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Stratus OCT

Model 3000 Instrument and Stratus Review Software Version 7.0

User Manual
ii

Copyright
© 2010 Carl Zeiss Meditec, Inc. All rights reserved.

Trademarks
Stratus OCT and GPA are either registered trademarks or trademarks of Carl Zeiss Meditec,
Inc. in the United States and/or other countries.
Windows is either a registered trademark or trademark of Microsoft Corporation in the
United States and/or other countries.
All other trademarks used in this document are the property of their respective owners.

Stratus OCT User Manual PN 2660021134133 A


Contents iii

Contents

(1) Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1


•Intended Use/Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
•Purpose Of This User Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
•What's New? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
•Stratus OCT User Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
•Stratus OCT System Described . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
•Stratus OCT System Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
•WARNING: User Changes to Software or Hardware . . . . . . . . . . . . 1-9
•Instrument Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
•Tips to Avoid Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
•Embedded Windows License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
•Product Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
•Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
•Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . 1-13
•Accessory Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
•Symbols and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
•Password Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
•Instrument Disposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
(2) Prepare To Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
•Power Up The System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
•Navigate To The Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
•Prepare The Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
•Enter Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
(3) Acquire Scans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
•Adjust the Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
•Initiate a Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
•Position The Patient Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
•Optimize Scan Image. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
•Adjust Scan Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8
•Acquire Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
•Other Scan Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
(4) Scan Acquisition Protocols . . . . . . . . . . . . . . . . . . . . 4-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
•The Scan Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
•The Protocol Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
•General Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3

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iv Contents

•Scan Protocol Descriptions, Options And Tips . . . . . . . . . . . . . . . . .4-6


•Repeat Scan Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
(5) Analyze Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
•Initiate An Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
•Selection Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
•Print Analysis Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
•Export to DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
(6) Analysis Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
•The Analyze Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
•Protocol Lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
•General Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
•Normative Data and Its Applicability. . . . . . . . . . . . . . . . . . . . . . . .6-6
•Edit Layers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8
•Analyses and Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
•Image Processing Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-37
(7) Data Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
•Find and Select Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
•Print Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
•Add a New Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
•Edit Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
•Merge Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
•Create and Edit Visit Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
•Edit Exam Record Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
•Edit Clinical Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
•Categorize Patient Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
•Create and Assign Patient Diagnoses . . . . . . . . . . . . . . . . . . . . . . 7-11
•Register, Edit and Assign Medical Staff . . . . . . . . . . . . . . . . . . . . . 7-14
•Register, Edit and Assign Insurance Companies . . . . . . . . . . . . . . 7-15
•Delete Patient, Visit and Exam Records . . . . . . . . . . . . . . . . . . . . . 7-17
•Site ID and Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
•Defragment Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
(8) Archive, Retrieve & Backup . . . . . . . . . . . . . . . . . . . . 8-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
•The Patient Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
•Data Maintenance Requirements . . . . . . . . . . . . . . . . . . . . . . . . . .8-2
•Recommendations For Automated Data Maintenance . . . . . . . . . .8-3

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Contents v

•Archive Registration and Management . . . . . . . . . . . . . . . . . . . . . .8-4


•Care of DVD Archives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5
•Format DVD-RAM Disks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6
•DICOM Archive and Retrieve Workflow . . . . . . . . . . . . . . . . . . . . . .8-8
•Retrieve Scan Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
•Clear Archived Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
(9) Export and Import Scan Data . . . . . . . . . . . . . . . . . . 9-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
•Privacy and Data Integrity Features. . . . . . . . . . . . . . . . . . . . . . . . . 9-1
•OCT Image Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
•Database Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6
•Import Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
(10)Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 10-1
•Chapter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
•Handling Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
•Hard Disk Defragmentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
•Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
•Report Signs Of Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
•List of User Replacement Accessories . . . . . . . . . . . . . . . . . . . . . . 10-3
(11)Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
•Tomographic Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
•Fundus Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
•Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
•Fuse Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•Measurement Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•System Input Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•Physical Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
•System Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
•Table Loading Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
(12)Legal Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
•Stratus OCT Instrument Legal Notices . . . . . . . . . . . . . . . . . . . . . . 12-1
•Stratus Review Software Legal Notices . . . . . . . . . . . . . . . . . . . . . 12-4
•Carl Zeiss Meditec, Inc. Electronic End User License Agreement . . 12-4
•Carl Zeiss Meditec, Inc., Limited Warranty for Software . . . . . . . . 12-6
•Software Support Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
(A) Networking Guidelines. . . . . . . . . . . . . . . . . . . . . . . . A-1

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vi Contents

•Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
•Instrument Network Capabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
•Stratus Review Software Network Capabilities . . . . . . . . . . . . . . . . A-1
•WARNING: Risks of Internet Connectivity . . . . . . . . . . . . . . . . . . . .A-2
•Stratus Review Software: Third Party Software . . . . . . . . . . . . . . . .A-2
•Prohibited Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Network Activities Not Supported . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Not Recommended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-3
•Network File Server Minimum Requirements. . . . . . . . . . . . . . . . . .A-3
•Network File Server Recommendations . . . . . . . . . . . . . . . . . . . . . .A-4
•Using The Network File Server. . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
•Configuration for Direct Export to a Personal Computer . . . . . . . . .A-6
(B) Configuration Guide . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
•Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
•Data Transfer Overview: Import or Retrieve Data . . . . . . . . . . . . . .B-2
•Configuration for Export via Preexisting Office Network . . . . . . . . .B-3
•Stratus to Review Station Direct Network Connection (Crossover Cable)
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13
(C) Normative Database for Macula and 
RNFL Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
•Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-2
•Data Analysis and Normalization . . . . . . . . . . . . . . . . . . . . . . . . . .C-2
•Age Coefficient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-3
•Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-5
(D) Data Transfer Using CDs and DVDs . . . . . . . . . . . . . . D-1
•Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-1
•Compatible CD and DVD Media Formats. . . . . . . . . . . . . . . . . . . . .D-1
•Compatible Data Transfer Functions . . . . . . . . . . . . . . . . . . . . . . . .D-1
•Stratus OCT Data Transfer Instructions . . . . . . . . . . . . . . . . . . . . . D-2
•Proper CD and DVD Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
•Formatting for Drag-to-Disc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
•Roxio Software Configuration—Eject Settings . . . . . . . . . . . . . . . D-4
•Warning: User Changes to Hardware or Software . . . . . . . . . . . . . D-5
(E) Using a Network Storage Device. . . . . . . . . . . . . . . . E-1
•Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
•NAS Device Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
•NAS Device Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
•NAS Device Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2

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•Install and Configure the NAS Device . . . . . . . . . . . . . . . . . . . . . . .E-2


•Cleaning the NAS Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-6
(F) Printer Configuration Instructions . . . . . . . . . . . . . . F-1
•Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1
•Printer Safety Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1
•Approved Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2
•Accessory Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2
•Installation Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-2
•Network Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
•USB Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3

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viii

Stratus OCT User Manual PN 2660021134133 A


Introduction 1-1

(1) Introduction
The ZEISS Stratus OCT Model 3000 (Stratus OCT) 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. Stratus OCT Review Software enables you to view, analyze and manage
Stratus OCT data on a personal computer; it provides all the Stratus OCT instrument
functionality, except scan acquisition, in a remote location. The name Stratus OCT (derived
from “stratum,” Latin for “layer”) refers to its unique ability of direct cross-sectional
imaging of the layers of the retina. The Stratus OCT minimizes patient discomfort as it
permits detailed examination of the retina and optic nerve head at the office or clinic. The
Stratus OCT facilitates diagnosis and management of retinal diseases and glaucoma.

Intended Use/Indications For Use


The Stratus OCT is a high resolution tomographic device for the viewing and axial cross
sectional imaging of posterior ocular structures. It is used for in vivo imaging and
measurement of the retina, retinal nerve fiber layer, macula, and optic disc. The Stratus
OCT with Retinal Nerve Fiber Layer (“RNFL”) and Macula Normative Database is a
quantitative tool for the comparison of retinal nerve fiber layer and the macula in the
human retina to a database of known normal subjects. It is intended for use as a
diagnostic device to aid in the detection and management of ocular diseases, including but
not limited to, macular edema, central serous retinopathy, and glaucoma.
.

 Note: The Stratus OCT and Stratus Review Software are not intended to
be used as the sole diagnostic for disease.

Patient Population
The Stratus OCT instrument may be used on all adults and children (over the age of six) in
need of diagnostic evaluation of the eye. This includes (but is not limited to) patients with
the following disabilities or challenges:
• Wheelchair user
• Very low or not measurable visual acuity
• Fixation problems
• Deafness
• Large body, but not those above 99th percentile based on anthropomorphic data
There is a general requirement that the patient be able to sit upright and be able to place
their face in the chin and forehead rest of the instrument (with or without supplemental
human or mechanical support).

Stratus OCT User Manual PN 2660021134133 A


1-2 Introduction

Part of the Body


The Stratus OCT instrument is designed for in-vivo viewing and axial cross-sectional
imaging and measurement of posterior ocular structures. In addition, the system physically
interacts with the patient’s forehead and chin.

Application
The Stratus OCT instrument is designed for continuous use, although it is expected that
most sites operate the instrument for 10 hours or less per day, indoors, within a medical
office or hospital setting. This setting shall have clean air free of soot, vapors from
adhesives, grease, or volatile organic chemicals. Other Operating Environment
specifications are given in Chapter 11. Application related warnings are given in Chapter 1
and elsewhere.

Operator Profile
We assume that users are clinicians with professional training or experience in the use of
ophthalmic imaging equipment, and in diagnostic interpretation of the images generated.
Specific assumptions regarding the profiles of individuals performing instrument operation
or data interpretation are given below. This manual contains information that will aid in
the proper instrument operation and interpretation of the resultant data.

Instrument Operation
Demographic
The user should be adult, and at least one of the following:
• Ophthalmologist
• Nurse
• Certified Medical Technician
• Ophthalmic Photographer
• Non-certified Assistant

Occupational Skills
The user should be able to perform all of the following tasks:
• Power on the unit and log on
• Enter, find, and modify patient identifying data
• Clean surfaces that contact patient
• Position patient with the instrument, including moving the patient, the instrument,
the table height, and the patient’s chair
• Select and acquire a scan
• Review and save a scan or try again
• Generate an analysis report using available analysis protocols

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• Review the analysis report for completeness


• Output the analysis report
• Archive data
• Turn off the instrument

Data Interpretation
Demographic
The user should be one of the following:
• Ophthalmologist or other Medical Doctor
• Optometrist

Occupational Skills
The user should have the following skills:
• Computer literate
• Ability to work with elderly patients and those with disabilities

Job Requirements
The user should have training and certification to interpret the analysis in the treatment of
ophthalmic diseases or other eye-related medical issues, as required by governing bodies.

Purpose Of This User Manual


Carl Zeiss Meditec 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 Stratus OCT, we do not offer
instruction in diagnostic interpretation of the images generated. This manual does not
attempt to do so.

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1-4 Introduction

What's New?
This User Manual includes information on new and modified features of the Stratus OCT
system. For customers who are upgrading from version 6.0 or earlier, the following
describes differences and where information can be found in this user manual.

If you are upgrading from version 6.0


Features that can be licensed:
• DICOM connectivity: allows archive and retrieval of patient records through the
DICOM server. The Modality Worklist retrieves today’s patients and allows you to set
parameters for patient search. Export to DICOM exports current analysis report to
DICOM server.
The following additional change should be noted:
• New caliper color is easier to see when placed on anatomy shown in color

If you are upgrading from version 5.0


Features that can be licensed:
• Multi-Slice Report: assemble multiple B-scan slices on one page for side-by-side
comparisons to images from prior visits and other combinations (see page 6-35).
• DICOM connectivity: export data in DICOM format, receive modality work list from a
central computer. See the DICOM Addendum.

The following additional changes should be noted:


• Enhanced Repeat Scan functionality and inclusion of a Repeat button on the Scan
tab to launch the feature (see page 4-11).
• Filter for Today's Patients in the MAIN WINDOW.
• Enhanced Advanced Search in the MAIN WINDOW (see page 2-7).
• Patient Merge tool is enhanced and specific steps have been modified (see page 7-4).
• Optic Nerve Head Analysis screen and printout are simplified, with key measured
organized in one simple table (see page 6-23).
• Minor changes to the look of other printouts and inclusion of exam time.
• Re-ordering of the scan icons to show the more commonly used scans first on the list.
• Minor change to the wording on the SCAN ALIGNMENT and SCAN ACQUISITION screens
and a reminder to save data before returning to the MAIN WINDOW.
• Minor modification to the Analyze tab, including separating the Image
Processing Protocols from the Analyses & Reports.

• Compatible with Windows® XP on the instrument PC. Starting in 2009, new
computers for the instrument will be loaded with Windows XP.
• Compatible with Windows® Vista for review stations.

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If you are upgrading from version 4.0


Additional features that can be licensed:
• Guided Progression Analysis (GPA™) Advanced Serial Analysis that helps the user
interpret changes in RNFL measurements over time (see page 6-26).
• Layer Editing tool gives the ability to manually adjust the retinal layer boundaries for
macula or RNFL analysis (see page 6-8).
• OCT Image Export: new options for bulk export of OCT scan images (see page 9-2).

The following additional changes should be noted:


• Change to the user interface for registering a license.
• Export screen: includes thumbnails of OCT and fundus images, combined selection
and quick access with toolbar buttons, Advanced Search capability.
• Other changes to the menu structure, explained throughout the user manual.
• Accepts regional date/time formats as entered in the Windows Regional Options
settings.
• Compatible with display resolutions higher than 1024 x 768, including wide screen.
• No limitation on file size when exporting to a network location.
• Stratus OCT™ Review Software has the identical look as the Instrument Software.

Stratus OCT User Manual


This user manual is intended for the operation of the Stratus OCT instrument and Stratus
OCT system software.

Stratus Review Software User Manual


This user manual is also intended for operation of the Stratus Review Software. Stratus
Review Software running on a separate computer is functionally identical to the software
running on the Stratus OCT instrument except for the ability to acquire images.
Information specific to Stratus Review Software is noted as such herein. The following
sections or documents, in particular, contain information specific to Stratus Review
Software:
• See the installation instructions accompanying Stratus Review Software for specific
requirements for Stratus Review Software, such as minimum system requirements for
installation.
• Appendix (B) Configuration Guide contains information to enable transfer of
Stratus OCT data to a computer running Stratus Review Software via network
connection or removable media.
If you are using Stratus Review Software, you can ignore Chapters (2) Prepare To Scan
and (3) Acquire Scans.

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1-6 Introduction

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 Stratus OCT, 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).
• Data Management, explained in Chapter (7).
• Archive, Retrieve & Backup, explained in Chapter (8).
• Export and Import Scan Data, explained in Chapter (9).
Chapters (10), (11) and (12) cover Routine Maintenance, instrument Specifications
and Legal Notices, respectively. Users who wish to use the Stratus OCT in a networked
environment should see Networking Guidelines.

Stratus OCT System Described


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

How The Stratus OCT 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 micrometer scale, versus the 100-micrometer scale for ultrasound. Another
important difference is that optical interferometry does not require contact with the tissue
examined, unlike ultrasound.
The Stratus OCT 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 Stratus OCT 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 reference mirror at known distances. When the
Stratus OCT 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.

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Introduction 1-7

The Stratus OCT interferometer electronically detects, collects, processes and stores the
echo delay patterns from the retina. With each scan pass, the Stratus OCT 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 Stratus OCT 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 Stratus OCT delineates intraretinal, cross-sectional anatomy with axial resolution of
10 micrometers and transverse resolution of 20 micrometers. The Stratus OCT software
package includes scan acquisition protocols and analysis protocols. Together they enable
you to analyze the optic disc, retinal nerve fiber layer and the macula with a single
instrument. The Stratus OCT facilitates the evaluation of both glaucoma and vitreoretinal
disease. The Stratus OCT 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 Stratus OCT histories, so you can monitor patients over time. The inkjet printer
enables you to generate color hard copy.

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1-8 Introduction

Stratus OCT System Hardware


The Stratus OCT system hardware consists of the Patient Module; 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 (11).

Flat Screen Patient Module


Video Monitor
Focus Adjustment
Knob
Keyboard
Computer Unit Joystick
Blue PM
System Power
Function Buttons
Switch

Table Height Printer


Switch
Wheel Chair
Mouse Accessible
(not pictured) Power Table
Caster

Figure 1-1 Stratus OCT System Hardware

Software and Storage Media


Carl Zeiss Meditec pre-installs all software necessary to operate the Stratus OCT. We
recommend the use of a network solution for daily archive and backup, either a network
file server or network attached storage device. You can purchase a network attached
storage device designed for this purpose from Carl Zeiss Meditec.

 Note: We recommend you use the automated data maintenance features to archive
scans and backup the patient database. This helps ensure the preservation of
patient data in case of computer malfunction. See Chapter (8), Archive, Retrieve &
Backup.

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Introduction 1-9

Stratus OCT Hard Drive Partitions


For Stratus OCT systems shipping with software version 5.0 and later, the hard drive is
partitioned into C: and F: drives. The C: drive is reserved for operating system and Stratus
application files, while the F: drive is reserved for data files. Besides the Stratus database,
the F: drive contains the My Documents folder and the computer Desktop. Thus, files you
save to the Desktop can be found in the F: drive.

WARNING: This warning applies to Stratus OCT systems that shipped with software
version 5.0 and later; these systems have the hard drive partitioned into C: and F: drives.
Do not export or save data to the C: drive of a Stratus instrument. The C: drive
is relatively small and can be filled up quickly, which renders the system
unusable. The F: drive is reserved for data and therefore is relatively large. If
you want to export or save data to the Stratus hard drive, either locally or to a
connected Stratus system on the network, select (a location in) the F: drive as
the target.

WARNING: User Changes to Software or Hardware


The Stratus OCT is a medical device. The software and hardware have been
designed in accordance with U.S., European and other international medical
device standards designed to protect clinicians, users and patients from
potential harm caused by mechanical, diagnostic or therapeutic failures.
Unauthorized modification of Stratus OCT software or hardware (including
peripherals) can jeopardize the safety of operators and patients, the
performance of the instrument, and the integrity of patient data.
Unauthorized modification also voids the instrument warranty.

Approved Software

 Note: Carl Zeiss Meditec does not provide technical support for the use of third party
software.
Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved software, including
updates and patches to the Windows® operating system and security software.

 Note Regarding Network Security: Stratus OCT Software Version 7.0 is compatible
with Windows 2000 Service Pack 4, which is primarily a security update to the
Windows operating system. Therefore, if you connect the Stratus OCT to an office
network, we encourage you to install Service Pack 4. Furthermore, please consider
the information in Networking Guidelines. If you connect the Stratus OCT to the
Internet, which is not recommended, see WARNING: Risks of Internet
Connectivity on page A-2.

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1-10 Introduction

Instrument Installation
Only an authorized Carl Zeiss Meditec service representative should install the Stratus OCT.
We do not provide assembly and installation instructions. In consultation with the buyer,
Carl Zeiss Meditec schedules a free on-site installation appointment to coincide with
delivery. System installation and initial calibration require approximately one business day.

 Note: Only trained CZM personnel may perform calibration.

Care in Handling
Use extreme care when handling and transporting the Stratus OCT shipping boxes. The
instrument contains fragile optics that require highly precise alignment.

Installation Requirements
• The instrument with the optional power table requires an area at least 6' x 8' (1.80 m
by 2.4 m) for installation and patient comfort during use.
• To prevent heat buildup that could damage the instrument, you must install it in a
ventilated room and must not block the ventilated instrument covers that allow heat
to dissipate from the device. For more information on acceptable operating
conditions, see the specifications for Environmental Conditions on page 11-2.
• The Stratus OCT should operate on a dedicated power outlet. Based on your
specification, we configure your Stratus OCT at the factory to use either 100/120V or
220/240V line voltage.

Tips to Avoid Damage

 Note: Users are not authorized to dismantle or modify the Stratus OCT hardware. To
transport the instrument outside the office, you must consult with a Carl Zeiss
Meditec service technician. Failure to do so voids all warranties offered with the
Stratus OCT.
• Only Carl Zeiss Meditec authorized technicians should disassemble or service this
instrument. In the case of malfunction, error messages or operational problems, call
Carl Zeiss Meditec customer service: In the U.S., call 800-341-6968. Outside the U.S.,
contact your local Carl Zeiss affiliate or distributor.
• This instrument has no special measures to protect against harmful ingress of water
or other liquids (classified IPXO—ordinary equipment). Do not place containers of
liquid on or near the instrument, and do not use aerosols on or near it.
• In case of a non-medical 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 customer service: In the U.S., call 800-341-6968. Outside the U.S., contact
your local Carl Zeiss affiliate or distributor.

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Introduction 1-11

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

Embedded Windows License


Each Stratus OCT instrument is issued with an embedded Windows license. The license
number is of interest only to CZM service personnel. The license label is affixed underneath
the front computer cover, and is inaccessible to users.

Product Compliance
Complies with 93/42/EEC Medical Device Directive.

Complies with US and Canadian medical electrical system safety requirements.

Product Safety
• IEC 60601-1
• UL 60601-1
• CSA C22.2 No. 601.1-M90
This instrument is classified as follows:
• Class I Equipment – Protection against electrical shock.
• Type B – Degree of protection against electric shock of applied part (chin and
forehead rests).
• Ordinary Equipment (IPX0)– Degree of protection against ingress of liquids (none).
• Continuous Operation – Mode of operation.

WARNING: To prevent electric shock, the instrument must be plugged into an


earth grounded outlet. Do not remove or disable the ground pin. Only an
authorized Carl Zeiss Meditec service representative may install the
instrument.

WARNING: Do not use the printer or the instrument with an extension cord or
a power strip (multiple portable socket outlet). For additional safety, do not
plug the printer and the instrument into the same wall outlet. Failure to
observe this warning could result in electrical shock to the patient and/or
examiner.

WARNING: Do not open the instrument covers. Opening the instrument


covers could expose you to electrical and optical hazards.

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1-12 Introduction

WARNING: To maintain patient safety, peripheral devices, such as printers,


must be placed at least 1.5 meters (4.9 feet) away from the patient, such that
the patient cannot touch a peripheral device with any part of his or her body
while being examined. In addition, the instrument operator must not attempt
to touch the patient and a peripheral device at the same time while
examining the patient.

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: 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.

WARNING: Avoid tipping. To avoid tipping, the printer supplied with the
instrument must be maintained in its place and no others are to be used. Do
not use the instrument on an uneven or sloped surface. Also, do not roll the
table in deep pile carpet or over objects on the floor such as power cords.
Failure to observe these precautions could result in tipping of the instrument
and/or table and resulting injury to operator or patient and damage to the
instrument.

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: Do not scan patients who have been injected with photo-dynamic
therapy (PDT) treatment drugs, such as Visudyne®, in the previous 48 hours.
Failure to observe this warning could result in unintended exposure and
uncontrolled treatment of neovascular vessels

WARNING: This device contains visual stimuli, including flickering light and
flashing patterns, between 5 and 65 Hz. Medical professionals need to
determine whether this device should be used for patients who may be
photosensitive, including those with epilepsy.

Disclaimer: Carl Zeiss Meditec 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.

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Introduction 1-13

Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope Guidance


#71): Because prolonged intense light exposure can damage the retina, the
use of the device for ocular examination should not be unnecessarily
prolonged. While no acute optical radiation hazards have been identified for
direct or indirect ophthalmoscopes, it is recommended that the exposure time
for the patient’s eye be limited to the minimum time that is necessary for
diagnosis. Infants, aphakes and persons with diseased eyes will be at greater
risk. The risk may also be increased if the person being examined has had any
exposure with the same instrument or any other ophthalmic instrument using
a visible light source during the previous 24 hours. This will apply particularly if
the eye has been exposed to retinal photography. Note: This medical device
has no user adjustable intensity settings for light incident on the retina, nor
does it produce UV radiation or short-wavelength blue light.

Caution: Federal law restricts this device to sale by or on the order of a


Physician or Practitioner.

Electromagnetic Compatibility (EMC)


EN 60601-1-2 compliant

 Note: The Stratus OCT has special EMC precaution requirements and needs to be
installed and put into service according to the EMC information provided herein.

 Note: Portable and mobile RF communications equipment can affect medical


electrical equipment.

WARNING: The use of accessories, transducers and cables other than those
specified may result in increased emissions or decreased immunity of the
equipment.

WARNING: The Stratus OCT should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration in
which it will be used.

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1-14 Introduction

Guidance and manufacturer’s declaration - electromagnetic emissions


The Stratus OCT is intended for use in the electromagnetic environment specified below. The customer or user of
the Stratus OCT should assure that it is used in such an environment
Emissions Test Compliance Electromagnetic environment -
guidance
The Stratus OCT uses RF energy only
RF emissions Group 1 for its internal function. Therefore,
CISPR 11 its RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions Class A
CISPR 11 The Stratus OCT is suitable for use in
all establishments other than
Harmonic emissions Class A
domestic and those directly
IEC 61000-3-2
connected to the public low-voltage
Voltage fluctuations/ Complies power supply network that supplies
flicker emissions buildings used for domestic
purposes.

Guidance and manufacturer’s declaration - electromagnetic immunity


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

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Introduction 1-15

Guidance and manufacturer’s declaration - electromagnetic immunity


The Stratus OCT is intended for use in the electromagnetic environment specified below. The customer or user of
the Stratus OCT should assure that it is used in such an environment
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Stratus OCT, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.

Recommended separation distance


d = 1.17 P

Conducted RF 3 Vrms 3V d = 1.17 P 80 MHz to 800 MHz


IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m d = 2.33 P 800 MHz to 2,5 GHz
IEC 61000-4-3 80 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the
compliance level in each frequency
range.b Interference may occur in the
vicinity of equipment marked with the
following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.


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

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1-16 Introduction

Recommended separation distances between portable and mobile RF communications equipment


and the Stratus OCT
The Stratus OCT is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Stratus OCT can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the Stratus OCT as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
d = 1.17 P d = 1.17 P d = 2.33 P
0,01 0.117 0.117 0.233
0,1 0.370 0.370 0.737
1 1.170 1.170 2.330
10 3.700 3.700 7.368
100 11.700 11.700 23.300
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.


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

Accessory Equipment
WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (e.g.,
IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore, all configurations shall comply with the system
standard IEC 60601-1-1. Any person who connects additional equipment to
the signal input part or signal output part configures a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult the
technical service department or your local representative.

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Symbols and Labels

Caution, consult accompanying documents. Note: There are important operating and maintenance
instructions found in the manual.

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

Fuse

Type B applied parts

Manufacturer

Authorized European Community Representative

Serial number

Catalog number / part number

Model number

European Conformity

Protective Packing Symbols


The protective packing symbols specify the handling requirements and the transport and
storage conditions.

Handling Requirements Transport and Storage Conditions

Relative Humidity (10% to 100%, including


Fragile, Handle with Care
condensation)

Temperature (-40 to +70 deg. C)


Keep Dry
Atmospheric Pressure Limits (500 hPa to 1060 hPa)

This end up

 Note: The instrument is not intended to be transported outside its original package.

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1-18 Introduction

Password Protection

 Note: The following information and instructions are intended for the use of the
Stratus OCT in a standalone setting. If you have installed the Stratus OCT 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. In general, we recommend that you
use good practices in creating, administering and securing passwords.
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 Stratus OCT
computer. The Stratus OCT is shipped with Windows password protection turned on but
with auto-logon enabled so that users do not have to enter a password. The result is that,
upon system startup, any user has administrator privileges (access to all functions) via the
default user account.

 Note: If you disable auto-logon, the Stratus OCT 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. After logging on, you
may have to launch the Stratus OCT software by double-clicking on the STRATUS
OCT Host desktop icon.

Administrator Privileges
Administrators belong to the Administrators Group by default. The default user account is
an administrator account.
• Users in the Administrators Group can use all Stratus OCT functions.
• Administrators can modify the computer and install programs—and thereby
implement Stratus OCT software upgrades.
• Only administrators can create new user accounts, manage network settings and read
the files of other users.

Default Windows User Name, Password and Workgroup Name


Stratus OCT systems that shipped with software version 5.0 or later have a different default
user name, password and workgroup name than systems that shipped with any earlier
software version. Passwords are case-sensitive.
Stratus OCT shipped with Version 6.0 or later Stratus OCT shipped before Version 6.0
User Name Zeiss Administrator
Password November171846 tomography
Workgroup Name CZM Workgroup

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Introduction 1-19

How to Activate Password Protection


You implement password protection in Windows by disabling auto-logon. You may then
create one or more new user accounts that have a user name and password. When you
create user accounts, you must select Other—Administrator. Only users with administrator
privileges can use all features of the Stratus application.
To activate password protection, follow these steps:
1. Power up the system. Exit the Stratus OCT 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 1-2 Users and Passwords Dialog Activated

WARNING: Do not attempt to remove, edit the properties or edit the


passwords of the “Administrator” or “Zeiss” or “Tech Support” accounts.
Failure to observe this warning could disable access to the system.

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.

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1-20 Introduction

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

Figure 1-3 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.
• 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 Stratus OCT software by double-clicking on the STRATUS OCT Host
desktop icon.

Log On after Restart

 Note: If the Stratus OCT is connected to a network file server, you may be required to
log on to the server as well as the instrument. Check with your network
administrator for the required log on procedures.
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.

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

Instrument Disposition
When it comes time to upgrade the Stratus OCT, please contact Carl Zeiss Meditec 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.

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Prepare To Scan 2-1

(2) Prepare To Scan

Chapter Overview
This chapter explains in detail how to prepare for scanning with the ZEISS Stratus OCT.
Along the way, it describes the Stratus OCT MAIN WINDOW, from which all functions
originate. Scan preparation consists of the following:
• Power Up The System (page 2-1).
• Navigate To The Main Window (page 2-2).
• Prepare The Patient (page 2-4).
• Enter Patient Data (page 2-5).

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 Stratus OCT System Hardware drawing
on page 1-8). Press the switch and hold it down for 3-4 seconds to activate power to all
components. The Stratus OCT software loads automatically. It requires about 45 seconds
for the Stratus OCT START WINDOW to display (pictured below). During this time, buttons on
the keyboard and the Patient Module are disabled.

Figure 2-1 Stratus OCT Start Window

Power Down the System


To power down the system, exit the Stratus OCT software (click File > Exit or click the
at upper right) to enter the Windows environment. Then select Shut Down from the

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2-2 Prepare To Scan

Windows Start menu at lower left. For later models with soft shutdown, this will power
down the whole system. On earlier models, you must flip the computer power switch off to
shut down the whole system.

Soft Shutdown
To prevent abrupt shutdowns of the system, later models of Stratus OCT power down only
through the computer software. On these models, pressing the power switch while the
instrument is running will not power down the system.

The Main Menu and Toolbar


The main menu and toolbar (below) are on nearly every screen.

Figure 2-2 The Main Menu and Toolbar


From left to right, the buttons are Select Patient, Select Acquisition Protocol, Select
Analysis Protocol, Advanced Search, Print, Home, Edit Layers, OCT Image Export and
DICOM Export. The three Select buttons all lead to the MAIN WINDOW (pictured below). The
Advanced Search button opens a search screen. When active, the Print button prints the
current screen. The Home button returns you to the Stratus OCT START WINDOW. The Edit
Layers button opens the Edit Layer dialog to edit the retinal layer boundaries; it is available
when you have an applicable analysis open. See Edit Layers on page 6-8 for more
information. The OCT Image Export button opens the OCT Image Export Options dialog to
select options and export all OCT scan images for the current patient. See OCT Image
Export on page 9-2 for more information.

Navigate To The Main Window


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

Stratus OCT Main Window


The MAIN WINDOW has four functional areas:
• The Patient List with Category and Search fields (upper left)
• The Scan List (center)
• The Scan and Analyze Tabs with Activity radio buttons (right)

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Prepare To Scan 2-3

• The Patient and Scan Group Images Tabs (lower left)

Figure 2-3 The Stratus OCT 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.

