medicine ophthalmology optical coherence tomography of ocular diseases.stratus 3.0 user manual

Model 3000

USER MANUAL

STRATUSOCT USER MANUAL COVERPN 55641-1 REV. A 4/03

ADDRESS

Carl Zeiss Meditec Inc.5160 Hacienda DriveDublin, CA 94568(877) 486-7473(925) 557-4100FAX: (925) 557-4101e-mail: [email protected]

Carl Zeiss Meditec AGGoeschwitzer Strasse 51–5207745 JenaGermany+49-3641-220-333FAX: +49-3641-220-282e-mail: [email protected]

Copyright © 2003 Carl Zeiss Meditec Inc. All rights reserved.

This book may not be reproduced in whole or in part by any means of information storage, retrieval or reproduction without permission. For information, call or write Carl Zeiss Meditec.

.

ADDRESS STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

TABLE OF CONTENTS / I

TABLE OF CONTENTS

1-I POSSIBILITIES

1 INTRODUCTIONPURPOSE OF THIS USER MANUAL ...................................................................... 1-1

Organization of The Manual......................................................................................1-1

STRATUSOCT SYSTEM DESCRIBED ...................................................................... 1-1How The STRATUSOCT Works...................................................................................1-1How It Works for You............................................................................................... 1-2

STRATUSOCT SYSTEM HARDWARE .....................................................................1-3Software and Storage Media ..................................................................................... 1-3

INSTRUMENT INSTALLATION ..............................................................................1-3Care in Handling ..................................................................................................... 1-3Installation Requirements ......................................................................................... 1-4Tips to Avoid Damage.............................................................................................. 1-4

PASSWORD PROTECTION ................................................................................. 1-4Recommendations ................................................................................................... 1-4How to Activate Password Protection ........................................................................ 1-5Log On after Restart ................................................................................................ 1-6

SAFETY PRECAUTIONS ..................................................................................... 1-7EMI STATEMENT............................................................................................ 1-7SYMBOLS DEFINED.......................................................................................... 1-7INSTRUMENT DISPOSITION ............................................................................... 1-8

2 PREPARE TO SCANCHAPTER OVERVIEW ........................................................................................2-1POWER UP THE SYSTEM ...................................................................................2-1

The Main Menu and Toolbar .................................................................................... 2-1

NAVIGATE TO THE STRATUSOCT MAIN WINDOW .................................................2-1STRATUSOCT Main Window ...................................................................................... 2-1Navigation in General ............................................................................................. 2-2

PREPARE THE PATIENT .................................................................................... 2-3Dilate the Patient (Optional) ................................................................................... 2-3Select the Fixation Method...................................................................................... 2-3The Patient Experience ........................................................................................... 2-3

ENTER PATIENT DATA.....................................................................................2-4The Patient List ...................................................................................................... 2-4Select a Patient .......................................................................................................2-5Add/Edit Patient Records .........................................................................................2-5

3 ACQUIRE SCANSCHAPTER OVERVIEW ........................................................................................3-1ADJUST THE HEIGHT .......................................................................................3-1

How to Adjust The Height ....................................................................................... 3-1

INITIATE A SCAN............................................................................................ 3-2Alignment and Acquisition Scan Modes ....................................................................3-3

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Center Line Display .................................................................................................3-3

POSITION THE PATIENT MODULE...................................................................... 3-4Caution ................................................................................................................. 3-4Tools to Position the PM......................................................................................... 3-4How to Position the PM.......................................................................................... 3-4

OPTIMIZE SCAN IMAGE ....................................................................................3-5Adjust Z-offset .......................................................................................................3-5Optimize Polarization..............................................................................................3-6

ADJUST SCAN PLACEMENT .............................................................................. 3-6Click and Drag........................................................................................................3-7Scan, Landmark and Fixation LED Controls................................................................3-7Disc and Fovea Buttons .......................................................................................... 3-8

ACQUIRE SCANS ............................................................................................ 3-8How to Acquire Scans ............................................................................................ 3-8Optional Scan Review Window .................................................................................3-9

OTHER SCAN ADJUSTMENTS ........................................................................... 3-10Adjust Scan Pattern Parameters .............................................................................. 3-10Adjust Scan Variables ............................................................................................. 3-11Define Custom Scan .............................................................................................. 3-12OCT Image Tab..................................................................................................... 3-12Video and Lamp Parameter Tab............................................................................... 3-14Information Tabs ................................................................................................... 3-14

4 SCAN ACQUISITION PROTOCOLSCHAPTER OVERVIEW........................................................................................4-1THE SCAN TAB ...............................................................................................4-1THE PROTOCOL GROUPS..................................................................................4-1

Activity Radio Buttons .............................................................................................4-1Glaucoma Protocols ................................................................................................4-1Retina Protocols..................................................................................................... 4-2All Protocols.......................................................................................................... 4-2

GENERAL TIPS ............................................................................................... 4-2Scan Protocols Are Correlated with Analysis Protocols .............................................. 4-2Table of Correlations .............................................................................................. 4-3Exiting Scans ......................................................................................................... 4-3Which Scan Parameters Can Be Adjusted When........................................................ 4-3Number of A-Scans ................................................................................................ 4-4Size vs. Resolution ................................................................................................. 4-4Aligning Large Scan Patterns ................................................................................... 4-4Measuring Nerve Fiber Thickness ............................................................................ 4-4

SCAN PROTOCOL DESCRIPTIONS, OPTIONS AND TIPS .......................................... 4-5Repeat....................................................................................................................4-5Line .......................................................................................................................4-5Circle .....................................................................................................................4-5Raster Lines ............................................................................................................4-5Cross Hair ............................................................................................................. 4-6Radial Lines ........................................................................................................... 4-6Macular Thickness Map .......................................................................................... 4-6Optical Disc .......................................................................................................... 4-6Proportional Circle ................................................................................................. 4-6Concentric 3 Rings ................................................................................................. 4-6RNFL Thickness (3.46) ........................................................................................... 4-7

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TABLE OF CONTENTS / III

Nerve Head Circle .................................................................................................. 4-7RNFL Thickness (2.27xdisc) .................................................................................... 4-7X-Line ................................................................................................................... 4-7RNFL Map ............................................................................................................. 4-7Time-Efficient or Fast Scans .................................................................................... 4-7

5 ANALYZE SCANSCHAPTER OVERVIEW ........................................................................................5-1INITIATE AN ANALYSIS .....................................................................................5-1

Select a Patient ....................................................................................................... 5-1Select Scan Group(s) ............................................................................................... 5-1Select an Analysis Protocol ......................................................................................5-3Click Analyze or Scan Selection................................................................................5-3

SELECTION WINDOW....................................................................................... 5-4Exclude Scans from Analysis.................................................................................... 5-4

PRINT........................................................................................................... 5-5Customize Printouts ................................................................................................5-5

6 ANALYSIS PROTOCOLSCHAPTER OVERVIEW ....................................................................................... 6-1THE ANALYZE TAB.......................................................................................... 6-1PROTOCOL LISTS ............................................................................................ 6-1

Quantitative Analysis Protocols ................................................................................6-1Image Processing Protocols..................................................................................... 6-2

GENERAL TIPS................................................................................................6-2Analysis Protocols Are Correlated with Scan Patterns ................................................ 6-2Table of Correlations .............................................................................................. 6-3Scan Direction Legend ............................................................................................ 6-3SNR & Accepted A-Scans%..................................................................................... 6-3

NORMATIVE DATA AND ITS APPLICABILITY.......................................................... 6-3QUANTITATIVE ANALYSIS PROTOCOLS................................................................6-4

General Information ............................................................................................... 6-4Retinal Thickness/Volume ....................................................................................... 6-5Retinal Thickness/Volume Tabular ............................................................................ 6-6Retinal Thickness/Volume Change............................................................................ 6-7RNFL Thickness ..................................................................................................... 6-8RNFL Thickness Average ......................................................................................... 6-9RNFL Thickness Map ..............................................................................................6-11RNFL Thickness Change......................................................................................... 6-12RNFL Thickness Serial Analysis .............................................................................. 6-13Optic Nerve Head.................................................................................................. 6-13Retinal Thickness ..................................................................................................6-18Retinal Map ..........................................................................................................6-18

IMAGE PROCESSING PROTOCOLS ......................................................................6-19Format of Display ................................................................................................. 6-20Normalize............................................................................................................ 6-20Align................................................................................................................... 6-20Normalize + Align ................................................................................................ 6-21Gaussian Smoothing.............................................................................................. 6-21Median Smoothing ................................................................................................ 6-21Proportional.......................................................................................................... 6-21

STRATUSOCT USER MANUAL TABLE OF CONTENTS / IIIPN 55641-1 REV. A 4/03

IV / TABLE OF CONTENTS

Scan Profile ..........................................................................................................6-22

7 THE STRATUSOCT BROWSER: DATA MANAGEMENTCHAPTER OVERVIEW........................................................................................7-1

Open And Close The STRATUSOCT Browser............................................................ 7-1

THE STRATUSOCT BROWSER ............................................................................ 7-2Customize the Browser Layout................................................................................. 7-2Browser Menus .......................................................................................................7-3

WHAT DOES THAT BUTTON DO?..................................................................... 7-4FIND AND SELECT RECORDS ............................................................................ 7-5SELECT PATIENT, VISIT AND EXAM RECORDS ..................................................... 7-7ANALYZE EXAMS ........................................................................................... 7-7

How To Run Analyses ............................................................................................. 7-7The Analysis Window ............................................................................................. 7-8

CATEGORIZE PATIENT RECORDS....................................................................... 7-9Create, Edit and Delete Categories .......................................................................... 7-9Place Patient Records in Categories ........................................................................ 7-10

CREATE AND ASSIGN PATIENT DIAGNOSES ........................................................7-11Create, Edit and Delete Diagnoses ..........................................................................7-11Assign Diagnoses to Patients ................................................................................. 7-12

REGISTER, EDIT AND ASSIGN MEDICAL STAFF.................................................... 7-13Register (Create), Edit and Delete Staff Records ...................................................... 7-13Assign Staff to Patient Records............................................................................... 7-14

REGISTER, EDIT AND ASSIGN INSURANCE COMPANIES......................................... 7-15Register (Create), Edit and Delete Insurance Company Records ................................ 7-15Assign Insurance Companies to Patient Records ...................................................... 7-16

ADD A NEW PATIENT.................................................................................... 7-16EDIT PATIENT RECORDS.................................................................................7-18MERGE PATIENT RECORDS..............................................................................7-18CREATE AND EDIT VISIT RECORDS................................................................... 7-19

To Create a New Visit Record ................................................................................. 7-19To Edit Visit Records ............................................................................................. 7-19

EDIT EXAM RECORD REMARKS AND NOTES...................................................... 7-20EDIT CLINICAL NOTES ................................................................................... 7-21DELETE EXAM, VISIT AND PATIENT RECORDS .................................................... 7-21

Delete Exam Records............................................................................................. 7-21Delete Visit Records.............................................................................................. 7-21Delete Patient Records ..........................................................................................7-22

8 ARCHIVE SCANS & BACKUP DATABASECHAPTER OVERVIEW........................................................................................8-1THE PATIENT DATABASE..................................................................................8-1ARCHIVE VS. BACKUP ......................................................................................8-1WHY ARCHIVE/BACKUP SCANS......................................................................... 8-2FORMAT DVD-RAM DISKS ............................................................................. 8-2ARCHIVE/BACKUP SCHEME............................................................................... 8-3HOW TO ARCHIVE.......................................................................................... 8-3

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TABLE OF CONTENTS / V

Deselect Exams (Optional) ...................................................................................... 8-5Access Archived Scans............................................................................................ 8-5

DATABASE BACKUP ........................................................................................8-5DEFRAGMENT DATABASE.................................................................................8-7

9 ROUTINE MAINTENANCECHAPTER OVERVIEW ........................................................................................9-1

Note Regarding Warranty ......................................................................................... 9-1

HANDLING ERROR MESSAGES ............................................................................9-1ROUTINE CLEANING.........................................................................................9-1

Forehead and Chin Rests.......................................................................................... 9-1The Ocular Lens...................................................................................................... 9-1

REPORT SIGNS OF WEAR ..................................................................................9-1Fundus Illumination Lamp ....................................................................................... 9-2Power Fuses........................................................................................................... 9-2

10 SPECIFICATIONSTOMOGRAPHIC IMAGING................................................................................. 10-1FUNDUS IMAGING ......................................................................................... 10-1ELECTRICAL REQUIREMENTS............................................................................. 10-1START-UP .................................................................................................... 10-1MEASUREMENT UNITS ....................................................................................10-2CALIBRATION................................................................................................10-2DISPLAY MONITOR ........................................................................................10-2SYSTEM INPUT DEVICES..................................................................................10-2DISK STORAGE..............................................................................................10-2ENVIRONMENTAL CONDITIONS.........................................................................10-2PHYSICAL DIMENSIONS...................................................................................10-2SYSTEM WEIGHT............................................................................................10-2TABLE LOADING CAPACITY..............................................................................10-2STANDARDS AND APPROVAL ...........................................................................10-2EMBEDDED WINDOWS LICENSE........................................................................10-2INTENDED USE .............................................................................................10-3

11 LEGAL NOTICESLIMITED WARRANTY........................................................................................ 11-1LIMITATION OF LIABILITY ................................................................................ 11-2SERVICE CONTRACT....................................................................................... 11-2NOTIFICATION OF COPYRIGHT......................................................................... 11-2SOFTWARE LICENSE AGREEMENT ...................................................................... 11-2

License Terms and Conditions ................................................................................. 11-3

ACKNOWLEDGMENT........................................................................................11-3

INDEX

STRATUSOCT USER MANUAL TABLE OF CONTENTS / VPN 55641-1 REV. A 4/03

VI / TABLE OF CONTENTS

VI / TABLE OF CONTENTS STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

POSSIBILITIES / 1-I

1-i POSSIBILITIES

“Biopsies without surgery. Non-contact, non-invasive, near-cellular, micron resolution diagnosis in vivo. Research at the Massachusetts Institute of Technology and top ophthalmic thought leaders around the world offers the hope that Optical Coherence Tomography will one day take the place of traditional biopsies.”

—Industry Week, V246, N16, P60 (1)

Figure 1 The STRATUSOCT START WINDOW

STRATUSOCT USER MANUAL POSSIBILITIES / 1-IPN 55641-1 REV. A 4/03

1-II / POSSIBILITIES

1-II / POSSIBILITIES STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

INTRODUCTION / 1-1

1 INTRODUCTION

Congratulations on the purchase of your Zeiss STRATUSOCT Model 3000 (STRATUSOCT). The STRATUSOCT enables examination of the posterior pole of the eye at an extremely fine spatial scale, without surgical biopsy or even any contact with the eye. The name STRATUSOCT (derived from “stratum,” Latin for “layer”) refers to its unique ability of direct cross-sectional imaging of the layers of the retina. The STRATUSOCT minimizes patient discomfort as it permits detailed examination of the retina and optic nerve head at the office or clinic. The STRATUSOCT facilitates diagnosis and management of retinal diseases and glaucoma.

PURPOSE OF THIS USER MANUAL

Zeiss designed this User Manual to serve as a training, usage and reference guide. We assume that users are clinicians or technicians with professional training or experience in the use of retinal imaging equipment, and in diagnostic interpretation of the images generated. While we offer training in the use of the STRATUSOCT, we do not offer instruction in diagnostic interpretation of the images generated. This manual does not attempt to do so.

ORGANIZATION OF THE MANUAL This introductory chapter provides a system description, installation and safety information. Chapters 2 through 6 are organized according to the normal sequence of operation of the STRATUSOCT, followed by data management and data transfer functions in Chapters 7 through 9, as follows:

• PREPARE TO SCAN, explained in Chapter 2.• ACQUIRE SCANS, explained in Chapter 3.• SCAN ACQUISITION PROTOCOLS, described in Chapter 4.• ANALYZE SCANS, explained in Chapter 5.• ANALYSIS PROTOCOLS, described in Chapter 6.• THE STRATUSOCT BROWSER: DATA MANAGEMENT, explained in Chapter 7.• ARCHIVE SCANS & BACKUP DATABASE, explained in Chapter 8.

Chapters 9, 10 and 11 cover ROUTINE MAINTENANCE, instrument SPECIFICATIONS and LEGAL NOTICES, respectively.

STRATUSOCT SYSTEM DESCRIBED

The STRATUSOCT is a computer-assisted precision optical instrument that generates cross sectional images (tomograms) of the retina with ≤ 10 microns axial resolution. It works by using an optical measurement technique known as low-coherence interferometry.

HOW THE STRATUSOCT WORKS The principle of operation of interferometry is analogous to ultrasound, except that it uses light rather than sound. The difference permits measurement of structures and distances on the ≤ 10 micron scale, versus the 100-micron scale for ultrasound. Another important difference is that optical interferometry does not require contact with the tissue examined, unlike ultrasound.

The STRATUSOCT contains an interferometer that resolves retinal structures by measuring the echo delay time of light that is reflected and backscattered from different microstructural features in the retina. The STRATUSOCT projects a broad bandwidth near-infrared light beam (820 nm) onto the retina from a super luminescent diode. It then compares the echo time delays of light reflected from the retina with the echo time delays of the same light beam reflected from a

STRATUSOCT USER MANUAL INTRODUCTION / 1-1PN 55641-1 REV. A 4/03

1-2 / INTRODUCTION

reference mirror at known distances. When the STRATUSOCT interferometer combines the reflected light pulses from the retina and reference mirror, a phenomenon known as interference occurs. A photodetector detects and measures interference. Although the light reflected from the retina consists of multiple echoes, the distance traveled by various echoes is determined by varying the distance to the reference mirror. This produces a range of time delays of the reference light for comparison.

The STRATUSOCT interferometer electronically detects, collects, processes and stores the echo delay patterns from the retina. With each scan pass, the STRATUSOCT captures from 128 to 768 longitudinal (axial) range samples, i.e., A-scans. Each A-scan consists of 1024 data points over 2 mm of depth. Thus the STRATUSOCT integrates from 131,072 to 786,432 data points to construct a cross sectional image (tomogram) of retinal anatomy. It displays the tomograms in real time using a false color scale that represents the degree of light backscattering from tissues at different depths in the retina. The system stores the scans you select for later analysis.

HOW IT WORKS FOR YOU The STRATUSOCT delineates intraretinal, cross-sectional anatomy with axial resolution of ≤10 microns and transverse resolution of 20 microns. The STRATUSOCT software package includes 19 scan acquisition protocols and 18 analysis protocols. Together they enable you to analyze the optic disc, retinal nerve fiber layer and the macula with a single instrument. The STRATUSOCT facilitates the evaluation of both glaucoma and vitreoretinal disease. The STRATUSOCT video camera enables you to view the patient's fundus as you work, and to store video and scan images together. The data management system enables you to keep STRATUSOCT histories, so you can monitor patients over time. You can archive images and data on rewritable DVD-RAM discs. The inkjet printer enables you to generate color hard copy.

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INTRODUCTION / 1-3

STRATUSOCT SYSTEM HARDWARE

The STRATUSOCT system hardware consists of the Patient Module (PM); the Computer Unit; the Flat Screen Video Monitor; the keyboard, mouse and color inkjet printer. The hardware mounts on a wheelchair accessible motorized power table. The table accommodates elevation adjustment to each patient's height. The illustration below labels hardware elements. System specifications are in Chapter 10.

Figure 2 STRATUSOCT System Hardware

SOFTWARE AND STORAGE MEDIA Zeiss pre-installs all software necessary to operate the STRATUSOCT. We also provide three unformatted, rewritable digital versatile disk (DVD) cartridges to archive the patient database.

INSTRUMENT INSTALLATION

Only a Zeiss service representative should assemble and install the STRATUSOCT. This manual does not provide assembly and installation instructions. The buyer should make a free on-site installation appointment to coincide with delivery. System integration and calibration require approximately one business day.

CARE IN HANDLING The STRATUSOCT hardware is shipped in separate boxes. Use extreme care when handling and transporting the boxes. In particular, the box containing the Patient Module contains fragile optics that require high precision alignment.

System Power Switch

Keyboard

Flat Screen Video Monitor

Focus Adjustment Knob

Patient Module

Joystick

Mouse

Wheel Chair Accessible

Power Table

Caster

Table Height Switch

Printer

Blue PM Function Buttons

Floppy Disk Drive

DVD-RAM Drive

Computer Unit

Note: Archive scans and backup the patient database daily to ensure the preservation of patient data in case of computer malfunction. See Chapter 8, ARCHIVE SCANS & BACKUP DATABASE.


1-4 / INTRODUCTION

INSTALLATION REQUIREMENTS • The instrument requires an area at least 6' x 8' (1.80 m by 2.4 m) for installation and patient comfort during use.

• The STRATUSOCT should operate on a dedicated power outlet. Based on your specification, we configure your STRATUSOCT at the factory to use either 100V, 115V, or 230V line voltage.

TIPS TO AVOID DAMAGE

• This instrument has no special measures against harmful ingress of water (IPX0 classification). Do not place the instrument in or near a wet or moist environment. Do not allow condensation to form on the instrument. Do not place a container holding liquid on top of the instrument.

• Only Zeiss technicians should disassemble or service this instrument. In the case of malfunction, error messages or operational problems, call Carl Zeiss Meditec for service at 1-877-486-7473 (1-877-HUMPHREY) in the U.S.A., or contact your local Carl Zeiss office or distributor.

• In case of emergency related to the instrument, unplug the power cord from the wall outlet and call for service immediately.

• There are no user-replaceable parts in the instrument. For the replacement of any component, accessory, or peripheral, including fuses and lamps, call Carl Zeiss Meditec for service at 1-877-486-7473 (1-877-HUMPHREY) in the U.S.A., or contact your local Carl Zeiss office or distributor.

• Although this instrument is designed for continuous operation, it should be turned off when not in use for an extended period.

PASSWORD PROTECTION It is the user’s responsibility to implement whatever instrument and data security measures are desired or appropriate. This section instructs you how to use the Windows operating system to require users to enter a password before they can access the STRATUSOCT computer. The STRATUSOCT is shipped with Windows password protection turned off, so that upon system startup, any user has administrator privileges (access to all functions) via the default user account.

RECOMMENDATIONS

You implement password protection in Windows by turning on password protection and then creating one or more new user accounts that have a user name

Note: To transport, dismantle or modify the STRATUSOCT hardware, you must consult with a Zeiss service technician before you disconnect any of the components. Failure to do so voids all warranties offered with the STRATUSOCT.

Note: If you establish password protection, the STRATUSOCT software will not launch automatically upon system startup. You will be required to log on to the computer by entering a valid user name and password combination. Then you will have to launch the STRATUSOCT software by double-clicking on the STRATUS OCT Host desktop icon.

Disclaimer: The following recommendations and instructions are intended for the use of the STRATUSOCT in a standalone setting. If you have installed the STRATUSOCT in a network environment, we assume that you will apply your own user account management procedures. We do not offer recommendations or instructions for password protection in a network environment.


INTRODUCTION / 1-5

and password. If you implement password protection, Carl Zeiss Meditec recommends the following:

1. We strongly recommend that you do not create Standard users or Restricted users. Such users cannot use all of the STRATUSOCT functions.

2. Use good practices in creating, administering and securing passwords.

HOW TO ACTIVATE PASSWORD PROTECTION To activate password protection, follow these steps:

1. Power up the system. Exit the STRATUSOCT program (click File > Exit or click the at upper right) to enter the Windows environment.

2. Click Windows Start > Settings > Control Panel. In the Control Panel, double-click Users and Passwords.

3. In the Users and Passwords dialog box, select the checkbox near the top that says “Users must enter a user name and password to use this computer.” This activates the Add, Remove and Properties buttons.

Figure 3 Users and Passwords Dialog Activated

4. Click the Add button. The Add New User dialog box appears. Enter a user name and record it. The user name is not case sensitive. (The other information is optional.) Click Next.

5. You will be prompted to enter and to confirm a new password for this user name. The password is case sensitive. Record the password you have entered. When finished, click Next.

Warning: Every new user account that you create must have administrator privileges. (How to do this is described below.) Only users with administrator privileges can use all of the STRATUSOCT functions.

Warning: Do not attempt to remove, edit the properties or edit the passwords of the “Administrator” and “Tech Support” accounts. Failure to

observe this warning could disable access to the system.


1-6 / INTRODUCTION

6. The Add New User dialog box now lets you select the level of access of the new user account. For every new user account, you must select the Other radio button and then select Administrators from the drop down list, as in the example below.

Figure 4 Select Other, Administrators

7. Click Finish. You will return to the Users and Passwords dialog box, and the new account you created will be listed by User Name and Group. All new users should be the Administrators group. • To add more user accounts, repeat steps 4 through 7.

8. When finished adding accounts, click OK to implement your changes and exit. You can restart the STRATUSOCT software by double-clicking on the STRATUS OCT Host desktop icon.

LOG ON AFTER RESTART The first time you restart the system after implementing password protection, you will have to do the following:

1. The Select Netware Logon dialog box will appear. Click Cancel. A Netware Network dialog box will appear. Click Yes.

2. The Windows Logon dialog box will appear with “Administrator” in the User Name field. Delete “Administrator” and type in the user name you wish to use. Then enter the corresponding password in the Password field. The password is case sensitive. Click OK.

3. The Getting Started with Windows 2000 dialog box will appear. Uncheck the box at lower left that says, “Show this screen at startup.” Then click Exit.

4. We recommend that you set the Windows taskbar properties to auto hide. Right-click on the taskbar and click Properties. In the Properties dialog box, select the checkbox next to Auto hide. Then click OK.

5. We recommend that you create a desktop shortcut to format DVD-RAM disks. To do this, click Windows Start > Programs > DVD-RAM, and right-click on DVDForm and select Create Shortcut. Then drag the new DVDForm shortcut to the desktop.

After the first time you log on with a new user name, you will be prompted to enter the user name and password only. The system will open to the Windows desktop.

Warning: Do not create Standard or Restricted users because they cannot use all of the STRATUSOCT functions.


INTRODUCTION / 1-7

Double-click the STRATUS OCT Host desktop icon to launch the STRATUSOCT software.

SAFETY PRECAUTIONS

• The STRATUSOCT is Type B, Class I protection equipment.• Do not use the instrument on an uneven or sloped surface. Apply the wheel

locks except when moving the instrument table. Also, do not roll the table in deep pile carpet or over objects on the floor such as power cords.

