iTrace Operators Manual Sw ver 5.2 Rev A

Copyright Notice Copyright © 2013, Tracey Technologies, Corp. All rights reserved. No part of this manual may be reproduced without permission from Tracey Technologies, Corp. Trademarks Microsoft and Windows are trademarks of Microsoft Corporation.

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TABLE OF CONTENTS PREFACE

6

GENERAL WARNINGS AND NOTICES IDENTIFICATION AND CERTIFICATION/PRECAUTIONARY LABELING SYMBOL LEGEND INDICATIONS FOR USE SYSTEM SPECIFICATIONS*: CHAPTER 1

GETTING STARTED

11

WELCOME NEW USER GETTING HELP WARRANTY INFORMATION

11 12 12

CHAPTER 2 GETTING TO KNOW YOUR SYSTEM DATA ACQUISITION UNIT - DAU CLEANING AND MAINTENANCE COMPUTER REQUIREMENTS DAU AND COMPUTER SETUP DATA STORAGE RECOMMENDATION CHAPTER 3

LEARNING THE BASICS

16 16 17 19 20 20 20 21 21 22 22 23 24 24 25 25

NEW AND EXISTING PATIENTS

26

KEY FEATURES TO ADD NEW PATIENT TO EDIT PATIENT’S DATA TO DELETE A PATIENT TO EXPORT PATIENT DATA TO IMPORT PATIENT DATA TO SELECT OR CHANGE THE STORAGE LOCATION FOR YOUR PATIENT DATA TO VIEW PATIENT DATA FROM VERSION 3 AND EARLIER TO PERFORM A QUICK WAVEFRONT CALIBRATION CHECK TO SEARCH FOR A PATIENT TO EDIT SETTINGS TO ACTIVATE SOFTWARE CHAPTER 5

13 13 14 14 15 15

NEW USER INSTALLATION AND TRAINING TO INSTALL YOUR ITRACE SOFTWARE SPECIAL FUNCTION KEYS TO USE THE JOYSTICK TO PRINT A SCREEN TO SAVE A DISPLAY COMMON DISPLAY OPTIONS TO VIEW ANOTHER DISPLAY TO ENLARGE A DISPLAY TO VIEW DISPLAY IN 3D TO CHANGE DISPLAY ELEMENTS TO SELECT ZONE SIZE TO COMPARE ABERRATIONS TO POWER THE SYSTEM ON TO POWER THE SYSTEM OFF: CHAPTER 4

6 7 8 10 10

THE EXAMINATION PROCESS

27 28 29 29 30 30 31 32 33 34 35 37 38

CAPTURING A WAVEFRONT EXAM Patient Positioning

38 38 3

Focusing and Processing Verifying a WF Exam Accepting or Rejecting the Exam CAPTURING A CORNEAL TOPOGRAPHY EXAM Verifying the CT Exam Accepting or Rejecting the Exam Accepting or Rejecting the Color Image CHAPTER 6

38 42 46 47 49 50 52

PATIENT EXAM REVIEW

55

TO VIEW A PATIENT’S EXAMS THE EXAM LIST SCREEN To Select Exams To Edit Exam Details To Delete an Exam EXAM SUMMARY DISPLAY NAVIGATION Task Buttons WF SUMMARY DISPLAYS WF Summary Options Menu Navigation WF VERIFICATION DISPLAY WF Verification Options Menu Navigation WF or CT Verification Options Menu – Editing Pupil, Limbus and Vertex VFA SUMMARY DISPLAY To View a VFA Summary Display WF COMPARISON DISPLAY To View the WF Comparison Display ANGLE KAPPA/ALPHA DISPLAY To View and Use the Angle Kappa and Alpha Display CORNEAL TOPOGRAPHY SUMMARY DISPLAYS CT Summary Options Menu Navigation CT VERIFICATION DISPLAY CT Verification Options Menu Navigation CT COMPARISON DISPLAY To View the CT Comparison Display OD/OS CT SUMMARY DISPLAY To View the OD/OS Display WF AND CT SUMMARY DISPLAYS To View WF & CT Summary Display WF Options Menu Navigation in the WF and CT Summary Displays Special WF & CT Summary Displays: Chang Analysis Special WF & CT Summary Displays: OU WF & CT Overview WAVETOUCH DISPLAY To View and Use the WaveTouch Display To Complete the Lens Order TORIC PLANNER To View and Use the Toric Planner - IOL To View and Use the Toric Planner – Toric IOL Enhancement To View and Use the Osher Alignment To View and Use the Zaldivar Caliper To View and Use the Zaldivar Caliper within Osher Alignment Tool OTHER FUNCTIONALITY AVAILABLE ON THE EXAM LIST SCREEN To Send Auto-Refraction and Keratometry Data To Display a Multi-Exam Multi-Exam Options Menu Navigation To Display an Average of Multiple Exams

