Bio-logic Auditory Evoked Potential

(AEP) System

Bio-logic Auditory Evoked Potential (AEP) System

Instructions for Use Manual

Copyright © 2013
Natus Medical Incorporated
 ®
Bio-logic Auditory Evoked Potential

(AEP) System

Instructions for Use Manual

011986 Rev. A

Copyright © 2013
Natus Medical Incorporated

Navigator Pro AEP Instructions for Use 1 011986 Rev A

COPYRIGHT © 2013 Natus Medical Incorporated is the year that this unpublished work was originally
created or revised. NATUS MEDICAL INCORPORATED (Natus) owns the rights to this work and intends to
maintain the contents as an unpublished copyrighted material. In the event of an inadvertent or deliberate
publication, Natus Medical Incorporated intends to enforce this right under the copyright laws as a published
work. Those having access to this work may not copy, use, or disclose the information in this work unless
expressly authorized to do so in writing by Natus Medical Incorporated.

Natus Medical Incorporated

One Bio-logic Plaza
Mundelein, Illinois 60060-3700
U.S.A.

Telephone: (847) 949-5200 FAX: (847) 949-8615

Global Sales & Support: 1-800-303-0306
Natus Bio-logic Technical Support: 1-800-272-8075
www.natus.com

Natus Europe GmbH

Robert-Koch-Str. 1
D-82152 Planegg
Germany
Phone: +49 (0)89 / 83942-0
Fax: +49 (0)89 / 83942-186

MANUAL CONTENTS ARE THE COPYRIGHT OF NATUS MEDICAL INCORPORATED

ALL RIGHTS RESERVED

Bio-logic® is a registered trademark of Natus Medical Incorporated

Navigator® Pro is a trademark of Natus Medical Incorporated
Microsoft® and Windows® are registered trademarks of Microsoft Corporation

Navigator Pro AEP Instructions for Use 2 011986 Rev A

Table of Contents
AEP ....................................................................................................................................................... 5
Indications For Use ............................................................................................................................... 5
Safety and Proper Use Information ...................................................................................................... 6
Installing the AEP system ..................................................................................................................... 8
Minimum Computer Specifications .......................................................................................... 8
Installation Policy ..................................................................................................................... 9
Hardware Installation ............................................................................................................... 9
Cable Connections to Navigator Pro Unit .............................................................................. 10
Connection Scheme for Navigator Pro System ..................................................................... 11
AEP Quick Guide ................................................................................................................................ 12
Patient Preparation ............................................................................................................................. 14
Electrode Connections .......................................................................................................... 14
Starting the AEP program ................................................................................................................... 17
Opening a patient file ............................................................................................................. 18
Begin data collection ............................................................................................................. 19
Orientation to the Main Test Screen ...................................................................................... 20
Recording Controls ................................................................................................................ 20
Collecting the Data ................................................................................................................ 22
Reviewing/Analyzing the Data ............................................................................................................ 25
Using and adjusting cursors .................................................................................................. 27
Adding Labels ........................................................................................................................ 28
Labels toolbar ........................................................................................................................ 29
Selecting and Moving the Waveform ..................................................................................... 29
Access to Functions ........................................................................................................................... 31
Additional Wave Analysis Functions ..................................................................................... 33
Waveform Display Scale ....................................................................................................... 35
Viewing Waveform Records and Calculations ...................................................................... 37
Normative Data Display through the GraphMaster Option ................................................................. 38
Printing the AEP Report ..................................................................................................................... 39
Patient & Test Information (P&TI) Database ...................................................................................... 40
Database – Form View .......................................................................................................... 41
Archiving, Backing up, Copying Patient Data ..................................................................................... 42
Delete a Patient Record Permanently ................................................................................... 43
Appendices ......................................................................................................................................... 44
Collection Protocols ............................................................................................................... 44
Recording tab ........................................................................................................................ 47
Stimulus tab ........................................................................................................................... 48
Amplifier tab ........................................................................................................................... 51
Label/Calculation tab ............................................................................................................. 53
Report Setup....................................................................................................................................... 54
Changing the layout of a report template .............................................................................. 55
Moving Fields into the Report Template ................................................................................ 56
Deleting and Moving Fields on the Template ........................................................................ 57
Modifying the text in the Field Labels .................................................................................... 58
Troubleshooting Guide ....................................................................................................................... 59
Environmental Noise Reduction Checklist ......................................................................................... 61
Self-Diagnostic Check of the Navigator Pro Unit ................................................................................ 62
Self-Diagnostic Check of the Patient Cable ....................................................................................... 64
Folder Structures for AEP 7.2............................................................................................................. 65
Calibration of the Equipment .............................................................................................................. 65
Precautions and Safety Instructions ................................................................................................... 66
Equipment Identification Label and Markings ..................................................................................... 67
Classification.......................................................................................................................... 67
Warning Labels and Symbols ................................................................................................ 67
Electrical Installation Requirements ...................................................................................... 67
Grounding Requirements ...................................................................................................... 67

Navigator Pro AEP Instructions for Use 3 011986 Rev A

 Power Plug Requirements ..................................................................................................... 68
Use only the following power plug configurations. ............................................................................. 68
Types of Hospital Facility Groundings ................................................................................... 68
Hazards of Improper Electrical Installations .......................................................................... 68
Environmental Conditions ...................................................................................................... 68
Room Topography ................................................................................................................. 68
Environmental Specifications ............................................................................................................. 72
Temperature .......................................................................................................................... 72
Humidity ................................................................................................................................. 72
Condensation......................................................................................................................... 72
Flammability........................................................................................................................... 72
EMC Specifications ............................................................................................................... 72
System Hookups ................................................................................................................... 72
Installation Verification ........................................................................................................................ 73
System Diagnostic and Verification Tests ............................................................................. 73
Precautions During System Operation ............................................................................................... 74
Signal Output and Input ...................................................................................................................... 75
Care and Maintenance ....................................................................................................................... 75
Cleaning................................................................................................................................. 75
Inspection .............................................................................................................................. 75
Disassembly and Storage...................................................................................................... 75
Maintenance .......................................................................................................................... 75
Electrical Requirements ...................................................................................................................... 76
Isolated or non-isolated power .............................................................................................. 76
15 or 20 amps ........................................................................................................................ 76
BTU Offset ............................................................................................................................. 76
Magnetic Field ....................................................................................................................... 76
Room Shielding ..................................................................................................................... 76
Fluorescent Lights ................................................................................................................. 76
Thickness of the Conduit ....................................................................................................... 76
INDEX ................................................................................................................................................. 77

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AEP
The Auditory Evoked Potential (AEP) software program, when used with the Bio-logic Navigator® Pro unit,
can perform the test procedures necessary to generate most Auditory Evoked Potentials. Operators can collect
& analyze patient data, print test results, store the data in the Bio-logic Patient and Test Information (P&TI)
database, and retrieve and review stored data.

AEP can be purchased with 1 or 2 channels and can be used with the following transducers: TDH-39
headphones, Bio-logic Insert earphones, bone oscillator, or sound field speakers.
AEP comes standard with three stimulus options, click, toneburst and custom.

Default protocols include ABR (1 & 2 channel), ECochG, AMLR, Forty (40) Hz response,
Other optional features that can expand your AEP capabilities are:
• GraphMaster normative data
• P300
• Electroneuronography (ENOG)

Indications For Use

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human
physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-
related disorders. Auditory stimuli are presented to the patient’s ear through an earphone or headphones, and
the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes
placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral
audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory
nervous system abnormalities.

The Bio-logic Navigator Pro EP System can be used for patients of all ages, from children to adults, including
infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the
prescription and supervision of a physician or other trained health care professional.

Navigator Pro AEP Instructions for Use 5 011986 Rev A

Safety and Proper Use Information
WARNING
Single use screening supplies (ear couplers, sensors/electrodes, ear
tips/inserts) and their packaging materials contain small parts that may
present a choking hazard. Supplies and packaging should be placed away
from the baby’s head and hands while preparing to screen. When screening
is completed, screening supplies and all packaging materials should be
accounted for and disposed of properly.

CAUTION
The Navigator Pro is intended for use by a heath care professional or a
technician who is trained and supervised by a health care professional or
accredited organization.

WARNING
Never turn power on or off with a patient connected to the system. Only
qualified personnel should use this device. Please read this section before
installing any of the hardware. Refer to this section when you operate,
transport, store, or re-install the system.

WARNING
All of the disposable supplies from Natus that are coupled to the scalp are
latex-free and comprised of hypoallergenic material. Natus is not
responsible for disposable items purchased from another vendor. Carefully
read and follow the proper use instructions that accompany any disposable
items.

WARNING
Make sure that any platform, table, cart, or other surface used during the
operation, transport, or temporary or permanent storage of the system and
its components is adequate, sturdy, and safe. Natus is not responsible for
any injury or damage that may result from inadequate, poorly constructed,
or unapproved transports, carts, operating surfaces

WARNING
Never use equipment that has parts missing or equipment that might
contain loose parts inside of it (that is, inside an enclosed portion of the
equipment). If you suspect a piece of equipment has missing or loose parts,
make contact with Natus Medical Incorporated.

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 WARNING
Never place powered equipment (that is, equipment that operates with an
electric power source) on any flammable surface. Avoid this whether the
equipment is active or not.

CAUTION
Simultaneous use of the Navigator Pro and other patient-connected
equipment, such as a cardiac pacemaker or other electrical implants, may
interfere with recording of auditory evoked potentials.

WARNING
Simultaneous use of the optional ENOG electrical stimulator and other
patient-connected equipment, such as a cardiac pacemaker or other
electrical implants, may not be appropriate. Consult the Digitimer operator’s
manual.

CAUTION
The optional ENOG electrical stimulator is appropriate only for
percutaneous stimulation, meaning electrical stimulation through the skin.
Use of needle electrodes for stimulation is NOT recommended. Consult the
Digitimer operator’s manual.

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Installing the AEP system
As part of the purchase price for your AEP system, you may receive installation services and one training
session from your local Natus representative. Contact your local representative when you receive your system
to schedule installation and training.

CAUTION
This system is intended for use as a medical instrument only. The
software installed on this system has been verified and validated for
that use, as long as no other unintended or unauthorized software is
installed and running at the same time. Do not install, download, save,
or transfer other programs, software, or data on this equipment without
first consulting Natus Medical Incorporated. Doing so may interfere
with the proper operation of this software.