• To avoid tipping, the printer supplied with the instrument must be maintained in its place and no others are to be used.

EMI STATEMENT This instrument meets various international standards for electromagnetic interference (EMI). However, if you experience interference from a radio, TV or other electrical receiving device, attempt the following corrective measures:

1. Move the receiving device and the STRATUSOCT away from each other.2. Reorient the radio or TV antenna.3. Plug the STRATUSOCT into a different electrical outlet so that the instrument

and the interfering equipment are on different branch circuits.

SYMBOLS DEFINED

Indicates that power is OFF. Found on the power switch.

Warning: To prevent electric shock, the instrument must be plugged into an earthed ground outlet. Do not remove or disable the ground pin. Only

a Zeiss technician may install the instrument.

Warning: Do not open the instrument covers. Opening the instrument covers could expose you to electrical and optical hazards.

Warning: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor replace original

system components with substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of the table height adjustment

mechanism, instability of the table, tipping and damage to the instrument, and injury to operator and patient.

Warning: Do not scan the same location on the retina with the same scan pattern for more than 10 minutes per day. Failure to follow this guideline

could result in overexposure of the patient’s eye to optical radiation.

Warning: This instrument may cause ignition of flammable gases or vapors. Do NOT use in the presence of flammable anesthetics such as

nitrous oxide, or in the presence of pure oxygen.


1-8 / INTRODUCTION

Indicates that power is ON. Found on the power switch.

Indicates that there are important operating and maintenance instructions found in the manual.

Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.

Indicates a fuse is present near this symbol.

Parts of the instrument that touch the patient are of Type B according to the IEC standard.

INSTRUMENT DISPOSITION When it comes time to upgrade the Zeiss STRATUSOCT, please contact Carl Zeiss Meditec at 1-877-HUMPHREY (1-877-486-7473) to inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the instrument, please dispose of it in accordance with local and national requirements.


PREPARE TO SCAN / 2-1

2 PREPARE TO SCAN

CHAPTER OVERVIEW This chapter explains in detail how to prepare for scanning with the Zeiss STRATUSOCT. Along the way, it describes the STRATUSOCT MAIN WINDOW, from which all functions originate. Scan preparation consists of the following:

• POWER UP THE SYSTEM (page 2-1).• NAVIGATE TO THE STRATUSOCT MAIN WINDOW (page 2-1).• PREPARE THE PATIENT (page 2-3). • ENTER PATIENT DATA (page 2-4).

POWER UP THE SYSTEM The computer power switch activates power to all system components. It is the switch on the upper left corner of the computer (see the STRATUSOCT SYSTEM HARDWARE drawing on page 1-3). Press the switch to activate power to all components. The STRATUSOCT software loads automatically. It requires about 45 seconds for the STRATUSOCT START WINDOW to display (pictured in Chapter 1-I.). During this time, buttons on the keyboard and the Patient Module are disabled.

• To power down the system, exit the STRATUSOCT software (click File > Exit or click the at upper right) to enter the Windows environment. Then select Shut Down from the Windows Start menu at lower left. When the screen says, “It's now safe to turn off your computer,” press the computer power switch to power down the whole system.

THE MAIN MENU AND TOOLBAR The main menu and toolbar (below) are on nearly every screen.

Figure 5 The Main Menu and ToolbarFrom left to right, the buttons are Select Patient, Select Acquisition Protocol, Select Analysis Protocol, Print, Home and Show Old Fundus Image. The three Select buttons all lead to the STRATUSOCT MAIN WINDOW (pictured below). The Home button returns you to the STRATUSOCT START WINDOW. When active, the Print button prints the current screen. Show Old Fundus Image is active when using the REPEAT scan protocol. It switches between the current fundus video image and the saved fundus photo of the scan you are repeating.

• Double-click on the toolbar (away from any button) to customize the button layout.

Operation is menu-driven. This means that you do not have to memorize any commands. You can access options easily by clicking on the toolbar buttons and menu headings.

NAVIGATE TO THE STRATUSOCT MAIN WINDOW

Clicking any of the first three Select toolbar buttons leads to the STRATUSOCT MAIN WINDOW. It is the primary user interface, from which you can initiate all functions.

STRATUSOCT MAIN WINDOW The MAIN WINDOW has four functional areas:

• The Patient List with Category and Search fields (upper left);• The Scan List (center);

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• The Scan and Analyze Tabs with Activity radio buttons (right);• The Patient and Scan Group Images Tabs (lower left).

Figure 6 The STRATUSOCT MAIN WINDOW

Each area has its own functionality, which the manual describes in the context of its use.

Resize Functional Areas• You can resize any area by placing the pointer over its interior edge until the

two-headed arrow appears. Then click and drag to resize.

NAVIGATION IN GENERAL To navigate among alternatives on the screen, use the mouse to move the screen pointer. Once you reach your selection, click the mouse. For example, to initiate a scan, move the pointer to the Select Analysis Protocol button and click the mouse.

Text Convention• This manual means “left-click” when it says, “click,” except where

“right-click” is specified.Access Menu OptionsTo access the options offered through each menu, click on the menu headings. Then click on an option to select it. Click outside all menu options to make the options disappear.

• Some menus are fields tagged with a down-arrow (drop-down lists). To access these menu options, click on the down-arrow.

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• Grayed-out menu options or buttons are not available.

PREPARE THE PATIENT Patient preparation includes dilating the patient (optional), selecting the fixation method, and preparing the patient for the exam experience.

DILATE THE PATIENT (OPTIONAL) Dilation is optional. The pupils of the subject eyes must be at least 3.0 mm. Images acquired through too small pupils may be truncated on the ends, or the OCT signal may be weak, leading to a lack of image intensity and clarity.

SELECT THE FIXATION METHOD The STRATUSOCT provides for internal or external patient fixation. Internal fixation is more reproducible and is the preferred method. External fixation is indicated when visual acuity in the eye to be scanned is too poor to provide stable fixation. With both methods, you have precise control of the fixation target location.

Internal FixationIn this method, the patient uses the study eye to fixate on a target light inside the ocular lens. If you select internal fixation, instruct the patient to look at the green light inside the ocular lens.

• You control the internal fixation target location on screen during scan acquisition (see SCAN, LANDMARK AND FIXATION LED CONTROLS on page 3-7).

• With this method, you and/or the patient may find it helpful to cover the patient's fellow eye with an eye patch. This may increase the patient's ability to fixate steadily on the target.

External FixationWith the external fixation method, the patient uses the fellow eye to fixate on a target light external to the ocular lens. The STRATUSOCT is equipped with a detachable external fixation target arm. It attaches at the top corners of the head mount on either side. You must position it manually for central or horizontal fixation.

• If you select external fixation, instruct the patient to look at the red blinking target light at the end of the external fixation arm. You can manipulate the cap at the end of the target arm to adjust the intensity of the target light.

• It is important to situate the target light level with the patient's fellow eye and as far as possible from the patient.

THE PATIENT EXPERIENCE The patient experience with the STRATUSOCT is normally brief and comfortable. An experienced operator can acquire several scans from each eye in the space of 5-7 minutes. An exam usually requires the patient to look inside the ocular lens of the Patient Module for 1-3 minutes at a time for each eye, depending on the number of scans desired. The instrument acquires most scans in about 1 second. The additional time is required to position the Patient Module (PM) before scanning and to optimize scan quality. The patient need not remain in the head mount throughout an examination, since the operator can reposition the PM as needed. Note that the STRATUSOCT is never to contact the patient's eye.

• If you select internal fixation, we recommend that you cover the patient's fellow eye while scanning. This enables the patient to fixate more steadily.

Note: The forehead and chin rests should be cleaned between each examination with an alcohol prep swab.



• During positioning, what the patient sees with the study eye is a rectangular field of red punctuated with a green target light. Normally, the patient can look at this field for several minutes at a time without discomfort or tiredness.

• During scan alignment, the patient sees the scan pattern in motion on the red field. It is traced rapidly at first, while in scan alignment mode, then more slowly in scan acquisition mode.

• Finally, during scan acquisition, the patient sees a bright greenish-white flash, like a camera flash. This is the video camera acquiring a red-free fundus image for storage with the scan image. (The operator has the option of acquiring scans without the flash, and therefore without a high contrast image.)

• Except for the most photosensitive, the flash should not be uncomfortable, and the patient may experience numerous such flashes without harm. However, he or she may find it startling at first, so the patient should be made aware of it in advance. As with any flash, the patient may see shadow images for a few seconds.

ENTER PATIENT DATA The STRATUSOCT integrates the patient database with scanning and analysis. Scanning is disabled until you select a patient from the database, or add a new one. You cannot change patient information during the exam. However, you can edit or delete patient records after the exam.

THE PATIENT LIST The patient list is on the upper left side of the MAIN WINDOW.

Figure 7 The Patient List in MAIN WINDOW

Category FieldIf you have created patient categories (using the Define Categories option on the Tools menu), you can use the drop down list to select a category of patients for display in the patient list.

Patient List ViewsYou can change the view of the patient list. Right-click anywhere in the list and the pop-up menu gives you the view options: Details (the default view), List and Small Icon. Click one to adjust the view.

• Details View: In this default view, the list is sorted by name. Click the ID heading to sort by ID number. Click the Patient Name or ID headings to invert the order. To adjust the column layout, drag the ID heading to the left of the Patient Name heading.

• List View: In this view, the ID number does not appear.• Small Icon View: In this view, you can click and drag names to customize

the order for the current session.



SELECT A PATIENT Click the desired name in the patient list to select it. The selected name is highlighted in blue. You can select only one patient at a time. Use the arrow keys or the scrollbar to move through the list.

The Search FieldType in the Search field above the list to search by last name or ID number. When enough letters or numbers have been typed to specify a patient, that name will be gray-highlighted in the list. Press the Tab key to select that name.

The Patient TabOn the lower left, this tab shows the selected patient's information.

Figure 8 The Patient Tab in MAIN WINDOW

ADD/EDIT PATIENT RECORDS Add and manage patient records using the Add/Edit Patient dialog box.

Figure 9 The Add/Edit Patient Dialog BoxIn the upper center of the MAIN WINDOW are the patient Add and Edit buttons, pictured at left.

• To create a new patient record, click Add. Enter data for the First name, Last name and Birthday (mm/dd/yyyy format), at least, in order to proceed. Click Ok when finished.



• To edit a patient record, select a patient from the list and click Edit. Edit the fields as desired and click Ok when finished. You can also use the Patient menu to add or edit patient records.

• You can enter the patient's axial length and refractive correction (spherical equivalent) in the Edit Patient dialog box. This is for record-keeping only. It has no impact on the angle and magnification of scan patterns when projected into the eye during scanning.

• You should backup the patient database weekly in order to be able to restore it in case of computer malfunction. See the instructions in Chapter 8.

You have now prepared the patient and the STRATUSOCT to acquire scans. For instructions to acquire scans, see Chapter 3.


ACQUIRE SCANS / 3-1

3 ACQUIRE SCANS

CHAPTER OVERVIEW This chapter explains in detail how to acquire STRATUSOCT scans. It covers the following steps:

• ADJUST THE HEIGHT for patient comfort (below).• INITIATE A SCAN (on page 3-2).• POSITION THE PATIENT MODULE (on page 3-4).• OPTIMIZE SCAN IMAGE (on page 3-5).• ADJUST SCAN PLACEMENT (on page 3-6).• ACQUIRE SCANS (on page 3-8).• OTHER SCAN ADJUSTMENTS (on page 3-10).

The STRATUSOCT offers 19 scan acquisition protocols to acquire retinal scans. Their characteristics and applications are covered in Chapter 4.

ADJUST THE HEIGHT Once you have entered or selected a patient record (see ENTER PATIENT DATA, page 2-4), the next step is to adjust the instrument height for patient comfort. Seat the patient on the patient side of the STRATUSOCT, facing the operator.

• It is important to optimize patient comfort by properly adjusting the height of the table and/or chin cup. This permits lengthy examination with a clear, consistent view of the fundus, resulting in high quality OCT images.

HOW TO ADJUST THE HEIGHT There are two ways to adjust the height:

• You can raise or lower the entire STRATUSOCT desktop using the table height switch. This switch is underneath the center of the table on the operator side (see the STRATUSOCT SYSTEM HARDWARE drawing on page 1-3).

• For finer adjustments, you can raise or lower the chin cup. Use the knobs below the chin cup on either side (see FIGURE 10 below).

Figure 10 Height AdjustmentWith the patient seated, follow these steps to adjust the height:

1. Raise or lower the desktop to bring the forehead rest approximately level with the patient's forehead.

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2. Before asking the patient to place his or her chin on the chin cup, move the Patient Module (PM) safely away from the patient's face. Use the black joystick located on the operator side of the PM. If locked, press the joystick button on top to release the PM.

3. Now have the patient place his or her chin on the chin cup. The patient's forehead should press firmly against the forehead rest without any neck or back strain. You may need to readjust the height of the tabletop or the patient's chair position.

4. Adjust the height of the chin cup so that the eyes align with the alignment markers on the side of the patient head mount. The adjustment knobs are below the chin cup on both sides of the PM (see figure above).

INITIATE A SCAN To position the PM for scanning, you must initiate a scan. First, select a scan acquisition protocol using the Scan Tab, below.

Figure 11 The Scan Tab in STRATUSOCT MAIN WINDOW

• If not in the MAIN WINDOW, click the Select Acquisition Protocol button to display it, as pictured at left. If necessary, click the Scan Tab to bring it to the front.

• From the MAIN WINDOW, select a scan acquisition protocol from the Scan Tab. You can either click the protocol and then click the Scan button at the

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ACQUIRE SCANS / 3-3

bottom, or double-click the protocol. This activates the SCAN ACQUISITION WINDOW, as pictured below.

Figure 12 The SCAN ACQUISITION WINDOW

It allows you to adjust video and scan parameters from a single interface, enabling the acquisition of high quality scans.

ALIGNMENT AND ACQUISITION SCAN MODES The Scan Mode button, at lower left of the window, toggles between alignment

and acquisition scan modes.

• Alignment Mode: The scanner activates by default in scan alignment mode. In this mode, the scanner traces an aiming pattern rapidly and continuously, which you can see in the video monitor. Alignment mode is useful for scan placement on the desired retinal feature.

• Acquisition Mode: Click the Scan Mode button to switch to scan acquisition mode. In this mode, the scanner traces the actual scan pattern to be used more slowly. The scanner must be in acquisition mode to acquire scans.

In preparation for the next step, the important features to note beside the Scan Mode button are the scan image (left side) and video image (upper right). The other functions available in this window will be detailed in the usual sequence of their application.

CENTER LINE DISPLAY Right-click anywhere in the scan image and a vertical line appears in the center of the scan image. Click again to remove it. This can be useful to ADJUST SCAN PLACEMENT—see page 3-6.


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POSITION THE PATIENT MODULE

Once the SCAN ACQUISITION WINDOW is active, you can begin to position the Patient Module (PM) for scanning.

CAUTION

TOOLS TO POSITION THE PM Use the following tools to position the PM for scanning:

• The joystick to make gross and fine adjustments of the PM in the horizontal plane—side to side, forward and back. The joystick is located on the rear (operator side) of the PM.

• The joystick knob makes fine vertical adjustments. The joystick spins in either direction to move the PM up or down slowly and smoothly. It works whether or not the joystick is locked. Turn the joystick clockwise to raise the PM, counter-clockwise to lower it.

• The focus adjustment knob retracts and extends the ocular lens. Focus adjustment knobs are located on both sides of the PM at the patient's eye level (see the STRATUSOCT SYSTEM HARDWARE drawing on page 1-3). From the operator side, turn the knob toward you to extend the lens toward the patient. Turn it away from you to retract it. This adjusts the focus of the video camera whose black and white image you see on your monitor.

HOW TO POSITION THE PM The immediate goal of positioning is to acquire a video image and a scan image of the desired retinal feature. The black and white video image aids you in accurately positioning the instrument and placing the scan, but the final goal is to acquire a high quality scan image.

You must position the PM manually, using the joystick to make adjustments in three dimensions. It is a reiterative process of positioning with the joystick, focusing the ocular lens and positioning further. All the while, use the live video image to observe the position and focus with respect to the study eye. (While not usually necessary, adjustments to the video image are possible—see VIDEO AND LAMP PARAMETER TAB, page 3-14, for instructions.)

1. At the outset, focus on the study eye from a distance before moving the PM. Instruct the patient to look straight ahead. Then press the joystick button to unlock the PM and move it toward the study eye. Place it so that the ocular lens is approximately one inch from the study eye.

2. Manipulate the joystick—move for lateral adjustments and twist for vertical adjustments—to center the video image on the pupil. Refocus the image if necessary. Then, using the joystick, gently push the PM toward the eye so the video image moves through the pupil and the fundus comes into view.

3. Manipulate the joystick and adjust the focus knob until you see retinal features. With the joystick, carefully continue to push the PM toward the eye and make vertical adjustments until the STRATUSOCT beeps, which is a signal that the PM is the correct distance from the eye for scanning. It beeps when it begins to acquire a retinal scan image, which is visible as a band of contrasting color (green, yellow, red) against the blue background noise on the monitor. Adjust the focus as necessary to bring the retinal features into clear view.

Caution: The optimal position of the PM ocular lens is ~9 mm or ~3/8” from the study eye. When positioned properly, the ocular lens

may touch the eyelashes or the nose. Practice the utmost care to avoid contact with the patient's eye.


ACQUIRE SCANS / 3-5

4. Instruct the patient to fixate on the green target light. If necessary, further adjust the PM position from side to side, up and down, until the retinal image fills the screen and is evenly illuminated. Shadows from the edge of the pupil should be eliminated, if possible, for best scanning results. Press the joystick button to lock the PM in place.

While the PM is locked, you can still adjust the focus and twist the joystick to adjust height. With experience, you may find that you have condensed steps 2 through 4 into one continuous step.

OPTIMIZE SCAN IMAGE To optimize the scan image requires two steps: adjust Z-offset and optimize polarization. The goal of optimizing the scan image is to yield the strongest scan signal, and thus the best scan image. Better images are more defined, and have more red and yellow color.

• The experienced user may also successfully optimize the scan image by making slight adjustments to the focus and/or to the three-dimensional positioning of the PM.

ADJUST Z-OFFSET In the usual course of a scan, the first thing you do after positioning is adjust the Z-offset (axial position) of the scan. The axial length of the STRATUSOCT scan image is 2 mm while the eye length is 10-fold larger. So, if the axial range is not correct, the retina is not scanned, and you see nothing but noise in the live scan image. The 2 mm axial “window” must be positioned to bracket the retina, making it visible in the scan image.

• Once you bring the retina into range for the first scan, it is likely to be visible subsequently. Still, you are likely to adjust Z offset from scan to scan to center the retinal scan image.

• During PM positioning, the STRATUSOCT beeps when it begins to scan the retina. If the retinal image is already visible on the monitor, you can skip step 1 below.

To bring the scan image into view along the Z-axis, follow these steps:

1. Click the Optimize Z-offset button on the Scan Parameter Tab (pictured below).

2. Click the Z-offset arrow buttons (to the right of the Optimize button) to bring the entire retinal scan image into view.

• Shift-click (hold down the Shift key and click) the arrows to move in larger increments.

Note: It is not necessary to spend a long time trying to get the best possible view of the fundus. It is more important to have a strong scan image signal than an excellent fundus video image.


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• The left arrow searches posteriorly (lower in the scan image), and the right arrow searches anteriorly (higher in the scan image).

Figure 13 The Scan Parameter Tab• These methods are operative in both ALIGNMENT AND ACQUISITION SCAN MODES

(see page 3-3), but they are usually done in scan alignment mode right after positioning the PM.

• It is not necessary for the retinal scan image to be centered. The important issue is that none of the image be cut off.

OPTIMIZE POLARIZATION Polarization is adjustable so you can optimize the interferometer signal strength by matching the polarization of light reflected from the retina. This optimizes the scan image, which results in more yellow and red color in the image. It is necessary to adjust Z offset before polarization so the retina is visible in the color scan image while you adjust polarization.

• Once you have a retinal scan image on the screen, click the Optimize Polarization button on the Scan Parameter Tab (pictured above).

• You can incrementally adjust the polarization using the Polarization arrow buttons. If you do, you may note that there are several local maxima in the 180-degree range of polarization. These optional polarization settings may yield scan signals comparable to and occasionally better than the signal achieved using the Optimize button.

• Polarization should be adjusted when initiating scanning on each new eye. It need not be readjusted when performing a series of consecutive scans on an eye if it has been done at the beginning of the series.

• You can use the Optimize Polarization button in both ALIGNMENT AND ACQUISITION SCAN MODES (see page 3-3). The results of adjusting the polarization may be better appreciated when the scanner is in slow mode.

ADJUST SCAN PLACEMENT Accurate scan placement on the desired retinal feature is nearly automatic with the STRATUSOCT, because:

1. The instrument detects which eye is being scanned and,2. It automatically places the fixation target in the correct location for the eye and

scan acquisition protocol you have selected.


ACQUIRE SCANS / 3-7

Still, the SCAN ACQUISITION WINDOW offers two intuitive and easy methods to precisely adjust scan placement, so you can scan the exact part of the retina you want.

CLICK AND DRAG You can simply click and drag the scan pattern and put it exactly where you want it. As long as the video image is live, scan placement is always adjustable.

Move the Scan PatternBy default, the click and drag method works on the scan pattern. To drag the scan pattern, position the pointer near the center of the scan pattern until the four-headed arrow appears (as pictured at left). Then click and drag.

• The two-headed arrow appears when the pointer is near the edge of a scan pattern. Click and drag with this arrow to adjust the scan size, and the angle if available (see SIZE and ANGLE, page 3-10 for more information).

Move the Fixation LEDClick and drag works on the fixation LED if it is sufficiently separated from the scan pattern, or if you select Move Fixation LED from the drop-down list as illustrated in FIGURE 14 below. After you save the first scan in a related series, you can no longer move the fixation LED (see WHICH SCAN PARAMETERS CAN BE ADJUSTED WHEN, page 4-3, for more information).

• Why move the fixation target? Aside from changing between fovea and disc locations, it may not be clear why one would want to adjust the fixation target location. The usual reason is to bring another portion of the retina into view or into the center of view so that the scan pattern may be applied to it. For example, there may be a particular area of pathology away from the macula or the optic disc.• When freezing the video image of the macula, you may observe better

contrast when you move the fixation LED to bring part of the optic disc into view on the edge of the video image. It may also help in orienting your observations.

SCAN, LANDMARK AND FIXATION LED CONTROLS The upper right portion of the Scan Parameter Tab contains on-screen controls to

move the scan, landmark and internal fixation LED (light-emitting diode). The default position for the scan and landmark is the center of the video image. The

Note: Both the scan placement methods described below work in both alignment and acquisition scan modes.

Note: Right-click anywhere in the scan image and a vertical line appears in the center of the scan image. Click again to remove it. This is useful to determine if you have centered the desired retinal feature, e.g., the fovea.

4-headed arrow—Moves the whole scan pattern or

fixation LED.

2-headed arrow—Changes the length and angle of scan patterns.


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default fixation LED location is either the center (fovea mode) or 15° nasally (disc mode), depending on the scan protocol.

Figure 14 The Scan, Landmark and Fixation LED Controls• Click the triangle on the drop down list and select what you want to move.

The default is to move the scan.• THE Details Tab IN SCAN ACQUISITION WINDOW (pictured on page 3-14) shows the

x and y positions of the scan, landmark and fixation LED, in mm, relative to 0,0 at the center of the video image.

• Click the arrow buttons to move the selected feature in the indicated direction. One click moves the feature 0.1 mm. Click the central circle button to return it to the default position.

LandmarkThe landmark is a pulsating point of light that is by default centered in every scan pattern. It can be moved independently and placed on a point of reference to enable reproducibility of scan pattern placement.

DISC AND FOVEA BUTTONS In most cases, the fovea and/or the optic disc are the primary points of clinical interest. Zeiss designed all of its scan acquisition protocols for scans on one or the other location by default, although they may be used in other locations. Thus, the STRATUSOCT places the fixation target either centrally (fovea mode) or approximately 15° nasally (disc mode), depending on the scan protocol. On the THE Scan Parameter Tab (on page 3-6), you can click the Disc or Fovea button, seen at left, to select one or the other default location.

ACQUIRE SCANS With the scan image optimized and the scan placed accurately, you can begin to acquire scans. To acquire scans, you can use either:

• The Acquire Scan buttons along the bottom of the SCAN ACQUISITION WINDOW, seen below;

Figure 15 The Acquire Scan Buttons• Or the two blue function buttons on the Patient Module (PM). These

buttons are near the joystick.

HOW TO ACQUIRE SCANS There are three steps to acquire STRATUSOCT scans:

1. Switch to scan acquisition mode, if you have not already done so.• On-Screen: Click the Scan Mode button.• Blue PM buttons: Press the left button once.

2. Freeze the scan, with or without flash.


ACQUIRE SCANS / 3-9

• On-Screen: Click the Freeze with Flash button, except with highly photosensitive patients, for whom you should click the Freeze without Flash button.

• Blue PM buttons: Again, press the left button once. Flash is used unless you uncheck the Freeze with Flash option in the Scan menu (click Scan > Freeze with Flash, as at left).

3. Save the scan.• On-Screen: If you are satisfied with the quality of the scan image frozen on

screen, click the Save button. The video and scan images will be saved to the hard disk drive. If not, click Cancel to return to scan acquisition mode and acquire another scan.• Optional Scan Review: The STRATUSOCT continuously scans and saves up

to eight scans in temporary memory. Therefore, you can review the last several scan images and select which one to save. Click the Review button to go to the SCAN REVIEW WINDOW. Detailed instructions for scan review are below.

• Blue PM buttons: Press the right blue button to save the scan image frozen on screen. The right blue button is only active when a scan is frozen, and saving scans is its only use.

OPTIONAL SCAN REVIEW WINDOW When you click the Review button after freezing a scan, the SCAN REVIEW WINDOW appears, as pictured below.

Figure 16 The SCAN REVIEW WINDOW

Along the bottom, it displays thumbnails of the last several scan images, up to eight total. The selected thumbnail image is highlighted with blue borders and displayed full size. The fundus photo is at upper left. The left thumbnail image is the last one acquired (the one frozen on the SCAN ACQUISITION WINDOW). It is selected by default.


