Zeiss CIRRUS HD-OCT 500, CIRRUS HD-OCT 5000 User Manual

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2660021156446 B2660021156446 B

CIRRUS HD-OCT

User Manual – Models 500, 5000

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Tradema rks

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

2660021169012 Rev. A 2017-12 CIRRUS HD-OCT User Manual

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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

iii

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

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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

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

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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

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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

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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

vii

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

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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

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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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

9-1

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

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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

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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

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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 Database

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

4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A-24

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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

xiii

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

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

C-1

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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

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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

Symbols and Labels

1- 1

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.

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Warning and Caution Definitions

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

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.

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Cautions

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 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.

, in the previous 48 hours. Failure to observe this

1- 3

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

Patient

buttons in the head away from the chinrest. Clicking either of these buttons in the 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.

Acquire

screen, always prompt the patient to sit back and move the

Acquire

Finish

screen causes

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Protection of Patient Health Information

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.

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Product Safety

Safety

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.

1- 5

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: 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.

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Safety

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: (United States) Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Optical Safety

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.

• 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.

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Safety

CAUTION: Applicable Phototoxicity Statements (FDA CDRH Ophthalmoscope Guidance #71): Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the exposure time for the patient’s eye be limited to the minimum time that is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. 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.

CAUTION: In case of an emergency, disconnect the appliance coupler from the back of the instrument.

1- 7

When the power cord is connected to the instrument, the green light on the power switch will start flashing. When the power switch is pressed, the light will change to solid green and the entire instrument will be powered.

Networking Safety

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

Network Attached Storage Device Safety

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

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

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Safety

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

Printer Safety

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

WARNING: When using the printer in the USB configuration, you must power the printer through an isolation transformer. Failure to observe this warning could result in electrical shock to the patient and/or examiner. To do so, you must use a special power cable. In North America, the required cable has an IEC–320–14 connector on one end and a NEMA S–15R connector on the other end. This cable is included in the accessory kit shipped with the instrument.

WARNING: To directly connect a printer to the CIRRUS HD-OCT using a network patch cord (UTP cable), only use an unshielded RJ–45 connector. Use of a shielded network patch cord will ground the printer through the CIRRUS HD-OCT, which could result in electrical shock to the patient and/or examiner. It could also invalidate the system safety approval. In this configuration, the printer must be placed at least 1.5 m away from the patient.

CAUTION: If you use a non–approved device or if you connect it incorrectly—for example, by plugging the printer into the wall while using a USB connection, or by using a shielded network (UTP) cable—you could invalidate the system safety approval.

CAUTION: 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 instruction could result in electrical shock to the patient and/or examiner.

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Record and Data Safety

Patient Record Deletion

CAUTION: Deletion is permanent in Native Archive mode; you cannot recover a patient record nor retrieve its archived exams, because deleting a patient record includes deleting that patient’s index data. The deleted index data includes where the archived exam data can be found.

Patient Records Merge

CAUTION: Be certain that you select the correct patient records to merge. Once you merge patient records, you must use the Move Scan feature to separate the merged file.

Data Archive and Retrieve

CAUTION: We strongly recommend that you archive daily to a network archive location (a network file server or network attached storage device). If you do not archive at all, paper records are the only way to retain patient information in case of system hard drive malfunction.

Record and Data Safety

1- 9

Risks of Internet Connectivity

CAUTION: When connected to the Internet, the CIRRUS HD-OCT may be vulnerable to serious security risks, including viruses and worms that could disable your system or adversely affect its performance. Internet connectivity enables third party software, software drivers and updates to be downloaded to your system, either automatically or intentionally. Installation of any unapproved software, including drivers, could degrade the performance of the instrument and/or lead to corrupted diagnostic or therapeutic information and may void the instrument warranty.

Windows Automatic Update

CAUTION: All non–high–priority updates (driver, hardware or optional updates, etc.) should not be installed.

Prohibited Activities

The following activities are prohibited using the CIRRUS HD-OCT instrument.

CAUTION: Attempting to perform these prohibited activities may void your CIRRUS HD-OCT warranty and may result in damage to your CIRRUS HD-OCT system. Zeiss is not responsible for software upgrades or repairs necessitated by the attempted performance of the following prohibited activities.

• Do not relocate the CIRRUS HD-OCT database to a network file server.

• Do not share CIRRUS HD-OCT folders with other computer systems via the network.

• Do not share the CIRRUS HD-OCT system printer on the network if the printer is connected to the USB port.

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Networking Guidelines

CIRRUS HD-OCT provides IT–Network capabilities in order to allow for data archiving as well as information sharing within the clinical environment and across medical facilities.

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

Refer to the connectivity.

CIRRUS OCT Installation Guide

Electromagnetic Compatibility (EMC)

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

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

CAUTION: The CIRRUS HD-OCT has special EMC precaution requirements and needs to be installed and put into service according to the EMC information provided herein.

CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment.

for all additional information on network

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Electromagnetic Compatibility (EMC)

Guidance and manufacturer’s declaration – electromagnetic emissions

The CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCT should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment – guidance

The CIRRUS HD-OCT uses RF energy only for RF emissions CISPR 11

Group 1

its internal function. Therefore, its RF

emissions are very low and are not likely to

cause any interference in nearby electronic

equipment.