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

Access Menu Options


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

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Prepare The Patient


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

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

Dilate the Patient (Optional)


Dilation is an optional procedure to aid in the acquisition of an OCT image. Images of
patients with pupils smaller than 3.2 mm may have a decreased image quality due to the
blocking of the instrument signal by the iris. Adequate scans may be obtained from small
pupils, but require a higher level of user skill to obtain them. If dilation is needed, one drop
of tropicamide (0.5% or 1.0%) ophthalmic solution may provide adequate effects.
Tropicamide is a commonly used mydriatic for routine eye exams. Side effects of dilating
drops are rare, but could include life- or sight-threatening reactions such as acute
glaucoma, cardiac irregularities, increased intraocular pressure and sudden high blood
pressure.

Select the Fixation Method


The Stratus OCT 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 Fixation
In 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 3-9).
• 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 Fixation
With the external fixation method, the patient uses the fellow eye to fixate on a target light
external to the ocular lens. The Stratus OCT 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.

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Prepare To Scan 2-5

• 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 Stratus OCT 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 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 patient module as needed. Note that the Stratus OCT 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.
• 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 Stratus OCT integrates the patient database with scanning and analysis. Scanning is
disabled until you select a patient from the database. You cannot change patient
information during the exam. However, you can edit or delete patient records after the
exam. You can add a patient to the database in the MAIN WINDOW (see Add/Edit Patient
Records, page 2-9).

DICOM Workflow for Modality Worklist


When the CZM DICOM Gateway is properly installed and configured an a Stratus OCT
instrument, you can retrieve a list of patients who are schedule for exams (DICOM Modality
Worklist).

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2-6 Prepare To Scan

 Note: The DICOM workflow for Modality Worklist is available if DICOM1 Integration
is licensed and activated.
To display a list of scheduled patients, click on Search Worklist Patients. The MODALITY
WORKLIST dialog appears.

Figure 2-4 Modality Worklist


By default, the Date Range will be the current date. Click on the Search button to see a list
of all patients scheduled for the date range. Select the desired studies, click Save, then
click Done. The patients will appear in the Patient List of the MAIN WINDOW. The patient
records you selected will be saved to the local database. You will not see a confirmation
message after successfully saving the study to the local database.
You can also access today’s patients by clicking on the Retrieve Today’s Patients button on
the Main Screen. This bypasses the Modality Worklist dialog.

The Patient List


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

Figure 2-5 The Patient List in Main Window

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Prepare To Scan 2-7

Category Field
If you have created patient categories (select Options > Register > Categories to create
categories), you can use the drop down list to select a category of patients for display in
the patient list.

Today’s Patients
Today’s Patients is the list that is shown when you click on Search Worklist Patients. this list
shows the patients that are scheduled for the day.

Patient List Views


You 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) and List. 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 Patient ID. 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 Patient ID does not appear.

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 Field


Type in the Search field above the list to search by last name or patient ID. 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.

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Advanced Search
Stratus OCT provides an Advanced Search dialog to serach for patients using additional
parameters such as patient category, diagnosis, scan type, insurance company, doctor,
clinical trial ID, or subject reading ID, etc. Advanced Search is available from the Toobar.

Figure 2-6 Advanced Search Dialog


Using the available fields, enter or select search parameters and click Search. Search
parameters are not case-sensitive. The search returns all matching patients in the patient
list where you started.

 Note: The search returns only the patients that match all search parameters used. If
your search does not return all patients desired, you may want to broaden your
search by using fewer parameters or partial information. Clicking Search without
using any parameters returns all patients in the source database.

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Prepare To Scan 2-9

The Patient Tab


On the lower left, this tab shows the selected patient's information.

Figure 2-7 The Patient Tab in Main Window

Add/Edit Patient Records


Click the Patient: Add or Edit buttons in the upper center of the MAIN WINDOW, next to the
Search field, to access the PATIENT RECORD WINDOW. (You can also select Add Patient or
Edit Patient from the Patient menu.) Use this window to add and manage patient records.

Figure 2-8 The Patient Record Window


• To create a new patient record, click Add. On the General Data Tab, the required
fields are labeled in red. Enter data for the Last Name, First Name and Date of
Birth (mm/dd/yyyy format), at least, in order to proceed. Click OK when finished.

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• To edit a patient record, select a patient from the list and click Edit. Edit the fields as
desired and click OK when finished.
• If desired, you can enter a variety of other patient information using the available
tabs. All information entered is for record-keeping only. It has no impact on scanning.
• For eyes that are smaller or larger than average, we recommend you input the
Spherical Equivalent and Axial Length (in mm).

 Note: The refractive information is for record-keeping purposes only. Stratus


performs the scans on all eyes in exactly the same way, independent of refractive
information.
• You should backup the patient database regularly to be able to restore it in case of
computer malfunction. See the instructions in Chapter (8).

Allow Clear Exams


When the Stratus OCT database reaches capacity, you must make space by clearing scan
data that has been archived. However, you can prevent the exam records of any patient
from being among those cleared, if you click the No radio button in the Allow Clear
Exams area on the right. The Yes radio button is selected by default, allowing the Stratus
OCT to clear this patient’s exams when necessary, and only if they have been archived
(copied) first. See the section Clear Archived Exams on page 8-14 for more
information.

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Acquire Scans 3-1

(3) Acquire Scans

Chapter Overview
This chapter explains in detail how to acquire Stratus OCT scans. It covers the following
steps:
• Adjust the Height for patient comfort (below).
• Initiate a Scan (on page 3-3).
• Position The Patient Module (on page 3-5).
• Optimize Scan Image (on page 3-6).
• Adjust Scan Placement (on page 3-8).
• Acquire Scans (on page 3-10).
• Other Scan Adjustments (on page 3-13).
The Stratus OCT offers 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 2-5),
the next step is to adjust the instrument height for patient comfort. Seat the patient on the
patient side of the Stratus OCT, facing the operator.

 Note: Before placing the head in the headrest, we recommend the patient touch the
metal base of the Stratus OCT instrument, to prevent electrostatic shock near the
patient's eye.
• 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 Stratus OCT desktop using the table height switch.
This switch is underneath the center of the table on the operator side (see the
Stratus OCT System Hardware drawing on page 1-8).

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3-2 Acquire Scans

• For finer adjustments, you can raise or lower the chin cup. Use the knobs below the
chin cup on either side (see Figure 3-1 below).

Eye Position Marker

Chin Cup

Chin Cup Height


Adjustment Knob

Figure 3-1 Height Adjustment


With the patient seated, follow these steps to adjust the height:
1. Raise or lower the tabletop to bring the forehead rest approximately level with the
patient's forehead.
2. Before asking the patient to place his or her chin on the chin cup, move the patient
module safely away from the patient's face. Use the black joystick located on the
operator side of the patient module. If locked, press the joystick button on top to
release the patient module.
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 patient module (see figure above).

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Initiate a Scan
To position the patient module for scanning, you must initiate a scan. First, select a scan
acquisition protocol using the Scan Tab, below.

Figure 3-2 The Scan Tab in Stratus OCT Main Window


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

 Note: The Repeat Scan function is explained on page 4-11.


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

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3-4 Acquire Scans

double-click the protocol. This activates the SCAN ACQUISITION window, as pictured
below.

Figure 3-3 The Scan Acquisition Window


The SCAN ACQUISITION window allows you to adjust video and scan parameters from a single
interface, enabling the acquisition of high quality scans.
The Repeat button to the left of the Scan button allows you to repeat any saved scan group
using the same parameters. The Repeat Scan Function is explained on page 4-11.

Alignment and Acquisition Scan Modes


The Mode button, at lower left of the window, toggles between alignment and acquisition
scan modes.
• Alignment Mode: The scanner activates by default in Go to 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 Go to Scan Acquisition 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.

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In preparation for the next step, the important features to note 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 3-8.

Position The Patient Module


Once the SCAN ACQUISITION WINDOW is active, you can begin to position the patient module
for scanning.

Caution: The optimal position of the patient module 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.

Tools to Position the Patient Module


Use the following tools to position the patient module for scanning:
• The joystick to make gross and fine adjustments of the patient module in the
horizontal plane—side to side, forward and back. The joystick is located on the rear
(operator side) of the patient module.
• The joystick knob makes fine vertical adjustments. The joystick spins in either direction
to move the patient module up or down slowly and smoothly. It works whether or not
the joystick is locked. Turn the joystick clockwise to raise the patient module,
counter-clockwise to lower it.
• The focus adjustment knob retracts and extends the ocular lens. It should be set at
the number that corresponds to the patient’s refractive correction, in diopters, if
known. Focus adjustment knobs are located on both sides of the patient module at
the patient's eye level (see the Stratus OCT System Hardware drawing on page
1-8). 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 Patient Module


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 patient module manually, using the joystick to make adjustments in
three dimensions. It is a reiterative process of positioning with the joystick, focusing the

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3-6 Acquire Scans

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 3-18,
for instructions.)
1. At the outset, focus on the study eye from a distance before moving the patient
module. Instruct the patient to look straight ahead. Then press the joystick button to
unlock the patient module and move it toward the study eye. Place it so that the
ocular lens is approximately 25 mm (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. Then, using the joystick, gently
push the patient module toward the eye so the video image moves through the pupil
and the fundus comes into view.
3. Instruct the patient to look at the green target light. With the joystick, carefully
continue to push the patient module toward the eye and make vertical adjustments
until the Stratus OCT beeps, which is a signal that the patient module 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.
4. Instruct the patient to continue to fixate on the green target light. If necessary, further
adjust the patient module 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 patient module in place.
While the patient module 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.

 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.

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.
• You can also optimize the scan image by making slight adjustments to the focus
and/or to the three-dimensional positioning of the patient module.

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 Stratus OCT 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

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Acquire Scans 3-7

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 patient module positioning, the Stratus OCT 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.
• The up arrow searches posteriorly (lower in the scan image), and the down arrow
searches anteriorly (higher in the scan image).

Figure 3-4 Scan Parameter Tab


• These methods are operative in both Alignment and Acquisition Scan Modes
(see page 3-4), but they are usually done in scan alignment mode right after
positioning the patient module.
• 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.

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• 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 3-4). 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 Stratus
OCT, 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.
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.

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

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.

 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.

Move the Scan Pattern


By default, the click and drag method works on the scan pattern. To drag the scan pattern,
4-headed arrow—Moves the whole
position the pointer near the center of the scan pattern until the four-headed arrow
scan pattern or fixation LED.
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 3-14 for more information).
2-headed arrow—Changes the
length and angle of scan patterns.

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Acquire Scans 3-9

Move the Fixation LED


Click 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 3-5
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 4-4, 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 default fixation LED location is
either the center (fovea mode) or 15° nasally (disc mode), depending on the scan protocol.

Figure 3-5 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 3-19) 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.

Landmark
The landmark is a pulsating point of light that appears in the video monitor in addition to
the scan pattern. You can move it independently or together with the scan pattern. To
move the landmark, use the menu options on the Scan Parameter Tab.

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Fixation can be challenging in patients with significant pathology or poor visual acuity. The
Landmark tool can aid in positioning the scan pattern relative to anatomical landmarks.
For example, it may be placed on the edge of the optic nerve head and used in centering a
Fast Macular Thickness Map scan pattern on the fovea. When using the Repeat Scan
function, the prior image shows the landmark position. The operator can align the new
scan with this position.

Disc and Fovea Buttons


In most cases, the fovea and/or the optic disc are the primary points of clinical interest. Carl
Zeiss Meditec designed most 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 Stratus OCT
places the fixation target either centrally (fovea mode) or approximately 15° nasally (disc
mode), depending on the scan protocol. On the Scan Parameter Tab (on page 3-7),
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.

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 acquire scans, you can use either:


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

Figure 3-6 The Acquire Scan Buttons


• Or the two blue function buttons on the patient module. These buttons are near the
joystick.

How to Acquire Scans


There are three steps to acquire Stratus OCT scans:
1. Switch to scan acquisition mode, if you have not already done so.
• On-Screen: Click the Go to Scan Acquisition Mode button.
• Blue patient module buttons: Press the left button once.
2. Freeze the scan, with or without flash.
• On-Screen: Click the Freeze with Flash button, except with highly photosensitive
patients, for whom you should click the Freeze without Flash button.

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• Blue patient module 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 Stratus OCT 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. See the detailed instructions for the Scan Review Window on
page 13.
• Blue patient module 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. Press the left blue button to cancel saving and return to
scan acquisition mode.

 Note: If you click the Cancel button before saving, you will be asked if you want to
save.

Signal Strength Indicator and Scan Messages


The Stratus OCT evaluates the signal strength of frozen or saved scan images and assigns a
number from 0 (worst) to 10 (best), which it displays in the signal strength field. The
Stratus OCT also analyzes the vertical placement and completeness of the scan image and,
if applicable, returns one of the messages “Scan too high,” “Scan too low” or “Scan
missing data” in the scan message field. The signal strength and scan message fields
appear on the SCAN ACQUISITION WINDOW (Figure 3-3, page 3-4), the SCAN REVIEW
WINDOW (Figure 3-7, page 3-13), the SELECTION WINDOW (Figure 5-4, page 5-4) and on
all analysis output windows and analysis printouts. The additional message “Analysis
Confidence Low” can appear in the scan message field on the analysis output windows
and printouts of all quantitative analysis protocols, except for the Optic Nerve Head
analysis.

Interpreting Signal Strength and Scan Messages


Signal strength provides a guideline for scan image quality. In general, greater signal
strength indicates a better image and thus higher confidence in the resulting analyses.
When acquiring a scan, the operator should try to optimize the OCT image to achieve a
signal strength of 7 or greater and a uniform brightness across the scan. In general, if the
signal strength is below 5, or if any scan message appears, the scan should be repeated. It
is important to note that whenever you analyze a scan, you should also check the analysis
results for the message “Analysis Confidence Low.” If this message appears, the results
could be unreliable.

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Note that media problems associated with many retinal diseases (vitreous opacities,
hemorrhages, lens opacities, etc.) can make it impossible to achieve a signal strength of 5,
even with careful scanning. Nevertheless, such scans can be useful for visual analysis of
the retinal structure and the association between the retinal layers. In assessing retinal
status, visual analysis of the retinal structure is important and may be highly indicative.
Furthermore, if you find that the retinal layer boundaries (white lines generated by the
analysis algorithm) clearly conform to the visible tissue contours, the resulting
measurements are reliable, even if the signal strength is below 5. At the same time, when
the retinal layer boundaries do not conform to the visible tissue contours, the resulting
measurements will not be accurate in those areas, even if the signal strength is 7 or
greater. Note that the RNFL boundary can be difficult to identify, so analysis of RNFL
images with a signal strength below 5 is not recommended.

Scan Messages
The scan messages “Scan too high,” “Scan too low” and “Scan missing data” are
descriptive of what you see on screen. When the scan is too high or too low on the screen,
the analysis algorithm frequently fails. When either message appears, the operator should
repeat the scan, using the Z-Offset arrow buttons to raise or lower the scan image as
necessary. When data is missing, usually from a patient's blink, the scan image is
incomplete and unsuitable for analysis. The operator should repeat the scan, instructing
the patient not to blink during scan acquisition.

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Scan Review Window


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

Figure 3-7 The Scan Review Window


Along the bottom, it displays thumbnails of the last several images captured during
scanning, 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.
• 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 Stratus OCT 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.

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Adjust Scan Pattern Parameters


The Scan Pattern Parameter area (pictured at left) is found in the upper left of the Scan
Parameter Tab (see page 3-7). 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 4-4 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.

Size
For 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
2-headed arrow
the size (and the angle, if applicable—see below). It is easier to adjust size exactly by
Changes the length and angle
typing in the new value.
of line scans
• When “Radius 1" and “Radius 2" appear, Radius 1 refers to the aiming circle and
Radius 2 refers to the scan acquisition circle.

Angle
0° (also 360° or -360°) Scan For the Line scan protocol (page 4-7), you can adjust the angle of the line. The default
proceeds from 9 to 3 o’clock. angle is 0° (horizontal from left to right). Compass degree measurements describe the
point of origin and the angle as seen in the video monitor. The 9 o’clock position is defined
as 0° on the compass. Degrees increase on the compass counterclockwise and decrease
180° or -180°. Scan proceeds
clockwise. This notation style enables the user to control not only the angular position of
from 3 to 9 o’clock.
the line, but also its point of origin.
• Of course, this is significant when locating a point of pathology like a macular hole.
90° or -270°. Scan proceeds For example, note that a 180° line looks just like a zero degree line in a frozen video
from 6 to 12 o’clock. image, but the 180° line originates at the 3 o’clock position.
• 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 Lines
When this field is available, you can adjust the number of lines from 6 to 24 lines.

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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 3-8 The Scan Variables Dialog Box

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). 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 Stratus OCT software or restart the system.
• You can also adjust the number of A-scans using the OCT Image Tab while
scanning (see page 3-18).

Axial Scan Length and Number of Data Points


The axial scan length is fixed at 2 mm. For each A-scan, the Stratus OCT acquires a fixed
number of 1024 axial data points through the 2 mm depth. At the default value of 512
A-scans, the Stratus OCT 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 Time


The 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).

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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 3-9 The Define Custom Scan Dialog Box


• Use the Scan drop-down list to select scan patterns already offered by the Stratus
OCT 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 3-14).
• 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.

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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 3-10 The OCT Image Tab (Scan Acquisition Window)

Noise and Range


These 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 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 Stratus OCT 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

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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-Scans
The 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 3-15).

Video and Lamp Parameter Tab


This tab enables you to control video image brightness and contrast, and lamp brightness
to suit your preference.

Figure 3-11 The Video and Lamp Parameter Tab

Video Brightness and Contrast


Radio 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 Brightness
This 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.

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Indicators Tab
This tab provides patient and scan information.

Figure 3-12 The Indicators Tab in Scan Acquisition Window

Details Tab
This 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 3-13 The Details Tab in Scan Acquisition Window

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

Figure 3-14 The Comment Tab in Scan Acquisition Window

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Scan Acquisition Protocols 4-1

(4) Scan Acquisition Protocols

Chapter Overview
This chapter explains the applications and attributes of the scan acquisition protocols
offered by the Stratus OCT. 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 4-3).
• Scan Protocol Descriptions, Options And Tips (on page 4-6).

The Scan Tab


You can select scan acquisition protocols from the The Scan Tab in Stratus OCT Main
Window (pictured on page 3-3).
• 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 3-3 and following for further operational instructions.

Scan Tab Views


Right-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. Click on the icon to see the
entire name.
• 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 Stratus OCT groups the scan protocols four ways for your convenience.

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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 3-16). Eight of the protocols fall in the Glaucoma and/or the
Retina groups (two are in both). The others may be considered general-purpose scan
protocols, and can be used to build custom scan protocols.
• In the Large Icon view, click on the icon to see the entire name.

Glaucoma Protocols
The protocols designed for glaucoma detection and management are:
• Fast Macular Thickness Map (Fast Mac)
• Macular Thickness Map
• Fast RNFL Thickness (3.4)
• Fast Optic Disc
• RNFL Thickness (3.4)
• RNFL Thickness (2.27xdisc)
• RNFL Map
• Fast RNFL Map
• Optic Disc

Retina Protocols
The protocols designed for other retinal pathologies are:
• Fast Macular Thickness Map (Fast Mac)
• Macular Thickness Map

All Protocols
The All radio button displays all protocols together. They are listed below in their default
order on the Scan Tab.
• Fast Macular Thickness Map (Fast Mac)—Glaucoma and Retina
• Macular Thickness Map—Glaucoma and Retina
• Fast RNFL Thickness (3.4)—Glaucoma
• Fast Optic Disc—Glaucoma
• Line
• Cross Hair
• Line
• Raster Lines

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• X-Line
• Circle
• RNFL Thickness (3.4)—Glaucoma
• RNFL Thickness (2.27xdisc)—Glaucoma
• RNFL Map
• Fast RNFL Map—Glaucoma
• Proportional Circle
• Concentric 3 Rings
• Nerve Head Circle
• Optic Disc—Glaucoma

General Tips
The following information and usage tips apply to all scan protocols. Scan Protocol
Descriptions, Options And Tips, starting on page 4-6, 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 analysis protocols are of two kinds:
Analyses and Reports (see page 6-13) and Image Processing Protocols (see page
6-37). Carl Zeiss Meditec designed the image processing protocols for use with any scan.
However, we designed each 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
Analysis Protocol Designed for Scan Group(s)
Retinal Thickness Any scan protocol except (Fast) Optic Disc: 1 group on macula
Retinal Map Line, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD group on
macula
Retinal Thickness/Volume Tabular Line, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on macula
Retinal Thickness/Volume Change Line, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups on macula
RNFL Thickness Any scan protocol except (Fast) Optic Disc: 1 group around disc

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Analysis Protocol Designed for Scan Group(s)


RNFL Thickness Average Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: 1 OS and/or 1 OD of same radius around
disc
RNFL Thickness Map (Fast) RNFL Map, Concentric 3 Rings: 1 OS and/or 1 OD group around disc
RNFL Thickness Change Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), 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 (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: Up to 4 OD and/or 4 OS groups of same
radius around disc.
GPA Advanced Serial Analysis RNFL Thickness (3.4) or Fast RNFL Thickness (3.4): Up to 8 OD and/or 8 OS
groups of same radius around disc.
Optic Nerve Head (Fast) Optic Disc: 1 group on disc

Exiting Scans
You may exit any scan at any time and return to the 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 Stratus OCT 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 in a set, the ones you have
already saved are retained. 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 landmark. The
individual Scan Protocol Descriptions, Options And Tips (starting on page 4-6)
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.

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• 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 (3.4) 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 3-17), or through the Scan Variables option on the Scan
menu before scanning (see Number of A-Scans, page 3-15). 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 3-14.) 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 3-15.) 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 patient module a few millimeters laterally or vertically
to accommodate the edge of the scan pattern. If this fails, try moving the patient module
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 Layer Thickness


When you measure nerve layer 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 distance to the retinal surface. When this variation is minimized, the scan

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image appears most nearly horizontal on your monitor. Try to minimize this variation by
adjusting the patient module 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 Stratus OCT constructs all 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 3-14. To Adjust Scan
Placement, see page 3-8. To Optimize Scan Image, see page 3-6.

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.
• 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 Stratus OCT 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 Optic Disc and Fast RNFL Map—or a 3x1 display—for Fast RNFL
Thickness (3.4)—so that you can observe each line or circle scan separately as it updates,
and align appropriately.

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Fast Macular Thickness Map (Fast Mac)


The Fast Macular Thickness Map (Fast Mac) protocol combines the six Macular
Thickness Map scans into one scan (see page 4-7). 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.

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 use with the analyses
that measure retinal thickness.

Fast RNFL Thickness (3.4)


The Fast RNFL Thickness (3.4) protocol combines the three RNFL Thickness (3.4) circle
scans into one scan (see page 4-8). This protocol acquires three 3.4 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 Optic Disc


The Fast Optic Disc protocol combines the six Optic Disc scans into one scan (see page
4-10). 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.

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.

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

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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 3-16). 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.

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.

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 with two line scans that share a center point. You can average same-size
scans later and use this pattern to build custom scans. The default X pattern consists
Adjusting size of bounding box: of two perpendicular lines of length 3 mm. You can adjust line scan length by
At left: increased height.  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.

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 layer 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.

RNFL Thickness (3.4)


The RNFL Thickness (3.4) protocol enables you to acquire three circle scans of diameter 3.4
mm around the optic disc. The only parameter you can alter is the number of A-scans—but
normative data applies only to scans acquired using the default 512 A-scans. The 3.4 mm
diameter circle represents a standard or typical size used to measure RNFL thickness. This

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glaucoma protocol provides a simple way to acquire scans to which you can apply RNFL
thickness analyses.

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 3.4 mm diameter.
It is from this ratio that the multiplication factor of 2.27 is derived (1.5 x 2.27  3.4).

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 6-20).
• 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.

Fast RNFL Map


• The Fast RNFL Map protocol combines the six RNFL Map concentric circle scans into
one scan (see page 4-9). 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.

Proportional Circle
The Proportional Circle protocol enables you to tailor a circle scan of the peripapillary nerve
fiber layer 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.

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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 layer 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.

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 3.4 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.

Optic Disc
• The Optic 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 6-23).

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Repeat Scan Function


The Repeat function allows you to repeat any saved scan group using the same set of
parameters. Repeat parameters include scan size, angle and placement, fixation LED
placement, and landmark placement. When you repeat a scan group, the parameters
unique to each scan in the series is recalled and repeated in the same order. You cannot
adjust any parameters except placement. The Repeat function allows you to compare
placement during and after scan acquisition.
1. To repeat a scan, first select a patient from the Patient List in the MAIN WINDOW.
2. Select a desired scan protocol from the Scan Tab.
3. Click the Repeat button at the bottom of the Scan Tab. The Repeatability Wizard
dialog appears.

Figure 4-1 Repeatability Wizard


4. Select OD or OS in the Eye Type field. The prior scans will appear in the pull-down
menu.
5. From the pull-down menu, select the scan you want to repeat, and review the fundus
image saved with this scan.
6. Click the Repeat button. If you do not want to repeat any of the prior scans, or if you
do not see any prior ones of this type, click the New Scan button to skip the Repeat
function and initiate a new scan.

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7. In the video window you will see the prior and new fundus images toggle back and
forth automatically. The prior scan will have the word PRIOR in the upper left corner.
You can change the toggle speed in the Video and Lamp dialog. Move the slider in
the Prior Fundus Toggle or select a number. The higher the number, the faster the
images toggle. At the “0” setting the image does not toggle.

Figure 4-2 Changing the Prior Fundus Toggle Speed


8. Adjust the scan placement or fixation target to match placement of the prior scan.
9. Proceed with acquiring the new scan.
10.As the two image toggle back and forth, compare the newly acquired fundus image
to the prior image. If they are an acceptable match, click Save. If not, click Cancel to
repeat the scan.

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Analyze Scans 5-1

(5) Analyze Scans

Chapter Overview
Carl Zeiss Meditec equips the Stratus OCT with software to assist you with analysis of scan
images. This chapter explains how to analyze scans with the Stratus OCT.
We designed the Stratus OCT software for analysis of the posterior segment of the eye. To
analyze scans using the Stratus OCT 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 5-5).
Lastly, this chapter explains how to Print Analysis Output (page 5-6). The Stratus OCT
has 19 analysis protocols to analyze scans you have acquired. Their characteristics and
applications are discussed in Chapter (6).

Initiate An Analysis
You must initiate analysis from the 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 patient ID. You can select one patient at a time. See The Patient List
on page 2-6 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.

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The Scan List


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

Figure 5-1 The Scan List in the 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.

The Scan Group Images Tab


On 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 5-2 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.

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 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.

Select an Analysis Protocol


When you select a scan group for analysis, the Stratus OCT disables (grays out) all
incompatible analysis protocols, leaving only compatible analyses available for selection.
Select an analysis protocol using the Analyze Tab, pictured below.

Figure 5-3 The Analyze Tab in the 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.

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• Scan selection is optional, and you can do the same by using the Scan Group
Images Tab, as explained on page 5-2.
If you try to run an incompatible analysis, a message will so inform you.

Selection Window
When you click the Scan Selection button at the bottom of the Analyze Tab, the SELECTION
WINDOW appears.
Video image
Patient Data Exam list Scan comments field Fundus video image adjustment controls

Thumbnail Scan image


scan images adjustment controls OCT scan image
Figure 5-4 The Selection Window
This window permits you to select which exams and scans to include in the analysis and to
enter individual scan comments. The window displays the scan image of the highlighted
thumbnail (first scan by default). Click on a thumbnail to display that scan.

Image Adjustment
Adjustments that you make to the scan image Level and Window, and to the fundus image
Brightness and Contrast affect the images here and on the resulting analysis output
window and printouts. You can make the following adjustments.

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• For the scan image, select Color or Grayscale. Use the sliders to adjust Level, Window
and % Zoom. Click the Default button to reset the scan image to the default settings.
• Level sets the reflectivity threshold that is filtered out as background noise, and
apportions the color scale according to the relative reflectivity found in the scan
image. At low levels, the scan image appears all white, at high levels, all black.
• Window sets the portion of the color scale that is applied to the scan image
display. At low settings, the scan image appears black and white, at high settings,
red and yellow.
• 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.
• For the fundus image, use the sliders to adjust Brightness and Contrast and % Zoom.
The default settings are zero.

Export JPEG
• 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. Each scan image will be
exported in a separate file, which is named by combining the following, in order:
last name, first name, date of birth, date and time of scan, scan type. This is how
Stratus provides the patient and scan data with the image. Note that, if desired, you
can obscure the patient identifying information by changing the file name before
saving.

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 exam in the exam list is highlighted. Click on the desired exam to
display its images.
• Selected checkboxes 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.

 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.

 Note: When you deselect scans to exclude them from analysis, the Stratus OCT
remembers which scans you have excluded and continues to exclude them from
analysis until you change the scan selection again.
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.

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 Note: From applicable analysis output windows, Stratus gives you the ability to edit
the retinal boundary layers automatically provided by the retinal and RNFL thickness
algorithms. For more information, see Edit Layers on page 6-8.

Print Analysis Output


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 analysis output in
portrait layout.

Print Scan Comments


If you have selected Print Scan Comments from the File menu (click File > Print Scan
Comments), you will get a second printout page that includes individual scan comments
for every scan in the group. When Print Scan Comments is selected, it has a checkmark
beside it, as seen at left.
Exam comments, entered in the Comment Tab of the SCAN ACQUISITION WINDOW (Figure
3-14, page 3-19), cannot be printed with the analysis output. Exam comments are printed
when you Print Clinical Notes (page 7-2).

Save As PDF File


You can save any analysis output as a PDF file by selecting Save As PDF File from the File
menu (click File > Save As PDF File). Use the Save dialog that opens to name and save the
file anywhere on the C: drive, on DVD or on the network server. The PDF printout looks
exactly like the paper printout.

Customize Printouts With Site ID And Logo


The Stratus OCT 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.
You can create a clinical site ID and designate a graphic logo. The logo graphic must be in
bitmap format and have a “.bmp” extension. If necessary, you must copy the logo graphic
file from the source system to removable media. Then insert the disk into its drive on the
Stratus OCT and follow these steps:

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1. Click Options > Register > Clinical Site ID. The Clinical Site ID dialog box appears.

Figure 5-5 The Clinical Site ID Dialog Box


2. To enter the clinic name, type up to 64 characters, including spaces, in the Clinical
Site ID field.
3. To select a clinic logo for display on printouts, click the Browse button. Use the
Browse dialog box to find the logo graphic file on the hard drive or the inserted
removable media.
4. Select the logo graphic file and click OK. The graphic file is copied to the database file
for the Stratus OCT. 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

Export to DICOM
You can export any report to the DICOM system by following these steps:
1. From any analysis screen, click on the Export to DICOM toolbar button, or click on
Export to DICOM in the Data menu. You will see a dialog showing that the report is
being exported to the DICOM system.

Figure 5-6 Exporting to DICOM Archive

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2. When the DICOM export is completed, you will see the following dialog confirming
that the report was sent to the DICOM system:

Figure 5-7 Report Confirmation


3. Click OK.

 Note: Before using the Export to DICOM function, make sure that the Clinical Site ID
is configured on the instrument. To do this, click Options > Register > Clinical Site
ID. Enter the clinic name and click Save. If you do not do this step, you will get an
error message when you try to export to DICOM.

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Analysis Protocols 6-1

(6) Analysis Protocols

Chapter Overview
The Stratus OCT offers analysis protocols, divided between:
• Analyses and Reports (page 6-13).
• Image Processing Protocols (page 6-37).
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 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.

Activity Radio Buttons


The 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 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 Glaucoma and Retina protocols are quantitative analysis protocols.
• None of the image processing protocols is a Glaucoma or Retina protocol. They are
applicable to any scan group.

 Note: You can apply only one analysis protocol at a time. You cannot apply analysis
protocols additively. No analysis changes the original scan image data.

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Analyses and Reports


The Stratus OCT offers analysis and report protocols, which you can group in the Glaucoma
and Retina lists. Some Glaucoma protocols are repeated in the Retina protocol list, since
they are useful for both applications.