Minimum Computer Specifications

Computer System IBM compatible computer ( 1GHz or better)

A minimum of 2GB dynamic RAM memory
80 GB Hard Disk (minimum)
CD-RW Drive
Available USB or serial port to connect required Navigator® Pro EP unit
this line needs to stand alone, not alongside CD-RW Drive

Operating System Windows XP Pro

Windows 7 32-bit or 64-bit

UL Compliance An isolation transformer if computer chassis leakage exceeds 100 micro

amps.

Printing Devices Windows XP Pro compatible printer

Windows 7 32-bit or 64-bit compatible printer

Navigator Pro AEP Instructions for Use 8 011986 Rev A

Installation Policy
If you purchased a complete AEP system from Natus Medical Incorporated, including the computer, then the
software is already installed at the time of delivery.
If you purchased a kit and are using it with a computer that you supplied through a separate purchase, refer to
the Minimum Computer Specifications and verify that your computer meets these requirements. If it does not
meet them, your kit may not function properly.
Natus manufactures medical equipment that includes hardware and application software that is installed on a
standard computer.
We encourage the customer to purchase the complete system, including the computer from Natus.
The computer provided by Natus is tested with all of our hardware and applications. The configuration of the
operating system is optimized to avoid conflicts with the operation of Natus applications.

Natus warrantees the Navigator Pro system for a period of one year and this warranty includes the Natus
supplied computer. Natus’s warranty does not cover compatibility problems that can arise when the customer
adds non-Natus software or hardware to a Natus supplied computer.
Note: Natus Medical is not responsible for resolving incompatibilities between the kit and a
computer that is provided by the customer or authorized Natus dealer representative.

Hardware Installation
WARNING
Each of the colored plastic housings on the cables displays arrows that identify
the top of the connector. This helps align the cable connector male plug to the
female jack on the side of the Navigator Pro system module. Careful alignment
of the cable plug to the jack is important to reduce the chance of bending the
metal pins inside the male connector. You must insert the plugs completely
into the corresponding jacks for the system to operate properly. Never twist
these connectors during insertion or removal. Twisting the connector in the
socket may damage the metal pins and cause communication problems
between the Navigator Pro system module and the computer. It may also
cause other system malfunctions involving stimulus delivery or system
recording.

Navigator Pro AEP Instructions for Use 9 011986 Rev A

Cable Connections to Navigator Pro Unit
Hardware installation of the Navigator Pro system involves connecting several cables. Five (5) circular female
connectors are on three sides of the Navigator Pro module. Each of these connectors has a different pin
configuration. This reduces the risk of plugging the wrong cable into the connector. Additionally, colored
rings around the connector sockets on the sides of the Navigator Pro module match the color of the plastic
housing around the circular male connector end of the cable.

This figure shows color-coding for the connectors on the Navigator Pro module and cables:

You have a choice of transducers when purchasing your Navigator Pro system. All transducers must be
supplied by Natus Medical to assure that they meet proper specifications. Depending on what you choose,
some of the connector jacks on the sides of the Navigator Pro system will remain unused. For the system to
operate, however, connections must be made to the blue (electrode connection cable), the red (serial cable) or
USB connector, the power supply connector, and the yellow connector (transducer cable) for delivery of the
stimulus into the ear.
Once the cable connections are made into the Navigator Pro module, an additional connection must be made to
enable communication between the Navigator Pro Hardware and the computer. Insert either the 9-pin D
connector (female) end of the serial cable or the USB connector into the computer.

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Connection Scheme for Navigator Pro System

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AEP Quick Guide
1a. Open New File 1b. Open an Existing File
• Open Patient window is automatically displayed on • Open Patient window is automatically displayed on
startup or Select Open Patient icon. startup or Select Open Patient icon.
• Complete all required fields such as patient ID, Last • Use the drop down arrow to select by Patient ID or Last
Name, Birthdate, etc. Required fields are designated by Name. If there is patient information in the fields already,
an asterisk (*). select Clear All and then use the drop down to find the
new patient.
• Optional: Enter any additional fields.
• To review data, select box(s) next to test date. Select
• Select Accept. (Once Accept is selected you may enter
Review Data.
Physician and Tested by.)
• To review existing data while collecting new data, select
• Select Begin Test.
box(s) next to test date. Select Begin Test.

2. Enter Additional Patient information (optional) 3. Select Protocol

• After a patient has been entered into the Open Patient • Select desired protocol from drop-down list.
window, To enter additional data for a new patient: • Apply the electrodes to the patient using the correct montage
-- From Open Patient window, select Database button. for the number of channels you will be collecting.
-- Complete fields under Patient Info Tab. • Set up the patient with the proper transducers as defined in
-- Close Patient and Test Information window. the selected protocol.

4. View or Modify Collection Protocols (optional) 5. Check Impedance

• Select Setup and then Collection Protocols. • Select Impedance Check icon in the recording controls box

• When impedance is acceptable, select Stop Impedance

OR
Check.
• Select Amplifier Parameters and/or Stimulus Parameters
• If impedance is not acceptable, correct problem.
icon in the recording controls box
NOTE: Impedance check continuously cycles
• Modify parameters as desired.
through all inputs so any changes take a few
• To use protocol, but not save changes, select OK. moments to appear on the screen.
• To save a new protocol, select Save As and designate a
new name.
• To overwrite the existing protocol, select Save.

Navigator Pro AEP Instructions for Use 12 011986 Rev A

AEP Quick Guide [contd.]

6. Begin Collection
• Select View EEG icon to check the EEG prior to recording. • Allow program to collect to maximum number of sweeps as
defined in protocol.
• Select Record icon to begin averaging, when EEG is
acceptable.
OR
Note: the stimulus always ramps up to the full
intensity and ramps down when averaging is • Select Stop icon to stop collection before maximum number
stopped. of sweeps as defined in protocol is reached.

OR

• Select Exceed Max icon to collect beyond maximum

number of sweeps as defined in protocol.

OR

• Select Clear Average icon to restart collection without

saving the current data.
7. View Waves 8. Mark Waves
As the waves collect, they load automatically as defined in Move cursor to desired point on active wave.
Default Display Parameters. • Click the number in the toolbar representing the label you
To manually load waves want.
Click on the desired panel or select A or B in the bottom of the
data tree window. OR
In the Control Panel:
• Right click on wave. Left click and choose label, then Left
• Select radio button for channel 1, channel 2, ipsi, contra or
click on the desired label.
both.
To View Marked Point Information:
• Select the box next to the waveform to load.
• Select the Marked Point Info icon or View, Marked Point
OR Information,
• Right click on wave and Left click on Marked Point
• Right click on the letterbox next to the desired Information.
record and select desired channel to load.
To view waves in the Review Data screen, fully expand the OR
data tree by right clicking on “+” next to data and
choosing level 6. Expand the data tree to level 6 for both • Place Cursor 1 (C1) on first point and Cursor 2 (C2) on
panels, A & B. second point.
• Latency and Amplitude for C1 and C2 and the difference
between the two (C2-C1) are displayed below the panel.

9. Print Report
• Select Patient, and then Print Report. A print preview of the report will be displayed.
OR

• Click on the printer icon on the tool bar at the top left of the screen
• To select report templates other than the default, use the drop down arrow in the middle of the printing toolbar.
• Select Print icon.

Navigator Pro AEP Instructions for Use 13 011986 Rev A

Patient Preparation
• Prepare the skin at the electrode sites that match the collection montage for a one or two channel
recording. [Refer to electrode montage diagrams]
• Use a skin preparation material e.g. NuPrep™ on a cotton swab or gauze pad to clean each electrode site.
• Affix the disposable electrodes or fill the reusable electrode cups with conductive electrode paste before
applying to the patient.
• Connect the electrodes to the patient cable and check the impedance in the AEP program. (for two channel
protocols, a jumper cable must be used – refer to the electrode montage diagrams)
• Impedance should be 5 kOhms or less. The difference between electrodes should not exceed 2 kOhms.
• Place a foam tip for the red insert earphone into the right ear and the blue into the left ear. Proper
placement of the transducers into the ears insures good quality data.
• The patient should be relaxed and quiet, on a bed or reclining chair.
• The test room should be controlled for minimizing both ambient acoustic noise and electrical interference.

Electrode Connections
.

1-Channel Recordings

• Both connectors for Channel 1 (Input 1 and Input 2) will be used as well as the Common
connector.
• For 1-channel recordings, the inputs for Ch. 2 are not used and should be empty.
• No jumper should be connected to the patient cable.
• When changing ear stimulated, it is not necessary to switch the electrode wires in the patient
cable, when using an ‘Electrode Switching Enabled’ montage. Important: Electrode Switching
must be enabled in the collection protocol. When using electrode switching, the non-test
ear will always automatically be assigned as the common or ground electrode. Refer to the
chart below to insure the electrodes are plugged in correctly.

Navigator Pro AEP Instructions for Use 14 011986 Rev A

2- Channel Recordings
• The inputs of channel 1 & 2 are used in the patient cable
• A jumper connects two inputs together so that one electrode site is shared by two connectors

Navigator Pro AEP Instructions for Use 15 011986 Rev A

 cca

Navigator Pro AEP Instructions for Use 16 011986 Rev A

Starting the AEP program
1. Activate the computer and wait until the Windows "Desktop" screen appears.

Select the AEP shortcut icon to start the program.

When the software loads, it searches for the Navigator Pro unit, and displays the first screen of the AEP
program.

If the AEP program cannot communicate with the Navigator Pro unit an error message appears:

2. Make sure that the Navigator Pro module is powered ON.

- Verify that the USB or serial cable connects securely to both the Navigator Pro module and to the
computer.
- Verify that the power supply for the Navigator Pro module is properly connected to the power
source and to the Navigator Pro

Select the Retry option.

3. Alternatively, in the AEP program, click on Hardware Setup, Enable Hardware.

Navigator Pro AEP Instructions for Use 17 011986 Rev A

Opening a patient file
When you open the AEP program with the Navigator® PRO module connected, the software automatically
displays the Open Patient window. You can then use that window to open an existing patient file or create a
new patient file.
Note: Patient ID, Last Name, and Birthdate are the default required fields that must be entered to
proceed with data collection.
Select Accept and then Begin Test.

Navigator Pro AEP Instructions for Use 18 011986 Rev A

Begin data collection

Select a protocol from the drop down list. You only have access to protocols that your hardware supports
(e.g.: you will not have P300 protocols unless you purchased P300).