1- 11

RF emissions CISPR 11

Harmonic emissions IEC 61000–3–2

Voltage fluctuations/flicker emissions

Class A The CIRRUS HD-OCT CIRRUS are suitable for

use in all establishments other than domestic

Class A

establishments and those connected to a low

voltage power supply network which supplies

buildings used for domestic purposes.

Complies

IEC 61000–3–3

Guidance and manufacturer’s declaration – electromagnetic immunity

The CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCT should assure that it is used in such an environment.

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Electrostatic Discharge (ESD) IEC 61000–4–2

± 6 kV contact ± 8 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000– 4–4

± 2 kV for power supply lines ± 1 kV for input/output lines

Surge IEC 61000–4–5 ± 1 kV differential mode

± 2 kV common mode

Voltage dips, short interruptions, and voltage variations on power supply input lines. IEC 61000–4– 11

<5% U

(>95% dip in UT)

for 0,5 cycle 40% U

(60% dip in UT) for

5 cycles 70% U

(30% dip in UT) for

25 cycles <5% U

(95% dip in UT)

for 5 sec

± 2 kV for power supply lines ± 1 kV for input/output lines

± 1 kV differential mode ± 2 kV common mode

(>95% dip in UT)

<5% U

for 0,5 cycle 40% U

(60% dip in UT) for

5 cycles 70% U

(30% dip in UT) for

25 cycles <5% U

(95% dip in UT)

for 5 sec

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CIRRUS HD-OCT requires continued operation during power mains interruptions, it is recommended that the CIRRUS HD-OCT be powered from an uninterruptible source.

Power frequency (50/60 Hz) magnetic field IEC 61000–4–8

is the a.c. mains voltage prior to application of the test level.

3 A/m 3 A/m Power frequency magnetic fields should be at levels

characteristic of a typical location in a typical commercial or hospital environment.

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d 1.17 P=

d 2.33 P=

RoHS Compliance

Guidance and manufacturer’s declaration – electromagnetic immunity

The CIRRUS HD-OCT is intended for use in the electromagnetic environment specified below. The customer or user of the CIRRUS HD-OCT should assure that it is used in such an environment.

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the CIRRUS HD-OCT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

Conducted RF IEC 61000– 4–6

Radiated RF IEC 61000–4–3

Note 1: At 80 MHz and 800 MHz, the higher frequency applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

3 V

3 V/m

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. vicinity of equipment marked with the following symbol:

800 MHz to 2,5 GHz

Interference may occur in the

RoHS Compliance

The product is RoHS-compliant according to Directive 2011/65/EU.

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2 Introduction

Intended Use

Indications for Use

Intended Use

The CIRRUS™ HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head, Ganglion Cell and Asian Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. In addition, the system physically interacts with the patient's forehead and chin.

2-1

Usage

The CIRRUS normative databases are quantitative tools for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS Asian Normative Database is a quantitative tool for the comparison of these measurements to a database of normal subjects of Asian descent. The CIRRUS HD-OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

NOTE: The CIRRUS HD-OCT is not intended to be used as the sole diagnostic method for disease.

The CIRRUS 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 13 "Specifications". Application–related warnings are given in this chapter

and elsewhere.

CIRRUS HD-OCT is not a portable device. It is intended for placement in one location. However, there is no permanently installed infrastructure associated with the instrument, and it can be moved between locations following the applicable guidelines and warnings in this chapter.

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Intended Operator Profile

CIRRUS operators are clinicians or technicians with professional training or experience in the use of ophthalmic imaging equipment. Specific assumptions regarding the profiles of individuals performing instrument operation are given below.

Demographic

An adult with one of the following qualifications:

•Ophthalmologist or other Medical Doctor

• Optometrist or equivalent

•Nurse

• Certified Medical Technician

• Ophthalmic Photographer

• Non–certified Assistant

Occupational Skills

Must possess all of the following skills:

Job Requirements

• Computer literate

• Basic knowledge of the eye

• Ability to work with elderly patients and those with disabilities

Must be able to perform all of the following operations:

• Power on the unit and log on

• Enter, find and modify patient identifying data

• Clean surfaces that contact patient

• Position patient with the device, including moving the patient, the device, the table height and the patient's chair

• Select and acquire scan

• Review and save scan or try again

• Generate analysis report using available analysis protocols

• Review the analysis report for completeness

• Output analysis report

•Archive data

• Turn off the unit

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Data Analyst Profile

CIRRUS data is to be interpreted by clinicians or technicians with professional training in diagnostic interpretation of the images generated. Specific assumptions regarding the profiles of individuals who carry out data interpretation are given below. This guide contains information that will aid in the proper interpretation of the resultant data.

Demographic

Must have one the following qualifications:

Occupational Skills

Must possess all of the following skills:

Data Analyst Profile

• Ophthalmologist or other Medical Doctor

• Optometrist or equivalent

• Computer literate

• Ability to work with elderly patients and those with disabilities

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Job requirements

Subject Profile

Must be able to perform the following requirements:

• Training and certification as required by governing bodies to interpret the analysis in the treatment of ophthalmic diseases or other eye-related medical issues.

CIRRUS shall be used on all adults in need of diagnostic evaluation of the eye, including patients with the following disabilities or challenges:

• Wheelchair user

• Very low or not measurable visual acuity

• Fixation problems

• Postural 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).