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• Click any thumbnail image to display it full size. The highlighted image is saved when you click the Save button. If you do not want to save any of the scan images, click Cancel to return to scan acquisition mode and acquire another scan

OTHER SCAN ADJUSTMENTS To acquire scans with the STRATUSOCT does not usually require adjustments beyond those already covered in this chapter. Other possible adjustments before or during scan acquisition were kept for this section to avoid complicating the operating instructions unnecessarily.

ADJUST SCAN PATTERN PARAMETERS The Scan Pattern Parameter area (pictured at left) is found in the upper left of the THE Scan Parameter Tab (see page 3-6). You can use it to adjust several parameters including scan size, angle or number of lines in the pattern.

• The availability of these parameters for adjustment depends on the scan protocol—see WHICH SCAN PARAMETERS CAN BE ADJUSTED WHEN on page 4-3 for information on which you can adjust. When available, the Value field has a white background. Just click in the field and type a value. When unalterable, the Value field has a gray background.

SizeFor many scan protocols, you can adjust the size of the scan pattern, that is, the length of line scans or the radius/diameter of circle scans.

• For size parameters, measurements are in mm. The size range of scan lines is from 3 mm to 10 mm. The range of scan circles is from 1.5 mm to 10 mm diameter (0.75 mm to 5 mm radius).

• To adjust size, you can also move the pointer near the edge of the scan pattern until a two-headed arrow appears (as at left), and then click and drag the arrow to adjust the size (and the angle, if applicable—see below). It is easier to adjust size exactly by typing in the new value.

• When “Radius 1" and “Radius 2" appear, Radius 1 refers to the aiming circle and Radius 2 refers to the scan acquisition circle.

AngleFor the LINE scan protocol (page 4-5), you can adjust the angle of the line. The default angle is 0° (horizontal). Compass degree measurements describe the point of origin and the angle as seen in the video monitor. The nasal position is defined as 0° on the compass (3 o'clock OD, 9 o'clock OS). Degrees increase on the compass inferiorly and decrease superiorly. For example, for the right eye, degrees increase clockwise from 0° to 360°, and decrease counterclockwise from 0° to -360°. This notation style enables the user to control not only the angular position of the line, but also its point of origin.

• Of course, this is significant when locating a point of pathology like a macular hole. For example, note that a 180° line looks just like a zero degree line in a frozen video image, but the 180° line originates on the temporal side of the eye.

• Also note that with this notation, every positive compass point has an alternative representation 360° removed on the negative scale. For example, 180° and -180° yield the same line with the same point of origin, as do 90° and -270°.

Number of LinesWhen this field is available, you can adjust the number of lines from 6 to 24 lines.

2-headed arrow—Changes the length and angle of scan patterns.

OD: 0° (also 360° or -360°) Proceeds nasal to temporal.

OS: 0° (also 360° or -360°) Proceeds nasal to temporal.

OS: 180° or -180°. Scan proceeds temporal to nasal.

OD/OS: 90° or -270°. Scan proceeds inferior to superior.


ACQUIRE SCANS / 3-11

ADJUST SCAN VARIABLES From the Scan menu, select Scan Variables (click Scan > Scan Variables) to reveal the Scan Variables dialog box. The name of the currently selected scan protocol appears at the top.

Figure 17 The Scan Variables Dialog BoxNumber of A-ScansBy default, the number of A-scans is 512 for all protocols except the Fast Scan protocols (fixed at 768 A-scans total). Before scanning, you can adjust this number to 256 or 128 using the drop-down list. Click the down-arrow to view and select an option.

• Note that in scan alignment mode, the aiming pattern always consists of 64 A-scans.

• The number of A-scans is in effect the transverse resolution of the scan, that is, the number of transverse data points acquired.

• Changes you make apply to the selected scan protocol until you change it again, restart the STRATUSOCT software or restart the system.

• You can also adjust the number of A-scans using the OCT IMAGE TAB while scanning (see page 3-13).

Axial Scan Length and Number of Data PointsThe axial scan length is fixed at 2 mm. For each A-scan, the STRATUSOCT acquires a fixed number of 1024 axial data points through the 2 mm depth. At the default value of 512 A-scans, the STRATUSOCT thus acquires 524,288 data points for each scan. The range of data points per scan is 131,072 (128 A-scans minimum) to 786,432 (768 A-scans maximum for the Fast Scan protocols).

A-Scans per Second and Scan TimeThe number of A-scans per second is fixed at 400. At the default value of 512 A-scans, one scan requires 1.28 seconds. The maximum possible time for any single scan is 1.92 seconds (768 A-scans). The minimum is 0.32 seconds (128 A-scans).



DEFINE CUSTOM SCAN This Scan menu option enables you to define your own scan acquisition protocol. Click Scan > Define Custom Scan (as pictured at left) to display the Define Custom Scan dialog box.

Figure 18 The Define Custom Scan Dialog Box• Use the Scan drop-down list to select scan patterns already offered by the

STRATUSOCT and customize them. • To change parameter values, click in the value fields and type in the desired

values (within possible ranges—see ADJUST SCAN PATTERN PARAMETERS, page 3-10).

• Type a name and click Ok to save your custom scan.• Use the Name drop-down list to recall previously saved custom scans, which

you can change and re-save, or delete.

OCT IMAGE TAB Click the OCT Image Tab on the SCAN ACQUISITION WINDOW to adjust OCT image noise and range values, or the number of A-scans for the scan protocol you have selected.

Figure 19 The OCT Image Tab (SCAN ACQUISITION WINDOW)



Noise and RangeThese two sliders are set by default to filter the low end (background noise) and high end (saturation signal) of the OCT interferometer signal. We recommend the the default settings, which are indicated by a mark on each slider, but you can adjust these settings to suit your preference.

• Noise refers to the level of signal that is considered background noise. At the default setting, noise appears as random blue or green speckles in the black background. The slider operates on a percentage scale: from 0, where nothing is considered noise and so no signal is filtered out, to 100, where everything is considered noise and so all signal is blocked. In effect, decreasing the noise adjustment increases the sensitivity of the scanner: you get a stronger signal from the retina, but its clarity may be compromised by noise. Conversely, when you increase the noise adjustment, background noise decreases, but the intensity and definition of the scan image decreases also. You must balance reduced noise against scan image quality.

• Range refers to the range of interferometer signal levels depicted with the false color scale in the STRATUSOCT scan image. The upper end of the range sets the saturation signal value. The scan image color scale depicts a range of relative signal values with reference to the saturation value as the upper limit. When set properly, the saturation value corresponds to the strongest reflected signal from the retina, and the color scale brackets the entire range of the reflected signal strengths from the retina. If set too high, the range of retinal reflectance is compressed into the cool colors of the scale, or is off the scale below (depicted as black). This makes the retinal image weak or nonexistent. If set too low, the range of retinal reflectance is compressed into the warm colors of the scale, or is off the scale above (depicted as white, the saturation signal color). This makes the retinal image poorly defined or appearing as undifferentiated white.• The slider operates on a percentage scale. At zero, the weakest detectable

signal is assigned the saturation color in the scan image, and the image is all white. At 100, only the strongest detectable signal is assigned the saturation color in the scan image, and very little retinal signal is strong enough to be depicted in the scan image.

Number of A-ScansThe OCT Image Tab also has radio buttons to select the transverse resolution in terms of the number of A-scans for each scan pass. By default, the number of A-scans is 512 for all protocols except the Fast Scan protocols (fixed at 768 A-scans total). You cannot adjust this number after you save the first scan in a series of related scans. In these cases, the radio buttons will be grayed out. This variable is also adjustable before initiating a scan through the Scan menu (see NUMBER OF A-SCANS, page 3-11).



VIDEO AND LAMP PARAMETER TAB This tab enables you to control video image brightness and contrast, and lamp brightness to suit your preference.

Figure 20 The Video and Lamp Parameter Tab Video Brightness and ContrastRadio buttons for dark and light eyes offer preset video brightness and contrast settings. Otherwise, move the sliders or type in the value fields to adjust the settings.

Lamp BrightnessThis affects the video image by increasing the illumination inside the eye. Move the slider or type in the value field to adjust the lamp brightness. Even the 100% setting is safe for the normal patient's eye.

INFORMATION TABS The lower left side of the SCAN ACQUISITION WINDOW has three informational tabs: Indicators, Details and Comment.

Indicators TabThis tab provides patient and scan information.

Figure 21 The Indicators Tab in SCAN ACQUISITION WINDOW

Details TabThis tab specifies the x and y position of the scan pattern, the landmark and the fixation LED, in mm with respect to the center of the video image. The 0,0 position is perfectly centered. It also shows the number of A-scans per second, which is fixed at 400.

Figure 22 The Details Tab in SCAN ACQUISITION WINDOW



Comment TabOnly the Comment Tab is interactive. Click it to type in comments about the scan or patient and store this information with the scan.

Figure 23 The Comment Tab in SCAN ACQUISITION WINDOW


SCAN ACQUISITION PROTOCOLS / 4-1

4 SCAN ACQUISITION PROTOCOLS

CHAPTER OVERVIEW This chapter explains the applications and attributes of the 19 scan acquisition protocols offered by the STRATUSOCT. While the previous two chapters provide operating instructions, this chapter is designed to help the user select which protocol to use and know how to use it. See Chapter 3 for instructions to apply these protocols. This chapter includes information about:

• THE SCAN TAB, from which you select protocols (below).• THE PROTOCOL GROUPS, listed in Activity groups (below).• GENERAL TIPS about the protocols (on page 4-2).• SCAN PROTOCOL DESCRIPTIONS, OPTIONS AND TIPS (on page 4-5).

THE SCAN TAB You can select scan acquisition protocols from the THE Scan Tab IN STRATUSOCT MAIN WINDOW (pictured on page 3-2).

• If not in the MAIN WINDOW, click the Select Acquisition Protocol button to display it, as pictured at left.

• If already in the MAIN WINDOW and the Scan Tab is not displayed, click the Scan Tab to display it.

• To select a protocol and initiate a scan, you can either click the protocol and then click the Scan button at the bottom, or double-click the protocol. See INITIATE A SCAN, page 3-2 and following for further operational instructions.

Scan Tab ViewsRight-click anywhere in the Scan Tab to select among four views:

• Details: In this view, the scan protocols are listed by Scan Groups (name) and include a Description column. You can drag the headings to rearrange the columns. Click on the headings to invert the order.

• Large Icon: In this view, the protocols are listed with icons that depict their scan pattern. You can drag the icons to rearrange their order.

• List: In this view, the protocols are listed by name only and cannot be rearranged.

• Small Icon: In this view, the protocols are listed by name only, but you can rearrange them by clicking and dragging.

THE PROTOCOL GROUPS The STRATUSOCT groups the scan protocols four ways for your convenience.

ACTIVITY RADIO BUTTONS The four Activity radio buttons above the Scan Tab enable you to display the protocol groups: those designed for examination for Glaucoma, or of the Retina (other retinal pathologies), All scan protocols and any Custom protocols you have created (see DEFINE CUSTOM SCAN on page 3-12). Nine of the 19 protocols fall in the Glaucoma and/or the Retina groups (three are in both). The others may be considered general-purpose scan protocols, and can be used to build custom scan protocols.

GLAUCOMA PROTOCOLS The protocols designed for glaucoma detection and management are:

1. REPEAT

2. MACULAR THICKNESS MAP

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3. OPTICAL DISC

4. RNFL THICKNESS (3.46)

5. RNFL THICKNESS (2.27XDISC)

6. FAST MACULAR THICKNESS MAP

7. FAST OPTICAL DISC

8. FAST RNFL THICKNESS (3.46)

9. FAST RNFL MAP

RETINA PROTOCOLS The protocols designed for other retinal pathologies are:

1. REPEAT

2. MACULAR THICKNESS MAP

3. FAST MACULAR THICKNESS MAP

ALL PROTOCOLS The All radio button displays all 19 protocols together. They are listed below in their default order on the Scan Tab.

1. REPEAT—Glaucoma and Retina2. LINE

3. CIRCLE

4. RASTER LINES

5. CROSS HAIR

6. RADIAL LINES

7. MACULAR THICKNESS MAP—Glaucoma and Retina8. OPTICAL DISC—Glaucoma9. PROPORTIONAL CIRCLE

10. CONCENTRIC 3 RINGS

11. RNFL THICKNESS (3.46)—Glaucoma12. NERVE HEAD CIRCLE

13. RNFL THICKNESS (2.27XDISC)—Glaucoma14. X-LINE

15. RNFL MAP

16. FAST MACULAR THICKNESS MAP—Glaucoma and Retina17. FAST OPTICAL DISC—Glaucoma18. FAST RNFL THICKNESS (3.46)—Glaucoma19. FAST RNFL MAP—Glaucoma

GENERAL TIPS The following information and usage tips apply to all scan protocols. SCAN PROTOCOL DESCRIPTIONS, OPTIONS AND TIPS, starting on page 4-5, provides a description for each protocol, including its adjustment options and specific usage tips.

SCAN PROTOCOLS ARE CORRELATED WITH ANALYSIS PROTOCOLS When selecting a scan protocol, it is important to keep in mind the analysis

protocol(s) that you can apply to the resulting scan image. The 18 analysis protocols are of two kinds: eleven QUANTITATIVE ANALYSIS PROTOCOLS (see page 6-4) and seven IMAGE PROCESSING PROTOCOLS (see page 6-19). Zeiss designed the image processing protocols for use with any scan. However, we designed each

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quantitative analysis protocol for use with a certain scan type (line or circle) or scan pattern made on a certain retinal location (macula or disc). Several of the scan protocols are designed for use with a limited subset of analysis protocols. An analysis protocol might work on an unintended scan type, but even if it does, it may not provide meaningful output. The table below shows the scan protocols for which we designed each quantitative analysis protocol.

TABLE OF CORRELATIONS

EXITING SCANS You may exit any scan at any time and return to the STRATUSOCT MAIN WINDOW by clicking the Cancel button or any of the three Select toolbar buttons.

• Line, Circle, Proportional Circle and the four Fast Scan protocols permit you to repeat the scan protocol multiple times. You must click Cancel to exit the SCAN ACQUISITION WINDOW.

• The other scan protocols consist of either a single scan or a limited number of scans. For these patterns, the STRATUSOCT returns you to the MAIN WINDOW automatically after you save the last scan in the series.

Exiting a Scan Series before Completion• If you exit a scan series before completing all the scans, the ones you have

already saved are not deleted automatically. They will appear in the list of the patient's scans.

WHICH SCAN PARAMETERS CAN BE ADJUSTED WHEN Scan parameters adjustable for some or all scan protocols include size, number of

lines, angle, number of A-scans, placement of scan pattern, fixation LED and

Analysis Protocol Designed for Scan Group(s)RETINAL THICKNESS Any scan protocol: 1 group on maculaRETINAL MAP RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 group

on maculaRETINAL THICKNESS/VOLUME RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 OS

group and/or 1 OD group on maculaRETINAL THICKNESS/VOLUME TABULAR

RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 OS and/or 1 OD group on macula

RETINAL THICKNESS/VOLUME CHANGE

RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 2 OS and/or 2 OD groups on macula

RNFL THICKNESS Any scan protocol: 1 group around discRNFL THICKNESS AVERAGE CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS

(3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: 1 OS and/or 1 OD of same radius around disc

RNFL THICKNESS MAP RNFL MAP, CONCENTRIC 3 RINGS: 1 OS and/or 1 OD group around disc

RNFL THICKNESS CHANGE CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: 2 OS and/or 2 OD of same radius around disc

RNFL THICKNESS SERIAL ANALYSIS

CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: Up to 4 OD and/or 4 OS groups of same radius around disc.

OPTIC NERVE HEAD (FAST) OPTICAL DISC: 1 group on disc



landmark. The individual SCAN PROTOCOL DESCRIPTIONS, OPTIONS AND TIPS (starting on page 4-5) explain which parameters you can adjust for each protocol. However, the following rules apply, with the noted exceptions. These rules are not repeated for each individual protocol.

• Scan and fixation LED placement are always adjustable—whenever the video image is live.

• Initial placement depends on the preceding scan in a series. When you save one scan in a series of scans, the next scan in the series begins with the same placement of the scan pattern, landmark and fixation LED.• Exception: The only exception is the RNFL Map protocol, which places

the scan pattern (but not the fixation LED) back in the center.• For scans in a related series, only scan and fixation LED placement are

adjustable after the first scan. Several scan protocols consist of a series of related scans you acquire one by one. To preserve the design integrity of these scan protocols, you cannot adjust the size, number of lines, number of A-scans or placement of the landmark after you save the first scan in the series. In this way, the analyses designed to apply to these scan protocols will be meaningful.• Exceptions: The only exceptions are the RNFL Thickness (3.46) and

the RNFL Map protocols. The former permits you to resize the aiming circle for all 3 scans; the latter permits you to adjust scan size for all 6 scans, and both permit you to adjust placement of all features for every scan.

• For scans in a related series, the landmark and scan are locked in their relative position after the first scan. This is so you can use the landmark as a siting feature, enabling you to keep each scan in a series in its preset pattern of relative placement. Thus, you can preserve the design integrity of the scan pattern and the meaningfulness of applicable analyses.

NUMBER OF A-SCANS By default, the number of A-scans is 512 for all protocols except the Fast Scan protocols (fixed at 768 A-scans total). However, you can adjust this number using the OCT IMAGE TAB while scanning (see page 3-12), or through the Scan Variables option on the Scan menu before scanning (see NUMBER OF A-SCANS, page 3-11). Note that in scan alignment mode, the aiming pattern always consists of 64 A-scans.

SIZE VS. RESOLUTION Note that scan resolution decreases as you increase scan size (length or radius). (To adjust scan size, see SIZE, page 3-10.) This is because the scanner takes a certain number of A-scans along each scan irrespective of size. (For most scans, you can adjust the number of A-scans—see ADJUST SCAN VARIABLES, page 3-11.) Conversely, scan resolution increases as you decrease scan size.

ALIGNING LARGE SCAN PATTERNS If the alignment is not correct for large scan patterns, part of the scan beam may be blocked at the pupil edge. This causes parts of the scan image to be very weak or absent entirely. In this case, reposition the PM a few millimeters laterally or vertically to accommodate the edge of the scan pattern. If this fails, try moving the PM 1-2 mm towards or away from the eye. When the alignment is correct, the scan image appears equally strong over its whole length.

MEASURING NERVE FIBER THICKNESS When you measure nerve fiber thickness using any of the circle scan types, it is desirable that the scan beam be as perpendicular to the retina as possible. As the scan proceeds around the circle, if the beam is not perpendicular, there may be



significant variation in axial range to the retinal surface. When this variation is minimized, the scan image appears most nearly horizontal on your monitor. Try to minimize this variation by adjusting the PM laterally by small amounts. This adjusts where the scan beam enters the pupil and its angle of incidence on the retina.

SCAN PROTOCOL DESCRIPTIONS, OPTIONS

AND TIPS

There are two basic scan patterns: lines and circles. The STRATUSOCT constructs all 19 scan protocols from line or circle scans. Below are descriptions of each scan protocol along with its adjustment options and tips. For instructions to adjust scan size, angle or number of lines, see ADJUST SCAN PATTERN PARAMETERS on page 3-10. To ADJUST SCAN PLACEMENT, see page 3-6. To OPTIMIZE SCAN IMAGE, see page 3-5.

REPEAT The Repeat protocol allows you to repeat any saved scan group using the same set of parameters. Repeated parameters include scan size, angle and placement, fixation LED placement and landmark placement. This protocol enables you to easily assess retinal changes between examinations and thereby to monitor pathologies. When you repeat a scan group, the parameters unique to each scan in the series are recalled and repeated in the same order. You cannot adjust any parameters except placement. To repeat a scan, select the desired scan group in the MAIN WINDOW. Then click Repeat.

• The LANDMARK (see page 3-7) is a useful tool to duplicate placement precisely.• When acquiring or reviewing a Repeat scan, click the Show Old Fundus

Image button to toggle between the current fundus video image and the saved fundus photo of the scan you are repeating. You can also click Scan > Show Old Fundus Image.

LINE Select Line to acquire multiple line scans without returning to the MAIN WINDOW. The default pattern is a horizontal line (0°) of length 5mm. You can adjust the length, angle and placement of each scan. This general-purpose protocol enables you to acquire multiple line scans, each of which you can repeat or tailor individually. You can average same-size scans in later analysis. You can also use this scan to build a custom protocol.

CIRCLE Select the Circle protocol to acquire multiple circle scans without returning to the MAIN WINDOW. Circle scans are normally applied around the optic disc (peripapillary region) to measure nerve fiber thickness. This general-purpose protocol enables you to acquire multiple circle scans, each of which you can repeat or tailor individually. You can average same-size scans in later analysis. You can also use this scan to build a custom protocol. The default pattern is a circle of radius 1.73 mm. You can adjust the radius of each scan.

RASTER LINES The Raster Lines protocol consists of a series of 6 to 24 equally spaced parallel line scans over a rectangular region the size of which you determine. This general-purpose protocol enables you to examine a rectangular region of interest on the retina more or less thoroughly, depending on the size of the region and number of lines employed. The default pattern has 6 lines over a 3 mm square. The scan series proceeds from superior to inferior; each scan proceeds from nasal to temporal.

• You can adjust the height and width of the aiming box, and the number of lines. The height of the aiming box affects the spacing between the lines. The width of the aiming box determines the line scan length. After you save the first scan in the series, you cannot make further adjustments.



CROSS HAIR The Cross Hair protocol consists of two perpendicular line scans that intersect at their centers to form a cross. This protocol is useful to examine a particular point of clinical interest in slices through the centers of the four quadrants. The default line scan is 3 mm long. You can adjust scan length by adjusting the height (affects vertical line) and width (affects horizontal line) before saving the first scan. After you save the first scan, you cannot make further adjustments.

RADIAL LINES The Radial Lines protocol consists of a series of 6 to 24 equally spaced line scans through a common central axis, like spokes on a wheel. It is a general-purpose pattern that is repeated in several other protocols with variations in size and adjustability of parameters. This protocol provides maximum adjustability, and you can use it to DEFINE CUSTOM SCANS (see page 3-12). The default pattern has 6 lines of 6 mm length. You can adjust the length of all the scan lines by adjusting the aiming circle size, or by adjusting the length of the first scan in the series. After you save the first scan in the series, you cannot make further adjustments.

MACULAR THICKNESS MAP The Macular Thickness Map protocol is a version of the radial lines pattern. It consists of a series of 6 to 24 equally spaced line scans through a common central axis. The diameter of the aiming circle (and thus line length) is fixed at 6 mm. The number of lines is adjustable until you save the first scan in the series. This protocol is designed for examination of macular thickness as an indicator of glaucoma. It is designed for use with the analyses that measure retinal thickness.

OPTICAL DISC The Optical Disc pattern is a 4 mm version of the radial lines pattern. It consists of a series of 6 to 24 equally spaced line scans through a common central axis. The diameter of the aiming circle (and thus line length) is fixed at 4 mm. The number of lines is adjustable until you save the first scan in the series. It is designed exclusively to examine the optic disc for indications of glaucoma. The scans you create with it are for use with the OPTIC NERVE HEAD analysis protocol (see page 6-13).

PROPORTIONAL CIRCLE The Proportional Circle protocol enables you to tailor a circle scan to account for the variability in size of the optic disc. This general-purpose protocol allows you to acquire multiple scans without returning to the MAIN WINDOW. You can average measurements from same-size scans later, and you can build custom scans with this protocol. The default pattern provides an aiming circle of 1.5 mm radius and a multiplication factor of 1. For each scan, you can adjust the size of the aiming circle and its multiplication factor, which together determine the scanning circle size. You can match the aiming circle size with the optic disc size. Then, through the multiplication factor, you can employ the scanning circle size you prefer, which you can then repeat for multiple scans.

CONCENTRIC 3 RINGS The Concentric 3 Rings protocol consists of three equally spaced concentric circle scans with radii in the ratio of 1:2:3. Like other circle scan patterns, this protocol is designed for use around the optic disc to measure nerve fiber thickness. You can use it to build custom scans. The default radii of the three circles are 0.9 mm, 1.81 mm and 2.71 mm. The scans proceed from smallest to largest. You can adjust the radius for each of the three circles, which can render the 1:2:3 ratio invalid. Note that when you change the radius of the first or second circle, the radius of the second or third circle reverts its predefined value of 1.81 or 2.71 mm.

Note: Since you can adjust the placement of the second and third scans, it is possible to render the circles non-concentric.



RNFL THICKNESS (3.46) The RNFL Thickness (3.46) protocol enables you to acquire three circle scans of diameter 3.46 mm around the optic disc. No parameters are alterable. The 3.46 mm diameter circle represents a standard or typical size used to measure RNFL thickness. This glaucoma protocol provides a simple way to acquire three scans that can be averaged and to which you can apply RNFL thickness analyses.

NERVE HEAD CIRCLE The Nerve Head Circle protocol enables you to acquire a single circle scan around the optic disc. The default pattern has an aiming circle of diameter 1.5 mm (“Radius 1"), and a scanning circle of diameter 3.46 mm (“Radius 2"). You can adjust both Radius 1 and Radius 2. This general-purpose protocol enables you to tailor a single circle to examine RNFL thickness. It can be used to build custom scans.

RNFL THICKNESS (2.27XDISC) Select RNFL Thickness (2.27xdisc) to acquire a single circle scan around the optic disc that is 2.27 times the radius of the aiming circle. The default pattern has an aiming circle of 1.5 mm radius. The multiplication factor is fixed at 2.27. You can adjust the aiming circle size. This glaucoma protocol enables you to account for variations in size of the optic disc as you measure RNFL thickness around it. The typical diameter of the optic disc is approximately 1.5 mm, and the standard circle around it to measure RNFL thickness is 3.46 mm diameter. It is from this ratio that the multiplication factor of 2.27 is derived (1.5 x 2.27 ≈ 3.46).

X-LINE The X-Line protocol consists of two line scans that intersect at their centers to form an X. This general-purpose protocol is useful to examine a particular point of clinical interest in slices through the periphery of the four quadrants. You can average same-size scans later and use this pattern to build custom scans. The default X pattern consists of two perpendicular lines of length 3 mm. You can adjust line scan length by adjusting the height and width of the imaginary box surrounding the X. Adjusting either height or width affects the length and angle of both lines equally. After you save the first scan, you cannot make further adjustments.