CAUTION
Protocol settings, data fields and controls are typically optimized for
the various protocols during installation. Only trained and experienced
users should change these settings. To create a new protocol, we
recommend that you start with the protocol that is most similar to what
you want. Natus assumes no responsibility for any problems that may
arise from improper use.

Navigator Pro AEP Instructions for Use 19 011986 Rev A

 Orientation to the Main Test Screen

Toolbars

Channel
Selection Waveform display
& area - Panel B
P300 Waveform
Selection display area -
Closes the Panel A
control
panel
window

Recording Data Acquisition EEG View Display EEG View Display

Controls Info Channel 1 Channel 2

The AEP program uses the Main Test Screen to collect data. It gives you all of the information you need to
track the progress of your test or to change test parameters during data collection. The splitter between Panel
A and Panel B can be moved left or right to create a Split screen or a Full screen. Note: Pull down the
“display” menu and select “default display” to return to the default split screen display.

Recording Controls – also accessible from the Collection drop-down menu

Navigator Pro AEP Instructions for Use 20 011986 Rev A

 Clear Average: Resets the average. Use this to start a recording over again and
discard sweeps that were collected.

Exceed max: Exceeds the maximum number of sweeps preset in the protocol.

Change stimulated ear: Changes the stimulus from one ear to the other ear.

Stimulus Parameters: Displays Stimulus Tab in collection protocol setup dialog.

Amplifier Parameters: Displays Amplifier Tab in collection protocol setup

dialog.

Increase Intensity: Increases the stimulus intensity by the dB step size specified
in the protocol.

Decrease Intensity: Decreases the stimulus intensity by the dB step size specified
in the protocol.

Impedance test: Checks the impedance of each electrode.

Stop test (recording): Stops the averaging/data collection.

View EEG/Pause: Displays EEG in the EEG View Display.

Pause lets you pause the averaging process during collection. Stimulation
continues during the Pause.

Record: Starts data collection.

Stimulus Ear indicator: The intensity of the stimulus is

displayed below the head and next to the ear being stimulated.
The right or left headphone flashes indicating the ear being
stimulated. The amplifier symbol flashes during averaging.

Navigator Pro AEP Instructions for Use 21 011986 Rev A

Collecting the Data
Important: When actively collecting data, the display of the waveforms comes from settings
in the Setup, Default Display Parameters

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 Match: Matches all displayed waveforms by intensity.
Align: Aligns all displayed waveforms so they are equally separated.
Waveform Grouping Superimpose: Matches all displayed waveforms by intensity and
superimposes their baselines.
User Positioning: Retains user positioning of waveforms.
Alt – displays the alternating waveform
Alternating Polarity Rare & Con – displays the rarefaction and condensation waveforms
Wave Display Differential – displays the difference between the rarefaction & condensation
waveforms

Show Flat Line - flat lines the beginning of the epoch that is being blocked.
Stimulus Blocking
Appearance Show Response - displays the stimulus artifact in the epoch that is being
blocked.

Displays the Left Ear waveforms in Panel A (on the left)

Panel Selection Ear-Panel Same
and the Right Ear waveforms in Panel B (on the right).

Ear-Panel Displays the Left waveforms in Panel B and the Right

Opposite waveforms in Panel A.

All-Right Panel Displays all waveforms on Panel B.

All-Left Panel Displays all waveforms on Panel A.

The application automatically uses the largest waveform

Auto-Specific
Display scale on the panel to scale all other waveforms to the same
Scaling
specific display scale.

Specific Scale
Scales all waveforms to a scale defined by the user.
(uV)

Uses the specific scale based on the epoch (window) size,

Epoch-Based which is defined in each protocol.
Scaling Default values are provided and can be changed by the
user.
—Off: No AEP data appears on the display.
—Channel 1: Channel 1 data appears on the display
—Channel 2: Channel 2 data appears on the display.
—Ipsilateral: Ipsilateral data appears on the display.
AEP & P300 —Contralateral: Contralateral data appears on the
display.
—Both: Contralateral and Ipsilateral or both channels of
data appear on the display.

—Off: No P300 data appears on the display.

—Infrequent: Infrequent P300 data appears on the
display.
P300
—Frequent: Frequent P300 data appears on the display.
—Both: Frequent and Infrequent P300 data appears on
the display.

Navigator Pro AEP Instructions for Use 23 011986 Rev A

 Latency Grid Shows or hides a latency grid on the waveform panels.

Waveform Baseline Shows or hides a waveform baseline.

Important: For the display of ipsilateral and/or contralateral waveforms, the

application uses information regarding the stimulated ear from the Stimulus tab and
the input 1 and input 2 electrode position identifiers entered in the Amplifier tab of
the Collection Parameters setup dialog. If these are not correctly defined in relation
to the way the electrodes are plugged into the patient cable, then the application
may display unexpected waveforms on the panels.

Navigator Pro AEP Instructions for Use 24 011986 Rev A

Reviewing/Analyzing the Data
When reviewing saved data, select Panel A or B by clicking in a blank area of the panel or by clicking the A or B
button at the bottom of the field tree. The panel you have selected will have a grey bar at the top of it.

Choose the channel to be displayed from the

Control Panel at the top of the field tree.

Note: the selection can remain set as “ipsi” for all

recording protocols. You may then choose to
display the contralateral waveforms or both
ipsi and contra by right clicking in the boxes in the data tree.

Expand the field tree by clicking on the + sign or

right clicking and selecting a level.

Click in any of the boxes to display a wave on the panel.

Right clicking in certain areas of the field tree is an

alternative way of accessing some functions.

Navigator Pro AEP Instructions for Use 25 011986 Rev A

Panel A is selected and displays those collections selected by the user for display from the field tree.

Panel B is selected and displays those collections selected by the user for display from the field tree.

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Using and adjusting cursors

Select Cursor 1 by using or .

Select Cursor 2 by using or .
Move the cursors by:
—Clicking on or . Moves 10 points for each click.
—Clicking on the waveform location where you want the cursor.
—Using the arrow keys on the keyboard. Moves 1 point for each key press.
The Home icon moves the cursors to the far left or home location.
Note: A cursor status area below the waveform panel shows latency and amplitude information
for each cursor location and inter-cursor measures.

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Adding Labels

After positioning the cursor, add a label to the waveform by clicking on the corresponding label number in the
toolbar, or right click on the waveform, left click on label menu item and select the desired label.
Move a label by placing the cursor to the desired location and remarking the label.
Delete all labels on the waveform by clicking on the icon. You cannot delete only one label at a time.

Navigator Pro AEP Instructions for Use 28 011986 Rev A

Labels toolbar

1-5 Labels 1-5 These numbers represent the labels in the protocol. If you place
A Label Set can your mouse on the number, a tool tip will display the actual label
contain up to 10 (e.g. = 1 = I, 2 = II, 3 = III, 4 = IV and 5 = V)
labels.
Modify label set Changes the label set associated with the highlighted wave(s).

Delete label Deletes all of the labels on the highlighted wave(s). A single label
cannot be deleted.

Selecting and Moving the Waveform

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Select the waveform by left clicking on it (this highlights the tag and puts an asterisk to the right of the
waveform) or click on the corresponding record in the field tree.
Click on or to select all waveforms.

When a waveform is the currently collecting record, the tag in front of the wave will be highlighted in Yellow.
When data collection has completed, the tag will be highlighted in Blue for the left ear, Red for the right ear,
and Green for a both (bilateral) ears waveform.

Move a waveform by left clicking on it and dragging it up or down, or select the wave and use the or
icons or use the up and down arrow keys on the keyboard.

Multiple waveforms can be selected by holding the Ctrl key and left clicking either on level six (polarity of
stimulus & masking) of the field tree or on the waveforms in the panel.

Waveforms can also be selected and repositioned from the Display drop-down menu.
Note: Choose “default layout” from the Display drop-down menu to resize the panels and data tree to their
original settings.

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Access to Functions
Access functions by right clicking on a waveform or the panel.

Right clicking on a specific waveform gives access to the commands below. Note these functions can
also be accessed from the drop-down menus and toolbar buttons.

Lists labels that can be applied to the waveform. The label will be applied at the location of
Label
the active cursor.
Wave info Launches Wave Information dialog to review collection parameters.
List of analysis comments. When applied, an abbreviation appears on the record in the field
Analyze
tree so that users can identify it easily. These analysis comments include:
Defines the waveform as the “Minimum Response Level” (the
Min. Response Level
lowest intensity where a response is observed).
Response Defines the waveform as showing a “Response.”
Threshold Defines a waveform as representing the “Threshold.”
Shows that the waveform exhibited no response to the test
No Response
stimulus.
Launches an Edit Comment display to enter a comment for an individual selected
Comment
waveform. This is displayed in the Records List.
Erases the selected waveform(s) on the active panel. This only erases the waveform from
Erase
the display. It is not a permanent deletion of the waveform.
Marked
Point Launches the Marked Point Information display for the wave under the mouse cursor.
Information
Digital Filter Launches a read-only dialog box displaying the digital filter settings for this waveform as it
Setting is currently displayed on the panel.

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 Right clicking on the panel (not on a specific waveform) gives access to the following commands.
Note these functions can be accessed from the drop-down menus and toolbar buttons.

Set Display Launches the Set Display Scale dialog box. Scaling will be applied to the selected
Scale waveform(s) on the panel
Show flat line – displays a flat line at the beginning of the epoch that is being blocked.
Blocking
Show response – displays the stimulus artifact/response in the portion of the epoch which is
Appearance
being blocked.
Alt Lists options related to displaying a waveform collected using an alternating polarity
Waveform stimulus.
Displays alternating Rarefaction Displays the
Alternating only
polarity waveforms only. on/off rarefaction waveform.

Rarefaction/Con- Displays the individual Displays the

Condensation
Rarefaction and condensation
densation only on/off
Condensation waveforms waveform.
Displays Alternating, Displays the
Alt/Rare/Cond Differential
Rarefaction , and difference between
Only on/off
Condensation waveforms. rare and con.
Displays the alternating
Alternating on/off
waveforms.
Wave
These options relate to the waveform position on the panel.
Position
Matches all displayed
Aligns all displayed waveforms
waveforms on the active panel
Align on the active panel so their Match
according to their critical
baselines are equally separated.
collection parameters.
Moves the highlighted
Matches all displayed
waveform(s) up. Selection of the
Super- waveforms based on critical
Move up up arrow key on the keyboard or
impose collection parameters and
clicking and dragging the wave
superimposes their baselines.
up will also move the wave.
Moves the highlighted
waveform(s) down. Selection
Transfers selected waveform(s)
Move of the down arrow key on the
Transfer from the active panel to the other
down keyboard or clicking and
panel.
dragging the wave down will
also move the wave.
Erases selected waveform(s) on
active panel. This only erases
Erase the waveform from the
display. It is not a permanent
deletion of the waveform.

