
function, which makes them helpful for locating site lesion and for making
management decisions.

About AABR® Technology

The Echo-Screen device delivers broadband clicks at 35 dB nhL, 45 dB nHL,


or 55 dB nHL intensity levels to the patient’s ears through either Echo Couplers
or an ear probe. Each click evokes a series of identifiable brain waves from the
auditory brainstem. This brainwave activity is called the ABR (auditory
brainstem response).
Like the TEOAE and DPOAE modes of the Echo-Screen device, AABR
technology uses a statistical approach for the PASS criteria which is based on
binomial statistics. Because an ABR shows different characteristic shapes

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Echo-Screen User’s Guide
Echo-Screen Device Technology Configurations

during an individual’s life period, the algorithm is optimized by pre-filtering the


measured brain signals with a typical pattern. The Echo-Screen device uses a
pattern which represents the typical waveform during the first year of life.
Nevertheless, AABR technology may also be used for older children as well as
adults. Due to sub-optimal fit it may take longer to achieve a PASS result.
A PASS result from AABR technology indicates that an electric brainstem
response to a 35 dB nHL, 45 dB nHL, or 55 dB nHL broadband stimulus could
be detected. The spectrum of the stimulus includes all frequencies between
500 and 4000 Hz, but due to filtering in the ear canal and other influences, the
main region tested is between 2000 and 4000 Hz. In this region most significant
losses can be found. A REFER result indicates that the necessary significance
level for a PASS could not be reached.
As compared to the measurement of otoacoustic emissions, ABRs discriminate
more precisely between mild and moderate hearing losses. Consequently, its
specificity for the detection of moderate hearing losses is higher.
ABRs are particularly appropriate for testing hearing in newborns, infants, and
children for the following reasons:
• ABRs are not influenced by vigilance. Therefore, they can be
measured during sleep. Sleep is the ideal state for measuring ABRs
because during this state muscle potentials have the least influence
over the measurements.
• Investigations show that the psycho-acoustic hearing threshold has a
strong correlation with the response threshold of the brain stem. This
means that if an ABR is measurable as a response to an acoustic
stimulus, it is safe to assume that the individual can hear the stimulus
unless there is cortical brain damage.
On the downside, care must be taken during measurement and evaluation to
avoid false results, because the amplitude of the response is frequently below
100nV and, therefore, considerably lower than that of a scalp
electroencephalogram (EEG) or electromyogram (EMG).

Echo-Screen Device Technology Configurations

The Echo-Screen system is available as a single or multi-step hearing


screener. The following models or technology configurations are available:

Model Technology Configuration

Echo-Screen T TEOAE technology

Echo-Screen D DPOAE technology

Echo-Screen A AABR technology

Echo-Screen T/D TEOAE & DPOAE technology

Echo-Screen T/A TEOAE & AABR technology

Echo-Screen D/A DPOAE & AABR technology

Echo-Screen T/D/A TEOAE, DPOAE & AABR technology

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Screening Device & Components
The Echo-Screen Hearing Screener is a handheld, battery-operated device
containing a set of customized electronic components that incorporate one or
a combination of TEOAE, DPOAE, and AABR technologies. It also has an
infrared (IR) port which can be used to transfer or print screening results.

Front View

Figure 1—Elements of the Echo-Screen

Graphic LC
Display

LED Indicator

OK Button

Soft Keys

Navigation Arrows

Alphanumeric
Keypad

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Echo-Screen User’s Guide
Display & Control Panel

Display & Control Panel

Keys, Terms,
Functions Table 1.Button functions

Button Text on display Mode

OK N/A •

Switches on the device
Activates the selected item
OK Button • Starts screening functions

 OFF
BACK


Switches off the device from the main menu
Reverts to the previous menu/display
Soft key right SELECT
• Cursor for selecting Date/Time
STOP
• Discontinues screening



N/A •

Cursor for navigating the menus / scrolling up
Steps up the value of the setting in the
"Date/Time" menu
Navigation
arrow up



N/A • Cursor for navigating the menus /scrolling
down
• Steps down the value of the setting in the
Navigation
"Date/Time" menu
arrow down

 MENU
OPT (Option)


Reverts to the main menu
Shows artifact and stimulus stability rate
Soft key left (TEOAE)
SKIP
PAUSE • Skips test functions (DPOAE)
• Interrupts screening (AABR)

Navigation Press the navigation arrows (up or down) to scroll through the menu items.
Selected items are highlighted black.
Press OK to activate menu functions highlighted by the black bar and to confirm
selections.
The current function of the soft keys is displayed in the bottom line of the
display.

CAUTION: Never use any type of sharp instrument on the plastic keypad.
Reliable operation of Echo-Screen device can no longer be guaranteed if sharp
instruments are used.

Data Entry Use the alphanumeric keypad to enter numbers and letters. Use the arrow keys
on the keypad (< and >) to move backwards and forwards.

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Echo-Screen User’s Guide
Display & Control Panel

Top View Figure 2—Echo-Screen Top View

Infrared window ABR cable socket Ear Probe/Y Probe


cable socket

Bottom View Figure 3—Echo-Screen Bottom View

Connector to PC data transfer cable

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Echo-Screen User’s Guide
Display & Control Panel

Back View Figure 4—Echo-Screen Back View

Label with serial number

Rechargeable NiMH battery


pack

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Echo-Screen User’s Guide
Ear Probe Cable

Ear Probe Cable

The ear probe cable is designed for conducting TEOAE, DPOAE, and AABR
tests. Different sized ear tips are attached to the probe tip and then inserted into
the patient’s ear canal for testing.

Figure 5—Probe Tips

Acoustic filter Probe tip

Probe body

Test cavity The test cavity is used to test the functionality of the ear probe cable. The probe
tip of the ear probe cable is inserted into the test cavity.

Figure 6—Test Cavity

Y Probe Cable

The Y probe cable is designed for conducting AABR tests. The colored
adapters of the cable generate clicks, which are delivered to the patient’s ears
through Echo Couplers. The Y probe cable is designed specifically for use with
Echo Couplers.

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Echo-Screen User’s Guide
ABR Cable

Figure 7—Y-Probe Cable


Blue Echo Coupler adapter
for the left ear

Red Echo Coupler


adapter for the right
ear

Connector to
Echo-Screen

ABR Cable

The ABR cable is designed for AABR tests. The cable consists of colored clips
which attach to Natus disposable snap electrodes. The cable transmits the
patient’s responses back to the Echo-Screen device.

Figure 8—ABR Cable

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Echo-Screen User’s Guide
Screening Supplies

Screening Supplies

Echo Couplers &


Snap Electrodes Echo Couplers are designed for conducting AABR tests. They attach to the Y
probe cable and are placed over the patient’s ear during testing. The Echo
Couplers are designed for newborn patients and are intended for single-patient
use.
The snap electrodes are specialized low impedance electrodes designed for
AABR tests. They allow the ABR signals to be transmitted across the infant’s
skin to the Echo-Screen device. The sensors are coated with a conductive
adhesive.

Figure 9—Echo Coupler and Snap Electrodes

Disposable Snap Electrodes


Port for one
Echo Coupler
Adapter

Skin prepping materials, such as NuPrep® gel, remove surface oil or skin
debris at the sensor sites on the patient. These products lower the electrical
impedance of the skin and can improve the sensor connections. Your service
representative can provide information and options for supplies and prepping
materials.

Ear Tips The colored ear tips attach onto the probe tip end of the ear probe cable and
are inserted into the patient’s ear canal for TEOAE, DPOAE, or AABR tests.
The ear tips are available in different sizes to accommodate testing with
newborns, children, and adults.

Figure 10—Ear Tips

Colored Ear Tips

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Echo-Screen User’s Guide
Screening Supplies

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Setting Up the Device
Initial Setup

This section provides instructions for the initial setup of the Echo-Screen device
prior to screening.

IMPORTANT: Ensure that the Echo-Screen device has all the appropriate
settings for your facility’s protocol prior to screening patients.

Unpacking the
Echo-Screen device Unpack the Echo-Screen system carefully. Inspect the equipment for possible
visual damage and ensure you have received all parts and accessories.
If damage has occurred, do not attempt to operate the device. Instead, contact
Natus Technical Service or your authorized service representative.

Storing the
Echo-Screen Device The Echo-Screen device is shipped in a protective carrying case. When not in
use, the device should remain in its carrying case to prevent damage.
The Echo-Screen device should be stored between the temperatures of 0-40ºC
(32-104ºF).

CAUTION: Extreme storage or operation temperatures may cause the


LED to crack (in extremely cold conditions) or affect the calibration of the
instrument.

Charging the Battery


Pack The Echo-Screen device is shipped with a partially charged battery pack. Prior
to first use, the battery must be charged.

CAUTION: Use only the Natus approved battery charger (REF 900729)
delivered with the Echo-Screen device. Battery chargers not approved by
Natus may not meet electrical and safety standards. Use of other chargers may
cause damage to the device and Natus is not liable for damages caused by
their use.

WARNING: When the device battery requires replacement, always charge


batteries outside of the immediate patient care area.

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Echo-Screen User’s Guide
Initial Setup

Removing the
Battery Pack and
Connecting the Figure 11—Releasing the Battery Pack
Charger 1. Place the Echo-Screen device on a
flat surface with the back side facing
upward.
2. Use the index finger of the other
hand to press the button of the
battery until it clicks. Slide the battery
downward to remove it from the
housing.

Figure 12—Charging the Battery


The charger socket is located on the
inside of the battery pack.
3. Insert the plug of the charger into the
charger socket of the battery pack.
4. Plug the charger into a mains power
socket. Charging starts automatically.

Note: The battery pack takes approximately two hours to charge


completely.

Note: The battery pack for the Echo-Screen system allows


approximately 10 hours of continuous use once it is fully charged.

Monitoring the
Battery Charge
The Echo-Screen battery charger controls the charge process automatically.
Process
The LED on the bottom of the charger indicates when the battery is charging
and when it is fully charged. The LED will also indicate any faults evident in the
system (see Battery charging LED messages on page 19).

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Echo-Screen User’s Guide
Initial Setup

Table 2.Battery charging LED messages

LED on * Rapid Charge: The battery pack is being


I------------------------I charged.