RNFL MAP The RNFL Map protocol consists of a set of six concentric circle scans of predetermined radius. The six scans proceed in order of increasing radius as follows, in mm: from 1.44 to 1.69 to 1.90 to 2.25 to 2.73 to 3.40. This glaucoma protocol is designed to thoroughly assess retinal nerve fiber layer thickness. The predetermined scan sizes provide optimum results for the RNFL THICKNESS MAP analysis protocol (see page 6-11).

• You can adjust the radius of each scan circle, although it is not advisable to do so if you plan to apply the RNFL Thickness Map analysis. When you change the radius or scan placement, the next scan circle reverts to the predetermined size and central placement.

TIME-EFFICIENT OR FAST SCANS The four time-efficient or fast scan protocols are designed to simplify the process and shorten the time to acquire the scan series used most frequently to detect glaucoma or other retinal pathologies. All four protocols share the following characteristics and advantages:

• They combine a three-scan or six-scan series into one scan acquired in 1.92 seconds.

• All parameters are fixed: you cannot adjust scan size or the number of lines.

Adjusting size of bounding box: At left: increased height. At right: increased width.



• Scan alignment and placement are required only once.• They may improve the accuracy of relative scan placement among the lines or

circles compared to acquiring scans one by one, because scans are acquired at almost the same time.

• You can acquire multiple scans without returning to the MAIN WINDOW. In effect, this enables you to repeat whole scan series for later analysis and comparison.

• After saving a fast scan, you can switch between the left and right eyes without returning to the MAIN WINDOW. The STRATUSOCT automatically detects which eye is being scanned and adjusts the display accordingly.

• They each acquire 768 A-scans total. These 768 A-scans are less than the total A-scans acquired one by one at 512 A-scans per line or circle. Note, however, that it is more than adequate for meaningful analysis with the applicable analysis protocols. Increased resolution for the fast scan types would require three or more seconds of scanning, which tends to introduce greater errors from patient movement.

Specialized Display of Fast Scans• The real-time scan image automatically divides into either a 3x2 display—for

Fast Macular Thickness Map, Fast Optical Disc and Fast RNFL Map—or a 3x1 display—for Fast RNFL Thickness (3.46)—so that you can observe each line or circle scan separately as it updates, and align appropriately.

Fast Macular Thickness MapThe Fast Macular Thickness Map protocol combines the six MACULAR THICKNESS MAP scans into one scan (see page 4-6). This protocol acquires six 6 mm radial line scans in 1.92 seconds of scanning. You cannot alter the size or number of lines. This retina protocol is designed for use with the retinal thickness analyses.

Fast Optical DiscThe Fast Optical Disc protocol combines the six OPTICAL DISC scans into one scan (see page 4-6). This protocol acquires six 4 mm radial line scans in 1.92 seconds of scanning. You cannot alter the size or number of lines. This glaucoma protocol is designed for the optic nerve head analysis.

Fast RNFL Thickness (3.46)The Fast RNFL Thickness (3.46) protocol combines the three RNFL THICKNESS (3.46) circle scans into one scan (see page 4-7). This protocol acquires three 3.46 mm diameter circle scans in 1.92 seconds of scanning. You cannot alter the size of the circles. This glaucoma protocol is designed for use with the RNFL thickness analyses.

Fast RNFL MapThe Fast RNFL Map protocol combines the six RNFL MAP concentric circle scans into one scan (see page 4-7). This protocol acquires six circle scans of predetermined radius in 1.92 seconds of scanning. You cannot alter the size or number of circles. This glaucoma protocol is designed for use with the RNFL THICKNESS MAP protocol.


ANALYZE SCANS / 5-1

5 ANALYZE SCANS

CHAPTER OVERVIEW Zeiss equips the STRATUSOCT with software to assist you with diagnostic analysis of scan images. This chapter explains how to analyze scans with the STRATUSOCT.

We designed the STRATUSOCT software for diagnostic analysis of the posterior segment of the eye, and particularly for detection of glaucomatous defects. To analyze scans using the STRATUSOCT software involves the following:

• INITIATE AN ANALYSIS (below).• SELECT A PATIENT and SELECT SCAN GROUP(S) (below).• SELECT AN ANALYSIS PROTOCOL (page 5-3). • CLICK ANALYZE OR SCAN SELECTION (page 5-3).

• The optional SELECTION WINDOW (page 5-4).• EXCLUDE SCANS FROM ANALYSIS and proceed (page 5-4).

Lastly, this chapter explains how to PRINT the analysis results (page 5-5). The STRATUSOCT has 18 analysis protocols to analyze scans you have acquired. Their characteristics and applications are covered in Chapter 6.

INITIATE AN ANALYSIS You must initiate analysis from the STRATUSOCT MAIN WINDOW. If not in the MAIN WINDOW, click the Select Analysis Protocol button to display it, as pictured at left. To initiate an analysis requires that you:

1. Select a patient.2. Select a scan group or groups.3. Select an analysis protocol.• An optional step is scan selection.

SELECT A PATIENT Click the desired name in the patient list to select it, or type in the Search field above to search by name or ID number. You can select one patient at a time. See THE PATIENT LIST on page 2-4 for tips on using the list and searching.

SELECT SCAN GROUP(S) Click to highlight the desired scan group in the scan list. Hold down the Ctrl (Control) key and click to select multiple groups.

The Scan ListThe scan list shows all saved scan groups of the selected patient.

Figure 24 The Scan List in the STRATUSOCT MAIN WINDOW

It is organized by scan Date, OD Scan Groups and OS Scan Groups. The latter two name the scan group by the scan acquisition protocol used (see Chapter 4). A number at the end of the group name (e.g., Circle 2) specifies the order in which groups of the same name were created.

• You can click on the Date heading to invert the order. • Click on a date to display scans acquired on that date.

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The Scan Group Images TabOn the lower left, this tab shows thumbnail scan and video images for the last selected group. When you select multiple groups, the last selected group is highlighted in a darker shade.

Figure 25 The Scan Group Images Tab in MAIN WINDOW

• You can adjust the size of the displayed images. Right-click anywhere in the frame and the pop-up menu gives you the options Larger, Smaller and Default. If necessary after enlargement, use the scroll bar on the right to view all the images. You can click Larger and Smaller several times.

• Optional Scan Selection Step: By default, all scans of each selected scan group are included in an analysis. In the Scan Group Images Tab, note that all scans are selected (highlighted in blue). If you do not wish to include all scans of the group, you may select scans for inclusion by clicking on their images. Hold the Ctrl (Control) key and click to select multiple scans. Only highlighted scans are included.Note: Some analyses assume or require a predetermined number of scans for analysis. Deselecting scans may prevent the analysis from working. Some analyses may work with less than the optimal number of scans, but yield output that relies more on interpolation and may be less accurate in interpolated areas.

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ANALYZE SCANS / 5-3

SELECT AN ANALYSIS PROTOCOL Select an analysis protocol using the Analyze Tab, pictured below.

Figure 26 The Analyze Tab in the STRATUSOCT MAIN WINDOW

CLICK ANALYZE OR SCAN SELECTION When you have selected a protocol, you can either:

1. Start the analysis immediately by clicking the Analyze button or by double-clicking the protocol;

Or:

2. Click the Scan Selection button to inspect one or more scans for exclusion from the analysis. This leads to the SELECTION WINDOW, described on page 5-4.

• Scan selection is optional, and you can do the same by using the Scan Group Images Tab, as explained on page 5-2.


5-4 / ANALYZE SCANS

SELECTION WINDOW When you click the Scan Selection button at the bottom of the Analyze Tab, the SELECTION WINDOW appears.

Figure 27 The SELECTION WINDOW

This window permits you to select which scans to include in the analysis. The window elements include thumbnail scan and video images accompanied by check boxes (on the left); the scan group list (upper left-center); the fundus video image (upper right) and the scan image (lower right) of the highlighted thumbnail (first scan by default). The window offers image adjustment controls for the scan image (lower left-center) and the video image (upper right).

• Click the Auto L/W button to reset the scan image. • Select the Log Abs. Reflectance checkbox to display the scan image color

scale, which indicates the reflectivity of the scan image above the background noise.

• Click the Export JPEG button to export the selected scan image.

EXCLUDE SCANS FROM ANALYSIS Use the SELECTION WINDOW to visually inspect scans for exclusion from the analysis. Click a thumbnail image to display it full-size.

• By default, the first group in the scan group list is highlighted. Click on the desired scan group in the list to display its images.

Note: JPEG compression entails loss of image data. Exported JPEG images are not intended for diagnostic use, but for use in presentations. In addition, they do not contain patient information. It is the clinician’s responsibility to associate patient information with exported images.


ANALYZE SCANS / 5-5

• Selected check boxes indicate which scans are included in the analysis. By default, all scans are included. Click to deselect the checkbox and exclude a scan from the analysis.

When you have made your selections, click Analyze to proceed with the analysis. If you do not wish to proceed, click Cancel at any time and return to the MAIN WINDOW.

PRINT To print any analysis output screen, select Print from the File menu (click File > Print), or click the Print button on the toolbar. The attached color printer prints the screen in about 10 seconds. Although the Print button is always active, in fact you can print only from analysis output screens.

CUSTOMIZE PRINTOUTS The STRATUSOCT enables you to customize your analysis printouts with a clinic name and logo (or other graphic). Once selected, these elements will appear in the lower right corner of all analysis printouts.

The logo graphic must be in bitmap format and have a “.bmp” extension. You must copy the logo graphic file from the source system to either a floppy disk or a DVD-RAM disk. Then on the STRATUSOCT, insert the disk into its drive and follow these steps:

1. You must access the Clinical Site ID dialog box through the STRATUSOCT BROWSER. To reach the STRATUSOCT BROWSER, select View from the Data menu (click Data > View).

2. In the STRATUSOCT BROWSER, select Clinical Site ID from the Utilities menu (click Utilities > Clinical Site ID). The Clinical Site ID dialog box appears.

Figure 28 The Clinical Site ID Dialog Box

Note: Most analysis protocols assume or require a predetermined number of scans in a group. Deselecting scans may prevent the analysis from working. Some analyses may work with less than the optimal number of scans, but yield output that relies more on interpolation and may be less accurate in interpolated areas.


5-6 / ANALYZE SCANS

3. To enter the clinic name, type up to 64 characters, including spaces, in the Clinical Site ID field.

4. To select a clinic logo for display on printouts, click the Browse button. Use the Browse dialog box to find the logo graphic file. If you are transferring the graphic file from floppy disk, look in the floppy (A:\) drive; if from DVD-RAM disk, look in the DVD (D:\) drive.

5. Select the logo graphic file and click OK. The graphic file is copied to the database on the STRATUSOCT. Back in the Clinical Site ID dialog box, the Preview pane displays the selected logo. Click the Save button when finished.Note: The logo is resized to fit the entire Preview pane. When printed, the logo is resized to fit in a small square area of fixed size. This can affect the appearance of the logo on printouts, especially if it is rectangular


ANALYSIS PROTOCOLS / 6-1

6 ANALYSIS PROTOCOLS

CHAPTER OVERVIEW The STRATUSOCT offers 18 analysis protocols, divided between:

• QUANTITATIVE ANALYSIS PROTOCOLS (eleven protocols, page 6-4).• IMAGE PROCESSING PROTOCOLS (seven protocols, page 6-19).

This chapter describes each analysis protocol and provides general and specific usage tips. See Chapter 5 ANALYZE SCANS for detailed instructions to perform analyses of scan images.

THE ANALYZE TAB You can select analysis protocols from THE Analyze Tab IN THE STRATUSOCT MAIN WINDOW (pictured on page 5-3). Click to select the desired analysis protocol.

• If not in the MAIN WINDOW, click the Select Analysis Protocol button to display it, as pictured at left.

• If already in the MAIN WINDOW and the Analyze Tab is not displayed, click the Analyze Tab to display it.

• To select a protocol and initiate analysis, you can either click the protocol and then CLICK ANALYZE OR SCAN SELECTION at the bottom, or double-click the protocol. See INITIATE AN ANALYSIS on page 5-1 for further instructions.

Analyze Tab ViewsYou can change the view of the protocol list. Right-click anywhere in the list and the pop-up menu gives you the options Details and List. Click one to adjust the view accordingly.

• In the default Details view, you can click the Protocol heading to invert the order.

Activity Radio ButtonsThe Activity radio buttons above the Analyze Tab group the analysis protocols according to their diagnostic application: Glaucoma, Retina (other retinal pathologies), and All. You cannot define custom analysis protocols, so the Custom radio button is unavailable.

PROTOCOL LISTS While you can group the 18 analysis protocols by their diagnostic application, it is important to understand an alternate grouping based on the distinction between quantitative analysis protocols and image processing protocols. Quantitative analysis protocols measure the scan images, while image processing protocols process the raw scan images into a more useful image.

• All 11 Glaucoma and Retina protocols are quantitative analysis protocols.• None of the 7 image processing protocols is a Glaucoma or Retina

protocol. They are applicable to any scan group.

QUANTITATIVE ANALYSIS PROTOCOLS The STRATUSOCT offers 11 quantitative analysis protocols, which you can group in

the Glaucoma and Retina lists. Glaucoma protocols number one through three are repeated in the Retina protocol list, since they are useful for both applications.

Note: You can apply only one analysis at a time. You cannot apply analysis protocols additively because no analysis changes the original scan image data on which all analyses are based.

STRATUSOCT USER MANUAL ANALYSIS PROTOCOLS / 6-1PN 55641-1 REV. A 4/03

6-2 / ANALYSIS PROTOCOLS

Glaucoma1. RETINAL THICKNESS/VOLUME (OU)2. RETINAL THICKNESS/VOLUME TABULAR (OU)3. RETINAL THICKNESS/VOLUME CHANGE (OU)4. RNFL THICKNESS (Single Eye)5. RNFL THICKNESS AVERAGE (OU)6. RNFL THICKNESS MAP (OU)7. RNFL THICKNESS CHANGE (OU)8. RNFL THICKNESS SERIAL ANALYSIS (OU)9. OPTIC NERVE HEAD (Single Eye)

Retina1. RETINAL THICKNESS (Single Eye)2. RETINAL MAP (Single Eye)3. RETINAL THICKNESS/VOLUME (OU)4. RETINAL THICKNESS/VOLUME TABULAR (OU)5. RETINAL THICKNESS/VOLUME CHANGE (OU)

IMAGE PROCESSING PROTOCOLS The STRATUSOCT offers seven image processing protocols. They apply mathematical algorithms to assist you with visual analysis of the scan image. They change the appearance of the scan image. They do not change the raw scan data. These protocols are applicable to any scan and fall in neither the Glaucoma group nor the Retina group. You must select the All radio button to access them.

1. NORMALIZE

2. ALIGN

3. NORMALIZE + ALIGN

4. GAUSSIAN SMOOTHING

5. MEDIAN SMOOTHING

6. PROPORTIONAL

7. SCAN PROFILE

GENERAL TIPS The following general information and usage tips apply to all analysis protocols. Starting below, this chapter provides a description and specific usage tips for each protocol.

ANALYSIS PROTOCOLS ARE CORRELATED WITH SCAN PATTERNS When selecting a protocol, it is important to remember that the 18 protocols are of

two kinds: 7 image processing protocols and 11 quantitative analysis protocols. Zeiss designed the image processing protocols for use with any scan. However, each quantitative analysis protocol is designed for use with a certain scan type (line or circle) or scan pattern made on a certain retinal location (macula or disc). Several of the scan protocols are designed for use with a specific analysis protocol, or with a limited subset of analysis protocols. An analysis protocol might work on an unintended scan type, but even if it does, it may not provide meaningful output. The table below shows the scan protocols designed for each quantitative analysis protocol.

6-2 / ANALYSIS PROTOCOLS STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03


TABLE OF CORRELATIONS

SCAN DIRECTION LEGEND

The analyses that display a processed scan image include a legend that indicates the path and direction of the currently displayed scan, as shown in the examples at left. The legend enables you to orient the scan image with respect to the scan path. The scan angle (in degrees, for line scans) is at lower right. See ANGLE on page 3-10 for an explanation of the angle notation.

SNR & ACCEPTED A-SCANS% The RETINAL THICKNESS and RNFL THICKNESS analyses display the signal to noise ratio (SNR) in decibels and Accepted A-scans% at bottom right. Zeiss provides these measures to enable the user to make judgments about the technical quality of particular scans. As a guideline, an exam having a SNR of less than or equal to 30dB, or less than 95% accepted A-scans, should be retaken. If the SNR is between 30 and 33dB, it may be advisable to retake the exam.

NORMATIVE DATA AND ITS APPLICABILITY.

Carl Zeiss Meditec gathered data from several hundred normal eyes acquired at multiple sites to create a normative database for RNFL thickness.

Analysis Protocol Designed for Scan Group(s)RETINAL THICKNESS Any scan protocol: 1 group on maculaRETINAL MAP RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 group

on maculaRETINAL THICKNESS/VOLUME RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 OS

group and/or 1 OD group on maculaRETINAL THICKNESS/VOLUME TABULAR

RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 1 OS and/or 1 OD group on macula

RETINAL THICKNESS/VOLUME CHANGE

RADIAL LINES, (FAST) MACULAR THICKNESS MAP: 2 OS and/or 2 OD groups on macula

RNFL THICKNESS Any scan protocol: 1 group around discRNFL THICKNESS AVERAGE CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS

(3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: 1 OS and/or 1 OD of same radius around disc

RNFL THICKNESS MAP RNFL MAP, CONCENTRIC 3 RINGS: 1 OS and/or 1 OD group around disc

RNFL THICKNESS CHANGE CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: 2 OS and/or 2 OD of same radius around disc

RNFL THICKNESS SERIAL ANALYSIS

CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE: Up to 4 OD and/or 4 OS groups of same radius around disc.

OPTIC NERVE HEAD (FAST) OPTICAL DISC: 1 group on disc

Disclaimer: Zeiss is not offering and does not offer advice or instruction in the diagnostic interpretation of OCT images. It is the clinician’s

responsibility to make diagnostic interpretations of OCT scans.

Note: RNFL normative data is an optional feature that may not be activated on all instruments. If you do not have this feature and want to purchase it, please contact Carl Zeiss Meditec. In the U.S.A., call 1-877-486-7473; outside the U.S.A., contact your local Carl Zeiss Meditec affiliate or distributor.



The scan protocols FAST RNFL THICKNESS (3.46) and RNFL THICKNESS (3.46) (at the default 512 A-scans per second) were used to acquire the normative data. The normative database is applicable only to scans acquired with these scan protocols. Normative data that is age-matched to the patient appears only when you perform the RNFL THICKNESS AVERAGE protocol on either FAST RNFL THICKNESS (3.46) scans or a single RNFL THICKNESS (3.46) scan at the default 512 A-scans per second.

• Normative data will not appear when you analyze two or more RNFL THICKNESS (3.46) scans that have been averaged, or if you analyze a FAST RNFL THICKNESS (3.46) scan from which scans have been deselected.

When the RNFL THICKNESS AVERAGE protocol is applied to an applicable scan type, the age-matched normative data appears. It uses a white-green-yellow-red color code, as seen in the legend at left, to indicate the normal distribution percentiles. The color code applies to each particular A-scan location in the graph, to the quadrant and clock hour averages in the circular graphs, and to the OD and OS columns of the data table. Among same-age individuals in the normal population, the percentiles apply to each particular RNFL thickness measurement as follows:

• The thinnest 1% of measurements fall in the red area. Measurements in red are considered outside normal limits (red < 1%, outside normal limits).

• The thinnest 5% of measurements fall in the yellow area or below (1% ≤ yellow < 5%, suspect).

• 90% of measurements fall in the green area (5% ≤ green ≤ 95%).• The thickest 5% of measurements fall in the white area (white > 95%).

QUANTITATIVE ANALYSIS PROTOCOLS

These protocols yield quantitative and visual information that facilitates the detection and management of retinal diseases, especially glaucoma.

GENERAL INFORMATION Methods to Measure Retinal and RNFL ThicknessThe STRATUSOCT calculates retinal thickness as the distance between the vitreoretinal interface (VRI) and the junction between the inner and outer segment of the photoreceptors, which is just above the retinal pigment epithelium (RPE). It calculates RNFL thickness as the distance between the VRI and the RNFL posterior boundary. The retinal and RNFL thickness algorithms use an iterative process, applying various techniques in a fixed and logical progression, first to obtain rough estimates of the layer boundaries, and then to refine the estimates. The algorithm calculations operate on reflectivity values (in decibels) in the individual A-scans. These algorithms take advantage of the STRATUSOCT’s high resolution, resulting in a highly refined objective measurement of retinal or RNFL thickness. The processed scan image shows the boundaries in white.

Note: Subject ethnicity was self-reported by the patients in the population comprising the normative database but was NOT used as a variable in constructing the normative database for RNFL thickness.Note: Normative data will not appear for patients under 18 years of age.

Note: Clinicians must exercise judgment in the interpretation of the normative data. For any particular measurement, note that 1 out of 20 normal eyes (5%) will fall below green.



RETINAL THICKNESS/VOLUME Application: Select Retinal Thickness/Volume to obtain for each eye two circular maps centered on the macula that depict retinal thickness and volume. This analysis protocol operates on one OD and/or one OS scan group made with the RADIAL LINES or (FAST) MACULAR THICKNESS MAP protocols.

Output Display

Figure 29 Retinal Thickness/Volume Analysis Output• The output display has the same layout for both thickness and volume

analysis. The upper map always presents retinal thickness using a color code. The color scale appears to the right. The lower map shows either average retinal thickness (in microns) or volume (in mm3) in each area. The default output is a thickness analysis. Click the radio button at upper right to display the volume analysis.

• A key of the map circle diameters appears at right below the color scale. The default diameters are 1, 3 and 6 mm. Click the 3.45 mm radio button at upper right to change to circle diameters of 1, 2.22, and 3.45 mm.

• On the lower right, numeric information for each eye includes: Foveal Thickness which represents the calculation of average thickness in microns +/- the standard deviation for the center point, where all the scans intersect; and Total Macular Volume of the retinal map area in mm3.



RETINAL THICKNESS/VOLUME TABULAR Application: Select Retinal Thickness/Volume Tabular to obtain all the output

of the RETINAL THICKNESS/VOLUME analysis (see above), plus a data table that includes thickness and volume quadrant averages, ratios and differences among the quadrants and between the eyes. This analysis protocol operates on one OD and/or one OS scan group made with the RADIAL LINES or (FAST) MACULAR THICKNESS MAP protocols.

Output DisplayThe output display includes all the elements of the RETINAL THICKNESS/VOLUME analysis (see above), with a slightly different arrangement to accommodate the table, pictured below.

Figure 30 Table from Retinal Thickness/Volume Tabular



RETINAL THICKNESS/VOLUME CHANGE Application: Select Retinal Thickness/Volume Change to assess changes in

retinal thickness or volume between examinations. This analysis protocol operates on 2 OD and/or 2 OS scan groups made with the RADIAL LINES or (FAST) MACULAR THICKNESS MAP protocols.

Output Display

Figure 31 Retinal Thickness/Volume Change Output• The default output displays thickness change between exams. Click the radio

button at upper right to display the volume change analysis. The output has the same layout for both thickness and volume change analysis. The upper map always presents retinal thickness change using a color code. The color scale appears to the right. The lower map shows the change in either average retinal thickness (in microns) or volume (in mm3).

• A key of the map circle diameters appears at right center. The default diameters are 1, 3 and 6 mm. Click the 3.45 mm radio button above to change to diameters of 1, 2.22 and 3.45 mm.



RNFL THICKNESS Application: Select RNFL Thickness to obtain graphs of retinal nerve fiber layer thickness along circle scans made around the optic disc (peripapillary region). You can apply this protocol to any one scan group at a time. While it functions with line scans, the output includes circle characteristics like quadrant and clock hour averages, which are not meaningful for line scans. Anomalous results occur for scans passing through, rather than around, the optic disc.

Output Display

Figure 32 RNFL Thickness Analysis Output• The output graphs show RNFL thickness (green line, in microns) on the

vertical axis versus A-scan location on the horizontal axis. The graph indicates the temporal, superior, nasal and inferior quadrants. If you analyzed more than one scan, use the scroll bar on the left to see the results for the other scans.

• You can find RNFL thickness at each A-scan location. Drag the pointer anywhere in the scan image or type in the A-Scan Value field and a vertical line on the graph appears corresponding to the pointer location. RNFL Thickness at that A-scan location appears at bottom right.

• Click the Caliper ON checkbox to measure distances between the cross-shaped calipers that appear. Caliper Length appears at bottom right.

• SNR & ACCEPTED A-SCANS% are displayed at bottom right. See page 6-3 for details on the use of these measures.

• On the lower left appear circular diagrams showing quadrant and clock-hour RNFL thickness averages. Overall RNFL Average thickness appears at lower right.



Export ResultsThe Export button enables you to export the results of the RNFL Thickness analysis. This feature enables you to further analyze and manipulate the data using third party software. When you click Export, a dialog box appears, prompting you for a filename. You can name the file and save it anywhere on the hard, floppy or DVD disk. The default name is Export_1. The output is a set of six files with the same name and different extensions, for example:

Export_1.txt (patient information in ASCII text format)Export_1.raw (raw scan data in binary format)Export_1.bmp (processed scan image in bitmap format)Export_1.vi1 (fundus video image in bitmap format)Export_1.spd (raw scan data in ASCII text format)Export_1.rnf (RNFL Thickness result in ASCII text format)

RNFL THICKNESS AVERAGE Application: Select RNFL Thickness Average to obtain graphs of RNFL thickness averaged over multiple circle scans of equal radius around the optic disc (peripapillary region). You can apply this analysis to one OD and/or one OS scan group of equal radius made from the CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE protocols. Normative data will appear in the output if you analyze FAST RNFL THICKNESS (3.46) or RNFL THICKNESS (3.46) scans with the appropriate number of scans selected, as described in NORMATIVE DATA AND ITS APPLICABILITY. on page 6-3.

