Combo Visual Function Analyzer

Version 4.1 Software

Operator's Manual

Tracey Technologies Corp.

16720 Hedgecroft Drive, Suite 208
Houston, Texas 77060
Customer Support: (281) 445-1666
[email protected]
www.traceytech.com

IFU 7.5-4-2 Rev. A

0120
Copyright Notice

Copyright © 2009, Tracey Technologies Corp. All rights reserved. No part of this manual
may be reproduced without permission from Tracey Technologies Corp.

Trademarks

Microsoft Windows and Windows XP are trademarks of Microsoft Corporation.

Table of Contents
PREFACE...................................................................................................................................... 5
GENERAL WARNINGS AND NOTICES .............................................................................................. 5
SYMBOL LEGEND .......................................................................................................................... 6
INDICATIONS FOR USE ................................................................................................................... 7
SYSTEM SPECIFICATIONS ............................................................................................................... 7

CHAPTER 1 GETTING STARTED ............................................................................................ 8

WELCOME NEW USER ................................................................................................................... 8
GETTING HELP .............................................................................................................................. 9
WARRANTY INFORMATION ........................................................................................................... 9
CHAPTER 2 GETTING TO KNOW YOUR SYSTEM ............................................................. 10
DATA ACQUISITION UNIT - DAU ................................................................................................ 10
CLEANING AND MAINTENANCE ................................................................................................... 11
COMPUTER..................................................................................................................................11
DATA STORAGE .......................................................................................................................... 12
CHAPTER 3 LEARNING THE BASICS .................................................................................. 13
NEW USER INSTALLATION AND TRAINING ................................................................................... 13
INSTALLING YOUR TRACEY iTrace SOFTWARE .............................................................................. 14
SPECIAL FUNCTION KEYS............................................................................................................ 16
TO USE A JOYSTICK .................................................................................................................... 17
TO PRINT A SCREEN..................................................................................................................... 17
TO SAVE A DISPLAY.................................................................................................................... 17
COMMON DISPLAY OPTIONS ....................................................................................................... 18
TO VIEW ANOTHER DISPLAY ...................................................................................................... 18
TO ENLARGE A DISPLAY............................................................................................................. 19
TO VIEW A DISPLAY IN 3D........................................................................................................ 19
TO CHANGE DISPLAY ELEMENTS ................................................................................................ 20
TO SELECT ZONE SIZE ................................................................................................................ 21
TO COMPARE ABERRATIONS ....................................................................................................... 21
TO POWER SYSTEM ON ......................................................................................................................... 22
TO POWER SYSTEM OFF .............................................................................................................. 22
CHAPTER 4 NEW AND EXISTING PATIENTS .................................................................... 23
KEY FEATURES........................................................................................................................... 24
TO ADD NEW PATIENT ................................................................................................................ 25
TO EDIT PATIENT DATA ............................................................................................................. 26
TO DELETE A PATIENT ................................................................................................................ 26
TO EXPORT PATIENT DATA ........................................................................................................ 27
TO IMPORT PATIENT DATA ...........................................................................................................27
TO SELECT OR CHANGE THE STORAGE LOCATION FOR YOUR PATIENT DATA ............................28
TO VIEW PATIENT DATA FROM OLDER ITRACE SOFTWARE ........................................................ 28
TO PERFORM A QUICK CALIBRATION CHECK ............................................................................. 29
TO SEARCH FOR A PATIENT ........................................................................................................ 30
TO EDIT SETTINGS.............................................................................................................................. 31
TO ACTIVATE SOFTWARE ........................................................................................................... 32
CHAPTER 5 THE EXAMINATION PROCESS ...................................................................... 33
CAPTURING A WAVEFRONT EXAM .............................................................................................. 33
FOCUSING AND PROCESSING ........................................................................................................ 33
VERIFYING A WF EXAM ............................................................................................................. 36
SAVING THE EXAM ...................................................................................................................... 41
RETAKING THE EXAM ................................................................................................................ 41
TAKING A CT EXAM ................................................................................................................... 42
CHAPTER 6 PATIENT EXAM REVIEW ................................................................................ 44
TO VIEW A PATIENT’S EXAM ....................................................................................................... 44
TO SELECT WF OR CT EXAM ...................................................................................................... 45
TO DISPLAY A MULTI-EXAM ..................................................................................................... 45
MULTI-EXAM OPTIONS MENU NAVIGATION .............................................................................. 47
TO DISPLAY AN AVERAGE OF MULTIPLE EXAMS ....................................................................... 47
TO VIEW TRACEY VFA SUMMARY DISPLAY ............................................................................. 49
TO VIEW WF AND CT SUMMARY .............................................................................................. 50
WF VERIFICATION DISPLAY........................................................................................................ 51
WF VERIFICATION OPTIONS MENU NAVIGATION ........................................................................ 52
WF OR CT VERIFICATION OPTIONS MENU – EDITING PUPIL AND LIMBUS.................................... 53
WF SUMMARY DISPLAYS............................................................................................................ 55
WF SUMMARY OPTIONS MENU NAVIGATION ............................................................................. 56
TRACEY VFA SUMMARY DISPLAY.................................................................................................... 57
WF COMPARISON DISPLAY ......................................................................................................... 58
CT VERIFICATION DISPLAY ........................................................................................................ 59
CT VERIFICATION OPTIONS MENU NAVIGATION ........................................................................ 61
CT SUMMARY DISPLAY.............................................................................................................. 61
CT SUMMARY OPTIONS MENU.................................................................................................... 62
CT COMPARISON DISPLAY ................................................................................................................ 63
OD/OS CT SUMMARY DISPLAY .................................................................................................. 64

APPENDIX A TECHNICAL INFORMA TION........................................................................ 65

MAP LAYERS .............................................................................................................................. 65
DISPLAY TYPES ......................................................................................................................... 65
APPENDIX B ZERNIKE MODES CHART.............................................................................. 67
APPENDIX C INSTALLATION INSTRUCTIONS......................................................................................68
APPENDIX D CALIBRATION VERIFICATION INSTRUCTIONS.......................................................70
GLOSSARY................................................................................................................................. 71
SOFTWARE LICENSE AND WARRANTY STATEMENT .................................................. 73
Preface
General Warnings and Notices
Important! Always follow these instructions to help guard against personal injury and damage
to your Tracey iTrace Visual Function Analyzer system.

NOTE: The User(s) of the Tracey iTrace are responsible

for ANY and ALL interpretations, diagnosis, and
treatment plans using the data generated by the
Tracey iTrace.

The Tracey iTrace Visual Function Analyzer is a Class I laser product. It

contains two laser diodes, one a Class IIIb laser diode with a 785 nm wavelength,
and one a Class IIIa laser diode with a 655 nm wavelength.

CLASS 1
To avoid inadvertent exposure to laser radiation, never operate the system
LASER PRODUCT with the covers opened or removed. Doing so may expose the user or others
to stray laser radiation.

Any service requiring access to the interior of the system should be performed
only by Tracey Technologies authorized personnel or agents who have received
specific system training.

Operate the external computer and peripheral devices and all computer software following all
guidelines supplied by the computer and software manufacturer or supplier.

Operate the Tracey iTrace Visual Function Analyzer only from the type of power source
indicated on the product-rating label.

Carefully read all instructions prior to use. Retain all safety and operating instructions for future
use.

Observe all contra indications, warnings, and precautions noted in this manual.

5
Symbol Legend

Caution. Please read and follow all warnings and notices.

Class 1 Laser Product - The Tracey iTrace Visual Function Analyzer is a

Class I laser product. It contains two laser diodes, one Class IIIb laser
diode with a 785 nm wavelength, and one Class IIIa laser diode with a
655 nm wavelength.

Class 1 Protected against electric shock by connecting the

equipment to protective earth ground
Type B Meets the leakage current requirements and the patient
applied part is isolated from the equipment

Protective earth (GROUND) required

This symbol denotes that this device must be disposed of in accordance

with the WEEE. Further details can be found in EN 50419:2005;
regulations as set out by the 2002/96/CE directive, subsequently
superseded by 2003/108/CE. For disposal, please contact Tracey
Technologies or your local distributor.

Special precautions regarding Electromagnetic Compatibility (EMC)

exist with the iTrace VFA and the equipment must be installed and put
into service in compliance with the IEC 60417-5134 standards. All
iTrace users should be trained in electrostatic discharge (ESD)
precautionary procedures.

6
Indications for Use

The Tracey iTrace Combo Visual Function Analyzer is used to measure the refractive, wavefront
and corneal topographic data of the human optical system.
The iTrace performs these primary tasks:

• Captures an eye image

• Measures 256 points of light projected through the pupil onto the retina
• Plots the points and calculates Zernike polynomial wavefront data
• Captures image of projected Placido rings and calculates corneal topography data
• Generates displays to view the data
• Saves exam data in an organized database
• Automatically centers, sizes the scan pattern within the pupil, and captures the data
• Verifies focus and alignment
• Combines corneal wavefront data and total eye wavefront data to generate a lenticular
aberration analysis with iTrace Premium software.

System Specifications:

Measurement Range: +/-15 D sphere

+/-10 D cylinder
Pupil Scan Size: 2.5 mm to 8.0 mm diameter
Accuracy: +/- 0.10 D
Reproducibility: +/- 0.10 D
Footprint Dimensions: 13.0 in (33.0 cm) x 17.0 in (43.2 cm)
Weight: 27.4 lb (12.4 kg)

7
Chapter 1 Getting Started

Please read the Operator's Manual in its entirety before using your Tracey iTrace System.

Welcome New User

Congratulations on acquiring your new Tracey iTrace Combo Visual Function Analyzer
(iTrace). Chapter 2 acquaints you with your systems hardware: the data acquisition unit
(DAU), the computer, and printer. Chapter 3 covers the basics of using your system, from
powering on and off to using your iTrace software and working with the screens. Chapter 4
of this manual reviews how to examine patients and keep track of your data.

With your new iTrace, you will now have the ability to look at the entire refraction of the
eye with the highest level of objective measure and detail. In fact, viewing a refractive map
of the entrance pupil which covers the refractive power of the entire eye on a point-by-point
basis, as opposed to the basic refractive numeric summary of sphere and cylinder, will have
an enormous impact on your practice in terms of speed, accuracy and the clinical care of
your patients.