LED flashing every * Trickle Charge: The battery pack is fully charged.
1.3 seconds
I-- -- -- -- -- -- -- I

LED flashing every * Fault Condition: The charger has detected a


0.3 seconds fault.
I- - - - - - - - - - - - - - I

Battery Test Press the OK button to turn on the Echo-Screen device. The device
automatically runs a battery test.
If the necessary minimum voltage should drop, the change battery message
appears on the display and the Echo-Screen device switches off automatically.
If this occurs, exchange the NiMH-battery pack and recharge it as soon as
possible.

Figure 13—Battery Indicator


If the battery symbol appears in the top
right corner of the display, you can no
longer activate any functions other
than navigating through the menu. If
this occurs, exchange the NiMH
battery pack and recharge it as soon
as possible.

Battery Safety
Information CAUTION: The charger is for indoor use only and should be protected
against moisture.

CAUTION: Do not use the charger with non-rechargeable batteries.

CAUTION: Keep the battery away from fire, as it can explode. Incorrect
handling, applying excessive charging current or reversing the poles, can
overcharge or destroy the battery.

CAUTION: Do not open, alter or dismantle the battery pack.

CAUTION: Do not place the battery pack in contact with metal objects.

CAUTION: The battery pack terminals must not be short-circuited under


any circumstances.

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Echo-Screen User’s Guide
Initial Setup

Increasing Service
Life • Use only the recommended battery charger unit.
• Charge the battery pack at room temperature whenever possible.
• Do not drop the battery pack or expose it to sharp impact.
• Store in a cool, dry place.
• Keep the battery pack terminals clean. (Clean with a soft cloth if neces-
sary)

Battery
Replacement &
Disposal To obtain a replacement battery pack, contact Natus Technical Service or your
authorized service representative. Follow your institution’s protocol for the
proper disposal of the battery pack.

Language,
Date/Time, Testing
Alert & Background
Light Settings Basic settings on the Echo-Screen device such as language, date/time, and
testing alert sounds can be selected and changed.

1. Power on the Echo-Screen device


and select Options from the main
menu display.

2. Select Settings 1 from the Options


menu and press OK to continue.

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Initial Setup

Language 1. Select Language to view the


available language options for
operating the Echo-Screen system.

2. Select the appropriate language


3. Press OK to confirm and return to the
main Settings 1 menu.

Note: You must press OK to confirm a new language setting. Pressing


 (MENU) returns to the main menu display without storing the new
language setting. Pressing  (BACK) returns to the Settings 1 display
without storing the new language setting.

Date / Time 1. Select Date/Time from the


Settings 1 display and press OK to
view the date and time setting.
2. Press  (SELECT) to select the
appropriate date or time unit.
3. Use the up and down navigation
arrows to increase or decrease the
selected date or time value.
4. Press OK to confirm the new date
and time setting and return to the
Settings 1 menu or press (MENU)
to confirm the new date and time
setting and return to the main menu
display.

Date / Time Format 1. Select Date/Time Format from the


Settings 1 menu and press OK to
view the current format that appears
on the Date/Time display.
2. If required, scroll to select a different
format and press OK to confirm.
The new format is automatically
displayed.

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Echo-Screen User’s Guide
Initial Setup

3. Press OK to return to the Settings 1 display or press  (MENU) to return


to the main menu display. You can also press  (BACK) to return to the
Date/Time format display.

Note: You must press OK to confirm a new date/time format. Pressing


 (MENU) returns to the main menu display without storing the new
format. Pressing  (BACK) returns to the Settings 1 display without
storing the new format.

Background
Lighting (display) 1. Select Backlight from the Settings 1
menu and press OK to continue.
2. Select On or Off for the background
lighting and press OK to confirm.
If you select On, the background lights
up. If no keys are pressed, the light
automatically turns off after 20
seconds, and turns back on when a
key is pressed.

Note: You must press OK to confirm a new backlight setting. Pressing


(MENU) returned to the main menu without storing the new setting.
Pressing  (BACK) returned to the Settings 1 menu without storing the
new setting.

Sounds 1. Select Sounds from the Settings 1


menu to select the sounds that are
associated with the operation of the
Echo-Screen device.
2. Select a sound option and press OK
to confirm and return to the
Settings 1 menu.

Select this: To do this:

Sounds off Turn off all sounds.

Key click Hear a click when a button on the Echo-Screen device


is pressed.

Pass/Refer jingle Hear a jingle when the Echo-Screen device displays a


PASS or REFER result.

Jingle and key click Hear a click when a button is pressed and a jingle
when the Echo-Screen device displays a PASS or
REFER result.

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Echo-Screen User’s Guide
Initial Setup

Note: You must press OK to confirm a new sound setting. Pressing


(MENU) returns to the main menu without storing the new setting.
Pressing  (BACK) returns to the Settings 1 menu without storing the
new setting.

Default Test Mode You can designate the default test mode (TEOAE, DPOAE, or AABR) that is
used for measurements.
1. Select Default Measurement from
the Settings 1 menu.
2. Select TEOAE, DPOAE, or ABR as
the default mode.
3. Press OK to confirm and return to the
Settings 1menu.

Note: You must press OK to confirm a new default measurement setting.


Pressing (MENU) returns to the main menu without storing the new
setting. Pressing  (BACK) returns you to the Settings 1 menu without
storing the new setting.

Data Input, User


Access, & Patient
Data Display
Settings You can use the Settings 2 menu to define data input methods, user access
privileges, and patient data display modes for the Echo-Screen device.
1. Select Settings 2 from the Options
menu and press OK to continue.

2. Select Edit mode, User mode, or


Patient list mode and press OK to
continue.

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Echo-Screen User’s Guide
Initial Setup

Edit Mode You can use Edit mode to define the default data input method for the
Echo-Screen device.
1. Select the appropriate edit mode:
• Select Hold mode to hold a key
down until the character appears on
the Echo-Screen display.
• Select Tap mode to tap a key
several times until the character
appears on the Echo-Screen display.
2. Press OK to confirm your selection
and return to the Settings 2 menu.

Note: You must press OK to confirm a new edit mode setting. Pressing
(MENU) returns to the main menu without storing the new setting.
Pressing  (BACK) returns the Settings 2 menu without storing the new
setting.

User Mode User mode designates whether the Echo-screen device is to be operated by a
single user or by multiple users.
1. Select the appropriate user mode
setting:
• Select Single (no login) if you do
not need to specify the user name or
ID. This option disables the login
function.
• Select Multi (login) if multiple users
operate the Echo-Screen device.
This option enables the login
function. When the Echo-Screen
device is powered on, a user name
or corresponding ID must be selected
in order to proceed.
2. Press OK to confirm the selection
and return to the Settings 2 menu.

Note: You must press OK to confirm a new user mode setting. Pressing
(MENU) returns to the main menu without storing the new setting.
Pressing  (BACK) returns to the Settings 2 menu without storing the
new setting.

Note: If the Multi (login) mode is enabled, the user ID (maximum of five
characters) in included on the Echo-Screen result label printouts. The user
name (maximum of 21 characters) is not included on the label printout.

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Echo-Screen User’s Guide
Initial Setup

Setting User Login


Names and IDs Before you can use the Echo-Screen device, you must enter user login names
or IDs into a personal computer (PC) by using EchoLinkII software and then
transfer them to the Echo-Screen device. A maximum of 100 user names and
IDs can be stored in the Echo-Screen device.
To set up user login names and IDs:

1. Connect the Echo-Screen device for either wireless (infrared) or cable data
transfer. (See Transfer & Deletion of Patient Data on page 53 for details
about wireless and cable data transfer.)

2. Open the EchoLinkII software on the computer and then open Settings
from the main EchoLinkII menu.

3. Select User Login List from the Settings menu. A User Login List
appears.

4. Enter the appropriate User IDs (maximum 5 characters) and User Names
(maximum 21 characters) into the User Login List.

5. Click Upload to transfer the user names and IDs to the Echo-Screen
device.

Note: You must restart the Echo-Screen device after the upload is
complete.

Note: If any changes to the user names or IDs are required, they must be
made by using EcholinkII software and then uploaded again to the
Echo-Screen device.

Note: The Echo-Screen device prints only the User ID on the results label
printout. The User Name does not appear on the results label printout.

Patient List Mode Patient List Mode designates how the Echo-Screen device lists patient
information on the Patient List display.
1. Select the appropriate list mode:
• Select List by last names to list
patients by their last name in the
order in which they were entered into
the Echo-Screen system.
• Select List by ID numbers to list
patients by their ID number in the
order in which they were entered into
the Echo-Screen system.
2. Press OK to confirm your selection
and return to the Settings 2 menu.

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Echo-Screen User’s Guide
Initial Setup

Note: You must press OK to confirm a new patient list setting. Pressing
(MENU) returns to the main menu without storing the new setting.
Pressing  (BACK) returns to the Settings 2 menu without storing the
new setting.

ABR Configuration
Setting You can use the ABR configuration option to set the appropriate voltage
frequency and stimulus level for AABR testing.
1. Select ABR configuration from the
Options menu and press OK to
continue.

2. Select Notch filter and press OK to


check or preset the voltage
frequency for the Echo-Screen
device.

ABR Notch Filter


Frequency 1. Select the appropriate setting:
• Select 50 Hz (Europe) to use the
voltage frequency for Europe.
• Select 60 Hz (US) to use the voltage
frequency for the United States.
• Select Ask before test to
automatically display the ABR Notch
filter options after the AABR test
method is selected.

Note: Check the regional mains voltage frequency before changing the
setting on the Echo-Screen device.

Note: You must press OK to confirm a new notch filter setting. Pressing
(MENU) returns to the main menu without storing the new setting.
Pressing  (BACK) returns to the ABR Configuration menu without
storing the new setting.

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Echo-Screen User’s Guide
Initial Setup

ABR Stimulus Level 1. Select Stimulus level from the ABR


configuration menu to preset the
stimulus level for AABR testing.
2. Select one of the stimulus levels —
35 dB nHL, 45 dB nHL, or 55 dB
nHL — or select Ask before ABR
test to allow the user to choose the
appropriate stimulus level before
each AABR test.
3. Press OK to confirm the ABR
stimulus level selection and return to
the ABR configuration menu.