Output Display

Figure 33 RNFL Thickness Average Analysis OutputThe graphs indicate the nasal, superior, temporal and inferior quadrants. When

Note: It is the clinician’s responsibility to associate patient information with exported files.



applied to the appropriate kinds of scans (see page 6-3), the OD and OS graphs include green, yellow and red areas. The color bands are based on the age-matched normative data. The color code applies to each particular A-scan location in the graph, to the quadrant and clock hour averages in the circular maps at top center, and to the OD and OS columns of the data table (but not to the OD–OS column). Among same-age individuals in the normal population, the percentiles apply to each particular RNFL thickness measurement as follows:

• The thinnest 1% of measurements fall in the red area. Measurements in red are considered outside normal limits (red < 1%, outside normal limits).

• 5% of measurements fall in the yellow area or below (1% ≤ yellow < 5%, suspect).

• 90% of measurements fall in the green area (5% ≤ green ≤ 95%).• The thickest 5% of measurements fall in the white area (white > 95%).

Tabular Data Defined

Note: Clinicians must exercise judgment in the interpretation of the normative data. For any particular measurement, note that 1 out of 20 normal eyes (5%) will fall below green. Note: Subject ethnicity was self-reported by the patients in the population comprising the normative database but was NOT used as a variable in constructing the normative database for RNFL thickness. Normative data will not appear for patients under 18 years of age. The normative data appears only when you analyze either FAST RNFL THICKNESS (3.46) scans or a single RNFL THICKNESS (3.46) scan at the default 512 A-scans per second. Normative data will not appear when you analyze two or more RNFL THICKNESS (3.46) scans that have been averaged, or if you analyze a FAST RNFL THICKNESS (3.46) scan from which scans have been deselected.

Smax/Imax: the maximum thickness in the superior quadrant divided by the maximum thickness in the inferior quadrant.Smax/Imax: the maximum thickness in the inferior quadrant divided by the maximum thickness in the superior quadrant.Smax/Tavg: the maximum thickness in the superior quadrant divided by the average thickness in the temporal quadrant.Imax/Tavg: the maximum thickness in the inferior quadrant divided by the average thickness in the temporal quadrant.Smax/Navg: the maximum thickness in the superior quadrant divided by the average thickness in the nasal quadrant.Max-Min: the maximum thickness minus the minimum thickness.Smax: the maximum thickness in the superior quadrant.Imax: the maximum thickness in the inferior quadrant.Savg: the average thickness in the superior quadrant.Iavg: the average thickness in the inferior quadrant.Avg. Thickness: thickness averaged over all 256 test points



RNFL THICKNESS MAP Application: Select RNFL Thickness Map to obtain for each eye two maps of RNFL thickness in an annular area around the optic disc (peripapillary region). You can apply this protocol to one OD and/or one OS scan group made from the (FAST) RNFL MAP or CONCENTRIC 3 RINGS protocols.

Output Display

Figure 34 RNFL Thickness Map Analysis Output• The upper map presents RNFL thickness using a color code. The color scale

appears at upper right. The lower map shows average RNFL thickness in the inner and outer areas of eight map sectors, in microns. A key of the map circle diameters appears at right center (fixed at 2.9 and 6.8 mm).



RNFL THICKNESS CHANGE Application: Select RNFL Thickness Change to assess changes in RNFL thickness between examinations. You can apply this protocol to two OD and/or two OS scan groups of equal radius made from the following protocols: CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE.

Output Display

Figure 35 RNFL Thickness Change Analysis Output• The graphs show RNFL thickness change between examinations (vertical

axis) versus A-scan location (horizontal axis). The graphs indicate the temporal, superior, nasal and inferior quadrants.

• To the right, circular diagrams show quadrant and clock-hour RNFL average thickness changes between examinations.



RNFL THICKNESS SERIAL ANALYSIS Application: Select RNFL Thickness Serial Analysis protocol to do a comparative analysis of RNFL thickness over time. You can apply this analysis simultaneously to up to four OD and/or four OS scan groups of equal radius and same scan type. You may choose from the following protocols: CIRCLE, PROPORTIONAL CIRCLE, (FAST) RNFL THICKNESS (3.46), RNFL THICKNESS (2.27XDISC) or NERVE HEAD CIRCLE.

Output Display

Figure 36 RNFL Thickness Serial Analysis Output• The legend at bottom distinguishes the lines by exam date.

OPTIC NERVE HEAD Application: Select Optic Nerve Head to access a multi-featured interactive analysis of the optic nerve head. You can apply this analysis to one (FAST) OPTICAL DISC scan group at a time. On the same display window, the output enables you to interactively assess and measure the optic nerve—disc, cup, rim and cup/disc ratios—using each scan individually and a composite of all scans.

Overview of the Analysis:Using six radially acquired cross-sectional line scans, Optic Nerve Head (ONH) analysis quantifies the amount of nerve fiber at the optic nerve head. It calculates two measures of nerve fiber quantity. One is the cross-sectional area of the nerve fiber above the cup. This is called the Rim Area (Vert. Cross Section). It is indicated in red on the individual radial scan (on the left side of the screen). The other measure is the minimum distance between the RPE and the RNFL surface. On each side of the nerve head, the analysis calculates this distance—indicated as yellow lines—then averages them to yield the Avg Nerve Width @ Disc. The analysis calculates these values for each of the radial line scans and then integrates them to give results for the entire nerve head. The analysis screen presents the integrated values on the right side along with a composite image of the nerve head constructed from all scans.



Method of Optic Nerve Head AnalysisFor each scan in the group, the Optic Nerve Head analysis detects the anterior surface of the RNFL and the RPE. It detects the RNFL surface by searching each A-scan from anterior to posterior until it finds reflectivity above a threshold value. From below the RNFL surface, it searches each A-scan posteriorly for the highest rate of change in reflectivity to find the RPE surface. Having determined these boundaries, the algorithm detects and measures all features of disc anatomy based on the anatomical markers (disc reference points) on each side of the disc where the RPE ends. It locates and measures the Disc Diameter by tracing a straight line between the two disc reference points. It measures Cup Diameter on a line parallel to the disc line and offset anteriorly by 150 microns (by default—Cup Offset is adjustable). It determines Rim Area using the cup line as a posterior boundary; for the rim lateral boundaries it uses lines extended from the disc reference points perpendicular to the disc line and up to the anterior surface of the disc. The results of these detection and measurement algorithms are displayed graphically on the scan image. In the output display, you can adjust the placement of the disc reference points, and thus the resulting measurements. Optic Nerve Head analysis then combines the analysis and measurement of each individual scan into a composite image and measurements of the whole optic nerve head.

Output Display

Figure 37 Optic Nerve Head Analysis Output



• Layout: The output display is divided in two sides. Each side has its own functionality, but the two sides also interact with each other. The left side shows an Individual Radial Scan Analysis. The right side shows the Optic Nerve Head Analysis Results.

Individual Radial Scan AnalysisThe left side has a large scan image (top) and a small video image (bottom) for each of the radial line scans. Use the left-side scroll bar to view the results for the rest of the scans. Between the two images appear disc, cup and rim measurements, and a set of tools to adjust the analysis and the scan image. The scan image has a color graphic overlay that defines the measured anatomical features, as follows.

• Selecting Scans for Inclusion in Analysis

• Individual Scan Image Measurements• Rim Area (Vertical Cross Section): The red-hashed area above the cup line

to anterior surface of disc.• Average Nerve Width @ Disc: The average of the nerve bundle widths at

the disc on each side, which appear as a straight yellow line from each disc reference point to the nearest point on the anterior surface.

• Disc Diameter: The straight, light blue line between the two disc reference points, indicated by a light blue cross inside a circle. The disc reference points correspond to the top and inner edges of the RPE, and this line is known as the RPE Anatomic line, or the disc line.

• Cup Diameter: The dashed, straight red line. This line extends into the rim in light blue, where it represents the posterior boundary of the rim.

• Rim Length (Horizontal): This is the disc diameter minus the cup diameter.Available Adjustments for Individual Radial Scan Analysis

• Move the Disc Reference Points: Click and drag the disc reference points to adjust the analysis. This is the most important interactive functionality because it determines all the measurements. We designed this feature in case the user believes, based on visual analysis of the scan image, that the disc reference points can be placed more accurately.

• ReAnalyze button: Click Reanalyze and the disc reference points will return to their original positions, along with the resulting measurements.

• Adj Display button: Click Adj Display to adjust the appearance of the scan image and/or the graphic overlay. It does not affect the measurements. When you click this button, the Adjust Display dialog box appears as at left, offering several graphics and color options.• The default scan image appearance is set from the data. There are four

window/level presets you can choose. You can adjust Level and Window separately: Use the sliders, or type a value in the fields from zero to 4095.

Note: The ONH analysis is unique in that you can deselect individual scans on the analysis output window and thereby exclude them from the analysis. To deselect a scan, clear the Use This Scan Data checkbox. The analysis changes immediately when you deselect the scan. Note further that deselecting individual scans in the SELECTION WINDOW (see page 5-4) is not effective when performing an ONH analysis. That is, all six radial line scans are always included even if you deselect the exams in the SELECTION WINDOW. This also applies when you deselect exams from THE STRATUSOCT ANALYSIS WINDOW (see page 7-8).



You can adjust the color of the graphic overlay independently using the Brightness slider at bottom. Click Set W/L from Data to return to the default image.

• Zoom: Click Z In to zoom in or Z Out to zoom out.• Clear Graphics button: Click Clear Graphics to remove the graphic

overlay. Click Show Graphics to reinstate them.• Surface Sensitivity: Ranging from zero to 20, the surface sensitivity value

determines what reflectivity threshold value is considered to be the anterior surface. Higher values create a higher threshold, meaning potential artifacts and noise are better ignored in defining the surface. This can affect measurements.

Optic Nerve Head (ONH) Analysis ResultsThe right side of the output display features a composite image of the nerve head constructed from all scans. It does not change as you scroll the individual scans, but it does incorporate the changes you make to each individual scan analysis. Below the composite image appears a set of whole optic nerve head measurements of the disc, cup, rim and disc/cup ratios. At far right and lower right are tools to adjust the composite image and its analysis, and to save multiple analysis results and select results previously saved.

Composite Image Features and FunctionalityThe composite image traces the outlines of the disc in red and the cup in green. It shows the longest vertical and horizontal lines across the disc and cup in red and green, respectively. The nasal (N), inferior (I), temporal (T) and superior (S) quadrants are indicated along with the eye (OD or OS). For each scan, it shows the disc reference points with a red cross inside a circle and the cup edges with small green crosses.

• The path of each scan is traced with a blue line, except for the scan currently displayed on the left side. It is traced in yellow and has a small yellow cross at one end that indicates its point of origin. You can click each line to change it to the currently displayed scan. If you adjust the scan image appearance or the placement of its disc reference points, its scan line will thereafter be traced in a lighter shade of blue, until you Reanalyze it. The new position of the disc reference points will be reflected in the composite image.

• You can click buttons to Zoom In, Zoom Out and Clear Points on the composite image.

• Composite Image Measurements• Vertical Integrated Rim Area (Volume): This is an estimate of the total

volume of RNFL tissue in the rim calculated by multiplying the average of the individual rim areas times the circumference of the disc.

• Horizontal Integrated Rim Width (Area): This is an estimate of the total rim area calculated by multiplying the average of the individual nerve widths times the circumference of the disc.

• Disc Area: The area bounded by the red outline of the disc in the composite image.

• Cup Area: The area bounded by the green outline of the cup in the composite image.

• Rim Area: Disc area minus cup area.



• Cup/Disc Area Ratio: Ratio of cup area to disc area.• Cup/Disc Horizontal Ratio: Ratio of the longest horizontal line across the

cup to the longest horizontal line across the disc.• Cup/Disc Vertical Ratio: Ratio of the longest vertical line across the cup to

the longest vertical line across the disc.• Image Background Options: You can select among three image

background options. Click a check box at lower right to change the appearance of depth and contour in the image: • None: This default option shows a solid gray background without any

appearance of depth.• Aligned to Disc: This option shows the retina surface as background to

the disc and cup plots using a shaded gray surface in a way similar to a shaded relief topographic map. This option attempts to correct for movement of the retina between scans by using the disc positions within each radial scan. The blue shading represents the surface and volume of the cup, as if it were filled with water to its surface. The surface of the cup, and hence the blue shading, is adjustable via the Cup Offset for Topo setting. (“Topo” refers to the topographic map of the retinal surface). Cup Area and Cup Volume measurements based on the adjustable cup surface appear at bottom right. Because of the scan alignment, the cup area calculated from the topo can differ from the cup area calculated from the planar cup positions.

• Aligned to Surface: This option differs from the previous option only in the type of alignment used to correct for retinal motion. In this case, the retinal surface is used.

• Save Current Result/Select a Saved Result: Click the Save Current Result button on the lower right to save the current Optic Nerve Head analysis results. This is useful if you adjust the placement of the disc reference points for one or more scan lines, and wish to be able to recall the resulting measurements and images. This feature enables you to save and recall several variations of the ONH analysis, depending on the combination of adjustments you make to disc reference points of the individual scan lines. By default, the ONH analysis reanalyzes the scan data and displays the original result each time you run it. Use the Select a saved Result drop-down list to select a result you have saved previously.



RETINAL THICKNESS Application: Select Retinal Thickness to obtain graphs of retinal thickness for any scan. Retinal Thickness analyzes any one scan group at a time.

Output Display

Figure 38 Retinal Thickness Analysis Output• The output graph shows retinal thickness (green line, in microns) on the

vertical axis versus A-scan location on the horizontal axis. The scale is linear. If you analyzed more than one scan, use the scroll bar on the left to see results for the other scans.

• You can find the retinal thickness at any one of the A-scan locations. Drag the pointer anywhere in the scan image or type in the A-Scan Value field and a vertical line corresponding to the selected A-scan location appears on the graph. Retinal Thickness at that location appears in microns at bottom right.

• Click the Caliper ON checkbox to measure distances between the cross-shaped calipers that appear. Caliper Length appears at bottom right.

• SNR and Accepted A-scans% appear at bottom right. See SNR & ACCEPTED A-SCANS% on page 6-3 for details on the use of these measures.

Export ResultsThe Export button enables you to export the results of the Retinal Thickness analysis. This feature enables you to further analyze and manipulate the data using third party software. See EXPORT RESULTS on page 6-9 for instructions to use the export feature.

RETINAL MAP Application: Select Retinal Map to obtain two maps of retinal thickness in a circular area centered on the macula. One map shows retinal thickness using a color code, and the other shows average retinal thickness (in microns) in nine map sectors. This analysis protocol operates on one RADIAL LINES or (FAST) MACULAR THICKNESS MAP scan group at a time. These scan protocols consist of a group of 6 to 24 line scans arranged in a spoke pattern. The algorithm computes retinal



thickness separately for each line scan, and combines the results to construct the circular maps.

Output Display

Figure 39 Retinal Map Analysis Output• On the lower left, the analysis output includes two retinal thickness maps. The

left map presents retinal thickness using a color code. The color scale appears below. The right map shows average retinal thickness in each area, in microns. Each map consists of three concentric circles, the outer two divided into sectors. A key of the map circle diameters appears at lower center. Just above the key is a pair of radio buttons to adjust the display.

• The default map circle diameters are 1, 3 and 6 mm. Click the 3.45 mm radio button to change to circle diameters of 1, 2.22 and 3.45 mm.

• On the lower right, numeric information includes Center, which represents the calculation of average thickness (in microns) +/- the standard deviation for the center point, where all six scans intersect; and Total Volume of the retinal map area in mm3.

IMAGE PROCESSING PROTOCOLS

The STRATUSOCT offers seven image processing protocols to assist with visual analysis of the scan image:

1. NORMALIZE

2. ALIGN

3. NORMALIZE + ALIGN

4. GAUSSIAN SMOOTHING

5. MEDIAN SMOOTHING

6. PROPORTIONAL

7. SCAN PROFILE



These protocols apply mathematical algorithms to change the appearance of the scan image. They do not change the raw scan data. All these protocols operate on only one scan group at a time. If you select more than one group, only the first group will be processed.

FORMAT OF DISPLAY Six of seven image processing protocols share a common format of display, as seen below. The exception is the Scan Profile protocol.

Figure 40 Common Output Window for Image ProcessingThe top left quadrant shows the processed OCT Image. The bottom left shows the raw Scanned Image. The top right shows the fundus Video Image. The bottom right shows Personal and Scan information. Use the scroll bar on the left to view the results for each scan in the group. You can adjust the appearance of the processed scan image with the controls located at top center.

NORMALIZE Select Normalize to eliminate background noise and to use the whole color scale in the processed scan image. This function normalizes scan images with respect to noise and signal strength. In other words, when you apply this function to scan images made with different noise or signal strength, the resulting images appear equally “bright,” i.e., have the same range of color.

The scan image false color scale operates in a signal value range of 0—255. Normalize displays as zero (black) data points with values less than or equal to the average noise level. It displays as 255 (saturated or white) data points with values greater than or equal to the maximum signal value minus a fixed constant. It adjusts intervening signal values to maintain their relative position in the new range. The resulting scan image uses the entire color scale to express the relative reflectivity of the retinal structures between the noise and saturation signal levels.

ALIGN Select Align to correct the data for effects due to patient motion in the axial direction. Slight movements of the head toward and away from the instrument



cause the scan image to shift vertically, resulting in low-frequency “wiggles.” (This also happens if the scan beam is not perpendicular to the retina over the whole scan—see ALIGNING LARGE SCAN PATTERNS on page 4-4.) To correct for this movement, this algorithm compares each of the longitudinal samples (A-scans) in the data set with its neighbor in a process called correlation. In effect, it slides A-scan 2 in relation to A-scan 1 until the data align. Then it slides A-scan 3 in relation to the now-aligned A-scan 2, and so on until all A-scans are aligned.

NORMALIZE + ALIGN Select Normalize + Align to perform both the above functions.

GAUSSIAN SMOOTHING The two smoothing functions average out noise and blend the colors of the scan image. Smoothing may be useful to appreciate more fully the large-scale features in the data. The drawback, of course, is that some small details may be lost.

Gaussian Smoothing works by calculating a moving average of signal values in a 3 × 3 region. It weights the signal values according to a Gaussian function, such that the outer points in the region are weighted less than the center point.

MEDIAN SMOOTHING Median Smoothing is similar to Gaussian smoothing, except that it uses the median value of the 3 × 3 region (i.e., the middle value when ordered by size) instead of the moving average value weighted by location. The advantage of Median Smoothing is that it removes noise while preserving small details in the data.

PROPORTIONAL Select Proportional to obtain a processed scan image that is true in its horizontal and vertical proportions. Compared to the usual presentation of STRATUSOCT scan images, the proportional scan image appears compressed vertically. This is because STRATUSOCT scan images are usually presented in a fixed size that elongates the image vertically, in order to allow the viewer to perceive more detail throughout the longitudinal plane of the retina. Since scans are of varying length, the proportional scan image may appear either horizontally elongated or compressed in comparison to the usual presentation, depending on the actual scan length.

Note: The Align function may introduce artifacts in the scan image, since it cannot distinguish true retinal height changes from apparent changes due to patient motion. Furthermore, the process does not work equally well on all types of images. The operator must use judgment in interpreting the results.



SCAN PROFILE Select Scan Profile to display an interactive profile of all signal values for any single scan group, as pictured below.

Figure 41 Scan Profile Analysis OutputThis protocol provides signal values for all 1024 data points of each A-scan, and has features for detailed comparative and technical analysis of the scan data.

The primary output is a graph of interferometer Signal Intensity values (reflectivity) for all 1024 longitudinal data points of each A-scan. The output graph shows signal values of the first A-scan location by default. The Scanned Image (upper left) is unprocessed. When you move the pointer over the scan image, the graph changes dynamically with A-scan location. Under Cursors Information, the current A-scan location appears at lower right (e.g., “At Location ==> 1").

Measure A-Scan LocationYou can measure and compare signal values at each A-scan location. The graph offers three cursors to measure and compare signal values through the depth of each A-scan. Each A-scan consists of 1024 data points on the longitudinal axis (from 1 to 1024 anterior to posterior) over 2 mm of depth. There are two vertical cursors. You can drag the red cursor 1 or green cursor 2 along the 1024 data points. At lower right, the signal value at the indicated data point appears in decibels. For example, the red “Cursor 1 Value is 12.1 dB at [data point] 253.” At bottom right, “Difference is” and “Distance is” give, respectively, the signal value difference and distance between the red and green cursors. The blue horizontal cursor has a particular purpose described next.

Signal Offset Threshold ComparisonThe blue cursor 3 enables you to make threshold comparisons among the signal values in the A-scan. The blue cursor has a second horizontal line offset from it by 6.8 decibels by default. You can change the offset value by clicking in the “Offset is” field, typing a new number and clicking the Change button next to it. The



offset value range is -56 to +56 decibels. By aligning the blue cursor or its offset line with a particular signal value—usually a signal peak or trough on the graph—you can visually identify data points that cross or fail to cross the chosen offset threshold.


THE STRATUSOCT BROWSER: DATA MANAGEMENT / 7-1

7 THE STRATUSOCT BROWSER: DATA MANAGEMENT

CHAPTER OVERVIEW This chapter introduces the STRATUSOCT BROWSER and explains its uses for data management. The topics covered in the current chapter include:

• THE STRATUSOCT BROWSER, page 7-2

• FIND AND SELECT RECORDS, page 7-5

• ANALYZE EXAMS, page 7-7

• CATEGORIZE PATIENT RECORDS, page 7-9

• CREATE AND ASSIGN PATIENT DIAGNOSES, page 7-11

• REGISTER, EDIT AND ASSIGN MEDICAL STAFF, page 7-13

• REGISTER, EDIT AND ASSIGN INSURANCE COMPANIES, page 7-15

• ADD A NEW PATIENT, page 7-16

• EDIT PATIENT RECORDS, page 7-18

• MERGE PATIENT RECORDS, page 7-18

• CREATE AND EDIT VISIT RECORDS, page 7-19

• EDIT EXAM RECORD REMARKS AND NOTES, page 7-20

• EDIT CLINICAL NOTES, page 7-21

• DELETE EXAM, VISIT AND PATIENT RECORDS, page 7-21

This manual treats data transfer functions in separate chapters:

• ARCHIVE SCANS & BACKUP DATABASE, Chapter 8.

OPEN AND CLOSE THE STRATUSOCT BROWSER Open

When you select any of the Data menu options from the STRATUSOCT MAIN WINDOW, the STRATUSOCT BROWSER launches.

• When you click View, the BROWSER opens in Data Management/Review mode. When you click Archive, the BROWSER opens in Data Transfer Mode. The difference is that checkboxes appear next to the records in Data Transfer Mode, so you can select records for data transfer (archive).• You can switch modes in the BROWSER by selecting from the options in the

View menu.CloseTo exit the BROWSER and return to the MAIN WINDOW, select Exit from the File menu (click File > Exit) or click the at upper right. You cannot exit the STRATUSOCT software entirely from the BROWSER.

STRATUSOCT USER MANUAL THE STRATUSOCT BROWSER: DATA MANAGEMENT / 7-1PN 55641-1 REV. A 4/03

7-2 / THE STRATUSOCT BROWSER: DATA MANAGEMENT

THE STRATUSOCT BROWSER The STRATUSOCT BROWSER enables you to manage the patient and scan data you have collected. Here we introduces its features, menus and buttons.

Figure 42 Features of the STRATUSOCT BROWSER

CUSTOMIZE THE BROWSER LAYOUT The STRATUSOCT BROWSER displays three kinds of lists: Patients, Visits and Exams. You can customize certain elements of the layout of these lists.

• You can resize the Patients, Visits and Exams areas: move the pointer over a vertical border separating two areas until the resize cursor appears, as shown at right. Then, click and drag to resize.

• The Exams list can be made to completely cover the Visits list. In this case, when you select a patient, all of that patient’s exams will appear in the Exams list.

Patients AreaThe Patients area always lists names alphabetically by last name and may not be customized (except for the size of the area).

Visits AreaThe Visits area lists visits by most recent date, by default. You can click any of the column headings to invert the date order. You can click and drag the column headings to rearrange the columns.

Caption BarMenu Bar

ToolbarSearch Now

Button and Fields

Patient, Visitand ExamRecord Areas

Current PatientInformation

Note: Numbers are considered prior to letters in ordering of all lists.

7-2 / THE STRATUSOCT BROWSER: DATA MANAGEMENT STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03


• You can resize the column width by moving the pointer over the border between the column headings until the Resize Column cursor appears, as shown at right. Then click and drag to resize the column.

Exams AreaThe Exams area lists exams by date and time, most recent first, by default.

• You can sort the exams by Eye, Type or Instrument by clicking on the so-named column headings.

• Click again on any column heading to invert the order.• You can click and drag the column headings to rearrange the columns.• You can resize the column width by moving the pointer over the border

between the column headings until the Resize Column cursor appears, as shown at right above. Then click and drag to resize the column.

BROWSER MENUS The STRATUSOCT BROWSER menu bar enables you to access all data management functions. The menu bar menus, which often correspond to the toolbar buttons, contain the following items:

File Menu• Export: This feature is for use in clinical studies only, in consultation with

Carl Zeiss Meditec.• Archive: Enables you to archive records to a DVD-RAM disk.• Select All/Deselect All: Click Select All to select all records. Once records

are selected, the menu item becomes Deselect All, by which you can deselect all selected exams.

• Exit: Quits the STRATUSOCT BROWSER.

Record Menu • Search: Opens the RECORD SEARCH WINDOW where you can enter or select search criteria and execute patient record searches.

• Patient: Opens the PATIENT RECORD WINDOW where you can create, edit or delete patient records.

• Clinical Notes: Opens the CLINICAL NOTES WINDOW where you can view Visit Notes, Exam Remarks and Exam Notes.

• Visit: Opens the VISIT RECORD WINDOW where you can create, edit or delete visit records.

• All Visits: Opens the VISIT HISTORY WINDOW, through which you can manage all of a patient’s visit records.

• Exam: Opens the EXAM RECORD WINDOW where you can edit or delete exam records.

• Categories: Enables you to open two windows, as follows:• CATEGORIZE PATIENT RECORDS WINDOW to categorize records.• RECORD CATEGORY SETTINGS WINDOW to create, edit or delete categories.

• Refresh: Refreshes the list of displayed records.



WHAT DOES THAT BUTTON DO?