To measure refraction on a spatially resolved basis requires the ability to look at the
wavefront aberrations of the eye on a point-by-point basis. The iTrace actually analyzes light
that is directed into the eye focused onto the retina creating a secondary light source as it is
reflected from the retinal surface and projected out the exit pupil. The iTrace uses the
fundamental thin beam principle of optical ray tracing to measure the refractive power of the
eye on a point-by-point basis. The simplicity of measuring one point in the entrance pupil at
a time is unique to the Tracey system.

Your iTrace system is designed to very rapidly fire a series of very small parallel light
beams one at a time, within microseconds into the entrance pupil. These beams of light
pass through the entrance pupil of the eye in an infinite selection of software selectable
patterns. With new designs of the photo detector system, iTrace can easily measure a large
dynamic range of aberrations and maintain high resolution. This should provide for a
significant advantage when measuring a physiologic system, such as the eye, which can
easily have a tremendous range of refractive errors.

Additionally, since each point is sequentially measured there is never any confusion of
which entrance pupil location registers with the retinal spot detected. As the iTrace system
directly measures the point spread function of the eye with its retinal spot detection, it can
then easily provide for full calculation of wavefront deformation of the eye.

8
 Your iTrace system also captures and processes corneal topography data. Wavefront data of
the cornea is combined with wavefront data of the eye to obtain the industry's first-ever
lenticular aberration analysis in Tracey’s Premium iTrace software.

Getting Help
Telephone Support is available by calling (281) 445-1666.

Questions may be submitted via E-mail to [email protected]

Or

by fax to (281) 445-3050.

Warranty Information

Your Tracey system comes with a standard one-year warranty for parts and labor on the
components purchased from Tracey Technologies including software updates (see warranty
information in the back of this manual). Extended Service Agreements are available from
Tracey Technologies. Contact your sales representative or Tracey Technologies at (281) 445-
1666 for more information.

NOTE: The User(s) of the Tracey iTrace are Responsible for ANY and
ALL interpretations, diagnosis, and treatment plans using the
data generated by the Tracey iTrace.

9
Chapter 2 Getting to Know Your System

The Tracey iTrace Combo Visual Function Analyzer provides the ability to offer your
patients accurate, repeatable, and prompt refractive measurements of the complete optical
system in the eye. The iTrace performs these primary tasks:

• Captures an eye image

• Measures 256 points within the patient's entrance pupil
• Generates numerous customized displays to view the data
• Saves exam data in an organized database
• Automatically centers, sizes the scan pattern within the pupil, and captures the data
• Verifies focus and alignment
• Prints any of the provided displays
• Saves displays as bitmap files
• Combines corneal wavefront data and total eye wavefront data to generate a lenticular
aberration analysis with iTrace Premium software.

The system also has provisions for these functions:

• Displaying and analyzing exam data in user-defined custom formats

• Setting and changing system parameters
• Patient database management

This chapter describes the primary components of your system: the Data Acquisition Unit,
the external computer, and the data storage recommendation. Chapter 3 discusses the basics
of using your system, and navigating around the menus.

Data Acquisition Unit - DAU

This is the main component of the iTrace VFA system. It is used to
project and record the points of light as they enter through the pupil and
focus on the retina. The iTrace software uses these data points to
produce the various displays. The Data Acquisition Unit (DAU)
features an adjustable focusing target, pupil size detector, and an
OD/OS detector.

It also features a Placido-based corneal topography analyzer. The back-

lighted Placido rings are projected onto the corneal tear film, and the
image is auto-captured when device is at the proper working distance
and the projected laser beam is centered in the live video image. The
iTrace software then defines the ring edges and calculates corneal curvature, corneal refractive
power, and corneal wavefront data.

10
 Getting to Know Your System

The DAU also contains an internal optometer. The optometer is the fixation device for alignment
of the patient’s line of sight with the laser axis. It also serves to relax the patient’s
accommodation by providing a target of increasing/decreasing spherical correction from +7D to -
5D primarily.

Additionally, the DAU contains the power supply, data transmission and image capture
processing boards. This unit is not serviceable by the customer, and only trained Tracey service
engineers should open and service this component.

Cleaning and Maintenance

The exterior of these units may be cleaned with a dry cloth. Avoid getting any moisture or liquid
on/in the system. DO NOT touch the optics inside the eyepiece. If necessary, compressed air
may be used to remove dust inside the optical eyepiece. BEFORE using the air, power the
system off.

Computer
The computer is an external computer (laptop or desktop model) supplied by Tracey or by the
customer. Laptop/Desktop computers must meet these minimum specifications*:

• CPU: Intel Pentium or Celeron Core 2 Duo or Core Duo processor with minimum 2.0
GHz speed

• 1 GB RAM (Main Memory)

• CD-RW or DVD±R Multi-function Drive

• HD Capacity: 200GB Minimum

• 2 USB 2.0 Ports for connecting iTrace acquisition unit and color printer

• Integrated 10/100 Ethernet LAN

• Microsoft Windows XP Home or Pro Operating System, or Microsoft Vista Home

Premium OS

• Color Printer (USB or wireless) for Printing Displays (Optional)

Our tests have shown excellent result with the following preferred computer manufacturers:
Sony, Acer, HP and Toshiba.

*These specifications are subject to change.

11
 Getting to Know Your System

Data Storage Recommendation

Tracey recommends that you backup your patient file databases using the CD-RW or DVD±R
Multi-function drive, or external hard drive. In case of a computer hardware failure or database
corruption, your patient files can be restored readily.

NOTE: The User(s) of the Tracey iTrace Combo is responsible for

ensuring the patient data is backed-up and stored on an external
source.

12
Chapter 3 Learning the Basics

This chapter covers the basics of using the iTrace software. Chapter 3 is especially helpful
for new computer users to get you going quickly on your new iTrace system. This chapter
describes features and functionality available in the iTrace Basic and Premium software
versions. Features only available with the Premium software are denoted with asterisks
(*). This chapter includes the following topics:

New User Installation and Training

Install your iTrace Software
Special keyboard keys
Using the Joystick
Printing a screen
Saving a display
Using common display options
Powering system on and off

New User Installation and Training

A Tracey-certified installation representative may install your new iTrace system and verify
calibration. You then will receive training from a Tracey-certified training specialist. Training
on the iTrace and its software should take approximately 2 hours, however be prepared to spend
a significant portion of the day with the training specialist learning to operate the iTrace software
and equipment. If possible, it can be helpful to schedule some patients for an actual examination
near the end of training. The training specialist will do the following:

Explain the hardware components

Train you on the operation of the hardware and software
Train you on the iTrace Wavefront exam process
Train you on the iTrace Corneal Topographer exam process
Explain the different displays
Explain how to customize displays based on your practice needs

13
 Learning the Basics

To Install your iTrace software

1 Your laptop computer, if supplied by Tracey Technologies, may have the iTrace
software pre-installed and ready to use. If so, there is no need to follow this procedure.
Simply double click on the iTrace 4.1 icon on your desktop to launch the software.
If you are supplying the computer, you will need to install the software. To do so, start
your computer. Log on with your username. Your username must have administrator
privileges to install new software. If not, please contact your system administrator for
support.
2 Please disable any anti-virus program running on your computer. If your OS is Vista,
you will need to turn off the User Account Control feature. Please contact Tracey
Technologies if you need instructions for this process.
3 Insert iTrace installation CD.
4 The software should install itself, if not, run Windows Explorer, click on the drive letter
where the installation CD was inserted, and then run the file setup.bat.
This installation procedure will:
• create a desktop shortcut and a quick launch icon if so choose.
• install and update necessary database drivers.

NOTE: During the next steps, Windows may give a warning that the hardware does not
meet compatibility test. Please ignore this warning and click on Continue Anyway button
to proceed with the installation.

5 Turn on the power on the iTrace DAU (set-up instructions provided in the companion
iTrace Quick Setup Guide and in Appendix C of this manual).
6 Verify the USB cable is plugged into the iTrace DAU. Plug in other end of USB cable
into any available USB port on the computer.
7 Windows will recognize the new iTrace VFA hardware and bring up an installation
wizard for it. Let the computer find and install the drivers automatically. When you
later launch the iTrace software for the first time, the computer may present another
installation wizard when it recognizes the iTrace DAU. Again, let the computer find
and install the drivers automatically. Once finished, the iTrace software will start.
8 Exit the iTrace software, then relaunch
the software by double-clicking the
iTrace 4.1 Software icon on your
Windows desktop. The software will
perform a system test lasting a few
seconds, and is ready when cursor
becomes an arrow.

Select this option and type

C:\Tracey\Drivers in the text
box and click Next, Windows
then will install the driver
correctly. 14
 Learning the Basics

If windows can’t find the driver,

select this option and click Next.

15
 Learning the Basics

Special function keys

The iTrace program uses these special function keys frequently.

use to move from field to field. The Shift + Tab combination keys move the
cursor to the previous field. Using the Tab key is a quicker way to move through fields
than using the mouse pad.

use for moving the cursor to the left, right, up, and down. The cursor
indicates your position in a text entry field and takes the form of a blinking vertical bar.
The up and down arrow keys also are used for manually adjusting the scan diameter size
in the pupil during the acquisition process. The right and left arrow keys also are used to
manually adjust the fixation target +/- diopter steps as set in the accommodation
parameters.

also known as the Return key, can be used in lieu of clicking OK. During
acquisition process the ENTER key is used to toggle between Manual and Auto alignment
functions for each exam.

use in combination with other keys. For instance, CTRL + ESC means to hold
down the CTRL key and then press the ESC key. This is useful when selecting a number of
patient exams for export or import. It is also used to de-select an exam that is already
highlighted.

use in conjunction with other keys. For instance, Shift + Tab means to hold
down the Shift key and then press the Tab key.
use to cancel the acquisition process. Using the ESC key is a quicker way
than using the mouse pad to move back one screen in the software.

change the C4 (defocus) term on the Retinal Spot Diagram display. It

simulates moving the retina forward and backward through the Conoid of Schturm

use to reset the Retinal Spot Diagram after using F1/F2.

use to provide continuous change in Retinal Spot Diagram over the range of
+10 to -10 D of change.

press to view the data point positions on the detector. Select any display button
to exit.

use to begin a continuous one-time recycle cycle through the signals for each
sample point.

press to view simulated raw detector signals.

reset target to 0 diopters

16
 Learning the Basics

To Use the Joystick

The joystick is used to position the DAU in front of the patient's eye for data acquisition. The
four operations performed by moving the joystick are listed below:

To move the image left or right in small increments, move the joystick
in the left or right direction.
To move the image up or down, twist the joystick clockwise (up) or
counter-clockwise (down).
To focus the image in small increments, move the joystick to the
forward or backward.
To capture an image while in manual mode , press and release the
acquisition button on top of the joystick.