Note: The 55 dB nHL stimulus level can only be used for AABR tests that
are conducted with the ear probe cable. The Y Probe cable cannot be used
for AABR tests conducted at the 55 dB nHL stimulus level.

Note: You must press OK to confirm a new stimulus level setting.


Pressing (MENU) returns to the main menu without storing the new
setting. Pressing  (BACK) returns to the ABR Configuration menu
without storing the new setting.

Storing Default
Comments Comments regarding the patient’s state, test environment, and so forth can be
entered or selected for each screen and stored with the results.
You can enter a maximum of 25 default comments into the EchoLinkII software
by using a personal computer (PC) and then transfer them to the Echo-Screen
device prior to testing. At the time of the test, you can select one of the default
comments.
To set up default screening comments for the Echo-Screen device:

1. Connect the Echo-Screen device for either wireless (infrared) or cable data
transfer (See Transfer & Deletion of Patient Data on page 53 for detailed
instructions on wireless and cable data transfer).

2. Open EchoLinkII software from the PC and access Settings from the main
EchoLinkII menu.

3. Select Comments List from the Settings menu. A list of 25 default


comments is displayed.

4. Revise or update the comments list as necessary.

Note: Comments are limited to 21 characters.

5. Click Upload to transfer the comments to the Echo-Screen device.

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Initial Setup

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Preparing for Testing
TEOAE & DPOAE Tests

The ear probe cable is required for TEOAE and DPOAE tests.
Plug the connector of the ear probe cable into Ear Probe socket (A) located at
the top of the Echo-Screen device (see Figure 14).
When connecting the cable to the housing, the red dot on the cable connector
must be aligned with the red dot above the socket of the Echo-Screen device.

Figure 14—Ear Probe and ABR Electrodes sockets

Alignment dot

B A

Note: Use the Test Cavity to conduct a probe test prior to testing. One
probe test per day is recommended. (See Equipment Checks on page 61
for instructions on conducting a probe test).

When disconnecting the cable, grasp the sleeve of the connector and pull it out
to release it from the socket. Do not pull the connector by the cable.

AABR Tests

Connecting the ABR


Cable The ABR cable is required for conducting AABR tests.
Plug the ABR cable into the ABR Electrodes socket (B), which is located on the
top of the Echo-Screen device (see Figure 14). Ensure that the red dot of the
ABR cable connector is aligned with the red dot above the ABR Electrodes
socket (B).
When disconnecting the ABR cable, grasp the sleeve of the connector and pull
it out to release it from the socket. Do not pull the connector by the cable.

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Echo-Screen User’s Guide
AABR Tests

Connecting the Ear


Probe Cable or Y
You can use either the ear probe cable or the Y probe cable for AABR tests:
Probe Cable
• If you want to insert the probe into the patient’s ear, the ear probe cable is
required.
• If you want to conduct the AABR test by using Echo Couplers, the Y probe
cable is required. The Y probe cable connects to the Ear Probe socket of
the Echo-Screen device. When connecting the Y probe cable to the hous-
ing, the white arrow on the cable connector must be aligned with the red
dot above the Ear Probe socket of the Echo-Screen device.

Note: Echo Couplers are intended only for use with newborn patients.

When disconnecting either the ear probe or the Y probe cable, grasp the sleeve
of the connector and pull it out to release it from the socket. Do not pull the
connector by the cable.

Checking the Test


Environment Ensure that patients are screened in a quiet location.

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Screening Procedure
Screening Procedure

IMPORTANT: Prior to running a test, ensure that the Echo-Screen device has
all of the appropriate settings. See Setting Up the Device on page 17 for
detailed instructions on setting up the Echo-Screen device.

Note: Before the first screen of the day, conduct a probe test to check the
functionality of the ear probe and Y probe cables. (For additional
information see Probe Test on page 61 in the “Equipment Checks”
chapter).

Note: For demonstration or training purposes, you can perform a quick


test without entering patient information. This test function applies to all
technology configurations (TEOAE, DPOAE, and AABR). For more
information, see Quick Test on page 59.

Step 1: Power on the


Echo-Screen device Press the OK button to switch on the Echo-Screen device. A five-second
battery test automatically occurs.
During start-up, the LED control light lights up in red and green for
approximately one second.
Both the configuration of the device and the software version are indicated on
the display of the Echo-Screen device.
The device proceeds automatically to the main menu. The main menu grants
access to all the other menu functions.

Note: The Echo-Screen automatically powers off if no keys are touched


within approximately 10 minutes.

Skipping a Battery Test


You can go directly to the main menu display without going through the battery
test at the initial start-up of the device. To skip the battery test:
• Press the OK button.
• Press any button. The main menu is displayed automatically.

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Screening Procedure

Step 2: Enter Patient


Information 1. Select Measure from the main menu
display. Press OK to continue.

2. From the Patient List display, select


the name of a patient already stored
in the device or press  (ADD) to
enter information for a new patient.
3. Using the alphanumeric keypad,
enter Patient ID, Name, Date of
Birth and Patient Status. The
Patient Status is preset to
out-patient. Enter zero ("0") to
change the status to in-patient.
4. Confirm each data entry by pressing
OK. Press (CLEAR) to delete
incorrect inputs.
5. After all patient information is
entered, press OK to save the
information.
6. Review patient data and press OK to
continue.
The Patient Data display provides an overview of the information entered for
the patient:
• Patient ID
• Name (Last, First)
• Date of birth
• Patient status (in-patient or out-patient)

Step 3: Prepare
Patient and Attach
Supplies TEOAE and DPOAE Tests
The ear probe cable is required for TEOAE and DPOAE testing. Ensure that
the ear probe cable is properly connected to the Echo-Screen device.

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Fitting the Probe

1. Check the patient´s ear canal and select an ear tip that fits. You may have
to try out different sizes to find an ear tip that provides the most secure fit.
Recommended ear tip sizes for patients:
• Newborns: 4 mm - 5.5 mm, Mushroom, and Tree
• Children: 6 mm - 10 mm
• Adults: 9 mm - 12 mm, 13.7 mm, and 17.8 mm

WARNING: The probe tip must not be placed into the ear canal at any time
without using a proper ear tip.

IMPORTANT: Accurate measurements can only be guaranteed using the ear


tips provided.

2. Push the ear tip onto the probe tip until it sits against the probe. Large ear
tips should be oriented so that their raised side faces the probe. Smaller
ear tips should be oriented so that their enlarged side faces the probe (see
figures below):

Figure 15—Ear Tip Attachment

Large
ear tip

Small
ear tip

Correct ear tip Incorrect ear tip


attachment attachment

Once the ear tip is attached,


a small projection of the
probe tip should be visible.

IMPORTANT: When attaching and removing the ear tip, hold onto the
housing of the probe and not the ear probe cable itself.

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Echo-Screen User’s Guide
Screening Procedure

Figure 16—Probe Inserted


3. Insert the probe into the auditory
canal so that it maintains a stable
position by itself.

IMPORTANT: Ensure the probe has a snug fit. Any leakage may lead to a
prolonged test time due to distortion and excessive noise.

WARNING: If a probe with an unsuitably sized ear tip is used or if excessive


force is applied, the ear canal may be irritated.

Note: It is acceptable to use the same ear tip for both ears. If there is
suspicion of infection in the external auditory canal, the ear tip should be
exchanged before testing continues on the other ear.

Tips for obtaining a good probe fit


• It may be necessary to pull the external ear slightly backwards, similar
as for an otoscopy.
• Spontaneous movements of the head can be easily compensated for
by reducing the strain on the probe cable. This can be achieved either
by forming a big loop which is loosely held with one hand close to the
head of the patient or by using the cable clip. In the latter case, attach
the cable clip to a surface that is close to the patient’s head (e.g.
patient’s shirt collar or baby’s blanket).
• Avoid possible contact of the cable with any vibrating or gliding
surfaces during measurement.

Note: In the event of a probe error, ensure that the probe tip channels are
free and the probe is connected. See Probe Test on page 61 in the
“Equipment Checks” chapter and Maintenance of the Probe Tip on page 67
in the “Maintenance” chapter.

AABR Tests
Electrodes must be attached to the patient’s skin for AABR tests. In addition,
you can either insert the ear probe (as described for TEOAE & DPOAE testing)
or place Echo Couplers over the patient’s ear when conducting AABR tests.

Applying snap electrodes (ABR cable)


Ensure that the ABR cable is properly connected to the Echo-Screen device.

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Figure 17—Electrode Placement

1. Connect the colored sensor clips of


the ABR cable to a triplet of
disposable snap electrodes. Attach
the clips to the electrodes before
removing them from their adhesive
liner card.

2. With the colored clips attached, apply the electrodes for the AABR test to
the patient as follows:
• Sensor with white clip: vertex (high forehead)
• Sensor with black clip: common (cheek)
• Sensor with red clip: nape (centered, back of neck)

Skin Prepping
Techniques Skin prepping reduces electrical impedance across the patient’s skin, which
allows for better conductivity of the small electrical signals that constitute the
ABR. Conductivity is enhanced by moisture, for example skin fluid or saline
solution. Conductivity is impeded by dry skin or oil on the skin.
In general it is not necessary to prepare the patient’s skin when conducting a
test with the Echo-Screen device; however, patients with oily skin or body hair
at the sensor sites typically exhibit higher impedance and may require prepping
in order to be successfully screened.
• Oily skin responds well to cleaning with mild soap and water followed
by prepping with NuPrep® gel (gel for neonates).
• Dry skin responds well to prepping with saline or NuPrep® gel, or a
drop of saline under each sensor.

Prepping Tips
• Prep the skin by creating some friction, but never using force. Be sure
you are moving the prepping pad over the skin, and not just moving the
skin under your fingers.
• Always prep an area slightly larger than the sensor site.
• Place infants on their side and tilt the head gently forward for easier
access to the nape sensor site. Separate the folds of the skin with one
hand and prep with the other.
• A drop of saline can help rehydrate slightly dry sensors, and may add
enough moisture to adequately decrease a marginal impedance
reading.
• If impedance readings are high, ensure that the sensors are attached
to the patient and cable clips are attached to the sensors. Also check

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Echo-Screen User’s Guide
Screening Procedure

to see if the ABR cable is properly connected to the Echo-Screen


device.
• If Nape and Vertex impedance readings are high, prep Common site
first.

