Zeiss CIRRUS HD-OCT 500 User manual

2660021156446 B2660021156446 B
CIRRUS HD-OCT
User Manual – Models 500, 5000

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
ii
Copyright
© 2017 Carl Zeiss Meditec, Inc. All rights reserved.
Trademarks
CIRRUS, AngioPlex, ChamberView, FastTrac, FORUM, GPA, and Live OCT Fundus. are either
registered trademarks or trademarks of Carl Zeiss Meditec, Inc. in the United States and/or
other countries.
Windows, Windows Media, Windows Server, and Microsoft are either registered
trademarks or trademarks of Microsoft Corporation in the United States and/or other
countries.
Mac OS, iMac, iPad, and QuickTime are either registered trademarks or trademarks of
Apple Inc. in the United States and/or other countries.
All other trademarks used in this document are the property of their respective owners.
Patents
www.zeiss.com/meditec/en_us/imprint/patents

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
iii
1 Safety and Certifications
Symbols and Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Warning and Caution Definitions . . . . . . . . . . . . . . . . . . 1-2
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Protection of Patient Health Information . . . . . . . . . . . . 1-4
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Record and Data Safety . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Networking Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . 1-10
RoHS Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
2 Introduction
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Intended Operator Profile . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Demographic. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Occupational Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Job Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Data Analyst Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Demographic. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Occupational Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Job requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Subject Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Installation and Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
User Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Accessing PDF Versions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Instruction Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
3 System Overview
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Power Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Power Down Through Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Power Down Through Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
iv
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Licensed Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Basic Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Toolbar Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Navigation Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Components of Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
4 System Administration
Institution Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Station Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Staff Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Register New Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Edit Staff Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Delete Staff Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Category Registration and Maintenance . . . . . . . . . . . . 4-4
Category Registration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Edit Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Delete Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Archive Setup and Selection . . . . . . . . . . . . . . . . . . . . . 4-6
Set up a CIRRUS HD-OCT Archive . . . . . . . . . . . . . . . . . . . . . . 4-6
Change The Current Archive. . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Set Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Archive/Synchronize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Archive Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Normative Data Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
DICOM Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Display Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
IPv4 / IPv6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Preventive Maintenance Service Notifier. . . . . . . . . . . . . . . . . . . . . . 4-11
User Login/Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
User Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
User Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Logout Locks the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Automatic Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
5 Clinical Workflow
The Importance of Good Clinical Workflow . . . . . . . . . . 5-1
Patient Good Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Specific to Iris Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Specific to Fundus Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
v
Daily Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Start of Day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
End of Day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Archive Saved Exams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Shut Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Patient Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Add New Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Find Existing Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Advanced Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Add or Remove Categories for Existing Patient Records . . . . . 5-7
View Today’s Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
How Today’s Patients List Is Populated . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Patient ID Search Conflicts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Patient Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Optional Dilation of Patient’s Eye(s) (Posterior Segment) . . . 5-10
Position the Patient on the Chinrest . . . . . . . . . . . . . . . . . . . 5-10
Optional Eyelid Elevation . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Patient Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Of Special Note for Anterior Scans . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
6 Acquiring Scans
Overview of Scan Types. . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Posterior Segment Scans. . . . . . . . . . . . . . . . . . . . . . . . . 6-2
CIRRUS OCT Angiography . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Angiography Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Montage Angio Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
ONH Angiography Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Macula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Macular Cube 200x200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Macular Cube 512x128 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Optic Nerve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Optic Disc Cube 200x200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Macular and Optic Disc Cube Scans . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Visualization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Macular or Optic Disc Cube Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Raster Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Guidelines for Raster Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Anterior Segment Scans . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Scan Preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Instrument Imaging Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Scan Acquisition Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Scan Pattern Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Aligning Scans Corrected for Beam Scanning Geometry and Corneal Refraction 6-7