The STRATUSOCT BROWSER toolbar enables you to access the most commonly used functions. This section shows the most commonly used STRATUSOCT BROWSER buttons and briefly explains their function. The BROWSER toolbar buttons are displayed first. Other buttons are found on one or more other windows accessed through the BROWSER.

View Menu• Select Data Transfer Mode to enable selection of records for data transfer.

Checkboxes will appear next to all records.• Select Data Management/Review mode for data management functions

that do not involve data transfer (export or archive).

Analysis Menu• Stratus OCT: Opens the STRATUSOCT ANALYSIS WINDOW where you can select

scans and an analysis protocol and launch an analysis.• Analyze: Opens the STRATUSOCT ANALYSIS WINDOW where you can select

scans and an analysis protocol and launch an analysis.

Utilities Menu • Register Staff: Opens the STAFF REGISTRATION WINDOW where you can create, edit or delete staff records.

• Register Insurance Companies: Opens the INSURANCE COMPANY REGISTRATION WINDOW where you can create, edit or delete insurance company information.

• Register Diagnoses: Opens the DIAGNOSIS REGISTRATION WINDOW where you can create, edit or delete short and long form diagnosis names.

• Clinical Site ID: Enables you to add or change the clinic name and logo, which will appear on all analysis printouts.

Options Menu

• Toolbar: Activates (checked) or deactivates (unchecked) toolbar display.

Records Search buttonOpens the RECORD SEARCH WINDOW where you can select criteria and search for patient records.Patient Record buttonOpens the PATIENT RECORD WINDOW where you can create, edit or delete patient records.Visit Record buttonOpens the VISIT RECORD WINDOW where you can create, edit or delete visit records.All Visit Records buttonOpens the VISIT HISTORY WINDOW where you can manage all of a patient’s visit records.



FIND AND SELECT RECORDS This section explains how to find and select records with the STRATUSOCT BROWSER, which is necessary to analyze or manage them. Topics covered include:

• SEARCH FOR PATIENTS, below• SELECT PATIENT, VISIT AND EXAM RECORDS, page 7-7

Search for PatientsThe search function enables you to find the patient records you want. You can search in two ways:

1. Use the Search Now button and search fields in the STRATUSOCT BROWSER.

Figure 43 Search Now Button and Fields in STRATUSOCT BROWSER

• If you click the Search Now button without entering anything in the search fields, STRATUSOCT will return every name in the database.

Categorize Patient Records buttonOpens the CATEGORIZE PATIENT RECORDS WINDOW where you can apply categories to and remove them from patient records.Analyze buttonOpens the STRATUSOCT ANALYSIS WINDOW where you can select scans for analysis and an analysis protocol.Refresh buttonRefreshes the BROWSER to reflect the addition of new records.Create New Record buttonEnables you to create a new record in the current context.Edit Current Record buttonActivates the fields in the current record so you can edit them.Save Record buttonSaves the current record.Delete Current Record buttonDeletes the current record.Undo Changes buttonCancels the changes you have made.Search Now buttonExecutes a record search according to the criteria you have entered/selected in the RECORD SEARCH WINDOW.Clinical Notes buttonOpens the CLINICAL NOTES WINDOW where you can view the clinical notes.Add/Remove Diagnoses button (OD or OS)Opens the ADD/REMOVE DIAGNOSES WINDOW, enabling you to add and remove diagnoses from a patient record.



• To refine your search, type in one or more search fields, and then click Search Now or press Enter. If you enter partial information, STRATUSOCT searches based on that. For example, if you enter just the letter ‘p’ in the Last Name field, it returns all patients whose last name begin with ‘p’.

2. Use the RECORD SEARCH WINDOW.

Figure 44 The RECORD SEARCH WINDOW

• To access it, either click the Records Search button or select Search in the Record menu.

• To use it, type in one or more fields or use the drop-down menus to select search criteria. Then click Search Now or press Enter. To start over, click Delete All Search Criteria.

• You cannot type in fields with drop-down menus but must select from the available options. You must have created insurance companies, physicians and diagnoses using the Utilities menu options. You must have created categories using the Record > Categories option.

• You can search using any combination of criteria.• After you perform a search, the search area of the BROWSER displays the

search criteria you last used above the Search Now button and fields, as below.

Figure 45 Search Area Showing Last Criteria

OR



• To clear the additional search criteria from the BROWSER, you must return to the RECORD SEARCH WINDOW, click Delete All Search Criteria, and then click Search Now or press Enter.

• The RECORD SEARCH WINDOW does not close automatically after you search; it gives you the option of searching again. Close it when you wish.

SELECT PATIENT, VISIT AND EXAM RECORDS

The results of your search are displayed in the STRATUSOCT BROWSER. Results are listed by patient only. You must click a patient to display visits and a visit to display exams.

Select PatientsYou may select multiple patients, for example, for the purpose of categorizing their records. (See CATEGORIZE PATIENT RECORDS on page 7-9.) To select patients: click on one, Ctrl-click on multiple patients, Shift-click on two patients and all intervening names will be selected, or just click and drag in the list to select multiple adjacent patients.

• If you select more than one patient, no visits or exams will appear.• If you select only one patient, a list of his visits will appear in the Visits list.

Select VisitsTo select visits: click on one, Ctrl-click on multiple visits, Shift-click on an adjacent range, or just click and drag in the list to select multiple adjacent visits. The exams for every selected visit will appear in the Exams list.

Select ExamsTo select exams: click on one, Ctrl-click on multiple exams, Shift-click on an adjacent range, or just click and drag in the list to select multiple adjacent exams.

After you select patient visit(s) or exam(s), you can analyze the exam(s) and display the results. For details, see ANALYZE EXAMS, page 7-7.

ANALYZE EXAMS This section explains how to initiate analyses from the STRATUSOCT BROWSER.

HOW TO RUN ANALYSES The ways to run analyses from the STRATUSOCT BROWSER are as follows:

• Double-click Exam: Double-click on one exam (scan group). You will be able to exclude individual scans from the analysis.

• Use the Analyze Button: Or, select one or more exams and click the Analyze button. The Analyze option is also available in the Analysis menu.

• Analysis Menu: Seen at left: Stratus OCT and Analyze do the same thing.• Double-click Patient: You can also double-click on one patient and select

exams from all that patient’s scan groups.• Double-click Visit(s): You can double-click on one or more visits and select

exams from the selected visit(s).• Right-click Patient, Visits or Exams: You can right-click on one patient, or

one or more selected visits or exams and select Stratus OCT or Analyze.



THE ANALYSIS WINDOW Since the STRATUSOCT BROWSER does not provide for selection of an analysis protocol, all analyses initiated from the BROWSER lead to the STRATUSOCT ANALYSIS WINDOW, where you can select an analysis protocol as well as which scans to include in the analysis.

Figure 46 The STRATUSOCT ANALYSIS WINDOW

The STRATUSOCT ANALYSIS WINDOW is like the SELECTION WINDOW (see page 5-4), except that it also offers the ability to choose an analysis protocol. What exams are available for selection in the STRATUSOCT ANALYSIS WINDOW depends on whether you first select a patient, one or more visits, or one or more exams.

• If you first select a patient, all exams from all visits will be available for selection; if you start with a visit, all exams from that visit will be available; if you select individual exams, only those exams will be available to choose from.

• You can also initiate analyses from the STRATUSOCT MAIN WINDOW. For details on this alternative, see Chapter 5 ANALYZE SCANS. For information on the ANALYSIS PROTOCOLS, see Chapter 6.

• Click the Export JPEG button to export the selected scan image.Note: JPEG compression entails loss of image data. Exported JPEG images are not intended for diagnostic use, but for use in presentations. In addition, they do not contain patient information. It is the clinician’s responsibility to associate patient information with exported images.



CATEGORIZE PATIENT RECORDS

You can create your own categories and place patient records in them. This enables you to search for groups of patient records by category.

• Note: Category names are case-sensitive, which affects their uniqueness in searching for them. For example, “control group” and “Control Group” would be treated as different categories.

The search function in the STRATUSOCT BROWSER already enables you to find patient records based on the following criteria: first, middle and last name, patient ID, gender, date of birth, visit date, insurance company, insurance ID number, physician, diagnoses, and exam type. You can even search for key words in visit or exam notes. Still, any number of reasons may prompt you to create and use categories as an additional search criteria. For example, in larger institutions that have thousands of patient records, creating categories enables you to subdivide a very large database. This reduces search time and generally makes managing patient records easier. As another example, you may create categories to contain patients who participate in a study.

In general, the advantage of the categories function is that it provides you the ability to create groups of your own design for any reason, and to directly control their membership. All other search criteria arise from objective data (with the exception of diagnoses that you create and assign, albeit based on exam data).

CREATE, EDIT AND DELETE CATEGORIES Create

Only the Examples category is pre-installed. To create new categories, follow these steps:

1. Click on the Record menu in the menu bar of the BROWSER.

Figure 47 The Record > Categories Menu2. Select Categories > Category Settings from the Record menu.



The RECORD CATEGORY SETTINGS WINDOW appears.

Figure 48 The RECORD CATEGORY SETTINGS WINDOW

3. Click the New Patient Record Category button. 4. Type the desired name in the Patient Record Category Name field.

• If before saving you decide not to create a new category, click the Undo Changes button or just close the window. A dialog will ask you to confirm that you wish to discard the edits. Click OK to discard or Cancel to continue typing the category name.

5. When you have entered the new category name, click the Save Patient Record Category button. You can repeat steps 3 through 5 to create additional categories.

EditTo edit a category name, click the category name you wish to edit and then click the Edit Selected Patient Record Category button. Edit the name and click the Save Patient Record Category button.

DeleteTo delete a category and remove references to it in all records, click the category you wish to delete and then click the Delete Selected Patient Record Category button. You must confirm your choice in the CONFIRM dialog box.

PLACE PATIENT RECORDS IN CATEGORIES To place patient records into categories you have created, follow these steps:

Note: If you edit a category that you have already assigned to one or more patients, the edited category name is still attached to those patients. Therefore, you can find those patients by searching for the edited category name.



1. Select one or more patients to categorize in the BROWSER Patients list: click on one, Ctrl-click on multiple patients, Shift-click on two patients and all intervening names will be selected, or just click and drag in the list to select multiple adjacent patients.

2. Then click the Categorize Patient Records button. This option is also available under Categories in the Record menu (see FIGURE 47), or you can right-click in the selected records and select Categorize. The CATEGORIZE PATIENT RECORDS WINDOW appears.

Figure 50 The CATEGORIZE PATIENT RECORDS WINDOW

3. The Add to Selected Categories radio button is selected by default. Select one or more categories to add the selected patients to: click on one, Ctrl-click on multiple categories, Shift-click on an adjacent range, or just click and drag in the list.

4. Click Apply to apply the selected category or categories without closing the window. Click OK to apply the categories and close the window. Click Cancel to cancel the current action and close the window.

To remove patient records from categories in which they are placed, follow the same steps except select the Remove from Selected Categories radio button.

CREATE AND ASSIGN PATIENT DIAGNOSES

STRATUSOCT provides a predefined list of diagnoses that you can assign to patients. It also enables you to create new diagnoses and edit diagnoses. Besides being an important record-keeping function, once you assign diagnoses you can search for patients by diagnosis.

CREATE, EDIT AND DELETE DIAGNOSES To create diagnoses for use in STRATUSOCT, follow these steps:

Note: When this radio button is selected, all categories appear in the list, not just those to which the selected records belong.

Figure 49 Selecting patients while holding down Ctrl key

Note: Diagnosis names are case-sensitive, which affects their uniqueness in searching for them. For example, “glaucoma” and “Glaucoma” would be treated as different diagnoses.



1. In the STRATUSOCT BROWSER, click on the Utilities menu and select Register Diagnoses. The DIAGNOSIS REGISTRATION WINDOW opens. A predefined list of diagnoses appears.

Figure 51 The DIAGNOSIS REGISTRATION WINDOW

2. In the DIAGNOSIS REGISTRATION WINDOW, you can create (register), edit and delete diagnoses.• To create a new diagnosis, click the Create New Diagnosis Forms

button.• To edit a diagnosis, click on the diagnosis you wish to edit and click the

Edit Selected Diagnosis Forms button.3. In either case, this activates the fields for editing. Edit the names in the

Diagnosis Short Form and Diagnosis Long Form fields as desired. Then click the Save Diagnosis Form button.• To discard the changes before saving, click the Undo Changes button.

You must confirm your choice in the CONFIRM dialog box.

To delete a diagnosis and remove references to it in all records, click the diagnosis you wish to delete and then click the Delete Selected Diagnosis Forms button. You must confirm your choice in the CONFIRM dialog box.

ASSIGN DIAGNOSES TO PATIENTS You can assign diagnoses to patients and revoke them in the PATIENT RECORD WINDOW while creating or editing a patient record. To do so, follow these steps:

1. First, you must reach an active PATIENT RECORD WINDOW by editing or creating a patient record. To reach an active PATIENT RECORD WINDOW, see ADD A NEW PATIENT, page 7-16, or EDIT PATIENT RECORDS, page 7-18.

Note: If you edit a diagnosis that you have already assigned to one or more patients, the edited diagnosis name is still attached to those patients. Therefore, you can find those patients by searching for the edited diagnosis name.

or



2. While creating/editing a patient record, the two Add/Remove Diagnoses buttons (one for each eye) become active. Click the appropriate one for the eye to which you will assign the diagnoses. In either case, the ADD/REMOVE DIAGNOSES WINDOW appears.

Figure 52 The ADD/REMOVE DIAGNOSES WINDOW

3. Select one or more diagnoses from the list of Available Diagnoses on the left and then click the Add button to assign them to the current eye and patient.• To remove diagnoses currently assigned to this patient, select one or more

from the Selected Diagnoses list on the right and then click the Remove button.

4. Click the OK button to accept the diagnoses or click the Cancel button to discard the changes.

5. Back in the PATIENT RECORD WINDOW, click on the Save Patient Record button to save your changes to the patient record. You can also click on the Undo Changes button if you do not want to keep the changes you just made.

REGISTER, EDIT AND ASSIGN MEDICAL STAFF

STRATUSOCT enables you to create and edit medical staff records and assign staff to patient records. Besides its record-keeping function, once you assign staff to patient records, you can search for patients by staff.

REGISTER (CREATE), EDIT AND DELETE STAFF RECORDS To register (create) and/or edit medical staff records, follow these steps:

Note: Medical staff names are not case-sensitive. For example, “Richards” and “richards” would be treated as the same name in a search.



1. Select Register Staff from the Utilities menu. The STAFF REGISTRATION WINDOW appears:

Figure 53 The STAFF REGISTRATION WINDOW

2. In the STAFF REGISTRATION WINDOW, you can create (register), edit and delete staff records.• To create a new staff record, click the Create New Staff Record button. • To edit a staff record, select it from the Available Staff Records list, and

then click the Edit Selected Staff Record button. 3. In either case, this activates the fields for editing. Edit the staff record fields as

desired and then click the Save Staff Record button.• To discard the changes before saving, click the Undo Changes button.

You must confirm your choice in the CONFIRM dialog box.To delete a staff record and remove references to it in all records, select it from the Available Staff Records list, and then click the Delete Selected Staff Record button. You must confirm your choice in the CONFIRM dialog box.

ASSIGN STAFF TO PATIENT RECORDS To assign registered medical staff to a patient record, follow these steps:

1. In the STRATUSOCT BROWSER, click a name to select the desired patient record, and then click the Patient Record button. You can also select Patient from the Record menu or right-click the patient name and select Edit. The PATIENT RECORD WINDOW appears.

2. In the PATIENT RECORD WINDOW, click the Edit Current Patient Record button. This activates all the fields, enabling you to enter data.



3. Use the Attending Physician and Referring Physician drop-down lists to select an attending and/or referring physician from among those registered. After making the desired changes, click the Save Patient Record button. • To discard the changes before saving, click the Undo Changes button.


REGISTER, EDIT AND ASSIGN INSURANCE

COMPANIES

STRATUSOCT enables you to create and edit insurance company records and assign them to patient records. Besides its record-keeping function, once you assign insurance companies to patient records, you can search for patients by insurance company.

REGISTER (CREATE), EDIT AND DELETE INSURANCE COMPANY

RECORDS To register (create) and/or edit insurance company records, follow these steps:

1. Select Register Insurance Companies from the Utilities menu. The INSURANCE COMPANY REGISTRATION WINDOW appears:

Figure 54 The INSURANCE COMPANY REGISTRATION WINDOW

2. In the INSURANCE COMPANY REGISTRATION WINDOW, you can create (register), edit and delete records. • To create a new record, click the Create New Insurance Company

Record button. • To edit a current record, select it from the Available Insurance Company

Records list, and then click the Edit Selected Insurance Company Record button.

3. In either case, this activates the fields for editing. Edit the Insurance Company Name field as desired and then click the Save Insurance Company Record button.

Note: Insurance company names are case-sensitive, which affects their uniqueness in searching for them. For example, “Prudential” and “prudential” would be treated as different names.



• To discard the changes before saving, click the Undo Changes button. You must confirm your choice in the CONFIRM dialog box.

To delete an insurance company record and remove references to it in all records, select it from the Available Insurance Company Records list, and then click the Delete Selected Insurance Company Record button. You must confirm your choice in the CONFIRM dialog box.

ASSIGN INSURANCE COMPANIES TO PATIENT RECORDS To assign a registered insurance company to a patient record, follow these steps:


2. In the PATIENT RECORD WINDOW, click the Edit Current Patient Record button. This activates all the fields, enabling you to enter data.

3. Use the Insurance Company drop-down list to select one from among those registered. After making the desired changes, click the Save Patient Record button.• To discard the changes before saving, click the Undo Changes button.


ADD A NEW PATIENT You can add a new patient through the STRATUSOCT BROWSER.

Warning: Every patient record has an identifier that consists of the Name (First, Middle, Last), Date of Birth, Gender and ID Number in

combination. It is possible to unintentionally merge patient records by assigning a new patient record the exact same identifying information.

Once this occurs, there is no way to separate the combined records of the erroneously merged patients. However, it is possible to DELETE EXAM

RECORDS that do not properly belong to a patient record (see page 7-21). Make certain that you enter the identifying patient information correctly.



To create a new patient record in the database, follow these steps:

1. From the STRATUSOCT BROWSER, click the.Patient Record button in the toolbar You can also select Patient from the Record menu or right-click the patient name and select Edit. The PATIENT RECORD WINDOW appears.

Figure 55 The PATIENT RECORD WINDOW

2. In the PATIENT RECORD WINDOW, click the Create New Patient Record button. This activates all the fields, enabling you to enter data.

3. After entering the desired patient data, click the Save Patient Record button. • You must enter at least a first or last name and date of birth to save a

record.• To discard the edits without saving a new record, click the Undo Changes

button. You must confirm your choice in the CONFIRM dialog box.



EDIT PATIENT RECORDS

To edit an existing patient record, follow these steps:


2. In the PATIENT RECORD WINDOW, click the Edit Current Patient Record button. This activates all the fields, enabling you to enter data.• To view (but not edit) the clinical notes for the patient, click the Clinical

Notes button You must edit them from either the EXAM RECORD WINDOW or VISIT RECORD WINDOW (see page 7-21).

3. After making the desired changes, click the Save Patient Record button. • To discard the changes before saving, click the Undo Changes button.


MERGE PATIENT RECORDS In STRATUSOCT, every patient record has an identifier that consists of the Name (First, Middle, Last), Date of Birth, Gender and ID Number in combination. It is possible that two or more patient records may exist for the same patient because this information was entered differently on separate occasions.

To correct such errors, it is possible to merge two or more patient records in STRATUSOCT. To merge records, you must edit the information in the identifier fields to make it perfectly identical. To do so, see EDIT PATIENT RECORDS just above. When you save the record, STRATUSOCT recognizes all records with the same identifiers as a single patient record, and you will observe just one record for the patient in the patient list.

• The identifier fields are case-sensitive and do consider spaces as characters. If the identifier fields in two patient records appear to be identical, check for extra spaces between words or at the end of the fields.

Warning: Every patient record has an identifier that consists of the Name (First, Middle, Last), Date of Birth, Gender and ID Number in

combination. It is possible to unintentionally merge patient records by editing a patient record so that it has the exact same identifying

information as another record. Once this occurs, STRATUSOCT recognizes only one record, and there is no way to separate the combined records of the erroneously merged patients. However, it is possible to DELETE EXAM RECORDS that do not properly belong to a patient record (see page 7-21). To avoid unintentional merging of patient records, you must make certain that you enter a unique combination of Name (First, Middle, Last), DOB,

Gender and ID Number when editing patient records.

Warning: Be certain that you select the correct patient records to merge. Once you merge patient records, there is no way to separate the combined records of erroneously merged patients, although it is possible to DELETE EXAM RECORDS that do not properly belong to a patient record (see page

7-21).



CREATE AND EDIT VISIT RECORDS

Visit records contain fields for OD Ocular Health, OS Ocular Health and Visit Notes which are specific to the visit. You can edit this information or create new visit records.

TO CREATE A NEW VISIT RECORD 1. In the STRATUSOCT BROWSER, select the desired patient name. If it is a new patient, you must first create a new patient record—see ADD A NEW PATIENT, on page 7-16.

2. Then click the Visit Record button or select Visit from the Record menu.The VISIT RECORD WINDOW appears.

Figure 56 The VISIT RECORD WINDOW

3. Click the Create New Visit Record button to activate the fields for data entry. You cannot enter a visit date. The current date is used automatically.

4. Enter the desired information and then click the Save Record button.• To discard the changes before saving, click the Undo Changes button.


TO EDIT VISIT RECORDS 1. In the STRATUSOCT BROWSER, select the desired patient name.2. Then you can either:

• Select a single visit to edit. Then click the Visit Record button or select Visit from the Record menu, or right-click the visit date and select Edit.

• Or: Click the All Visit Records button or select All Visits from the Record menu. The VISIT HISTORY WINDOW appears listing all visits for that patient. To edit one, select it and click the Edit Current Visit Record button.

Note: STRATUSOCT will not permit you to merge patient records with identical visit dates because it assumes that patients can visit only once per day. You cannot edit visit dates in STRATUSoct.

Note: You cannot edit the visit date.



3. In either case, you eventually reach the VISIT RECORD WINDOW (FIGURE 56). If necessary to activate the fields for editing, click the Edit Current Record button.

4. Add or edit the desired fields for OD Ocular Health, OS Ocular Health and Visit Notes. You cannot edit the visit date.

5. After making the desired changes, click the Save Record button. • To discard the changes before saving, click the Undo Changes button.


EDIT EXAM RECORD REMARKS AND NOTES

For an exam record, you can edit only the fields for Remarks and Exam Notes. This information pertains to the specific exam. To edit exam record remarks and notes, follow these steps:

1. In the STRATUSOCT BROWSER, select the exam you want to edit and then select Exam from the Record menu or right-click the exam and select Edit. The EXAM RECORD WINDOW appears.

Figure 57 The EXAM RECORD WINDOW

2. In the EXAM RECORD WINDOW, if necessary, click the Edit Current Exam Record button. This activates the Remarks and Exam Notes fields, enabling you to enter data.• Add or edit the desired information. When finished, click the Save Record

button.• To discard the changes before saving, click the Undo Changes button.




EDIT CLINICAL NOTES While clinical notes may be of a general nature regarding a patient, in STRATUSOCT, clinical notes pertain to specific visits and exams. You must edit (or add) clinical notes in either the EXAM RECORD WINDOW or the VISIT RECORD WINDOW. To do so, follow these steps:

1. In the STRATUSOCT BROWSER, select the desired patient record and then select either a visit record or exam record.• If you selected a visit, click the Visit Record button or select Visit from

the Record menu, or right-click the visit and select Edit to open the VISIT RECORD WINDOW.

• If you selected an exam, select Exam from the Record menu or right-click the exam and select Edit to open the EXAM RECORD WINDOW.

2. In either window, click the Edit Current Record button to activate the fields for editing.

3. Add or edit the desired exam/visit notes or remarks. Note that in the VISIT RECORD WINDOW, you can also enter IOP’s and Cup and Disc measurements.

4. After making the desired changes, click the Save Record button. • To discard the changes before saving, click the Undo Changes button.


DELETE EXAM, VISIT AND PATIENT RECORDS

Deleting records must be done sequentially. That is to say, STRATUSOCT will not permit you to delete a visit record if that visit has any exam records in it; and it will not permit you to delete a patient record if it has any visit records in it. And you must delete exam records and patient records one at a time. (You can delete multiple visit records at once.) Therefore, to delete a patient record, you must first delete each exam record the patient has, and then delete all visit records the patient has, before you can then delete the patient record itself.

DELETE EXAM RECORDS You must delete exam records one at a time. To delete an exam from the patient record, follow these steps:

1. In the STRATUSOCT BROWSER, select the exam record you wish to delete.2. Select Exam from the Record menu to open the EXAM RECORD WINDOW.3. In the EXAM RECORD WINDOW, click the Delete Current Record button. You

must confirm your choice in the CONFIRM dialog box.• To speed the deletion of multiple exam records, you can leave the EXAM

RECORD WINDOW open while you go back to the BROWSER and click on the next exam record to delete. It will then appear in the EXAM RECORD WINDOW for deletion. Repeat for each exam record you wish to delete.

In the BROWSER, you can verify that the deleted exams no longer appear in the Exams list for that visit.

DELETE VISIT RECORDS You can delete one or more visit records at once. To delete visits from the patient record, follow these steps:

1. In the STRATUSOCT BROWSER, select the visit record (date) you wish to delete. It must first have no exam records in it or you cannot delete it.

2. Click the Visit Record button, or select Visit from the Record menu to open the VISIT RECORD WINDOW.



• If you plan to delete multiple visit records, click the All Visit Records button to open the VISIT HISTORY WINDOW. All visit records appear there. You can select for deletion at the same time every visit record that has no exam records in it: click on one, Ctrl-click on multiple visits, Shift-click on two visits and all intervening visits are selected, or click and drag to select multiple adjacent visits.

3. In either the VISIT RECORD WINDOW or the VISIT HISTORY WINDOW, click the Delete Current Record button. You must confirm your choice in the CONFIRM dialog box.

If you are deleting visits one at a time, repeat the steps for each visit record you wish to delete. In the BROWSER, you can verify that the deleted visits no longer appear in the Visits list for that patient.