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Grid Displays horizontal and vertical lines per division on the panel.

Baseline
Displays a baseline through the waveform.
On/Off

Erases a selected waveform(s). This only erases the waveform from the display. It is
Erase
not a permanent deletion of the waveform.

If the waveforms have been manually moved to a different location on the panel, refresh
Refresh
will move the waveforms back based on the wave position algorithm in effect.

Highlights all of the waveforms in the panel. Any action that you perform after selecting
Select All
this option affects all of the waveforms.

Additional Wave Analysis Functions – access from Analysis drop-down menu and
toolbar buttons

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 Select All Selects all of the waveforms on the active panel.

Deselect All Deselects all of the waveforms on the active panel.

Invert Inverts the selected waveform(s) on the active panel.

Smoothens the selected waveform(s) to the degree defined in the smooth

Smooth
list control.
Smooth Sets the number of points to smooth (e.g.: 7 = 7 point smoothing). Zero (0)
list equals no smoothing.
Increases the display size of selected waveform(s) by ~ 1% each time
Increase
selected.
Decreases the display size of selected waveform(s) by ~ 1% each time
Decrease
selected.
Allows you to select the type of scaling used. Only selected waveforms on
Scale
the active panel will be affected.

Gives a list of labels to apply to selected waveforms. The label is applied at the location of
Label
the active cursor.

Delete
Deletes all of the labels on the highlighted wave(s).
Labels

Modify
Changes the label set to be used to mark waveforms.
Label Set
Digital Digitally filters the selected waveform(s). Waves are saved in the database
Filter based on the filters set during collection. Post hoc digital filtering cannot
(optional extend the filter settings wider than the filter settings used at the time of
feature) collection.
Note: To activate these icons, you must highlight more than one waveform. Select
Calculations the first waveform, then hold down the control (Ctrl) key and select a 2nd
waveform. This highlights 2 waveforms.
Weighted Add: Averages 2 or more
waveforms together. Weighting is Unweighted Add: Sums 2 or more waveforms
based on the number of sweeps in each together equally with no weighting.
waveform.
Weighted Subtract: Subtracts the 2nd
waveform highlighted from the 1st Unweighted Subtract: Subtracts the 2nd
waveform highlighted. Weighting is waveform highlighted from the 1st waveform
based on the number of sweeps in each highlighted. No weighting is used.
waveform.
Correlate: Provides a correlation between 2
selected waveforms. Set Cursor 1 and
Save Calculated Waves: Saves the Cursor 2 around the section of waveforms you
calculated waveforms as a permanent want to correlate (e.g. Wave V). Highlight
part of the test database. both waveforms. If the correlation is 0.90,
then the section of the waveform in between
the cursors is 90% similar.

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 Waveform Display Scale

Note: If all the waveforms on the panel are scaled the same, the scaling will be displayed in the top left corner
of the panel. If the waveforms are not scaled the same, no value will appear.

0.50 uV

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Changing the Display Scale – accessed by right clicking on a panel or from the toolbar or
Analysis drop-down menu

Auto-specific scaling: Identifies the largest selected waveform and scales all other
selected waveforms on the active panel relative to largest
waveform.
Scaling radio
Specific scale: Scales all selected waveforms to a defined scale.
buttons
Epoch-based scaling: Sets a specific scale based on the epoch (window) size.
Epoch based scaling defaults are setup in the Default.
Display Parameters section.

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Viewing Waveform Records and Calculations – accessed by right-clicking on a
wave or from the toolbar or the View drop-down menu

Lists Toolbars. The toolbars with a checkmark next to them

Toolbars
will be displayed.
If checked, enables the Status bar at the bottom of the screen
Status Bar
that displays the status of the Navigator Pro hardware.
If checked, enables the Tabs at the top left corner which
Tabs
reflects the patient(s) for whom tests are open.
If checked, the collection options (recording options around
Collection Views the head, the sweeps/artifacts box and EEG windows) will be
displayed.
Provides a Latency/Intensity graph for click stimuli utilizing
GraphMaster (optional)
the Boys Town normative data, as well as other graphs.
Allows you to browse through protocol(s), sequences, and
Browser
labels/calculations sets and to print them.
Provides a list of impedance values collected during the test
Impedance table
session(s) if they have been saved.

Records list Provides a list of test records.

Shows the collection parameters for the highlighted

Record/Wave info
waveform.
Provides latency and amplitude information for the marked
Marked point info
points of the highlighted waveform.
Provides interaural latency and amplitude difference
Interaural Latency/ information for the marked points of highlighted waveforms.
Amplitude difference Select two waves collected with identical parameters, except
for the stimulus ear.
Allows entry of the most recent audiogram for the patient.
Audiogram
Multiple audiograms are not saved.

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Normative Data Display through the
GraphMaster Option

GraphMaster is a graphic display of marked point latency data (click stimuli only), compared to age-specific
normative data. Shaded areas reflect age specific normative ranges.

Graph Lists fields Lists of the graphs available.

As many as four different graphic displays may appear on the GraphMaster View
Graph displays screen.
Note: Use the graphs that match the decibel reference used for collecting the data.

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Printing the AEP Report

To choose a report other than the default report, click the drop down arrow next to the report name to access
the other reports.

Note: You must choose a report that matches the data on the screen. The Report Templates are
designed to match the label set of the marked points in the protocol. Use of an inappropriate report
template can result in the mislabeling of the marked points in your report.

Tips for preventing the waveform panels printing on a second page

• Waveform panels that are scaled so that they do not scroll will take up the least amount of room on
the report.

At the Main Screen:

• Select all waves on a panel and use the match function
• Select all waveforms and scale the waveforms so that the panel does not scroll.
• Perform the same function for the other panel in order for the panel sizes (A & B) to match.

In the Report Preview screen:

• Click on Settings, choose Panels Scale and then Custom. This process will alter the height and/or
width of both panels equally.

Note: It is possible to print a report to .PDF format which may be used to interface with electronic
medical records. Natus Medical does not provide this capability as part of our software.

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Patient & Test Information (P&TI) Database

Access the database from the Patients, Database drop-down or from the database toolbar or by clicking the
database button on the Open Patient dialog.

Select a patient by highlighting the patient file in the table and double click on it. This will bring the patient
information into the Open Patient dialog box.

Select a patient and click on the Form View icon. The Form view provides access to additional
information for that patient’s record.

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Database – Form View

Patient Info, Test Info, Test Results tabs

– Displays information about the selected patient
– Gives a template for creating a new patient file
– Enables user to add information to a record, including free text

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Archiving, Backing up, Copying Patient Data
Archive – Copies test records to a pre-defined database “archive” location with the option of deleting test
results and patient information from the current database. If you choose to delete tests only, the patient names
will remain in the database and indicate the date the file was archived in the database.

Copy – Copies test records to a pre-defined “copy” database location.

Backup – Creates an XML file of the entire database without deleting files from the database.

Steps for Archiving, Copying, Backing up Data

1. Setup the data path (not needed for Backup)

• At the Main Screen, select Setup, Data Paths.

• Type in a Path Name (e.g. Archive or Copy).
• Type in the File Path (e.g. C:\ProgramData\Natus\PTI\Archive) or use the browser to locate the file
path.
• If the path does not exist, it states, “Folder does not exist. Do you want to create?” Click OK (path is
created).
• Check if it is a removable drive, such as A: or zip drive.

2. Setup the default data paths for archive, copy and backup

• At the Main Screen, select Setup, Patient, Defaults.

• Select the default location for the archived or copied data using the drop down arrow in the applicable
field.
• Next to Default Backup Location, click the browse button. Select the path you want your
Backup file to be placed (usually C:\ProgramData\Natus\PTI\Backup)
• Save the selections

3. Archiving Patient Data

• In the Database, select File, Archive Record.

• Complete the Query box for which patient records to archive.
• After selecting OK, the number of records to be archived is displayed.
• Selecting ‘Delete Tests after Archive’ will remove the test data and leave patient name and ID or
‘Delete Tests and Patients after Archive’ moves the entire record from the (active) database to the
archive database. (This is recommended to keep an efficient database).
• If the patients’ names are retained in the database, each patient archived will have the date, time and
archive disk label of the archive in the Table or Form view.

4. Retrieving Archived Patient Data

• In the Database, Table view, change the database location (window on toolbar that reads ‘AEP’ for
the default active database) to the folder where the archived data resides.
• If data is stored on a removable drive, select ‘Other’. The Open browser appears. Locate the path
where the database resides. Select the blpatients.mdb file and click Open.

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5. Backing up Patient Data

• Backup creates a backup of newly created or modified patient files that have not been previously
backed up in XML format.
• Select Patient, Database Tools, Backup Databases.
• Verify the source and destination before proceeding with the backup.
• Automatic backups can be scheduled by accessing Setup, Patient, Backup.

6. Restoring Backed up Data

• Open the Database Recover program on the desktop.

• Browse to locate the directory where the backup file is stored.
• Under Backup Path, Highlight the backup file “Backup.xml.”
• Browse to the destination directory, then select OK
• To view the data through AEP, access the database and change the database location (window on
toolbar that reads ‘AEP’ for the default active database) to the folder where the restored data resides.

Delete a Patient Record Permanently

• In the Database, Table view, highlight the record(s) you want to delete.
• Select File, Delete Record and the number of records selected is displayed.
• Choose whether you want to “Delete Tests Only”. This will delete the tests, but the patient’s
information will remain in the database.
• Choose “Do not Prompt if File is Not Archived”, if you want the application to proceed deleting
all selected records, even if they have not been archived. If this is not checked you will be
alerted for each test record that is not archived.
• Click OK to permanently delete the selected test records.

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Appendices
Collection Protocols

Recommendation:
The Protocol Name field gives a list of default protocols.
To create a New Protocol, start with the protocol that is most similar and edit it until it meets your needs.
Click on ‘Save As’ and enter a new name for your protocol so that you still have access to the default protocol.

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 Protocol Name field Lists the names of the protocols that exist in the AEP system, in alphabetical order.

Add New Creates a new protocol under a new name.

Makes the currently selected protocol, the default protocol whenever you launch the
Make Default
application.