Installation and Setup

If you have purchased a new CIRRUS HD-OCT instrument, it will arrive with licensed software fully installed. Your Zeiss Service Representative will arrive shortly thereafter, and

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2-4

User Documentation

will work with your IT personnel to set up your network and archiving protocol based on the workflow of your institution.

If you are upgrading a CIRRUS HD-OCT instrument with new software, refer to the

HD-OCT Installation Guide

installation.

If you are installing version HD-OCT software on a separate PC or Laptop, in order to run stand alone Review Software, it is highly recommended that you only install the software with assistance of an IT professional. This will ensure that your computer is properly connected to reflect your clinical networking environment. This will increase security and reduce the chance of any loss of patient data.

Refer to the

User Documentation

CIRRUS HD-OCT user documentation includes the following:

delivered with your CIRRUS kit, for instructions on software

CIRRUS HD-OCT Installation Guide

• Hardware Installation

• Software Installation

•Network Setup.

• Installation Guide

• User Manual (this manual)

CIRRUS

for all questions regarding:

• Release Notes

User documentation has been written to train, use, and serve as a reference for proper installation, network access, operation, scanning and data analysis. The User Manual is delivered in PDF format, but you may request a hardcopy manual at any time.

Training is offered by Zeiss in the use of CIRRUS. Such training does diagnostic interpretation of the data and analyses.

Accessing PDF Versions

The PDF version of this User Guide is provided in two ways:

1. Through the instrument: Select On–Line Manual from the Help (click Help > On-Line Manual) menu to access the user guide information through the CIRRUS software.

2. Via USB drive. Included in the instrument accessory kit. You can view the user guide PDF either using the CIRRUS system computer, or any other computer.

Once opened, you can switch between the user guide and the CIRRUS application by pressing Alt+Tab, as shown on the right.

Organization

This User Manual has been written to provide a comprehensive overview of the CIRRUS HD-OCT system and its software. It provides guidelines for successful

not

include training in

• Clinical setup and workflow

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• Data acquisition and acceptance

• Analysis and interpretation of CIRRUS data

A set of normative data studies is provided for comparison during patient assessment.

In addition, instructions and information are provided to ensure that data is safely managed and that the system is properly maintained.

Instruction Conventions

• “Click” means “left–click” except where “right–click” is specified.

• Chains of menu items are indicated with the use of the “>” symbol between items. For example, “File > Exit” directs you to select Exit in the File menu.

User Documentation

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User Documentation

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3 System Overview

Hardware

As shown in Figure 3-1, the CIRRUS HD-OCT system is delivered as a single unit, except for keyboard, mouse, and an optional height–adjustable worktable.

Hardware

3-1

1 Motorized Patient Alignment Unit 6 Integrated Video Monitor 11 Keyboard

2 Dual Chinrest with Automatic Right/Left Sensors 7 Connectors (USB, network, etc.) and labels under rear cover 12 System Power Switch

3Imaging Aperture 8USB Ports (2) 13 Power Table (Optional)

4Head Rest 9Table Height Control

5 Port for External Fixation Arm 10 Mouse

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Patients are instructed to sit at a 90 degree angle to the Integrated Video monitor, with chin on the Chinrest, head against the Head Rest, and selected eye looking into the Imaging Aperture. This procedure is discussed in detail in Chapter 5 "Clinical

Workflow".

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3-2

Hardware

Power Up

The instrument is powered on just under the monitor (12).

The software will start automatically, and run a Data Validation Check which, once passed, will allow you to begin setting up your instrument, by pressing Continue.

Should the software fail for any reason, contact Zeiss Customer Service immediately.

Power Down

You can power down the system either through hardware or through software.

CAUTION: We strongly recommend you power down through software to permit automatic archiving on shutdown and to avoid abrupt shutdowns that could result in loss of patient data.

Power Down Through Software

1. Click Logout at the upper right on the ID Patient screen.

2. If archiving is set to occur upon shutdown, (see "Archive/Synchronize" on page 4-8), the system will prompt you to archive. This is true in both Native and DICOM Archive modes.

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Execute the desired option to advance to the Exit Dialog.

3. When you archive or close the Archive dialog (see above), the Exit Dialog will ask if you are sure you want to exit.

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4. Click Yes to exit the CIRRUS software.

•If you click No, the Login dialog will appear.

After you exit the system software through the soft shutdown sequence, Shutdown the CIRRUS HD-OCT instrument as you would any other PC.

Power Down Through Hardware

CAUTION: We strongly recommend you power down through software to permit automatic archiving on shutdown and to avoid abrupt shutdowns that could result in loss of patient data.

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Software

Overview

Software

To power down through hardware, press the system power switch. The system will automatically close the operating system and power down the system. You will not have access to the computer operating system.

The CIRRUS HD-OCT instrument is delivered with software installed. The set of licenses you purchased with the instrument will determine which scans are available (see Licensed

Applications below). Your CIRRUS HD-OCT kit includes a USB flash drive with CIRRUS

software. This can be installed on one or more separate workstations (PC’s or laptops), to allow for review and analysis of data scanned on the CIRRUS HD-OCT instrument.