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
vi
Center Corneal Scans on the Corneal Vertex. . . . . . . . . . . . . . . . . . . . 6-7
Anterior Chamber and Cornea External Lenses . . . . . . . . . . . 6-7
Attaching an External Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Anterior Chamber Scan (Chamber View™). . . . . . . . . . . . . . . 6-8
Guidelines for Anterior Chamber Scan Acquisition . . . . . . . . . . . . . . . 6-9
Anterior Segment Cube Scan . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Guidelines for Anterior Segment Cube 512x128 Scan Acquisition . . . 6-11
HD Angle Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Guidelines for HD Angle Scan Acquisition . . . . . . . . . . . . . . . . . . . . 6-13
HD Cornea Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
Guidelines for HD Cornea Scan Acquisition . . . . . . . . . . . . . . . . . . . 6-14
Wide Angle-to-Angle Scan . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Guidelines for Wide Angle-to-Angle Acquisition . . . . . . . . . . . . . . . . 6-16
Pachymetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Guidelines for Pachymetry Scan Acquisition . . . . . . . . . . . . . . . . . . . 6-17
Anterior Segment 5–Line Raster Scan . . . . . . . . . . . . . . . . . 6-18
Guidelines for Anterior Segment 5 Line Raster Scan Cornea Acquisition 6-19
Acquire Screen and Controls . . . . . . . . . . . . . . . . . . . . . 6-19
Acquire Screen Toolbar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Available Scans List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Scan Organizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Iris Viewport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
Scan Position Montage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
6x6 mm Montage Angio Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
8x8 mm Montage Angio Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
Fundus Viewport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
Mouse Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Live Scan Viewports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
General Acquire Procedure . . . . . . . . . . . . . . . . . . . . . . 6-28
To Begin Scan Acquisition: . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28
Set Up for Maximum Image Quality . . . . . . . . . . . . . . . . . . . 6-31
Iris image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Fundus image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
B-scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
For All Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
Tracking and Repeat Scans . . . . . . . . . . . . . . . . . . . . . . 6-32
Repeat Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
FastTrac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Troubleshooting FastTrac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
7 Scan Quality Check
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Quality Check Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Criteria for Image Acceptance . . . . . . . . . . . . . . . . . . . . 7-5

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
vii
Fundus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
OCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Check for Saccades and Banding . . . . . . . . . . . . . . . . . . . . . . 7-5
Advanced RPE Analysis Acceptance Criteria . . . . . . . . . . . . . . 7-6
CIRRUS OCT Angiography Acceptance Criteria . . . . . . . . . . . . 7-7
Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Decorrelation Tails . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Segmentation Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Anterior Segment Acceptance Criteria . . . . . . . . . . . . . . . . . 7-11
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Anterior Segment Cube Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Pachymetry Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
8 Analysis
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Image Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Normative Database Comparisons . . . . . . . . . . . . . . . . . . . . . 8-3
Adjusting Slab Locations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Preset Slab Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Standard Presets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Create Global Custom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Create Scan Custom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Posterior Segment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Macular Thickness Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Fovea Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
ETDRS Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
ILM–RPE Layers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Slab Overlay ILM–RPE Thickness Map. . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Additional Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Macular Change Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Manual Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Macular Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Synchronized Data Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
XML Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Macular Thickness OU Analysis. . . . . . . . . . . . . . . . . . . . . . . 8-16
Advanced RPE Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17
RPE Elevation Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-18
Sub–RPE Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Ganglion Cell OU Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-22
En Face Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
En Face Analysis Preset Slabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-25
ONH and RNFL OU Analysis . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
RNFL Thickness Maps and Deviation from Normal Maps. . . . . . . . . . 8-29
Changing RNFL Calculation Circle Placement . . . . . . . . . . . . . . . . . . 8-30
TSNIT Thickness Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30
RNFL Data Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-31
RNFL and ONH Normative Databases. . . . . . . . . . . . . . . . . . . . . . . . 8-31

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
viii
Advanced Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-31
Guided Progression Analysis . . . . . . . . . . . . . . . . . . . . . . . . 8-31
Parameter Summary Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32
Summary Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33
RNFL & ONH Guided Progression Analysis . . . . . . . . . . . . . . . . . . . . 8-34
Ganglion Cell Guided Progression Analysis. . . . . . . . . . . . . . . . . . . . 8-38
Anterior Segment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-41
Anterior Chamber Depth and Lens Vault . . . . . . . . . . . . . . . 8-41
Angle-to-Angle Distance . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-42
Using Anterior Chamber Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-42
Using Wide Angle-to-Angle Analysis . . . . . . . . . . . . . . . . . . . . . . . . 8-43
Corneal Thickness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-43
In Pachymetry Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44
View Dropdown. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44
In HD Cornea Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-49
In Anterior Chamber Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-49
In Anterior Segment Cube Analysis . . . . . . . . . . . . . . . . . . . . . . . . . 8-49
In HD Images Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-50
Epithelial Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-51
In Pachymetry Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-51
Central Corneal Thickness (CCT) Measurement. . . . . . . . . . . 8-52
Angle Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-53
In HD Angle Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-53
In Anterior Chamber Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-54
In Wide Angle-to-Angle Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-55
Specialized and Integrative Visualization Tools . . . . . . . 8-55
High Definition Images Analysis . . . . . . . . . . . . . . . . . . . . . 8-55
Change the Displayed Scan Line . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-57
Image Display Options Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-57
Single Eye Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-58
The Panomap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-59
3D Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-60
View Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-61
Show Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-62
Clip Selector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-62
Clip Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Lighting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Light Direction Adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Greyscale Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Animation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Animation Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Movie Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-64
AutoRecord Keyframes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-65
Take Snapshot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-65
Width, Height, and A–Scan Adjustments . . . . . . . . . . . . . . . . . . . . . 8-66
Mouse Rotates/Mouse Translates. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-66
Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-66