Note: Alcohol can be effective for babies with very oily or sebaceous skin,
but it dries the skin as well. If alcohol use is permitted, you may need to
follow with a wet gauze wash and/or prep with NuPrep gel to rehydrate the
skin.

Applying Echo
Couplers (Y probe
Ensure that the Y probe cable is properly connected to the Echo-Screen device.
cable)
IMPORTANT: The Echo Coupler is disposable and designed for
single-patient use. Do not reuse.

Note: Echo Couplers are designed for use only with newborn patients.

Note: Echo Couplers are intended only for use with the Y probe cable.
Do not attempt to use Echo Couplers with the ear probe cable.

Figure 18—Probe Attached to Ear Coupler

1. Insert the red and blue Echo Coupler


adapters of the Y probe cable into
the side hole of each Echo Coupler
(see left). The Echo Couplers should
remain attached to their adhesive
Echo Coupler liner.

Y Probe Cable 
Echo Coupler Adapter

WARNING: Do not insert the red and blue Echo Coupler adapters directly
into the patient’s ear canal. The adapters must be inserted into the Echo
Couplers prior to testing.

2. Remove the Echo Couplers from their adhesive liner and place over the
baby’s ears as follows:
• Echo Coupler with red adapter: Right ear
• Echo Coupler with blue adapter: Left ear

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Screening Procedure

Step 4: Start
Screening/Monitor
Progress Select the appropriate test mode
(TEOAE, DPOAE, or ABR) from the
Measure display and press OK to
continue.

TEOAE Screening
Procedure 1. Select TEOAE from the Measure
display and press OK to continue.
Additional information such as patient
state, or testing environment can be
entered for a TEOAE test.

2. Select Comments to enter a


comment for the patient:
Select a default comment already
stored in the Echo-Screen device or
press  (TYPE) to enter a new
comment.

3. Press OK to continue.

Note: A maximum of 25 default comments can be entered within


EchoLinkII software via a PC and transferred to the Echo-Screen device
prior to testing. (See Storing Default Comments on page 27 in the “Setting
Up the Device” chapter for instructions on storing default comments.)

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Echo-Screen User’s Guide
Screening Procedure

4. Select the ear to be tested (right or


left).
5. Ensure that the probe is inserted
properly into the patient’s ear and
press OK to continue.

Calibration is performed before the test


begins. The test automatically begins
after calibration completes.

The test progress is displayed (see


example at left).
If the Unstable message appears,
check the probe fit.
The test can be stopped at any time by
pressing  (STOP).

Press  (OPT) to show the artifact


and stimulus rate values:
• S: Stimulus stability rate should be at
least 80%.
• A: Artifact rate should be below
20%.
If these conditions are not met and a
REFER result is obtained, you should
re-screen the patient.

If the result is PASS, the PASS


message appears before the detailed
results are displayed.

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The detailed results are displayed as


follows:
• Time: Screen duration (dependent
on ambient noise conditions)
• TEOAE: Significance of the TEOAE
signal being present
• A: Artifact rate
• S: Stimulus stability rate
• Graphical display: Illustrates the
statistical waveform with significance
limits.
If the result is REFER, detailed results
are displayed immediately after the
test.
In the case of a REFER result, you
should conduct another TEOAE test
under better conditions.
6. At the completion of the test, press
 (BACK) to test another ear or
press  (MENU) to view, print, or
transfer results.

DPOAE Screening
Procedure 1. Select DPOAE from the Measure
menu and press OK to continue.
Additional information such as patient
state, or testing environment can be
entered for a DPOAE test.

2. Select Comments to enter a


comment for the patient:
Select a default comment already
stored in the Echo-Screen device or
press  (TYPE) to enter a new
comment.

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Echo-Screen User’s Guide
Screening Procedure

3. Press OK to continue.

Note: A maximum of 25 default comments can be entered within


EchoLinkII software via a PC and transferred to the Echo-Screen device
prior to testing. (See Storing Default Comments on page 27 in the “Setting
Up the Device” chapter for instructions on storing default comments.)

4. Select the ear to be tested (right or


left).
5. Ensure that the probe is inserted
properly into the patient’s ear and
press OK to continue.

Calibration and probe fit is verified


before the test begins. If the probe
does not fit properly, the message
LEAK is displayed. Adjust the position
of the probe.
The probe fit is followed by a balance
test to make sure that the two
microphones function properly.
The screen automatically begins when
calibration is completed.
The test progress is displayed (see
example at left). At the top of the
display, the frequencies of the DPOAE
screen are shown. The test progresses
in the order of highest frequency pair
to lowest frequency pair:
• 3325Hz & 4000 Hz
• 2675Hz & 3200 Hz
• 2075Hz & 2500 Hz
• 1675Hz & 2000 Hz

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The key note symbol indicates which


tone pair is currently in progress.
During the test, the results are
indicated by the following symbols:
• checkmark (pass)
• S (skipped)
• R (refer)

2000 Hz 4000 Hz

2500 Hz 3200 Hz

If necessary, you can press  (SKIP) to skip the current frequency. The test
will proceed to the next frequency pair.
To cancel the entire test, press  (STOP).

The overall test ends successfully with


a PASS result if at least three of the
four frequency ranges could be
registered.
A PASS message appears before
detailed results are displayed.

Detailed results are displayed in order


of increasing frequencies (only for f2,
2000Hz - 4000 Hz).
6. At the completion of the test, press
(BACK) to test another ear or
press  (MENU) to view, print, or
transfer results.
7.

AABR Screening
Procedure IMPORTANT: Prior to AABR screening, verify that the ABR notch filter
frequency (50 Hz or 60 Hz) and stimulus level (35, 45, or 55 dB nHL) are set
according to your facility’s screening protocol. See ABR Configuration Setting
on page 26 of the “Setting Up the Device” chapter for detailed instructions on
setting the ABR configurations.

1. Verify that either the ear probe cable or Y probe cable is connected to the
ear probe socket of the Echo-Screen device.

2. Verify that the ABR cable is connected to the ABR electrodes socket of the
Echo-Screen device.

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Echo-Screen User’s Guide
Screening Procedure

3. Select ABR from the Measure


display and press OK to continue.

Using the ear probe


cable (ear tips) for
Additional information, such as patient state or testing environment, can be
AABR tests: entered for an AABR test.
1. Select Comments to enter a
comment for the patient:

2. Select a default comment already


stored in the Echo-Screen device or
press  (TYPE) to enter a new
comment.
3. Press OK to continue.

Note: A maximum of 25 default comments can be entered within


EchoLinkII software via a PC and transferred to the Echo-Screen device
prior to testing. (See Storing Default Comments on page 27 of the “Setting
Up the Device” chapter for detailed instructions on storing default
comments.)

4. Select the ear to be tested (right or


left).
5. Ensure that the probe is inserted
properly into the patient’s ear and
that sensors are attached to the
appropriate sites.
6. Press OK to continue. (Proceed to
“Monitoring the AABR test progress”
on page 44.)

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Echo-Screen User’s Guide
Screening Procedure

Using the Y probe


cable (Echo
Couplers) for AABR
tests: Additional information, such as patient state or testing environment, can be
entered for an AABR test.
1. Select Comments to enter a
comment for the patient:

2. Select a default comment already


stored in the Echo-Screen device or
press  (TYPE) to enter a new
comment.
3. Press OK to continue.

Note: A maximum of 25 default comments can be entered within


EchoLinkII software via a PC and transferred to the Echo-Screen device
prior to testing. (See Storing Default Comments on page 27 of the “Setting
Up the Device” chapter for detailed instructions on storing default
comments.)

4. Select the method for testing the ears


(Right & Left Sequential or Single
ear).
If the Single ear method is selected,
select the ear to be tested (right or
left).

5. Ensure that the Echo Couplers are placed correctly over the baby’s ears
and that sensors are attached to the appropriate sites.

6. Press OK to continue. (Proceed to “Monitoring the AABR test progress” on


page 44.)

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Echo-Screen User’s Guide
Screening Procedure

Monitoring the
AABR test progress An Impedance test is automatically
performed prior to testing:
• White indicates skin impedance of
the vertex electrode (high forehead).
• Red indicates skin impedance of the
nape electrode (back of neck).
White and Red impedance values
must be below 12,000 Ohms for the
test to proceed. (Optimum value is
less than 4,000 Ohms).
• Balance indicates the difference of the skin impedances of the vertex
and nape electrodes. This value must be below 4,000 Ohms for the test
to proceed (Optimum value is less than 2,000 Ohms).
If impedance values are high, try the following:
• Consider waiting a few minutes to see if the electrodes can build up an
optimal connection with the skin.
• Prep the electrode sites and ensure that the electrodes have been
attached correctly.
• Check whether the ABR cable is properly connected to the
Echo-Screen device.
• Try using a new set of electrodes to lower impedance.

1. When the impedance values are acceptable, press OK to continue.

Calibration is performed before the


actual test starts.
For stimulus calibration there is a "time
out" of approximately two minutes. If
no button is pressed during this time,
the measurement is stopped. The test
automatically begins when calibration
is complete.

The test progress is displayed as the


test proceeds.
• Time: screening duration
• ABR: probability of detecting an
ABR signal
The measurement can be regarded as
a "race" between screen duration and
ABR. If "time" wins, the result will be
REFER. If "ABR" wins, the result will
be PASS.
• EEG: amplitude of the total registered potential.

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Screening Procedure

The lower EEG value allows an easier test. If the EEG signal is too high (due
electrical noise or muscular artifacts) the indicator light on the front panel
display will flash red. The data measured during this time will be ignored.
The time bar and the EEG are directly correlated. Therefore, if the EEG is high,
the time bar will proceed slower.

If necessary, press (PAUSE) to pause the test or press  (STOP) to cancel


the test.
When the test is completed, the result
is displayed.
2. Press OK to conduct another ABR
test or view, print and transfer
results.