Glaucoma
• Retinal Thickness/Volume (OU)
• Retinal Thickness/Volume Tabular (OU)
• Retinal Thickness/Volume Change (OU)
• RNFL Thickness (Single Eye)
• RNFL Thickness Average (OU)
• RNFL Thickness Map (OU)
• RNFL Thickness Change (OU)
• RNFL Thickness Serial Analysis
• GPA Advanced Serial Analysis (Available only if licensed)
• Optic Nerve Head (Single Eye)
• Multi-Slice Report (Available only if licensed)

Retina
• Retinal Thickness (Single Eye)
• Retinal Map (Single Eye)
• Retinal Thickness/Volume (OU)
• Retinal Thickness/Volume Tabular (OU)
• Retinal Thickness/Volume Change (OU)
• Multi-Slice Report (Available only if licensed)

Image Processing
The Stratus OCT 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.
• Proportional
• Align
• Normalize + Align
• Gaussian Smoothing
• Median Smoothing
• Scan Profile

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General Tips
The following general information and usage tips apply to all analysis protocols. Starting
with Retinal Thickness/Volume on page 6-13, 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 protocols are of two kinds:
image processing protocols and quantitative analysis protocols. Carl Zeiss Meditec
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.

Table of Correlations
Analysis Protocol Designed for Scan Group(s)
Retinal Thickness Any scan protocol except (Fast) Optic Disc: 1 group on macula
Retinal Map Line, (Fast) Macular Thickness Map: 1 group on macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS group and/or 1 OD group on
macula
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 1 OS and/or 1 OD group on macula
Tabular
Retinal Thickness/Volume Line, (Fast) Macular Thickness Map: 2 OS and/or 2 OD groups on
Change macula
RNFL Thickness Any scan protocol except (Fast) Optic Disc: 1 group around disc
RNFL Thickness Average Circle, Proportional Circle, (Fast) RNFL Thickness (3.4), 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 (3.4), 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 (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle: Up to 4 OD and/or 4 OS groups of
same radius around disc.
GPA Advanced Serial Analysis RNFL Thickness (3.4) or Fast RNFL Thickness (3.4): Up to 8 OD and/or 8
OS groups of same radius around disc.
Optic Nerve Head (Fast) Optic Disc: 1 group on disc
Multi-Slice Report Any scan protocol

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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 3-14 for an explanation of
the angle notation.

Signal Strength Indicator and Scan Messages


The Stratus OCT evaluates the signal strength of frozen or saved scan images and assigns a
number from 0 (worst) to 10 (best), which it displays in the signal strength field. The
Stratus OCT also analyzes the vertical placement and completeness of the scan image and,
if applicable, returns one of the messages “Scan too high,” “Scan too low” or “Scan
missing data” in the scan message field. The signal strength and scan message fields
appear on the SCAN ACQUISITION WINDOW (Figure 3-3, page 4), the SCAN REVIEW WINDOW
(Figure 3-7, page 3-13), the SELECTION WINDOW (Figure 5-4, page 5-4) and on all
analysis output windows and analysis printouts. The additional message “Analysis
Confidence Low” can appear in the scan message field on the analysis output windows
and printouts of all quantitative analysis protocols, except for the Optic Nerve Head
analysis.

Interpreting Signal Strength and Scan Messages


Signal strength provides a guideline for scan image quality. In general, greater signal
strength indicates a better image and thus higher confidence in the resulting analyses.
When acquiring a scan, the operator should try to optimize the OCT image to achieve a
signal strength of 7 or greater and a uniform brightness across the scan. In general, if the
signal strength is below 5, or if any scan message appears, the scan should be repeated. It
is important to note that whenever you analyze a scan, you should also check the analysis
results for the message “Analysis Confidence Low.” If this message appears, the results
could be unreliable.
Note that media problems associated with many retinal diseases (vitreous opacities,
hemorrhages, lens opacities, etc.) can make it impossible to achieve a signal strength of 5,
even with careful scanning. Nevertheless, such scans can be useful for visual analysis of
the retinal structure and the association between the retinal layers. In assessing retinal
status, visual analysis of the retinal structure is important and may be highly indicative.
Furthermore, if you find that the retinal layer boundaries (white lines generated by the
analysis algorithm) clearly conform to the visible tissue contours, the resulting
measurements are reliable, even if the signal strength is below 5. At the same time, when
the retinal layer boundaries do not conform to the visible tissue contours, the resulting
measurements will not be accurate in those areas, even if the signal strength is 7 or
greater. Note that the RNFL boundary can be difficult to identify, so analysis of RNFL
images with a signal strength below 5 is not recommended.

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Scan Messages
The scan messages “Scan too high,” “Scan too low” and “Scan missing data” are
descriptive of what you see on screen. When the scan is too high or too low on the screen,
the analysis algorithm frequently fails. When either message appears, the operator should
repeat the scan, using the Z-Offset arrow buttons to raise or lower the scan image as
necessary. When data is missing, usually from a patient's blink, the scan image is
incomplete and unsuitable for analysis. The operator should repeat the scan, instructing
the patient not to blink during scan acquisition.

“Analysis Confidence Low” Message


The Stratus OCT detects when the scan image being analyzed has anomalies that prevent
reliable detection of the retinal layer boundaries, which reduces the reliability of the
analysis. These anomalies may be due to pathology or to an area of weak signal in the
scan. In these cases, the analysis output screen and printout will include the message:
“Analysis Confidence Low.” When it appears, the operator should use the Edit
Layers feature (see page 6-8), or repeat the scan. This message can appear on the
analysis output windows and printouts of all quantitative analysis protocols except the
Optic Nerve Head analysis.

Layer On/Off
All the quantitative analysis output screens except the Optic Nerve Head protocol include a
Layer On checkbox, which is selected by default. When selected, the retinal layer
boundaries, detected by the analysis algorithm, appear as white lines in the analyzed scan
image. Click to clear the Layer On checkbox and hide the layer boundaries. For information
about editing the layers, see Edit Layers on page 6-8.

Caliper On
All the quantitative analysis output screens except the Optic Nerve Head protocol include a
Caliper On checkbox. When selected, the analysis output displays a set of cross-shaped
calipers you can click and drag to measure distances directly in the analyzed scan image.
The caliper distance is reported at lower right.

Mirror Image
For line scans, click on the Mirror Image checkbox to view the mirror image of the scan and
associated graphical data. When the scan angle is between 90º (6 o’clock origin) and 270º
(12 o’clock origin), the Mirror Image checkbox is selected by default.

Note Regarding Processed Scan Images

 After scan acquisition, the Stratus OCT automatically processes OCT scan images
that appear in subsequent screens, such as analysis output windows. A-scan
alignment is included in this processing. As a result of the alignment process, solid
black areas, which represent no reflectivity signal, may appear near the top and

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bottom of the scan image. These are artifacts of the alignment processing algorithm
and are not clinically meaningful.

Normative Data and Its Applicability


Carl Zeiss Meditec gathered data from several hundred normal eyes acquired at multiple
sites to create normative databases for RNFL thickness and for macular thickness. The
Stratus OCT normative database study was designed to obtain normative data for RNFL
and macular thickness from healthy subjects ages 18 to 86. Reference intervals established
in the normative database study are used by the physician to compare individual patient
measurements to those acquired in a normal population. See Normative Database for
Macula and RNFL Measurements, for a detailed description of how this normative
database was generated, including the selection criteria employed in the clinical study, a
discussion of data acquisition and analysis, and the establishment of normal limits.

 Note: RNFL and Macula Normative Databases are optional features that may not be
activated on all instruments. If you do not have these features and want to purchase
them, contact Carl Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S.,
contact your local Carl Zeiss affiliate or distributor.

 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 RNFL and Macula normative databases.

 Note: Normative data will not appear for patients under 18 years of age. Normative
data will not appear for patients whose records were imported into the system with
their date of birth obscured.

Disclaimer: Carl Zeiss Meditec 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.

RNFL Normative Database


The scan protocols Fast RNFL Thickness (3.4) and RNFL Thickness (3.4) (at the
default 512 A-scans) were used to acquire the RNFL thickness normative data. The RNFL
Normative Database is applicable only to scans acquired with the same 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 (3.4) scans or a
single RNFL Thickness (3.4) scan at the default 512 A-scans.
• RNFL thickness normative data will not appear when you analyze two or more RNFL
Thickness (3.4) scans that have been averaged, or if you analyze a Fast RNFL
Thickness (3.4) 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

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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%).

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

Macula Normative Database


The Fast Macular Thickness Map (Fast Mac) scan protocol was used to acquire the
macular thickness normative data. The Macula Normative Database is applicable only to
scans acquired with this scan protocol. Normative data that is age-matched to the patient
appears when you perform the Retinal Thickness, Retinal Thickness/Volume
Tabular, or Retinal Map analysis protocols on a Fast Macular Thickness Map (Fast
Mac) scan.
When the Retinal Thickness, Retinal Thickness/Volume Tabular, or Retinal Map
analysis protocols are applied to a Fast Macular Thickness Map (Fast Mac) scan, the
age-matched normative data appears. It uses a light red-light yellow-green-yellow-red
color code, as seen in the legend at left, to indicate the normal distribution percentiles. The
color code applies as follows:
• In the Retinal Thickness output, to each particular A-scan location in the thickness
chart.
• In the Retinal Thickness/Volume Tabular output, to the circular maps of retinal
thickness or volume, and to the OD and OS columns of the data table.
• In the Retinal Map output, to the circular maps of retinal thickness.
Among same-age individuals in the normal population, the percentiles apply to each
particular retinal thickness measurement as follows:
• The thickest 1% of measurements fall in the light red area. Measurements in light red
are considered outside normal limits. (light red > 99%, above normal limits).
• The thickest 5% of measurements fall in the light yellow area or above (95% < light
yellow  99%, suspect above normal)
• 90% of measurements fall in the green area (5%  green  95%).

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• The thinnest 5% of measurements fall in the yellow area or below


(1%  yellow < 5%, suspect below normal).
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered below normal limits (red < 1%, below normal limits).

 Note: Clinicians must exercise judgment in the interpretation of the macula


normative data. For any particular measurement, note that 2 out of 20 normal eyes
(10%) will fall either above or below green.

Edit Layers

 Note: Edit Layers is an optional feature that may not be activated on all instruments.
If you do not have this feature and want to purchase it, contact Carl Zeiss Meditec.
In the U.S., call 1-877-486-7473; outside the U.S., contact your local Carl Zeiss
affiliate or distributor.
Version 5.0 and higher of Stratus OCT software includes the ability to edit layers, that is, to
manually adjust the placement of the retinal layer boundaries, between which Stratus
measures the retina and RNFL thickness. The functionality described in this section is
available with all of the Analyses and Reports (see the list on page 6-2), except the
Optic Nerve Head analysis, which has a similar but distinct interactive capability.
Carl Zeiss Meditec designed the edit layer capability to give you direct control over
placement of the retinal layer boundaries, enabling you to substitute your judgment in
place of the automated outcome of the Stratus thickness algorithms. This is especially
useful in cases where the retina has structural anomalies or pathology that may cause the
algorithms to incorrectly trace the actual boundaries.

Access the Layer Edit Dialog


When any applicable analysis is open, the Edit Layer button becomes available, as well as
the Edit Layer option in the Data menu. When available, click the Edit Layer button in the
toolbar or select Edit Layer from the Data menu (click Data > Edit Layer). The Layer Edit
Dialog opens.

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Figure 6-1 The Layer Edit Dialog


If the analysis includes multiple scan groups and/or scans from more than one eye, initially
it displays the first scan in the first group for the right eye. The currently selected scan is
open for editing in the large pane at the top; its thumbnail is highlighted in blue at lower
left and it is identified by the text below the thumbnails at bottom left. The layer
boundaries are white (by default) until edited. (They are also white if you leave a scan
without saving your edits and later return to it.) While editing, the layers are pink, until
saved. Layers already edited and saved are yellow when you open them for editing again.
By default, the last set of layer edits are displayed for each scan, unless another set of layer
edits has been set as the default--see Working with Saved Layer Edits on page 6-11.

 Note: The line colors mentioned are the default colors. You can Adjust the Edit
Layer Line Colors, as explained on page 6-10 below.

 Note: After saving, Stratus treats all scans in a series as a group, with respect to
whether they have been edited or not. Therefore, all layers of all scans in a series
will appear yellow after saving, as if all scans had been edited and saved, even if
only one of the scans in that series has been edited. This does not apply between
series.
The scan orientation marker appears at lower right, along with the number of scans in the
current series just to its left. The Layer History field is empty and grayed out (unavailable)
until you edit and save new layers. If edited layers are already saved, the Layer History

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field is empty and white; click in it to select the layers you want to use as the basis for the
edits you are about to make. The Undo button becomes available after you begin editing
layers and remains available until you save the current layer edits.

Adjust the Edit Layer Line Colors


Click Options > Preferences and select the Edit Dialog Line Color tab to adjust the
colors of the lines in the Edit Layer Dialog.

Figure 6-2 Edit Dialog Line Color Tab of the Preferences Dialog
You can click the Color Picker button for the Default Color (original lines before editing),
the Edit Color (line color while editing), and the Edited Color (line color after saving edits).
Click OK to save your changes and exit the Preferences dialog.

Navigation
Within a scan group (or series) you must click on a thumbnail to select it for editing. If
necessary, use the scroll bar to the right of the thumbnails to access all of the thumbnails
in the series. You can navigate to the previous or next series (scan group) by clicking the
Previous or Next arrow buttons in the Series area near the bottom right. When you reach
the last series for the right eye, clicking Next takes you to the first series for the left eye. To
save time, do not click Save until you have completed edits on all scans in a group.

Edit Layers
Editing layers is done manually in a simple click and drag process. Follow these instructions
to edit layers:
1. Click and drag a layer boundary, shaping and placing it in the desired location by your
mouse movement. You can draw and redraw the line or any portion of it repeatedly,
selecting any point on a line to start each successive drawing action.
Note that when you mouse over a line, it “pops,” or becomes thicker. As long as you
hold the left mouse button down, the layer boundary line tracks your cursor as you
move it in the screen, and each time you release the mouse button, it lets go of the
line on screen. Then you can click again at any point on either boundary line and drag
the line from that point. The boundary lines you trace will never break. However, they
will not cross each other.

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 Note: You can also hold down the Alt key, click and drag the cursor (Alt-click)
repeatedly; each click creates an anchor at the clicked point, from which the cursor
will trace a straight line until you click again. This method enables you to trace the
desired boundary in straight line segments. It can be used freely in combination
with the regular click and drag method.
2. At any time desired, click Undo to undo the last editing step you completed. You can
click it repeatedly to undo each step in succession.
3. When satisfied with your edits, click Save. Stratus assigns a unique identifier to the
saved layer edits composed of the current date, time, instrument serial number and
software version. This identifier will appear in the Layer History field.

 Note: To save time, do not click Save until you have completed edits on all scans in a
group.
4. Click Discard or the at upper right to close the Layer Edit Dialog. You will return
the analysis window from which you began.

Working with Saved Layer Edits


Analysis windows that include edited layers indicate either Original layers displayed
View/Select Edited layers or Edited layers displayed View/Select optional
layers.

or

The example below displays edited layers and highlights the message.

Figure 6-3 Analysis with Edited Layers Displayed

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1. Click either of these links and a selection dialog called Edit History Data for the
Selected Exams will appear, as below.

Figure 6-4 Edit History Data for the Selected Exams Dialog
The dialog displays one row for each scan series (scan group) in the current analysis.
You can change the layer edits used for the analysis for each series independently.
2. To do so, click in the Layer History column at right on the row corresponding to the
series you want to change.
That item will change to a drop-list from which you can view and select the saved
layer edits by clicking on the down-arrow at the right edge of the field, for example:

Figure 6-5 Selecting alternate layers


• Click Original Layer to select for that scan series the original layers generated
automatically by Stratus OCT.
3. When finished, click OK to apply the selected layers to the current analysis, which will
be re-run and reappear.
• Click Set Default to make the current set of layer edits the default set, that is, the
set that will be displayed and used the next time you run the same analysis on the
same set of scans.

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• Click Cancel to discard your selection of saved layer edits without applying them.
A dialog will prompt you to confirm your choice.

Analyses and Reports


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

General Information
Methods to Measure Retinal and RNFL Thickness
The Stratus OCT 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 Stratus
OCT’s high resolution, resulting in a highly refined objective measurement of retinal or
RNFL thickness. The processed scan image shows the boundaries in white.

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 Line or (FAST) Macular
Thickness Map protocols.

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Output Display

Figure 6-6 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
micrometers) 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 upper right. 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 micrometers +/- 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 Line or (FAST) Macular Thickness Map protocols. Normative data will
appear in the output if you analyze a Fast Macular Thickness Map (Fast Mac) scan,
as described in Macula Normative Database on page 6-7.

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Output Display
The output display includes all the elements of the Retinal Thickness/Volume analysis
(see above), with a different arrangement to accommodate the table.

Figure 6-7 Retinal Thickness/Volume Tabular Analysis Output


When applied to a Fast Macular Thickness Map (Fast Mac) scan, the macula
normative data color code applies to the OD and OS columns of the data table, and to the
lower circular maps. The lower maps show average retinal thickness (or volume) for each
map sector, in micrometers, and applies the normal distribution percentile colors to those
sector averages. To the lower right of the table, the Normal Distribution Percentile
legend appears.
Among same-age individuals in the normal population, the percentiles apply to each
particular retinal thickness measurement as follows:
• The thickest 1% of measurements fall in the light red area. Measurements in light red
are considered outside normal limits. (light red > 99%, above normal limits).
• The thickest 5% of measurements fall in the light yellow area or above (95% < light
yellow  99%, suspect above normal)
• 90% of measurements fall in the green area (5%  green  95%).
• The thinnest 5% of measurements fall in the yellow area or below
(1%  yellow < 5%, suspect below normal).
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered below normal limits (red < 1%, below normal limits).

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 Note: Clinicians must exercise judgment in the interpretation of the macula


normative data. For any particular measurement, note that 2 out of 20 normal eyes
(10%) will fall either above or 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 macular thickness. Normative data will not appear for
patients under 18 years of age. The macula normative data appears only when you
analyze a Fast Macular Thickness Map (Fast Mac) scan.

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 Line or (FAST) Macular Thickness Map protocols.

Output Display

Figure 6-8 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 micrometers) or
volume (in mm3).

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• A key of the map circle diameters appears at upper right. 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 one scan group of any scan protocol at a time, except (Fast) Optic Disc.
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 6-9 RNFL Thickness Analysis Output


• The output graphs show RNFL thickness (green line, in micrometers) 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.

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• On the right appear circular diagrams showing quadrant and clock-hour RNFL
thickness averages. Overall RNFL Average thickness appears at lower right.
• Click the Caliper ON checkbox to measure distances between the cross-shaped
calipers that appear. Caliper Length appears at lower right.

Export Results
The 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, the Export As dialog appears as below:

Figure 6-10 The Export As Dialog


• The dialog prompts you for a filename. You can name the file and save it in any
available location. 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)

 Note: It is the clinician’s responsibility to associate patient information with


exported files.

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 (3.4), RNFL Thickness
(2.27xdisc) or Nerve Head Circle protocols. Normative data will appear in the output
if you analyze Fast RNFL Thickness (3.4) or RNFL Thickness (3.4) scans with the

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appropriate number of scans selected, as described in RNFL Normative Database on


page 6-6.

Output Display

Figure 6-11 RNFL Thickness Average Analysis Output


The graphs indicate the nasal, superior, temporal and inferior quadrants. When applied to
the appropriate kinds of scans (see RNFL Normative Database on page 6-6), the OD
and OS graphs include a white-green-yellow-red color code based on the age-matched
RNFL 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%).

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

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 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 RNFL normative data appears only when you
analyze either Fast RNFL Thickness (3.4) scans or a single RNFL Thickness (3.4)
scan at the default 512 A-scans. RNFL normative data will not appear when you
analyze two or more RNFL Thickness (3.4) scans that have been averaged, or if
you analyze a Fast RNFL Thickness (3.4) scan from which scans have been
deselected.

Tabular Data Defined


Imax/Smax: the maximum thickness in the inferior quadrant
divided by the maximum thickness in the superior quadrant.
Smax/Imax: the maximum thickness in the superior quadrant
divided by the maximum thickness in the inferior 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.

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Output Display

Figure 6-12 RNFL Thickness Map Analysis Output


• The upper map presents RNFL thickness using a color code. The color scale appears at
right. The lower map shows average RNFL thickness in the inner and outer areas of
eight map sectors, in micrometers. A key of the map circle diameters appears at upper
right (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 (3.4), RNFL Thickness (2.27xdisc) or Nerve Head Circle.

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Output Display

Figure 6-13 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 of the graphs, for each eye, circular diagrams show quadrant and
clock-hour RNFL average thickness changes between examinations.

RNFL Thickness Serial Analysis


Application: Select RNFL Thickness Serial Analysis 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 (3.4), RNFL
Thickness (2.27xdisc) or Nerve Head Circle.

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Output Display

Figure 6-14 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) Optic 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. 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 Average Nerve Width at 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.

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Method of Optic Nerve Head Analysis


For 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 micrometers (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 6-15 Optic Nerve Head Analysis Output

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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. Carl Zeiss Meditec 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.
• Clear Graphics button: Click Clear Graphics to remove the graphic overlay. Click Show
Graphics to reinstate them.
• Zoom: Move the slider up or down to the zoom in or out.
• Surface Sensitivity: Surface sensitivity determines what reflectivity threshold value is
considered to be the anterior surface. Higher sensitivity creates a higher threshold,
meaning potential artifacts and noise are better ignored in defining the surface. This
can affect measurements.
• Cup Offset: This adjustment defines where the cup begins. Increase or decrease the
value by using the left and right arrows.
• Cup Offset for Topo: Adjusts the surface of the cup in the composite image. Increase
or decrease the value by using the left and right arrows.

Optic Nerve Head (ONH) Analysis Results


The 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.

Composite Image Features and Functionality


The 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.

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• You can click and drag the Zoom In and Zoom Out sliders, click on and Clear Points on
the composite image.
• Composite Image Measurements:
• Disc Area: The area bounded by the red outline of the disc in the composite
image.
• Rim Area: Disc area minus cup area.
• Rim Cross Sectional Area: This is an estimate of the total rim area calculated
by multiplying the average of the individual scan widths across the nerve head
times the circumference of the disc.
• Rim 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.
• Cup Area: The area bounded by the green outline of the cup in the composite
image.
• Cup Volume: This is an estimate of the total volume, represented by the blue
shading of the cup as if it were filled with water to its surface.
• 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.
• Cup/Disc Area Ratio: Ratio of cup area to disc area.
• 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.

GPA Advanced Serial Analysis

 Note: GPA Advanced Serial Analysis is an optional feature that may not be activated
on all instruments. If you do not have this feature and want to purchase it, contact
Carl Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your
local Carl Zeiss affiliate or distributor.
The GPA Advanced Serial Analysis protocol is an advanced version of RNFL Thickness Serial
Analysis designed to assist you in managing glaucoma by helping you determine whether
the rate of RNFL loss is statistically significant. When the analysis includes compatible
exam data from four or more visits (per eye), the analysis output includes a linear

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regression analysis and reports whether or not any observed RNFL loss over the included
visits is statistically significant with 95% or higher confidence. The analysis can be applied
to one or both eyes and can include up to 8 exams (from 8 visits) for each eye—up to 16
total exams per analysis. If you select two scans taken on the same day, Stratus
automatically selects the best scan from that day (in terms of scan quality factors).
Notes on Using GPA in Clinical Practice
Stratus OCT GPA Advanced Serial Analysis does not evaluate “progression of
glaucoma,” which can only be assessed through evaluating changes in several clinical
factors including optic nerve head appearance and visual fields. GPA only refers to
change in the nerve fiber layer thickness as assessed by statistical analysis. Such change
or progression of RNFL thickness may or may not be clinically relevant.
GPA is not meant to diagnose. Diagnosis is the responsibility of the practitioner, who
should base diagnosis upon many parameters, many or most of which are not assessed
by Stratus.
GPA Advanced Serial Analysis provides a statistical analysis (linear regression) of RNFL
thickness average versus age. Linear regression fits test data to a linear model,
assuming that the measurements are independent, normally distributed, and that
variability does not depend on the size of the measurement. Rates of change estimated
by linear progression may provide useful information, even in cases where change has
not been completely linear. Projections based upon linear regression analysis should be
used to alert the practitioner to what might happen in the future assuming linearity, but
not to predict future change. In any case, linear regression is a statistical analysis, and
cannot replace clinical evaluation of the patient’s status and progress.
RNFL thickness is expected to decrease slowly as a function of normal aging. Literature1
shows an age-related loss as low as 0 μm per year to as high as 0.31 μm per year. All of
these results are based on cross-sectional data. An individual patient’s normal aging
rate may vary.
Because the exact rate of change for any individual is unknown, Stratus reports
statistical significance if the 95% confidence limits on the slope exclude zero, rather
than determining if they exclude normal age-related loss. If Stratus reports that a rate of
change is statistically significant, but the 95% confidence limits include a rate
consistent with normal aging, the observed change may be due to normal aging.

1. Ramakrishnan R, Mittal S, Sonal A, et al. Retinal nerve fibre layer thickness measurements in normal Indian
population by optical coherence tomography. Indian J Ophthalmol. 2006;54:11–15.
Sony P, Sihota R, Tewari Hem K, et al. Quantification of the retinal nerve fibre layer thickness in normal Indian
Eyes with optical coherence tomography. Indian J Ophthalmol. 2004;52:303–309.
Hougaard JL, Ostenfeld C, Heijl A, et al. Modeling the normal retinal nerve fiber layer thickness as measured
by Stratus optical coherence tomography. Graefes Arch Clin Exp Ophthalmol. 2006.
Budenz DL, Anderson DR, Varma R, et al. Determinants of normal retinal nerve fiber layer thickness by Stratus
OCT. Ophthalmology. 2007;114:1046–1052.
Parikh RS, Parikh SR, Sekhar GC, et al. Normal age-related decay of retinal nerve fiber layer thickness. Ophthal-
mology. 2007;114:921–926.
Ronald S. Harwerth Age-Related Losses of Retinal Ganglion Cells and Axons. Investigative Ophthalmology &
Visual Science, October 2008, Vol. 49, No. 10.

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Application: Select GPA Advanced Serial Analysis to do a statistical analysis of RNFL


thickness over time. You can apply this analysis simultaneously to up to eight OD and/or
eight OS scan groups of equal radius and same scan type. All scans you choose must be
from either RNFL Thickness (3.4) or Fast RNFL Thickness (3.4).

Output Display

For each eye analyzed, the display includes:


• The upper graph draws lines for RNFL thickness versus A-scan location (and TSNIT
location).
• The lower graph plots data points for RNFL thickness average versus age. If four or
more points are plotted, the lower graph also will include a regression line, and text
below the graph will report the rate of change (with standard deviation) and whether
any observed RNFL loss trend is statistically significant.
• RNFL thickness data table: The table color-codes each exam, which is identified by
date, time and number of scans; the same colors are applied to the graph lines and
points to distinguish the exams there.
• The table also includes an SS,Q column, indicating for each exam the signal
strength (SS) value and any quality (Q) messages that apply. The QC legend at
upper right explains the quality messages that may be indicated by the letters A
through F.
• The table provides numerical RNFL thickness averages—overall and for the
superior and inferior halves. Each thickness average value is highlighted by the
applicable normative data color. Among same-age individuals in the normal

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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%).

Understanding Guided Progression Analysis


GPA Advanced Serial Analysis guides you in the analysis of progression by providing a
statistical analysis of RNFL thickness average versus age. When the analysis includes
compatible exam data from four or more visits (per eye), the analysis output includes a
linear regression analysis and reports whether or not any observed RNFL loss over the
included visits is statistically significant with 95% or higher confidence.

RNFL Thickness Average vs. Age Plot


The RNFL thickness average versus age plot by itself allows you to visually examine any
potential trends in the data over time. The graph color-codes each point on the plot of
average thickness to match the RNFL thickness data table—for instance, the pink point
corresponds to the fourth row in the table.

Trend Line
The line on the plot represents a linear regression to determine if there is a statistically
significant rate of RNFL loss. Linear regression is a common method for determining if a set
of data that is subject to normal variability is consistent with a linear trend. If the trend is
decreasing, the patient may be losing nerve fiber layer.

WARNING: The trend line and regression result represent a statistical analysis.
The clinician should review all scans and all other clinical information, and use
his or her own judgment to determine if clinically relevant change is occurring
in the patient.

Regression Result Text


The regression result text below the plot reports the regression analysis result.
Rate of change: -0.609 +/- 10.2µ/year*
Statistically not significant P > 5%

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• Rate of change (slope): The reported rate of change is the best unbiased estimate of
the slope, or rate of change, based on the given points. Stratus reports the rate of
change in units of micrometers per year (μ/yr).
• Confidence range: Stratus also reports the range of slopes that are consistent with the
data with 95% confidence. The true slope may be larger or smaller than the best
estimate that Stratus reports, but there is 95% confidence that the slope is inside the
region given by the slope +/- the confidence range. For example, if the regression
result reported by Stratus is:
Rate of change: -4.5 micrometers/year +/- 3 µ/year
then there is 95% confidence that the rate of change of average RNFL thickness is
between -7.5 micrometers per year and -1.5 micrometers per year.
• Statement of significance: When the confidence bounds include zero, the regression
result text reports that the rate of change is Statistically not significant,
because there is not 95% confidence that the slope is decreasing. Stratus also reports
Statistically not significant when the best unbiased estimate of the slope is
positive, because increasing RNFL thickness is not consistent with glaucomatous
damage.
When the slope is negative and the 95% confidence range does not include zero,
then there is 95% confidence that a decreasing trend of RNFL thickness exists. Stratus
will then report that the rate of change is Statistically significant with P < 5%,
because there is less than a 5% probability that the negative slope occurred by
chance.

WARNING: Because scan variability depends on image quality factors such as


signal strength and scan placement, it is possible to observe a statistically
significant slope that does not indicate glaucomatous progression. Carefully
examine the profiles, the scan quality factors, the scans themselves, and all
other clinical information that is available before making a judgment about
whether a patient is experiencing glaucomatous loss of RNFL.

Stratus will also calculate the 99% and 99.9% confidence ranges. If the 99% confi-
dence range does not include zero, and the slope is negative, then the significance
statement regarding the rate of change will be Statistically significant with P <
1%. If the 99.9% confidence range does not include zero, and the slope is negative,
then the significance statement will be Statistically significant with P < 0.1%.

Retinal Thickness
Application: Select Retinal Thickness to obtain graphs of retinal thickness for any scan.
Retinal Thickness analyzes one scan group of any scan protocol at a time, except (Fast)
Optic Disc. Normative data will appear in the output if you analyze a Fast Macular
Thickness Map (Fast Mac) scan, as described in Macula Normative Database on
page 6-7.

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Output Display

Figure 6-16 Retinal Thickness Analysis Output


• The output graph shows retinal thickness (black line, in micrometers) 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 micrometers at bottom right.
• Click the Caliper ON checkbox to measure distances between the cross-shaped
calipers that appear. Caliper Length appears at bottom right.
• Click the Mirror Image checkbox to horizontally reverse the scan image and the
corresponding Thickness Chart.
When applied to a Fast Macular Thickness Map (Fast Mac) scan, the normative
data color code applies to each particular A-scan location in the graph. The resulting color
bands of light red, light yellow, green, yellow and red indicate the normal distribution
percentiles for the age-matched normative data. Among same-age individuals in the
normal population, the percentiles apply to each particular retinal thickness measurement
as follows:
• The thickest 1% of measurements fall in the light red area. Measurements in light red
are considered outside normal limits. (light red > 99%, above normal limits).

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• The thickest 5% of measurements fall in the light yellow area or above (95% < light
yellow  99%, suspect above normal)
• 90% of measurements fall in the green area (5%  green  95%).
• The thinnest 5% of measurements fall in the yellow area or below
(1%  yellow < 5%, suspect below normal).
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered below normal limits (red < 1%, below normal limits).

 Note: Clinicians must exercise judgment in the interpretation of the macula


normative data. For any particular measurement, note that 2 out of 20 normal eyes
(10%) will fall either above or below green.

 Note: Subject ethnicity was self-reported by the patients in the population


comprising the macula normative database but was NOT used as a variable in
constructing the normative database for retinal thickness. Normative data will not
appear for patients under 18 years of age. The macula normative data appears only
when you analyze a Fast Macular Thickness Map (Fast Mac) scan.