The

Installation Guide,

your kit, provides instructions on how to install the software on separate (PC or Laptop) workstations (called Review Stations), or upgrade software on your CIRRUS HD-OCT instrument.

which can also be found on the USB flash drive that comes with

3-3

Licensed Applications

The CIRRUS HD-OCT instrument is delivered with the following basic licenses:

• All Posterior Segment Scans/Analyses

• Anterior segment 5 line raster

• Anterior Segment Cube 512x128

Access to the following options depends on the licenses purchased with the CIRRUS HD-OCT instrument:

• OCT Angiography

•HD Angle

•HD Cornea

•Pachymetry

• Wide Angle-to-Angle

To add a license to your CIRRUS HD-OCT instrument, contact your Zeiss Sales Representative for a license key. See the on how to unlock licenses.

Basic Screens

except

OCT Angiography

CIRRUS HD-OCT Installation Guide

for information

There are four root screens (shown in Figure 3-4) for the CIRRUS system, from which all other functionality derives:

• Patient Screen – The first screen seen on start up. You will always be using one of the three tabs on the Patient Screen to select or add a patient of interest before scanning or analysis can take place. The Patient Screen is fully described in Chapter 4

"System Administration" and Chapter 5 "Clinical Workflow".

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3-4

Patient Screen

Acquire Screen

Analysis Screen

Scan Quality Check Screen

Software

• Acquire Screen – Described in connection with each of the scans available with your software license. See Chapter 6 "Acquiring Scans" for detailed descriptions.

• Quality Check Screen – After the completion of any scan, the Quality Check Screen will appear, allowing the clinician who made the scan, to review it for quality. If adequate, the scan will be completed; if not, the clinician will be returned to the previous Acquire Screen. See Chapter 7 "Scan Quality Check" for a full description of Quality Check Screens.

•Analysis Screen – Following scan acquisition and acceptance, data is reviewed on the Analysis Screen. The exact layout of the Screen is determined by the Analysis type selected. See Chapter 8 "Analysis" for a complete discussion of Analysis Screen.

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All CIRRUS software screens are comprised of three main parts as shown in Figure 3-5.

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Software

The Toolba r and Navigation Bar options are discussed below. The main Working portion of the screen will be described as they appear in the discussion of software functionality in the chapters which follow.

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3-5

Toolbar Options

Each of the main CIRRUS screens has a series of associated menus and options that pertain to the way in which the screen is used. An overview of these items are shown here, however, additional options may become available during scan acquisition and analysis, and are described in the relevant chapters elsewhere.

The CIRRUS Toolbar appears above all of the 4 main CIRRUS screens shown in Figure

3-4. Access to information shown on the current screen, as well as a set of menus,

Records, Edit, Tools , and Help, is always shown on the main CIRRUS Toolbar. Click to select menus and menu items. Note the following general characteristics of the menus.

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• Disabled menu items appear in gray. These items are not available in the current context.

• Items with an ellipsis [“...”] following indicate the menu item launches a dialog giving you further options before the command is executed.

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3-6

Records Menu – DICOM Archive

Records Menu – Native Archive

Software

The table below identifies and describes the items in each menu, and indicates when each item is enabled. Note the keyboard shortcuts to the right of applicable menu items.

Menu Items and Descriptions Enabled in Mode

•Clear Archived Exams: Prompts you to clear exams when disc space is low.

• Preferences...: Archive/Synchronize: During instrument startup or shutdown, alerts the user to archive exams and clear data after archiving. Normative Database Settings allows selection of the normative database to be used as the default. Display Options allows change to default setting. DICOM Archive allows you to disable Auto–Query and/or Auto–Archive. IPv4 / IPv6 allows you to select Internet Protocol version.

•DICOM Archive: Allows archive of patient records through the DICOM server.

• DICOM Retrieve: Allows retrieval of patient records through the DICOM server.

• Search Worklist Patients...: Opens the Modality Worklist dialog, allowing you to set parameters for patient search through the DICOM server.

• Import Exams...: Opens the Import Options dialog to import a CIRRUS export database or to select specific patients to import.

• Export Exams...: Opens the Export Options dialog, where you can select and export patient records.

• Print Patient list...: Prints patient list that is displayed on the main screen.

• Print Today’s Patient list...: Prints today’s patient list that is displayed on the View Today’s Patients tab.

• Retrieve Archived Exams...: Retrieves selected archived exams from the Native archive.

• Archive Now...: Archives all unarchived exams to the Native archive.

•Clear Archived Exams: Prompts you to clear exams when disc space is low.

•Archive Management: In Native Archive mode only, allows you to create archive locations and set default parameters.

ID Patient mode

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Software

Edit Menu – Native Archive

Edit Menu – DICOM Archive

Tools M enu

Menu Items and Descriptions Enabled in Mode

• Preferences...: Archive/Synchronize: During instrument

startup or shutdown, alerts the user to archive exams. Selecting DICOM Archive, user may disable Auto–Query of Modality Worklist. Display Options allows change to default setting. IPv4 / IPv6 allows you to select Internet Protocol version 4 or 6.

• Search Worklist Patients...: Opens the Modality Worklist

dialog, allowing you to set parameters for patient search through the DICOM Worklist server.

• Import Exams...: Opens the Import Options dialog to

import a CIRRUS export database or to select specific patients to import.

• Export Exams...: Opens the Export Options dialog, where

you can select and export patient records.

• Print Patient list...: Prints patient list that is displayed on

the main screen.

• Print Today’s Patient list...: Prints today’s patient list that is

displayed on the View Today’s Patients tab.

ID Patient mode

3-7

• Patient Record...: Opens the Patient Edit dialog for the

current patient, to view and/or edit the record.