Removes any protocol you choose from the protocol list. Some protocols cannot be
Delete
deleted.

Recording tab Displays the Recording parameters.

Stimulus tab Displays the Stimulus parameters.

Amplifier tab Displays the Amplifier parameters.

Labels/Calculation
Displays the Labels/Calculations/Areas for that protocol.
tab

Save command Saves changes made to the protocol permanently.

Saves any changes made to a protocol to a new protocol name. The program retains the
Save As
original protocol with its original parameters.

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 Closes the Collection Protocol Setup screen and implements any changes you have
OK command made. The program uses these changes for subsequent tests in the session. To save
them permanently, you must use the Save or Save As commands.

Cancel command Closes the Collection Protocol Setup screen without implementing any changes.

Applies any changes to the protocol you have selected or are creating but leaves the
Apply command dialog box open.. The program uses these changes for subsequent tests in the session.
To save them permanently, use the Save or Save As commands.

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Recording tab

Epoch Time (ms) Select the desired epoch time for the recording window in milliseconds (ms).

# Points field Sets the number of points (samples) in the epoch i.e. resolution of the cursor.
Determines the start of the epoch relative to stimulus onset. By entering a non-zero
millisecond (ms) value in the Pre/Post time, you can start the collection before or
Pre/Post Time slide
after the stimulus is delivered. Negative values begin the epoch prior to stimulus
control
onset. Positive values begin the epoch after stimulus onset. An entry of zero (0)
starts the epoch at the onset of the stimulus.
Blocks high amplitude activity in a portion of the epoch from being counted as an
Blocking slide control artifact. Typically used to avoid the situation where a large stimulus artifact will
cause rejection of the entire epoch.
Sets the maximum number of averages you want to include in the recording. The
Maximum # of Averages
recording will automatically terminate when this number is achieved.
Save Impedance Test
Checking this box, saves the impedance test values with the recording.
Values

Note: Refer to the AEP Reference Guide for information on the other parameter settings.

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Stimulus tab

This field contains a list of the transducers that you can use with the AEP system.
Transducer
Transducers include:

Headphones
Insert Earphones
Bone Oscillator
Ear Determines the ear(s) to be stimulated: Left, Right, or Binaural (both).

Polarity Determines the stimulus polarity: Condensing, Rarefaction, or Alternating.

Determines the intensity (dB level) to begin stimulating and the decibel reference (SPL,
Intensity
nHL, or HL).

Navigator Pro AEP Instructions for Use 48 011986 Rev A

 If selected, the stimulus stays on between averages of the same intensity. If the
Continuous Stimulus intensity is increased or decreased or other stimulus parameters are changed, the
stimulus ramps down and ramps back up until it reaches the new intensity level.

Sets a correction value to apply to the latency caused by the delay from acoustic tubes
Insert Delay (ms)
on insert earphones. For all Bio-logic supplied tubes, the correction is 0.8 ms.

Stim Rate (per sec) Sets the number of stimuli presented per second.

Triggers in from an external stimulation device to begin response recording. All

parameters of the stimulus are controlled by the external device. The AEP system
performs only the recording functions.
Trigger In
This is used for Electrical ABR.
Note: You must purchase a Trigger Cable to use this feature. If performing EABR, you
must also purchase a RF filter.

Intensity Step Determines the amount by which the intensity increases or decreases.

Sends a sync pulse to activate an external stimulus device.

This is used with the digitimer (additional hardware) for Electroneuronography.
Trigger Out Pulse
Note: You must purchase a Trigger Cable to use this feature. AEP is triggered on the
positive edge of a pulse of at least 100 usec duration and between 2.5 to 8 volt
amplitude (TTL compatible).

Determines the stimulus type used for the test. Options are Click, Toneburst, or Custom.
Stimulus Type Note: Custom stimuli can be designed by researchers. For additional information, refer to
the Navigator Pro Reference Guide.

Click Duration (usec) Determines the duration of the click. The default of 100 usec is most commonly used.

Frequency (Hz) Determines the frequency of the toneburst stimulus.

Determines the type of Ramping used for the toneburst stimulus. Options are Linear,
Ramp
Hanning, Gaussian and Blackman. Displayed when Toneburst is selected.

Plateau (cycle) Determines the Plateau of the toneburst. Displayed when Toneburst is selected.

Rise/Fall (cycle) Determines the Rise/Fall of the toneburst. Displayed when Toneburst is selected.

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 Masking Parameters: Determines the contralateral masking type applied to the
protocol: None, White or Pink.
Masking Type
White masking is typically used for AEP protocols and has a flat frequency response
across the entire frequency range.
Appears when contralateral masking is selected. Defaults to the current stimulus
Transducer
transducer except for bone oscillator, which defaults to insert earphones.
Appears when contralateral masking is selected. Sets the intensity you want to use for
Intensity
the masking and the decibel references: SPL, nHL, or HL.
Link mask level If selected, links the masking intensity to the stimulus intensity. If you increase or
with stim level decrease the stimulus by a selected increment, the masking increases or decreases by
changes the same increment.

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Amplifier tab

2 - Channel

1 - Channel

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 Select the checkbox under the Channel 2 item to activate the second channel. If you
purchased a single-channel system, the second channel is not available.

Channel Enable Note: If Channel 2 is enabled, make sure that Input 2 for both Channel 1 & 2 is
checkboxes set according to how you plan to plug the electrodes into the patient cable. This is
important for automatic loading of collecting waves. Use A1 (left ear) for
Channel 1 Input 2 and A2 (right ear) for Channel 2 Input 2 if you use the
standard 10-20 system of electrode placement.

Determines the amplifier gain. More gain is needed for smaller responses and less
Gain
gain is needed for larger responses. The default value for ABR is 100,000.

Select these checkboxes to activate artifact rejection for each channel. Each gain
setting has a default artifact rejection level. To change the artifact rejection
independently from the gain, type in the value desired.
Artifact Reject
Note: If excessive environmental noise causes every sweep to be rejected, turn off
the Artifact Reject (deselect checkbox) and record the noise to determine the
frequency of the noise.

Low Filter (Hz) Sets the low cutoff filter setting. This is a High Pass filter.

High Filter (Hz) Sets the high cutoff filter setting. This is a Low Pass filter.

Select these checkboxes to apply the notch filter settings for each channel. The notch
filter should only be used when troubleshooting 50 Hz or 60 Hz noise. If noise
Notch Filter
disappears when the notch filter is on, check the electrical outlet and the electrical
environment (other equipment).
Selection is based on the 10-20 Electrode Placement System and the electrode montage
being used.
Input 1
NOTE: Settings in these fields combined with which ear is being stimulated,
determines whether a channel is “Ipsilateral” or “Contralateral”.
Selection is based on the 10-20 Electrode Placement System and the electrode montage
being used.
Input 2
NOTE: Settings in these fields combined with which ear is being stimulated,
determines whether a channel is “Ipsilateral” or “Contralateral”.
For 1-channel protocols, allows for automatic switching (through the program), of
reference and ground electrodes based on the stimulated ear. The user does not have to
Electrode Switching
manually move electrodes. Requires plugging in electrodes in a specific way. Follow
the instructions on the screen.
Sample Tag Displays sample tags for each Channel.

Edit Tag command Select the Edit Tag button to launch the Edit Tag setup display.

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Label/Calculation tab

Choose the appropriate label set for the protocol or select the closest label set
Label Set Name
and edit it to meet your needs.
Edit Label Set Accesses the Label/Calculation/Ratio Setup dialog box for editing.

Edit Select this command button to edit the fields on the dialog box.

New Creates a new Label Set under a new name.

Save Saves the Label Set changes under the current name.
Saves the Label Set changes under a new name. The original label set remains
Save As
with the original values.
Labels,
Displays the label(s), calculation(s), ratio(s) and area(s) defined for the
Calculations, Ratios,
selected protocol.
Areas
Closes the Label/Calculation/Ratio Setup dialog box and implements any
OK command
changes you have saved.
Closes the Label/Calculation/Ratio Setup dialog box without implementing
Cancel command
any changes.

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Report Setup
Report Setup is found in the drop-down list under “Setup”

Launches a Facility Name dialog box to enter the Facility name. This will
Edit Facility Name
print near the top of the report(s).
Edit User Defined Launches a User Defined Comment dialog box to enter a fixed comment. This
Comment field can be added to a report template.

Set Default Font Launches a Set Default Font dialog box.

Populates the Print Report screen with a specific report template. Use the
Use default template
browse button to select the preferred template.
Displays the data path location for the report templates. The default location
Templates’ path depends on the Windows Operating System. Refer to the Folder Structures
section of the Appendix.

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Changing the layout of a report template
The Setup, Report Layout, AEP enables the user to access the report templates and make changes to them.
Choose the report template name from the drop down list that is the one you want to edit or use as a basis for
creating a new report template.

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Moving Fields into the Report Template
The Field Tree appears on the right side of the template. The Field Tree contains components of a report that
you might want to print. If this tree is not displayed:
1. Click on View and then Field Tree.
2. Select a desired report component from the field tree and drag it to the desired location on the
template.
If there is a “+” in the box next to the field option, click on the “+” to display additional report
components.

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Deleting and Moving Fields on the Template
To select a section or field component:

1. Left click the mouse and drag a box around the entire section you want to delete or move. When you
release the mouse button the fields you selected will display surrounded by small boxes around the
perimeter.
To select a field component that is not wanted, hold down the shift button on the keyboard and click
on the unwanted field.

Click the left mouse button and drag a box

around the area you wish to delete or move. Be
sure to include all of the desired fields, some of
which may not be populated with values.

Release the left mouse button and the fields

will be selected. Note that the empty fields
under the labels now have boxes around them.

To delete the selected fields, click the delete key on the keyboard.

2. To move the selected fields as a group:

—Place the mouse over the section so that it becomes a cross hatch.
—Click and hold the left mouse button and drag the section to the desired location. Then, release the
mouse button.
—Alternately, you can use the Nudge Up, Nudge Down, Nudge Right and Nudge Left toolbar icons
(see below) to move the section to a new location.

3. To undo any change that you made in error, click on the Undo button .

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Modifying the text in the Field Labels
Right click on the Field Label you want to change to display a Component Properties dialog box.
a. Click on Text tab to modify the text of the label.

b. Click Font tab to modify the font of the text.