Export Results
The 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.
When you click Export, the Export As dialog appears as below:

Figure 6-17 The Export As Dialog


• The dialog prompts you for a filename. You can name the file and save it to any
available location. 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.rth(Retinal Thickness result in ASCII text format)

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 Note: It is the clinician’s responsibility to associate patient information with


exported files.

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 micrometers) in nine map sectors. This analysis
protocol operates on one Line 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. Normative data will appear in the output if you
analyze a Fast Macular Thickness Map (Fast Mac) scan, as described in Macula
Normative Database on page 6-7.

Output Display

Figure 6-18 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 micrometers. Each map consists of three
concentric circles, the outer two divided into sectors. A key of the map circle diameters
appears at bottom center.

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• Below the right map a pair of radio buttons appear, to adjust the diameter of the
maps displayed. 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 micrometers) +/- the standard deviation for the
center point, where all six scans intersect; and Total Volume of the retinal map area
in mm3.
When applied to a Fast Macular Thickness Map (Fast Mac) scan, the normative
data color code applies to the circular map on the right. The right map shows average
retinal thickness for each map sector, in micrometers, and applies the normal distribution
percentile colors to those sector averages. The normal distribution percentile legend
appears below the right map.
Among same-age individuals in the normal population, the percentiles apply to each
particular retinal thickness measurement as follows:
• The thickest 1% of measurements fall in the light red area. Measurements in light red
are considered outside normal limits. (light red > 99%, above normal limits).
• The thickest 5% of measurements fall in the light yellow area or above (95% < light
yellow  99%, suspect above normal)
• 90% of measurements fall in the green area (5%  green  95%).
• The thinnest 5% of measurements fall in the yellow area or below
(1%  yellow < 5%, suspect below normal).
• The thinnest 1% of measurements fall in the red area. Measurements in red are
considered below normal limits (red < 1%, below normal limits).

 Note: Clinicians must exercise judgment in the interpretation of the macula


normative data. For any particular measurement, note that 2 out of 20 normal eyes
(10%) will fall either above or 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 macular thickness. Normative data will not appear for
patients under 18 years of age. The macula normative data appears only when you
analyze a Fast Macular Thickness Map (Fast Mac) scan.

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Multi-Slice Report
Application: Select Multi-slice Report to create a report comparing:
• all slices from a given scan on the same day (example: six scans from Fast Macular
Thickness Map), or
• slices from two different time periods, or
• any combination of slices from up to two time periods.
Note: Multi-Slice Report is an optional feature that may not be activated on all
instruments. If you do not have this feature and want to purchase it, contact Carl
Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your local
Carl Zeiss affiliate or distributor.
Output Display

Figure 6-19 Multi-Slice Report

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To generate a report:
1. Select a patient and highlight the exams that you want to include in your report, You
can select up to two time periods.

Figure 6-20 Select Multiple Scans for Multi-Slice Report


2. Select Multi-Slice Report and then click on the Scan Selection button. The following
window appears.

Figure 6-21 Scan Selection for Multi-Slice Report

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3. Thumbnails of the scans appear along the left side of the screen, with checked boxes
indicating they are selected. Un-check the box to the right of each scan you do not
want to include in your report.
4. Near the bottom of the window, click the Multi-Slice Report button.
5. A PDF report is created and will open automatically.

Image Processing Protocols


The Stratus OCT offers seven image processing protocols to assist with visual analysis of the
scan image:
• Scan Profile
• Proportional
• Align
• Normalize + Align
• Gaussian Smoothing
• Median Smoothing
• 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.

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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 6-22 Common Output Window for Image Processing


The 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 Patient/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.
• Click the Caliper On checkbox to activate the calipers. See Caliper On, 6-5.
• Click the Mirror Image checkbox to horizontally reverse both images.

Proportional
Select Proportional to obtain a processed scan image that is true in its horizontal and
vertical proportions. Compared to the usual presentation of Stratus OCT scan images, the
proportional scan image appears compressed vertically. This is because Stratus OCT 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.

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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 4-5.) 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.

 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.

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

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 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

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average value weighted by location. The advantage of Median Smoothing is that it


removes noise while preserving small details in the data.

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

Figure 6-23 Scan Profile Analysis Output


This 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 OCT 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").
• Click the Mirror Image checkbox to horizontally reverse the scan image and the
corresponding Scan Profile Chart.
• Select Grayscale or Color (default) for the OCT image. Use the + and – buttons to
adjust the image brightness.

Measure A-Scan Location


You 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.

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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 green “Cursor 2 Value is
31.3 dB at [data point] 10.” 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 Comparison


The 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 36.2 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.

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Data Management 7-1

(7) Data Management

Chapter Overview
This chapter explains how to perform data management functions. The topics covered in
the current chapter include:
• Find and Select Records, page 7-1
• Print Patient Data, page 7-2
• Print Clinical Notes, page 7-2
• Add a New Patient, page 7-2
• Edit Patient Records, page 7-4
• Merge Patients, page 7-4
• Create and Edit Visit Records, page 7-6
• Edit Exam Record Notes, page 7-7
• Edit Clinical Notes, page 7-8
• Categorize Patient Records, page 7-8
• Create and Assign Patient Diagnoses, page 7-11
• Register, Edit and Assign Medical Staff, page 7-14
• Register, Edit and Assign Insurance Companies, page 7-15
• Delete Patient, Visit and Exam Records, page 7-17
• Site ID and Logo, page 7-19
• Defragment Database, page 7-20
This manual treats data transfer functions in separate chapters:
• Archive, Retrieve & Backup, Chapter (8).
• Export and Import Scan Data, Chapter (9).

 Note: If you are using DICOM Archive we recommend that you perform all patient
data management (merge, edit, delete patients) in FORUM, not on the Stratus OCT
instrument. When you retrieve data from forum the data on your instrument will be
automatically updated. The data is not updated if you archive to FORUM from your
instrument. Please read the instructions that accompany the FORUM application.

Find and Select Records


To find records, type in the Search field above the patient list to search by last name or
patient ID. 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.

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Advanced Search
Stratus OCT provides an Advanced Search dialog to search for patient records using
additional parameters such as patient category, diagnosis, scan type, insurance company,
doctor, clinical trial ID or subject reading ID, etc. You can access Advanced Search from the
Toolbar.
Using the available fields, enter or select search parameters and click Search. Search
parameters you type in are not case-sensitive. The search returns all matching patients in
the patient list where you started.

 Note: The search returns only the patients that match all search parameters used. If
your search does not return all patients desired, you may want to broaden your
search by using fewer parameters or partial information. Clicking Search without
using any parameters returns all patients in the source database.

Print Patient Data


From the PATIENT RECORD WINDOW (any tab), select Print from the Record menu (click
Record > Print) to get a printout of patient data for the current patient. The printout
includes information from all tabs of the PATIENT RECORD WINDOW except for clinical notes,
which can be printed separately as described next.

 Note: Comments printed as part of the patient data printout are taken from the
Comment Tab of the PATIENT RECORD WINDOW. These comments do not include scan
comments. Scan comments are a type of clinical notes, and are printed either as part
of the clinical notes printout, or as part of the analysis output (see Print Analysis
Output on page 5-6).

Print Clinical Notes


To print the clinical notes, click the Clinical Notes Tab to bring it to the front. Then click
the Print Clinical Notes button at lower right. You will get a printout of all clinical notes,
including all patient comments, visit comments, scan comments and exam comments. (See
Print Analysis Output on page 5-6 for instructions to print individual scan comments
along with analysis printouts.)

Add a New Patient


WARNING: Every patient record has an identifier that consists of the Name
(Last, First, Middle), Date of Birth, Gender and Patient ID 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 7-17). Make certain that you enter the
identifying patient information correctly.

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


1. From the MAIN WINDOW, click the Add button. The PATIENT RECORD WINDOW appears,

Figure 7-1 The Patient Record Window


2. Only the fields in red are required to save a record. These are Last Name, First
Name and Date of Birth. You can enter information on all tabs in the PATIENT
RECORD WINDOW. After entering the desired data, click the OK button to accept the
changes and close the window, or click the Apply button to apply the changes
without closing the window. Click the Cancel button to discard the changes and close
the window.

Allow Clear Exams


When the Stratus OCT database reaches capacity, you must make space by clearing scan
data that has been archived. However, you can prevent the exam records of any patient
from being among those cleared, if you click the No radio button in the Allow Clear
Exams area on the right. The Yes radio button is selected by default, allowing the Stratus
OCT to clear this patient’s exams when necessary, and only if they have been archived
(copied) first. See the section Clear Archived Exams on page 8-14 for more
information.

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Edit Patient Records


WARNING: Every patient record has an identifier that consists of the Name
(Last, First, Middle), Date of Birth, Gender and Patient ID 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, Stratus OCT 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 7-17). To avoid unintentional merging of patient
records, you must make certain that you enter a unique combination of Name
(Last, First, Middle), DOB, Gender and Patient ID when editing patient records.

To edit an existing patient record, follow these steps:


1. In the patient list, click a name to select the desired patient record. From the MAIN
WINDOW, click the Edit button. The PATIENT RECORD WINDOW appears.
2. In the PATIENT RECORD WINDOW, edit the desired information on all tabs. After editing
the desired data, click the OK button to accept the changes and close the window, or
click the Apply button to apply the changes without closing the window. Click the
Cancel button to discard the changes and close the window.

Merge Patients
In Stratus OCT, every patient record has an identifier that consists of the Name (Last, First,
Middle), Date of Birth, Gender and Patient ID 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, you can merge patient records using the Merge Patients function. To
merge records.

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1. In the Patient Menu, select Merge Patients. The Merge Patient dialog appears.

Figure 7-2 Merge Patients dialog


2. You can search for a patient using the last name, patient ID, or category. Use Ctrl and
left-click to select two patients, then click on the Merge Patients button. The Patient
Merge dialog appears.

Figure 7-3 Patient Merge dialog


3. Select the correct patient, and click Merge. The Confirm Merging dialog appears.

Figure 7-4 Confirm Merging dialog


4. Click OK to merge the two 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
7-17).

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 Note: Stratus OCT 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 Stratus OCT.

Create and Edit Visit Records


In the VISIT RECORD WINDOW, you can edit visit notes or create new visit records.

 Note: You cannot edit the visit date.

To Create a New Visit Record


1. In the MAIN WINDOW, 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 7-2.
2. Select Visit from the Patient menu, (click Patient > Visit). The VISIT RECORD WINDOW
appears.

Figure 7-5 The Visit Record Window


3. Click the Create New Visit Record button to activate the Visit Notes field for data
entry. You cannot enter a visit date. The current date is used automatically. The
Accession Number field can be edited unless the patient is selected from the using
the Search Worklist Patients dialog.
4. Enter the desired information and then click the Save Record button.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.

To Edit Visit Records


1. In the MAIN WINDOW, select the desired patient name.
2. Then you can either:
• Select a single visit to edit from the scan list and then select Visit from the Patient
menu (click Patient > Visit).

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• Or: Select Visit History from the Patient menu (click Patient > Visit History). The
VISIT HISTORY WINDOW appears listing all visits for that patient. To edit one, select it
and click the Edit Current Visit Record button.
3. In either case, you eventually reach the VISIT RECORD WINDOW (Figure 7-5). If
necessary to activate the fields for editing, click the Edit Current Record button.
4. Add or edit the 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. You must
confirm your choice in the CONFIRM dialog box.

Edit Exam Record Notes


For an exam record, you can edit only the Exam Notes field. This information pertains to
the specific exam. To edit exam notes, follow these steps:
1. In the MAIN WINDOW, select the specific exam you want to edit and then select Exam
from the Patient menu (click Patient > Exam). The EXAM RECORD WINDOW appears.

Figure 7-6 The Exam Record Window


2. In the EXAM RECORD WINDOW, if necessary, click the Edit Current Exam Record button.
This activates the Exam Notes field.
3. Add or edit the desired information. When finished, click the Save Record button.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.

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Edit Clinical Notes


While clinical notes may be of a general nature regarding a patient, in Stratus OCT, 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 MAIN WINDOW, select the desired patient and then select either a visit record or
exam record.
• If you selected a visit, select Visit from the Patient menu (click Patient > Visit) to
open the VISIT RECORD WINDOW.
• If you selected an exam, then select Exam from the Patient menu (click Patient >
Exam) 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. After making the desired
changes, click the Save Record button.
• To discard the changes before saving, click the Undo Changes button. You must
confirm your choice in the CONFIRM dialog box.

Categorize Patient Records


You can create your own categories and place patient records in them. This enables you to
search for patient records by category during data transfer operations such as import,
export, archive and retrieve. See Advanced Search on page 7-2 for more information.

 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 MAIN WINDOW enables you to find patient records by name or
patient ID, but is not as useful when searching for patients by group criteria, which you
may want to do during data transfer operations. 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. The Stratus OCT offers special features for use in categories designated for
clinical trials.
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).

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Create, Edit and Delete Categories


Create
Only the Default category is pre-installed. To create new categories, follow these steps:
1. Click Options > Register > Categories. The RECORD CATEGORY SETTINGS WINDOW
appears.

Figure 7-7 The Record Category Settings Window


2. Click the New Patient Record Category button. This activates the fields.
3. Type the desired name in the Category Name field, up to 32 characters, including
spaces. The name must be unique among category names. The name is
case-sensitive.
4. If the new category is for a clinical trial, click the Is clinical trial checkbox. This
activates the special fields applicable to clinical trial categories.
• The bolded fields Sponsor Name, Protocol ID and Site ID are required.
The Protocol Name and Site Name fields are optional. In all fields, you can
type up to 64 characters.

 Note: If you search for records using a clinical trial category, and no regular Patient
ID has been created for a patient in that clinical trial category, then the ID displayed
in the ID column for such patients will be either the Clinical Trial Subject ID or the
Subject Reading ID, depending on which one has been required.
5. When you have entered the desired information, click the Save Patient Record
Category button. You can repeat steps 2 through 5 to create additional categories.

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• If before saving you decide not to create a new category, click the Undo Changes
button or just close the window. You must confirm your choice in the CONFIRM
dialog box.

Edit
To edit a category, click the category you wish to edit and then click the Edit Selected
Patient Record Category button. Edit the desired fields and click the Save Patient Record
Category button.

 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.

Delete
To 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:
1. From the MAIN WINDOW, select Categorize Patients from the Patient menu (click
Patient > Categorize Patients). The CATEGORIZE PATIENTS WINDOW opens.

Figure 7-8 Categorize Patients Window

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2. At the top in the Select Operation area, select the Add Patients to Selected
Categories radio button.
3. In the Select Patients area, select the patient or patients to whom you will apply
categories. You can either click the checkbox next to the name, or you can select all
patients at once by clicking the Select All checkbox above the list. Click a selected
patient checkbox to clear it, or click Clear All at lower right to clear all the patient
checkboxes and start over.
• When you select a single patient, the Assigned Categories area appears at
lower right, and displays the categories to which that patient already belongs, if
any.
4. In the Select Categories area on the right, select one or more categories to apply
to the selected patients.
5. When you finish making your selections, click Apply. The selected categories are
applied to the selected patients. The window does not close, allowing to make more
category assignments.
6. When finished adjusting category assignments, click Close to exit the window.

Removing Patients from Categories


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

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

Create and Assign Patient Diagnoses


The Stratus OCT 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 during export and retrieve. See Advanced Search on page 7-2 for more
information.

 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.

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Create, Edit and Delete Diagnoses


To create diagnoses for use in Stratus OCT, follow these steps:
1. In the MAIN WINDOW, select Options > Register > Diagnosis. The DIAGNOSIS
REGISTRATION WINDOW opens.

Figure 7-9 The Diagnosis Registration Window


2. In the DIAGNOSIS REGISTRATION WINDOW, you can create (register), edit and delete
diagnoses.

or • 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 Diagnosis Code and
Diagnosis Description fields as desired. Only the bolded Diagnosis Code is
required; the Diagnosis Description is optional. 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.

 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.

 Note: Imported diagnosis codes do not retain the descriptions created for them on
the exporting instrument. For example, exporting instrument A has the description
“Retina” for diagnosis code 001, but importing instrument B has the description
“Glaucoma” for diagnosis code 001. When you view on instrument B a patient
record imported from instrument A with diagnosis code 001 assigned, the

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Data Management 7-13

description will read “Glaucoma,” as if the record were created on importing


instrument B.
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 Diagnoses Tab of the
PATIENT RECORD WINDOW while creating or editing a patient record. To do so, follow these
steps:
1. In the MAIN WINDOW, select the desired patient and click the Edit button, or select Edit
Patient from the Patient menu (click Patient > Edit Patient). The PATIENT RECORD
WINDOW appears.
2. In the PATIENT RECORD WINDOW, click the Diagnoses Tab to bring it to the front.

Figure 7-10 The Diagnoses Tab of the Patient Record Window


3. Select one or more diagnoses from the list of All Diagnoses on the left and then
click the Add button for the applicable eye, either OD above or OS below.
• To remove diagnoses currently assigned to an eye, select one or more from the
OD or OS list on the right and then click the Remove button.

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4. Click the OK button to accept the diagnosis changes and close the window, or click
the Apply button to apply the changes without closing the window. Click the Cancel
button to discard the changes and close the window.

Register, Edit and Assign Medical Staff


Stratus OCT 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 using the advanced Record Search function during export
and retrieve. See Advanced Search on page 7-2 for more information.

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

Register (Create), Edit and Delete Staff Records


To register (create) and/or edit medical staff records, follow these steps:
1. From the MAIN WINDOW, click Options > Register > Staff. The STAFF REGISTRATION
WINDOW appears:

Figure 7-11 The Staff Registration Window


2. In the STAFF REGISTRATION WINDOW, you can create (register), edit and delete staff
records.

or • To create a new staff record, click the Create New Staff Record button.

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• 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. Only the bolded Last Name and First
Name fields are required; other fields are optional.
• 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


You can assign registered medical staff to a patient as attending or referring physician, and
change staff assignments in the General Data Tab of the PATIENT RECORD WINDOW. To do
so, follow these steps:
1. In the MAIN WINDOW, select the desired patient and click the Edit button, or select Edit
Patient from the Patient menu (click Patient > Edit Patient). The PATIENT RECORD
WINDOW appears with the default General Data Tab showing (see Figure 7-1).
2. Use the Attending Physician and/or Referring Physician drop-down lists to
select one from among those registered.
3. Click the OK button to accept the changes and close the window, or click the Apply
button to apply the changes without closing the window. Click the Cancel button to
discard the changes and close the window.

Register, Edit and Assign Insurance Companies


Stratus OCT 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 during export and
retrieve. See Advanced Search on page 7-2 for more information.

 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.

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Register (Create), Edit and Delete Insurance Company Records


To register (create) and/or edit insurance company records, follow these steps:
1. From the MAIN WINDOW, select Options > Register > Insurance Company. The
INSURANCE COMPANY REGISTRATION WINDOW appears:

Figure 7-12 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.
• 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:
1. From the MAIN WINDOW, select the desired patient and click the Edit button. The
PATIENT RECORD WINDOW appears with the default General Data Tab showing (see
Figure 7-1).
2. In the Insurance area near the bottom, use the Company drop-down list to select
one from among those registered. You can also type an identification number in the
Insurance ID field.
3. Click the OK button to accept the changes and close the window, or click the Apply
button to apply the changes without closing the window. Click the Cancel button to
discard the changes and close the window.

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Delete Patient, Visit and Exam Records

Delete Patient Records


Stratus OCT permits you to delete a patient record and all its associated visit and exam
records at once. You must delete one patient record at a time. To do so, follow these steps:
1. In the MAIN WINDOW, select the patient record (name) you wish to delete.
2. Select Edit Patient from the Patient menu (click Patient > Edit Patient) to open the
PATIENT RECORD WINDOW.
3. In the PATIENT RECORD WINDOW, click the Record menu at top left and select Delete.
You must confirm your choice in the dialog box that appears.

Figure 7-13 Confirming a patient record deletion


• Click OK to confirm deletion or Cancel to cancel deletion.
In the MAIN WINDOW, you can verify that deleted patients no longer appear in the list.

Delete Exam Records

 Note: An exam record is a single item, named by scan type, under OD Scan Group
or OS Scan Group in the central list in the MAIN WINDOW. An exam record is the
same as a scan group, although an exam may consist of only one scan. The terms
“exam,” “exam record” and “scan group” are used interchangeably.
You can delete one exam record at a time by opening the EXAM RECORD WINDOW, or you can
delete one or more exam records (scan groups) at once using the Delete Scan Group(s)
option in the Patient menu.

Recommended Method
The simpler and therefore recommended method to delete one or more scan groups is to
use the Delete Scan Group(s) option in the Patient menu. Follow these steps:
1. Select any number of exam records from any visit for the current patient. Hold the Ctrl
key and click (Ctrl-click) to select multiple exams.
2. Select Delete Scan Group(s) from the Patient menu (click Patient > Delete Scan
Group(s) to delete the selected exams. You must confirm your choice in the dialog box
that appears.

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• Click OK to confirm deletion or Cancel to cancel deletion.


In the MAIN WINDOW, you can verify that the deleted exams no longer appear in the list.

 Note: If you delete all the exam records for a visit using this method, the visit record
also is deleted automatically. The visit record is not deleted automatically if you use
the following method to delete all exams for a visit.

Optional Method
You can delete exam records one at a time using this method, and if you delete all exams
from a visit, the visit will not be deleted automatically.
1. In the MAIN WINDOW, select the exam record you wish to delete.
2. Select Exam from the Patient menu (click Patient > Exam) 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.
In the MAIN WINDOW, you can verify that the deleted exam no longer appears in the list for
that visit.

Delete Visit Records

 Note: If you use the Delete Scan Group(s) option in the Patient menu to delete all
scan groups for a visit, the visit record also is deleted automatically.
You can delete one or more visit records at once. However, you cannot delete a visit record
unless you have first deleted all exam records for that visit. (See Delete Exam Records
on page 7-17.) To delete visits from the patient record, follow these steps:
1. In the MAIN WINDOW, select the visit record (date) you wish to delete. It must first have
no exam records in it or you cannot delete it.
2. Select Visit or Visit History from the Patient menu (click Patient > Visit or Patient >
Visit History) to open the VISIT RECORD WINDOW or the VISIT HISTORY WINDOW.
• If you plan to delete multiple visit records, click Patient > Visit History 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.

 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.
If you are deleting visits one at a time, repeat the steps for each visit record you wish to
delete. In the MAIN WINDOW, you can verify that the deleted visits no longer appear in the
list for that patient.

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Site ID and Logo

 Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic.
You can create a clinical site ID and designate a graphic logo. The logo graphic must be in
bitmap format and have a “.bmp” extension. You must copy the logo graphic file from the
source system either to compatible removable media or directly to the Stratus OCT hard
drive (for networked systems). For removable media, insert the media into its drive on the
Stratus OCT and follow these steps:
1. In the Stratus OCT MAIN WINDOW, select Register > Clinical Site ID from the Options
menu (click Options > Register > Clinical Site ID). The Clinical Site ID dialog box
appears.

Figure 7-14 The Clinical Site ID Dialog Box


2. To enter the clinic name, type up to 64 characters, including spaces, in the Clinical
Site ID field.
3. To select a clinic logo for display on printouts, click the Browse button. Use the
Browse dialog box to find the logo graphic file on the hard drive or removable media,
(depending on your transfer method).
4. Select the logo graphic file and click OK. The graphic file is copied to the database on
the Stratus OCT. 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

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Defragment Database
To maintain or restore peak performance of the Stratus OCT 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.

 Note: Depending on the database size, defragmentation may take several minutes.
To defragment the database:
1. In the Stratus OCT MAIN WINDOW, click Options > Defragment Database. The
DEFRAGMENT DATABASE WINDOW appears.

Figure 7-15 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.

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(8) Archive, Retrieve & Backup

Chapter Overview
The Stratus OCT offers several functions that together enable you to preserve your valuable
patient data and maintain database performance. Archive and backup are the core
functions required to preserve and recover your data in case of computer malfunction.
These functions can be set to occur automatically, and you can also archive manually.

Advisory: If you do not follow the instructions in this chapter, paper records
are the only way to confidently retain patient information.

Topics covered include:


• The Patient Database, below
• Data Maintenance Requirements, page 8-2
• Recommendations For Automated Data Maintenance, page 8-3
• Recommendations For Automated Data Maintenance, page 8-3
• Data Management Preferences, page 8-3
• Care of DVD Archives, page 8-5
• Format DVD-RAM Disks, page 8-6
• DICOM Archive and Retrieve Workflow, page 8-8
• Retrieve Scan Data, page 8-11
• Clear Archived Exams, page 8-14

The Patient Database


The Stratus OCT patient database contains two kinds of stored data:

1 2
Scan Data Index Database

• Scan data
reference locations

Scan data includes the OCT images generated during an examination, along with the
associated patient, visit and exam data.
The index database identifies each saved scan—by patient, visit, scan acquisition protocol
and location where the scan images are saved.

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Data Maintenance Requirements

Archive and Backup


Two actions must occur to protect your data from permanent loss:

1 2
Archive Backup

Scan Data Index Database


To enable excellent database performance along with long-term data protection, the
patient database separates data-intensive scan data from the index database. The
complete index database always remains on the Stratus OCT computer hard drive (unless
you delete individual patient data). You must backup (copy) the index database to a second
location to protect it from a computer malfunction that would otherwise render it
inaccessible. Backup is therefore a data protection function.
Archiving, on the other hand, serves both to protect data and to maintain database
performance. Scan data has unique and persistent identifiers that link it to the correct
patient information in the index database. Because of this, scan data can be safely
removed from the Stratus OCT computer hard drive. You must archive (copy) scan data to a
second location to protect it from permanent loss due to a computer malfunction. You can
readily retrieve archived scan data when the Stratus OCT is connected to the correct archive
volume.

Clearing Scan Data


Scan data remains on the instrument hard drive as long as possible, or until you choose to
remove it. Only when the hard drive gets too full must you clear enough hard disk space to
allow you to save more scans. With a new instrument, it takes many months up to a few
years before the Stratus OCT prompts you to clear scan data. If you do not clear (delete)
scan data when prompted, eventually the hard disk will reach capacity and prevent you
from saving new scans. At that point, you must clear scan data to save new scans.

WARNING: We recommend that you do not clear scan data unless it has been
archived. If you attempt to clear un-archived scan data, the Stratus OCT will
prompt you to confirm your choice before permanently deleting the scan
data.

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Recommendations For Automated Data Maintenance


To maximize data security and long-term database performance with minimal effort, we
recommend that you automate data maintenance. To do this, use the Data
Management Tab of the Preferences dialog, as described next.

WARNING: It is the user’s responsibility to protect their exam data from loss.
New scans acquired since your last archive, and changes to the scan index
database since your last backup are subject to permanent loss in case of
computer malfunction. We recommend that you automate data
maintenance, as described in this section.

Data Management Preferences


Follow these steps to automate data maintenance:
1. In the MAIN WINDOW, select Preferences from the Options menu (click Options >
Preferences). The Preferences dialog opens to the Data Management Tab:

Figure 8-1 The Data Management Tab in the Preferences Dialog


2. By default the checkboxs are empty. Select both checkboxes, as in Figure 8-1 above.
These selections have the effects described next.

Automated Data Maintenance Behavior


Auto Backup index database on shutdown
When selected, on shutdown the Stratus OCT will automatically backup (copy) the index
database to the current archive location.

WARNING: Failure to select this option to perform automatic backup may


result in the loss of medical exam data.

Auto Clear on startup/shutdown


When selected, on startup and shutdown the Stratus OCT checks the hard disk space
indicator. If it is not green, a dialog will inform you that the Stratus OCT will clear—
delete—archived exams. Un-archived exams will not be cleared. Click OK to proceed with
deletion of archived scan images, or Cancel to not clear.

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 Note: The Stratus OCT hard drive can hold several thousand scans before it will
prompt you to clear scan data. Scan data clearance is for long-term database
maintenance.
To preserve it and ensure fast access to it, the Stratus OCT tries to retain exam data, and
clears only enough exams to forestall the reappearance of the yellow or red indicator for
several days or weeks, depending on the acquisition rate of new exams. Exams are cleared
by last modification date, oldest first. For detailed information, see Clear Archived
Exams on page 8-14.

Archive Registration and Management


Archive registration is the process used to create and manage archive volumes. Each
archive volume on a network file server must have a unique name. When an archive is
registered, its name is added to a list of archives your Stratus OCT can access.

Access Archive Registration


You can access the Archive Registration dialog in two ways:
1. From the MAIN WINDOW, select Register > Archive from the Options menu (click
Options > Register > Archive).
2. On startup, the Stratus OCT checks the remaining disk space of the current archive
volume. When an archive volume nears capacity, the Stratus OCT prompts you to
create a new one. If you click Yes to proceed, the Archive Registration dialog appears.

Figure 8-2 The Archive Registration Dialog


It shows all registered archives, both network and DVD archives. (DVD archives have a local
path, not a network path.) The current archive is indicated on the left with an arrow.

Register Existing Network Archive(s)


If archive volumes created on different Stratus OCT instruments exist on the same network
file server, any Stratus OCT can access the scans of any other Stratus OCT instrument. This

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is a process called synchronization. (See Access Archived Scans on page 8-5 for
instructions to do this.) First you must register the network archive(s) of the other
instruments. To do so follow these steps:
1. From the MAIN WINDOW, select Options > Register > Archive. The Archive Registration
dialog appears.
2. In the Archive Registration dialog, click Add Existing. The Select an Archive Database
dialog appears. Only folders and archive volumes (always named ZDBArchive.GDB)
will appear in the dialog. Find and select the desired archive volume. Click OK.
3. Back in the Archive Registration dialog, the newly selected network archive will
appear in the list of registered archives.
4. Click Save to save the change and close the dialog. You can now access scan data
from the network archive folder you registered, when you synchronize as described
below.

Access Archived Scans


If a scan is archived, when you select the scan in the patient list of the MAIN WINDOW, the
Scan Group Images Tab shows you on which archive volume (by label) the scan can be
found. If you attempt to view or analyze a scan that is archived, a dialog box prompts you
to insert the archive disk where the scan is, as in the example below.

Figure 8-3 Sample Insert Archive Disk Dialog


To access those scans for review or analysis, install the indicated archive disk in the DVD
drive, and then click OK.

Care of DVD Archives


Remember that DVD archive disks contain valuable patient data. Treat them accordingly.
Unlike CDs, a sturdy plastic case encloses DVD-RAM disks, because they are more sensitive
to damage than CDs. They must be treated with greater care, if you are to preserve your
patient data from loss.

Recommendations To Preserve DVD Archives


Observe the following recommendations to maintain long-term access to your DVD archive
data:
• Never open the DVD-RAM case and remove the disk.
• To distinguish each archive, always label the DVD-RAM case with the unique archive
name, using permanent marker. Do not write on the disk itself.

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• We recommend you keep your DVD archives in a cabinet. Do not expose them to
bright light or sunlight for extended periods.
• To protect them from spills and other office accidents, do not leave them out on desks
for extended periods.
• Do not stack DVD-RAM disks on top of each other, nor place anything else on top of
a DVD-RAM, especially cups containing liquids.

Duplicate Full DVD Archives


For added security, duplicate the full DVD archive disk. Keep the original archive disk in a
secure location for use with the instrument as needed. Store the duplicate copy off-site in a
secure location.

Format DVD-RAM Disks


To archive, backup or export requires a DVD-RAM cartridge formatted in the Universal Disk
Format (UDF1.5). Carl Zeiss Meditec provides unformatted DVD-RAM cartridges that must
be formatted correctly to work in your DVD-RAM drive.
Brand: Carl Zeiss Meditec has qualified the following brands to work with the Stratus OCT:
• Verbatim 4.7 GB DVD-RAM Type 2
• Panasonic 4.7 GB DVD-RAM Type 2
• OptoDisk 4.7 GB DVD-RAM Type 2
• Imation 9.4 GB double-sided DVD-RAM
We recommend that you use one of these brands.