• Merge Two Patients...: Opens the Patient Merge dialog,

where you can select two patient records to merge.

• Delete Patient: Generates a confirmation prompt, asking

user if they wish to delete the selected or opened patient record from the database.

• Move Scan...: Opens the Move Scan dialog, where you can

select a patient file to move the selected scan into.

• Patient Record...: Enabled in DICOM Archive Mode, if a record is selected, but only to

use the Add/Remove Categories tab. If no record is selected, then all options are disabled.

• Live Fundus Overlay: Toggles the display of the overlay on

or off. When off, only the outline of the scan region is visible (the bounding box) and not the vertical and horizontal slice locations. The default is checked (overlay visible).

•

Colored OCT: Toggles the display of OCT images from color to grayscale.

• Inverted Gray scale for Raster: Changes black pixels to

white and white to black on gray scale raster scans.

ID Patient mode with a patient selected

ID Patient mode

ID Patient mode with a patient selected

Analyze mode

Acquire mode

Acquire and Analyze modes

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3-8

Tools > Options

Software

Menu Items and Descriptions Enabled in Mode

• Live OCT Center Lines: Toggles the display of a vertical “centering” line on OCT images. The default is checked (center lines visible).

• Auto Repeat: Automatically adjusts the ocular lens and chinrest to the previous settings for the same patient, eye, and acquisition function.

• Track ing: Toggles FastTrac™ on or off as a global choice for all scans.

• Print Configuration...: Opens the Printout Configuration dialog, where you can select the report options for Macular Thickness, ONH, and (HD 5 Line) Raster, as well as set Macula Multi-slice parameters.

• Scan Organizer...: Opens the Scan Organizer dialog from which you can choose to show or hide available scans, or change their order. See "Scan Organizer" on page 6-21.

• Export Audit Log File...:

Records certain events and identifies

them by date, time, and User ID. See "Log Files" on page 11-17.

• Change My Password...: Enables you to change the password for the current user.

•Options...: Enables access to the following options. Always

• Categories...: Enables you to create, edit, or delete

categories, which you can apply to patient records and search with.

• Institution Edit...: Enables you to customize your CIRRUS

HD-OCT and reports generated from it by adding or editing the institution name, ID Issuer, and optional logo graphic.

• Equipment Edit...: Open the Equipment Edit dialog,

where you can create a station name for the instrument, create DICOM AE Title, and view other equipment information.

• Users...: Enables you to create, edit, or delete staff as

users and designate their user privileges.

• Select Database...: Enables you to switch between

different instrument databases.

Acquire mode

Always

ID Patient mode

Admin mode

Always, except for user

ID Patient mode

When logged in as user

Review Software

admin

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Software

Help

Menu Items and Descriptions Enabled in Mode

• Keyboard Mouse Shortcuts...: Displays a categorized

listing of keyboard shortcut keys and mouse functions.

• On–Line Manual: Opens the CIRRUS User Manual PDF. Always

• License Registration...: Enables you to register a license

through the License Registration Utility that appears when you select a license type.

• View Licenses...: Opens the View Licensed Features dialog,

where you can view the licensing status of optional features.

• License Mode: Enables you to configure the licensing

option: Use floating licenses from FORUM or Use Node– Lock Licensing.

• Service Support...: Enables you to select the TeleService

web link for remote online servicing of the instrument, and save a Log file for troubleshooting.

• About....: Displays the About dialog, which provides

software version information.

Always

Review Software (DICOM Mode) Only

Always

3-9

Navigation Bar

The navigation bar resides at the bottom of all CIRRUS main screens and includes buttons by which from which you can direct CIRRUS operations.

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• ID Patient: Returns you to the ID Patient screen.

• Acquire: Initiates scan acquisition. Only active when a patient is selected.

• Analyze: Initiates analysis. Only active when a patient with saved scans is selected.

• Finish: Exits the current activity (scan or analyze) and returns you to the appropriate screen. Only active when in Acquire or Analyze modes.

Status Area

The status area at bottom left presents current status information using a single green– yellow–red indicator.

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Overall Status by Color

The overall instrument status is communicated by the color. The colors have the following meanings:

• Green means OK or normal: The instrument is functioning normally.

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3-10

Software

• Yellow means warning: The instrument is operational but a problem or set of problems exist.

• Red means critical: One or more serious problems exists that restricts use of the instrument.

Components of Status

The following components contribute to the overall status.

NOTE: Mouse over the status indicator and popup text will explain the current status in terms of the status components below.

Instrument Status

Indicates whether or not the instrument hardware is in communication with the system computer, and therefore capable of acquiring new scans. It can report status as either ready to acquire scans (green) or unable to acquire new scans (red).

• Red: If instrument status is red, we suggest you cycle power off and then power on the instrument). If the problem persists, contact CZMI customer service.

Hard Disk Status

Indicates available hard disk space status. It can report three statuses:

• Green: Adequate free hard disk space.

• Yell ow: Low hard disk space. When free hard disk space is low at startup, you must click Continue at system start before continuing to the login screen. Also, the system prompts you to clear archived exam data.

• Red: Critically low hard disk space. When hard disk space is critically low, the Acquire button is disabled. You must clear a sufficient amount of hard disk space by clearing archived exams to continue. If there are insufficient archived exams to be cleared, you must first archive exams and then clear them. You cannot clear unarchived exams. Once you have created space on your hard drive, the indicator will change to green. However, the Acquire button remains disabled until you shut down, then restart the CIRRUS application.