To Print a screen
To print a screen from the software:

1.Click button on lower right

corner. A Print selection window appears for
printer selection. Answer OK to print. Draft print
quality, which can be selected through Properties
button, will give the quickest printout.

To Save a display
You can save an entire screen as a graphic file. You can choose to save the screen as in BMP or
PNG file format.

1. Click button in lower right corner to save the entire screen as a BMP or
PNG file.

17
 Learning the Basics

Common display options

In a Verification or Summary display mode, the default screen contains 4 small displays. This
display setting and other common default settings can be changed by right mouse clicking on
any display to bring up the Options Menu and then select different options.

To View another display

Select from the Options Menu then choose another type.

After the display type is selected, a red dot will appear
indicating the type of display that was selected for the
screen.

18
 Learning the Basics

To Enlarge a display

Select “Large Window” option from Options Menu. This will

enlarge the display to fit the whole display area.

To View display in 3D*

The default display method is 2D. Display Method option is

available only in Summary display mode by clicking on one of
five Summary buttons. Right mouse-click to bring up the Options
Menu, highlight Display Method and choose 3D*.

3D

19
 Learning the Basics

To Change display elements

A display element is an overlay of image which you can layer

together to help with your data analysis. Not all displays contain
all the display elements. Some elements are only specific to that
display. Perform a right mouse click on any display to bring up
the Options Menu. Select any number of display elements
options toward the bottom of the menu list. As the elements are
selected, a green check mark will appear next to the element on the menu list.

Eye image Grid WF map

Pupil Corneal vertex Scan points

CT rings MTF graph* CT map

20
 Learning the Basics

To Select Zone Size*

You can choose different scan zone to view for the

multizone refraction display though the default
settings in Settings. To change zone size within the
current display*, bring up the Options Menu by right
mouse click. Select Zone option and then choose the
options. You can pick a distinct zone value from
2.0mm to 8.0mm, or Full Scan option for all the zones,
and Other allows you to choose an arbitrary value.

To Compare aberrations*

Different aberration types can be selected by bringing

up the Options Menu. Highlight Aberrations option
and then select the different types and the associated
zones. In the Basic 4.1 software, you can select to
display Total, Higher Order Total, or Lower Order
Total. In the Premium 4.1 software, you can also
choose to display only Defocus, Astigmatism, Coma,
Spherical and Trefoil abberations. Choose Other if you
want to enter an arbitrary value. Choosing Other option
in an RMS display will bring up the Aberrations Mask
screen*.

21
 Learning the Basics

To Power the System On

1 Verify all cable connections.

2 If using a surge protector, locate the power switch on the surge protector and move to the
ON position.

3 Locate the power switch or button on the laptop or desktop computer and place in the ON
position.

4 Wait until computer has finished its boot-up process and shows the Windows desktop
with all icons.

5 Double click on the icon on the Windows Desktop screen.

6 Locate the power button on the technician side of the iTrace DAU and press once to
illuminate. The power button will flash for a few seconds while running a system test and
then turn solid green. If it continues to flash, contact Tracey Technologies as this
indicates an error code.

7 Locate the power switch on the printer (if installed) and move to the ON position.

To Power the System Off:

1 Exit the iTrace program by repeat clicking button on the lower right corner of
the iTrace screen until you get to the main menu screen, then click button.
Confirm Yes to exit the program.

2 Remove and safely store any CD's from the computer

3 Click the button and select from the menu and

option in the pop-up window. The computer now will shut down.

4 Push the green power button on the iTrace DAU one time to de-illuminate.
5 If using a surge protector, place the surge protector power switch in the OFF position.

22
Chapter 4 New and Existing Patients

You will need to add all patients as new the first time they are examined. Once their patient
information has been entered, you will only need to select the patient's name from the patient
directory. To proceed with an exam, go to the Patient Exam List by double clicking on the
patient’s name or select the patient’s name and click “Select Patient”. From the Patient
Exam List, click “New WF Exam” or “New CT Exam” to begin the exam process covered in
Chapter 5.

23
 New and Existing Patients

Key Features

1 Patient Directory displays patient personal information from a database. Initially,

this area will contain no data until either a database file containing information is
selected or a new database file is created and new patients are added to it.

2 Column Search Fields allow search by column. Typing data in these fields will
get the corresponding data column in the Patient Directory searched. Clicking on a
column header (12) will sort the Patient Directory listing by that column.

3 New Patient adds new patients to the current database.

4 Select Patient brings up exam data of a highlighted patient entry in the Patient
Directory. Double clicking an entry in the Patient Directory will achieve the same
result.

5 Edit Patient brings up the patient data of a highlighted patient entry in the Patient
Directory.

6 Delete Patient allows deletion of highlighted patient entry.

7 Import Patient enables patient data and associated exam data to be imported from
other databases.

8 Export Patient enables patient data and associated exam data to be exported to
another iTrace database.

9 Settings shows the current preference settings. Initially it uses the default preferred
default values. Preferences can be edited and saved in this window.

10 Activation opens the software activation window displaying the current iTrace
software license type activated on the computer. It also enables the user to activate
additional features and functionality to the iTrace software though the license activation
codes obtained from Tracey Technologies.

11 Check will assist you with a quick check of the calibration of your iTrace DAU.

12 Exit will close and exit the iTrace program.

13 Sort indicator ascending or descending. Click on column header allow you to

switch the current sort order
24
 New and Existing Patients

To Add New Patient

1. Click on the button next to the Patient Directory.

2. Enter the patient's personal data. Use Tab key to advance to next field, Shift + Tab key
sequence to get to previous field. It is required that Last name, First name, DOB and
gender are entered for a new patient. Unspecified is available for calibration objects
or other tests where gender is not specified. Other data fields are optional.

Click on the drop down list arrow in Group field to select list of previously entered
data.

Enter OD and OS manifest refraction and keratometry data if desired by clicking on

the appropriate OD or OS Data buttons.

3. Click OK to save.

25
 New and Existing Patients

To Edit Patient’s Data

1. Select a patient.

2. Click .

3. Modify the Patient’s Data, with the exception of the name fields, DOB or sex.

4. Click OK to save.

To Delete A Patient
1. Select one patient or multiple patients by holding the Ctrl button while selecting each
patient.

2. Click then select “Delete” option

3. Confirm the requested action.

26
 New and Existing Patients

4. If you answer Yes, a second

warning window appears letting
you know that this action is
permanent. Answering Yes again to
this second warning will
permanently delete your selected
patient data from the database.

To Export Patient’ Data

1. Select one patient or multiple patients by holding the Ctrl button while selecting each
patient.

2. Click .

3. Patient’s data is exported to the Export file under the Tracey directory of the
computer’s hard drive. A compressed file has been created for each patient selected
that can be copied to an external storage device, stored to a network and imported to
another computer running iTrace software, or it can be emailed to import to another
computer.

To Import Patient’ Data

1. Click .

2. Locate patient’s .zip file in the list.

3. Select patient’s .zip file name and click Open.

The patient is added to the database.

27
 New and Existing Patients

To Select or Change the Storage Location for Your Patient Data

By default, your patient data is stored in a Microsoft Jet database that is located in a folder
titled Data within the Tracey folder of your computer’s hard drive. You have the option of
creating a network accessible database folder with the iTrace 4.1 software. Storing your
patient data on a network accessible drive will allow you and others to view the data from
any computer on the network that is running the iTrace 4.1 software. You can also create
multiple databases. To change the location of your database or create a new database, follow
these steps:

1. Click CTRL + D . The following dialog box will appear.

2. Click the radial button

labeled “Microsoft Jet”

3. In the box, type in the

location of the database or
click Browse… to locate
and select it.

4. Click OK. The iTrace

software will store your patient data in this new database until you return to this
screen and select another database.

Note: Please consult with your network administrator before creating a database on a network
drive. It is the user’s responsibility to ensure the integrity of their data on a network.

To View Patient Data from Version 3 and Earlier

If you have patient data captured in previous versions of the iTrace software, you can open
these databases as read-only to view the data displays. To open databases from version 3.x
and earlier:

1. Click CTRL + D . The following dialog box will appear.

2. Select “Microsoft Jet used

in iTrace version 3 and
earlier (read-only mode)

3. In the box, type in the

location of the database (an
*.mdb file) or click
Browse… to locate and
select it.

28
 New and Existing Patients

4. Click OK. The older patient list will appear. WF and CT

acquisition will not be accessible but you will be allowed to view exams.

Note: MySQL is not typically installed on your iTrace. It is available for practices that
may require a SQL-based database for networking or EMR compatibility. Selecting
MySQL when it is not installed will result an error message and you will need to
click CTRL + D again to switch back to Jet.

To Perform a Quick Calibration Check

You can quickly check the calibration of your iTrace by click the button on the
Patient List screen. If you require a documented record of the calibration of your iTrace, for
example if the practice is participating in a clinical study, please see Appendix D for detailed
instructions.

1. Click Check . The following dialog

box will appear.

2. The center hole of the iTrace’s

Placido disk is threaded for the use of
the calibration verification tool – a
cylindrical object that shipped with
your iTrace DAU. Insert the
calibration verification tool into the
center hole and turn right to slightly tighten. and click Yes.

3. The software will automatically capture the exam and provide a window indicating if
the calibration was within the accepted range. If the window indicates the test Failed,
please contact Tracey customer support at (281) 445-1666 or via email to
[email protected].