WARNING: Formatting erases any data currently on the disk. Be sure that the
disk is empty before formatting. Formatting a disk that contains archive or
backup data will permanently destroy that data!

Follow these steps to format a DVD-RAM disk:


1. Power up the system. Exit the Stratus OCT program (click File > Exit or click the at
upper right) to enter the Windows desktop. Be sure that the new DVD-RAM disk
cartridge is not write-protected: Check the switch near the lower left of the cartridge.
Install the new disk cartridge into the DVD drive.
2. Double-click the STRATUS DVD Formatter desktop icon, or click Windows Start >
Programs > Stratus OCT > STRATUS DVD Formatter. The Stratus OCT DVD Ram
Format Utility appears.

Figure 8-4 The Stratus OCT DVD Ram Format Utility

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3. Click Format DVD Ram Disk.


• The utility first checks the installed DVD for the presence of an OCT archive database.
If one is present, the following dialog appears.

Figure 8-5 Cannot format an archive disk


You cannot format an archive disk. Click OK and formatting will be cancelled.
• Next, the utility checks if the disk is empty. If it is not, the following dialog appears.

Figure 8-6 Formatting erases all files--confirm formatting


• Click No if you do not want to erase all files on the DVD; install another DVD instead.
Click Yes to erase all files and proceed with formatting.
4. When you proceed to formatting, the following dialog appears to remind you to use
the UDF1.5 file system format:

Figure 8-7 Format the DVD using the UDF 1.5 File System
• Click OK to close the dialog and proceed with formatting. The DVDForm dialog
appears.

Figure 8-8 The DVDForm Dialog

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8-8 Archive, Retrieve & Backup

5. Click on the down-arrow next to the Format Type field and select Universal Disk
Format (UDF1.5).

Figure 8-9 Select the UDF1.5 Format Type


6. Click Start. Formatting will begin. The progress bar across the bottom will indicate
formatting progress. A dialog will notify you when formatting is complete.
7. Click OK to dismiss it. The DVDForm dialog reappears.
8. When finished, click Close or on the to exit the program.

DICOM Archive and Retrieve Workflow

Overview
Features include: Archive to DICOM server and Retrieve from DICOM server. DICOM
Archive and Retrieve is only available with the DICOM2 Integration license. Native archive
is not available when DICOM2 is designated for use with Archive and Retrieve.

Archive to DICOM Server


The auto archive feature is not present when the DICOM2 Integration license is activated.
With DICOM2, the user must manually archive each exam individually.
From the MAIN WINDOW, click on Data and find DICOM Archive on the pull down menu,
as shown at left. The DICOM Archive dialog appears:

Figure 8-10 DICOM Archive Dialog


You can define a time range for exam dates to archive by checking the Exam Date
Interval box and filling in the desired date range in the From and Through boxes. In
order to archive the exams taken today, it is recommmended that you check the Exam
Date Interval box and leave the From and Through dates as today. Press Archive to

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begin the process. Confirm archive process by Clicking Yes on the popup dialog, as shown
below.

 Note: If you do not establish an exam date interval to archive, DICOM Archive will
attempt to archive every exam it can find on the instrument which has not been
archived.

Figure 8-11 Popup Dialog


Archive progress is displayed while the archving takes place. You can stop the archive
process at any time by clicking on the Stop button.

Figure 8-12 Archive Progress


When archiving is complete, a summary log is displayed listing successfully archived
patients along with the number of exams that failed archiving and the number of exams
skipped because they were archived to DVD and cleared. Close the Summary Log and
click on the Close button in the archive dialog.

Retrieve from DICOM Server


The auto retrieve feature is not present when the DICOM2 Integration license is activated.
With DICOM2, the user must manually retrieve each patient individually through the
DICOM Retrieve form. To retrieve patients from the DICOM Server:

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1. Click on DICOM Retrieve in the Data pull down menu on the MAIN WINDOW, as
shown at left. The QUERY RETRIEVE FORM dialog is displayed, similar to the one shown
below.

Worklist
query
parameters

Patient list

Figure 8-13 Query Retrieve Form Dialog


2. Set the query parameters, then press the Search button. A list of patient will be
displayed.
You can specify a range of study dates by checking the Study Date box in the DICOM
QUERY AND RETRIEVE FORM dialog. The default setting for the Study Date box is
unchecked. If left unchecked, all studies for the selected patients will be retrieved. If
the box is checked the default date range is today's date, and only studies performed
on today's date are retrieved. If the box is checked and a date range is specified, just
the studies performed during that date range are retrieved.

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3. If you want to view details of a particular patient, click on the desired patient, and
then click on the Details button. The PATIENT DETAILS screen is displayed:

Figure 8-14 Patient Details Screen


4. When finished viewing this information, click on the Close button.
5. If you want to retrieve this patient data, click Retrieve. You will only be able to select
and retrieve one patient at a time. A progress bar is displayed during the retrieval
process.
6. Once the retrieval is complete, click Done to close the QUERY RETRIEVE FORM. The
application returns to the same tab that was previously selected before DICOM
Retrieve.

 Note: Modality for the Stratus OCT instrument is OPT. Other modality options are
provided for searching purposes only. A patient with a modality other than OPT will
not be retrieved on a Status OCT instrument.

 Note: If you encounter connectivity issues, follow the instructions on the dialog
message and/or ensure that your DICOM Gateway is currently running and is
properly configured. See the DICOM Gateway 2 User Manual for further information.

Retrieve Scan Data


To retrieve scan data is to copy all scan data from an archive volume—on DVD or the
network file server—to the Stratus OCT hard drive, thereby making it available for viewing
and analysis without connection to the archive volume. You can retrieve archived scan data
made on any Stratus OCT instrument with any OCT software down to version A1.1.

 Note: The Stratus OCT instrument and review software require the DVD drive be set
to drive letter D: in order to retrieve data from version 2.0 and 3.0 archives. Ensure
the DVD drive letter is set to D: before retrieving data from version 2.0 and 3.0
archives. (This is the instrument default when shipped from the factory.)

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8-12 Archive, Retrieve & Backup

Registration and Retrieval


When you retrieve from a DVD archive volume, it is registered automatically on the Stratus
OCT. In contrast, to retrieve from a network archive volume, it must first be registered. If it
is not yet registered, see the instructions to Register Existing Network Archive(s) on
page 8-4.

How To Retrieve
To retrieve scan data, follow these steps.
1. Make sure that the archive volume is accessible. If it is a DVD archive, insert the DVD
into its drive on the Stratus OCT. If it is a network archive, it must be registered, and
the Stratus OCT must have access to the network file server.
2. From the MAIN WINDOW, select Retrieve from the Data menu (click Data > Retrieve).
The RETRIEVE WINDOW opens, showing the archive contents in the path from which you
last retrieved. (The first time you retrieve, it shows the archive contents of any inserted
DVD, by default). If the window is accessing the desired source archive, skip to step
5.

Figure 8-15 The Retrieve Window


• If no archive volume is accessible on the path from which you last retrieved, for
example, if you last retrieved from DVD and no DVD is present in the drive, the
Archive Selection dialog will appear automatically, as in Figure 8-16 below.

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3. To select a different source archive, click the Select Source Archive button, or click
File > Select Source Archive. The Archive Selection dialog appears.

Figure 8-16 The Archive Selection Dialog


4. The Archive Selection dialog shows the name, location and description of all
registered network archives. To retrieve from a network archive, select the desired
network archive and click OK.
• To register an existing archive not listed, click Register Archive to open the Archive
Registration dialog.
• To retrieve from the inserted DVD archive, click the Select DVD button.
5. When the RETRIEVE WINDOW opens, the Patients list shows the names of all patients
with exams in the archive. Click the checkboxes to select the patients whose exams
you wish to retrieve. To select specific exams to retrieve, click on the selected patient’s
visit date(s), then select the exams.
• To select all exams at any time, click the Select All/Deselect All button, or click
File > Select All. To start over making selections after you have begun, click the Select
All/Deselect All button, or click File > Deselect All.
6. When you have made your selections, click the Retrieve button, or click
File > Retrieve. The Retrieve Options dialog appears.

Figure 8-17 The Retrieve Options Dialog

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7. The Retrieve Options dialog gives you the option to remove references to the source
archive media, which will enable you to re-archive the exams to a new or different
archive volume. To enable re-archiving, select the Remove reference to the archive
media checkbox. When you retrieve with this option selected, the Stratus OCT will no
longer recognize that the exam data is on the source archive, although a copy of the
data remains. Instead, the Stratus OCT will treat the retrieved exams as un-archived.
Click OK to begin retrieval, or click Cancel to cancel retrieval.
8. When you click OK, retrieval begins and a Progress dialog appears.

Figure 8-18 Retrieval Progress Dialog


• When retrieval is complete, the Stratus OCT notifies you.

Figure 8-19 Retrieval finished

Clear Archived Exams


Manual clearance of hard disk space is not required if you follow the
Recommendations For Automated Data Maintenance. If you have opted not to
use the automated clearance feature, follow the instructions below to clear hard disk space
manually.
Scan data remains on the instrument hard drive as long as possible, or until you choose to
remove it. With a new instrument, it takes many months up to a few years before the
Stratus OCT prompts you to clear scan data. If you do not clear (delete) scan data when
prompted, eventually the hard disk will reach capacity and prevent you from saving new
scans. At that point, you must clear scan data to save new scans.

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WARNING: We recommend that you do not clear scan data unless it has been
archived. If you attempt to clear un-archived scan data, the Stratus OCT will
prompt you twice to confirm your choice before permanently deleting the
scan data.

The Stratus OCT retains patient records on the hard drive to preserve exam data and ensure
fast access to it. Therefore, you can clear hard disk space only when the database indicator
is yellow or red. If you attempt to clear disk space when the database indicator is green,
you will receive the following message:

Figure 8-20 Enough disk space--cannot clear exams

 Note: The exam clearance function, whether automatic or manual, has the same
characteristics:
• The Stratus OCT clears only enough exams to forestall the reappearance of the yellow
or red indicator for several weeks or months, depending on the acquisition rate of
new exams.
• It does not clear exams that have not been archived, nor does it clear exams of
patients for whom you have not allowed clearance of their exams. (For more
information, see Allow Clear Exams on page 7-3.)
• Among those allowed to be cleared, archived exams are cleared oldest first, based on
the last modification date. The modification date for an exam is changed when you
change which scans are selected for inclusion in an analysis and run the analysis.
When the database indicator is yellow or red, perform the following steps to clear disk
space.
1. From the MAIN WINDOW, select Clear Archived Exams from the Options menu (click
Options > Clear Archived Exams). A dialog informs you of the details and asks you to
confirm that you wish to clear archived exams.

Figure 8-21 Clear Archived Exams Confirm Dialog


2. Click Yes to clear archived exams now, or click No to cancel exam clearance.

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Export and Import Scan Data 9-1

(9) Export and Import Scan Data

Chapter Overview
The Stratus OCT offers the capability of exporting data for viewing and analysis on another
Stratus OCT instrument. This chapter explains how to export and import Stratus OCT data,
but first it details the technical measures employed to ensure patient privacy and data
integrity. These are the topics covered:
• Privacy and Data Integrity Features, page 9-1
• OCT Image Export, page 9-2
• Database Export, page 9-6
• Import Data, page 9-10

Privacy and Data Integrity Features


It is the user’s responsibility to observe applicable privacy restrictions and to maintain data
integrity. The Stratus OCT incorporates options in its data transfer functions that enable the
user to do this.

Patient Privacy
The Stratus OCT gives you the choice to export exam data without information that could
identify the patient. When you choose to export data in this way, the Stratus OCT does
export the following clinically relevant patient data: gender, ethnic group, axial length,
assigned patient categories and diagnoses and physician comments. You have the further
option to export a complete date of birth, the month and year of birth only, or no date of
birth. The patient name is not exported and neither is the following potentially identifying
information: patient ID, insurance company name, telephone numbers and attending and
referring physician. Instead, anonymous patient records include a unique Patient Export
ID and the originating clinic’s Site ID.

 Note: When you import patient records that were exported without identifying
information, the Stratus OCT displays those patients with the originating clinic Site
ID as the last name and the Patient Export ID as the first name. Users who wish to
obtain additional medical information about an anonymous patient must contact
the originating clinic to request information using the Patient Export ID. The
originating clinic can then search for the patient with the Patient Export ID
provided (see Find and Select Records on page 7-1).

Data Integrity
Stratus OCT guards data integrity through the following features.

Cannot Edit Identifying Information


The Stratus OCT applies a permanent electronic tag to patient records that are imported
without patient identifying information and treats them as a protected category of data.

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For these records, you cannot edit the following fields: Last Name, First Name, Middle
Names, Gender, Date of Birth, and Patient ID. You can edit other fields of the
anonymous patient record, as well as analyze, archive and re-export the data. Data that is
imported with identifying patient information can be edited without restriction.

Updating Imported Records


For all imported patient records, it is possible to import new scan data and update patient
data. In the case of records imported without patient identifying information, the Patient
Export ID enables updating of the patient record. Once created, the Patient Export ID
is fixed. It is also unique among those created on all Stratus OCT instruments because part
of it is derived from the unique serial number of the Stratus OCT instrument on which it
was created. If during import the Stratus OCT encounters information associated with a
Patient Export ID already imported, the Stratus OCT does the following:
• imports all scan data (exams) not previously imported, but never deletes nor
overwrites any scan data already imported;
• updates patient data (e.g., axial length, patient categories, etc.) only if it was created
on a later date than the data already imported. This prevents overwriting of newer
patient data with older.

Removable Export Media Use Restrictions


The Stratus OCT prevents you from mingling export data with archive or backup data on
the same removable media. The Stratus OCT will not write export data to media that
already contains archive or backup data. Only one export database can be present on a
given media. If you attempt to export to media that already has an export database, you
will be asked if you wish to overwrite the previous database before export can continue.
Similarly, the Stratus OCT will not write archive or backup data to media that already
contains export data.

WARNING: It is possible to reuse removable media for export, but you must
overwrite—and in the process delete—the current export database. You can
also repurpose any dedicated removable media, but only if you first delete all
files on the media or reformat it—and thereby permanently erase all data on
it.

OCT Image Export

 Note: OCT Image Export is an optional feature that may not be activated on all
instruments. If you do not have this feature and want to purchase it, contact Carl
Zeiss Meditec. In the U.S., call 1-877-486-7473; outside the U.S., contact your local
Carl Zeiss affiliate or distributor.
To facilitate the transfer of Stratus OCT image data for viewing on electronic medical record
systems or on a standard computer, Stratus offers the ability to export OCT scan images in
standard image formats (JPEG or BMP) to any accessible location. This feature is called OCT

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Image Export, and it is available both in the MAIN WINDOW and through the EXPORT
WINDOW.

 Note: When you start OCT Image Export through the EXPORT WINDOW, you have the
flexibility to select specific exams for image export. You must export all scan images
for the selected patient when you start OCT Image Export from the MAIN WINDOW.

 Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic. See Site ID and
Logo on page 7-19.

WARNING: Do not export or save data to the C: drive of a Stratus instrument.


The C: drive is relatively small and can be filled up quickly, which renders the
system unusable. The F: drive is reserved for data and therefore is relatively
large. If you want to export or save data to the Stratus hard drive, either
locally or to a connected Stratus system on the network, select (a location in)
the F: drive as the target.

From the Export Window


Follow these steps to use OCT Image Export from the EXPORT WINDOW:
1. In the MAIN WINDOW, select Export from the Data menu (click Data > Export). The
EXPORT WINDOW opens.

Figure 9-1 Export Window

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9-4 Export and Import Scan Data

2. Select the patients and exams whose scan images you wish to export. When you
select a patient, all their visits and exams appear and are selected by default. Deselect
those you do not wish to export. You can select exams from multiple patients.
• Click the Select All button to select the scan images of all patients for export. The
button toggles to Deselect All. Click Deselect All to clear all your selections and
start over. Be aware that exporting a large number of scans can take considerable
time to complete.
• If the Show Thumbnails button is selected, you can view thumbnails for the scan
group you click on the right, the row for which will be highlighted in blue. See the
example below. Note that a scan group can be highlighted in blue, meaning its
thumbnails will be shown, while its selection checkbox is clear. In this case, its
scans will not be exported.

Figure 9-2 Export Window Showing Thumbnails

 Note: A gray patient or visit checkbox with a gray checkmark means that some of
the items it contains are selected and some are not selected.

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Export and Import Scan Data 9-5

3. Click the OCT Image Export button on the toolbar, or select OCT Image Export from
the File menu. The OCT Image Export Options dialog appears.

Figure 9-3 OCT Image Export Options Dialog


4. Select the desired options:
• Select either JPEG or BMP in the Export File Type field.
• Click Browse to find and select the desired export path.

 Note: Each scan image will be exported in a separate file, which is named by
combining the following, in order: last name, first name, date of birth, date and
time of scan, scan type. This is how Stratus provides the patient and scan data with
the image. Note that the patient name and date of birth can be obscured, as
explained next.
• To obscure patient data upon export, select the Obscure Patient checkbox. You
then will have further options to obscure the patient date of birth: fully, partially,
or not at all. Identifying data is never included on the image itself. It is included,
when not obscured, in the name of the exported image file. If obscured, the site
name is substituted for the patient name in the image file name.

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9-6 Export and Import Scan Data

5. When finished making your selections, click OK to start export. A Progress dialog
appears and shows export progress. A Notice dialog tells you when export is finished.

Figure 9-4 Export Progress and Completion Notice

From the Main Window


Follow these steps to use OCT Image Export from the MAIN WINDOW:
1. In the MAIN WINDOW, select one patient, all of whose scan images you will export.
2. Click the OCT Image Export button on the toolbar, or select OCT Image Export from
the Data menu. The OCT Image Export Options dialog appears. (See Figure 9-3
above.)
3. From this point, follow steps 4. and 5. starting on page 9-5. The options are
identical.

Database Export
The Stratus OCT offers the ability to export data to another Stratus OCT instrument. Unlike
OCT image export, this method exports all available Stratus OCT data for the patients and
exams you select. You have the option to obscure patient data.

 Note: You must create a Clinical Site ID to successfully export images and data,
because exported data must be associated with the source clinic. See Site ID and
Logo on page 7-19.

Export Media & Methods


It is possible to export data:
1. To removable media. Compatible removable media can include optical media
(DVD-RAMs, CDs and DVDs) as well as USB devices, depending on your equipment.

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Export and Import Scan Data 9-7

2. To a network destination. The export options dialog enables you to select a network
destination. Users are responsible for setting up and maintaining their own networks,
and for selecting the desired network destination when exporting.
3. Directly to a Stratus OCT instrument. To do this, the sending and receiving platforms
must be connected by an RJ-45 crossover cable between their respective ethernet
ports. It is the user’s responsibility to acquire and install the necessary crossover
cable, to configure both instruments to communicate (see Networking
Guidelines) and to select the correct export path when exporting.

 Note: If there is a Stratus export database on the intended export media, the Stratus
OCT warns you first that it will overwrite it. 

Click Cancel if you do not wish to overwrite the previously exported data. To
successfully export multiple patient records to a single export media, you must
select them during a single export operation.

Export Steps
To export a Stratus database to another Stratus OCT instrument, follow these steps:
1. If you are exporting to removable media, insert the media into its drive. If not, skip to
the next step.

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9-8 Export and Import Scan Data

2. From the MAIN WINDOW, select Export from the Data menu (click Data > Export) to
reach the EXPORT WINDOW. The Patients list displays every name in the patient
database. Each name has an empty checkbox by it.

Figure 9-5 The Export Window


3. Select the checkboxes next to the patients whose exams (scan groups) you wish to
export. If necessary, use the Search button and fields to find and select the patients
whose data you wish to export. To search using additional criteria, click the Records
Search button or select Advanced Search in the Record menu (click Record >
Advanced Search). For additional information, see Advanced Search on page 7-2.
For each selected patient, all his exams are selected by default. If you do not wish to
export all the exams of the selected patients, use the list on the right to deselect visits
and/or exams.

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Export and Import Scan Data 9-9

4. When you have finished making your selections, select Database Export from the File
menu (click File > Database Export). The Export Options dialog box appears:

Figure 9-6 The Export Options Dialog


5. The dialog prompts you to Enter Media Label Name. The left field, which is grayed out
and unalterable, contains the instrument serial number followed by a dash and an
archive number generated automatically, starting with “0001” and increasing by one
each time you export. In the right field, you can type up to 11 more characters,
including spaces.
6. The Export Path field initially shows the last export path used. You can export data
to removable media, to any location in a network path or to hard disk. To change the
export path, click Browse to find and select the desired export path.

WARNING: This warning applies to Stratus OCT systems that shipped with software
version 5.0 and later; these systems have the hard drive partitioned into C: and F: drives.
Do not export or save data to the C: drive of a Stratus instrument. The C: drive
is relatively small and can be filled up quickly, which renders the system
unusable. The F: drive is reserved for data and therefore is relatively large. If
you want to export or save data to the Stratus hard drive, either locally or to a
connected Stratus system on the network, select (a location in) the F: drive as
the target.

 Note: For all Stratus OCT systems, if you export to the instrument’s hard disk, please
be aware that it is possible to completely fill the hard disk, at which point you will
be unable to save new exams. The Windows operating system will warn you as you
approach hard disk capacity.
7. To export data anonymously, select the Obscure Patient checkbox. The patient name
is not exported and neither is the following potentially identifying information: patient
ID, insurance company name, telephone numbers and attending and referring

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9-10 Export and Import Scan Data

physician. Instead, anonymous patient records include a unique Patient Export ID


and the originating clinic’s Site ID. You will then have the further option of obscuring
the date of birth: either fully, partially or not at all.
8. When finished making your selections, click OK to begin exporting data. To abort
export, click Cancel. Note that if you are exporting a large set of data, it can take
minutes to stop the export process after clicking Cancel.

 Note: Stratus OCT enables you to export cleared archive data. If the cleared data is
on a network archive, the data will be exported from the archive automatically. If
the file server is not connected, you will be prompted to connect with it. If the
cleared data is on a DVD archive, you will be prompted to insert the archive disk by
its label. If more than one archive DVD is required, you must attend the instrument
during export and insert the indicated archive disk(s) when prompted.
9. When you click OK in the Export Options dialog box, export begins. The Progress
dialog box shows export progress. It can take several seconds to several minutes for
the Stratus OCT to finish writing to the disk, depending on the number of exams you
selected for export.
• At any time, you can click the Cancel button to abort export and no data will be
exported.
10.When the export process is complete, a Notice dialog will prompt you to write the
label on the export DVD disk. Label the disk as instructed and click OK.

Import Data
To import data, follow these steps:
1. If you are importing data from removable media, insert the media containing export
data created with Stratus OCT software version 2.0 or later, or with Stratus Review
Software, into its drive. If you are importing from any other path on the network or
hard drive, skip to step 2.
2. From the MAIN WINDOW, select Import from the Data menu (click Data > Import). The
IMPORT WINDOW opens. Proceed to step 3. below unless the Import Options dialog
appears automatically.

Specify the Import Path


The first time you initiate import, an Import Options dialog box appears as below.

Figure 9-7 The Import Options Dialog


• In the Import Path field, the last selected import source path appears. You can
import data from removable media, from the local hard drive (if an export

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Export and Import Scan Data 9-11

database has been copied there) or from any location in a network path through a
mapped drive. Click Browse to find and select the desired import path, or type in
the desired import path. When finished, click OK.
• If you are importing from a network location, the instrument must be connected
to the source system.

Figure 9-8 The Import Window


• To view the source path or to select a different import source path, click the Select
Source Path button or click File > Select Source Path and the Import Options dialog
appears. It displays the current import source path. See Figure 9-7 above.
3. The IMPORT WINDOW displays the list of all patients found in the export database. Click
the checkboxes to select the patients whose exams you wish to import. Click File >
Select All or the Select All button to select all exams at any time.
• To select specific exams to archive, click on the selected patient’s visit date(s),
then select the exams.
• To start over making selections after you have begun, click File > Deselect All.
4. When you have made your selections, click the Import button or click File > Import.
Import begins and a Progress dialog appears.
The Progress dialog box shows import progress. It can take several seconds to several
minutes for the Stratus OCT to finish importing to the hard drive, depending on the

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9-12 Export and Import Scan Data

number of exams in the export database. A message notifies you when the operation
is complete.

Figure 9-9 Window Showing Import Progress and Finished Notice


• At any time, you can click the Cancel button to abort import. The import process
will stop after the next whole patient record has been imported. Already imported
patient records will not be removed.
• If a record is not transferred due to error or another reason, a message reports it
in the text field of the Progress dialog, and the dialog remains open after the
operation completes, until you click Close. If all data is transferred successfully,
the Progress dialog closes automatically when the operation completes.
• Click Data > Refresh Patient List in the MAIN WINDOW to check for imported
patient data. Stratus OCT displays anonymous imported records in the patient list
with the originating Site ID as the first name and the encoded Patient Export
ID as the last name.

 Note: For patients imported with the date of birth obscured, normative data will not
be presented in the analysis.

WARNING: Imported diagnosis codes do not retain the descriptions created


for them on the exporting instrument. For example, exporting instrument A
has the description “Retina” for diagnosis code 001, but importing instrument
B has the description “Glaucoma” for diagnosis code 001. When you view on
instrument B a patient record imported from instrument A with diagnosis
code 001 assigned, the description will read “Glaucoma,” as if the record
were created on importing instrument B.

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Routine Maintenance 10-1

(10) Routine Maintenance

Chapter Overview
Carl Zeiss Meditec designed the Stratus OCT instrument to require very little user
maintenance besides cleaning. This chapter covers the handling of error messages,
defragmentation of the hard drive, routine cleaning and reporting signs of wear.

Note Regarding Warranty

 Note: The Stratus OCT instrument 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, we may provide user-installed software updates
to fix software deficits.

Handling Error Messages


In normal instrument start-up, the Stratus OCT START WINDOW appears. If an error message
appears during start-up, or at any time, document the error number and report it to Carl
Zeiss Meditec Customer Support at 1-800-341-6968 (in the U.S.), or your local distributor.
Often error messages can be resolved with solutions provided over the telephone.
Please be prepared to provide Customer Support with the serial number of your instrument.
The serial number is on a label attached to the left side of the Patient Module where the
cables connect to the Patient Module.

Hard Disk Defragmentation


Defragmentation of the Stratus OCT computer hard disk becomes necessary when you
begin to clear archived scans regularly. The process of deleting data and then writing again
to the hard disk fragments the hard drive, which degrades database and system
performance over time. To maintain peak performance, we recommend that you
defragment the hard disk with the same frequency you clear archived scans.

 Note: Since hard disk defragmentation usually requires several hours to complete,
we recommend that you start defragmentation at the end of the day and let the
process run overnight. If defragmentation is not complete in the morning, it does no
harm to stop defragmentation and continue using the instrument.
To defragment the hard drive, follow these steps:
1. Exit the Stratus OCT software (click File > Exit or click the at upper right) to enter
the Windows environment.
2. Click Windows Start > Programs > Accessories > System Tools > Disk Defragmenter.
The Select Drive dialog appears.
3. Select the C: drive and click OK to begin defragmentation.

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10-2 Routine Maintenance

• For the defragmenter to complete in a reasonable amount of time (overnight),


processes that write to the hard drive should not be running. Otherwise, the
defragmenter will restart repeatedly because the hard drive contents have changed.
Such processes include many screensavers. We suggest you disable screensavers
temporarily and turn off your monitor while the defragmenter is running.

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.

 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.

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
Stratus OCT 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 Carl Zeiss Meditec
customer service when there is a problem with the instrument, even if you suspect that only
these parts need replacement. In the U.S., call 1-800-341-6968. Outside the U.S., contact
your local Carl Zeiss affiliate or distributor. Only Carl Zeiss service engineers are authorized
to disassemble the instrument and replace any parts.

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.

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Routine Maintenance 10-3

Power Fuses
The Stratus OCT 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 Stratus OCT voids all warranties and liabilities.

List of User Replacement Accessories


Part Number Description
2660100022511 Power Cord, North America, Hospital Grade, 18 Gauge, Gray
2660100022581 Power Cord, Europe, CEE 7/7 10 Amp
2660021121801 Power Cord, China
2660021132846 Keyboard, Mini Black PS/2
2660021125244 Mouse, USB/PS2 Black
0000001245896 Dust Cover, Instrument
2660021110076 Paper, Ink Jet, 24 lb. 8 ½ x 11
3197519003000 Fixation Device (Jointed)
0000001053040 Fixation Device (Flexible)
3197519005000 Occluding Sleeve for Fixation Device
3013509052000 Red Fixation Lamp
2660100006566 Alcohol Wipes
2660100007672 Camera Lens Cleaner
2660100007673 Camera Lens Wipes
2660021120114 Quick Guide
2660100008025 Eye Patch with Elastic Strap
0000001243954 Cover OCT3 Connector Panel
2660021122883 Cable BNC to RT-ANGL-BNC 3 Ft. (for OCT3 P5 PC)
2660021123281 Printer, HP 6940
2660021125246 Monitor 20” Black

To order: In the U.S., call 1-800-341-6968. Outside the U.S., contact your local Carl Zeiss
affiliate or distributor.

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10-4 Routine Maintenance

Stratus OCT User Manual PN 2660021134133 A


Specifications 11-1

(11) 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, Optic Disc, Proportional Circle, Concentric 3 Rings, RNFL Thickness
(3.4), Nerve Head Circle, RNFL Thickness (2.27xdisc), X-Line, RNFL Map, Fast Macular
Thickness Map, Fast Optic Disc, Fast RNFL Thickness (3.4), 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: 26° (horizontal) x 21° (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:
100/120V~ systems:(± 10%), 50/60Hz, 6A

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11-2 Specifications

220/240V~ systems:(± 10%), 50/60Hz, 3A


• Power consumption: 700VA

Fuse Ratings
• Main fuses: (under power input of table and back of computer):
Fuse ratings Table Computer Quantity
100/120V~ systems 6.3A 6.3A 2 each
220/240V~ systems 3.15A 6.3A 2 each

Start-up
No special operator precautions needed for initial start-up.

Measurement Units
All units on the Stratus OCT are measured in the SI format. Unless otherwise noted,
measurements are made in micrometers.

System Input Devices


Keyboard, mouse, Patient Module function buttons

Computer
• Internal storage
• Color flat panel display

Environmental Conditions
Transport and Storage
Temperature:-40 to +70 deg. C
Relative Humidity:10% to 100%, including condensation
Atmospheric Pressure:500 hPa to 1060 hPa

Operation
Temperature:+10 to +40 deg. C
Relative Humidity:30% to 75%, excluding condensation
Atmospheric 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).

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Specifications 11-3

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 Stratus OCT
system components installed in their original configuration. In this original configuration,
the table loading capacity is 63.3 kg (139.5 lbs.) ± 5%.

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.

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11-4 Specifications

Stratus OCT User Manual PN 2660021134133 A


Legal Notices 12-1

(12) Legal Notices

Stratus OCT Instrument 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 Stratus OCT Model 3000, excluding components and
software as stated below (the “Stratus OCT”) 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 Stratus OCT is
defective, promptly report the defect to ZEISS. Whenever possible, We will provide “in the
customer's office” service to repair Your Stratus OCT. However, at Our discretion, repairs
may be made in Our repair department. In this case, We will pay all shipping costs unless
Your Stratus OCT 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 Stratus OCT 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 Stratus OCT, 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 Stratus OCT and
programs.

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12-2 Legal Notices

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 claim, loss, liability, or damage
caused or alleged to be caused directly or indirectly by any software supplied with the
Stratus OCT or by ZEISS.
Every reasonable effort has been made to ensure that the product manuals and
promotional materials accurately describe the Stratus OCT 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 ZEISS, 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 STRATUS OCT 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 Stratus OCT warranty expires. For information, call the Customer Service
Department at 1-800-341-6968.

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Legal Notices 12-3

Software Copyright
The software program (“Software”) included with your Stratus OCT is a proprietary product
of 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 © 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 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 1-800-341-6968.