Network (Archive) Status

Indicates available network (archive) storage space and availability status. It can report three statuses:

• Green: Network available with adequate network archive disk space.

• Yell ow: Low network archive disk space or network unavailable. When archive disk space is low, you will be prompted to change the archive location, but you can continue using the same archive location for now. The message Archive volume is not available indicates that the current archive location is not accessible.

• Red: Critically low network archive disk space. When archive disk space is critically low, CIRRUS will stop archiving to this location. You must change to a new archive location to re–start archiving.

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Software

DICOM Connectivity Status

• Green: DICOM functions, if DICOM was selected during installation, are normal.

NOTE: On rare occasions, the DICOM features may not actually be available even though the Status Indicator is green, indicating that you are connected to DICOM. If this occurs, check the DICOM Gateway Configuration IP address (see the

5000 Installation Guide

• Red: Networking and search errors are reported, along with recommendations for resolution.

) and ensure that the IP address is set to: 127.0.0.1.

CIRRUS HD-OCT Models 500,

3-11

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Software

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4 System Administration

The person assigned as the Administrator for the CZMI network in your clinic will oversee the administrative functions of the software. These functions can be broken down into the following parts:

• Institution Setup

• Station Setup

•Staff Setup

• Category Registration

•Archive Setup

These topics are discussed in the sections which follow.

Adding patients and managing patient workflow is discussed in Chapter 5 "Clinical

Workflow".

Institution Setup

4-1

It is not necessary, but highly recommended, that the person assigned as the CIRRUS Administrator set up information that uniquely identifies your institution, whether office, clinic, or hospital.

To Specify your Institution name and add a logo (if desired):

1. From the Toolbar, click Tools > Options > Institution Edit The dialog box opens as shown in Figure 4-1.

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2. In the Name field, type the name of your institution. The field requires at least one character and accepts up to 64 characters, including spaces. The name field cannot be empty.

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4-2

Station Setup

3. Add the value of the Issuer of Patient ID in this field. The Issuer of Patient ID field denotes assigning authority of patient IDs entered at a particular site or practice. As a recommendation, it should be set to the same value on every instrument in the practice and to the same value as in the leading patient information system, if applicable. If the Issuer of Patient ID already exists—for example, the same one used in the previous software version—the value appears in the Issuer of Patient ID field, where it can be edited, if desired. Changes made to the identifier of the Issuer of Patient ID will be applied to patients going forward; the change will not appear on patient information already in the database.

4. Add Institution Logo Graphic (Optional). The graphic must be in bitmap format (.bmp). Use Browse to navigate to the graphic file of your choice. The selected file will appear in the Preview pane, which is 150 pixels square (1.9 cm or 0.75 inches square at 200 pixels/inch), and will be stretched or constrained to fit it. The graphic will then appear in these proportions on analysis reports, though in a smaller size.

5. Click Save to save your changes and exit the dialog, or click Close to exit the dialog without saving.

NOTE: You must restart the CIRRUS application to cause changes to the Institution Name to appear in the header of reports.

Station Setup

For every instrument or Review station, a unique station name and AE Title must be specified in order distinguish CIRRUS HD-OCT instruments, Review Stations, and any additional CZMI equipment your institution may use.

To access the Equipment Edit dialog, you must be logged in as the steps to create (or edit) the station name of the instrument:

1. From the Toolbar select Tools > Options > Equipment Edit. An example dialog box appears as shown in Figure 4-2.

Admin. Follow these

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Staff Accounts

Register New Staff

Staff Accounts

2. In the Station Name and AE Title fields, type in the desired information. The remainder of the information is already set.

NOTE: The AE Title is originally determined during setup of the DICOM Gateway which is discussed in Chapter 11 "Data Management". These names must match.

3. Click Save to save your changes and exit the dialog, or click Close to exit the dialog without saving.

It is strongly recommended that you create individual user accounts for each staff member who acquires or analyzes scans, and that staff members routinely log out to secure the instrument. Following these procedures helps prevent unauthorized access to CIRRUS HD-OCT data and functions, and enables accurate record–keeping.

For record–keeping, CIRRUS HD-OCT records the user name under which each scan is acquired; it displays the current user next to the Logout link at upper right.

4-3

1. From the Toolbar ("Toolbar Options" on page 3-5) select Tools > Options > Users. The Staff Registration dialog box will appear as shown in Figure 4-3.

2. Click New. The New Staff dialog box appears.

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3. Edit the staff registration fields as desired. A staff record must have either a last name or first name or both; other fields are optional. To log in with the specified user ID and acquire scans, the Operator checkbox must be selected. When finished with your changes, click Save. Both user names and passwords are case–sensitive. Once logged in, any user can change his or her own password by selecting Options > Change My Password see "Toolbar Options" on page 3-5. The of this feature by creating new user accounts with a temporary password, providing it to the user, and asking the user to change the password.

Admin may take advantage

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Category Registration and Maintenance

Edit Staff Records

To edit medical staff records, follow these steps:

1. In the Staff Registration dialog, select a staff record and click Edit. The Staff Edit dialog opens. It resembles Figure 4-3 above except that the name of the selected staff appears in the title bar.

2. Edit the staff registration fields as desired and then click Save. Only the bold Last Name and First Name fields are required; other fields are optional.

