Zeiss 3000 User manual

User Manual
Stratus OCT
Model 3000 Instrument and Stratus Review Software Version 7.0

Stratus OCT User Manual PN 2660021134133 A
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

Contents
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•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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•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

Contents
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•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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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:
•Wheelchairuser
• 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).

Introduction
Stratus OCT User Manual PN 2660021134133 A
1-2
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

Stratus OCT User Manual PN 2660021134133 A
Introduction 1-3
• Review the analysis report for completeness
• Output the analysis report
•Archivedata
•Turnofftheinstrument
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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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:
•EnhancedRepeat 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.
•EnhancedAdvanced 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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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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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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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
Video Monitor Patient Module
Focus Adjustment
Knob
Blue PM
Function Buttons
Keyboard
Joystick
Printer
Wheel Chair
Accessible
Power Table
Caster
Table Height
Switch
Computer Unit
System Power
Switch
Mouse
(not pictured)
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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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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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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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.