License Terms and Conditions


1. In consideration of payment of the License fee which is part of the price You paid for
Your Stratus OCT, and Your agreement to abide by the terms and conditions of this
License and the Limited Warranty, ZEISS grants to You a non-exclusive,
non-transferable and non-assignable license to use and display this Software on a
single Stratus OCT, under the terms of this License. If the Stratus OCT on which You
use the Software is a multi-user system, this License covers all users on that single
system.
2. The license is granted solely for the use of Your own internal computing requirements
and does not grant You any right, title or ownership in the licensed software or its
documentation. You own the physical media, Stratus OCT, 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. This license does not include the right to make copies of software, nor to transfer the
software or copies from the Product(s) to third parties, nor to extract, modify or
incorporate any part of the software or source code, without prior written consent

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12-4 Legal Notices

from ZEISS and payment of licensing fees. Further, sales of Stratus OCT instruments
may not include any software or software licensee transfers. You may not sublicense,
rent or lease 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. ZEISS does not claim that the
software provided is free from defects and shall have no obligation to supply software
upgrades (i.e., new versions, or new, or in-line releases).

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.

Stratus Review Software Legal Notices


IMPORTANT PLEASE READ CAREFULLY BEFORE ACCEPTANCE

Carl Zeiss Meditec, Inc. Electronic End User License Agreement

Notification of Copyright
NOTICE TO USER: THIS IS A CONTRACT BETWEEN YOU AND CARL ZEISS MEDITEC, INC.
("ZEISS") BY INSTALLING ANY OR ALL OF THIS APPLICATION COMPONENTS, YOU ARE
ACCEPTING ALL THE TERMS AND CONDITIONS OF THIS AGREEMENT. This ZEISS End User
License Agreement accompanies a STRATUS(r) software product ("Software") and related
explanatory materials ("Documentation"). The term "Software" shall also include any
upgrades, modified versions, updates, additions and copies of the Software licensed to you
by ZEISS. You must read this Agreement carefully before indicating your acceptance at the
end of the text of this Agreement. If you do not agree with the terms and conditions of this
Agreement, decline where instructed, and you will not be able to use the Software. You
should then return this Software, together with all the packaging, to ZEISS or the location
where you obtained it.
This software program is a proprietary product of ZEISS and in certain instances contains
material proprietary to other companies. These proprietary products are protected by
copyright laws, international treaty, and under your purchase agreement with ZEISS
governing your use of the software. Installation of this software indicates your acceptance
of this agreement. If you have any questions concerning this agreement, contact Carl Zeiss
Meditec, Inc., Attention Customer Service, 5160 Hacienda Drive, Dublin, CA 94568.

License Agreement
This is a license agreement and not an agreement for sale. ZEISS continues to own the copy
of the Software and the physical media contained in this package and any other copy that
you are authorized to make pursuant to this Agreement. ZEISS hereby grants to You a

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Legal Notices 12-5

nonexclusive license to use the Software and Documentation, provided that You agree to
the following:
1. Use of the Software.
1.1. You may install the Software in a single location on a hard disk or other storage device
of up to the number of computer licenses that have been purchased from ZEISS.
1.2. You may make one backup copy of the Software, provided your backup copy is not
installed or used on any computer.
2. Copyright. The Software is owned by ZEISS and its suppliers, and its structure,
organization and code are the valuable trade secrets of ZEISS and/or its suppliers. The
Software is also protected by United States Copyright Law and International Treaty
provisions. You must treat the Software just as You would any other copyrighted material,
such as a book. You may not copy the Software or the Documentation, except as set forth
in the "Use of the Software" section. Any copies that You are permitted to make pursuant
to this Agreement must contain the same copyright and other proprietary notices that
appear on or in the Software. Trademarks shall be used in accordance with accepted
trademark practice, including identification of trademark owner's name. Trademarks can
only be used to identify printed output produced by the Software. Such use of any
trademark does not give You any rights of ownership in that trademark. Except as stated
above, this Agreement does not grant You any intellectual property rights or trademark in
the Software.
3. Transfer. You may not rent, lease, sublicense or lend the Software or Documentation.
You may, however, transfer all Your rights to use the Software and Documentation to
another person or legal entity provided that (i) You transfer this Agreement, the Software,
including all copies, updates and prior versions and all copies of font software converted
into other formats, and the Documentation to such person or entity, (ii) You retain no
copies, including copies stored on a computer, and (iii) that the receiving party agrees to
be bound by the terms and conditions of this Agreement.
4. Limited Warranty. Neither ZEISS nor anyone else who has been involved in the creation,
production or delivery of this Software shall be liable for any direct, indirect, consequential
or incidental damages (including damages for loss of business profits, business
interruption, loss of business information, and the like) arising out of the use or inability to
use such Software even if ZEISS has been advised of the possibility of such damages. For
further warranty information, please contact the Carl Zeiss Meditec, Inc., Customer Service
Department.
5. Governing Law and General Provisions. This Agreement will be governed by the laws in
force in the State of California excluding the application of its conflicts of law rules. This
Agreement will not be governed by the United Nations Convention on Contracts for the
International Sale of Goods, the application of which is expressly excluded. If any part of
this Agreement or its application becomes illegal, unenforceable, or void, such provision
will be changed and interpreted so as to best accomplish the objectives of that provision to
the extent allowed by law, and the remaining provisions of this Agreement will continue in

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12-6 Legal Notices

full force and effect. You agree that the Software will not be shipped, transferred or
exported into any country or used in any manner prohibited by the United States Export
Administration Act or any other export laws, restrictions or regulations. This Agreement
shall automatically terminate upon failure by you to comply with its terms. This Agreement
may only be modified in writing signed by an authorized officer of Carl Zeiss Meditec, Inc.
This is the entire agreement between ZEISS and You relating to the Software and the
Documentation and it supersedes any prior representations, discussions, undertakings, end
user license agreements, communications or advertising relating to the Software and the
Documentation.
6. Notice to United States Government End Users. The Software and Documentation are
"Commercial Items," as that term is defined at 48 C.F.R. §2.101, consisting of "Commercial
Computer Software" and "Commercial Computer Software Documentation," as such terms
are used in 48 C.F.R. §12.212 or 48 C.F.R. §227.7202, as applicable. Consistent with 48
C.F.R. §12.212 or 48 C.F.R. §§227.7202-1 through 227.7202-4, as applicable, the
"Commercial Computer Software" and "Commercial Computer Software Documentation"
are being licensed to U.S. Government end users (i) only as "Commercial Items" and (ii)
with only those rights as are granted to all other end users pursuant to the terms and
conditions herein.
Unpublished-rights reserved under the copyright laws of the United States.
Carl Zeiss Meditec, Inc., 5160 Hacienda Drive; Dublin, CA, USA.
For Your future reference a copy of this End User License Agreement will be accessible after
You install the Software. If You have any questions regarding this Agreement or if you wish
to request any information from ZEISS, please use the address information enclosed in this
product to contact the local Carl Zeiss Meditec office serving your country or write to
Customer Support Department, Carl Zeiss Meditec, Inc., 5160 Hacienda Drive, Dublin, CA
94568.
STRATUS(r) is a registered trademark of Carl Zeiss Meditec, Inc. Windows is a registered
trademark of Microsoft Corporation.
By use of the Software, You acknowledge that You have read this license agreement and
limited warranty, understand them, and agree to be bound by their terms and conditions.

Carl Zeiss Meditec, Inc., Limited Warranty for Software


Defined Terms:
“You”, “Your”, or “Licensee”: Buyer
ZEISS: Carl Zeiss Meditec, Inc., 5160 Hacienda Drive, Dublin, CA 94568 USA
Software: Software made by Carl Zeiss Meditec, Inc.
3rd Party Products: Products, hardware and software supplied by ZEISS but not made by
ZEISS.
Outside Elements: Hardware or software that ZEISS has not supplied, authorized or
confirmed for use in Buyer’s Site Survey.

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Legal Notices 12-7

Site Survey: Document filled out by Buyer detailing the local operating environment for the
Software.
Term of Warranty: This Warranty will be effective for a period of forty-five (45) days from
the date of shipment to You (“Warranty Term”).
Scope of Limited Warranty for Software: ZEISS warrants that (i) it has the right to license or
sublicense the Software to You for the purposes and subject to the terms and conditions
set forth in ZEISS’ standard terms and conditions (ii) the Software will be fit for the
purposes described in ZEISS' user documentation (iii) that the Software will perform in
substantial conformity to published specifications during the Warranty Term. ZEISS DOES
NOT WARRANT THAT THE ZEISS SOFTWARE IS ERROR-FREE OR WILL OPERATE WITHOUT
INTERRUPTION OR WILL MEET YOUR SPECIFIC NEEDS. YOU ARE RESPONSIBLE FOR ALL
DATA BACKUPS, DATA ARCHIVING, AND DATA TRANSFER.
Updates: At no cost to You, ZEISS will provide You with maintenance updates (i.e.: bug
fixes) during the Warranty Term. ZEISS will not be obligated to provide new Software
releases or 3rd Party Product upgrades.
Remedies for Software Failure: During the Warranty Term, ZEISS' obligation under this
Warranty is limited, at ZEISS’ discretion, to repair, adjustment and/or replacement of any
Software which proves to be defective in material or workmanship. You must give ZEISS
notice of any defect within the Warranty Term to make a claim under this Warranty. If the
Software fails to substantially conform to its published specifications, ZEISS shall, at its
own expense, use all commercially reasonable efforts to correct such failure.
Software support to correct failures will be provided as follows:
• For installation issues, up to two (2) hours of free remote technical support.
• For non-installation issues, unlimited telephone support during the warranty period.
Remote Technical Support will be provided from 6:30 AM to 5:00 PM Pacific Time, except
during ZEISS holidays.
Repair or replacement will be ZEISS' sole obligation and exclusive remedy hereunder.
THESE ARE YOUR EXCLUSIVE REMEDIES AND CONSTITUTE ZEISS' SOLE LIABILITY FOR ANY
WARRANTY CLAIMS. YOU AGREE THAT ZEISS, ITS AFFILIATES AND REPRESENTATIVES,
WILL HAVE NO LIABILITY TO YOU FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES SUCH AS EXCESS COSTS INCURRED, LOSS OF DATA, OR FOR LOST PROFITS OR
REVENUE FROM SOFTWARE FAILURE. This provision does not affect third party claims for
personal injury arising in products liability or from ZEISS’ negligence. Some states do not
allow the exclusion or limitation of consequential or incidental damages, so the above
limitation or exclusion may not apply.
To maintain this Warranty, You must use the Software in accordance with ZEISS’
instructions for use, and maintain Your hardware and software in the same configurations
as You have provided in Your Site Survey.
You will void this Warranty if: You install Outside Elements not authorized or confirmed for
use by ZEISS in the Site Survey.

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12-8 Legal Notices

Warranty Exclusions: This Warranty does not apply to Software that has been damaged by
accident, virus or similar program based corruption, negligence, misapplication, alteration
or modification, including a change to the configuration of the system as reported in Your
Site Survey (without submitting a new Site Survey and receiving confirmation from ZEISS).
These warranties are exclusive and in lieu of all other warranties, whether written, oral,
express, implied, or statutory. EXCEPT AS PROVIDED HEREIN, NO EXPRESSED OR IMPLIED
WARRANTIES, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, QUIET ENJOYMENT, SYSTEM
INTEGRATION AND DATA ACCURACY, WILL APPLY. THERE ARE NO WARRANTIES WHICH
EXTEND BEYOND THOSE DESCRIBED IN THIS DOCUMENT AND THE PRIOR STATEMENTS
BY ANY ZEISS REPRESENTATIVE SHALL NOT MODIFY OR EXPAND THESE WARRANTIES.
This Warranty May Be Transferred if: before You make the proposed transfer, You provide
ZEISS with a written request and You receive written confirmation from ZEISS that it will
accept the transfer.

Software Support Agreement


In the U.S., a Software Support Agreement is available after the new Stratus Review
Software warranty expires. For information, call the Customer Service Department at
1-800-341-6968. Outside the U.S., contact your local Carl Zeiss affiliate or distributor.

Stratus OCT User Manual PN 2660021134133 A


Networking Guidelines A-1

(A) Networking Guidelines

Notice

 Users are responsible for network setup and maintenance, including installation and
configuration of all necessary hardware and software. Carl Zeiss Meditec Technical
Support is limited to testing network connectivity of the Stratus OCT. Technical
Support cannot troubleshoot or repair problems with network connectivity. Please
observe the following guidelines regarding networking of the Stratus OCT
instrument.

 Note: These guidelines apply to version 7.0 of Stratus OCT system software.

Note: A network drive can be either a network file server (computer) or a


network attached storage device (NASD); their behavior is the same with
respect to the Stratus OCT. This manual uses the terms “network drive” and
“network file server” interchangeably.

Instrument Network Capabilities


The Stratus OCT is networkable. Version 7.0 software supports the following.
• Windows and Novell networks.
• Creation of user accounts
• Networking via a local area network or intranet.
• Users can archive to and retrieve from a network drive, and synchronize with other
Stratus OCT instrument databases via the network file server.
• Users can backup to and restore from a network drive. Users can configure the
instrument for automatic backup.
• Users can import from and export to a network drive.
• Users can export data from a Stratus OCT instrument to a remote personal computer
either via a local area network or by direct cable connection.

Stratus Review Software Network Capabilities


Stratus Review Software is capable of being used in a network environment for the
following data transfer tasks:
• Import from a network file server or another Stratus review station
• Import from a locally shared folder to which you have previously exported data from a
Stratus OCT instrument
• Export locally to a shared folder, from which you can then import using a Stratus OCT
instrument or another Stratus review station.
• Archive to and retrieve from a network file server

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A-2 Networking Guidelines

• Synchronizing with registered network archives from networked Stratus OCT


instruments and from other instances of Stratus Review Software.

 Note: The simplest way to transfer data from a Stratus instrument to a review
station is to register the network archive to which the Stratus instrument
automatically archives and synchronize on the review station PC.
See Chapter (5), Archive and Retrieve, and Chapter (6), Import and Export Scan
Data, for instructions to archive, retrieve, import, export and synchronize Stratus OCT
data.

WARNING: Risks of Internet Connectivity


Networking is to be limited to a local area network, intranet or a direct cable
connection. We strongly recommend that you do not access the Internet with
the Stratus OCT, nor expose the Stratus OCT to the Internet through its
connection to the local area network. Accessing the Internet with the Stratus
OCT can disable or degrade system performance. When exposed to the
Internet, the Stratus OCT is vulnerable to serious security risks, including
viruses and worms that could disable your system or adversely affect its
performance. Internet connectivity enables third party software, software
drivers and operating system updates to be downloaded to your system,
either automatically or intentionally. Installation of any unapproved software,
including drivers and operating system updates, could degrade the
performance of the instrument and/or lead to corrupted diagnostic or
therapeutic information and may void the instrument warranty.

 Note: Stratus OCT Software Version 7.0 is compatible with Windows 2000 Service
Pack 4, which is primarily a security update to the Windows operating system.
Therefore, if you connect the Stratus OCT to an office network, we encourage you to
install Service Pack 4.
• It may be possible to install printer drivers for network printing, but this is not
supported by Carl Zeiss Meditec. See the section: Network Activities Not
Supported below.

Stratus Review Software: Third Party Software


WARNING: It is possible that Stratus Review Software functionality may be
adversely affected by the presence, installation, or use of third party software
on the same computer. The user, and not Carl Zeiss Meditec, assumes all risks
associated with third party software.

Approved Third Party Software

 Note: Carl Zeiss Meditec does not provide technical support for the use of approved
third party software.

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Networking Guidelines A-3

Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved software, including
approved updates and patches to the Windows operating system and security software.

Prohibited Activities
The following activities are prohibited using the Stratus OCT instrument.

WARNING: Attempting to perform these prohibited activities may void your


Stratus OCT warranty and may result in damage to your Stratus OCT system
software. Carl Zeiss Meditec is not responsible for software upgrades or
repairs necessitated by the attempted performance of the following
prohibited activities.

• Do not relocate the Stratus OCT database to a network drive.


• Do not share Stratus OCT folders with other computer systems via the network.
• Do not share the Stratus OCT system printer on the network.

Network Activities Not Supported


Carl Zeiss Meditec does not support the following network activities, although they may be
possible.

 Note: The user bears responsibility for any system performance degradation or any
other change or defect resulting from the attempt to perform the following
activities. Carl Zeiss Meditec is not responsible for software repairs or
upgrades necessitated by the attempted performance of the following
network activities.
• Network printing, i.e., printing with a printer other than the Stratus OCT system
printer. If you wish to use a third party printer, seek technical support from your
printer manufacturer. Repairs necessitated by the attempt to print using a non-system
printer are not covered under warranty.

Not Recommended
It is not recommended to print to any black and white printer because the printouts
depend on color codes to convey information.

Network File Server Minimum Requirements


The network file server must meet the following minimum requirements:
• Server class 800 MHz processor with 128 KB cache
• 256 MB RAM
• Windows, Unix or Linux server operating system

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A-4 Networking Guidelines

• NTFS drive partition(s) for Stratus OCT data. Stratus OCT is compatible only with NTFS
on network drives.

 Note: You can use SAMBA with Unix and Linux file servers.
• 100 GB available disk space for data storage
• Tape backup unit

Network File Server Recommendations


In addition to the minimum requirements listed above, we recommend the following for
the network file server:
• A mirrored RAID array for data storage—strongly recommended.
• An uninterruptible power supply (UPS)—strongly recommended.
• Backup drive: AIT 50 GB native/130 GB compressed or DLT 40 GB native/80 GB
compressed
• It is the user’s responsibility to protect their exam data from loss by frequent
backup of the network server. Backup media should be of archival quality, and the
media should be stored in a secure, remote location.

WARNING: Failure to backup the network file server may result in the loss of
medical exam data.

• The file server must be started prior to networked Stratus OCT instruments and shut
down after Stratus OCT instruments.
• Strongly recommended that the file server not be used for interactive programs, such
as web browsing or word processing.

Using The Network File Server


Using a network file server is recommended in offices that have a local area network,
especially if you have multiple Stratus OCT instruments. Once you have set up the
instrument(s) on the network, the benefits are:
• You can use the network file server for routine archive and backup, export and import,
without the need for using and managing multiple DVD-RAM disks.
• If you have multiple Stratus OCT instruments on the network, you can synchronize
each of the instruments with the others via the network, so you can access all Stratus
OCT exam data acquired in your office.

Set Up Network Archiving

 Note: Configuring the server and the instrument for archiving to a network file
server should be attempted only by a network administrator or system
administrator, and the following instructions are intended only for personnel with
such expertise. Users are responsible for network setup and maintenance. Carl Zeiss

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Networking Guidelines A-5

Meditec Technical Support is limited to testing network connectivity of the Stratus


OCT. Technical Support cannot troubleshoot or repair problems with network
connectivity.
1. On the network file server, create a folder named “Stratus OCT Archive” or the like.
Make this a shared folder.
2. To ensure access to the shared folder on the network file server:
• On the Stratus OCT, create a new administrator account for use as the default
account. (See the instructions to create new accounts under Password Protection
in Chapter 1.)
• On the server, create a new account with the same username and password as on the
Stratus OCT.
3. On the Stratus OCT, map a network drive to the shared folder you have created on the
server.
A. Open Windows Explorer: Right-click the Windows Start button and select Explore.
B. In Windows Explorer, select Map Network Drive from the Tools menu (click Tools
> Map Network Drive). The Map Network Drive dialog appears.
C. Select a drive letter.
D. Click Browse to find and select the shared folder you created on the network file
server. You will have to first find the file server name (machine name), and then
the folder. (Do not clear the Reconnect at logon checkbox, which is selected by
default.)
E. When you have selected the correct folder and returned to the Map Network Drive
dialog, click Finish. You have now mapped a network drive to the shared folder.
4. On the Stratus OCT instrument, you must register the new archive on the network file
server to make it current.
A. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options
menu (click Options > Register Archive). The Archive Registration dialog appears.
B. In the Archive Registration dialog, click New. The New Archive Registration dialog
appears.
C. In the New Archive Registration dialog, the Archive Name field is made up of
two parts. The first part is generated automatically and cannot be changed; it is
composed of the model number, serial number and archive sequence number. You
can add a suffix to the name using the second part of the field, if you wish.
• The Mark as current checkbox is selected by default. Do not change this
selection if you wish to use the archive you are about to register as the current
archive.

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A-6 Networking Guidelines

• The Disabled checkbox is not selected by default. Select the Disabled


checkbox if you do not wish to archive to or synchronize from this archive.
D. Click the Browse button next to the Local Path field to find and select the local
drive letter you have mapped to the shared archive folder on the network file
server. When you select the local drive letter, the Network Path field is
completed automatically.
E. If you wish, you can enter up to about 85 characters in the Description field to
describe the archive you have registered.
F. When finished, click Save to register the new archive. It will now be the current
archive to which scan data is copied when you save scans.

Data Transfer Over the Network


Once you have configured the instrument and the server for archiving, you can perform all
data transfer functions as explained in the respective sections of this manual. See Chapter
(8), Archive, Retrieve & Backup, and Chapter (9), Export and Import Scan Data,
for instructions to archive, retrieve, backup, import, export and synchronize Stratus OCT
data.

 Note: If you attempt a data transfer function when the network is down or the
server is down, the function will fail and the instrument will notify you that a
connection could not be established. In this case, if auto-archive is on, all scans
saved while the network/server is down will not be archived automatically. You must
archive these scans manually when service is restored. See the instructions to
perform Access Archived Scans on page 8-5.

Configuration for Direct Export to a Personal Computer


It is possible to export data from a Stratus OCT to a personal computer (PC) via either a
local area network or a direct cable connection. To accomplish this, it is necessary to
configure both the Stratus OCT and the PC. To view and analyze data on the PC, you can
use compatible third-party software.

Terminology
The “source system” is the Stratus OCT system, from which you will export; the “target
system” is the remote computer to which you will export data.

 Note: The choice and use of third party software on the target system for viewing
and analysis is at the user’s discretion. Carl Zeiss Meditec does not specify
compatible third party software, nor support its use.

 Note: Carl Zeiss Meditec does not provide technical support for direct
export to a personal computer. The following configuration requirements
pertain to the example of direct export from the Stratus OCT to a PC running
Windows 2000. We intend these requirements for information technology (IT)
specialists, who will understand how to implement them. The user bears

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Networking Guidelines A-7

responsibility for any source or target system performance degradation or any other
change or defect resulting from the attempt to perform these tasks.

 Note: The requirements below are for a target system running Windows 2000 or XP.
If your intended target system is running another operating system, it may be
possible to configure it to import from the Stratus OCT, but the configuration
requirements may be different and are not explained here.

Configuration requirements
1. If transferring data via a network, connect both the source and target systems to the
network using a standard cable. If transferring via direct connection between source
and target, connect the two using a crossover cable. The Stratus OCT system has a
network connector (ethernet port) on the rear of the computer.
2. The source and target systems must have computer names, and these must be
different. If necessary, create a computer name of your choice for one or both
computers.
3. Both source and target systems must share the same set of networking protocols, as
follows. (The Stratus OCT is shipped with the following protocols properly configured.)
• Client for Microsoft Networks
• File and Printer Sharing for Microsoft Networks
• Internet Protocol (TCP/IP)
4. On the target system, create a shared folder that will receive the imported data and
enable access to the target system from the source system.
5. On the source system, map a network drive to the shared folder you created on the
target system in step 4. If the target system is password protected, you must access it
with a user account having either Standard User or Administrator privileges in
Windows 2000, or having Computer administrator privileges in Windows XP.
6. The Stratus OCT is configured by default to use DHCP. If the source system is
connected to a network that uses static IP addressing, the following TCP/IP
parameters must be configured: IP address, Subnet, and Default gateway.

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A-8 Networking Guidelines

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Configuration Guide B-1

(B) Configuration Guide

Overview
This document provides configuration instructions to enable transfer of Stratus OCT data
from a Stratus instrument to a personal computer (PC) running Stratus Review Software (a
Stratus review station) via network connection or removable media. It provides an overview
of data transfer methods, and addresses two kinds of network connection, as follows:
• Data Transfer Overview: Import or Retrieve Data, starting on page B-2
• Configuration for Export via Preexisting Office Network, starting on page
B-3.
• Stratus to Review Station Direct Network Connection (Crossover Cable)
Instructions, starting on page B-13

 Note: Import Data to Complete Process. To access exported data in Stratus Review
Software, you must complete the process by importing the data from the local
shared folder you will create as part of these instructions. See On the Review
Station PC: Import Data from the Local Shared Folder on page B-13.
Once Stratus OCT data is in the database of a review station PC, it is possible to transfer it
among Stratus network endpoints (Stratus instruments or PCs running Stratus Review
Software) via networking or any type of removable media compatible with both systems.
However, this document does not directly address any method of data transfer among PCs,
which is at the user’s discretion.

 Note: Carl Zeiss Meditec offers for sale a network attached storage device (network
drive or NASD) for archive and data transfer with Stratus OCT, and a network switch
kit for those with Stratus OCT systems that require retrofitting to use the NASD.
Instructions to install and use each of these items accompany them in their
respective kits.

 Note: Carl Zeiss Meditec offers for sale a kit with a USB hub you can attach to the
Stratus OCT to enable data transfer using a USB key (flash drive or jump drive). To
use this method, refer to the Stratus OCT USB Hub & Key Configuration Instructions
that accompany the kit.

WARNING: Users are responsible for network setup and maintenance,


including installation and configuration of all necessary hardware and
software. Carl Zeiss Meditec Technical Support is limited to testing network
connectivity of the Stratus OCT. Technical Support cannot troubleshoot or
repair problems with network connectivity. Please refer to Appendix (A)
Networking Guidelines for more information on the capabilities and
limitations of Stratus networking.

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B-2 Configuration Guide

WARNING: The user bears responsibility for any source or target system
performance degradation or any other change or defect resulting from the
attempt to perform these tasks.

WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.

Terminology
The “source system” is the Stratus OCT system, from which you will export; the “target
system” is the review station PC to which you will export data.

 Note: The choice and use of third party software on the target system for viewing
and analysis is at the user’s discretion. Carl Zeiss Meditec does not specify
compatible third party software, nor support its use.

 Note: The instructions below are for a review station PC running Windows 2000 or
XP. If your intended target system is running another operating system, it may be
possible to configure it to import from the Stratus OCT, but the configuration
requirements may be different and are not explained here.

Data Transfer Overview: Import or Retrieve Data


To transfer Stratus OCT data to a PC running Stratus Review Software, you can either:
• Import a Stratus database from a network drive or from a shared local folder to which
you have previously exported data using the Stratus OCT
Or
• Retrieve exams from an archive database, DVD-RAM, network drive, or DICOM server.

 Note: See Configuration for Export via Preexisting Office Network (page B-3)
for instructions to set up data transfer from the Stratus instrument to the review
station via a preexisting office network or Stratus to Review Station Direct
Network Connection (Crossover Cable) Instructions (page B-13) for transfer via
direct connection.

Importing or Retrieving from DVD-RAM

 Note: To import or retrieve from a DVD-RAM, you must have a DVD-RAM drive
installed on the PC. Users are responsible for installation of a DVD-RAM drive on
their PC. Carl Zeiss Meditec does not provide or specify a DVD-RAM drive for the
user’s PC, nor support the installation and configuration of a DVD-RAM drive on the
user’s PC.

Importing from CD or DVD

 Note: To import from CD or DVD, you must have installed on the importing PC both:

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Configuration Guide B-3

• A CD and/or DVD Read/Write drive (CD or DVD burner); it is not sufficient to have a
CD-ROM or DVD-ROM drive.
And
• Roxio Drag-to-Disc software (part of Roxio Easy CD and DVD Creator Version 6.0 or
higher) installed and properly configured on the importing PC.

For more information, including important details on configuration of the Roxio software,
see Appendix (D) Data Transfer Using CDs and DVDs.Importing from a local
folder
This step is subsequent to data transfer via export from a Stratus instrument or from
another review station PC. Export can occur via direct connection or a preexisting office
network. See the configuration instructions for each of these options below.

Importing or Retrieving from a Network Server

 Note: To import from a network server, the PC must be connected to the network
server, and both the server and the PC must be properly configured to communicate.
To retrieve from a network server, you must be archiving to the server from the
Stratus OCT. Users are responsible for network setup and maintenance, including
installation and configuration of all necessary hardware and software. Carl Zeiss
Meditec Technical Support cannot troubleshoot or repair problems with network
connectivity. See Appendix (A) Networking Guidelines for more information.

Notes on Retrieving

 Note: Stratus OCT does not permit archiving data to CD or DVD. Therefore, you can
retrieve archive data only from DVD-RAM or from a network drive.

 Note: You can retrieve Stratus OCT data from archives made with any Stratus OCT
Software Version down to A1.1.

 Note: For instructions to retrieve, see Retrieve Scan Data on page 8-11.

How to Import
To import data, follow the steps under Import Data on page 9-10.

Configuration for Export via Preexisting Office Network


This section explains how to configure the Stratus OCT and a review station PC to
communicate via your preexisting office network (a local area network or LAN). To do this,
the Stratus OCT and the review station PC each must be connected to the office network by
a standard network patch cable. It is the user’s responsibility to acquire and install the
necessary cables.

WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.

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Install the network cable


1. For both the Stratus OCT and the review station PC, plug one end of a standard
network patch cable into the computer ethernet port. Plug the other end of the cable
into the office network outlet.

Create a common Administrator user account

 Note: If you are using a file server to transfer Stratus data, create and use a user
account with the same username and password on all three network endpoints: the
Stratus instrument, the network file server and the review station PC. Follow the
instruction below.
1. On the Stratus OCT, create a new administrator account for use as the default
account. (See the instructions to create new accounts under Password Protection in
Chapter 1 of the Stratus OCT User Manual.)
2. On the review station (and the server), create and always use a new Administrator
account (Windows 2000) or Computer administrator account (Windows XP) with the
same username and password as on the Stratus OCT. To access user account settings:
• In Windows 2000, click Start > Settings > Control Panel > User Accounts.
• In Windows XP, click Start > Control Panel > User Accounts.

Configure the Review Station PC

 Note: Most networks use a DHCP server to automatically assign an IP address to the
review station PC and the Stratus instrument. In this case, you can skip these
instructions to Configure the Review Station PC, and those in the next section to
Configure the Stratus OCT. Skip ahead to On the Review Station PC: Create a
shared folder on page B-9. If your network uses static IP addresses, follow the
instructions below.
1. Open the Network Connections dialog:
For systems running Windows 2000, select Start > Settings > Network and Dial-up
Connections.
OR
For systems running Windows XP, select Start > Control Panel > Network Connec-
tions.

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Configuration Guide B-5

2. The Network (and Dial-up) Connections dialog appears (Figure B-1).

Figure B-1 Local Area Connection: Right-click and select Properties


3. Right-click the Local Area Connection icon, and then select Properties.

 Note: Some computers have multiple network connections. It is important to select


the Local Area Connection corresponding to the port where the network cable is
connected. These settings will not affect other ports.
The Local Area Connection Properties dialog appears (Figure B-2).

Figure B-2 Double-click Internet Protocol (TCP/IP)

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B-6 Configuration Guide

4. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-3).

Figure B-3 The Internet Protocol (TCP/IP) Properties Dialog


5. Write down and save any existing configuration parameters such as IP address,
Subnet mask and Default gateway. You may need these to reestablish a connection to
a preexisting network.
6. Select the Use the following IP address radio button, and then type in the IP address.

 Note: The first three parts of the review station IP address must match what is used
on the Stratus instrument. The fourth part must be a number between 2 and 255
that is unique to this system among all devices on the same network. In the example
in Figure B-3, the review station's IP address is 192.168.100.101. A compatible IP
address on the Stratus instrument would be 192.168.100.100.
7. Configure the Subnet mask as in Figure B-3. It should read 255.255.255.0. It must
be the same as on the Stratus instrument.
8. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.

 Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.

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Configuration Guide B-7

Configure the Stratus OCT


1. Exit the Stratus OCT software and open the Network Connections dialog by selecting
Start > Settings > Network and Dial-up Connections. The Network and Dial-up
Connections dialog appears (Figure B-4).

Figure B-4 Network and Dial-up Connections Dialog


2. Right-click on the Local Area Connection icon, and then select Properties as in
Figure B-4. The Local Area Connection Properties dialog appears (Figure B-5).