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 New and Existing Patients

To Search for a Patient

1. Search for an existing patient in the Patient Directory listing by using the scroll bar or
by using the Column Search Fields. The program will try to match the entered criteria
and then display the result in the corresponding Parent Directory column. For
example, typing a “b” in the First Name column search field will yield a list of
patients that have first name starting with a letter “b”.

The Patient Directory list will be empty if there is no match for the entered criteria.
Delete the search field criteria will get the Patient Directory list original data back.
Click on the drop down list arrows will get lists of unique column values.

2. Patients may be sorted by a specific field by clicking on the column header. For
example, clicking on First Name will sort the patient list alphabetically (A-Z) in
ascending order. If the list is already in ascending order then it will sort by
descending order. The S or T symbol on the column header indicates ascending or
descending order.

30
 New and Existing Patients

To Edit Settings
User preferences for the iTrace software are set and saved in the Settings dialog. To set or edit
the user preferences:

1. Click on button.

• The Sph-Cyl-Axis box allows the user to select

preferences for refraction, multi-zone refraction
and multi-zone Zernike analysis.

• The Acquisition box controls the properties of

the fixation target (Badal Optometer) that the
patient views during an examination. When
Enable autofixation field is checked the
optometer is set to +6.5 D and 20 pre-exam
laser spots are projected through the entrance
pupil. This data is then used to calculate the
patient’s spherical equivalent. The fixation
target is moved to the patient’s far point
(spherical equivalent plus ½ the cylinder) for
the patient to view during the examination. If Enable fogging field is checked then
the target is moved an additional 1D in the plus direction prior to capturing the exam
data. Fogging can only be enabled if auto-fixation is enabled. It is recommended
that both of these boxes be checked.

The Manual scan diameter box sets the iTrace to scan at this setting when it is in
manual acquisition mode.

Selecting Show animated scanning after new exam is taken will instruct the software
to animate the scan points in the WF Verifiation display.

• The Date format box enables you to select the date format you prefer to enter and
display.

2. Select OK to save your changes.

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 New and Existing Patients

To Activate Software
The iTrace 4.1 software is tiered to include basic functionality with the ability to purchase
additional features. The Software Activation window unlocks the features according to the
software license purchased. Upon initial installation, the user will need to activate the software
by clicking Activation. Subsequently, if the user purchases additional software upgrades, the
features can be unlocked by clicking Activation. The user can also verify the currently activated
software license by clicking Activation.

1. Click on button.

2. The Software Activation dialog box

appears. To change the license type,
click on Change license type… The
Software Activation key entry box will
open. Alternatively, to exit, click on
Close.

3. To change the license type, you

must obtain a software
activation key code from
Tracey Technologies customer
service. To do so call 1-281-
445-1666 or email
[email protected]. You
will need to provide the
customer service representative
with the Hardware ID code from the Software Activation dialog box. The Hardware
ID code consists of four sets of five alpha-numeric characters. You will then receive
the software activation key, which is different string of four sets of five alpha-
numeric characters. You will enter the string in the space provided and click OK.

32
Chapter 5 The Examination Process

To proceed with the exam process from the Patient Directory, go to the Patient Exam List by
double clicking on the patient’s name or select the patient’s name and click “Select Patient”.
From the Patient Exam List, click “New WF Exam” or “New CT Exam” to begin the steps to
follow.
Capturing a Wavefront Exam
1. Position the patient in front of the iTrace unit with chin
and forehead resting against the chin and headrest. Adjust
the chinrest height so that the patient’s forehead is
pressed against the chin rest strap by twisting the chinrest
knob. The motorized table may also be adjusted up or
down for patient comfort.

Patient positioning is critical for accurate examination. It may be helpful to turn the
patient’s head so that the cone of the unit can move inside the plane of the patient’s
nose. Ask the patient to look through the DAU, keeping teeth together. The eye not
undergoing testing should be covered with an occluder. If the optometer is not being
used and the cap covering the line-of-sight is removed, ask the patient to fixate on a
distant target while looking through the viewing path of the DAU. Do not block the
patient's view, as this may promote accommodation and result in inaccurate
refractive measurements.

2. The ideal room condition for acquiring an image with a larger pupil is a dark
room. The pupil must be at least 2.5 mm to acquire an image. Pharmacologically
dilating the pupil removes the patient's ability to accommodate but may inhibit the
ability to accurately determine the difference between day and night vision. Dilation
may alter lenticular aberration and thus alter refraction measurements. Pupil dilation
using drops is the physician's prerogative based on the information needed. Exams
may be conducted with various levels of lighting to analyze the patient's vision
under different conditions.

Focusing and Processing

1. The iTrace automatically determines which eye is being examined - OD or OS.

2. The iTrace automatically detects the edge of the pupil and sizes the scan
pattern automatically. There are two possible capture modes available to the
examiner:

3. Auto Capture mode (this is the default acquisition mode): This mode should be used
on most patients to assure accurate measurement. The system will capture the scan
only when the laser axis is centered on the pupil.

33
 The Examining Process

a. Position the white cross hair slightly off-center in the entrance pupil.

b. Simultaneously, move the DAU in and out to bring the patient's iris details into
focus. You will notice (4) white dots in the center of the pupil. The system is in
focus when the iris details are crisp and clear. (Fig. 5-1) If for any reason the iris
details are not clear, use the four white dots to focus. The scan will be focused
when the four white dots are crisp and clear.

Figure 5-1 DAU focused, not centered

c. A green pupil outline will automatically appear and outline the entrance pupil
when the eye is nearly aligned. An additional green line to the center of the pupil
image will aid in alignment. Center the cross hair on the pupil center as indicated
by the green line, which will collapse upon proper centering (Fig. 5.2). The
iTrace will automatically capture the initial refraction, and then the video will go
blank for a few seconds. When the video image returns, align once again and the
iTrace will capture the 256-point scan.

34
 The Examining Process

Figure 5-2 DAU focused and centered

4. Semi-Automatic mode with or without Auto-Capture (Press the Enter key): May be
used when the examiner desires to control the size of the scan pattern, yet still have the
system auto-capture only when the patient is fixating and the pupil is well centered.
The system will only auto-capture if the pupil size is larger than the scan size.

a. If Auto-fixation is enabled, align and center on the eye and allow the unit to
make the initial quick refraction capture. The screen will go blank after the
capture. When the video image returns, press the Enter key to display the scan
pattern. If Auto-fixation has been disabled in your Preferences, you may press
the Enter key prior to beginning the scan. Adjust the diameter of the laser
points array larger or smaller using the up (increases the diameter) and down
(decreases the diameter) arrows on the keyboard.

b. Simultaneously, move the DAU in and out to focus patient's iris details. The
system is in focus when the iris details are crisp and clear (Fig. 5-2).

c. Center the white cross hair in the entrance pupil

d. The system will auto capture the scan when the eye is properly aligned. If the
auto-capture does not occur, simply align and focus as best as possible, and
press the joystick button to capture the scan. The scan array will remain in
view as long as the eye/patient is in proper alignment. The iTrace will
automatically capture the exam and present the Points Display for your
verification. Verification is necessary before saving any acquired exam data.

35
 The Examining Process

Figure 5-3 Captured eye image w/scan pattern

Verifying a WF Exam

36
 The Examining Process

Summary Data Screen

The patient data screen displays exam date and time,
location, physician and operator detail filled in at the
time of patient examination, the limbus diameter (as
drawn by the operator), the pupil diameter (best fit
circle to actual pupil shape), the scan diameter
(distance from center of laser spot on one side to the center of laser spot on the opposing side)
that is always less than the pupil size, and the fixation target position (far point +1D with
fogging).

The top left corner of the screen lists the name of the display, the
point that is displaying, and the number of points rejected or
missing (if any.) The rejected number of points is shown in Yellow
(caution) for 1 to 10 points rejected.

The color Red indicates that the data acquired is compromised and
the exam should be repeated because there are more than 10
rejected points.

Exams with more than 10 data points rejected should only be saved if this is the only data
possible. The data should be considered compromised and used only for diagnostic purposes; no
surgery plans should be made from this data.

NOTE: Patients with cataracts, scars or other vision obstacles may be measured with
missing data points. The missing data points will indicate size and location of the
impairment. The Retinal Spot Diagram and Point Spread Function displays will
provide representation of light/images focusing on the retina around the
cataract/scar.

Refraction Data Screen

The Auto Refraction number, in green, is derived from

the 4mm scan diameter (or the largest scan diameter if
scan diameter is less than 4 mm). The sphere and
cylinder are rounded to 1/8 D. Below the Auto
Refraction number is the multi-zone analysis. These
zone values can be changed in the Settings
option on the main menu.

37
 The Examining Process

Root Mean Square

The summary of the Combined Zernike RMS data
determined at the full scan size. By Combined RMS
Terms, we mean that for example the coma value is
composed of both vertical and horizontal 3rd order
coma as well as other higher order coma terms,
therefore, it is measure of the total coma aberrations
in the eye. Please note in the shown RMS window
that adding Low Order Aberrations to High
Order Aberrations does not equal the Total.

You must square the LOA term, square the HOA term, add them together and then take the
square root to get the Total value.

(3.468)2 + (0.165)2 = 12.054

√12.054 = 3.472

This math is used for combining Zernike terms, whether two as above or 21 HOA terms to
obtain the HOA value of 0.165 μm.

RSD Display

The RSD (Retinal Spot Diagram) is

shown at bottom left of screen. This

image showed a good data acquisition.

38
 The Examining Process

A RSD with severely skewed points

may indicate an error in the scan

and the exam should be retaken to

confirm the analysis.

HPP and VPP Displays

Verify the signals. The top display is the Horizontal

Point Profile, and the lower shows the Vertical Point
Profile. These show the position of the spot that was
reflected from the retina, by finding the center of each
profile in the X & Y planes, we can determine the
location of each individual spot on the retina. Viewing
each successive point using the or buttons on the
right of the Vertical Point Profile display will allow
you to verify the quality of the captured laser signals
for any exam.

39
 The Examining Process

Data Tool Bar

Using or button to move backward or forward through the signals. The

message box in the upper left corner indicates the current point number and the point locating
cross hair cursor in the Eye Image display also will highlight the current point on the pupil. Bad
points may be deleted at the user's discretion by clicking on the Delete button for each point
you feel may be inaccurate.