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 Troubleshooting Guide
Noisy recordings and Excessive artifacts
Patient variables
Post-auricular muscle reflex occurs at a latency of 10-15 msec. It can be so large in amplitude that it prevents averaging or obscures
the response.
• Use ear lobe placement of electrodes rather than mastoid.
• Check patient state.
• Place a pillow under the patient’s neck for support. Encourage patient to relax, close their eyes, and avoid clenching their teeth.
• Ensure electrode impedance is low (< 5 kOhms) and balanced (inter-electrode difference < 2 kOhms).
Equipment variables
Pause averaging and check for stimulation artifact in EEG.
• Separate sources of electromagnetic energy (power cable, stimulus cable, transducers, computer, monitor) away from cables
carrying patient response (patient cable, pre-amplifier, pre-amp cable).
• Keep electrodes together by braiding, taping or loosely knotting to improve common mode rejection.
• Make sure that all electrodes are of the same metal type.
• Re-chloride electrodes, if necessary.
• Separate Navigator Pro box from isolation transformer and from other power sources such as the power bricks for the computer
or the Navigator Pro box..
• Ensure the patient cable (blue connector) and transducer cable (yellow connector) are fully inserted.
• Ensure the patient cable (blue cable) does not cross any electrical device (printer) or other cables.
• Bone conduction: Stimulation artifact is common. Physically separate electrodes from oscillator and use alternating polarity.
Place electrodes on the front of ear lobe.
Environmental variables
• Make a minor change in the stimulus rate – this may eliminate minor interference seen in the EEG signal.
• With medical approval, temporarily disconnect patient from other equipment.
• Place the electrodes in a glass of water and position the glass in the location where the patient's head is usually positioned.
View the EEG signal on your system. If electrical interference is evident: Try moving the glass of water to a different location. If
you find a quieter spot, reposition the patient chair/bed to that location.
• Turn off electrical equipment in the test environment (cellular phones, pagers, computer monitors) and in adjacent rooms, if
possible.

60 (50) Hz interference
• Only rarely is 60 or 50 cycle noise the cause of noisy recordings or artifacts. Using a notch filter frequently produces ringing
which increases artifacts. So, to check for true 60 (50) Hz interference, temporarily enable the notch filter. If the problem goes
away, find and correct the source of the noise so that the notch filter may be disabled during actual data collection.
• Turn off fluorescent lights or lights with dimmer switches. Test the outlet to make sure it is grounded.
• In some cases, it will be necessary to install a dedicated electrical outlet or shield the test environment.

Navigator Pro AEP Instructions for Use 59 011986 Rev A

 High or open impedance
Equipment variables
• Make sure the patient cable/pre-amp cable and transducer are securely coupled to the Navigator Pro.
• Exchange the electrodes between two inputs to see if the problem follows the electrode.
• Try a different set of electrodes.
• Perform internal diagnostics loop test procedures.
• Perform internal diagnostics/internal calibration of Navigator Pro.

Software/Protocol variables
• Shorten the analysis window to 9 msec or less.
• Change the click rate slightly.
• Use a post-stimulation time (+1) or add blocked points.
• Decrease gain on all channels in one or two increments (e.g. Reduce 150,000 to 100,000; reduce 100,000 to 75,000.
• Use alternating polarity.
• Reduce high filter (low pass) to 1500 Hz., OR
• Raise low filter (high pass) to 50, 75 or 100Hz.
• Disable the artifact rejection as a last resort. Check if any useful, readable data can be collected. Interpret with caution as noise
is being averaged into the recording.
Communication Issues (PC to Navigator Pro hardware)
• USB or Serial communication between the device and the host computer may be lost as a result of electrical interference. When
communication is lost, it can be re-established after the interference has ended by clicking on the retry button on the dialog box.

Navigator Pro AEP Instructions for Use 60 011986 Rev A

Environmental Noise Reduction Checklist
The Navigator Pro has been designed to reject noise through artifact rejection. This checklist can assist you with
troubleshooting if noise is affecting the acquisition of AEP data.

1. Navigator Pro box should not be close to the isolation transformer.

2. Separate the patient cable from the transducer cable and from any power supplies and cables.

3. If possible, avoid clipping the transducer stimulus boxes to the patient. Clip to a pillowcase instead. Do not let the
tubing of the transducers touch the electrodes or rub on the patient’s clothing.

4. Do not place the ground electrode close to the heart (front or back of the patient). Noise can be generated by a
large EKG.

5. Turn off any unnecessary external computer monitors.

6. Turn off fluorescent light(s) or dimmer switches when operating the equipment. Do not have dimmer set in the
middle position.

7. Turn off/Unplug any equipment in the same room as the system i.e. monitor, computer, typewriter, coffee pot etc.
Of course, temporarily disabling medical monitoring equipment used on the patient must be performed by a
qualified nurse or physician.

8. Only plug the Navigator Pro into the supplied isolation transformer. Do not use outlet strips or extension cords.
Connect the isolation transformer directly to wall outlet.

9. If patient is lying on a chair that plugs in – unplug the chair. If patient is lying on a metal bed, do not have
electrodes touching the metal of the bed.

10. Use a dedicated circuit (line) for the system (i.e. AEP system is only system in outlet.) Verify with an electrician
or Bio-medical dept. If not using dedicated line – other office equipment (i.e. copier) can introduce noise.

11. Assure that your wall outlet is grounded and wired correctly. Verify with an electrician or Bio-medical dept.

12. Do you have a radio station transmission tower nearby? This will create noise.

13. Are there any large devices in adjacent rooms or adjacent floor (e.g. X-ray equip. MRI, refrigerators, air
conditioner – window unit, elevator motors, etc.)

14. Do not use cellular phones when operating the equipment.

15. If 60 or 50 Hz noise is present (in most window sizes there will be only 1 or 2 cycles present), turn on the notch
filter and see if the noise disappears. See Protocol – Amplifier Tab section.

16. Click on View EEG button on the collection screen. Place the electrodes into a cup of water and walk the cup of
water and electrodes around the room to identify the noise source. Watch the EEG window, as you get closer to the
noise source the EEG will become noisier.

17. If only artifact is being collected, turn off the artifact rejection so that data collection can occur. Collect the noise,
so that you can fax it to Natus to determine the frequency of the noise to assist you with troubleshooting.

18. Move the system to a different room away from the existing location. Move system to a different part of the
building if noise cannot be resolved.

Navigator Pro AEP Instructions for Use 61 011986 Rev A

Self-Diagnostic Check of the Navigator Pro
Unit
The Navigator Pro hardware module contains components responsible for the stimulus output to the transducer
and an amplifier that increases the incoming signal from the electrodes. Within the AEP software there is a
Self Diagnostic procedure that can be performed which assesses the integrity of these components and
calibrates them.
To perform the Self Diagnostic Procedure:
1. Make sure the Navigator Pro unit is powered on and connected to the computer.

CAUTION
Be careful not to twist the patient electrode cable and transducer
connectors as you remove them. Metal pins inside the connectors can be
bent or broken by twisting, using excessive force, or if they are not
positioned correctly.

2. Disconnect the patient and transducer cables from the Navigator Pro unit.
3. Connect the system loop test cable (part number: 541-TSTCBL) to both the blue and yellow-ringed
sockets on the right side of the Navigator Pro system by matching the connector color to the color
ring around the socket. Make sure the flat side of the molded connector faces the label side of the
box. Be sure to push the connector into the socket as far as it will go.

Yellow Connector

Blue Connector

4. After setting up the system with the loop test cable, follow this process to test the internal components
of the Navigator Pro module:

Navigator Pro AEP Instructions for Use 62 011986 Rev A

 Click Hardware Setup
and Self Diagnostic . . .

. . .to get a Self Diagnostic message box

Click Continue. . .

Click Details. . .

. . . to get a Self Diagnostic

message box

5. If the Self-test fails, contact Natus Technical Support for assistance.

6. If the Self-test passes, this indicates that the Navigator Pro module itself is working properly. This
process bypasses the acoustic transducers and patient electrode cable and electrodes. Therefore, these
should be checked separately if you are troubleshooting data collection issues.
7. If you have the loop test cable to patient cable adapter (part number 001077) you can also check the
functionality of the patient cable. This is described in the next section.

Navigator Pro AEP Instructions for Use 63 011986 Rev A

Self-Diagnostic Check of the Patient Cable

The Loop Test Cable to Patient Cable Adapter (001077) is an adapter cable used to connect the loop test cable
(541-TSTCBL) to the patient connection cables (541-NAVC10). This adapter is used for troubleshooting
purposes only. It attaches to the patient input cable and can be used to eliminate the patent cable as the
problem area. The Loop Test Cable to Patient Cable Adapter has a Blue Mini-Din connector on one end and
five colored 1.5 mm “touch-proof” connectors on the other end.

The cable does not attach to the patient nor should it be used when a patient is connected to the device.

Connecting the Loop Test Cable to Patient Cable Adapter

The blue mini-din female connector of the adapter connects to the blue mini-din male connector of the System
Loop Test Cable. The yellow end of the Loop Test cable attaches to the Navigator Pro unit at the
headphone/transducer connector (yellow ring).

The 1.5 mm touch proof connectors attach to the patient cable. These touch proof connectors are color coded
to match the input connectors on the patient cable. The connections are attached as indicated in the table.

— Patient Cable Input — Adapter Cable Connector Color

— Common — Red
— Input 1 Channel 1 — White
— Input 2 Channel 1 — Blue
— Input 1 Channel 2 — Black
— Input 2 Channel 2 — Green

The Patient Cable blue mini-din attaches to the Navigator Pro unit at the patient connector (blue ring). Follow
the section above for performing a system self-diagnostic using the cable.

If the Self Diagnostic test passes using this cable, then you can rule out problems with the patient cable.

Navigator Pro AEP Instructions for Use 64 011986 Rev A

Folder Structures for AEP 7.2
For Win7:

Configuration and logs:

C:\ProgramData\Natus\AEP

Patient and Test Data:

C:\ProgramData\Natus\PTI

Patient and Report Templates:

C:\Users\Public\Natus\BLReports

For WinXP:

Configuration and logs:

C:\Documents and Settings\All Users\Natus\AEP

Patient and Test Data:

C:\Documents and Settings\All Users\Natus\PTI
Note: In case of an upgrade the PTI will be in C:PTI location

Patient and Report Templates:

C:\Documents and Settings\All Users\Documents\Natus\BLReports

Also, note when browsing in Windows explorer, Documents part shows up as “Shared Documents”,
but when you look in the address bar after selection it will show just Documents.