Figure B-5 Local Area Connection Properties Dialog

 Note: The Connect using: hardware will be different for Pentium 4 based
computers.

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B-8 Configuration Guide

3. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-6).

Figure B-6 Internet Protocol (TCP/IP) Properties Dialog


4. Select the Use the following IP address radio button, and then type in the IP address.

 Note: The first three parts of the Stratus OCT IP address must match what is used on
the review station PC. The fourth part must be a number between 2 and 255 that is
unique to this system among all devices on the same network. In the example in
Figure B-6, the IP address is 192.168.100.100. A compatible IP address on the
review station PC would be 192.168.100.101.
5. Configure the Subnet mask as in Figure B-6. It should read 255.255.255.0. It must
be the same as on the review station PC.
6. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.

 Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.

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Configuration Guide B-9

On the Review Station PC: Create a shared folder


1. Create a local folder on the review station for exported data. The new folder can be
created in any available path on the hard disk drive. In the example below, the new
folder was created by right-clicking on the Windows desktop, and then selecting New
> Folder (Figure B-7).

Figure B-7 Right-click on desktop, select New > Folder


Continuing the example, the new folder created on the Windows desktop was named
Netshare (Figure B-8).

Figure B-8 Right-click new folder, select Sharing and Security

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B-10 Configuration Guide

2. Right click on the new folder, and then select Sharing and Security as in Figure B-8.
The Netshare Properties dialog opens to the Sharing tab (Figure B-9).

Figure B-9 Select the sharing properties


3. Select Share this folder as in Figure B-9. You can change the Share Name if desired.

 Note: The default share name is the same as the folder name. We recommended you
use the default share name.

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Configuration Guide B-11

4. Click Permissions and the Permissions dialog appears (Figure B-10).

Figure B-10 Permission for Netshare Dialog


5. Make sure all the Allow checkboxes are selected to grant Full Control, Change and
Read permissions to everyone, as in Figure B-10.
6. Click OK to save your changes and close the Permissions dialog. Then click OK to save
your changes and close the Netshare Properties dialog.

On the Stratus OCT: Map a drive letter to the shared folder


1. Right-click on the My Computer icon, and then select Map Network Drive as in
Figure B-11.

Figure B-11 Right-click My Computer, select Map Network Drive

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B-12 Configuration Guide

The Map Network Drive dialog appears (Figure B-12).

Figure B-12 Select an unused drive letter


2. Click the down-arrow next to the Drive field, and select an unused drive letter from
the list as in Figure B-12.
3. In the Folder field, enter the review station computer name and shared folder name.
Use the format “\\computer name\shared folder name” as shown below (Figure
B-13). In this example, the review station's computer name is station1 and the
shared folder name is netshare. The names are not case-sensitive.

Figure B-13 Enter the review station computer name and shared folder name

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Configuration Guide B-13

 Note: To find the review station computer name:


• On systems running Windows 2000, right-click on the My Computer desktop icon and
select Properties. Then select Network Identification to find the computer name.
• On systems running Windows XP, select Start, right-click My Computer and select
Properties. Then select Computer Name to view the computer name.

 Note: You must use two backslashes before the computer name as shown in the
example.

 Note: You must select the Reconnect at logon checkbox to allow the system to
reconnect to the shared drive each time Windows starts.
4. Click Finish to save your changes and close the Map Network Drive dialog.

On the Stratus OCT: Export Data to the Local Shared Folder


The new drive letter will now be available during the export process on the Stratus
instrument. In this example, the drive letter N: was mapped to the shared folder on the
review station. To export to the review station PC from the Stratus instrument, select the
mapped drive letter (N: in this case) as the export target. For more detail, refer to
Database Export on page 9-6.

On the Review Station PC: Import Data from the Local Shared Folder
To have access in Stratus Review Software to the data exported from the instrument, you
must complete the process by importing it from the local shared folder you created as
described above. In the example, this is the folder named Netshare on the Windows
desktop (Figure B-8). For details, see Import Data on page 9-10.

 Note: For patients imported with the date of birth obscured, normative data will
not be presented in the analysis.

Stratus to Review Station Direct Network Connection


(Crossover Cable) Instructions
This section explains how to configure a direct network connection between the Stratus
OCT and a PC running Stratus Review Software. If you do not have a preexisting
networking infrastructure, this option provides an alternative. To do this, the sending and
receiving platforms must be connected by an unshielded RJ-45 crossover cable between
their respective ethernet ports. It is the user’s responsibility to acquire and install the
necessary crossover cable.

WARNING: When networking the Stratus OCT, use only network cables with
an unshielded RJ-45 connector. Use of a shielded network cable in the Stratus
OCT could result in electrical shock to the patient and/or examiner.

 Note: You should use a direct connection should only if no other networking
infrastructure exists, for the following reason: In this scenario, the Stratus
instrument and the review station PC will each be configured with a static IP address

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B-14 Configuration Guide

and dedicated crossover network cable. While so configured, both the Stratus OCT
and the review station PC will be limited in the ability to communicate via other
network connections.

 Note: A direct connection allows patient data to be transferred from the Stratus to
the Review Station utilizing the Stratus software's Export feature. A direct network
connection should not be used to synchronize with archived data.

Direct Connection Procedure


Install the network crossover cable
1. Plug one end of the RJ-45 crossover cable into the ethernet port on the Stratus OCT.
Plug the other end of the cable into the ethernet port on the review station PC.

Configure the Review Station PC


1. Open the Network Connections dialog:
For systems running Windows 2000, select Start > Settings > Network and Dial-up
Connections.
OR
For systems running Windows XP, select Start > Control Panel > Network Connec-
tions.
2. The Network (and Dial-up) Connections dialog appears (Figure B-14).

Figure B-14 Local Area Connection: Right-click and select Properties


3. Right-click the Local Area Connection icon, and then select Properties.

 Note: Some computers have multiple network connections. It is important to select


the Local Area Connection corresponding to the port where the crossover cable is
connected. These settings will not affect other ports.

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Configuration Guide B-15

The Local Area Connection Properties dialog appears (Figure B-15).

Figure B-15 Double-click Internet Protocol (TCP/IP)


4. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-16).

Figure B-16 The Internet Protocol (TCP/IP) Properties Dialog

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B-16 Configuration Guide

5. Write down and save any existing configuration parameters such as IP address,
Subnet mask and Default gateway. You may need these to reestablish a connection to
a preexisting network.
6. Select the Use the following IP address radio button, and then type in the IP address.

 Note: The first three parts of the review station IP address must match what is used
on the Stratus instrument. The fourth part must be a number between 2 and 255
that is unique to this system among all devices on the same network. In the example
in Figure B-16, the review station's IP address is 192.168.100.101. A compatible IP
address on the Stratus instrument would be 192.168.100.100.
7. Configure the Subnet mask as in Figure B-16. It should read 255.255.255.0. It must
be the same as on the Stratus instrument.
8. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.

 Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.

Configure the Stratus OCT


1. Exit the Stratus OCT software and open the Network Connections dialog by selecting
Start > Settings > Network and Dial-up Connections. The Network and Dial-up
Connections dialog appears (Figure B-17).

Figure B-17 Network and Dial-up Connections Dialog

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Configuration Guide B-17

2. Right-click on the Local Area Connection icon, and then select Properties as in
Figure B-17. The Local Area Connection Properties dialog appears (Figure B-18).

Figure B-18 Local Area Connection Properties Dialog

 Note: The Connect using: hardware will be different for Pentium 4 based
computers.

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B-18 Configuration Guide

3. Double-click Internet Protocol (TCP/IP) in the component list. The Internet Protocol
(TCP/IP) Properties dialog appears (Figure B-19).

Figure B-19 Internet Protocol (TCP/IP) Properties Dialog


4. Select the Use the following IP address radio button, and then type in the IP address.

 Note: The first three parts of the Stratus OCT IP address must match what is used on
the review station PC. The fourth part must be a number between 2 and 255 that is
unique to this system among all devices on the same network. In the example in
Figure B-19, the IP address is 192.168.100.100. A compatible IP address on the
review station PC would be 192.168.100.101.
5. Configure the Subnet mask as in Figure B-19. It should read 255.255.255.0. It must
be the same as on the review station PC.
6. Click OK to save your changes and close the Internet Protocol (TCP/IP) Properties
dialog. Click OK again to save changes and close the Local Area Connection
Properties dialog.

 Note: The system may prompt you that the computer must be restarted for the
changes to take effect. Restart the computer if so prompted.

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Configuration Guide B-19

On the Review Station PC: Create a shared folder


1. Create a local folder on the review station for exported data. The new folder can be
created in any available path on the hard disk drive. In the example below, the new
folder was created by right-clicking on the Windows desktop, and then selecting New
> Folder (Figure B-20).

Figure B-20 Right-click on desktop, select New > Folder


Continuing the example, the new folder created on the Windows desktop was named
Netshare (Figure B-21).

Figure B-21 Right-click new folder, select Sharing and Security

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B-20 Configuration Guide

2. Right click on the new folder, and then select Sharing and Security as in Figure
B-21. The Netshare Properties dialog opens to the Sharing tab (Figure B-22).

Figure B-22 Select the sharing properties


3. Select Share this folder as in Figure B-22. You can change the Share Name if
desired.

 Note: The default share name is the same as the folder name. We recommended you
use the default share name.

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Configuration Guide B-21

4. Click Permissions and the Permissions dialog appears (Figure B-23).

Figure B-23 Permission for Netshare Dialog


5. Make sure all the Allow checkboxes are selected to grant Full Control, Change and
Read permissions to everyone, as in Figure B-23.
6. Click OK to save your changes and close the Permissions dialog. Then click OK save
changes and close the Netshare Properties dialog.

On the Stratus OCT: Map a drive letter to the shared folder


1. Right-click on the My Computer icon, and then select Map Network Drive as in
Figure B-24.

Figure B-24 Right-click My Computer, select Map Network Drive

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B-22 Configuration Guide

The Map Network Drive dialog appears (Figure B-25).

Figure B-25 Select an unused drive letter


2. Click the down-arrow next to the Drive field, and select an unused drive letter from
the list as in Figure B-25.
3. In the Folder field, enter the review station computer name and shared folder name.
Use the format “\\computer name\shared folder name” as shown below (Figure
B-26). In this example, the review station's computer name is station1 and
the shared folder name is netshare. The names are not case-sensitive.

Figure B-26 Enter the review station computer name and shared folder name

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Configuration Guide B-23

 Note: To find the review station computer name:


• On systems running Windows 2000, right-click on the My Computer desktop icon and
select Properties. Then select Network Identification to find the computer name.
• On systems running Windows XP, select Start, right-click My Computer and select
Properties. Then select Computer Name to view the computer name.

 Note: You must use two backslashes before the computer name as shown in the
example.

 Note: You must select the Reconnect at logon checkbox to allow the system to
reconnect to the shared drive each time Windows starts.
4. Click Finish to save your changes and close the Map Network Drive dialog.
The new drive letter will now be available during the export process on the Stratus
instrument. In this example, the drive letter N: was mapped to the shared folder on the
review station. To export to the review station PC from the Stratus instrument, select the
mapped drive letter (N: in this case) as the export target. For more detail, refer to the
chapters on import and export in the Stratus OCT User Manual or Stratus OCT Review
Software User Manual.

Import Data from the Local Shared Folder


To have access in Stratus Review Software to the data exported from the instrument, you
must complete the process by importing it from the local shared folder you created as
described above. For details, see Import Data on page 9-10.

Reconnecting Review Station to a Preexisting Network


To reconnect the review station to a preexisting network, disconnect the crossover cable,
reconfigure the Local Area Connection’s TCP/IP properties to what they were before, and
stop sharing the shared folder. If the data folder is shared on a preexisting network, it may
be visible to all network users and the Internet. When not connected to the Stratus OCT, we
strongly recommended that you disable sharing of the data folder.

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B-24 Configuration Guide

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Normative Database for Macula and RNFL Measurements C-1

(C) Normative Database for Macula


and RNFL Measurements

Introduction
The Stratus OCT normative database study was designed to obtain normative data for
macular and RNFL thickness from healthy subjects ages 18 to 86. Six centers participated
in the prospective, non-comparative study. Enrolled subjects were representative of healthy
individuals with no history of eye disease and were carefully screened and evaluated for
eligibility. Generally, subjects presented to the clinical center for routine refraction analysis.
Medical and ophthalmic histories were taken prior to enrolling the subject in the study.
Subjects who had a history of diabetes, glaucoma, or ocular surgery (other than cataract or
refractive surgery more than 1 year ago) were disqualified from the study.

Selection Criteria
Subjects were given a complete ophthalmic examination (unless the subject was seen at
the clinic for a regular eye examination within the last 60 days); it included the following
tests:
A. Distance visual acuity using the Humphrey 24-2 SITA Standard threshold test,
bilaterally. Any defects found were verified with a second test.
B. Goldmann applanation tonometry.
C. Axial length measurement using an IOLMaster.
D. Slit lamp examination of the anterior segment of both eyes.
E. Dilated ophthalmoscopic examination, bilaterally.
F. Fundus photography of the maculas and the optic nerves of both eyes.
If the various ophthalmic examinations showed any abnormalities, the subject was
disqualified from the study. Excluded from the study were individuals with the following
characteristics:
A. Contraindications to dilation (including occludable anterior chamber angles), or
intolerance or hypersensitivity to topical anesthetics or mydriatics in either eye.
B. Ocular hypertension (IOP = 22 mm Hg in either eye) or glaucoma in either eye.
C. Evidence of reproducible visual field abnormality in either eye, defined as PSD
significant at p < 5% level, or abnormal Glaucoma Hemifield test result, or any
other pattern of loss which is consistent with ocular disease. The test must be

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C-2 Normative Database for Macula and RNFL Measurements

valid, as defined by a false positive rate of 15% or less, and fixation losses as
defined by the Heijl Krakau method of 20% or less. Unreliable visual fields may be
repeated at the discretion of the Investigator.
D. Intraocular surgery in the study eye within one year of enrollment.
E. Best corrected visual acuity in the study eye worse than 20/32 on ETDRS scale
(LogMar +0.2).
F. Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal
disease in either eye upon dilated examination by an ophthalmologist, or upon
evaluation of retinal photos.
G. Evidence of optic nerve or retinal nerve fiber layer abnormality in either eye upon
dilated examination by an ophthalmologist, or upon evaluation of retinal or optic
nerve photos.
H. History of diabetes.
I. Participation in any study involving an investigational drug within the past month,
or ongoing participation in a study with an investigational device.
J. Current or recent (within the past 14 days) use of an agent with photosensitizing
properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline).

Data Collection
After undergoing a thorough ophthalmic examination and qualifying, 260 subjects (aged
18-86 years) had scans of their retinas taken with the Stratus OCT device. The Fast
Macular Thickness Map (Fast Mac) scan protocol was used to acquire the macular
thickness data. For this scan type, a set of six intersecting scan lines, each consisting of
128 data points, was obtained in a single alignment and capture to evaluate macular
thickness. The Fast RNFL (3.4 mm) scan was used to acquire the peripapillary RNFL
thickness data. For this scan type, a set of three circles, each consisting of 256 data points,
was obtained in a single alignment and capture to evaluate peripapillary RNFL thickness
along a circle of radius 3.46 mm from the center of the optic disc.

Data Analysis and Normalization


This normative database is derived from a healthy population. Currently, any correlation
with a disease state is not known. Although the current database may be of clinical utility,
it is unclear how age is related to macular thickness or RNFL thickness.
Each individual sample data point from the 260 individuals was used to estimate the
distribution of macular thickness in a normal population at that macular scan point
location. Likewise, each individual sample data point from the Fast RNFL scan from the
260 individuals was used to estimate the distribution of RNFL thickness in a normal
population at that circle location. Each data point was normalized by a linear
age-dependent coefficient (see Age Coefficient on page C-3) that compensated for the
estimated change in thickness with subject age. The combined distribution of the
age-normalized thickness data point values was then used to estimate the variation of
macular thickness data for the population as a whole. It is assumed in this analysis that the

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Normative Database for Macula and RNFL Measurements C-3

variation in the distribution of thicknesses does not change with the age of the population.
The distribution was then transformed into a Gaussian distribution, which was then used to
calculate the 1%, 5%, 95% and 99% limits of the normal population. A detailed statistical
description of the data transformation follows:
A standard simple linear regression analysis was used in the data analyses. For each of the
128 data points of the six scan lines, the expected thickness (ET) was estimated as a linear
function of age, i.e., Expected Thickness = a + b X age, where a and b were constants. The
values of a and b could differ among the regression lines for the 128 data points of the six
scan lines. The Normal Limit was then derived based on the percentiles of the residuals,
i.e., the difference between the estimated expected thickness (ET) and the observed
thickness (rt), as follows:
ET(age) + NL(5%) < rt(age) < ET(age) + NL(95%),
Where
NL(5%) and NL(95%) were the estimated 5th and 95th percentiles of the residuals,
and
ET(age) + NL(5%) and ET(age) + NL(95%) were the 5% and 95% Normal Limits.
In order to better estimate the percentiles of the residuals, Manly’s exponential
transformation1 was used to transform the residuals so that the transformed residuals were
normally distributed. The percentiles of the transformed residuals were estimated based on
the normal distribution. Then the estimated percentiles of the residuals were derived by
converting the percentiles of the transformed residuals back to the original scale.

Age Coefficient
Analysis of subject demographics determined that expected thickness was dependent upon
age, but not significantly dependent upon other variables, i.e., right vs. left eye and
gender. Thus age correction is incorporated into the calculated results. Subject ethnicity
was self-reported by the subjects in the population comprising the normative database but
was not used as a variable in constructing the macular normative database.

1. Manly B. F. J. (1976) Exponential Data Transformations. The Statistician. Vol. 25, No. 1, pp
37-42.

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C-4 Normative Database for Macula and RNFL Measurements

As shown in Figure C-1 and Figure C-2, the data for each scan number comprises
multiple data points. As described previously, linear regression analysis was used to
determine the age coefficient.

Figure C-1 Thickness vs. Age for Line 1, Scan 1

Figure C-2 Thickness vs. Age for Line 1, Scan 65

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Normative Database for Macula and RNFL Measurements C-5

Figure C-3 illustrates how the age coefficient varies with A-scan number for a
representative scan line. The y-axis is the Age Regression Coefficient in micrometers per
year (μm/yr) and the x-axis is the A-scan number (1 through 128).

Figure C-3 Age Regression Coefficient vs. A-scan Number


Figure C-4 illustrates the relationship between Total Macular Volume (mm3) and age, as
observed in the study population.

Figure C-4 Total Macular Volume vs. Age in Study Population

Conclusion
The Macula Normative Database and RNFL Normative Database were based upon Stratus
OCT retinal scans collected from subjects whom, per protocol, were deemed representative
of a normal population. The Normative Databases establish reference values for specific
Stratus OCT retinal scans which the physician can use to compare individual patient
measurements to those acquired in a normal population.

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C-6 Normative Database for Macula and RNFL Measurements

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Data Transfer Using CDs and DVDs D-1

(D) Data Transfer Using CDs and


DVDs

Overview
Later models of Stratus OCT instruments are equipped with a DVD Multi-Drive and Roxio™
Drag-to-Disc software (part of Roxio Easy CD and DVD Creator 6), which together enable
you to transfer data using certain kinds of CDs and DVDs. This appendix explains the
features and limitations of Stratus OCT data transfer using CDs and DVDs, and provides
instructions for data transfer using CDs and DVDs.

Important Note: The Roxio software is pre-installed on the Stratus OCT


instrument and specially configured for use with it. Do not re-install Roxio
software. The Roxio CD included with your instrument is provided to satisfy
licensing requirements only.

Compatible CD and DVD Media Formats


Specifically, if your Stratus OCT has a DVD Multi-Drive and Roxio Drag-to-Disc software,
you can use the following types of CDs and DVDs to transfer data:
• CD–R
• CD–RW
• DVD–R, 4.7 GB for general use, Version 2.0
• DVD–RW, Version 1.1

 Note: You cannot use the following distinct media formats, which are incompatible
with the DVD Multi-Drive: DVD+R, DVD+RW.

 Note: The CDs or DVDs you use first must be formatted in the Drag-to-Disc format,
as explained in the section Formatting for Drag-to-Disc on page D-2.

Compatible Data Transfer Functions


If your Stratus OCT has a DVD Multi-Drive and Roxio Drag-to-Disc software, the following
data transfer functions are possible: export and import. See the additional information and
notes below for each transfer function.

 Note: On the Stratus OCT, you cannot archive to the E: drive (to a CD or DVD), either
automatically or manually. You cannot perform automatic backup to these media
either.

Export and Import


You can burn a Stratus export database to a CD or DVD for transfer to another Stratus OCT
instrument or to a personal computer (PC).

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D-2 Data Transfer Using CDs and DVDs

 Note: On a PC, it may be possible to view and analyze Stratus OCT data using third
party software. Beyond the instructions here, Carl Zeiss Meditec does not support
the import of Stratus OCT data to a PC; neither do we specify third party software
you can use on a PC to view and analyze Stratus OCT data, nor support its use.
• To successfully import from CD or DVD, the importing instrument or PC must also have
Roxio software (version 6 or greater)–properly configured, as explained in the Roxio
Software Configuration—Eject Settings on page D-4–plus a CD read/write
drive and/or a DVD read/write drive. You cannot import successfully using a CD-ROM
drive or a DVD-ROM drive.

 Note: Because the Stratus OCT export function overwrites any Stratus export
database previously written to that disk, only the exams transferred to that disk in
the last export session will be available for import to another Stratus OCT
instrument.

Stratus OCT Data Transfer Instructions


The actual data transfer functions--export and import--are done using the Stratus OCT
software in the usual way, except that you select the E: drive as the target or source drive
for data transfer, and you insert a compatible CD or DVD in the DVD Multi-Drive. See the
indicated sections of the user manual for details.
• See Export Steps on page 9-7 for instructions to export.
• See Import Data on page 9-10 for instructions to import.

 Note: You must first format the CD or DVD in Drag-to-Disc format, as described in
Formatting for Drag-to-Disc on page D-2.

Proper CD and DVD Care


Due to the sensitivity of medical exam data, Carl Zeiss Meditec selected the DVD-RAM
format for removable data storage on the Stratus OCT. The advantages of DVD-RAM are its
large capacity, its protective plastic case, which makes it less susceptible to damage than
regular DVDs, and its robustness through thousands of read/write cycles. On average, you
can write to a DVD-RAM up to 10,000 times, compared to 1,000 times for an average CD–
RW or DVD–RW.
We do not recommend that you use CDs or DVDs for long-term data storage. Use should
be limited to data transfer between systems. Take care to protect these media from
damage. We recommend you use hard plastic cases when transporting and shipping these
media. DVDs in particular are very susceptible to scratches that could render them
unreadable.

Formatting for Drag-to-Disc


This section explains how to format each of the compatible CD and DVD types using Roxio
Drag-to-Disc as it is installed on the Stratus OCT.

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Data Transfer Using CDs and DVDs D-3

General Steps
Specific format options for each media type are explained after these general steps, which
are common to all media types.
1. Install the CD or DVD into the Stratus OCT DVD Multi-Drive. Wait approximately 30
seconds for the drive to recognize the media type. If you attempt the next step before
the drive is ready, you will get an error message, “There is no disk.”
2. To access the Roxio Drag-to-Disc software, you do not have to close the Stratus OCT
software. Using your mouse, bring the screen pointer down to the bottom of the
screen. This will cause the Windows Task Bar to appear along the bottom. Notice the
icons in the System Tray at bottom right. (When you mouse-over an icon, its name
appears.) Right-click the Roxio Drag-to-Disc icon and select Format Disc. The
Drag-to-Disc Format Options dialog appears.
• You can also access Roxio Drag-to-Disc through the Windows Start menu: Start >
Programs > Roxio Easy CD and DVD Creator 6 > Drag-to-Disc.
Note: The first time you use Roxio software, you will be prompted to accept the
terms of the End User License Agreement. You must accept the terms to use the
software.
The available format options depend on the installed media type, as explained next.

CD–R and DVD–R Format Options


Figure D-1 Drag-to-Disc Right-Click

Figure D-2 CD-R Format Options


No format options are available for CD–R and DVD–R disks. If desired, type a name in the
Volume Label field. Click OK to begin formatting. A Drag-to-Disc Preparation dialog
appears during formatting (as at left). Formatting is brief. The dialog disappears when it is
complete. Once formatted, you cannot format CD–R and DVD–R disks again, nor can you
erase them. You can write repeatedly to the disk, but each write operation uses disk space.
Figure D-3 Read-only Media Less disk space will be available for each successive write operation.

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D-4 Data Transfer Using CDs and DVDs

CD–RW and DVD–RW Format Options

Figure D-4 CD-RW (left) and DVD-RW (right) Format Options


For a new, blank CD–RW, you have only the option to perform a full format. If the CD–RW
was previously formatted, you can perform a quick or full format. A full format requires
25-45 minutes.
For a DVD–RW you can perform a full format or a quick format at any time. A full format
requires 40 to 90 minutes; a quick format requires a few minutes.

 Note: Both quick and full formatting effectively erase any data currently on
the disk. Use these options with care to prevent loss of patient data.
The Advantage of Full Format

For both CD–RW and DVD–RW, full format has this advantage: the disk ejects immediately
when you eject it. If the disk is quick formatted, it requires 1 to 4 minutes for the disk to
eject, as illustrated below.

Figure D-5 Waiting to Eject a Quick Formatted Read/Write Disk

Erasing Read/Write Disks


You can erase or re-format both CD–RW and DVD–RW disks. Use these options carefully:
Once you erase or re-format, you will no longer have access to the data that was present.
If you erase CD–RW or DVD–RW disks, you must re-format them to use them again.

Roxio Software Configuration—Eject Settings


To successfully import Stratus OCT data from a CD or DVD, the importing instrument or PC
must be able to write to the CD or DVD (as well as read it). Therefore, when ejecting the CD

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Data Transfer Using CDs and DVDs D-5

or DVD, the CD or DVD must not be “finalized” (or closed), which is a process normally
used to enable the CD or DVD to be read on any computer. Finalizing a CD or DVD prevents
data from being written to it.
When shipped from the factory with the Stratus OCT, the Roxio Drag-to-Disc software is
properly configured so that CDs and DVDs are not finalized. Do not change the
configuration of the Roxio Drag-to-Disc software, particularly the eject settings. The correct
eject settings are seen in Figure D-6 below.

Figure D-6 Roxio Drag-to-Disc Settings


Users who wish to use CDs or DVDs to transfer Stratus OCT data to a PC must have
installed Roxio software (version 6 or greater) configured not to finalize the disk upon
eject, as in Figure D-6. These are not the default settings when you install Roxio yourself.
To access the Drag-to-Disc settings, right-click the Roxio Drag-to-Disc icon in the System
Tray and select Settings.

Warning: User Changes to Hardware or Software


Users who wish to install a DVD Multi-Drive or Roxio software on a Stratus OCT instrument
not so equipped are explicitly prohibited from doing so without first consulting Carl Zeiss
Meditec Technical Support. As of this writing, Carl Zeiss Meditec does not supply or
support the installation of a replacement DVD Multi-Drive on the Stratus OCT instrument;
and Roxio software is not approved for use on Stratus OCT instruments not equipped with
it at the factory.

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D-6 Data Transfer Using CDs and DVDs

Warning: Unauthorized modification of Stratus OCT software or hardware


(including peripherals) can jeopardize the safety of users and patients, the
performance of the instrument, and the integrity of patient data; it also voids
the instrument warranty.

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Using a Network Storage Device E-1

(E) Using a Network Storage Device

Introduction
This appendix provides safety information, requirements, recommendations and
configuration instructions for using a network attached storage device (NAS device), also
known as a network drive, with Stratus OCT. These instructions provide requirements and
recommendations for the NAS device, but are generic with respect to brand, the choice of
which is at the discretion of the user. You can attach the NAS device directly to the Stratus
OCT Ethernet port, or you can connect it via your office network (local area network or
LAN). These instructions cover both scenarios.
Once installed and correctly configured for use with the Stratus OCT, the NAS device serves
the same functions as a network server (primarily archiving), and the instructions in the
Stratus OCT User Manual for using a network server apply to use of the NAS device.

WARNING: We strongly recommend you use peripheral devices supplied or


approved by Carl Zeiss Meditec, when available, because they will have been
tested to work with the instrument. If you do, follow any specific
configuration instructions that accompany the device. If you use a peripheral
device that conforms with the requirements in this section but is not supplied
by Carl Zeiss Meditec, do not install any unapproved third-party software on
the instrument. Installation of any unapproved software, including drivers,
could degrade the performance of the instrument and/or lead to corrupted
diagnostic or therapeutic information and may void the instrument warranty.

Please refer to the Stratus OCT section of our website (www.meditec.zeiss.com/stratus) for
the current list of approved hardware and software. If you wish to use a third party
peripheral device, seek technical support from the device manufacturer. Repairs
necessitated by the attempt to use a non-approved peripheral device are not covered under
warranty.

NAS Device Safety Warnings


WARNING: Place the NAS device outside the patient environment. Peripheral devices
such as a NAS device must be placed at least 1.5 meters (4.9 feet) away from the
patient, such that the patient cannot touch a peripheral device with any part of his or
her body while being examined. In addition, the instrument operator must not
attempt to touch the patient and a peripheral device at the same time while
examining the patient. Failure to observe this warning could result in electrical shock
to the patient and/or examiner.

WARNING: To directly connect the NAS device to the Stratus OCT, use a network
patch cord only with an unshielded RJ-45 connector. Use of a shielded network patch
cord will ground the NAS device through the Stratus OCT, which could result in
electrical shock to the patient and/or examiner.

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E-2 Using a Network Storage Device

WARNING: Do not use the NAS device or the instrument with an extension cord or a
power strip (multiple portable socket outlet). For additional safety, do not plug the
NAS device and the instrument into the same wall outlet. Failure to observe this
warning could result in electrical shock to the patient and/or examiner.

NAS Device Requirements


For safety and minimally acceptable performance when used with Stratus OCT, the user
must select a NAS device with the following characteristics:
• 100BaseT or 1000BaseT Ethernet capable. For safety reasons, USB connection is not
permitted with Stratus OCT.
• Network patch cord for direct connection to Stratus OCT: UTP CAT5e cord with an
unshielded RJ-45 connector, at least 10 feet (3.05 meters) long to enable you to place
the NAS device outside the patient environment. See related safety warnings above.
Note that many network drives you purchase may contain patch cords that are
shielded or of insufficient length to use with Stratus OCT. In such cases, you must
purchase this cord separately.
• Drive media formatted using NTFS: Stratus OCT data is compatible only with NTFS.
• Approvals: The NAS device you select must conform with local agency requirements.
In Europe, CE approval is required. In North America, UL, CSA or equivalent approval
is required; and FCC approval is required.

NAS Device Recommendations


• Recommended storage capacity: At least as large as the Stratus OCT hard drive.
• Backup solution: To maintain redundancy of data backup, we strongly recommend
you use the backup solution of your choice for the NAS device, especially when you
have used the Stratus OCT long enough for it to begin deleting archived exams
automatically. Depending on the usage rate, it takes many months up to a few years
before Stratus OCT begins to clear archived exams automatically.
• You can use multiple or mirrored NAS devices as a backup solution, but when
you use two or more NAS devices concurrently, you must use a switch or
router. The switch/router may be directly connected to the instrument or
elsewhere on the local area network. Configuration in this scenario is the
user’s responsibility.

Install and Configure the NAS Device


You can attach the NAS device directly to the Stratus OCT Ethernet port, or you can connect
it via your office network (local area network or LAN). These instructions apply to both
scenarios.

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Using a Network Storage Device E-3

1. With the Stratus OCT and the NAS device turned off, use a network patch cord to
connect the NAS device either directly to the Stratus OCT, or to the office network
(local area network or LAN) on which the Stratus OCT resides. Refer to the
manufacturer’s instructions for details regarding installation of the NAS device.