4

55 55 57 57 57 58 58 59 60 61 62 62 62 63 63 64 64 65 73 74 74 76 77 77 78 78 79 79 80 81 81 82 83 85 85 85 89 92 93 95 96 96 96 97 98

APPENDIX A

TECHNICAL INFORMATION

100

APPENDIX B

ZERNIKE MODES CHART

103

APPENDIX C

DAU INSTALLATION INSTRUCTIONS

104

APPENDIX D

CALIBRATION VERIFICATION

106

APPENDIX E

VIEWER STATIONS

108

USING THE ITRACE SOFTWARE ON NETWORKED VIEWER STATIONS TO SELECT OR CHANGE THE STORAGE LOCATION FOR YOUR PATIENT DATA TO SET-UP A VIEWER STATION APPENDIX F

108 108 109

DATA EXPORT OPTIONS

110

EXPORTING PATIENT, EXAM DATA AND SCREENS TO XML EXPORTING PATIENT AND EXAM DATA TO AN EXCEL SPREADSHEET EXPORTING SCREENS TO DICOM IMAGE

110 110 113

GLOSSARY

115

SOFTWARE LICENSE AND WARRANTY STATEMENT

117

5

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 iTrace Visual Function Analyzer should only be operated by trained ophthalmic technicians. 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. Please note additional specifications for these laser components in the symbol legend on page 7. CLASS 1 LASER PRODUCT

To avoid inadvertent exposure to laser radiation, never operate the system with the covers opened or removed. Doing so may expose the user or others to stray laser radiation. Power must be disconnected prior to opening or removal of covers. 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. The iTrace Visual Function Analyzer complies with IEC 60601-1-2 and 60825-1 Edition 2.0 2007-03 standards. Operate the Tracey iTrace Visual Function Analyzer only from the type of power source indicated on the product-rating label. Isolation from the power mains is provided by the medical grade power supplies specified and supplied by Tracey Technologies. In accordance with IEC 60601-1-2, in order to disconnect the 6

mains from the iTrace Visual Function Analyzer, remove the power inlet cord from the wall power. Carefully read all instructions prior to use. Retain all safety and operating instructions for future use. Observe all contra indications, warnings, and precautions noted on the precautionary labels located at the base of the iTrace near the power and USB ports and those within this manual.

Identification and Certification/Precautionary Labeling Please note the location of the product Identification/Traceability and Certification/Precautionary labels on either side of the power connection and USB port at the base of the iTrace VFA as shown below.

7

Symbol Legend CAUTION. Please read and follow all warnings and notices. Class 1 Laser Product - The Tracey iTrace Visual Function Analyzer is a Class 1 laser product. It contains two laser diodes: 1) Class IIIb laser diode with a 785 nm wavelength, with maximum power of ≈50 mW and collimated beam with a maximum attenuated power of 4.6 mW; and 2) Class IIIa laser diode with a 655 nm wavelength, with maximum power of less than or equal to 2.5mw, and 2mrad beam divergence. Please note the timing and duration for these lasers during operation in the operating instructions within this manual. Class 1

Type BF

IPXO

Equipment protection against electric shock does not rely on Basic Insulation only, but includes an additional safety precaution provided by connection of the Equipment to the protective earth conductor. Meets the leakage current requirements and the patient applied part is isolated from the equipment

Ordinary protection against harmful ingress of water. 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 standards. All iTrace users should be trained in electrostatic discharge (ESD) precautionary procedures. This symbol denotes that there is a crush hazard at the manipulator where the unit slides on the base plate. Please take necessary precautions to avoid possible injury.

8

Please observe instructions for cleaning and disinfection of the iTrace Visual Function Analyzer found in the Cleaning and Maintenance section of this document. WARNING: The iTrace Visual Function Analyzer is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

24V

2.5A

The iTrace Data Acquisition Unit should be powered only with a medical grade power supply as provided Model #WSL524M (Tracey PN 200665), rated at 24V dc, 2.5A. Should isolation from the mains be necessary, in accordance with IEC 60601, in order to disconnect the mains from the iTrace Visual Function Analyzer, remove the power inlet cords from the wall power outlet. The External Computer should be powered only with a medical grade power supply as provided Model #GTM9100P12020-0.5-IM (Tracey PN 200772), rated at 19.5V dc, 3.9A.