Status messages
during AABR test: During the AABR screening, information about the current test conditions may
be displayed:
• Stimulus high or low indicates that the test stimulus has changed
during the measurement.If stimulus high is displayed, restart the test,
and if stimulus low is displayed, adjust the probe.
• A Bad conditions message is followed by a test abort. This indicates
that the test conditions are too poor for a successful measurement.
Either the patient is too restless or the electrode impedance changed
to unacceptable values. Retest the patient under better conditions or
change the electrodes.
• Interference indicates electrical interference due to electro-magnetic
fields (i.e. pumps, PC etc.). Try to move away from the source of
interference prior to conducting a test.

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Echo-Screen User’s Guide
Screening Procedure

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Screening Results
Viewing Results

1. To view results, select View Results


from the main menu display.
2. Press OK to continue.

3. From the Patient List display, select


the patient for whom you want to
view results.
4. Press OK to proceed to the Patient
Data display.

The Patient Data display indicates:


• Patient medical record number
• Patient name
• Patient date of birth
• Patient status (in-patient or
out-patient)
5. Press OK to view the test results.

The Results display shows the six


latest test results for the selected
patient, including the following
information:
• Type of test (DP = DPOAE, TE =
TEOAE, AA = AABR)
• Date of test
• Time of test
• Ear tested (R = Right, L = Left)
• Result (PS = PASS, RE = REFER))
6. Scroll to select a result.
7. Press OK to view the result in detail.

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Echo-Screen User’s Guide
Understanding PASS & REFER

Example: 
TEOAE result: REFER

Example: 
AABR result: PASS

Understanding PASS & REFER

TEOAE results Test result PASS:


A PASS result indicates the patient has normal cochlear outer hair cell function
at the time of testing. A PASS is determined by a statistical algorithm, based on
binomial statistics, ensuring a detection with high sensitivity.
Test result REFER:
If a REFER result is obtained, it is recommended that a repeat screen be
performed. A REFER may be obtained for a variety of reasons:
• Excessive cerumen or vernix is in the patient’s outer ear canal or is
blocking the ear probe. To avoid this, always check that the probe tip
and ear canal are free of such debris. Clean the probe tip and replace
the acoustic filter when necessary. Also, change the patient’s ear tip
before repeating the screen.
• Excessive environmental noise or restless patient. Calm the patient or
move to a different location before repeating the screen.
• Patient may have a sensori-neural hearing impairment.

DPOAE Results Test result PASS:


A PASS result indicates the infant has virtually normal outer hair cell function
in at least three out of four different frequency regions of the cochlea at the time
of testing. A single frequency pass is determined by a statistical algorithm,
based upon binomial statistics, ensuring detection with high sensitivity.
Test result REFER:
A REFER result indicates that no significant DP response could be detected in
at least two out of four frequency bands.

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Echo-Screen User’s Guide
Understanding PASS & REFER

Unlike TEOAEs, the result displayed for DPOAEs is specified for each
frequency tested.
Like TEOAEs the most common causes for non-detection of DPOAEs include:
• Excessive cerumen or vernix is in the patient’s outer ear canal or is
blocking the ear probe. To avoid this, always check that the probe tip
and ear canal are free of such debris. Clean the probe tip and replace
the acoustic filter when necessary.
• Excessive environmental noise or poor probe fit within the patient’s ear
canal. In DPOAEs, this is especially true for the lowest frequencies.
Therefore, if the two low frequency bands REFER and the two high
frequency bands PASS, it is likely due to a non-optimal screening
environment.
For the instances listed above, re-testing is recommended after improving the
test conditions.
It must be mentioned that retro-cochlear hearing losses cannot be detected
with a DPOAE test.

AABR Results Test result pass:


An AABR PASS indicates that an electric brainstem response to a 35 dB nHL
(45 and 55 dB nHL, respectively) broadband stimulus could be detected. A
PASS result suggests a broadband hearing loss greater than 30 dB nHL (40
and 50 dB nHL respectively) can be ruled out with a 99.5% statistical
confidence. AABR technology is screening mainly the 2 - 4 kHz band which is
most important for speech development.
Test result REFER:
If the necessary significance level (99.5%) for a PASS could not be reached, the
Echo-Screen device will issue a REFER result. If a REFER result is obtained,
a repeat screen is recommended. A REFER result can be due to various
factors:
• Poor signal-to-noise ratio. Ensure that the screening environment is
quiet. Also check to see if the probe is fitting well in the ear canal or that
the Echo Couplers are placed securely over the patient’s ears.
• High impedance levels. The noise in the electrode cable depends
strongly on the impedances. Try reducing the impedance levels by
prepping the sensor sites or replacing the sensors.
• Active or restless patient. If the patient is awake or active during the
AABR screen or if muscle tension exists, wait until the patient is asleep
or in a quiet state.
• Electrical interference. If electrical noise is suspected due to other
equipment, you may want to screen the patient in a different location.

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Echo-Screen User’s Guide
Understanding PASS & REFER

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Printing Results

Results from the Echo-Screen device can be printed onto a label printer via
wireless (infrared).

IMPORTANT: Use only the label printer provided by Natus.

WARNING: Remove the probe from the patient’s ear and detach the
electrodes before printing results.

Note: Tests cannot be conducted while the label printer is connected to


the Echo-Screen device.

To print results:
1. Power on the Echo-Screen device.
2. Select Print Results from the main
menu and press OK to continue.

3. From the Patient List display, select


the patient whose results you want to
print and press OK to continue.

4. Select Print menu from the Patient


Data display and press OK to
continue.

5. Turn on the printer and confirm that sufficient labels are loaded. Also
ensure that the printer’s infrared (IR) dongle is positioned approximately 6
inches (15 cm) from the IR window located at the top side of the
Echo-Screen device.

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Echo-Screen User’s Guide

The Print Results menu includes the


following printout options described in
the following table.:

Select this: To do this:

All Results Print all the stored test results for the selected patient. Press
OK to print all the results for the selected patient

Single Result List all the stored test results for the selected patient. Scroll to
select a single test result to be printed and press OK to print
it.

TEOAE Results Print all the stored TEOAE test results for the selected patient.
Press OK to print all the TEOAE results for the selected
patient.

DPOAE Results Print all the stored DPOAE test results for the selected
patient. Press OK to print all the DPOAE results for the
selected patient.

ABR Results Print all the stored AABR test results for the selected patient.
Press OK to print all the AABR results for the selected patient.

Example of a printout:
TEOAE, REFER result

Additional comments can be


handwritten in the Comment space.

Note: Any comments stored for a particular patient appear on the label
printout. The comments are automatically printed on a separate label.

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Transfer & Deletion of Patient Data

Data Transfer Using Wireless (Infrared) or Cable

Test records can be transferred from the Echo-Screen device to a personal


computer (PC) via wireless (infrared) or cable connection using EchoLinkII
software. Alternately, patient information can be entered to a personal
computer via EchoLinkII software and transferred to the Echo-Screen device.

Note: EchoLinkII software is required and must be installed on the


personal computer to transfer data.

Installing EchoLinkII
Software on the PC EchoLinkII software allows you to transfer Echo-Screen data to a personal
computer to conduct necessary data management functions.

IMPORTANT: Prior to installing EchoLinkII software, ensure that the personal


computer is utilizing Microsoft Windows 98, Windows 2000, Windows ME, or
Windows XP. A minimum of 16 MB RAM is recommended for the installation
of this software.

IMPORTANT: When installing software, contact your institution’s IS


department for assistance. You may need administrative privileges to install the
software.

To install the EchoLinkII application:

1. Insert the Echo-Screen User Manual/EchoLinkII CD-Rom (REF 900757)


into the CD-ROM drive of the personal computer. Access the CD from the
appropriate directory (C,D,E, or F). The CD-ROM drive is commonly listed
as the E:drive.

2. Click on the link to download the EchoLinkII software onto your personal
computer. A series of messages guide you through the installation
process.

Note: Once EchoLinkII software is installed on the PC, access the


EcholinkII Help menu for detailed instructions on utilizing the program.

Transferring Test
Records from the
To transfer data to a PC using Infrared (wireless):
Echo-Screen Device
to a PC 1. Open the EchoLinkII program on the PC.

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Echo-Screen User’s Guide
Data Transfer Using Wireless (Infrared) or Cable

2. Select Settings from the main EchoLinkII menu, and then select Options
from the Settings menu.

3. Set the appropriate hardware configuration by selecting the Infra Red


connection and the appropriate PC COM port where you will connect the
infrared adapter.

Note: Consult with your facility’s IS department to determine the


appropriate COM port connection.

4. Select Transfer/Delete from the


main menu of the Echo-Screen
device and press OK to continue.
5. Connect the infrared adapter to the
COM port of the PC.
6. Point the infrared adapter toward the
infrared window that is located at the
top of the Echo-Screen device.

7. Select Start infrared from the


Echo-Screen display and press OK
to continue. The Echo-Screen
device displays Waiting for PC.
8. Select Echo-Screen -> PC from the
main EcholinkII Patient menu to
begin the data transfer.

Note: While the data transfer is in progress, the distance between the
Echo-Screen device and the infrared adapter should not exceed
31.5 inches (80 cm).

IMPORTANT: Ensure that objects do not obstruct the path between the
infrared adapter and Echo-Screen device while the data transfer is in progress.

To transfer data to a PC using the cable:

1. Open the EchoLinkII program on the PC.

2. Select Settings from the main EchoLinkII menu, and then select Options
from the Settings menu.

3. Set the appropriate hardware configuration by selecting the Serial Line


connection and the appropriate PC COM port where you will connect the
PC data transfer cable.

Note: Consult with your facility’s IS department to determine the


appropriate COM port connection.

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Echo-Screen User’s Guide
Data Transfer Using Wireless (Infrared) or Cable

4. Select the appropriate baud rate. It is recommended that you try the higher
baud rate first. (The lower baud rate may be more suitable if you use a
laptop computer.)

5. Connect the data transfer cable to the Echo-Screen device. The connector
is located at the bottom of the Echo-Screen device. Connect the data
transfer cable to the appropriate PC COM port.

6. Select Echo-Screen -> PC from the main EchoLinkII Patient menu to


begin the data transfer.

Transferring Test
Records from the PC
To transfer data to the Echo-Screen device using infrared (wireless):
to the Echo-Screen
Device 1. Open the EchoLinkII program on the PC.