NOTE: The iTrace generates two sequential sets of 128 points each for capture. The 1 and 2
buttons let you select and switch between the first and second set of points. It is
important to verify and assess the quality and signal strength of each point acquired in
BOTH sets of points prior to saving any exam data.

40
 The Examining Process

Saving the Exam

1. Click button to save the

exam.
2. Enter exam details as desired.
3. Click OK button.

Note: The exam is not saved until this process is complete. The Save Exam button will
continue to be red until the save process is complete at which time the Save Exam
button will be grayed out.

Retaking the Exam

▪ If it is necessary to retake the exam without saving, click the button

▪ Warning box will appear to verify this selection. Answer Yes will return you to the patient
directory to retake the exam. A No will return you to the exam display.

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 The Examining Process

Taking a CT Exam

• The patient should be positioned in the same manner as for a wavefront exam, forehead
against the headrest, chin in the chinrest, and head turned in the direction away from the
eye to be examined.

• Select the patient from the data base and click the New CT button

• The iTrace automatically detects OD or OS.

• A video image will appear on the computer screen, showing the eye, the rings and the
central target. Using the joy stick, center the middle ring in the crosshairs and then move
the DAU in or out until the white spot crosses the center of the middle ring and crosshairs.
As it gets close, the white spot will turn red. The iTrace will automatically acquire the
exam when the middle ring and target are centered and the now red spot slowly crosses
this area.

• The CT Verification Display will appear after the exam is acquired. You need only to
review that the software has correctly detected the edges of the rings. There is no option
to edit this information; instead the operator would just retake the exam.

42
 The Examining Process

• If the edge detection was done without error, click on the save exam button and enter any
exam comment, then click OK to save.

43
Chapter 6 Patient Exam Review

This chapter explains how to select and display patient exams, the main features of WF and CT
exam displays and the right mouse click Option Menus that are available for them. This chapter
describes the features and functionality available in both the Basic and Premium iTrace software
versions. Features available only in the Premium version will be denoted with asterisks (*).

To View a Patient’s exams

1. Highlight a patient in the Patient Directory list.

2. Click “Select” or double-click on the highlighted patient.

3. The patient exams record is then displayed.

Exams are broken down by eye (OD/OS), exam type (WF/CT), and then listed sequentially by
exam # with the date, time, mode, clinic, physician, operator, Pre/Post, series #, and Note.

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 Patient Exam Review

To Select a WF or CT Exam
1. Select a WF or CT exam by left mouse click on the exam.

2. Click on button to view the exam. Double clicking on an exam will

achieve the same result.

To Display a Multi-Exam*
1. A multi-exam selection is valid only for WF exams and for a single eye instance (OD
or OS) at a time, and only with the Premium software version.

2. To prepare for a multi-exam viewing, exams first have to be assigned a numerical

order. This order is shown under the column named Series. By default, every exam is
assigned the same order number zero until the user manually changes it.

3. To assign a numerical order, select a WF exam. Click on .

4. A WF Exam Data screen will appear. Use the drop

down list in the Series field to assign a numerical order.
Repeat for other exams.

5. On the patient exams record display, select all the exams in a series by select the first
exam in order, and then hold down the Shift key and select the last exam. Another
way to select is to single left mouse click on each individual exam. To deselect a
selection, hold down Ctrl key and left mouse click on it.

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 Patient Exam Review

6. Click on the button to show a multi-exam summary display.

Key Features:
• Show maps that graph exam data points from the chosen series. Each map graphs data
based on its own criteria. The Sph Eq-Sph-Cyl map show data gradation between
exams for spherical and cylinder. The RMS map shows data from Total, Low Order,
and High Order RMS. The third map shows the data from min, max, and center
Refraction. The fourth map is the standard Refraction map.
1. Right mouse click on any display will open an options menu that allows some
customization to these displays. Not all options are available in all the displays.
One notable option is the Difference function, which will graph the data
differences from the first to the last exam in the series.

Difference
function on

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 Patient Exam Review

2. to print the current screen.

save the current screen to BMP file.

Multi-Exam Options Menu Navigation

This menu is activated by a right mouse click on any display. Not all options are
available to all displays. Some options will apply only to specific display type. Please
refer to Appendix B for display type descriptions.

Series # 1|2|3|…

Zone Size 2mm | 3mm | 4mm | …

Aberrations Piston | Tilt | Total | LO Total | Defocus | Astigmatism | HO Total |

Coma | Trefoil | Spherical | Mixed Astigmatism | Other…

Difference

Spot Size

Step Size .25 | .50 | .75 | 1.00 | … | Auto

To Display an Average of Multiple Exams*

1. A multi-exam average is valid only for WF exams and for a single eye instance (OD
or OS) at a time, and only with the Premium software version.

2. To prepare for a multi-exam viewing, exams first have to be assigned the same serial
number. This order is shown under the column named Series. By default, every exam
is assigned the same order number zero until the user manually changes it, so unless
the user has changed the series number, the following 2 steps will not be necessary.

3. To assign a numerical order, select a WF exam. Click on .

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 Patient Exam Review

4. A WF Exam Data screen will appear. Use the drop

down list in the Series field to assign the series number
of 0. Repeat for other exams.

5. On the patient exams record display, select all the exams in a series by select the first
exam in order, and then hold down the Shift key and select the last exam. Another
way to select is to single left mouse click on each individual exam. To deselect a
selection, hold down Ctrl key and left mouse click on it.

6. Click on the button to show an averaged summary display for multiple

exams.
7. The WF Verification Display will not show an eye image or the points profile displays
because the software is averaging multiple exams.

8. To save the Averaged Exam in the database, click on the button. The
Exam Note field will automatically populate with “Averaged Exam”.

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 Patient Exam Review

To View Tracey VFA Summary Display

• From the Patient Exam list, select an OD exam, and then select an OS exam. Click
on View button to see the Tracey VFA Summary Display.

Key Features:

• The VFA Summary Display (VFA) is an all-inclusive display that presents both eyes
side-by-side. The default maps shown for each eye are: Wavefront Map HO Total, PSF
HO Total and Simulated Snellen Letter HO Total. The Options Menu is available with a
right mouse click on the wavefront maps. Unlike other WF Summary screens, changes
made to the VFA Summary display will be saved as the default display. The VFA
Summary also provides exam data, auto-refraction, multi-zone refraction, RMS summary
data and Potential Visual Complaints for each eye. Potential Visual Complaints are
visual complaints commonly noted with particular HO Aberrations. The iTrace software
compares the RMS values for the patient and ranks the potential visual complaints using
a “+” sign or signs. The VFA Summary Display is also available from the WF Summary
displays by clicking the VFA button as detailed in following sections.

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 Patient Exam Review

To View WF and CT Summary*

▪ Select a WF exam and a CT exam for the same eye, click on View button and you will
transfer to the combined WF and CT Summary display*.

Key Features:
• The lower right corner displays the topography map of the cornea. The lower left
map shows the wavefront map of the cornea. The upper right map is the total
wavefront analysis of the eye, obtained during the iTrace scan. In the upper left
corner is the Wavefront Internal Optics map, created by subtracting the corneal
wavefront data acquired with the Vista corneal topographer from the wavefront data
of the entire eye. This correlates primarily to the aberrations of the lens. Right
clicking these displays brings up the options menu for that display. Please note that
all wavefront maps are displayed with the Defocus terms removed, showing a
wavefront with low order astigmatism and all higher order aberrations.

1. to print the current screen.

save the current screen to BMP file.

to view the Customizable WF and CT Summary Display.

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 Patient Exam Review

WF Verification Display

Key Features:
1. The WF Verification Display (Points) is the default first screen when a WF exam is
selected. Four default maps are shown on that screen; Eye Image, Retinal Spot
Diagram, Horizontal Point Profile, and Vertical Point Profile. Options Menu is
available with a right mouse click on any displays.

2.

to print the current screen.

save the current screen to BMP file.

switch between first and second set of data points.

advance to previous or next point. The current point is displayed in the upper
left corner of the display.

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 Patient Exam Review

accept current point.

delete current point.

3. Click on a point on the Eye Image

Reference Explanation
display or drag the
#. ## mm Radial distance (mm) from center to the
cursor to a point in the
point of interest
pupil to see
measurements in the upper right ##° The axis at the point of interest
corner of the display.

4. Click on the buttons to zoom in or out or to change the step size of the
opacity map. The buttons are used to change the middle value of the scale of
the opacity map display.

WF Verification Options Menu Navigation

This menu is activated by a right mouse click on either the eye image or the RSD display
panels. Please refer to Appendix B for display type descriptions.

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 Patient Exam Review

WF or CT Verification Options Menu – Editing Pupil and

Limbus
The iTrace 4.1 software enables the user to edit the pupil and the limbus line, thereby
obtaining a pupil or limbus (white-to-white) diameter. Generally, the iTrace software
will locate the pupil during a WF exam. This is not the case for a CT exam. To edit the
pupil or limbus, please follow these steps:

1. Within either the WF Verification Display (Points) or the CT Verification Display

(Rings), right mouse click on the eye image panel and select “Edit pupil and limbus”.

2. The Edit Pupil and Limbus screen will appear. To edit the pupil, click on the radial
button next to “Pupil” and then the radial button next to “Manual” to manually edit
the pupil line.

3. Click and hold the left mouse button on the edge of the pupil image and slowly drag
the mouse across the image while holding down the mouse button. A green circle
will appear. Continue to drag until the circle fits the pupil and release the mouse
button.

4. To return to the pupil line originally obtained by the iTrace software at exam capture,
click on the radial button labeled “Original”. The software can also recalculate the
pupil line. To do so, click on the radial button labeled “Auto”.

5. To edit and calculate the limbus diameter, click on the radial button labeled
“Limbus”.

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 Patient Exam Review

6. Click and hold the left mouse button on the edge of the limbus image and slowly drag
the mouse across the image while holding down the mouse button. A blue circle will
appear. Continue to drag until the circle fits the limbus and release the mouse button.
The limbus line will likely overlap the lids. The limbus diameter provided is only a
close approximation of the actual limbus diameter.