• To discard the changes before saving, click Cancel. A dialog prompts you to confirm

your choice.

Delete Staff Records

To delete medical staff records, follow these steps:

1. I n the Staff Registration dialog, select a staff record and click Delete. A dialog will ask you to confirm your choice.

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2. Click OK to confirm deletion, or click Cancel to cancel deletion.

You cannot delete a staff record if there are any references to it in exam data. If you try to delete it, a dialog appears and so informs you.

Category Registration and Maintenance

Category Registration

Patient Categories are created through the Category Registration dialog. Categories are essentially patient search criteria that allow CIRRUS HD-OCT users to search patient records by category. This function is not available in DICOM Archive mode.

To registe r a categor y:

1. S ele ct Tools > Options > Categories The Category Registration dialog opens as shown in Figure 4-5.

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Category Registration and Maintenance

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All categories already registered appear in the list, sorted alphabetically. None is selected by default.

2. Select New. The Category Edit dialog will appear as shown in Figure 4-6.

4-5

Edit Categories

Delete Categories

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3. In the Name field, type in a name for the new category, up to 64 characters, including spaces. You may enter an optional description.

4. Click Save. The new category now will be available to place patients in it.

NOTE: You cannot edit categories created at another institution.

1. I n th e Category Registration dialog (Figure 4-5), select a category and click Edit. The Category Edit dialog appears. (See Figure 4-6)

2. In the Name and Description fields, edit the category as desired.

3. Click Save to save your changes.

1. I n th e Category Registration dialog, select a category and click Delete. A dialog will ask you to confirm your choice.

2. Click OK to confirm deletion, or click Cancel to cancel deletion.

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Archive Setup and Selection

Operators as well as Admin’s may set up and specify archives. However, it is recommended that the Admin oversee archive setup, in order to ensure that patient data is kept cohesive and transparent within the institutional environment.

NOTE: You cannot set up an archive from a Review Station in instrument mode.

Set up a CIRRUS HD-OCT Archive

1. From the CIRRUS HD-OCT instrument, obtain the name and location of the shared folder on the Network File Server that will be used to archive your data (see Chapter 4 of the

CIRRUS HD-OCT Installation Guide

2. Log in as a CIRRUS operator.

3. From the Toolbar, select Records > Archive Management. The Archive Registration dialog box appears (see Figure 4-7).

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4. In the Archive Locations dialog, click New. The New Archive Registration dialog appears, as shown below (Figure 4-8).

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Archive Setup and Selection

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In the New Archive Location, your label will be made up of made up of two parts. The first part, shown at the top of the dialog box, is generated automatically and cannot be changed. It is composed of the model number, serial number and archive sequence number. You can add a suffix to the name using the second part of the field.

5. If you want to be able to identify this archive location via a distinct descriptor, specify it in the Descriptor field (up to 85 characters).

6. Click Browse next to the Path field to find and select the shared archive folder on the network file server.

7. Se l ec t Mark as Current, if you want to begin using this archive location.

8. Click Save to register the new archive. The new archive will now appear in the list of Archive Locations. The check mark to the left of the archive name indicates that this is your current archive location (Figure 4-9).

4-7

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9. Click Close to close the dialog box.

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Set Preferences

Change The Current Archive

1. From t he To olb ar, sel ect Records > Archive Management. The Archive Registration dialog box appears (see Figure 4-7).

2. Select the archive of interest.

3. Check Mark as Current.

4. Close.

Set Preferences

Archive/Synchronize

CIRRUS HD-OCT gives you a way to modify the default archive behavior for both Native and DICOM Archive modes. Select Records > Preferences to access the Preferences dialog at the Archive/Synchronize tab.

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Figure 4-10 displays the default settings for Archive/Synchronize. It is possible to

select one, neither or both Start up and Shutdown. When finished selecting your preferences, click OK to save your changes and exit, or click Cancel to exit without saving. The options are described below.

Archive Alerts

By default, the system alerts you to the presence of unarchived exams upon shutdown and asks if you want to archive them. Should you choose neither archive checkbox, the system will not prompt you to archive at all. However, when the hard disk status turns yellow, you may have to archive exams in order to clear enough archived exams to return the status to green. At that time, archiving may take several hours. You must archive if the hard disk status turns red and you cannot clear enough space to enable scanning and analysis. You can archive manually at any time by selecting Records > Archive Now.

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Normative Data Settings

If you have the Asian Normative Database License, the Normative Data Settings tab is displayed in the Preferences dialog.

The normative database selected from the Normative Data menu becomes the default setting used for image normative data analysis for all patients on the system, unless a different normative database is specified in a patient’s record (see "Add New Patients"

on page 5-2). If you do not have an optional Asian Normative Database license, the

Diversified normative database is used and the Normative Data Settings tab is not shown.

Set Preferences

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4-9

DICOM Archive

Select Records > Preferences to access the Preferences dialog, and then select the DICOM Archive tab.

In DICOM Archive Mode, the available options are shown in Figure 4-12. Checked options are the defaults—uncheck a checkbox to deselect an option. When finished, click OK to save those options or Cancel to leave this dialog.

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Enable Auto–Query/Retrieve: This option enables automatic query and retrieval from the

FORUM the FORUM DICOM archive. On deselection, query and retrieval must be manually

DICOM archive. Deselect this option when there is limited or no connectivity to

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Set Preferences

performed using Records > DICOM Retrieve. This is the for Native Mode. In Native Mode, this dialog appears as shown in Figure 4-13.