 Note: For safety, observe the warnings and requirements on page E-1 that relate to
the type and length of cord.
2. Turn on the NAS device and wait for initialization to complete before you turn on the
Stratus OCT. Often a color change in a light on the front of the NAS device indicates
initialization is complete, but see the manufacturer’s instructions for details on
initialization.
3. Turn on the Stratus OCT. After you complete the startup process, exit the Stratus
software, going to the Windows® desktop.
• In the system tray at lower right, you may observe a Local Area Connection
notice resulting from attachment of the NAS device. Ignore the message at
this point.
4. In the Stratus OCT CD drive, install the CD that accompanies the NAS device, which
will install and run the NAS device configuration program. Follow the on-screen
instructions, using the default settings. While running the NAS device configuration,
observe the following recommendations:
A. Installation Type: If you are presented with an option to choose a type of
installation, for example a choice between “typical,” “minimal” and/or “custom”
installation, we recommend you choose “typical” or “minimal.” Do not perform a
“custom” installation unless you have reason to do so and the knowledge and
experience required, which would be equivalent to that of a network or system
administrator.
B. Record Storage Drive Name: If you are presented with the option to change the
name of the NAS device, you can either use the default name or change it at your
discretion, but in either case, you must write it down, because you may need it to
complete configuration on the Stratus OCT. You can use the space below:
NAS Device Name (also known as Network ID):
C. Workgroup Name Must Match Stratus OCT Workgroup Name: If you are presented
with the option to change the workgroup name of the NAS device, you must make
it match the workgroup name of the Stratus OCT, which is “CZM” by default—this
name is not case-sensitive on Stratus OCT. If the Stratus OCT is connected to an
office network as part of a different workgroup name, then you must use that
workgroup name.
5. When you complete NAS device configuration, exit the configuration program and
remove the CD from the Stratus OCT CD drive.

On Stratus OCT, Map a Network Drive to the NAS Device


In some cases, the configuration software of the NAS device automatically maps the
correct folder of the NAS device to a drive letter on the Stratus OCT. When this is the case,

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E-4 Using a Network Storage Device

configuration is complete and the NAS device is ready to use. In other cases, you must map
a drive on the Stratus OCT to the proper folder of the NAS device using Windows Explorer,
as instructed below:
1. Back on the Windows desktop, open Windows Explorer: right-click on Start and select
Explore.
2. In the Explorer Address field, type two backlashes and then the NAS device name
you recorded in step 4.B. above, and press Enter. See the example below.

Figure E-1 Entering Device Name in Windows Explorer Address Field

 Note: If you failed to record it properly, note that you can often find the NAS device
name on a label on the back of the NAS device. The device name, for this purpose,
may be presented as the Network ID. Enter the entire network ID/device name
after the two backslashes, with no spaces.

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Using a Network Storage Device E-5

If you have typed the device name correctly, and the NAS device is correctly config-
ured and turned on, when you press Enter, Explorer should find the NAS device on the
left and display its contents on the right, as in the example below.

Figure E-2 Explorer Finds NAS Device and Displays Its Contents
3. Now you must map a drive on the Stratus OCT to the NAS device folder that is
accessible to all users for storage. In the example above, the folder named Public is
the correct folder. The folder name for your NAS device may be similarly indicative
that it is intended for use as the storage folder. Consult the manufacturer’s
instructions to determine which folder is intended for this purpose.

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E-6 Using a Network Storage Device

4. Click to select the correct storage folder. Then click Tools > Map Network Drive. The
Map Network Drive dialog appears.

Figure E-3 Map Network Drive Dialog


5. In the Drive field, select any available network drive letter, using the down-arrow on
the right. You may, for example, choose N: for network storage device.
• In the Folder field, note that the folder name is already selected and
unavailable to be changed.
• Do not clear the Reconnect at logon check box.
6. Click Finish. You have now completed configuration. To archive to the NAS device,
register the drive letter assigned to the NAS device as an archive volume. See
Archive Registration and Management on page 8-4 for details.

Cleaning the NAS Device


Regular periodic cleaning of the NAS device is not required. However, if the device
becomes dusty, you may clean it using a soft bristle brush such as a keyboard brush. Do
not use liquid cleaners unless specifically directed by the manufacturer, since they may drip
into the device and cause it to malfunction.

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Printer Configuration Instructions F-1

(F) Printer Configuration Instructions

Introduction
This document instructs you how to configure a printer for use with Stratus OCT™. These
instructions provide requirements and recommendations for the printer, but are generic
with respect to brand.

 Note: Carl Zeiss Meditec supplies and/or identifies specific printers that have been
approved for use with the instrument. An approved printer may come with detailed
configuration instructions, and users are advised to closely follow the instructions
supplied with the approved printer.
These instructions cover two configurations for communication between instrument and
printer:
1. Network Configuration (page 3), either via direct connection between
instrument and printer, or via connection of instrument and printer to a local area
network
2. USB Configuration (page 3), via direct USB connection between instrument and
printer

Printer Safety Warnings


WARNING: Except when powering the printer through the Stratus OCT
isolation transformer in the USB configuration, peripheral devices such as
printers must be placed at least 1.5 meters (4.9 feet) away from the patient,
such that the patient cannot touch a peripheral device with any part of his or
her body while being examined. In addition, the instrument operator must
not attempt to touch the patient and a peripheral device at the same time
while examining the patient. Failure to observe this warning could result in
electrical shock to the patient and/or examiner.

WARNING: When using the printer in the USB configuration, you must power
the printer through the Stratus OCT isolation transformer. Failure to observe
this warning could result in electrical shock to the patient and/or examiner. To
do so, you must use a special power cable. The required cable has an
IEC-320-14 connector on one end and a IEC-320-13 connector on the other
end. When the printer is purchased through Carl Zeiss Meditec, this cable is
included with the printer.

WARNING: To directly connect a printer to the Stratus OCT using a network


patch cord (UTP cable), only use an unshielded RJ-45 connector. Use of a
shielded network patch cord will ground the printer through the Stratus OCT,
which could result in electrical shock to the patient and/or examiner. It could
also invalidate the system safety approval.

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F-2 Printer Configuration Instructions

WARNING: Do not use the printer or the instrument with an extension cord or
a power strip (multiple portable socket outlet). For additional safety, do not
plug the printer and the instrument into the same wall outlet. Failure to
observe this warning could result in electrical shock to the patient and/or
examiner.

Approved Printers
Please refer to the Stratus OCT Technical Support section of our website
(www.meditec.zeiss.com/stratus) for the current list of approved hardware and software. If
you wish to use a third party printer, seek technical support from your printer manufacturer.
Repairs necessitated by the attempt to use a non-approved printer are not covered under
warranty.

WARNING: If you use a non-approved printer or if you connect it


incorrectly—for example, by plugging the printer into the wall while using a
USB connection, or by using a shielded network (UTP) cable—you could
invalidate the system safety approval. See the general warning regarding
Accessory Equipment below and the warnings regarding USB and network
connections on page F-1 above.

Accessory Equipment
WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards (e.g.,
IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment). Furthermore, all configurations shall comply with the system
standard IEC 60601-1-1. Any person who connects additional equipment to
the signal input part or signal output part configures a medical system, and is
therefore responsible for ensuring that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt, consult the
technical service department or your local representative.

Installation Overview
The following three general steps are common to all configurations. These steps are
explained further in the specific sections.
1. Printer hardware setup: Refer to the instructions provided with the printer to unpack
and set up the printer hardware.
2. Connect hardware to enable communication between instrument and printer. The
hardware used depends on the type of configuration you select: either a network
cable or a USB cable.
3. Configure the instrument software to communicate with the printer, including
installation of necessary printer drivers.

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Printer Configuration Instructions F-3

Network Configuration
Typically, no printer configuration is required for the network configuration. Three general
steps are required for configuration:
1. Connect the printer to the Stratus OCT via network cabling
2. Power on the printer
3. Install printer drivers on the Stratus OCT.
This is the usual sequence of steps, but follow the instructions provided with the approved
printer for details.

Using Network Cable(s) to Connect Stratus OCT and Printer


To establish network communication between the Stratus OCT and the printer, you can
directly connect instrument and printer with the network (ethernet) cable, or connect both
instrument and printer to the local area network or to a network switch/router/hub
connected to the Stratus OCT.

 Note: Use the same kind of network cable in all cases. (If you connect instrument
and printer to the network rather than to each other, you will need two network
cables.) Do not use an RJ-45 crossover cable for direct connection between
instrument and printer.

USB Configuration
No printer configuration is required for the USB configuration. Three general steps are
required for configuration:
1. Install printer drivers on the Stratus OCT
2. Connect the printer to the Stratus OCT via USB
3. Power on the printer
However, the sequence of steps may vary. Follow the instructions provided with the
approved printer to observe the correct sequence of steps.

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F-4 Printer Configuration Instructions

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I-1

Index results of using with unintended scan type 4-3, 6-3


Retina, list 6-2
A Retinal Map 6-33
Access Archived Scans 8-5 Retinal Thickness 6-30
Access Menu Options 2-3 Retinal Thickness/Volume 6-13
Accessory Equipment 1-16 Retinal Thickness/Volume Change 6-16
Acknowledgment, Legal 12-4 Retinal Thickness/Volume Tabular 6-14

Acquire Scan buttons 3-10 RNFL Thickness 6-17


RNFL Thickness Average 6-18
Acquire Scans 3-1, 3-10
RNFL Thickness Change 6-21
Acquisition Mode 3-4
RNFL Thickness Map 6-20
Activity Radio Buttons 4-2, 6-1
RNFL Thickness Serial Analysis 6-22
add a network archive 8-4
Scan Profile 6-40
Add/Manage Patient Records 2-9
Analysis Protocols Are Correlated with Scan Patterns 6-3
Adj Display button 6-25
analysis, exclude scans from 5-5
Adjust Scan Pattern Parameters 3-14
effect 5-3
Angle 3-14
Analyze button 5-3
angle and degrees 3-14
Analyze Scans 5-1
angle point of origin 3-14
Analyze Tab 5-3, 6-1
Number of Lines 3-14
Angle 3-14
Size 3-14
Value field 3-14 angle and degrees 3-14
Adjust Scan Placement 3-8 angle, point of origin 3-14
Adjust Scan Variables 3-15 Approved Printers F-2
A-Scans per Second and Scan Time 3-15 Approved Software 1-9, A-2
Axial Scan Length and Number of Data Points 3-15 Archive Registration 8-4
Number of A-Scans 3-15 archive registration, network 8-4
Adjust the focus 3-5 Archive Scans & Backup Database 8-1
Adjust The Height 3-1 Archive, Retrieve & Backup 8-1
Adjust Z-offset 3-6 Archive/Backup Scheme 8-3
adjusting scan parameters, when 4-4 archived scans, access 8-5
adjustments to the video image 3-6 A-scans
Align protocol 6-39 combined to form cross-sectional image 1-7
Aligning Large Scan Patterns 4-5 data points 1-7

Alignment and Acquisition Scan Modes 3-4 depth 1-7


transverse resolution 1-7
alignment markers 3-2
A-Scans per Second 3-15
Alignment Mode 3-4
A-Scans per second and Scan Time 3-15
Analysis Confidence Low 6-5
Auto Archive 8-4
Analysis Protocols 6-1
Auto Backup index database on shutdown 8-3
analysis protocols
application 4-3, 6-3
Auto Clear on startup/shutdown 8-3
cannot be applied additively 6-1 Automate Data Maintenance 8-3
General Tips 6-3 Available Adjustments for Individual Radial Scan Analysis 6-25
Glaucoma, list 6-2 axial “window” 3-7
Optic Nerve Head 6-23 Axial Length 2-10

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I-2

axial length of the scan image 3-6 Copyright, Software 12-3


Axial Resolution 11-1 Create a New Patient Record without Importing Exams 7-2
Axial Scan Length 3-15 Create and Assign Patient Diagnoses 7-11
Create and Edit Visit Records 7-6
B Cross Hair protocol 4-7
background noise 3-17 Cup Area 6-26
blue cursor 6-41 Cup Diameter 6-24
blue function buttons 3-10 Cup Offset 6-24
Blue patient module buttons 3-10 Cup/Disk Area Ratio 6-26
blue patient module buttons Cup/Disk Horizontal Ratio 6-26
left button 3-10 Cup/Disk Vertical Ratio 6-26
right button 3-11 Custom Scan 3-16
Blue PM buttons Customize Printouts 5-6
left button 3-10, 3-11
right button 3-11 D
brightness and contrast adjustment 3-18 Data Management 7-1
Data Management Preferences 8-3
C
data management preferences 8-3
Caliper On 6-5
Data menu
Cancel 3-11, 3-13, 4-4, 5-5
Export 9-8
Care in Handling 1-10 Import 9-10
case-sensitive records 7-11, 7-15 Data Protection Requirements 8-2
Categories, Create and Edit 7-9 Data Protection, Media Requirements 8-3
Categories, Place Patient Records in 7-10 Database Export 9-6
Categorize Patient Records 7-8 Database, Defragment 7-20
Category Field 2-7 Database, Patient 8-1
CE Mark 1-11 Default button 5-5
central circle button 3-9 Define Custom Scan 3-16
Change button 6-41 Define Custom Scan dialog box 3-16
chin cup 3-2 Defragment Database 7-20
Circle protocol 4-8 degrees and angle 3-14
Cleaning 10-2 Delete Exam Records 7-18
Cleaning Forehead and Chin Rests 10-2 Delete Patient Records 7-17
cleaning the ocular lens 10-2 Delete Patient, Visit and Exam Records 7-17
Clear Graphics button 6-25 Delete Visit Records 7-18
Clearing Scan Data 8-2 deleting exams 7-18
clinical notes, editing 7-8 deleting patients 7-17
color scale and interferometer signal range depicted 3-17 deleting visits 7-18
color scale of scan image 3-17 Details Tab 3-19
Comment Tab 3-19 Details View 4-1
Composite Image Features and Functionality 6-25 Diagnoses, create and assign 7-11
Composite Image Measurements 6-26 Diagnoses, edit 7-12
Computer Unit 1-8 DICOM 8-8
Concentric 3 Rings protocol 4-10

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I-3

Dilate the Patient 2-4 Print 5-6


Disk and Fovea Buttons 3-10 Find and Select Records 7-1
Disk Area 6-26 fixation LED
Disk Diameter 6-24 default locations 3-9, 3-10
Disk/Fovea buttons and fixation LED 3-10 Disk and Fovea buttons 3-10
DVD-RAM drive 8-6 fovea and disk locations 3-9, 3-10
moving to improve contrast and orientation 3-9
E Fixation LED, moving 3-9
Edit Clinical Notes 7-8 Fixation Method--Select 2-4
Edit Exam Record Remarks and Notes 7-7 fixation target light 2-4
Edit Layers 2-2 fixation target, moving 3-9
editing basic patient information 7-8 focus adjustment knob 3-5
editing patient information 7-4 Focus Adjustment Range 11-1
Electrical Requirements 11-1 Forehead and Chin Rests, Cleaning 10-2
Electromagnetic Compatibility (EMC) 1-13 Format of Display 6-38
Embedded Windows License 1-11 four-headed arrow 3-8
Enter Patient Data 2-5 Freeze with Flash, Scan menu 3-11
Environmental Conditions 11-2 functional areas, resize 2-3
Error Messages, Handling 10-1 Fundus Illumination Lamp 10-2
exams, deleting 7-18 fundus photo 3-13
Exclude Scans from Analysis 5-5 fuse replacement 10-3
Exiting Scans 4-4
Export And Import Scan Data 9-1 G
export archived data 9-10 Gaussian Smoothing protocol 6-39
Export Data 9-6 General Tips (analysis protocols) 6-3
export directly to another instrument 9-7 Glaucoma analysis protocols 6-2
Export Label dialog box 9-9 Glaucoma Protocols 4-2
Export Media & Methods 9-6 goal of positioning 3-5
export OCT images 9-2 green cursor 6-41
Export Retinal Thickness results 6-32
H
Export RNFL Thickness results 6-18
Handling Requirements 1-17
export to removable media 9-6
hardware elements 1-8
export via network 9-7
Home button 2-2
External Fixation 2-4, 11-1
Horizontal Integrated Rim Width (Area) 6-26
external fixation target 2-4
How It Works for You 1-7
F How The Stratus OCT Works 1-6
Fast Macular Thickness Map 4-7 How to Acquire Scans 3-10
Fast Optic Disc protocol 4-7 How to Adjust The Height 3-1
Fast RNFL Thickness (3.4) protocol 4-7 How to Position the Patient Module 3-5
Field of View 11-1
I
File menu
Illumination 11-1
Exit 2-1
Image Processing Protocols 6-2, 6-37
Export 9-9

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Align 6-39 Introduction 1-1


possible introduction of artifacts 6-39
application 4-3, 6-3 J
Format of Display 6-38 joystick 3-5
Gaussian Smoothing 6-39 joystick knob 3-5
Median Smoothing 6-39
Normalize 6-39 K
Normalize + Align 6-39 keyboard 1-8
Proportional 6-38
Scan Profile 6-40 L
Measure A-Scan Location 6-40 Lamp Brightness 3-18
Signal Offset Threshold Comparison 6-41 Lamp, expected life 10-2
image, small 3-13 Landmark 3-9
image, thumbnails 3-13 Large Icon View 4-1
Import Data 9-10, B-2 Layer On/Off 6-5
Imported data left blue button 3-10
Cannot Edit Identifying Information 9-1 Legal Notices 12-1
Data Integrity 9-1 License Agreement, Software 12-3, 12-4
DVD Disk Use Restrictions 9-2 License Terms and Conditions, Software 12-3
Patient Privacy 9-1 Limitation Of Liability 12-2
Privacy and Data Integrity Features 9-1 Limited Warranty for Software 12-6
Updating Imported Data 9-2
Line protocol 4-7
Indicators Tab 3-19
Lines 3-14
Individual Radial Scan Analysis 6-25
List of User Replacement Accessories 10-3
Information Tabs 3-18
List View 4-1
Comment Tab 3-19
lock the patient module 3-6
Details Tab 3-19
Log Abs. Reflectance checkbox 5-5
Indicators Tab 3-19
Initiate A Scan 3-3
M
Initiate A Scan--select a scan protocol 3-3 Macula Normative Database 6-7
Initiate An Analysis 5-1 Macular Thickness Map protocol 4-7
Installation Requirements 1-10 Macular Thickness Normative Data 6-7
Instrument Disposition 1-21 Macular Volume 6-14
Instrument Installation 1-10 Main fuses 11-2
insurance companies, create, edit and assign 7-15 Main Menu and Toolbar 2-2
insurance records are case-sensitive 7-15 Main Window
interferometer signal range, adjusting 3-17 functional areas 2-2
interferometry Manage Records 7-8
analogous to ultrasound 1-6
Manual
low-coherence, explained 1-6
Organization 1-6
principles 1-6
Purpose 1-3
Internal Fixation 2-4, 11-1 measurement algorithms 6-13
Internet Connectivity Risks A-2 Measurement Units 11-2
Interpreting Signal Strength 3-11, 6-4 Measuring Nerve Fiber Layer Thickness 4-5

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Media Requirements for Data Protection 8-3 number of A-scans 3-15


Median Smoothing protocol 6-39 Number of Data Points 3-15
Medical Staff Records, create and edit 7-14 Number of Lines 3-14
medical staff records, editing 7-14
Medical staff records, not case-sensitive 7-14 O
medical staff, assign to patient records 7-15 OCT Image Export 2-2, 9-2
Merge Patient Records 7-4 OCT Image Tab 3-17
merging Noise and Range 3-17

constraint on same visit dates 7-6 Number of A-Scans 3-18

merging records unintentionally 7-2 ocular lens 10-2


Method of ONH Analysis 6-24 ocular lens, retract and extend 3-5
Methods to Measure Retinal and RNFL Thickness 6-13 Optic Disc protocol 4-10
Mirror Image 6-5 Optic Nerve Head 6-23
mouse 1-8 Optic Nerve Head (ONH) Analysis
Adj Display button 6-25
Move the Disk Reference Points 6-25
Adjustments for Individual Radial Scan Analysis 6-25
Move the Fixation LED 3-9
Clear Graphics button 6-25
move the fixation target 3-9
Composite Image Features and Functionality 6-25
Move the Scan Pattern 3-8
Composite Image Measurements 6-26
Cup Area 6-26
N
Cup/Disk Area Ratio 6-26
Name drop-down list 3-16
Cup/Disk Horizontal Ratio 6-26
NAS Device configuration E-1
Cup/Disk Vertical Ratio 6-26
NAS Device Safety Warnings E-1
Disk Area 6-26
Navigation in General 2-3
Horizontal Integrated Rim Width (Area) 6-26
Nerve Fiber Layer Thickness, Measuring 4-5 Image Background Options 6-26
Nerve Head Circle protocol 4-10 Individual Radial Scan Analysis 6-25
Network Activities Not Supported A-3 Method 6-24
network activities, not supported A-3 Move the Disk Reference Points 6-25
network activities, proscribed A-3 Optic Nerve Head Analysis Results 6-25
Network Archive Registration 8-4 ReAnalyze button 6-25
network archive registration 8-4 Rim Area 6-26
Network Cable(s) F-3 Surface Sensitivity 6-25
Network Capabilities A-1 Vertical Image Rim Area (Volume) 6-26
Network Configuration F-3 Optic Nerve Head Analysis Results 6-25
Network Storage Device Configuration E-1 Optical Power 11-1
Networking Guidelines A-1, C-1 Optimize Polarization 3-7
Networking Risks A-2 Optimize Scan Image 3-6
new patient records, creating 7-2 Optimize Z-offset button 3-7
Noise 3-17 Optional Scan Review Window 3-13
Normalize + Align protocol 6-39 Options Menu, Preferences 8-3
Normalize protocol 6-39 Organization of The Manual 1-6
Normative Data and Its Applicability 6-6
Number of A-Scans 3-18, 4-5 P
Password 1-18

Stratus OCT User Manual PN 2660021134133 A


I-6

patient comfort Prepare To Scan 2-1


see Adjust the Height Print 2-2
Patient Database 8-1 Print button 5-6
Patient Experience 2-5 Print Clinical Notes 7-2
flash 2-5 Print Patient Data 7-2
time required 2-5 printer 1-8
what the patient sees 2-5 Printer Configuration F-1
patient information, editing 7-4, 7-8 Printer Safety Warnings F-1
Patient List 2-6 printers, approved F-2
Patient List Views 2-7 Product Compliance 1-11
Details View 2-7 Progress dialog box 9-10
List View 2-7
Proportional Circle protocol 4-9
Patient menu 2-9 Proportional protocol 6-38
Patient Module 1-8, 2-1, 2-5, 3-2, 3-5, 3-10, 11-2 Proscribed Network Activities A-3
blue function buttons 3-10
Protective Packing Symbols 1-17
patient module
protocols
lock 3-6
number and application 1-7
unlock 3-6
Purpose Of This User Manual 1-3
Patient Module, positioning 3-5
patient record Q
deleting exams from 7-18 Quantitative Analysis Protocols 6-13
patient record identifier 7-2 General Information 6-13
patient records, creating without importing 7-2 Quantitative Analysis Protocols, listed by application 6-2
patient records, deleting 7-17
patient records, merging 7-4 R
Patient Tab 2-9 Radial Lines protocol 4-7
patients, deleting 7-17 Radius 1 and Radius 2 3-14
Physical Dimensions 11-2 Range 3-17
PM range of interferometer signals depicted 3-17
see Patient Module Raster Lines protocol 4-8
point of origin 3-14 ReAnalyze button 6-25
Polarization and scan mode 3-8 records
Polarization, when to adjust 3-8 exam remarks and notes 7-7
Position The Patient Module 3-5 patient, merging 7-4
Position the Patient Module 3-5 red cursor 6-41
Position the Patient Module, How to 3-5 reflectivity values
Position the Patient Module, Tools 3-5 see Signal Intensity values
positioning tools Register a Network Archive 8-4
focus knob 3-5 Register, Edit and Assign Insurance Companies 7-15
joystick knob 3-5 Register, Edit and Assign Medical Staff 7-14
power down the system 2-1 Repeat Scan Function 4-11
Power Fuses 10-3 Replacement Accessories 10-3
Power Up The System 2-1 Report Signs Of Wear 10-2
Preferences, Data Management Tab 8-3 Resize Functional Areas 2-3

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resolution, transverse 3-15 optimize Z-offset 3-6


Retina analysis protocols 6-2 scan image vs. video image 3-6
Retina Protocols 4-2 Scan List 5-2
Retinal Map protocol 6-33 Scan menu
Retinal Thickness protocol 6-30 Define Custom Scan 3-16
Retinal Thickness/Volume Change protocol 6-16 Freeze with Flash 3-11
Retinal Thickness/Volume protocol 6-13 Scan Variables 3-15

Retinal Thickness/Volume Tabular protocol 6-14 Scan Messages 3-11, 3-12, 6-4, 6-5
Review button 3-13 Scan Messages, Interpreting 3-11, 6-4
right blue button 3-11 Scan Mode button 3-4, 3-10
Rim Area 6-24, 6-26 Scan Parameter Tab 3-7
Rim Area (Vert. Cross Section) 6-23 Scan Pattern Parameter area 3-14
RNFL Map protocol 4-9 Scan Pattern, moving 3-8
RNFL Normative Database 6-6 Scan Patterns 11-1
RNFL Thickness (2.27xdisc) protocol 4-9 Scan Pixels 11-1
RNFL Thickness (3.4) protocol 4-8 scan placement 3-8
RNFL Thickness Average protocol 6-18 and scan mode 3-8
automated features 3-8
RNFL Thickness Change protocol 6-21
Click and Drag 3-8
RNFL Thickness Map protocol 6-20
Move the Fixation LED 3-9
RNFL Thickness Normative Data 6-6
Move the Scan Pattern 3-8
RNFL Thickness protocol 6-17
Scan Profile protocol 6-40
RNFL Thickness Serial Analysis protocol 6-22
Scan Protocol Descriptions, Options And Tips 4-6
Routine Cleaning 10-2
Scan Protocol Groups 4-1
Routine Maintenance 10-1
Scan Protocols
Circle 4-8
S
Concentric 3 Rings 4-10
safety, NAS device E-1
Cross Hair 4-7
safety, printers F-1
Fast Scans
Save button 3-11, 3-13
Fast Macular Thickness Map 4-7
Scan Acquisition Protocols 4-1
Fast Optic Disc 4-7
Scan Acquisition Time 11-1
Fast RNFL Thickness (3.4) 4-7
Scan Acquisition Window 3-4 Line 4-7
Scan Adjustments, Other 3-13 Macular Thickness Map 4-7
Scan button 4-1 Nerve Head Circle 4-10
Scan Direction Legend 6-4 Optic Disc 4-10
Scan drop-down list 3-16 Proportional Circle 4-9
Scan Group Images Tab 5-2 Radial Lines 4-7
scan image 3-5 Raster Lines 4-8
bringing it into view 3-7 RNFL Map 4-9
scan image and axial “window” 3-7 RNFL Thickness (2.27xdisc) 4-9
scan image color scale 3-17 RNFL Thickness (3.4) 4-8
scan image optimization X-Line 4-8
optimize polarization 3-7 scan protocols
application 4-3, 6-3

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Scan Protocols Are Correlated with Analysis Protocols 4-3 Software and Storage Media 1-8
Scan Protocols, all listed 4-2 Software Copyright 12-3
Scan Range 11-1 Software License Agreement 12-3, 12-4
Scan Review Window 3-13 Software Support Agreement 12-8
Scan Selection button 5-3 Specifications 11-1
Scan Selection for analysis, optional 5-2 CE Mark 1-11
Scan Speed 11-1 Electrical Requirements 11-1
Scan Tab 4-1 Environmental Conditions 11-2
Scan Tab Views 4-1 Fundus Imaging 11-1
Details View 4-1 Measurement Units 11-2
Large Icon View 4-1 Physical Dimensions 11-2
List View 4-1 Start-up 11-2
Small Icon 4-1 System Control Input Devices 11-2

Scan Time 3-15 System Weight 11-3


Table Loading Capacity 11-3
Scan Variables dialog box 3-15
Tomographic Imaging 11-1
Scan, Landmark and Fixation LED Controls 3-9
Spherical Equivalent 2-10
Scanners 11-1
Spot Size at Retina 11-1
Schedule for Archive and Backup 8-3
staff--create, edit and assign 7-14
search by name 5-1
Start Window 10-1
search by patient ID 5-1
Start-up 11-2
Search Field 2-7
Stratus Database Export 9-7
Search field 5-1
Stratus OCT
searching with case-sensitive criteria 7-11, 7-15
How it works 1-6
Select a Patient 2-7, 5-1
Stratus OCT password 1-18
select a scan acquisition protocol 3-3
STRATUSOCT
Select Acquisition Protocol button 4-1
applications 1-7
Select an Analysis Protocol 5-3
features and benefits 1-7
Select Analysis Protocol button 5-1, 6-1
histories and monitoring 1-7
Select Scan Group(s) 5-1
How it works for you 1-7
Select the Fixation Method 2-4 Main Window 2-2, 2-3
Select toolbar buttons 2-2, 4-4 Scan Tab 4-1
Selection Window 5-4 Navigate to the Main Window 2-2
Service Contract 12-2 resolution 1-7
Shadows 3-6 System Described 1-6
Signal Intensity values 6-40 System Hardware 1-8
Signal source 11-1 super luminescent diode (SLD)
Signal Strength Indicator 3-11, 6-4 OCT technology 1-6
Signal Strength, Interpreting 3-11, 6-4 wavelength 1-6
Signal Type 11-1 see also interferometry
Site ID And Logo 5-6 Surface Sensitivity 6-25
Size 3-14 Symbols and Labels 1-17
Size vs. Resolution 4-5 Symbols Defined 1-17
Small Icon 4-1 Synchronization Disabled 8-5

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System Control Input Devices 11-2 Lamp Brightness 3-18


system password 1-18 Video Brightness and Contrast 3-18
System Weight 11-3 Video Brightness and Contrast 3-18
video image 3-6
T video image, adjusting 3-18
table height switch 3-1 video image, adjustments 3-6
Table Loading Capacity 11-3 Video Monitor 1-8
consequences of reconfiguration 11-3 visit dates and merging patient records 7-6
Table of Correlations 4-3, 6-3 visit record
target light 3-6 deleting visits from 7-18
Text Convention 2-3 visit records, create 7-6
Third Party Software A-2 visit records, edit 7-6
thumbnail image 3-13 visits
Tips to Avoid Damage 1-10 deleting 7-18
Tomographic Imaging 11-1
Tools to Position the Patient Module 3-5 W
Total Macular Volume 6-14 Warranty, defined 12-1
Transport and Storage Conditions 1-17 Warranty, Limited 12-6
Transverse Resolution 11-1 Warranty, Note Regarding 10-1
transverse resolution 3-15 wear, report 10-2
two-headed arrow 3-8, 3-14 Which Scan Parameters Can Be Adjusted When 4-4
why move the fixation target 3-9
U Windows user name 1-18
unlock the patient module 3-6 Workgroup Name 1-18
USB Configuration F-3
User Changes to Software or Hardware 1-9 X
User Name 1-18 x and y positions
Using the Wireless Printer B-1, E-1, F-1 scan, landmark and fixation LED 3-9
X-Line protocol 4-8
V
Validated Antivirus Software A-2 Z
Value field 3-14 Z-offset and scan mode 3-7
Vertical Integrated Rim Area (Volume) 6-26 Z-offset arrow buttons 3-7
Video and Lamp Parameter Tab 3-18 Zoom buttons in Optic Nerve Head Analysis 6-25

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Stratus OCT User Manual PN 2660021134133 A


Carl Zeiss Meditec, Inc. Carl Zeiss Meditec AG


5160 Hacienda Drive Goeschwitzer Strasse 51-52
Dublin, CA 94568 07745 Jena
USA Germany
Toll Free: 1 800 341 6968 Phone: +49 36 41 22 03 33
Phone: +1 925 557 4100 Fax: +49 36 41 22 01 12
Fax: +1 925 557 4101 info@meditec.zeiss.com PN 2660021134133 A
info@meditec.zeiss.com www.meditec.zeiss.com Stratus OCT User Manual
www.meditec.zeiss.com Specifications subject to change

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