7. To remove the limbus line, select the radial button labeled “No limbus”.

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 Patient Exam Review

WF Summary Displays
There are 5 WF Summary displays. Four displays are pre-configured. While changes
can be made on these displays using the Options Menu, each time you exit from these
displays and return the default options will reappear. These displays are:

VFA Summary will be extremely useful as the screen that summarizes the
patient’s visual function. This screen is detailed in the next section of this manual.

UCVA/BCVA is preset to Refraction maps and PSF maps with Total (UCVA)
and High Order Total (BCVA) aberrations.

WF/RMS is preset to Wavefront maps with Total, HO Total and LO Total

aberrations and an RMS Total map.

Ref/WF is preset to Refraction maps and Wavefront maps with Total and HO
Total aberrations.

• The remaining WF Summary display (Custom*) may be customized by the user. It

is preset when the software is installed, but if changes are made via the right-mouse-
click Options Menu, these changes are saved (i.e, after changing exams or exiting
the software) until subsequent changes are made via the Options Menu.

Key Features:

1. Some displays have adjustable zoom buttons to enlarge or decrease the display
or to increase or decrease the scale step size.

2. Some displays have adjustable buttons to increase or decrease the scale level.

3. Some displays have a Zone Selection* bar to increase or

decrease the zone size displayed.

4. Default display method for most displays is 2D. You can change to 3D display* by
right mouse click on a display to bring up the Options Menu and select 3D. While the
display is in 3D mode, you can rotate the display to any viewing angle by holding
down the left mouse button and the drag the mouse in any directions.

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 Patient Exam Review

WF Summary Options Menu Navigation

This menu option is available in the summary displays. The options will vary depending
on the display type selected. Use a right mouse click on any display to show this menu.
The options not available with your software version will be grayed out. Please refer to
Appendix B for display type descriptions.

Wavefront map
Refraction map
Point Spread function
Selection denoted by
red circle ( ) Modulation Transfer function*
Snellen Letter*
Encircled Energy Function*
Root Mean Square
Annular / Zonal Refraction*
Selection denoted by 3D*
green check circle ( ) Large window
Zone size 2.0 mm – 10.0 mm* | Other*
Aberrations Piston
Tilt
Total
LO Total
Defocus*
Astigmatism*
HO Total
Coma*
Trefoil*
Spherical*
Mixed Astigmatism*
Other*
Show Map
Show Numbers
Show Eye Image
Selection denoted by Show Pupil
green check ( ) Show Corneal Vertex
Show Limbus
Translucent Map
Show Solid Surface* (when in 3D display)
Show Wire Mesh* (when in 3D display)
Letter Size* (Snellen Letter) 20/200, 20/100, … 20/20
Map Step Size .25 D, .50 D, .75 D… 2.00 D | Auto
Map Colors Colors 1, Colors 2, or Custom
Selection denoted by
green check ( ) Show 50% Energy Circle* (when viewing PSF)
Combined (when viewing RMS)
Selection denoted by Circle Round Maximum(when viewing Encircled Energy Function)
red circle ( ) Circle Round Centroid (when viewing Encircled Energy Function)
Save Zernike Coefficients
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 Patient Exam Review

VFA Summary Display

Key Features:

• The VFA Summary Display (VFA) is an all-inclusive display that presents both eyes
side-by-side. The default maps shown for each eye are: Wavefront Map HO Total, PSF
HO Total and Simulated Snellen Letter HO Total. The Options Menu is available with
a right mouse click on the wavefront maps. Unlike other WF Summary screens,
changes made to the VFA Summary display will be saved as the default display. The
VFA Summary also provides exam data, auto-refraction, multi-zone refraction, RMS
summary data and Potential Visual Complaints for each eye. Potential Visual
Complaints are visual complaints commonly noted with particular HO Aberrations.
The iTrace software compares the RMS values for the patient and ranks the potential
visual complaints using a “+” sign or signs.

1. To view the VFA Summary Display,

click in the WF Displays to
get Select a second WF exam screen.
Choose another exam and click OK.

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 Patient Exam Review

2. The VFA Summary Display is also available from the exam

list screen when you select an OD and OS exam and click the View button.

3. The VFA Summary Display appears.

4. to print the current screen.

to save the current screen to BMP file.

WF Comparison Display

Key Features:

• The Comparison Display shows the differences of same-eye data between 2 exams. The
upper right display shows the data from the first exam. The lower right display shows
the second exam data. The left-middle display is a map of the point-by-point difference
between the first and second exams. The Comparison Display is commonly used to
display the surgical effect between pre-op and post-op exams. You can use the Options
Menu to select other available methods and features for use in the comparison.
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 Patient Exam Review

1. Click button in WF Verification

Display or WF Summary Display to get
Select a second WF exam screen,
choose another exam and click OK.

CT Verification Display

The CT Verification Display (Rings) view is the default display. The user should examine the
edge detection analysis preformed by the software (red and yellow dots along alternating edges of
the rings) to be certain no gross errors occurred (cross over of one color to the other side of the
ring, missing ring edge detection, detection of non-ring edges, etc). If errors have occurred, the
exam should be repeated.

59
 Patient Exam Review

Summary Data
The patient data screen displays exam date and
time, location, physician and operator detail filled
in at the time of patient examination, the white-to-
white limbus diameter (as drawn by the operator,
the best fit circle to actual limbus shape), and the pupil diameter (as drawn by the operator, the
best fit circle to actual pupil shape).

Refractive Power Data

The refractive power data is the refractive power

over the entire area of the cornea within the central
3.00 mm zone. The box displays the steep and flat
axis and meridian, the astigmatism and overall
effective refractive power. The Refractive Power offers a better representation of those corneas
that may be steeper or flatter centrally versus at the 3 mm periphery.

Simulated Keratometry Data

The Simulated Keratometry data provides the
videokeratographic simulation of keratometry.
Mimicking an auto-keratometer, the keratometry
data is obtained at a 1.5 mm radius from the
corneal vertex. The steep, flat, and delta K with axes are displayed, along with the average K
reading.

Corneal Indices Panel

This panel includes the Central Radius/Power
measurement, the Best Fit Sphere and Conicoid,
the Q and E values, the Corneal Spherical
Aberration at the 6.00 mm zone and the I-S Axial
Power at 6.00 mm. If the central corneal power is above 47.2 D and the I-S Axial Power is above
1.4, the software will display the “Suspect Keratoconus” message, as shown here. These
thresholds are based on the Rabinowitz Keratoconus test. The message will only appear if both
thresholds are met. However, a patient could be diagnosed with keratoconus after only exhibiting
one of these parameters. Other testing should be completed before making a final diagnosis.

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 Patient Exam Review

CT Verification Options Menu Navigation

This options menu is available by right mouse click action on the display.

Show Rings
Show Pupil
Show Limbus
Edit pupil, limbus and rings

CT Summary Display

The CT Summary Display buttons offer the same features as on WF Verification Display. There
are 3 pre-configured summary views. Although you may change features using the Options Menu
while viewing a display, each time you open these pre-configured summary displays, the same
default settings will be shown. These displays are:

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 Patient Exam Review

CT Sum is preset with Axial, Local ROC, Z Elevation

with 3D display method, and Refraction maps

Local ROC is preset with large size Local ROC map.

3D Z-Elev is presets with a large 3D Z Elevation map.

You can save customized display settings by using the Custom button. Changes made to the
Custom Display will be saved until changed again. Click on Compare button to view the CT
Comparison Display.

CT Summary Options Menu Navigation

This option is active through a right mouse click on any display. The options available are
dependent upon the display type selected or software versions. If an option is not available with
your version of the software, it will be grayed out. Please refer to Appendix B for display type
descriptions.
Eye Image
Axial Map
Local ROC Map
Selection denoted by
red circle ( ) Refractive Map
Z Elevation Map
Wavefront Map
Root Mean Square
Selection denoted by 3D*
green check ( ) Large window

Selection denoted by Diopters

red circle ( ) Millimeters
Show Map
Show Numbers
Selection denoted by
Show Eye Image
green check ( )
Show Pupil
Show Limbus
Translucent Map
Map Middle Value Fixed, Auto
Map Step Size .25 D, .50 D, .75 D… 2.00 D | Auto
Map Colors Colors 1, Colors 2, or Custom
Reference Surface Best fit sphere
(when viewing Z Elevation) Best fit conicoid
User defined conicoid…

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 Patient Exam Review

CT Comparison Display

The Compare button allows you to select another CT exam to view differences between 2 exams.
Right clicking on any one of the three maps will bring up the Options Menu which allows you to
change the display type and certain features of the display. Changes to one map will affect all
three maps simultaneously.

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 Patient Exam Review

OD/OS CT Summary Display

Much like the VFA WF Summary, the OD/OS button allows you to select a fellow eye’s CT
exam to view 2 eyes simulataneously. Right clicking on any one of the three maps will bring up
the Options Menu which allows you to change the display type and certain features of the display.

64
APPENDIX A Technical Information

Map Layers Options

Show Map
Displays the color map in according to the default map type or the selected map type.

Show Numbers
Displays an overlay of numeric values placed radially across the entrance pupil or cornea.

Show Eye Image

Digital image of the eye placed behind the display for reference.

Show Pupil
Displays the green pupil line as it was recognized automatically during the exam process, as
it was determined automatically by the software, or as it was edited by the user.

Show Limbus
Displays the blue limbal line as it was edited by the user.

Translucent Map
Sets the map layer to appear translucent so as to enable the user to view the eye image
behind it.

Display Types
Wavefront Map: The wavefront map displays in color format the defects in optical
systems that prevent light from focusing to a compact spot on the macular region of the
retina. Where the patient's wavefront matches the perfect wavefront plane, the map color is
green. Where warmer colors are shown, the patient's wavefront is accelerated in front of the
perfect wavefront plane, and conversely, the cooler colors display where the patient's
wavefront is retarded behind the perfect wavefront plane. This display is essentially a more
advanced description of the eye's refractive error. Aberrations are measured as the
wavefront deviation, in microns, of the distance a patient's wavefront differs when compared
to a perfect wavefront plane.

Refraction Map: This map displays the refractive power span of the patient's eye in
dioptric power. Emmetropia would appear green, with warmer colors indicating increasing
myopia, and cooler colors displaying hyperopic refraction.