19.5V

3.9A

Should isolation from the mains be necessary, in accordance with IEC 60601, in order to disconnect the mains from the iTrace Visual Function Analyzer, remove the power inlet cords from the wall power outlet. The Tracey iTrace Visual Function Analyzer should be stored and transported at a temperature range of 5° C to 50° C / 40° F to 122° F and at a relative humidity range of 20% to 95% rH. The iTrace should be operated at a temperature range of 15° C to 30° C / 60° F to 85° F and a relative humidity range of 20% to 95% rH. During storage and transportation, keep packaging dry.

9

Indications for Use Indications for Use The iTrace 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.

System Specifications*: Measurement Range: Pupil Scan Size: Accuracy: Reproducibility: Footprint Dimensions: Weight:

+/-15 D sphere +/-10 D cylinder 2.5 mm to 8.0 mm diameter +/- 0.10 D +/- 0.10 D 13.0 in (33.0 cm) x 17.0 in (43.2 cm) 27.4 lb (12.4 kg)

*Specifications subject to change without notice.

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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 iTrace Visual Function Analyzer (iTrace). Chapter 2 acquaints you with your system’s hardware: the data acquisition unit (DAU) and the computer. 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 manage new and existing patients. Chapter 5 details how to examine patients and Chapter 6 explains how to review the exam 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.

11

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 lenticular aberration analysis.

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) 4451666 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.

12

Chapter 2 Getting to Know Your System The Tracey iTrace 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. 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 backlighted Placido rings are projected onto the corneal tear film, and the 13

Getting to Know Your System

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. 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 due to possible exposure to hazardous laser radiation.

Cleaning and Maintenance The iTrace chin rest, forehead strap, handles and any other part of the device which comes into contact with the patient should be cleaned thoroughly before use and between patient usage with isopropyl alcohol disinfecting wipes using light pressure. The exterior of these units, other than those listed above, may be cleaned with a dry cloth or antimicrobial dry wipes. 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. To properly maintain your iTrace Visual Function Analyzer, the user should check the device’s calibration periodically. Please refer to the steps in Chapter 4, To Perform a Quick Calibration Check, page 33.

Computer Requirements 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



Graphic Display Resolution: 

HD - 1360x768,



HD+ - 1600x900, or



Full HD - 1920x1080



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 14

Getting to Know Your System 

Microsoft Windows 7 or Windows 8 Professional OS – required for networking



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.

DAU and Computer Setup The iTrace DAU and Computer should be setup side by side and should utilize the medical grade power supplies provided by Tracey Technologies. The DAU is connected to the external computer via the supplied USB cable. The iTrace system should only be setup and operated with the supplied medical grade power supplies provided by Tracey Technologies. The USB port on the iTrace DAU is used to connect the DAU and the external computer via the supplied USB cable. The external computer should be powered with supplied medical grade power supply, model #GTM9100P12020-0.5-IM.

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

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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 5.2 HOYA iTrace Surgical Workstation Software Activation. This chapter includes the following topics: 

New User Installation and Training



Installing 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 per group session, 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 exam processes and acceptance criteria



Explain the different displays



Explain how to customize displays based on your practice needs

16

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 5.2 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 or Windows 7, 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 double click the file named “Setup”. 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 5.2 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.

17

Learning the Basics

If Windows can’t find the driver, select this option and click Next.

Select this option and type C:TraceyDrivers in the text box and click Next, Windows then will install the driver correctly.

18

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 acquisition functions for each exam type. 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. CTRL + D opens the database selection dialog. CTRL + A selects all patients. CTRL + S opens the camera settings dialog during iris image capture. Use in conjunction with other keys. For instance, Shift + Tab means to hold down the Shift key and then press the Tab key. Is also used to initiate image acquisition in lieu of the joystick button. 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. Use during wavefront exam acquisition to toggle the scan centration between pupil center and IR dot (visual axis) center. Use during wavefront exam acquisition to toggle the fixation target light on and off. 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. Use to begin a continuous one-time recycle cycle through the signals for each sample point. Reset target to 0 diopters

19

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, tilt the joystick 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 BMP, JPG or PNG file formats. 1. Click button in lower right corner to save the entire screen as a DCM, BMP, JPG, or PNG file. 2. The software will automatically choose the filename as the patients name (Last_First) and the current date/time stamp. You can rename the file as you wish or select a different Save To location. The software will also remember the last file type selected. You can change the file type as well.