Calibration of the Equipment

Calibration of equipment is RECOMMENDED by Natus. Most equipment used to test hearing is calibrated
on an annual or semi-annual basis. The calibration of equipment sold by Natus must be performed by the
factory or by an authorized Natus representative. Likewise, the repair of Natus equipment must be performed
by the factory or by an authorized Natus representative.

Navigator Pro AEP Instructions for Use 65 011986 Rev A

Precautions and Safety Instructions

WARNING
Equipment that supports this program must be designed to meet all applicable
medical equipment standards for patient isolation and electrical safety. Natus
assumes no responsibility for the equipment into which this program is
installed, or for errors and omissions made during the installation process. It is
the installer's responsibility to insure the finished system meets appropriate
equipment standards, such as IEC 60601, BS 5724, and UL2601.

WARNING
Never place powered equipment (that is, equipment that operates with an
electric power source) on any flammable surface. Avoid this whether the
equipment is active or not.

IMPORTANT
This device is intended for use by qualified personnel only. Please read this
section and the remainder of the AEP Instruction for Use Manual before
installing any of the AEP System hardware, Retain this section as a reference
while operating, transporting, storing or re-installing the AEP System
equipment.

Navigator Pro AEP Instructions for Use 66 011986 Rev A

Equipment Identification Label and Markings
Classification
The International Electrotechnical Commission classifies electro-medical equipment according to its power
source (external or internal) and the degree of protection it provided against shock. The AEP System is
classified as Class I electrical, Type BF, which means it qualifies as externally powered equipment capable of
protecting a patient from electrical shock, provided electrical parts, such as electrodes, have been applied to the
patient.

Warning Labels and Symbols

Symbols are often used on equipment in preference to words in order to simplify language differences and to
provide instant comprehension of warnings and markings in a restricted space. The following symbols appear
on AEP System equipment or in the AEP System User’s Manual.

Attention

Type BF equipment

Electrical Installation Requirements

All system equipment must be installed at a properly grounded site. This section gives detailed information on
how to ensure the installation site meets all necessary requirements.

Grounding Requirements
The desired installation site must have a grounding wire for electrically connecting the system equipment to a
properly grounded terminal (Earth). The grounded terminal shall be connected to the steel skeleton or under
the main reinforcing steel with any multiple grounding wires grounded at the same point. (One point
grounding.) The shield room or bed must also be grounded at the same grounding terminal as the installation
site.

Navigator Pro AEP Instructions for Use 67 011986 Rev A

Power Plug Requirements
Use only the following power plug configurations.

• A 3-pin power plug requires a 3-pin wall socket with a properly installed grounding pole. Verify
the wall receptacle is correctly grounded before inserting the 3-pin power plug.

• A 2-pin/3-pin adapter for connecting 3-pin power supply plugs into a 2-pin wall socket. The
grounding terminal on the adapter must be fixed with the free end secured to the ground terminal.

• A 2-pin power plug with a grounding terminal for a 2-pin wall socket. The grounding terminal on
the power plug must be secured to the ground terminal.

Types of Hospital Facility Groundings

Use the following information to verify the installation site has the appropriate grounding.
Grounding Resistance The ground resistance of grounding poles connected to
medical equipment must be 10 ohms or less.
Protective Grounding Protective grounding must be provided for patient safety
to let the leak current flow into the ground.
Functional Grounding This type of grounding is not a requirement for patient
safety, but will help to eliminate hums.

Hazards of Improper Electrical Installations

Improper electrical installations can cause electrical shock to either the patient or user. It can also damage
system equipment under a fault condition. Ensure patient electrodes do NOT come into contact with any
conductive material, including the grounded chassis of the computer.

Environmental Conditions
• Select a room with properly grounded power sources.

• Do not use or store AEP systems and equipment in places where chemicals are stored or where
there is a potential for gas leakage.

• Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and
temperature, poorly ventilated areas and dusty, saline or sulfuric air.

• Verify the selected site maintains a relative humidity between 25% and 95% (without
condensation).

• Verify all conditions meet the requirements listed in the Environmental Specifications section of
this manual.

Room Topography
• Place all equipment on an even, level surface. Avoid the potential for mechanical shock or
possible vibrations during setup system operation or when relocating the equipment.

• Verify the iso-transformer and all portable multiple socket-outlets are off the floor and in a dry
location.

Navigator Pro AEP Instructions for Use 68 011986 Rev A

 Guidance and manufacturer’s declaration – electromagnetic emissions
The Navigator Pro is intended for use in the electromagnetic environment specified below. The customer or the
user of the Navigator Pro should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The Navigator Pro uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions Class B The Navigator Pro is suitable for use in all establishments other
CISPR 11 than domestic, and may be used in domestic establishments and
Harmonic emissions Class A those directly connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic purposes,
Voltage fluctuations/ Complies provided the following warning is heeded:
flicker emissions
IEC 61000-3-3 Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the Navigator Pro or shielding
the location.

Guidance and manufacturer’s declaration – electromagnetic immunity

The Navigator Pro is intended for use in the electromagnetic environment specified below. The customer or the
user of the Navigator Pro should assure that it is used in such an environment.
IMMUNITY test IEC 60601 Compliance level Electromagnetic environment -
test level guidance
Electrostatic ± 6 kV contact ± 6 kV Floors should be wood, concrete
discharge (ESD) or ceramic tile. If floors are
± 8 kV air ± 8 kV covered with synthetic material,
IEC 61000-4-2 the relative humidity should be at
least 30%
Electrical fast ± 2 kV for power supply ± 2 kV Mains power quality should be
transient/burst lines that of a typical commercial or
hospital environment.
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV
lines
Surge ± 1 kV line(s) to line(s) ± 1 kV Mains power quality should be
that of a typical commercial or
IEC 61000-4-5 ± 2 kV line(s) to earth ± 2 kV hospital environment.
Voltage dips, short <5 % UT 100% dip Mains power quality should be
interruptions, and (>95 % dip in UT) that of a typical commercial or
voltage variations on for 0,5 cycle hospital environment. If the user
power supply input of the Navigator Pro requires
lines 40 % UT 60% dip continued operation during
(60 % dip in UT) power mains interruptions, it is
IEC 61000-4-11 for 5 cycles recommended that the Navigator
Pro be powered from an
70 % UT 30% dip uninterruptible power supply or a
(30 % dip in UT) battery.
for 25 cycles

<5 % UT 100% dip

(>95 % dip in UT)
for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) magnetic should be at levels characteristic
field of a typical location in a typical
commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

Navigator Pro AEP Instructions for Use 69 011986 Rev A

 Guidance and manufacturer’s declaration – electromagnetic immunity
The Navigator Pro is intended for use in the electromagnetic environment specified below. The customer or the
user of the Navigator Pro should assure that it is used in such an environment.
IMMUNITY test IEC 60601 Test Compliance Electromagnetic environment – guidance
Level level
Portable and mobile RF communications
equipment should be used no closer to any part of
the Navigator Pro, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3V

IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m

IEC 61000-4-3 80 MHz to 2,5 GHz

Where P is the maximum output power rating of

the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as

a
determined by an electromagnetic site survey,
should be less than the compliance level in each
b
frequency range.

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the Navigator Pro is
used exceeds the applicable RF compliance level above, the Navigator Pro should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orientating or relocating the Navigator Pro.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications

equipment and the Navigator Pro
The Navigator Pro is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Navigator Pro can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Navigator Pro as recommended below,

Navigator Pro AEP Instructions for Use 70 011986 Rev A

according to the maximum output power of the communications equipment.
Separation distance according to the frequency of transmitter
Rated maximum m
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter

0,01 0.12 0.12 0.20

0,1 0.37 0.37 0.63
1 1.17 1.17 2.0
10 3.69 3.69 6.32
100 11.67 11.67 20
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Navigator Pro AEP Instructions for Use 71 011986 Rev A

Environmental Specifications
Temperature
Operating: 10 to 35° C

Storage and transportation: -20 to 70° C

Humidity
Operating: 30% to 75% at 40° C non-condensing

Storage and transportation: 90% at 65° C

Note: These are maximums and should not be considered ‘normal’ operating or storage environments.

Condensation
Recovery Time after condensation to operations specifications: 24 hours

Flammability
UL94V-O

EMC Specifications
Cispr 11 B Conducted and Cispr 11 B Radiated Emissions
EN61000-4-2 Electrostatic Discharge Test
EN61000-4-3 Radiated Susceptibility Test
EN61000-4-4 Transient Susceptibility Test
EN61000-4-5 Surge Susceptibility Test
EN61000-4-6 Conducted Immunity Tests
EN61000-4-11 Voltage Fluctuations Test
EN61000-3-2 & EN61000-3-3 Dips and Flicker Test
RE 101 Magnetic Emissions Test

System Hookups

WARNING
Only use the Power Supply provided with the AEP system.

• Verify the system computer power supply (if present) is plugged into either:
—an iso-transformer from the 520-XFS family of iso-transformers

OR

—a 520-AMPS01 iso-transformer.

• Verify the maximum load for any multiple portable socket-outlet:

—does not exceed 750 VA for the 520-XFS family of iso-transformers
—does not exceed 100 VA for the 520-AMPS01

Navigator Pro AEP Instructions for Use 72 011986 Rev A

 • Do NOT use the multiple socket-outlets to power any equipment that isn’t a part of the AEP System.
(Adding other equipment may increase the current amount of leakage and exceed the safety limit.)

• Do not interconnect multiple pieces of equipment without verifying that the sum of all leakage
currents does not exceed the safety limit.

• Do not connect non-medical electrical equipment directly to a wall outlet if the AEP System is using
a multiple, portable socket-outlet with a separating iso-transformer. (The additional equipment may
increase the current amount of leakage and exceed the safety limit.)

• Do not connect equipment, which can potentially provide electromagnetic or other types of
interference. This may cause the AEP System equipment to function incorrectly.

• Verify the equipment is connected to a power line source with the following frequency, voltage and
current capacity.

Frequency: 50 / 60 Hz
Voltage: 100 – 240 VAC
Current Capacity: 15 Amps min.

• Use only Ink Jet printers for AEP System setups that use the AEP System isolation transformer.

Installation Verification
Use the following to verify all equipment is correctly installed before use.

• Verify all equipment and cables are undamaged and in good working condition.

• Verify all equipment and cables are connected according to the instructions in this manual.

• Verify unauthorized equipment is not connected to the system.

• Verify the equipment is properly grounded.

• Verify all circuitry with a direct connection to the patient has been checked twice.

• Verify all system or equipment batteries show the correct voltage and are in perfect working
condition.