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
ix
Straighten Volume Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-66
Transparent Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-67
Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-67
Advanced Visualization Analysis . . . . . . . . . . . . . . . . . . . . . . 8-68
Retinal Layers Automatically Detected and Displayed . . . . . . . . . . . . 8-69
Fundus Image Overlay Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-69
Slice and Slab Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-70
Function Buttons in Advanced Visualization . . . . . . . . . . . . . . . . . . . 8-71
9 CIRRUS OCT Angiography
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
CIRRUS OCT Angiography, Montage Angio, and ONH Angiography
Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
CIRRUS OCT Angiography Presets. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
B-Scan Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
AngioPlex Metrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Current View References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Overlays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Vessel Density and Capillary Perfusion . . . . . . . . . . . . . . . . . 9-11
Vessel Density vs. Capillary Perfusion . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Foveal Avascular Zone (FAZ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
AngioPlex Metrix Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16
Overlay Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
ETDRS Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Angiography and ONH Angiography Change Analysis . . . . . 9-19
Previous Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
Options Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Toggle Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
ONH Overlay and Angio Metrix Bar . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Selected Scan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
AngioPlex Metrix in Change Analysis . . . . . . . . . . . . . . . . . . . . . . . . 9-22
ONH RNFL Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
OCT Angiography Change - Manual Selection. . . . . . . . . . . . 9-23
AngioPlex Preset Algorithms . . . . . . . . . . . . . . . . . . . . . . . . 9-24
ONH Angiography Change Analysis Image Registration . . . . . . . . . . 9-27
10 Reports and Printing
Standard Print Options . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
The Report Preview Screen . . . . . . . . . . . . . . . . . . . . . . 10-2
Analysis Related Report Options. . . . . . . . . . . . . . . . . . 10-4
Macula Thickness Report Options . . . . . . . . . . . . . . . . . . . . . 10-4
The Macula Multi–Slice Option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
Macula Radial Report Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6
Advanced Visualization Report Options . . . . . . . . . . . . . . . . 10-6
ONH and RNFL Thickness Report Options . . . . . . . . . . . . . . . 10-8
Normative Data Details Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
x
High Definition Images Report (Raster Scan Options) . . . . 10-10
Guided Progression Report Options . . . . . . . . . . . . . . . . . . 10-11
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Latest Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Parameters Summary Table Report. . . . . . . . . . . . . . . . . . . . . . . . . 10-12
How to Read the GPA Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
Normative Data Details Reports. . . . . . . . . . . . . . . . . . . . . 10-15
Macula Thickness Normative Data Details Report . . . . . . . . . . . . . . 10-15
11 Data Management
FORUM/DICOM or Native Environment . . . . . . . . . . . . . 11-1
Importing and Exporting Data. . . . . . . . . . . . . . . . . . . . 11-1
Patient Privacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Data Integrity of Imported Records . . . . . . . . . . . . . . . . . . . 11-2
Import/Export Native Mode . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
FORUM/DICOM Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Transferring Images in OPT IOD and OP IOD Formats . . . . . 11-5
Data Queries and Search Options . . . . . . . . . . . . . . . . . 11-7
XML Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Batch XML Export. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
XML Export from Analysis Screens . . . . . . . . . . . . . . . . . . . . 11-9
Values Exported: Macular Thickness Analysis . . . . . . . . . . . . . . . . . 11-10
Values Exported: ONH and RNFL OU Analysis. . . . . . . . . . . . . . . . . 11-11
Export Values: Macular Change Analysis . . . . . . . . . . . . . . . . . . . . 11-12
Values Exported: Guided Progression Analysis . . . . . . . . . . . . . . . . 11-13
Values Exported: Ganglion Cell OU Analysis . . . . . . . . . . . . . . . . . . 11-14
Values Exported: Advanced RPE Analysis . . . . . . . . . . . . . . . . . . . . 11-15
Advanced Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Dat Files of ILM–RNFL Thickness Maps . . . . . . . . . . . . . . . 11-16
Txt Profiles of Neuro–retinal Rim Thickness and RNFL Thickness 11-16
Move Scan Data (Native Mode Only). . . . . . . . . . . . . . 11-16
Log Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
12 Routine Maintenance
Troubleshooting Power Problems . . . . . . . . . . . . . . . . . 12-1
If Not Using the Optional Power Table . . . . . . . . . . . . . . . . . 12-1
If Using the Optional Power Table . . . . . . . . . . . . . . . . . . . . 12-1
Handling Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Product Labels and Serial Number Location . . . . . . . . . . . . . . . . . . . 12-2
Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-2
Forehead and Chinrests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
External Surfaces of the Instrument . . . . . . . . . . . . . . . . . . . 12-3
Imaging Aperture Lens and External Lenses . . . . . . . . . . . . 12-3