2. Select Settings from the main EchoLinkII menu, and then select Options
from the Settings menu.

3. Set the appropriate hardware configuration by selecting the Infra Red


connection and the appropriate PC COM port where you will connect the
infrared adapter.

Note: Consult with your facility’s IS department to determine the


appropriate COM port connection.

4. From the EchoLinkII Patient List, select the patient records that you want
to transfer to the Echo-Screen device. To select a patient, click in the
checkmark column corresponding to the patient(s) of choice.

5. Select Transfer/Delete from the


main menu of the Echo-Screen
device and press OK to continue.
6. Connect the infrared adapter to the
COM port of the PC.
7. Point the infrared adapter toward the
infrared window that is located at the
top of the Echo-Screen device.

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Echo-Screen User’s Guide
Data Transfer Using Wireless (Infrared) or Cable

8. Select Start infrared from the


Echo-Screen display and press OK
to continue. The Echo-Screen
device displays Waiting for PC.
9. Select PC -> Echo-Screen from the
main EcholinkII Patient menu to
begin the data transfer.

Note: While data transfer is in progress, the distance between the


Echo-Screen device and the infrared adapter should not exceed
31.5 inches (80 cm).

IMPORTANT: Ensure that objects do not obstruct the path between the
infrared adapter and Echo-Screen device while the data transfer is in progress.

To transfer data to the Echo-Screen device using a cable:

1. Open the EchoLinkII program on the PC.

2. Select Settings from the main EchoLinkII menu, and then select Options
from the Settings menu.

3. Set the appropriate hardware configuration by selecting the Serial Line


connection and the appropriate PC COM port where you will connect the
PC data transfer cable.

Note: Consult with your facility’s IS department to determine the


appropriate COM port connection.

4. Select the appropriate baud rate. It is recommended that you try the
highest baud rate first. (The lower baud rate may be more suitable if you
use a laptop computer.)

5. From the EchoLinkII Patient List display, select the patient records that
you want to transfer to the Echo-Screen device. To select a patient, click in
the checkmark column corresponding to the patient(s) of choice.

6. Connect the data transfer cable to the Echo-Screen device. The connector
is located at the bottom of the Echo-Screen device. Connect the data
transfer cable to the appropriate PC COM port.

7. Select PC -> Echo-Screen from the main EchoLinkII Patient menu to


begin the data transfer.

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Echo-Screen User’s Guide
Data Transfer Using Wireless (Infrared) or Cable

Deleting Screening
Records IMPORTANT: The Delete data function deletes ALL records stored in the
Echo-Screen device at one time. Individual records cannot be deleted from the
Echo-Screen device. Ensure that the appropriate records are transferred to a
personal computer via EchoLinkII software prior to deletion.

1. Select Transfer/Delete from the


main menu.

2. Select Delete data from the


Transfer/Delete display and press
OK to continue.

3. Select Delete to delete all records


stored in the Echo-Screen device or
select Cancel to discontinue the
operation.
4. Press OK to confirm your selection.
After 5 seconds the program returns
automatically to the main menu.

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Data Transfer Using Wireless (Infrared) or Cable

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Quick Test
The Quick test function allows you to perform a screen without entering patient
information. This function can be applied to all technology configurations
(TEOAE, DPOAE, and AABR). It is useful for demonstration or training
purposes.

Note: No test data is saved in the Quick test mode.

To conduct a quick test:


1. Select Quick test from the main
menu.

2. Select the appropriate test mode


(TEOAE, DPOAE, or ABR) and
select OK to initiate a test.

See Screening Procedure on page 31 for detailed information about the


screening procedure.

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Echo-Screen User’s Guide

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Equipment Checks
You can perform a variety of equipment checks/self tests on the Echo-Screen
system.

1. Select Options from the main menu


and press OK to continue.

2. From the Options menu, you can:


• Run a variety of self tests (device
checks)
• Check the memory used on the
Echo-Screen device
• Obtain information about installed
hardware and software for the
Echo-Screen device.

The following sections provide a description of the equipment check options.

Performing Self
tests/Equipment
Checks Select Self test from the Options
menu and press OK to continue.

Probe Test 1. Select Probe test to check that the


ear probe cable and Y probe cable
are functioning properly.
2. Connect the cable to be tested to the
Echo-Screen device.

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Echo-Screen User’s Guide

IMPORTANT: One probe test per day is recommended for each cable prior to
screening patients.

Note: The probe tip of the ear probe cable must be inserted into the test
cavity before conducting a probe test. The Y probe cable does not need to
be inserted into the test cavity.

The following information is provided:


• Cable type
• Serial number of cable
• Date of the last cable calibration
3. Press any key to start the self test.

If the Probe failed message


appears, a list of troubleshooting tips
is displayed.
4. Press any key to return to the Self
test display. Repeat the probe test
after conducting the appropriate
troubleshooting procedures.

Discharge Battery Select Discharge battery from the


Self Test menu to discharge the
battery completely. It is recommended
to completely discharge a battery prior
to recharging.

Codec Test 1. Select Codec test to test the


functionality of the coder and
decoder components of the
Echo-Screen device.
2. If the Codec test OK message
appears, press any key to return to
the Self test menu.
If the Codec failure message
appears, the device switches off
automatically. Contact Natus
Technical Service or your authorized
service provider for further
assistance.

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LCD Display Test 1. Select LCD display test and press


OK to test the functionality of the
Echo-Screen display. The LCD test
passed message indicates that the
display is functioning properly.
2. Press any key to return to the Self
test menu.

Keypad Test 1. Select Keyboard test and press OK


to test the functionality of the
Echo-Screen device keypad.

2. A pattern of zeros "0" corresponding


to the Echo-Screen keypad appears
on the Keyboard Test display.
Pressing a key on the Echo-Screen
keypad changes the corresponding
"0" to a black bar. This indicates that
the key is functioning properly.
3. Press OK to return to the Self Test
menu.

Note: The OK button cannot be tested.

Memory Used The Memory used option provides information about the Echo-Screen
capacity for patient list memory and test result memory.
1. Select Memory used from the
Options menu and press OK to
continue.

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Echo-Screen User’s Guide

2. The percentage of memory allocated


to patient lists and test results is
displayed.
Press OK to automatically return to
the Options menu.

The Echo-Screen device is equipped with a permanent memory function, which


continuously stores all activated parameters and data even when the device is
in a switched off mode. Upon switching on the Echo-Screen device, the test
data is still available. A maximum of 250 records can be stored in the
Echo-Screen device.
When 80% of the Echo-Screen memory is used, the Echo-Screen device will
display a warning message. From this point on approximately 20 screens can
be carried out before the memory is completely full. After the first warning, the
Echo-Screen device will periodically display the percentage of memory used
after every five screens.
At this point data will need to be transferred to the PC via EchoLinkII software.
Once the data is transferred, it can be deleted from the Echo-Screen device.
See Transfer & Deletion of Patient Data on page 53 for detailed instructions on
data transfer and deletion.

Software and
Hardware
Information The SW/HW information option provides information about the Echo-Screen
system hardware, as well as the software installed on the device.

1. Select SW/HW information from the


Options menu and press OK to
continue.
The display provides the following
information:
• Type of software installed
(technology configuration)
• Software version
• Software release date
• Serial number of the Echo-Screen
device
• Date of the last calibration for the
Echo-Screen device
• Recommended date for the next
calibration
2. Press OK to return to the Options
menu.

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Error Messages & Troubleshooting
The following table provides a list of error messages that the Echo-Screen
device may display during the screening process, as well as troubleshooting
procedures. Contact Natus Technical Service or your authorized service pro-
vider if you have any questions.

Error Message Cause Solution

Probe Error! • Cable not connected • Ensure the ear probe cable is
• Probe tip occluded connected properly to the
Echo-Screen device.
• Check probe tip and acoustic filter.
Clean and/or replace as necessary.
• Check the probe housing for damage.

Cal FAIL Stimulus level calibra- • Ensure stable probe placement in


tion failed. patient’s ear.
• Test patient in a quiet environment.

Testing not possible! Impedance of elec- • Check electrodes and replace them if
trodes or balance is too necessary.
high. • Repeat test if patient is in a quiet
state.

Change battery Battery empty < 5.5 Volt Replace the battery before continuing the
test.

Battery charge low Replace the battery before continuing the


test.

Clock bat low Clock battery dis- Contact Natus Technical Service or your
charged authorized service provider (battery life-
time > 2 years).

Codec failure Codec is defective. Contact Natus Technical Service or your


Note: The device authorized service provider.
switches off automati-
cally after the "Codec
failure" message
appears.

LCD test failed Contact Natus Technical Service or your


authorized service provider.

LED flashes, numerical Internal error code • Note the error code.
code is displayed. • Contact Natus Technical Service or
your authorized service provider.

System error System malfunction Contact Natus Technical Service or your


authorized service provider.

The calibration date has Contact Natus Technical Service or your


expired. Please have authorized service provider for calibration.
the device calibrated
soon.

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Echo-Screen Maintenance
Cleaning the Echo-Screen Device

WARNING: The Echo-Screen device must be powered off and


disconnected from any external current prior to cleaning. All cables should also
be disconnected from the Echo-Screen device prior to cleaning.

The Echo-Screen device can be cleaned with a damp cloth. If necessary, apply
a surface disinfectant.

Note: Only use wiping disinfectant.

CAUTION: Ensure that no moisture gets inside the probe or into the device
cable sockets.

CAUTION: Never immerse the Echo-Screen device in water or other


cleaning solutions.

Maintenance of the Probe Tip

Cleaning,
Disinfection, &
Sterilization of the
Probe Tips
WARNING: The probe tip must not be placed into the ear canal at any time
without using a proper ear tip.

Figure 19—Parts of the Probe Tip


acoustic filter

probe tip

probe body

The probe tip does not usually come into contact with the skin or with secretions
from the ear canal since it is covered by an ear tip. However, if there is a large

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Echo-Screen User’s Guide
Maintenance of the Probe Tip

amount of cerumen in the ear canal, the probe tip may become occluded with
debris. If this occurs, clean or change the probe tip prior to testing.

CAUTION: The probe body contains sensitive components. Never attempt


to clean the sound apertures in the probe housing mechanically or with liquids.
Doing so may cause damage to the probe. Contact Natus Technical Service or
your authorized service provider for a periodic cleaning of the probe body.