System Diagnostic and Verification Tests

Before connecting the patient to the system equipment, perform all required system diagnostic tests described
in the AEP Instruction for Use Manual. All tests must pass.

Navigator Pro AEP Instructions for Use 73 011986 Rev A

Precautions During System Operation
WARNING
Never turn power on or off with a patient connected to the system. Only
qualified personnel should use this device. Please read this section before
installing any of the hardware. Refer to this section when you operate,
transport, store, or re-install the system.

WARNING
All of the disposable supplies from Natus that are coupled to the scalp are
latex-free and comprised of hypoallergenic material. Natus is not responsible
for disposable items purchased from another vendor. Carefully read and
follow the proper use instructions that accompany any disposable items.

WARNING
Make sure that any platform, table, cart, or other surface used during the
operation, transport, or temporary or permanent storage of the system and its
components is adequate, sturdy, and safe. Natus is not responsible for any
injury or damage that may result from inadequate, poorly constructed, or
unapproved transports, carts, operating surfaces

WARNING
Never use equipment that has parts missing or equipment that might contain
loose parts inside of it (that is, inside an enclosed portion of the equipment). If
you suspect a piece of equipment has missing or loose parts, make contact
with Natus Medical Incorporated.

WARNING
Never place powered equipment (that is, equipment that operates with an
electric power source) on any flammable surface. Avoid this whether the
equipment is active or not.

WARNING
This equipment is not protected from a cardiac defibrillator discharge. Using a
defibrillator while a patient is connected to the system equipment may
permanently damage the equipment.

1. Follow all safety procedures, giving careful and constant attention to the patient and system
equipment.
2. Follow hospital procedures to validate all electrodes are properly applied in order to prevent patient
burns while using electro-surgical equipment.
3. Turn the system power on BEFORE you attach electrodes to the patient. Remove the electrodes from
the patient BEFORE you turn the system power off. This avoids shock hazards from power surges.
4. Attach electrodes to the patient and the system hardware so that the electrode cables can neither
entangle nor strangle the patient.
5. Avoid direct contact between the patient and system equipment at all times.
6. Do not add other equipment that is not protected against ingress of liquids.
7. This equipment is not suitable for use in areas of flammable or anesthetic mixture.

Navigator Pro AEP Instructions for Use 74 011986 Rev A

Signal Output and Input
The system computer must NOT be used in a patient environment unless one of the following conditions is
met:

1. The system computer and all other peripheral devices are plugged into the isolation transformer.

2. The portable computer is powered by batteries. It does not plug into a wall outlet. No AC-powered
peripherals except the AEP System module (Navigator Pro) connect to the portable computer.

3. The system computer has an isolated power supply.

Care and Maintenance

This section gives users information on maintaining and caring for AEP System.

Cleaning
No special cleaning is required for this device. Ordinary, ‘house-keeping’ type cleaning to prevent the
accumulation of dust or debris is adequate.

Inspection
No special inspection procedures are required for this device.

Disassembly and Storage

The AEP System equipment requires careful handling during disassembly and storage.

1. Return all controls to their original positions and turn OFF all system equipment.

2. Carefully remove all connecting cables without using force.

3. Follow designated hospital procedures to clean AEP System equipment.

Maintenance
AEP System equipment requires professional maintenance and repair service. Never attempt to alter, modify or
repair this equipment on your own.

1. If the AEP System equipment is not functioning correctly, mark all defective parts clearly to prevent
accidental use before the appropriate repairs can be made.

2. When using a defibrillator, either protect the equipment against defibrillator discharge or remove all
patient cables and/or transducers to avoid system damage.

Navigator Pro AEP Instructions for Use 75 011986 Rev A

Electrical Requirements
Use the following requirements to avoid noise interference while recording activity from patients and to ensure
a consistent electrical environment for the computer system.

WARNING
Never turn power on or off with a patient connected to the system. Only
qualified personnel should use this device. Please read this section before
installing any of the hardware. Refer to this section when you operate,
transport, store, or re-install the system.

WARNING
Never place powered equipment (that is, equipment that operates with an
electric power source) on any flammable surface. Avoid this whether the
equipment is active or not.

Isolated or non-isolated power

Although AEP Systems will function with non-isolated power, Natus prefers isolated power for maximum
efficiency and safety.

15 or 20 amps
Although 15 amps are acceptable in smaller systems, a 20-amp service is preferable anytime the system in use
has a large amount of features.

BTU Offset
Natus computer systems release a maximum of 2000 BTU per hour.

Magnetic Field
Natus computer systems should operate without any interference in a magnetic field of 0.05 Gauss.

Room Shielding
Although Natus recommends room shielding, it is not absolutely required. Users may elect to shield the room
if the location is close to noise-generating equipment and should provide shielding if there are potential noise
level problems.

Fluorescent Lights
Although the AEP System works in a room with fluorescent lighting, incandescent lighting is preferred. Also,
dimmer switches can produce noise interference unless the switch is set at a full position.

Thickness of the Conduit

The thickness of the conduit and all electrical installations must meet the National Electrical Code and
applicable local codes.

Navigator Pro AEP Instructions for Use 76 011986 Rev A

INDEX
A F
Align ............................................................................ 32 Frequency .................................................................... 73
Alt. Polarity.................................................................. 32
Amplifier Parameters ................................................... 21
Amplifier tab .......................................................... 45, 51
G
Analyze ........................................................................ 31 Gain ............................................................................. 52
Archive ........................................................................ 42 GraphMaster .......................................................... 37, 38
Artifact Rejection ......................................................... 52 Grid ............................................................................. 33
Audiogram ................................................................... 37
Auditory Evoked Potential Troubleshooting Guide ..... 59
Auto Specific Scaling .................................................. 36 H
High Filter ................................................................... 52
B
Backup ......................................................................... 42 I
Baseline ....................................................................... 33
Impedance ................................................................... 21
Begin data collection.................................................... 19
Impedance Table ......................................................... 37
Blocking....................................................................... 47
Increase Intensity......................................................... 21
Browser ........................................................................ 37
Input 1 ......................................................................... 52
Input 2 ......................................................................... 52
C Insert Delay ................................................................. 49
Intensity....................................................................... 48
Calibration ................................................................... 65 Intensity Step ............................................................... 49
Channel Enable ............................................................ 52 Interaural Latency / Amplitude Difference .................. 37
Click Duration ............................................................. 49 Invert ........................................................................... 34
Comment ..................................................................... 31
Continuous Stimulus .................................................... 49
Copy patient record ...................................................... 42 L
Correlate ...................................................................... 34
Label/Calculation ........................................................ 53
Cursor 1 ....................................................................... 27
Labels .............................................................. 29, 31, 34
Cursor 2 ....................................................................... 27
Labels/Calculations tab ............................................... 45
Link mask level with stim level changes ..................... 50
D Low Filter .................................................................... 52
Database....................................................................... 41
Decrease Intensity ...................................................... 21 M
Delete a Patient Record ................................................ 43
Marked Point Information ..................................... 31, 37
Delete Labels ......................................................... 29, 34
Masking Type.............................................................. 50
Deselect All waveforms ............................................... 34
Match .......................................................................... 32
Digital Filter................................................................. 34
Maximum # of Averages ............................................. 47
Digital Filter Setting .................................................... 31
Modify Label Set................................................... 29, 34
Montage ...................................................................... 14
E
Edit Tag ....................................................................... 52 N
Electrical Requirements ............................................... 76
No Hardware Detected Error Message ........................ 17
Electrode Connections ................................................. 14
Notch Filter ................................................................. 52
Electrode Switching ..................................................... 52
Environmental Noise Reduction Checklist .................. 61
Environmental Specifications ...................................... 72 P
Epoch Time .................................................................. 47
Epoch-Based Scaling ................................................... 36 P&TI ........................................................................... 40
Equipment Identification Label and Markings ............. 67 Patient & Test Information .......................................... 40
Erase ................................................................ 31, 32, 33 Patient Preparation ...................................................... 14
Exceed Max ................................................................. 21 Pause ........................................................................... 21
Plateau ......................................................................... 49
Points per epoch .......................................................... 47
Polarity ........................................................................ 48
Pre/Post Time .............................................................. 47

Navigator Pro AEP Instructions for Use 77 011986 Rev A

Precautions and Safety Instructions ............................. 66 Stimulus tab........................................................... 45, 48
Precautions During System Operation ......................... 74 Stimulus Type ............................................................. 49
Protocol Name field ..................................................... 45 Stop ............................................................................. 21
Superimpose ................................................................ 32
R
T
Ramp ............................................................................ 49
Record .......................................................................... 21 Toneburst Frequency ................................................... 49
Record/Waveform Info ................................................ 37 Transducer ................................................................... 48
Recording tab ......................................................... 45, 47 Transducer Calibration ................................................ 65
Records list .................................................................. 37 Transfer ....................................................................... 32
Refresh ......................................................................... 33 Trigger In .................................................................... 49
Report Layout .............................................................. 55 Trigger Out Pulse ........................................................ 49
Report Setup ................................................................ 54 Troubleshooting Guide ................................................ 59
Report Template - Deleting Fields ............................... 57
Report Template - Moving Fields ................................ 56
Retrieve Archived Patient Data.................................... 42 U
Rise/Fall ....................................................................... 49 Unweighted Add ......................................................... 34
Unweighted Subtract ................................................... 34
S
Sample Tag .................................................................. 52 V
Save Calculated Waves ................................................ 34 View EEG ................................................................... 21
Save Impedance Test Values ....................................... 47 View menu and toolbar ............................................... 37
Scale................................................................. 32, 34, 36
Select All waveforms ............................................. 33, 34
Selecting and Moving the Waveform........................... 29 W
selecting multiple waveforms ...................................... 30
Wave info .................................................................... 31
Self Diagnostic....................................................... 62, 64
Wave Position ............................................................. 32
Smooth ......................................................................... 34
Waveform Calculations ............................................... 34
Specific Scale............................................................... 36
Weighted Add ............................................................. 34
Starting the AEP program ............................................ 17
Weighted Subtract ....................................................... 34
Stim Rate ..................................................................... 49
Stimulus Ear........................................................... 21, 48
Stimulus Parameters .................................................... 21

Navigator Pro AEP Instructions for Use 78 011986 Rev A

 Natus Medical Incorporated
1501 Industrial Road • San Carlos, CA 94070 • USA • Tel +1-800-303-0306 • +1-650-802-0400
www.natus.com

P/N 011986A