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
xi
LCD (Monitor) Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Top Fan Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
User Replacement Accessories . . . . . . . . . . . . . . . . . . . 12-5
Performance Verification Check . . . . . . . . . . . . . . . . . . 12-6
Install the Verification Test Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Run the Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-7
13 Specifications
HD-OCT Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
HD-OCT Imaging for Posterior Segment Scans . . . . . . . 13-1
HD-OCT Imaging for Anterior Segment Scans . . . . . . . . 13-1
Fundus Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Iris Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-2
Electrical, Physical and Environmental . . . . . . . . . . . . . 13-3
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Measurement Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
14 Legal Notices
Software Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Software License Agreement. . . . . . . . . . . . . . . . . . . . . 14-1
Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-2
A Normative Data Results
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
RNFL and Macula Normative Databases: Diversified . . . A-1
Inclusion and Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . A-2
Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Scan Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Database Population. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Age Coefficient – RNFL Thickness. . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Description of Macular Scan Parameters Used in CIRRUS HD-OCT . . . . A-6
Age Coefficient – Macula Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
Optic Nerve Head Normative Database: Diversified . . . . A-9
Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
Scan Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
xii
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11
Factors that Affect CIRRUS ONH Normative Ranges . . . . . . A-11
2Age. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12
Optic Disc Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12
Ethnicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12
Calculation of Normal Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12
Presentation of Normative Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13
Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-14
RNFL and ONH Normative Databases . . . . . . . . . . . . . . A-15
Distribution of Normals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16
Interactivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19
Ganglion Cell Normative Database: Diversified . . . . . . . A-19
Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20
Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20
Scan Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
Factors that Affect CIRRUS Ganglion Cell Analysis Normative Ranges A-21
Age. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-22
Ethnicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-22
Axial Length and Refractive Error . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24
Asian Normative Database4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-24
Inclusion and Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . A-25
Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25
Exclusion Criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25
Data Collection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26
Scan Selection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26
The Asian Dataset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-27
Normative Database Analyses . . . . . . . . . . . . . . . . . . . . . . . A-27
Description of RNFL Parameters. . . . . . . . . . . . . . . . . . . . . . A-28
Age Coefficient – RNFL Thickness . . . . . . . . . . . . . . . . . . . . A-28
Age Coefficient – Macula Thickness. . . . . . . . . . . . . . . . . . . A-29
Normal Values for Ganglion Cell Analyses . . . . . . . . . . . . . . A-30
Normal Values for Asian ONH Measurements . . . . . . . . . . . A-31
Factors that Affect ONH Normative Ranges . . . . . . . . . . . . . A-32
Age. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-32
Optic Disc Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-32
Ethnicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-32
Calculation of Normal Limits . . . . . . . . . . . . . . . . . . . . . . . . A-33
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-33