Point Spread Function Map: This map shows the optical image seen on the retina
created when a point source of light is viewed by the patient. For example, when looking at
a star, (point target at optical infinity), the PSF will show what that star will look like on the
retina. In other words, what the star looks like to the patient. The ideal PSF would be a
sharp point of light on the retina.

65
Modulation Transfer Function Map: This map displays the optical frequency
resolving quality of an optical system, and is the inverse of the Point Spread Function (PSF).
It describes how objects of different spatial details are viewed by the patient's optical
system. Both MTF and PSF help to describe the overall performance of an optical system.

Snellen Letter Map: This map displays how the patient's eye views the letter "E" as it
appears on the Snellen Acuity Chart, commonly used to measure a patient's vision. Just like
the Point Spread Function map shows how a point of light at infinity is viewed by the
patient's retina, the Snellen Letter Map show us how a patient actually sees the letter "E" of
various sizes, based on the effects of visual aberrations on visual acuity.

Root Mean Square (RMS): RMS is a measure of the magnitude of an aberration. This
value has no sign and is always positive. Total RMS is the total aberration of the eye from
the perfect wavefront. You can have RMS values for each specific Zernike term or
component of the aberrations of the eye.

Axial Map: This corneal topography map displays topographic corneal curvature, with
hotter colors displaying the steeper points on the corneal surface, and cooler colors showing
the flatter areas of the cornea. Axial Maps display the curvature at a certain point on the
corneal surface in axial direction relative to the center. It requires the calculation of the
center of the image. This map is used to display the optical power of the cornea.

Local Radius of Curvature Map: Very similar to the Axial Map, this corneal
topography map displays topographic corneal curvature, with hotter colors displaying the
steeper points on the corneal surface, and cooler colors showing the flatter areas of the
cornea. The Local ROC Map measures the curvature at a certain point on the corneal
surface in meridian direction relative to the other points on the particular rings measured.
This map is used to display the shape of the cornea.

Z-Elevation Map: This map displays the difference in elevation of a point on the corneal
surface relative to the same point on a spherical reference surface. The best mathematical
approximation of the actual corneal surface called best-fit sphere (displayed in the lower
right corner of the map) is calculated by software for every point on the elevation map. The
same surface would appear different when displayed against different reference radii.

Annular/Zonal Refraction Map: The zonular analysis always measures the spherical
aberration over a zone of corneal area which always includes the center region of the
cornea. The annular analysis calculates the spherical aberration only in a series of one
millimeter annulas segments, therefore it contains only the peripheral data, and not any
central data.

Encirled Energy Function. Encircled energy is calculated by first determining the total
energy of the PSF, then determining the maximum of the PSF. Circles of increasing radius
are then created at that maximum and the PSF energy within each circle is calculated and
divided by the total energy. As the circle increases in radius, more of the PSF energy is
enclosed, until the circle is sufficiently large to completely contain all the PSF energy. The
encircled energy curve thus ranges from zero to one, or from 0 to 100 percent.
66
APPENDIX B Zernike Modes Chart

67
APPENDIX C DAU Installation Instructions
Verify your package contents
The Tracey iTrace Combo VFA system is shipped in 2 packages, one box containing the iTrace Combo head,
computer, cables, and power supplies and the second containing the Chinrest and Joystick hardware. Please inspect
each container for completeness

Top Layer Middle Layer Bottom layer

Package 1 – iTrace DAU

Cables, Software CD, calibration iTrace Combo head Laptop

verification, reading rod
Hardware Box
Package 2 –

Base Chinrest assembly Manipulator

Tracey iTrace Combo Setup

There are two components that require assembly to properly set-up your Tracey iTrace Visual Function
Analyzer DAU (Diagnostic Acquisition Unit). They are the Chinrest Assembly and the Manipulator /
Joystick Assembly.

Chinrest Assembly
The Chinrest Assembly consists of two parts: From the bottom up, they
are the Base and the Chinrest.

These two parts are assembled with the Base on the bottom, and the
chinrest on top of it, connected with two Allen screws from below the
baseplate. Before tightening the two screws, verify that the Chinrest cup
is facing outward, toward the patient side of the Base. Tighten using the
Allen screwdriver included with your shipment.

68
Place the wheels of the Manipulator / Joystick Assembly onto the rails on the Base Assembly, making
sure that the wheels are aligned properly. Place the rail covers over the wheels by sliding them in from
the outer sides, and snapping them into place.

Manipulator / Joystick Final Assembly

Mount the iTrace Combo VFA head to the manipulator / joystick
(A) using the black knurled knob (B). The knob is inserted under
the patient side of the manipulator, and is tightened clockwise to
securely mount the iTrace head facing the patient. There is a control
key which will permit the placement only in the forward-facing
position. The iTrace Head should face forward toward the chinrest,
and is kept from rotating with the locking pin (C) in the
manipulator. A B

C
Final Connections
1. Connect the OD/OS sensor’s 2. Connect the iTrace Head 3. Connect the USB cable to the
black cable on the left side of Power supply cable to the left USB port on the lower right of
the iTrace Head to the connection on the iTrace head. the iTrace head. The other end
connection on the left side of the Connect other end of Power will connect to the laptop
Manipulator / Joystick. Supply cable to a surge- computer’s USB port.
protected power outlet.

69
APPENDIX D Calibration Verification
Verify calibration of your iTrace

Tracey Technologies recommends that you check the calibration of your iTrace routinely. If
ongoing documentation of the calibration is required, please follow the steps below. If your
iTrace fails to fall within the range of acceptable values, please contact Tracey customer
support at (281) 445-1666 or via E-mail to [email protected].

If a quick check of calibration is all that your circumstances require, you can follow the steps
on page 29.

Included with your iTrace VFA Combo is a cylindrical object called the Calibration
Verification tool. Use this tool to verify the
instrument’s calibration.

1 The center hole of the iTrace’s Placido disk is

threaded for the use of the calibration
verification tool. Insert the calibration
verification tool into the center hole and turn
right to slightly tighten.

2 Power on the system and launch the software.

3 Click on the Settings button, and change Vertex Distance to 0.0, and click OK to Save.

4 Select New Patient and name the patient Calibration Test. Select the patient that you
have just created by double clicking on the patient. Select New WF.

5 When the new wavefront screen appears press the spacebar key. The iTrace will take the
first reading to adjust the optometer appropriately. Then press the ENTER key.

6 The iTrace will display a series of red dots and allow you to capture a manual scan. The
scan size is displayed in the upper left of the screen. The scan size can be increased or
decreased using the up and down arrow keys on the keyboard. If not already a 6mm, set
the scan size to 6mm and then press the spacebar key.

7 The iTrace will acquire the exam and display the Points screen. On the right side of the
Points display is the auto refraction. The Green auto refraction should read -5.00
diopters sphere. Save the exam as a permanent record of the calibration verification test.

8 Upon completion of the calibration verification process, return to the main iTrace
software screen, and click on Settings and return the Vertex distance to its original
number (typically 12mm).

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GLOSSARY

Aberration. Aberrations describe the defects in optical systems that prevent light from
focusing to a compact spot. For the eye, it is essentially a more advanced description of the
eye's refractive error. Aberrations are measured as a wavefront deviation, in microns, of the
distance from a patient's wavefront to a perfect wavefront plane. In the wavefront arena,
lower order and higher order aberrations are used to describe a patient's vision and are
arranged as 1st order, 2nd order, 3rd order, etc. Generally, the higher the order aberration, the
smaller the impact on the patient's vision.

Aberrometer. A device for measuring the spatially resolved aberrations of the eye.

Coma. Coma is an aberration of the eye due to a misalignment of one or more optical
components. For example, the lens and apertures of an optical system are usually
constructed with their centers of each optical component along the optical axis. If one of
these components is moved off center, coma is induced. A familiar clinical example is an
excimer ablation not centered on the pupil.

Conjugate points. The location of the object and its corresponding image are called
conjugate points. For example, when you focus on an object, an image is formed on your
retina. In this case, your retina and the object you are looking at conjugate points.

Encirled Energy Function. Encircled energy is calculated by first determining the total
energy of the PSF, then determining the maximum of the PSF. Circles of increasing radius
are then created at that maximum and the PSF energy within each circle is calculated and
divided by the total energy. As the circle increases in radius, more of the PSF energy is
enclosed, until the circle is sufficiently large to completely contain all the PSF energy. The
encircled energy curve thus ranges from zero to one, or from 0 to 100 percent.

Higher Order Aberration. These are all aberrations above the second order series
aberrations (3rd order aberrations, 4th order aberrations, etc.). See the Zernike Pyramid.
Higher order aberrations cannot be corrected with conventional spectacles. These are
generally increasingly smaller percentage components of a patient's total refractive
aberrations.

Lower Order Aberration. This is the second order series of the Zernike Polynomial
expansion, which is sphere, with-the-rule cylinder, and oblique cylinder. The percentage mix
between with the rule and oblique cylinder will provide the axis. Therefore, lower order
aberration is simply the sphere, cylinder, and axis refractive errors in a patient's vision.

Modulation Transfer Function (MTF). This is the inverse of the Point Spread Function
(PSF). It describes how objects of different spatial details are viewed by the optical system.
Both MTF and PSF help to describe the overall performance of an optical system.

Point Spread Function (PSF). The optical image on the retina created by an optical system
when a point source of light is viewed. For example, when looking at a star, (point target at
optical infinity), the PSF will show what that star will look like on the retina. In other words,
what the star looks like to the patient. The ideal PSF would be a sharp point of light on the
retina.
71
Root Mean Square (RMS): RMS is a measure of the magnitude of an aberration. This
value is always positive. Total RMS is the total aberration deviation of the eye from the
perfect wavefront. You can have RMS values for each specific Zernike term or component
of the aberrations of the eye.

Tilt. Tilt in the wavefront describes how the PSF is displaced from the optical axis. Tilt terms
can arise from a prismatic error in the eye.

Trefoil, Tetrafoil, Pentafoil, Hexafoil. These are higher order aberrations shaped much like
3-sided, 4-sided, 5-sided, 6-sided "potato chip" shapes.