DELETE PATIENT RECORDS You can delete patient records one at a time. To delete a patient from the database, follow these steps:

1. In the STRATUSOCT BROWSER, select the patient record (name) you wish to delete. It must first have no visit records in it or you cannot delete it.

2. Click the Patient Record button, or select Patient from the Record menu to open the PATIENT RECORD WINDOW.

3. In the PATIENT RECORD WINDOW, click the Delete Current Record button. You must confirm your choice in the CONFIRM dialog box.• To speed the deletion of multiple patient records, you can leave the PATIENT

RECORD WINDOW open while you go back to the BROWSER and click on the next patient record to delete. It will then appear in the PATIENT RECORD WINDOW for deletion. Repeat for each patient record you wish to delete.

In the BROWSER, you can verify that the deleted patients no longer appear in the Patients list.

Note: If a selected visit contains exam records, the Delete Current Record button will not be active and you cannot delete the visit until you delete its exams.

Note: If a selected patient record contains visit records, the Delete Current Record button will not be active and you cannot delete the patient until you delete its visits.


ARCHIVE SCANS & BACKUP DATABASE / 8-1

8 ARCHIVE SCANS & BACKUP DATABASE

CHAPTER OVERVIEW

This chapter explains how to archive scans and backup the patient database, and the difference between the two. Topics covered include:

• THE PATIENT DATABASE, below• ARCHIVE VS. BACKUP, below• WHY ARCHIVE/BACKUP SCANS, page 8-2

• FORMAT DVD-RAM DISKS, page 8-2

• ARCHIVE/BACKUP SCHEME, page 8-3

• HOW TO ARCHIVE, page 8-3

• DATABASE BACKUP, page 8-5

• DEFRAGMENT DATABASE, page 8-7

THE PATIENT DATABASE The STRATUSOCT patient database contains two kinds of patient information: patient data and scan data. Patient data consists of information that identifies:

• each patient—by name, birthdate, ID number, categories, etc.• each visit—by patient and visit date• each saved scan—by patient, visit, scan acquisition protocol and location

where the scan is saved.Patient data cannot be removed from the STRATUSOCT, but it can—and should—be copied regularly.

Scan data in the patient database consists of saved scans. Every saved scan has a numeric identifier that enables it to be associated with a particular patient. However, scan data itself does not include patient information. Scan data is removed from the STRATUSOCT when you archive it. Scan data is also copied, but not removed, when you backup the patient database.

ARCHIVE VS. BACKUP Archiving scans is different from database backup. When you backup the patient database, you copy the entire database to the disk cartridge, but leave all of it on the STRATUSOCT. In contrast, when you archive scans, you copy the entire database to the disk cartridge, but remove only the scan data from the STRATUSOCT. (The patient data is never removed from the STRATUSOCT.) After archiving, the patient data associated with the archived scans is both on the STRATUSOCT hard drive and on the removable disk cartridge, but the scan data is only on the removable disk cartridge. Archiving creates room on the hard drive to save new scans. After

Advisory: Archive scans and backup the patient database daily to ensure the preservation of patient data in case of computer malfunction.

See ARCHIVE/BACKUP SCHEME on page 8-3.

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8-2 / ARCHIVE SCANS & BACKUP DATABASE

archiving, you can access archived scans just as if the data were present on the hard disk, as long as the archive disk cartridge is in the original disk drive.

WHY ARCHIVE/BACKUP SCANS

Since database backup copies the entire database to a disk cartridge, you may wonder why you should archive scans regularly. For two reasons:

• First, to maintain performance. STRATUSOCT operation can slow noticeably if too much scan data is on the hard disk at once. In addition, if scans are not archived, the hard disk will eventually fill up and prevent you from saving new scans. At that point, archiving is a necessity.

• Second, to reduce the effort required for database security. Archiving copies only new patient and scan data since you last archived, and therefore takes less time than database backup. It enables you to restore patient data saved before you last archived, in case of hard disk corruption.

Then, you may ask, why is it necessary to perform a database backup since archiving copies the entire database, piece by piece? For the following practical reasons:

• So you can restore all the patient data at once, in case of hard disk corruption. Because the patient data is never removed from the hard disk, hard disk corruption could destroy all the patient data at once. If you did not backup the database, when you come to have many archive disks, database restoration would be a tedious, time-consuming process, since the patient data is fragmented across many archive disks.

• Also, if you did not backup the database, you would not be able to search the database as a whole to determine on which archive disk(s) each patient's scan data resides.

Additionally, if you backup the database each time before you archive, and keep backup disks and archive disks separate, you will have two copies of the database, ensuring database security against corruption of archive disks. This two-copy approach is described in ARCHIVE/BACKUP SCHEME on page 8-3.

FORMAT DVD-RAM DISKS To archive, backup or export requires a DVD-RAM cartridge formatted in the “FAT32” format. Zeiss provides three unformatted DVD-RAM cartridges that must be formatted correctly to work in your DVD-RAM drive.

Warning: You must not use the same archive or backup disk cartridge in more than one OCT instrument. Use of an archive or backup disk

cartridge in more than one OCT instrument could cause the incorrect identification of patient data. We strongly advise that you physically label archive disk cartridges with the serial number of the OCT instrument to

which it is dedicated.

Warning: You must use dedicated archive disk cartridges. Do not store any other data on an archive disk cartridge. If you use an archive disk cartridge

to store any other kind of data, including OCT backup data, you may disable access to the archive data. If you encounter this problem, remove

the non-archive data from the disk cartridge to restore access.

Warning: Formatting erases any data currently on the disk. Formatting a disk cartridge previously used to archive or backup the STRATUSOCT

database will cause patient exam records to be permanently lost!

8-2 / ARCHIVE SCANS & BACKUP DATABASE STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03


For the Panasonic 4.7 GB DVD-RAM drive:1. Power up the system. Exit the STRATUSOCT program (click File > Exit or click

the at upper right) to enter the Windows environment. Be sure that the new DVD-RAM disk cartridge is not write-protected: Check the red switch near the lower left of the cartridge. Install the new disk cartridge into the DVD drive.

2. Click Windows Start > Programs > DVD-RAM > DVDForm.3. Click on the down-arrow next to Format Type and select FAT32.4. Click Start. A DVDFORM window will appear.5. Click Yes. Formatting will begin. When finished, click on the to exit the

program.To make a desktop “Format Shortcut” icon:

1. Right-click on the Windows desktop (outside all icons) and then click New > Short Cut.

2. The Create Shortcut dialog box appears. Click the Browse button and select the file in the following path:

C:\Program Files\DVD-RAM\Win2K\DVD-RAM Driver\DVD-FORM.EXE

3. Click Next and then click Finish. A new shortcut icon will appear on the Windows desktop.

ARCHIVE/BACKUP SCHEME The scheme can be summarized as backup followed by archiving every day. Using this scheme yields two copies each day of the patient database on separate sets of DVD disk cartridges. The scheme requires two sets of disk cartridges, one dedicated to archiving scans, and one dedicated to database backup. It consists of the following:

• Backup the database daily before archiving, using the dedicated backup disk cartridge. When one backup disk cartridge becomes full, format a new disk cartridge and dedicate it for use as another backup disk.

• Archive all new scans daily using the dedicated archive disk cartridge. When one archive disk cartridge becomes full, format a new disk cartridge and dedicate it for use as another archive disk.

• Store the archive and backup disk sets in separate locations, with the backup disk preferably outside the building where the instrument is.

HOW TO ARCHIVE We recommend that you archive scans each day you have saved new scans. To avoid disrupting patient flow, it is best to archive at the end of the day.

Note: Always backup before archiving to retain two complete copies of the both the patient and scan data. If you archive first, scan data will be removed before backup.

Note: If you have multiple archive disk cartridges, it is not necessary to archive all scans for a particular patient on the same disk. The patient database remains on the computer hard drive, and it gathers together the list of scans for every patient. Note: It does not harm the STRATUSOCT to leave it running overnight for archive or backup purposes.



To archive, follow these steps:

1. Insert a formatted DVD-RAM disk cartridge into its drive.2. From the STRATUSOCT MAIN WINDOW, select Archive from the Data menu

(click Data > Archive) to reach the STRATUSOCT BROWSER. (If you are already in the BROWSER, click View > Data Transfer Mode.). The STRATUSOCT BROWSER appears as below. (For details on the BROWSER, see Chapter 7.) It presents you with a list of patients who have exams that are not yet archived. Each of the patients has an empty checkbox by his name.

Figure 58 The STRATUSOCT BROWSER

3. Normally, users wish to archive all scans not previously archived. To do this, click File > Select All, and proceed to step 4. Otherwise, select the checkboxes next to the patients whose exams (scan groups) you wish to archive. For each selected patient, all his exams are selected by default. If you do not wish to archive all the exams of the selected patients, you can deselect exams, as instructed below. Exams not selected remain on the STRATUSOCT hard drive.

4. When you have finished making your selections, click File > Archive. If the inserted disk already contains an archive database, archiving begins immediately.• If the inserted DVD-RAM disk does not yet contain an archive database,

the Archive Label dialog box appears. The left field, which is grayed out and unalterable, contains the instrument serial number. In the right field the STRATUSOCT generates a number, starting with “001” and increasing by one for each new archive disk. However, we recommend that you type in a descriptive or identifying label. You can type up to 20 characters. Click OK when finished, or Cancel to abort.

5. A Progress dialog box shows archive progress. It can take several seconds to several minutes for the STRATUSOCT to finish writing to the disk, depending on the number of exams you selected. The Progress dialog box disappears when archiving is finished.



• If you are using a new archive disk, when the archive process is complete, a Notice dialog will prompt you to write the label on the archive DVD disk. Click OK.

DESELECT EXAMS (OPTIONAL) Deselecting specific exams is an optional step in the data transfer process. You must deselect exams for one patient at a time. If you do so, the BROWSER remembers the exams selected for every patient until you finish or exit the data transfer function. After you begin, if you wish to start over, click File > Deselect All.

Selecting Multiple Records• To select multiple patients, visits or exams, hold down the Ctrl key and click

(Ctrl-click) each one; or hold down the Shift key and click (Shift-click) on any two records and all intervening records will be selected.• You can display the visits of only one selected patient at a time. However,

you can display exams from multiple visits if you select multiple visits.To Deselect All the Exams From One Visit

• Select one patient and the Visits list shows all his visits with checkboxes selected by default. (When you select multiple patients, no visits are displayed.) Clear a visit checkbox to deselect all exams from that visit.

To Deselect Specific Exams• Select one or more visits and the Exams list shows all exams for the selected

visits with checkboxes selected by default. Clear an exam checkbox to deselect that exam.• When only some of a patient’s exams are selected, that patient’s checkbox

will be grayed and contain a gray checkmark. When only some exams from a specific visit are selected, that visit’s checkbox will appear likewise.

ACCESS ARCHIVED SCANS If a scan is archived, the patient's scan list shows on which archive disk it is (by label). To retrieve those scans for review or analysis, install the indicated archive disk in the DVD drive. If the correct archive disk is not in place, the message “Scan Not Available” appears when you attempt to view or analyze it.

DATABASE BACKUP

You must use a DVD disk to contain the database files. Follow this procedure to backup the database:

1. Insert a formatted DVD-RAM disk cartridge into its drive.2. Exit the STRATUSOCT software (click File > Exit or click the at upper

right) to enter the Windows environment.

Advisory: Archiving scans, as described above, does not ensure that the patient database can be fully restored in case of computer malfunction. It is essential to backup the database periodically. We recommend once a

week at a minimum.

Note: It does not affect the instrument or its performance to leave it running overnight for archive or backup purposes.



3. On the Windows desktop, double-click on the Zeiss STRATUSOCT Backup Utility shortcut, or click Windows Start > Programs > Zeiss > STRATUSOCT > Backup Utility. The BACKUP-RESTORE UTILITY WINDOW appears.

Figure 59 The BACKUP-RESTORE UTILITY WINDOW

4. Select the Database Backup radio button. • You have the option of selecting a new Backup Set Name and Backup

Directory location to store the database copy that you will create. Click the Browse button to select any available location on the hard drive or the DVD-RAM drive (the default d:\ drive). You can repeat the backup procedure to store multiple copies. However, we suggest that you backup one copy to removable storage media—a DVD-RAM cartridge—to preserve it from corruption due to computer malfunction.

• The patient database always remains and updates on the hard drive, and each time you back it up it is backed up in its entirety. Therefore, it is not necessary to give the backup copy a new name each time. Only the latest copy is required to restore the entire database since your last backup.

• When you have made your selections, click the Backup button.5. The Status area and the Progress meter indicate progress. You can click the

Abort Backup button at any time to abort. When finished, click the Quit button to exit to the desktop.

6. Keep the backup disk cartridge in a safe place.

Warning: The System Backup radio button enables backup of the STRATUSOCT system software. This function needs to be performed only

once upon installation by the Zeiss service representative who installs the system. Its purpose is to create a backup copy of the system software in case of computer malfunction. Restoration of the system software or the

patient database may be done only by or in consultation with a Zeiss service technician.



DEFRAGMENT DATABASE To maintain or restore peak performance of the STRATUSOCT database, we recommend that you defragment the database after each 1,000 patients, or when you notice that the patient list is loading more slowly.

To defragment the database:

1. From the STRATUSOCT MAIN WINDOW, select Options > Defragment Database. The DEFRAGMENT DATABASE WINDOW appears.

Figure 60 The DEFRAGMENT DATABASE WINDOW

2. Click Start. The DEFRAGMENT DATABASE WINDOW will show the progress of defragmentation and inform you when it is complete.

3. When complete, click Close.

Note: Depending on the database size, defragmentation may take several minutes.


ROUTINE MAINTENANCE / 9-1

9 ROUTINE MAINTENANCE

CHAPTER OVERVIEW Zeiss designed the STRATUSOCT to require very little user maintenance besides cleaning. This chapter covers the handling of error messages, routine cleaning and reporting signs of wear.

NOTE REGARDING WARRANTY

HANDLING ERROR MESSAGES

In normal instrument start-up, the STRATUSOCT START WINDOW appears. If an error message appears during start-up, or at any time, document the error number and report it to the Carl Zeiss Meditec service department at 1-877-486-7473 (1-877-HUMPHREY). Often error messages can be resolved with solutions provided over the telephone.

Please be prepared to provide the service department with the serial number of your instrument. It is located on the left side of the Patient Module where the cables connect to it.

ROUTINE CLEANING The forehead and chin rests, and to a lesser extent the ocular lens, are the only parts that require routine cleaning.

FOREHEAD AND CHIN RESTS The instrument parts that routinely contact the patient—the forehead and chin rests—should be cleaned between each examination with an alcohol prep swab. These parts are not removable. You also may use either a 2% glutaraldehyde solution or 1-10 bleach-water solution for disinfection.

THE OCULAR LENS The ocular lens of the Patient Module should not contact the patient's eye. It comes with a lens cap to cover it when not in use. Still, it may contact the eyelashes during normal use, and you should clean it to remove dust and oily smudges occasionally to ensure a true STRATUSOCT image. You may use an alcohol prep swab or cotton swab dipped in isopropyl alcohol. (You may use the Volk Precision Optical Lens Cleaner.) Wipe dry with a soft, non-linting cloth or tissue. If the lens inadvertently contacts the patient's eye, clean it before proceeding with the examination.

REPORT SIGNS OF WEAR During normal use, the fundus illumination lamp may wear out and require replacement. The power fuses may also require replacement when an unexpected power problem arises. Although these are relatively simple parts, attempts by the user to access and replace them may damage sophisticated precision hardware. In all cases, contact Zeiss customer service when there is a problem with the instrument, even if you suspect that only these parts need replacement. Call 1-877-486-7473 (1-877-HUMPHREY). Only Zeiss service engineers are authorized to disassemble the instrument and replace any parts.

Note: The STRATUSOCT has no user-replaceable parts, including lamps and fuses. The user must not attempt hardware repairs, including lamp and fuse replacement, without consulting Carl Zeiss Meditec service personnel. To do so voids the instrument warranty. However, Zeiss may provide user-installed software updates to fix software deficits.

Note: These latter disinfectants are skin irritants, so be sure to rinse repeatedly and thoroughly with a clean and soft wet cloth. Wipe dry with a clean and soft non-linting cloth.

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9-2 / ROUTINE MAINTENANCE

FUNDUS ILLUMINATION LAMP Under normal use, the fundus illumination lamp should last for three years. The lamp may need replacement when the fundus does not appear adequately illuminated despite proper alignment of the Patient Module with the eye.

POWER FUSES The STRATUSOCT is a modular system with each major subsystem possessing its own power fuses. Only Zeiss field service engineers are authorized to diagnose power problems and replace fuses. Tampering with fuses on the STRATUSOCT voids all Zeiss warranties and liabilities.

9-2 / ROUTINE MAINTENANCE STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

SPECIFICATIONS / 10-1

10 SPECIFICATIONS

TOMOGRAPHIC IMAGING • Purpose: Cross sectional imaging of fundus• Signal Type: Optical scattering from tissue• Signal source: Super Luminescent Diode (SLD), 820 nm• Optical Power: ≤ 750 microwatts at cornea. SLD current will shut off if a

safety circuit is activated (upon scanner failure)• Spot Size at Retina: 20 µm in tissue• Longitudinal/Axial Resolution: ≤ 10 µm in tissue• Transverse Resolution: 20 µm in tissue• Scanners: Galvanometric mirrors• Scan Patterns: Repeat, Line, Circle, Raster Lines, Cross Hair, Radial Lines,

Macular Thickness Map, Optical Disc, Proportional Circle, Concentric 3 Rings, RNFL Thickness (3.46), Nerve Head Circle, RNFL Thickness (2.27xdisc), X-Line, RNFL Map, Fast Macular Thickness Map, Fast Optical Disc, Fast RNFL Thickness (3.46), Fast RNFL Map

• Scan Pixels: Adjustable from 131,072 to 786,432 (1024 longitudinal x 128 to 768 transverse)

• Scan Speed: 400 A-scans per second• Scan Acquisition Time: Approx. 0.32 seconds (128 A-scans minimum.) to

approx. 1.92 seconds (768 A-scans maximum.)• Longitudinal (Depth) Scan Range: 2 mm in tissue

FUNDUS IMAGING • Purpose: Fundus alignment for tomographic imaging• Signal Type: CCD image• Field of View: 29° (horizontal) x 23° (vertical)• Focus Adjustment Range: -12 to +20 D (diopters)• Viewing Method: 15" Color Flat Panel Display• Illumination: Halogen Lamp• Internal Fixation: 32 × 16 Green LED dot matrix• External Fixation: Slit lamp type adjustable blinking LED

ELECTRICAL REQUIREMENTS

• Single phase:100V~ systems: (± 10%), 50/60Hz, 6A115V~ systems: (± 10%), 60Hz, 6A230V~ systems: (± 10%), 50/60 Hz, 3A

• Power consumption: 700VA• Main fuses: (under power input of table and back of computer):

• Fuse ratings: Table Computer Quantity100V~ & 115V~ systems: 8.0A 5.0A 2 each230V~ systems: 4.0A 2.5A 2 each

START-UP No special operator precautions needed for initial start-up.

STRATUSOCT USER MANUAL SPECIFICATIONS / 10-1PN 55641-1 REV. A 4/03

10-2 / SPECIFICATIONS

MEASUREMENT UNITS All units on the STRATUSOCT are measured in the SI format. Unless otherwise noted, measurements are made in microns.

CALIBRATION Calibration is not required.

DISPLAY MONITOR 15" Flat Panel High Resolution Color Video Monitor

SYSTEM INPUT DEVICES Keyboard, mouse, Patient Module function buttons

DISK STORAGE 40 Gigabyte or larger hard drive1.44 Megabyte 3.5" high-density floppy drive4.7 Gigabyte removable DVD-RAM drive

ENVIRONMENTAL CONDITIONS

Transport and StorageTemperature: -40 to +70 deg. CRelative Humidity: 10% to 100%, including condensationAtmospheric Pressure: 500 hPa to 1060 hPa

OperationTemperature: +10 to +40 deg. CRelative Humidity: 30% to 75%, excluding condensationAtmospheric Pressure: 700 hPa to 1060 hPa

PHYSICAL DIMENSIONS Fits in a cubic space of 83 cm (depth) x 119 cm (length) x 125 cm (nominal height with 30 cm of table travel) (33 in x 48 in x 50 in).

SYSTEM WEIGHT Complete system: 58.6 kg (129 lbs.), comprises Patient Module 24.5 kg (54 lbs.), computer 21.3 kg (47 lbs.), monitor 5.4 kg (12 lbs.), printer 6.4 kg (14 lbs.), keyboard and mouse 0.91 kg (2 lbs.).

TABLE LOADING CAPACITY The instrument table is specifically designed for use only with the original STRATUSOCT system components installed in their original configuration. In this original configuration, the table loading capacity is 63.3 kg (139.5 lbs.) ± 5%.

STANDARDS AND APPROVAL Satisfies the following standards:

UL 2601-1 (100-120V~ units)CSA 22.2 NO. 601.1 (100-120V~ units)EN60601-1 (230V~ units)EN60601-1-1 (230V~ units)EN60601-1-2 (230V~ units)EU Council Directive 93/42/EEC (230V~ units)

0297

EMBEDDED WINDOWS LICENSE

Each STRATUSOCT instrument is issued with an embedded Windows license. The license label is affixed to the back of the computer, underneath the back cover.

Warning: Do not reconfigure system components on the table, nor add non-system devices or components to the table, nor replace original

system components with substitutes not approved by Carl Zeiss Meditec. Such actions could result in failure of the table height adjustment

mechanism, instability of the table, tipping and damage to the instrument, and injury to operator and patient.

10-2 / SPECIFICATIONS STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

SPECIFICATIONS / 10-3

INTENDED USE The STRATUSOCT is intended for use as a diagnostic device to aid in the management of ocular diseases.

Note: The STRATUSOCT is not intended to be used as the sole diagnostic for disease.

STRATUSOCT USER MANUAL SPECIFICATIONS / 10-3PN 55641-1 REV. A 4/03

10-4 / SPECIFICATIONS

10-4 / SPECIFICATIONS STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

LEGAL NOTICES / 11-1

11 LEGAL NOTICES

LIMITED WARRANTY This Warranty gives you specific legal rights, and you may have other rights, which vary from state to state. For one year from the date of delivery (the “Warranty Period”) to the original purchaser (“You,” “Your,” “Purchaser”), Carl Zeiss Meditec Inc. (“Zeiss,” “Seller,” “We,” “Our,” “Us”) warrants its STRATUSOCT Model 3000, excluding components and software as stated below (the “STRATUSOCT”) to be free from defects in material or workmanship. In the event of failure, Seller's obligation is limited to repairing or replacing on an exchange basis the parts that have been promptly reported as defective by Purchaser during the Warranty Period and are confirmed as defective by Seller upon inspection. This Warranty covers all parts, labor, travel and expenses for the Warranty Period, except as otherwise stated herein. This Warranty only applies to the original Purchaser and shall not, in any way, be transferable or assignable.

The procedure for warranty claims shall be as follows: when You believe the STRATUSOCT is defective, promptly report the defect to Zeiss. Whenever possible, We will provide “in the customer's office” service to repair Your STRATUSOCT. However, at Our discretion, repairs may be made in Our repair department. In this case, We will pay all shipping costs unless Your STRATUSOCT is found upon inspection not to be eligible for repair under this Warranty, in which case You will be responsible for one-half the shipping costs. If Your STRATUSOCT is ineligible for repair under Warranty, We will notify You, and any repairs You authorize will be performed at Our normal rates. All replaced parts will become the property of Zeiss.

This Warranty specifically covers the STRATUSOCT, including the instrument table. This Warranty does NOT cover: consumable items such as operating supplies, paper or storage media, or the servicing of any external printer. Those items will be covered by their manufacturer's warranty and arrangement for service must be made through that manufacturer. This Warranty will NOT apply if repair or parts replacement is required because of accident, neglect, misuse, acts of God, transportation or causes other than ordinary use, or supplies or accessories that do not meet the proper operating specifications of Zeiss. This Warranty does NOT apply to any articles that have been repaired or altered except by Zeiss.

All data stored on the hard disk, magneto-optical and/or floppy discs are the Purchaser's records, and it is Your responsibility to preserve the integrity of these files. Zeiss is not responsible for the loss of patient files stored on the hard disk, floppy discs, backup magneto-optical discs or backup floppy discs.

You bear the entire risk as to the quality and performance of the software. Zeiss does not warrant that the software will meet Your requirements, that the operation of the software will be uninterrupted or error-free, or that all software errors will be corrected. You assume the responsibility for the installation, use and results obtained from the STRATUSOCT and programs.

The Warranty does NOT extend to any diskette that has been damaged as a result of accident, misuse, abuse, or as a result of service, or modification by anyone other than Zeiss. Should such software prove defective following its purchase, You (and not Zeiss) assume the entire cost of all necessary service, repair, or correction. Zeiss has no liability or responsibility to any person or entity with respect to any

STRATUSOCT USER MANUAL LEGAL NOTICES / 11-1PN 55641-1 REV. A 4/03

11-2 / LEGAL NOTICES

claim, loss, liability, or damage caused or alleged to be caused directly or indirectly by any software supplied with the STRATUSOCT or by Zeiss.

Every reasonable effort has been made to ensure that the product manuals and promotional materials accurately describe the STRATUSOCT specifications and capabilities at the time of publication. However, because of on-going improvements and product updates, We cannot guarantee the accuracy of printed materials after the date of publication, and disclaim liability for changes, errors or omissions. All instrument specifications are subject to change without notice.