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
xiii
B CIRRUS Algorithm Studies
Study 1: Retinal Segmentation and Analysis . . . . . . . . . . . . . . B-1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Results and Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Repeatability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
Study 2: Repeatability and Reproducibility of Illumination Area
Measurements Under the Retinal Pigment Epithelium . . . . . B-9
Phase 1: Inter–Device Variability . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Phase 2: Inter–Operator Variability. . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Study 3: Repeatability and Reproducibility of Macular Retinal Pigment
Epithelium Elevation Measurements . . . . . . . . . . . . . . . . . . . B-12
Phase 1: Inter–Device Variability . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12
Phase 2: Inter–Operator Variability. . . . . . . . . . . . . . . . . . . . . . . . . . B-12
Study 4: Repeatability and Reproducibility of GCA and ONH Parameters
B-15
Study 5: Anterior Segment Accuracy, Repeatability and Reproducibility
B-19
Benchtop Scanning Accuracy, Repeatability and Reproducibility . . . . B-19
CIRRUS HD-OCT Repeatability in Measuring Central Corneal Thickness B-19
Performance of CIRRUS HD-OCT RNFL Analysis. . . . . . . . . . . . . . . . . B-20
Study 6: CIRRUS OCT Angiography . . . . . . . . . . . . . . . . . . . B-22
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-22
C CIRRUS HD-OCT Repeatability and
Reproducibility of Anterior Scan Measurements
Study 1: Performance of Pachymetry and Anterior Chamber scan
measurements in normal corneas and in subjects with corneal
pathology, and performance of Pachymetry in post-LASIK
subjects, including repeatability, reproducibility, and comparison
to Visante C-1
Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Inclusion Criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Normal Cornea Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Corneal Pathology group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Post-LASIK group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Normal Cornea Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Corneal Pathology Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Post-LASIK Group. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
xiv
Study 2: Repeatability and reproducibility of Wide Angle to Angle
and HD Angle scan measurements in subjects with glaucoma,
including repeatability, reproducibility, and comparison to Visante
C-9
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
Data Collection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9
Data Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-9

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Symbols and Labels 1- 1
1 Safety and Certifications
Before using the CIRRUS HD-OCT, you must fully understand potential safety hazards. Read
the following safety warnings and cautions in their entirety before using the HD-OCT
instrument. Additional warnings and cautions are found throughout the instructions for
use.
Symbols and Labels
Warning
Caution
Note
Must Follow Instructions for Use
Stand–by
Fuse
Direct Current
Type B applied parts
Manufacturer
Authorized European Community Representative
Serial number
Catalog number / part number
Model number
Conforms to applicable European Directive(s)
CE Mark with identification number of DQS – accredited Notified Body for compliance assessment
to the European Union directives, including Medical Device Directive 93/42/EEC.

Warning and Caution Definitions
2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
1- 2
Warning and Caution Definitions
The terms WARNING and CAUTION and the symbol designating each are defined as
follows.
WARNING: Indicates hazards that, if not avoided, may cause severe injury or death.
CAUTION: Indicates hazards that, if not avoided, may result in minor or moderate injury,
or damage to or impaired performance of equipment.
Warnings
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 Zeiss service
representative may install the instrument.
WARNING: Do not open the instrument covers. (Exception: You may remove the rear cover
to access labels and connectors.) Opening the instrument covers could expose you to
electrical and optical hazards.
WARNING: To maintain patient safety, if the instrument is externally connected to non–
medical peripheral devices (i.e., printer, storage devices, etc.), the complete system must
comply with the system requirements in standard IEC 60601–1. This standard requires the
usage of an Isolation Transformer to power the non–medical peripheral device(s) if located
within 1.5 m from the patient. If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the instrument, a separation device must
be used or there shall be no electrical connection between the non–medical peripheral
device and the instrument.
WARNING: The person or the responsible organization connecting additional devices or
reconfiguring the system must evaluate the complete system to ensure compliance to the
applicable IEC 60601–1 requirements.
WARNING: The instrument operator must not attempt to touch the patient and the
peripheral device simultaneously.
Certification mark of CSA – Nationally recognized test laboratory for US and Canada
Disposal of the Product within the E.U. Do not dispose via domestic waste disposal system or
communal waste disposal facility.
Caution: Federal law (or United States) restricts this device to sale by or on the order of a licensed
healthcare practitioner

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Cautions 1- 3
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: The instrument itself is transportable and may be moved from one location to
another. However, if the instrument is placed on a power table provided by CZMI, do not
move the table to another location while the instrument and any other peripherals are
placed on it. Doing so may cause the system components to tip over and cause harm to the
patient, the operator, or others in the vicinity.
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.
Cautions
CAUTION: Failure to provide proper ventilation could potentially lead to heat build–up,
which could cause component failure and/or fire.
CAUTION: Users are not authorized to dismantle (except to remove the rear cover) or
modify the CIRRUS HD-OCT hardware. To transport the instrument outside the office, you
must consult with a Zeiss service technician.
CAUTION: Avoid tipping. 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.
CAUTION: When you complete scan acquisition and before you click the
Finish or ID
Patient
buttons in the Acquire screen, always prompt the patient to sit back and move the
head away from the chinrest. Clicking either of these buttons in the
Acquire screen causes
the chinrest to reposition itself beyond the point where the patient’s eye would contact the
lens if the head remained in the chinrest. Failure to observe this warning could result in
injury to the patient.
CAUTION: The operator should check that the patient is not holding on to the instrument
before or during tests. Although movement of the motorized chinrest is slow, giving plenty
of warning for patients to remove their fingers, there is potential for fingers to be squeezed
and possibly injured.