Probe Tip Cleaning


Procedure: Dry cleaning
Dry cleaning must be performed if any debris (i.e., cerumen) is detected at the
probe tip. Afterwards, proceed to Wet cleaning and disinfection on page 69 or
Wet Cleaning and Sterilization on page 69.
For dry cleaning:

1. Remove the probe tip (B) by pressing the release button (A) while pushing
the probe tip carefully upwards out of the probe case.

Figure 20—Removing the Probe Tip


B

2. Use the cleaning tool (C) to carefully remove the acoustic filter (D) from the
probe tip.

Figure 21—Removing the Acoustic Filter


C

3. Use the cleaning tool (C) to clean the sound channels of the probe tip from
the rear.

Figure 22—Cleaning the Sound Channels

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Echo-Screen User’s Guide
Maintenance of the Probe Tip

Wet cleaning and disinfection


Clean and disinfect the probe tip on a regular basis after every working day
(even if no occlusion of the probe tip is visible).
For wet cleaning:
• Use a wet tissue to clean the surface.
• Soak in a mild, lukewarm soap water bath (5-10 minutes).

CAUTION: Ensure that the sound channels are completely dry before
replacing the tip onto the body of the probe. Even the smallest amount of
moisture may dissolve any residual cerumen and thus contaminate the
sensitive acoustic filter in the body of the probe.

For disinfection:
• Use a chemical disinfectant of ethanol (70-80%), propanol (70-80%) or
aldehydes (2-4%).

Wet Cleaning and


Sterilization Clean and sterilize the probe tip if it is used in an infected ear canal.
For wet cleaning:
• Use a wet tissue to clean the surface.
• Soak in a mild, lukewarm soap water bath (5-10 minutes).

CAUTION: Ensure that the sound channels are completely dry before
replacing the tip onto the body of the probe. Even the smallest amount of
moisture may dissolve any residual cerumen and thus contaminate the
sensitive acoustic filter in the body of the probe.

For sterilization:
• Autoclave according to the recommended standards for rubber
materials (121°C/249°F, 45 minutes exposure time). Probe tips can be
exposed to a maximum temperature of 150°C/302°F for up to 45
minutes.

CAUTION: Do not exceed more than 50 sterilization cycles.

Changing the
Acoustic Filter If the calibration procedure fails and the message "Probe Error!" is displayed,
the acoustic filter of the probe may be damaged or obstructed. In such a case,
the acoustic filter needs to be changed.

IMPORTANT: Acoustic filters are disposable. Do not place used filters back
into the probe accessory box. Do not attempt to clean or disinfect the acoustic
filters.

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Echo-Screen User’s Guide
Maintenance of the Probe Tip

To change the acoustic filter:

1. Remove the probe tip (B) by pressing the release button (A) while pushing
the probe tip carefully upward out of the probe case.

Figure 23—Removing the Probe Tip


B

2. Use the cleaning tool (C) to carefully remove the acoustic filter (D) from the
probe tip.

Figure 24—Removing the Acoustic Filter


C

Cleaning,
Disinfection and
Sterilization of Ear The ear tips and cleaning wire can be used as disposables. However, if they are
Tips and Cleaning reused on multiple patients, they must be wet cleaned and disinfected between
Wire each use.
To clean the ear tips and cleaning wire, see Wet Cleaning and Sterilization on
page 69.

Note: Sterilization of ear tips is required if they are used with patients that
have infected ear canals. Sterilization of the cleaning tool is required if it is
used with a probe tip that has been exposed to an infected ear canal (see
Wet Cleaning and Sterilization on page 69).

CAUTION: Avoid exposing the ear tips to intense sunlight or UV light.

Cleaning of the Y
Probe Cable The Y probe cable should be cleaned after each working day; however, if there
is any risk of transfection, the Y probe cable should be cleaned prior to
screening a new patient.

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Echo-Screen User’s Guide
Maintenance of the Probe Tip

To clean the Y probe cable:

1. Disconnect the Y probe cable from the Echo-Screen device.

2. Clean the Y probe cable and Echo Coupler adapter with an alcoholic
disinfectant tissue.

CAUTION: Clean only with a wiping disinfectant. Ensure that no liquid


enters the Y probe cable.

CAUTION: Do not immerse the Y probe cable in liquid.

Maintenance of the
Battery Refer to Setting Up the Device on page 17 for detailed information on
maintenance of the battery.

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Maintenance of the Probe Tip

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Warranty
Echo-Screen® Hearing Screener Limited Product Warranty
Natus Medical Incorporated (“Natus”) warrants to the initial purchaser (“Purchaser”)
that each new Warranted Product, as defined below, purchased hereunder will be
free from defects in workmanship and materials for a specified period (“Warranty
Period”) of either:
a) Twelve (12) months from the date of its initial shipment to Purchaser, if purchaser
resides and utilizes the Natus device in the United States; or
b) Fifteen (15) months from the date of its initial shipment to Purchaser, if purchaser
resides and utilizes the Natus device outside of the United States.
The Warranted Product is defined as: the Echo-Screen device, the ear probe cable,
ABR cable, Y probe cable, the user manual and/or CD, Echo-Screen accessories
including any battery, battery charger and power cord provided by Natus, and any
Echo-Screen printer and related cables purchased from Natus. The carrying case
is not covered by this warranty.
Natus’ only obligation under this warranty is limited to repair or replacement, at
Natus’ option and election, of any Warranted Product (or part thereof) that Natus
reasonably determines to be covered by this warranty and to be defective in
workmanship or materials. Repair or replacement of Products under this warranty
does not extend the Warranty Period.
To request repair or replacement under this warranty, Purchasers outside the
United States should contact the Natus Authorized Distributor from whom the
Product was purchased. Purchasers in the United States should contact Natus
Technical Service at 1501 Industrial Road, San Carlos, California, 94070, USA,
telephone +1-650-802-0400, website www.natus.com. If, on the basis of the
information provided by the Purchaser, Natus reasonably believes that the defect
is covered by this warranty, Natus will authorize Purchaser to return the Warranted
Product (or part thereof) to Natus or its authorized service center. If the Product is
to be repaired rather than replaced, the Warranted Product will be repaired and
returned to the Purchaser. Natus shall determine whether to repair or replace
Products and parts covered by this warranty and all Products or parts replaced shall
become the property of Natus. In the course of warranty service, Natus may, but
shall not be required to, make engineering improvements to the Warranted Product
(or part thereof).
IMPORTANT: The warranty will become void if the probe cleaning instructions are
not strictly adhered to. If the probe is not regularly cleaned as directed in the
instructions, cerumen may result in blockage of the probe, where sensitive
components are contained and could be damaged.

Repair / After-Sales Service / Regular Checks


If the Echo-Screen is found to be defective or in some way varies from the
manufacturer’s specifications, an authorized dealer will repair, replace, or
re-calibrate the instrument at no cost to the purchaser while the Echo-Screen is
within the warranty period.
Service and repair of electro-medical equipment should be carried out only by the
equipment manufacturer or by authorized representatives. The manufacturer

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Echo-Screen® Hearing Screener Limited Product Warranty

reserves the right to disclaim all responsibility for the operation safety, reliability, and
performance of equipment, serviced or repaired by other parties.
The annual technical control is defined in accordance with the corresponding
instructions for audiometers.
While your Echo-Screen is being calibrated, it is possible to borrow a “loaner”
device so that your test program can continue.

Shipping Procedures
If Natus reasonably determines that a repair or replacement is covered by the
warranty, Natus shall bear the costs of shipping the repaired or replacement
Product to the Purchaser. All other shipping costs shall be paid by the Purchaser.
Risk of loss or damage during shipments under this warranty shall be borne by the
party shipping the Product.
Products shipped by the Purchaser under this warranty shall be suitably packaged
to protect the Product. If Purchaser ships a product to Natus in unsuitable
packaging, any physical damage present in the Product upon receipt and
inspection by Natus (and not previously reported) will be presumed to have
occurred in transit and will be the responsibility of the Purchaser.

Exclusions
This warranty does not apply to the battery, or to expendable items, or to normal
wear.
This warranty applies only to instruments purchased from authorized distributors or
representatives.
This warranty does not extend to any Warranted Products (or parts thereof): (a) that
have been subject to misuse, neglect or accident, (b) that have been damaged by
causes external to the Warranted Product, including by but not limited to failure of
or faulty electrical power, (c) that have been used in violation of Natus’ instructions
for use, (d) that have been attached to any accessory that has not been subject to
Natus’ control over quality of materials and design, (e) on which the serial number
has been removed or made illegible, (f) that have been modified by anyone other
than Natus or its authorized service center, unless authorized prior to such service
by Natus. The Echo-Screen calibration is not covered under the standard warranty.
Natus makes no warranty (a) with respect to use of Echo-Screen Hearing
Screeners, any non-Natus disposable products, or any other products that are not
Warranted Products, (b) with respect to any products purchased from a person
other than Natus or a Natus-authorized distributor, or (c) with respect to any product
sold under a brand name other than Natus unless such product has been subject
to Natus’ control over the quality of materials and design.
This warranty, together with any other express written warranty that may be issued
by Natus, is the sole and exclusive warranty as to Natus’ products, extends only to
the purchaser and is expressly in lieu of any other oral or implied warranties
including without limitation any implied warranty of merchantability or fitness for a
particular purpose. Natus shall not be liable for any incidental, special or
consequential loss, damage or expense (including, without limitation, lost profits)
directly arising from the sale, inability to sell, use or loss of use of any product.