LIMITATION OF LIABILITY THE WARRANTIES CONTAINED HEREIN ARE IN LIEU OF AND EXCLUDE ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR USE. NEITHER CARL ZEISS MEDITEC, MICROSOFT CORPORATION NOR ANY OTHER PARTY INVOLVED IN THE CREATION, PRODUCTION, OR DELIVERY OF THIS INSTRUMENT OR SOFTWARE (COLLECTIVELY REFERRED TO AS “CONTRIBUTOR(S)”) SHALL BE LIABLE FOR ANY DAMAGE, LOSS OF USE OR LOSS OF ANY KIND, ARISING OR RESULTING FROM ACTS OF GOD, YOUR PURCHASE, POSSESSION, FAILURE TO FULFILL YOUR RESPONSIBILITIES AS TO PROPER INSTALLATION, MANAGEMENT, SUPERVISION OR USE OF THE STRATUSOCT OR SOFTWARE WHETHER SUCH LIABILITY IS BASED IN TORT, CONTRACT OR OTHERWISE. IF THE FOREGOING LIMITATION IS HELD TO BE UNENFORCEABLE, ZEISS'S (AND CONTRIBUTOR(S)) MAXIMUM LIABILITY TO YOU SHALL NOT EXCEED THE COST PAID BY YOU FOR THE INSTRUMENT. ZEISS (AND/OR CONTRIBUTOR(S)) SHALL IN NO EVENT BE LIABLE FOR DIRECT, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING DAMAGE FOR LOSS OF BUSINESS OR ANTICIPATORY PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, AND THE LIKE), EVEN IF ZEISS OR ANY CONTRIBUTOR(S) HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF IMPLIED WARRANTIES OR CONSEQUENTIAL OR INCIDENTAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU.

SERVICE CONTRACT In the U.S.A., a Warranty Extension Agreement (Service Contract) is available after the one-year, new STRATUSOCT warranty expires. For information, call the Carl Zeiss Meditec Customer Service Department at 1-877-486-7473 (1-877-HUMPHREY).

NOTIFICATION OF COPYRIGHT

The software program (“Software”) included with your STRATUSOCT Model 3000 (“STRATUSOCT”) is a proprietary product of Carl Zeiss Meditec Inc. (“Zeiss”) and in certain instances contains material proprietary to Microsoft Corporation. These proprietary products are protected by copyright laws and international treaty. You must treat the software like any other copyrighted material.

Copyright © 2003 Carl Zeiss Meditec Inc. All rights reserved.

SOFTWARE LICENSE AGREEMENT

This Software license agreement (“License”) is a legal contract between the Purchaser (“You”, “Your” “Licensee”) and Zeiss governing Your use of the

11-2 / LEGAL NOTICES STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

LEGAL NOTICES / 11-3

Software. Opening the sealed package indicates Your acceptance of the terms and conditions of this License. If You have any questions concerning this License, contact Carl Zeiss Meditec, Attention Customer Service, 5160 Hacienda Drive, Dublin, CA 94568. Telephone 1-877-486-7473 (1-877-HUMPHREY).

LICENSE TERMS AND CONDITIONS 1. In consideration of payment of the License fee which is part of the price You paid for Your STRATUSOCT, and Your agreement to abide by the terms and conditions of this License and the Limited Warranty, Zeiss grants to You a non-exclusive right to use and display this Software on a single STRATUSOCT, under the terms of this License. If the STRATUSOCT on which You use the Software is a multi-user system, this License covers all users on that single system.

2. You own the physical media, STRATUSOCT, on which the Software is originally or subsequently recorded or fixed, but You understand and agree that Zeiss retains title and ownership to the Software recorded on the original disk copies and all subsequent copies of the Software.

3. This Software is copyrighted. Unauthorized copying of the Software, including Software that has been modified, merged or included with other software, is expressly forbidden. You may not, nor may You permit others to (a) disassemble, decompile or otherwise derive source code from the Software (b) reverse engineer the Software, (c) modify or prepare derivative works of the Software, (d) provide on-line or similar uses to third parties, or (e) use the Software in any manner that infringes the intellectual property or other rights of another party. You may be held legally responsible for any copyright infringement that is caused or encouraged by Your failure to abide by the terms of the License.

4. Zeiss may create updated versions of the Software, which You may purchase separately.

5. You may not sublicense, rent or lease the Software, but You may permanently transfer this License by delivering the original STRATUSOCT, media, written materials and materials comprising the Software package, including the Certificate of License, to a third party who accepts the terms and conditions of this Agreement. Upon transfer, You will simultaneously destroy all copies of the Software and accompanying materials in your possession. The new recipient of the Software and accompanying STRATUSOCT accepts this Agreement and is licensed under the terms of this Agreement upon initially using the Software.

6. Zeiss warrants the operation of the Software only with the operating system for which it was designed. Use of the Software with an operating system other than that for which it was designed will not be supported by Zeiss.

ACKNOWLEDGMENT You acknowledge that you have read all the provisions in this Chapter, including this License and Limited Warranty, understand them, and agree to be bound by their terms and conditions.

STRATUSOCT USER MANUAL LEGAL NOTICES / 11-3PN 55641-1 REV. A 4/03

11-4 / LEGAL NOTICES

11-4 / LEGAL NOTICES STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

INDEX / I-1

INDEX

AAbort Backup button 8-6Access Menu Options 2-2Acknowledgment, Legal 11-3Acquire Scan buttons 3-8Acquire Scans 3-1, 3-8Acquisition Mode 3-3Activity Radio Buttons 4-1, 6-1Add Patient dialog box 2-5Add/Manage Patient Records 2-5Add/Remove Diagnoses button (OD or OS) 7-5adding patient records 7-16Adj Display button 6-15Adjust Scan Pattern Parameters 3-10

Angle 3-10angle and degrees 3-10angle and nasal position 3-10angle point of origin 3-10Number of Lines 3-10Size 3-10Value field 3-10

Adjust Scan Placement 3-6Adjust Scan Variables 3-11

A-Scans per Second and Scan Time 3-11Axial Scan Length and Number of Data Points 3-11Number of A-Scans 3-11

Adjust the focus 3-4Adjust The Height 3-1Adjust Z-offset 3-5adjusting scan parameters, when 4-3adjustments to the video image 3-4Align protocol 6-20Aligning Large Scan Patterns 4-4Alignment and Acquisition Scan Modes 3-3alignment markers 3-2Alignment Mode 3-3All Visit Records button 7-4Analysis Menu in Browser 7-4Analysis Protocols 6-1analysis protocols

application 4-2, 6-2cannot be applied additively 6-1General Tips 6-2Glaucoma, list 6-2Optic Nerve Head 6-13results of using with unintended scan type 4-3, 6-2Retina, list 6-2

Retinal Map 6-18Retinal Thickness 6-18Retinal Thickness/Volume 6-5Retinal Thickness/Volume Change 6-7Retinal Thickness/Volume Tabular 6-6RNFL Thickness 6-8RNFL Thickness Average 6-9RNFL Thickness Change 6-12RNFL Thickness Map 6-11RNFL Thickness Serial Analysis 6-13Scan Profile 6-22

Analysis Protocols Are Correlated with Scan Pat-terns 6-2

analysis, exclude scans from 5-4effect 5-2

Analyze button 5-3, 7-5Analyze Exams from the Browser 7-7Analyze Scans 5-1Analyze Tab 5-3, 6-1Analyze Tab Views 6-1Angle 3-10angle and degrees 3-10angle and nasal position 3-10angle, point of origin 3-10archive

removes scan data from patient database 8-1Archive before backup to make two copies 8-3Archive Label dialog box 8-4Archive Scans & Backup Database 8-1Archive vs. Backup 8-1Archive, How to 8-3Archive/Backup Scans, Why 8-2Archive/Backup Scheme 8-3A-scans

combined to form cross-sectional image 1-2data points 1-2depth 1-2transverse resolution 1-2

A-Scans per Second 3-11A-Scans per second and Scan Time 3-11Auto L/W button 5-4Available Adjustments for Individual Radial Scan

Analysis 6-15Average Nerve Width @ Disk 6-15axial “window” 3-5axial length 2-6axial length of the scan image 3-5

STRATUSOCT USER MANUAL INDEX / I-1PN 55641-1 REV. A 4/03

I-2 / INDEX

Axial Resolution 10-1Axial Scan Length 3-11

Bbackground noise 3-13Backup 8-5, 8-6blue cursor 6-22blue function buttons 3-8Blue PM buttons 3-8

left button 3-8, 3-9right button 3-9

brightness and contrast adjustment 3-14Browser

buttons 7-4exiting 7-1launching 7-1Menus 7-3

Analysis Menu 7-4File Menu 7-3Options Menu 7-4Record Menu 7-3Utilities Menu 7-4View Menu 7-4

CCalibration 10-2Cancel 3-9, 3-10, 4-3, 5-5Care in Handling 1-3case-sensitive records 7-11, 7-15Categories

Create and Edit 7-9Place Patient Records in 7-10

Categorize Patient Records 7-9Categorize Patient Records button 7-5Category Field 2-4Caution--avoid contact with patient eye 3-4CE Mark 10-2central circle button 3-8Change button 6-22chin cup 3-1Circle protocol 4-5Cleaning 9-1Cleaning Forehead and Chin Rests 9-1cleaning the ocular lens 9-1Clear Graphics button 6-16Clinical Notes button 7-5clinical notes, editing 7-21color scale and interferometer signal range depicted

3-13color scale of scan image 3-13

Comment Tab 3-15Composite Image Features and Functionality 6-16Composite Image Measurements 6-16Computer Unit 1-3Concentric 3 Rings protocol 4-6Copyright Notification 11-2Create a New Patient Record without Importing

Exams 7-16Create and Assign Patient Diagnoses 7-11Create and Edit Visit Records 7-19Create New Record button 7-5Cross Hair protocol 4-6Cup Area 6-16Cup Diameter 6-14, 6-15Cup Offset 6-14Cup/Disk Area Ratio 6-17Cup/Disk Horizontal Ratio 6-17Cup/Disk Vertical Ratio 6-17Custom Scan 3-12Customize Printouts 5-5Customize the Browser Layout 7-2Customize the Patients, Visits and Exams Lists 7-2customize the toolbar 2-1

DData Management 7-1Data menu

Archive 8-4Database Backup 8-5Database, Defragment 8-7Database, Patient 8-1Define Custom Scan 3-12Define Custom Scan dialog box 3-12Defragment Database 8-7degrees and angle 3-10Delete Current Record button 7-5Delete Exam Records 7-21Delete Exam, Visit and Patient Records 7-21Delete Patient Records 7-22Delete Visit Records 7-21deleting exams 7-21deleting patients 7-22deleting visits 7-21Deselect Exams (Optional) 8-5Details Tab 3-14Details View 4-1Diagnoses, create and assign 7-11Diagnoses, edit 7-11Dilate the Patient 2-3Disk and Fovea Buttons 3-8Disk Area 6-16

I-2 / INDEX STRATUSOCT USER MANUALPN 55641-1 REV. A 4/03

INDEX / I-3

Disk Diameter 6-14, 6-15Disk Storage 10-2Disk/Fovea buttons and fixation LED 3-8Display Monitor 10-2DVD_RAM Disks, Format 8-2DVD-RAM drive 8-3

EEdit Clinical Notes 7-21Edit Current Record button 7-5Edit Exam Record Remarks and Notes 7-20Edit Patient dialog box 2-5editing basic patient information 7-21editing patient information 7-18Electrical Requirements 10-1Embedded Windows License 10-2EMI Statement 1-7Enter Patient Data 2-4Environmental Conditions 10-2Error Messages, Handling 9-1Exams Area 7-3exams, deleting 7-21Exclude Scans from Analysis 5-4Exiting Scans 4-3Export Results of Retinal Thickness 6-18Export RNFL Thickness results 6-9External Fixation 2-3, 10-1external fixation target 2-3

FFast Macular Thickness Map 4-8Fast Optical Disc protocol 4-8Fast RNFL Thickness (3.46) protocol 4-8Field of View 10-1File menu

Exit 2-1, 8-5Print 5-5

File Menu in Browser 7-3Find and Select Records 7-5fixation LED

default locations 3-8Disk and Fovea buttons 3-8fovea and disk locations 3-8moving to improve contrast and orientation 3-7

Fixation LED, moving 3-7Fixation Method--Select 2-3fixation target light 2-3fixation target, moving 3-7focus adjustment knob 3-4Focus Adjustment Range 10-1Forehead and Chin Rests, Cleaning 9-1

Format DVD-RAM Disks 8-2Format of Display 6-20Formatting--erases DVD disks 8-2four-headed arrow 3-7Freeze with Flash, Scan menu 3-9functional areas, resize 2-2Fundus Illumination Lamp 9-2fundus photo 3-9Fuse ratings 10-1fuse replacement 9-2

GGaussian Smoothing protocol 6-21General Tips (analysis protocols) 6-2Glaucoma analysis protocols 6-2Glaucoma Protocols 4-1gray checkmark 8-5grayed checkbox 8-5green cursor 6-22

Hhardware elements 1-3Home button 2-1Horizontal Integrated Rim Width (Area) 6-16How It Works for You 1-2How The STRATUSOCT Works 1-1How to Acquire Scans 3-8How to Adjust The Height 3-1How To Archive 8-3How to Position the PM 3-4

IIllumination 10-1Image Processing Protocols 6-2, 6-19

Align 6-20possible introduction of artifacts 6-21

application 4-2, 6-2Format of Display 6-20Gaussian Smoothing 6-21Median Smoothing 6-21Normalize 6-20Normalize + Align 6-21Proportional 6-21Scan Profile 6-22

Measure A-Scan Location 6-22Signal Offset Threshold Comparison 6-22

image, small 3-9image, thumbnails 3-9Indicators Tab 3-14Individual Radial Scan Analysis 6-15


I-4 / INDEX

Individual Scan Image Measurements 6-15Information Tabs 3-14

Comment Tab 3-15Details Tab 3-14Indicators Tab 3-14

Initiate A Scan 3-2Initiate A Scan--select a scan protocol 3-2Initiate An Analysis 5-1Installation Requirements 1-4Instrument Disposition 1-8Instrument Installation 1-3insurance companies, create, edit and assign 7-15insurance records are case-sensitive 7-15interferometer signal range, adjusting 3-13interferometry

analogous to ultrasound 1-1low-coherence, explained 1-1principles 1-1

Internal Fixation 2-3, 10-1Introduction 1-1IOP, intra-ocular pressure 7-21

Jjoystick 3-4joystick knob 3-4

Kkeyboard 1-3

LLamp Brightness 3-14Lamp, expected life 9-2Landmark 3-8Landmark and the Repeat protocol 4-5Large Icon View 4-1left blue button 3-8Legal Notices 11-1License Agreement, Software 11-2License Terms and Conditions, Software 11-3Limitation Of Liability 11-2Line protocol 4-5Lines 3-10List View 4-1lock the PM 3-5Log Abs. Reflectance checkbox 5-4

MMacular Thickness Map protocol 4-6Macular Volume 6-5Main fuses 10-1

Main Menu and Toolbar 2-1Main Window

functional areas 2-1Manage Records 7-9Manual

Organization 1-1Purpose 1-1

measurement algorithms 6-4Measurement Units 10-2Measuring Nerve Fiber Thickness 4-4Median Smoothing protocol 6-21Medical Staff Records, create and edit 7-13medical staff records, editing 7-13Medical staff records, not case-sensitive 7-13medical staff, assign to patient records 7-14menu bar

menus 7-3Menus, Browser 7-3Merge Patient Records 7-18merging

constraint on same visit dates 7-19merging records unintentionally 7-16Method of ONH Analysis 6-14Methods to Measure Retinal and RNFL Thickness

6-4mouse 1-3Move the Disk Reference Points 6-15Move the Fixation LED 3-7move the fixation target 3-7Move the Scan Pattern 3-7

NName drop-down list 3-12nasal position and angle 3-10Navigation in General 2-2Nerve Fiber Thickness, Measuring 4-4Nerve Head Circle protocol 4-7new patient records, creating 7-16Noise 3-13Normalize + Align protocol 6-21Normalize protocol 6-20Normative Data and Its Applicability 6-3Notification Of Copyright 11-2Number of A-Scans 3-13, 4-4number of A-scans 3-11Number of Data Points 3-11Number of Lines 3-10

OOCT Image Tab 3-12

Noise and Range 3-13


INDEX / I-5

Number of A-Scans 3-13ocular lens 9-1ocular lens, retract and extend 3-4Optic Nerve Head 6-13Optic Nerve Head (ONH) Analysis

Adj Display button 6-15Adjustments for Individual Radial Scan Analysis

6-15Clear Graphics button 6-16Composite Image Features and Functionality 6-16Composite Image Measurements 6-16Cup Area 6-16Cup/Disk Area Ratio 6-17Cup/Disk Horizontal Ratio 6-17Cup/Disk Vertical Ratio 6-17Disk Area 6-16Horizontal Integrated Rim Width (Area) 6-16Image Background Options 6-17

Aligned to Disk 6-17Aligned to Surface 6-17None 6-17

Individual Radial Scan Analysis 6-15Individual Scan Image Measurements 6-15Method 6-14Move the Disk Reference Points 6-15Optic Nerve Head Analysis Results 6-16ReAnalyze button 6-15Rim Area 6-16Surface Sensitivity 6-16Vertical Image Rim Area (Volume) 6-16

Optic Nerve Head Analysis Results 6-16Optical Disc protocol 4-6Optical Power 10-1Optimize Polarization 3-6Optimize Scan Image 3-5Optimize Z-offset button 3-5Optional Scan Review Window 3-9Options Menu in Browser 7-4Organization of The Manual 1-1

PPassword Protection 1-4patient comfort

see Adjust the Heightpatient data and scan data 8-1patient data vs. scan data 8-1Patient Database 8-1

Archive vs. Backup 8-1backup 8-5scan data vs. patient data 8-1

Patient Experience 2-3flash 2-4time required 2-3

what the patient sees 2-4patient information, editing 7-18, 7-21Patient List 2-4Patient List Views 2-4

Details View 2-4List View 2-4Small Icon View 2-4

Patient menu 2-6Patient Module 1-3, 2-1, 2-3, 3-2, 3-4, 3-8, 10-2Patient Module, positioning 3-4patient record

deleting exams from 7-21Patient Record button 7-4patient record identifier 7-16patient records, creating without importing 7-16patient records, deleting 7-22patient records, merging 7-18Patient Tab 2-5Patients Area 7-2patients, deleting 7-22Physical Dimensions 10-2PM

see Patient Moduleblue function buttons 3-8lock 3-5unlock 3-4

point of origin 3-10Polarization and scan mode 3-6Polarization, when to adjust 3-6Position The Patient Module 3-4Position the PM, goal of positioning 3-4Position the PM, How to 3-4Position the PM, Tools 3-4positioning tools

focus knob 3-4joystick knob 3-4

power down the system 2-1Power Fuses 9-2Power Up The System 2-1Prepare To Scan 2-1Print button 5-5printer 1-3Proportional Circle protocol 4-6Proportional protocol 6-21protocols

number and application 1-2Purpose Of This User Manual 1-1

QQuantitative Analysis Protocols 6-4

General Information 6-4Quantitative Analysis Protocols, listed by applica-


I-6 / INDEX

tion 6-1Quit button 8-6

RRadial Lines protocol 4-6Radius 1 and Radius 2 3-10Range 3-13range of interferometer signals depicted 3-13Raster Lines protocol 4-5ReAnalyze button 6-15Record Menu in Browser 7-3Record Search Window 7-6records

adding patient 7-16exam remarks and notes 7-20patient, merging 7-18

Records Search button 7-4red cursor 6-22reflectivity values

see Signal Intensity valuesrefractive correction (spherical equivalent) 2-6Refresh button 7-5Register, Edit and Assign Insurance Companies 7-15Register, Edit and Assign Medical Staff 7-13Repeat protocol 4-5Repeat protocol and the landmark 4-5Report Signs Of Wear 9-1Resize Functional Areas 2-2resolution, transverse 3-11Restoration of database 8-6Retina analysis protocols 6-2Retina Protocols 4-2Retinal Map protocol 6-18Retinal Thickness protocol 6-18

Export Results 6-18Retinal Thickness/Volume Change protocol 6-7Retinal Thickness/Volume protocol 6-5Retinal Thickness/Volume Tabular protocol 6-6Review button 3-9right blue button 3-9Rim Area 6-14, 6-16Rim Area (Vert. Cross Section) 6-13Rim Area (Vertical Cross Section) 6-15Rim Length (Horizontal) 6-15RNFL Map protocol 4-7RNFL Thickness (2.27xdisc) protocol 4-7RNFL Thickness (3.46) protocol 4-7RNFL Thickness Average protocol 6-9RNFL Thickness Change protocol 6-12RNFL Thickness Map protocol 6-11RNFL Thickness protocol 6-8

RNFL Thickness Serial Analysis protocol 6-13Routine Cleaning 9-1Routine Maintenance 9-1

SSafety Precautions 1-7Save button 3-9, 3-10Save Record button 7-5Scan Acquisition Protocols 4-1Scan Acquisition Time 10-1Scan Acquisition Window 3-3Scan Adjustments, Other 3-10Scan button 4-1scan data vs. patient data 8-1Scan Direction Legend 6-3Scan drop-down list 3-12Scan Group Images Tab 5-2scan image 3-4

bringing it into view 3-5scan image and axial “window” 3-5scan image color scale 3-13scan image optimization

optimize polarization 3-6optimize Z-offset 3-5

scan image vs. video image 3-5Scan List 5-1Scan menu

Define Custom Scan 3-12Freeze with Flash 3-9Scan Variables 3-11

Scan Mode button 3-3, 3-8Scan Not Available message 8-5Scan Parameter Tab 3-6Scan Pattern Parameter area 3-10Scan Pattern, moving 3-7Scan Patterns 10-1Scan Pixels 10-1scan placement 3-6

and scan mode 3-7automated features 3-6Click and Drag 3-7Move the Fixation LED 3-7Move the Scan Pattern 3-7

Scan Profile protocol 6-22Scan Protocol Descriptions, Options And Tips 4-5Scan Protocol Groups 4-1Scan Protocols

Circle 4-5Concentric 3 Rings 4-6Cross Hair 4-6Fast Scans

Fast Macular Thickness Map 4-8


INDEX / I-7

Fast Optical Disc 4-8Fast RNFL Thickness (3.46) 4-8

Line 4-5Macular Thickness Map 4-6Nerve Head Circle 4-7Optical Disc 4-6Proportional Circle 4-6Radial Lines 4-6Raster Lines 4-5Repeat 4-5RNFL Map 4-7RNFL Thickness (2.27xdisc) 4-7RNFL Thickness (3.46) 4-7X-Line 4-7

scan protocolsapplication 4-2, 6-2

Scan Protocols Are Correlated with Analysis Proto-cols 4-2

Scan Protocols, all listed 4-2Scan Range 10-1Scan Review Window 3-9Scan Selection button 5-3Scan Selection for analysis, optional 5-2Scan Speed 10-1Scan Tab 4-1Scan Tab Views 4-1

Details View 4-1Large Icon View 4-1List View 4-1Small Icon 4-1

Scan Time 3-11Scan Variables dialog box 3-11Scan, Landmark and Fixation LED Controls 3-7Scanners 10-1search by ID number 5-1search by name 5-1Search Field 2-5Search field 5-1Search for Patients 7-5Search Now button 7-5searching with case-sensitive criteria 7-11, 7-15Select a Patient 2-5, 5-1select a scan acquisition protocol 3-2Select Acquisition Protocol button 4-1Select an Analysis Protocol 5-3Select Analysis Protocol button 5-1, 6-1Select exams--deselect 8-5Select Patient, Visit and Exam Records 7-7Select Scan Group(s) 5-1Select the Fixation Method 2-3Select toolbar buttons 2-1, 4-3Selecting Multiple Records 8-5

Selection Window 5-4Service Contract 11-2Set W/L from Data 6-16Shadows 3-5Signal Intensity values 6-22Signal source 10-1Signal Type 10-1Size 3-10Size vs. Resolution 4-4Small Icon 4-1SNR & Accepted A-Scans% 6-3Software and Storage Media 1-3Software License Agreement 11-2Specifications 10-1

Calibration 10-2CE Mark 10-2Disk Storage 10-2Display Monitor 10-2Electrical Requirements 10-1Environmental Conditions 10-2Fundus Imaging 10-1Measurement Units 10-2Physical Dimensions 10-2Standards and Approval 10-2Start-up 10-1System Control Input Devices 10-2System Weight 10-2Table Loading Capacity 10-2Tomographic Imaging 10-1

spherical equivalent 2-6Spot Size at Retina 10-1staff--create, edit and assign 7-13Standards and Approval 10-2Start Window 1-i, 9-1Start-up 10-1STRATUSOCT

Analysis Window 7-8applications 1-2Browser

open and close 7-1features and benefits 1-2histories and monitoring 1-2How it works 1-1How it works for you 1-2Main Window 2-1, 2-2

Scan Tab 4-1Navigate to the Main Window 2-1resolution 1-2Start Window 1-iSystem Described 1-1System Hardware 1-3

super luminescent diode (SLD)OCT technology 1-1


I-8 / INDEX

wavelength 1-1see also interferometry

Surface Sensitivity 6-16Symbols Defined 1-7System Backup 8-6System Control Input Devices 10-2System Weight 10-2

Ttable height switch 3-1Table Loading Capacity 10-2

consequences of reconfiguration 10-2Table of Correlations 4-3, 6-3target light 3-5Text Convention 2-2thumbnail image 3-9Tips to Avoid Damage 1-4Tomographic Imaging 10-1Tools to Position the PM 3-4Total Macular Volume 6-5Transverse Resolution 10-1transverse resolution 3-11two-headed arrow 3-7, 3-10

UUndo Changes button 7-5unlock the PM 3-4Utilities Menu in Browser 7-4

VValue field 3-10Vertical Integrated Rim Area (Volume) 6-16Video and Lamp Parameter Tab 3-14

Lamp Brightness 3-14

Video Brightness and Contrast 3-14Video Brightness and Contrast 3-14video image 3-4video image, adjusting 3-14video image, adjustments 3-4Video Monitor 1-3View Menu in Browser 7-4visit dates and merging patient records 7-19visit record

deleting visits from 7-21Visit Record button 7-4visit records, create 7-19visit records, edit 7-19visits

deleting 7-21Visits Area 7-2

WWarranty, defined 11-1Warranty, Note Regarding 9-1wear, report 9-1What Does That Button Do? 7-4Which Scan Parameters Can Be Adjusted When 4-3why move the fixation target 3-7

Xx and y positions

scan, landmark and fixation LED 3-8X-Line protocol 4-7

ZZ-offset and scan mode 3-6Z-offset arrow buttons 3-5Zoom buttons in Optic Nerve Head Analysis 6-16


medicine ophthalmology optical coherence tomography of ocular diseases.stratus 3.0 user manual

Documents

addresscarl zeiss meditec

stratusoct works

stratusoct system hardware

instrument installation

password protection

means of information

storage media

installation requirements