Protection of Patient Health Information
2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
1- 4
CAUTION: 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 Zeiss. 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.
CAUTION: Do not use the printer, the instrument, or the optional power table with an
extension cord or a power strip (multiple portable socket outlet).
CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmologist 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 ophthalmologist, it is
recommended that the exposure time for the patient’s eye be limited to the minimum time
that is necessary for image acquisition. 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. 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: The appliance coupler is the main disconnect device of the instrument.
Position the instrument in such a way to have easy access to disconnect the appliance
coupler in case of an emergency. For the CIRRUS HD-OCT, the most accessible power cord
is the one that plugs into the bottom of the table.
CAUTION: In case of an emergency, disconnect the appliance coupler. For the CIRRUS
HD-OCT, the most accessible power cord is the one that plugs into the bottom of the table.
Protection of Patient Health Information
NOTE: Health care providers have responsibility for the protection of patient health
information (PHI), both hardcopy and electronic. To protect patient confidentiality of your
exported electronic data, the use of encryption is recommended and is the responsibility of
the user.
Safety
NOTE: If a serious incident has occurred in relation to this medical device, to the user, or to
another person, then the user (or responsible person) must report the serious incident to
the medical device manufacturer or the distributor. In the European Union, the user (or
responsible person) must also report the serious incident to the Competent Authority in the
state where the user is established.

CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12
Safety 1- 5
Product Safety
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 Zeiss service
representative may install the instrument.
WARNING: Do not open the instrument covers. Opening the instrument covers could
expose you to electrical and optical hazards.
WARNING: To maintain patient safety, if the instrument is externally connected to non–
medical peripheral devices (i.e., printer, storage devices, etc.), the complete system must
comply with the system requirements in standard IEC 60601–1. This standard requires the
usage of an Isolation Transformer to power the non–medical peripheral device(s) if located
within 1.5 m from the patient. If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the instrument, a separation device must
be used if there shall be electrical connection between the non–medical peripheral device
and the instrument.
WARNING: The person or the responsible organization connecting additional devices or
reconfiguring the system must evaluate the complete system to ensure compliance to the
applicable IEC 60601–1 requirements.
CAUTION: The instrument operator must not attempt to touch the patient and the
peripheral device simultaneously.
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: The instrument itself is transportable and may be moved from one location to
another. However, if the instrument is placed on a power table provided by CZMI, do not
move the table to another location while the instrument and any other peripherals are
placed on it. Doing so may cause the system components to tip over and cause harm to the
patient, the operator, or others in the vicinity.
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.
CAUTION: Avoid tipping. 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.

Safety
2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual
1- 6
CAUTION: When you complete scan acquisition and before you click Finish or ID Patient
in the Acquire Screen, always prompt the patient to sit back and move the head away from
the chinrest. Clicking either of these buttons in the Acquire screen causes the chinrest to
reposition itself beyond the point where the patient’s eye would contact the lens if the
head remained in the chinrest. Failure to observe this warning could result in injury to the
patient.
CAUTION: The operator should check that the patient is not holding on to the instrument
before or during tests. Although movement of the motorized chinrest is slow, giving plenty
of warning for patients to remove their fingers, there is potential for fingers to be squeezed
and possibly injured.
CAUTION: (United States) Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
CAUTION: 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 Zeiss. 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.
CAUTION: Do not use the printer, the instrument, or the optional power table with an
extension cord or a power strip (multiple portable socket outlet).
NOTE: The optional CIRRUS HD-OCT Power Table is safe to use within the patient
environment when the instrument is powered through it, as instructed herein.
Optical Safety
• IEC 60825–1
• EN ISO 15004–2
• Classification: Group 1 Instrument – Per EN ISO 15004–2. Group 1 instruments are
ophthalmic instruments for which no potential light hazard exists.
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.