74 P/N 051591E © 2010 Natus Medical Incorporated


Technical Specifications

Operating
Conditions Storage temperature range: 0 - 40°C (32 - 104° F)
Operation temperature range: 5 - 35°C (40 - 95° F)
Humidity: 20-80% rel.
Transport altitude: 0 - 12,000 ft. (0 - 3.65 km)

Technical Data

General weight Echo-Screen incl. battery pack and probe: 1.2 lbs (550 g)
size Echo-Screen incl. battery pack: 230 x 95 x 53 mm
battery 6V 1500mAh NiMH, easily changeable. 2 batteries
supplied with device
charger charge time approx. 2 hrs.
power consumption 1.2 W max
power management auto backlight control, auto switch off, 
2-level battery voltage sense, battery saver
operating time > 10 hrs with fully charged battery
CPU 16 bit fixed-point DSP, 22.1 MIPS
AD / DA converters 2 channels AD, 2 channels DA
resolution 16 bit
sampling rate variable
data memory 128 kByte built-in flash memory, unlimited storage
time
real time clock special battery, runs 2 years min.
interfaces RS232 up to 115 kbps, infrared, modem available
display 128 x 64 dot graphic LCD w/ switchable backlight
keyboard 17 keys
sound piezo beeper for key click and info / warning jingles
languages up to 6 user selectable languages available on the 
device. language packs can be uploaded by service
personnel
probe ultra-lightweight probe

TEOAE sampling rate 16 kHz


evaluation method Echo-Screen binomial statistics
stimulus nonlinear click sequence
click rate approx. 60 Hz
display statistical waveform, measurement progress, TEOAE 
detection level, noise level
button functions alternate display, restart, stop

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Echo-Screen User’s Guide
Technical Data

DPOAE sampling rate 12.8 kHz


evaluation method phase statistics
stimulus primary tone pair, f2/f1 = 1.24
frame length 512 samples
test frequencies f2 = 2, 2.5, 3.2, 4 kHz
test levels screening: 59/50dB SPL
measurements
per test: screening: 4 frequencies one level
display phase statistics diagram, measurement progress, noise
result display pass/refer for all tested levels and frequencies
button functions skip test, restart test, stop

AABR sampling rate 10.2 kHz


evaluation method binomial statistics on template-convoluted signal
stimulus 35 dB nHL click
click rate approx. 55 Hz
frame length 180 samples / 18 ms
amplifier gain 2000
amplifier CMRR > 100dB
input impedance 1010 || 55 pF
input bias current < 10 nA
amplifier noise 10 nV / Hz at 1kHz
input bandwidth 70 Hz, 4kHz
notch filter digital, -40dB at 50 Hz or 60 Hz (user configurable)
impedance sense
current 5  App
impedance sense
signal 1 kHz square wave
impedance sense
test range 1.99 k
impedance sense
accepted for test < 12 k
impedance control before measurement, periodically within
measurement
stimulus continues during impedance control
display statistical graph, measurement progress, EEG-level, 
ABR detection probability
button functions pause, restart, stop
electrodes disposable gel electrodes

Probe probe plug: 12-pin


probe cable: flexible, shielded cable, approx. length: 1m (3’)
frequency 
response: 200 Hz to 4.2 kHz (measured in 1.5 cm3 test cavity)
speakers: type: Magnetic ED 1913/Knowles low distortion
signal Bandwidth: 1.7 bis 4.8 kHz
nominal impedance (at 1 kHz): 1,500 
nominal DC resistance: 375 

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Echo-Screen User’s Guide
Technical Data

microphone: type: Electret, EM 3046/Knowles, with integrated FET


pre-signal bandwidth: 1.7 to 6.5 kHz
front-end sensitivity: approx.-55dB rel.1V/  bar 
(0.1 N/m2)
output impedance: 2,800 to 6,800  (4,400 nominal)
operating voltage: 0.9 to 20 VDC
dimensions: probe body: 10 mm in diameter x 35 mm
probe tip: 3 mm in diameter x 8 mm
probe adaptor: 4 mm to 12 mm in diameter, silicone
weight: probe incl. probe adaptor: 4g

Y Probe Cable overall length 1.20 m


length of cable 1.10 m
connector type ODU Minisnap PC
speaker Knowles Electronics Type: FH-3377
Echo Coupler disposable

Charger front-end data: 100 - 240 V AC +/- 10%


50 - 60 Hz, 200 mA
supported batteries: 5 NiCd/NiMH 1-2 Ah
operating 
temperature range: 0 - 40°C (32 - 104° F)
storage temperature 
range: -40 - +70°C
charge current:
rapid charge: 800mA +/- 6%
trickle charge: 21mA +/-15%
charge termination 
(HL to EL): -DU:approx. 0.7% with 5 cells (approx.12 mV/cell)
The -DU monitoring is activated after approx. 7 min. 
following commencement of charging.
maximum charging 
time: 2 1/2 hrs +/- 12%
charging control: cell voltage is measured and detected every 107 sec. 
during a zero current of 80 ms

Device Class 2a (according to Council Directive 93/42/EEC Appendix IX)

Applied Standards Council Directive 93/42/EEC concerning medical devices (1993)


German "Medizinprodukte Gesetz" (MPG) (1994)
EN ISO 9001 (2000)
EN 13485 (2000)
EN 60601-1 + A1 + A2 (1990 / 1993 /1995
EN 60601-1-2 (1993)

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Echo-Screen User’s Guide
Technical Data

Manufactured by Natus Europe GmbH 


Bärmannstrasse 38
D-81245 Munich, Germany

78 P/N 051591E © 2010 Natus Medical Incorporated


List of Illustrations

Figure 1: Elements of the Echo-Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9


Figure 2: Echo-Screen Top View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure 3: Echo-Screen Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure 4: Echo-Screen Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Figure 5: Probe Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure 6: Test Cavity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure 7: Y-Probe Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 8: ABR Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 9: Echo Coupler and Snap Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 10: Ear Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 11: Releasing the Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 12: Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 13: Battery Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Figure 14: Ear Probe and ABR Electrodes sockets . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Figure 15: Ear Tip Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Figure 16: Probe Inserted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Figure 17: Electrode Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Figure 18: Probe Attached to Ear Coupler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Figure 19: Parts of the Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Figure 20: Removing the Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Figure 21: Removing the Acoustic Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Figure 22: Cleaning the Sound Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Figure 23: Removing the Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Figure 24: Removing the Acoustic Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

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Index

A D
AABR data entry 10
description 7–8 data entry mode 24
preparing for 34–36 data input 23
screening procedure 41 data transfer 53
test results 45, 49 date/time
test setup 29 format 21
uses 1 setting 21
AABR® 7 default test mode 23
ABR (auditory brainstem response) 7 deleting patient data 57
ABR cable 14, 29, 34 device
ABR configuration setting 26 cleaning 67
ABR Notch Filter setting 26 components 9
ABR stimulus level setting 27 memory 61
acoustic filter 69 power up 31
age, minimum 1 setting up 17
alcohol 36 settings 20
alphanumeric keypad 10 storing 17
automatically powers off 31 technology configurations 8
unpacking 17
B use 1
background lighting 22 user interface 10
battery discharge battery 62
charging 17–18 disinfecting probe tip 67
connecting charger 18 Distortion Product Otoacoustic Emissions technology.
discharge 62 See DPOAE technology
disposal 20 DPOAE
removing 18 compared to TEOAE 7
replacing 20 description 6–7
safety 19 preparing for 32–34
skipping test 31 screening procedure 39
test 19 test results 41, 48
buttons, functions 10 test setup 29
uses 1
C
cables E
ABR 14, 29, 34 ear probe cable 13, 29, 30
cleaning 70 ear tip 15, 32–34
data transfer 54, 56 attachment 33
ear probe 13, 29, 30 cleaning 70
testing 13 recommended size 33
Y probe 13, 30, 36, 43 Echo Couplers 15, 30, 34, 36, 43
charging battery 17–18 EchoLinkII software 53
check equipment 61 Echo-Screen
cleaning back view 12
device 67 bottom view 11
probe 68, 69 elements 9
probe tip 67 top view 11
cleaning wire 70 edit mode 24
Codec test 62 electrodes, snap 15, 34
comments 37, 40, 42, 43, 52 entering data 10
storing 27 equipment checks 61
configurations, technologies 8 error messages 65
connecting charge 18
Control Panel buttons 10 F
Couplers, Echo 15 filter, changing 69

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format, date/time 21 printing


functions, buttons 10 infrared 51
results 51
G wireless 51
gestational age 1 printout 52
good probe fit 34 probe 32–34
dry cleaning 68
H fitting 33, 34
hardware information 64 wet cleaning 69
probe test 61
I
icons 10 Q
infrared Quick test 59
data transfer 53, 55
printing 51 R
initial setup 17 removing battery 18
intended use 1 replacing battery 20
results
K AABR test 45, 49
keypad test 63 DPOAE test 41, 48
keys 10 TEOAE test 39, 48
viewing 47
L
language 21 S
LCD test 63 safety
list of illustrations 79 battery 19
login names 25 saline 35
screening
M methods 1
maintaining probe tip 67 procedure 31
manufactured by 78 screening comments, default 27
memory, device 61, 63 self test 61
methods, screening 1 service life 20
minimum age 1 setting date/time format 21
settings 20
N ABR configuration 26
navigating device 10 ABR Notch Filter 26
NuPrep gel 15, 35 ABR stimulus level 27
background lighting 22
O data entry mode 24
date/time 21
OAE
default test mode 23
application 7
language 21
overview 5
patient list 25
recording 7
sounds 22
types 5
user information 25
use in screening 1
user mode 24
working with 7
setup
Otoacoustic Emissions. See OAE
AABR test 29
TEOAE & DPOAE test 29
P
skin preparation 15, 35
patient snap electrodes 15, 34
preparing AABR 34 software information 64
preparing TEOAE, DPOAE 32–34 sounds 22
patient data specifications 75
deleting 57 sterilizing probe tip 67
transfer from device 53, 54 storing comments 27
transfer from PC 55, 56 storing device 17
Patient Data display 32
patient information 32 T
patient list mode 25
technical specifications 75
patient list setting 25
technology configurations 8
power up device 31
TEOAE

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compared to DPOAE 7
description 5–6
preparing for 32–34
screening procedure 37
test results 39, 48
test setup 29
uses 1
test
cavity 13
equipment 61
quick 59
starting 37
test mode 23
testing battery 19
skipping test 31
time setting 21
transferring patient data 53, 54, 55, 56
Transient Evoked Otoacoustic Emissions technology.
See TEOAE
troubleshooting 65
types of OAEs 5

U
unpacking device 17
use of device 1
user interface 10
user login information 25
user setting 24

V
voltage frequency setting 26

W
warranty 73
wire, cleaning 70
wireless 53
data transfer 53, 55
printing 51

Y
Y probe cable 13, 30, 36, 43
cleaning 70

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Echo-Screen User’s Guide
P/N 051591E

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