20

Learning the Basics

Common display options

In a Summary display mode, the default screen generally contains 4 display panels. 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.

21

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

22

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

Limbus

Numbers

Pupil

Corneal vertex

Scan points

CT rings

Keratometry

Map

23

Learning the Basics

To Select Zone Size You can choose different scan zone to view for the multi-zone 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.

button in the bottom right corner of the display to decrease the You can also click on the zone size by 1 mm steps per click. The default zone size is 10 mm, so you will need to click the button several times to see the map change. Similarly, you can click the button to increase the zone size in 1 mm steps. The zone size is shown in the top left corner of the display panels.

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 iTrace software, you can select to display Total, Higher Order Total, or Lower Order Total. You can also choose to display only Defocus, Astigmatism, Coma, Spherical and Trefoil aberrations. Choose Other if you want to enter an arbitrary value. Choosing Other option in an RMS display will bring up the Aberrations Mask screen.

24

Learning the Basics

To Power the System On 1 Verify all cable and power 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. If it fails to illuminate solid green after this test period of about eight seconds 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

in the lower right corner of the iTrace

screen until you get to the main menu screen, then click program.

. Confirm Yes to exit the

2 Remove and safely store any CD's from the computer 3 Click the Start button and select Shut Down or Turn Off Computer from the menu and the Turn Off option in the pop-up window if presented. 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.

25

Chapter 4

New and Existing Patients

You will need to add all patients as new the first time they are examined. Once the 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

26

.

New and Existing Patients

Key Features 1 Sort indicator ascending or descending. Clicking on column header allows you to switch the current sort order

2 Patient Directory displays patient information from the current 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.

3 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 (13) will sort the Patient Directory listing by that column. Adds new patients to the current database.

4 5

Moves forward in the process by displaying the Exam List for the highlighted patient in the Patient Directory. Double clicking an entry in the Patient Directory will achieve the same result.

6

Brings up the patient demographic data of a highlighted patient entry in the Patient Directory to enable edits to demographic data.

7

Deletes the highlighted Patient entry.

8

Imports patient and associated exams from a different iTrace database.

9

Exports patient and associated exams to another iTrace database.

Exports and exam patient data to a Microsoft Excel spreadsheet file, as per parameters specified in Settings.

10

Displays the current Preference Settings. Initially it uses the default values. Preferences can be edited and backed-up in this window.

11

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.

12

13

Will enable a quick Verification of wavefront Calibration of your iTrace DAU. 27

New and Existing Patients

14

Will Exit the iTrace program.

15 Displays the total Number of Patients in the database. 16 Indicates if the software is set to Automatically Export data to Microsoft Excel spreadsheet as specified in Settings.

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, and DOB are entered for a new patient. Other data fields are optional. Click on the drop down list arrow in Group field to select a 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.

28

New and Existing Patients

To Edit Patient’s Data 1.

Select a patient.

2.

Click

3.

Modify the Patient’s Data.

4.

Click OK to save.

5.

.

When editing the patient’s name fields or the Date of Birth, the software will ask you to verify that you want to change this data. Note: Do not use the following characters in the Patient Last name, First name or Middle name fields: / : * ? “ < > |

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.

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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 will be exported to the Export file under the Tracey directory of the computer’s hard drive, or you may choose another location in the Browse For Folder window that appears. A compressed file is 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.

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New and Existing Patients

To Select or Change the Storage Location for Your Patient Data By default, your patient data is stored within Microsoft Jet databases that are 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 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 software. For more information, see Appendix F. 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 radio button labeled “Microsoft Jet”. 3. In the box, type in the folder address for the new database location 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. 5. If this software installation is on a network and is for viewing patient data only (i.e. it is not connected to the iTrace DAU), click on the check box next to Open as readonly. This will tell the software that this software instance will not be saving to the database and will not interfere with the database access sequence. If the Read-only checkbox is not checked, the clinic must take care to ensure that the software connected to the iTrace DAU is always the first software to access the database. Therefore using the checkbox is highly recommended. 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.

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New and Existing Patients

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 (readonly mode) 3. In the box, type in the location of the database (an *.mdb file) or click Browse… to locate and select it. 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.

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New and Existing Patients

To Perform a Quick Wavefront Calibration Check You can quickly check the WF calibration of your iTrace by clicking 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. a. Click Check . The following dialog box will appear. b. 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. c. 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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