Zernike Coefficient. Zernike is the name of a mathematician who created polynomial fitting
algorithms, which are an infinite series of orthogonal terms. This polynomial fitting routine is
mathematically the ideal analysis for evaluating the individual components of an optical
system’s aberrations. Most typically, Tracey uses 44 terms of the Zernike expansion series,
which completes through the 8th order of the Zernike polynomials.

72
Software License and Warranty Statement
1. DEFINITIONS

1.1. “Licensed Software” shall mean the Tracey-iTrace software, in machine-readable object code form,
along with any accompanying documentation, and including any Releases (as defined in Section 3.1)
thereto delivered by Tracey to Customer.

1.2. “Hardware” shall mean Tracey equipment and other hardware to be delivered pursuant to this
Agreement as set forth in Purchase Agreement. Hardware does not include PC/Laptop Computer
hardware, even when purchased through Tracey.

1.3. “iTrace System” shall mean the Tracey Visual Function Analyzer Combination Ray Tracing
Aberrometer/Topographer including the Licensed Software and the Hardware, or any component thereof,
as identified in Purchase Agreement listed below.

1.4. “PC/Laptop Computer” shall mean Tracey supplied or Customer supplied personal or laptop computer
that will run the Tracey iTrace software.

2. SOFTWARE LICENSE

Subject to the terms and conditions of this Agreement, Tracey hereby grants to Customer a nontransferable and
nonexclusive license to use the Licensed Software solely as part of the iTrace System. Customer may make
two (2), but not more than two (2) copies of the Licensed Software for archival purposes. Customer may not
de-compile, reverse engineer or otherwise attempt to derive or modify the source code of the Licensed
Software. Tracey reserves all rights and licenses not expressly granted to Customer. Title and copyrights to the
Licensed Software and any copies made by Customer remain with Tracey or it suppliers or licensers.

3. MAINTENANCE

3.1. Maintenance Services. For a period of one (1) year following the Effective Date (date of installation)
of the Agreement, Tracey shall provide Customer with the following maintenance and support services
(“Maintenance Services): (i) enhancements and modifications (“Releases”) of the Licensed Software when
made generally available to Tracey’s other Licensed Software customers; (ii) “hotline” telephone support
during Tracey’s normal business hours; (iii) updates to the documentation when made generally available
to Tracey’s other Licensed Software customers; (iv) customer bulletins; and (v) reasonable efforts at error
correction with the level of effort commensurate with the severity of the error. Customer may obtain
Maintenance Services for additional periods under a separate agreement with Tracey. Customer
understands and acknowledges that hardware upgrades may be required to utilize new Releases provided
hereunder. Customer is responsible for obtaining warranty/maintenance services on all peripheral
hardware, whether purchased from Tracey or independently.

3.2. Exclusions. Notwithstanding the foregoing, Tracey shall not be required to provide any Maintenance
Services relating to problems arising out of (i) Customer’s failure to implement all Releases and updates
to the Licensed Software, (ii) Customer’s use of the Licensed Software with Hardware not obtained from
Tracey; (iii) any alterations of or additions to the Licensed Software by parties other than Tracey; (iv) use
of the Licensed Software in a manner for which it was not designed; (v) use of the Licensed Software in a
manner or with hardware which it was not designed ; (vi) accident, negligence or misuse of the Licensed
Software; (vii) interconnection of the Licensed Software with other software products not supplied by
Tracey; (viii) inaccuracy in data entry. In addition, Tracey’s obligation to provide Maintenance Services
shall be contingent upon Customer providing Tracey reasonable access to all necessary personnel to
answer questions about any problems reported by Customer regarding the Licensed Software.

73
4. LIMITED WARRANTY
4.1. Warranty.

a. Hardware. Tracey hereby warrants that the Hardware will be free from defects in materials and
workmanship under normal use for a period of twelve (12) months from the Effective Date, or, with
respect to any repaired, reconditioned or replaced part, ninety (90) days from the date of delivery of
such to Customer.

b. Software. Tracey hereby warrants that the media or which the Licensed Software is recorded will
free from defects under normal use for a period of ninety (90) days from the date of delivery to
Customer. Customer’s and exclusive remedy, and Tracey’s sole and exclusive liability, under this
warrant will be Tracey’s replacement of the media.

4.2. Exclusions.

a. The express warranties set forth in Sections 4.1 above will not apply to defects arising out of the
causes identified in subsections 3.2(i)-(viii) above.

b. PC/Laptop Computer Hardware. The PC or Laptop Computer is not warranted by Tracey

Technologies. Customer is responsible for retaining warranty with the manufacturer of the PC or
Laptop Computer, whether purchased through Tracey Technologies or supplied by Customer.

4.3. Warranty Procedures. Customer will send Products with defects covered by the foregoing warranty to
a repair facility designated by Tracey. Customer will request authorization from Tracey prior to the return
of the Products for repair or replacement by Tracey. Upon such requests, Tracey will provide Customer
with an RMA tracer number to be prominently displayed on the shipping container for the defective
Product. Once Tracey authorizes the return of any defective Product, Customer will ship such defective
Product to the repair facility, freight prepaid, in its original shipping container. If original container is not
available, Customer must purchase shipping container from Tracey. If such defective Product is received
by Tracey during the applicable warranty period, Tracey will, at its sole option and expense, repair or
replace such Product employing at its option new or used Products to make such repair or replacement,
and will ship the repaired or replaced Product to Customer at Customer’s expense. As an alternative to
return of Products to Tracey, Tracey may, at its option dispatch an authorized technician to resolve
warranty concerns at Customer’s site. The foregoing states the sole liability and obligation of Tracey
arising out of this warranty.

4.4. Inspection and Testing Charge. In the event Tracey’s inspection and testing discloses that the returned
Product is not defective within the terms of this warranty, the Product will be subject to a one hundred
dollar ($100.00) testing charge.

4.5. Stored Data. Customer will be responsible for saving or backing up data contained in any Product
returned to Tracey for in warranty or out of warranty repairs or service. TRACEY WILL HAVE NO
RESPONSIBILITY FOR SUCH DATA AND WILL HAVE NO LIABILITY ARISING OUT OF
DAMAGE TO OR LOSS OF SUCH DATA WHILE THE PRODUCT IS IN TRACEY’S POSSESSION.

4.6. Disclaimer. EXCEPT FOR THE ABOVE EXPRESSED LIMITED WARRANTY SET FORTH IN
SECTION 4.1 ABOVE, TRACEY MAKES AND CUSTOMER RECEIVES NO WARRANTIES OR
CONDITIONS ON THE PRODUCTS, EXPRESS, IMPLIED, STATUTORY OR IN ANY OTHER
PROVISION OF THE AGREEMENT OR COMMUNICATION WITH CUSTOMER, AND TRACEY
SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OR MERCHANTABILITY, NON-
INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE. TRACEY DOES NOT
WARRANT THAT THE LICENSED SOFTWARE WILL MEET CUSTOMER’S REQUIREMENTS
OR THAT THE OPERATION OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR
ERROR FREE. CUSTOMER ASSUMES THAT RESPONSIBILITY FOR THE INSTALLATION,
USE, AND RESULTS OBTAINED FROM THE LICENSED SOFTWARE. SOME STATES DO NOT
ALLOW THE EXCLUSION OF IMPLIED WARRANTIES SO THE ABOVE EXCLUSIONS MAY
NOT APPLY TO CUSTOMER. THIS LICENSE GIVES CUSTOMER SPECIFIC LEGAL RIGHTS.
CUSTOMER MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE.

74
5. TERMINATION.

This Agreement is effective until terminated. Customer may terminate this Agreement upon notice to
Tracey at any time by removing from Customer’s system and destroying all copies of the Licensed Software.
Unauthorized copying of the Software or the accompanying documentation or otherwise failing to comply with
the terms and conditions of the Agreement will result in automatic termination of this license and will make
available to Tracey other legal remedies. Upon termination of this Agreement, the license granted herein will
terminate and Customer must immediately destroy the Licensed Software, and all copies thereof.

6. EXPORT RESTRICTION.

Customer agrees that Customer will not export or re-export the Software in any form without the
appropriate United States and foreign government licenses. Customer’s failure to comply with this provision is
a material breach of this Agreement.

7. U.S. GOVERNMENT RESTRICTED RIGHTS.

The Licensed Software is provided with RESTRICTED RIGHTS. Use, duplication or disclosure by the
Government is subject to restrictions as set forth in subparagraph (c)(1)(ii) of the Rights in Technical Data and
Computer Software clause at DFARS 252.227-7013 or in subparagraphs (c)(1) and (2) of the Commercial
Computer Software - `Restricted Rights at 48 CFR 52.227-19, as applicable. Contractor/Manufacturer is
Tracey Technologies, LLC, and 16720 Hedgecroft Drive, Suite 208, Houston, Texas 77060.

8. LIMITATION OF LIABILITY.

IN NO EVENT WILL TRACEY BE LIABLE FOR ANY LOSS OF DATA, LOST OPPORTUNITY OR
PROFITS, COST OF COVER OR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT
DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY. THIS LIMITATION WILL APPLY EVEN IF TRACEY OR AN AUTHORIZED DEALER
HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. THIS LIMITATION SHALL APPLY
NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
THIS PROVISION SHALL SURVIVE TERMINATION OF THIS AGREEMENT.

9. MISCELLANEOUS.

This is the entire agreement between the parties relating to the subject matter hereof and no waiver or
modification of the Agreement shall be valid unless in writing signed by each party. The waiver of a breach of
any term hereof shall in no way be construed as a waiver of any other term or breach hereof. If any provisions
of this Agreement shall be held by a court of competent jurisdiction to be contrary to law, the remaining
provisions of this Agreement shall remain in full force and effect. Tracey shall have no liability for its failure to
perform its obligations hereunder when due to circumstances beyond Tracey’s reasonable control. This
Agreement shall inure to the benefit of and be binding upon each party’s successors and assigns. This
Agreement is governed by the laws of the State of Texas without reference to conflict of laws principles. All
disputes arising out of this Agreement shall be subject to the exclusive jurisdiction of the State and Federal
courts located in Houston, Texas and the parties agree and submit to the personal and exclusive jurisdiction and
venue of these courts.

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For Customer Service Contact:
Customer Support : (281) 445-1666
Fax: (281) 445-3050
E-mail: [email protected]

76