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Purge Archived Data for Current Patient after Finishing Analysis: With data already saved to the DICOM Archive, this option automatically deletes current patient data from the local database when you click Finish on the Analysis screen.

Purge Archived Data for all Patients at Shutdown: With data already saved to the DICOM Archive, this option deletes all patient data from the local database when you shut down the CIRRUS application.

only

option available under this tab

Send OP and OPT IODs During Archive (Except After Saving): This functionality enables exporting image files from the instrument or CIRRUS Review Software in a standard DICOM format for viewing on a remote station. See "Transferring Images in OPT IOD and

OP IOD Formats" on page 11-5 and "FORUM/DICOM or Native Environment" on page 11-1 for more information. With this option enabled, you may choose the

desired prompt option:

• Send Without Prompt

•Prompt Before Sending

Enable Auto-Archive: This option enables automatic archiving of newly acquired exams or a modified analysis. Deselect this option when there is limited or no connectivity to the DICOM Archive. Exam data or modified analyses must be manually archived using Records > DICOM Archive, if Auto-Archive is disabled.

Display Options

A third option in the Preferences dialog, for both Native and DICOM Archive modes, is the Display Options, shown in Figure 4-14. This allows you to change the default setting,

Find Existing Patients, to Today’s Patients. Click the desired option, then click OK.

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Set Preferences

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IPv4 / IPv6

CIRRUS instruments work on networks that support Internet Protocol version 6, as well as version 4. CIRRUS Review Software works only on IPv4. This option allows you to select the desired Internet Protocol version, as shown in Figure 4-15. The default is IPv4. Consult your IT professional

before

changing this.

4-11

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Preventive Maintenance Service Notifier

The service notifier displays the next Preventive Maintenance date during software startup from 14 days before service is due until Field Service completes the scheduled maintenance and resets the date for the next required service.

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User Login/Logout

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User Login/Logout

User Login

The User Login dialog appears when the instrument passes the system check upon startup, and each time a user logs out of the system software.

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Select a user name from the drop–down list and enter the corresponding password to access the system software. Note that passwords are case–sensitive.

• No user names appear in the drop–down list until user accounts are created.

NOTE: It is strongly recommend that you create individual user accounts for each staff member who acquires or analyzes scans, and that staff members routinely logout to secure the instrument.

If you enter an invalid user name or password, a message will prompt you to try again.

When you log in successfully, the ID Patient screen ("Basic Screens" on page 3-3) appears.

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User Logout

User Login/Logout

Logout Locks the System

To prevent unauthorized access, you can lock the CIRRUS HD-OCT software at any time by selecting Logout at upper right. When you lock the CIRRUS HD-OCT, it reverts to the User Login dialog, enabling login again. Upon successful login, the system always returns to the ID Patient screen.

NOTE: The Logout button is not available on the Acquisition or Analysis screens. To logout of the application from those screens, you must click Finish or ID Patient to return to the ID Patient screen.

Automatic Logout

You can configure Windows to go into sleep, hibernate, or hybrid mode after a specified time has elapsed without user input and can also require a password on wakeup. For instructions on configuring these options, see the Windows documentation at Control Panel\All Control Panel Items\Power Options.

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User Login/Logout

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The Importance of Good Clinical Workflow

5 Clinical Workflow

The Importance of Good Clinical Workflow

Patient Good Practices

A session for collecting images typically takes several minutes for each eye. Aligning the patient and optimizing the scan account for most of the session time. The patient may rest between scans as needed.

Specific to Iris Imaging

• Center the iris image within the pupil, unless a slight offset is required for retina tilt or to avoid opacity.

• Focus on the iris detail.

Specific to Fundus Imaging

• Ensure the focus is sharp and clear with good visibility of the branching blood vessels.

5-1

Daily Tasks

Start of Day

• Center the scan overlay on the fovea for macular scans and on the optic nerve head for optic disc scans.

• Ensure uniform illumination without dark corners.

• Eliminate or reduce artifacts that may cast shadows on the OCT scans.

• Attempt to move floaters away from the region of interest by asking the research subject to look up, down, and from side to side.

• Minimize corneal opacities by realigning the pupil.

Each day that the CIRRUS HD-OCT system is to be used the following steps must be followed:

1. Start the CIRRUS HD-OCT instrument

2. Wait for the system check to complete. If the system check passes with a non–critical error, such as inadequate hard drive or network archive space, click Continue, and then log on to the application. Scanning can proceed with inadequate local storage space, as long as the scans can be archived elsewhere when the system is shut down.

NOTE: Login to the software. You must be assigned an account by the System Administrator to use the software NOTE: You may need to archive scans before acquiring new scans. If archive storage is inadequate, you can acquire new scans but will be prompted to archive all unarchived scans when shutting down the system. Or if a Database, Installation Files, or Instrument failure occurs, you will not be able to use the instrument. Contact your Zeiss representative.

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Patient Records

End of Day

Archive Saved Exams

On the ID Patient screen, on the Menu bar, click Records, and then click Archive Now and

Shut Down the System

1. O n the ID Patient screen, next to the Menu bar, click Logout.

2. If you are prompted to archive exams, in the Archive dialog box, click Archive, wait for the archive process to complete, and then click OK in the prompt asking if you want to exit.

3. Click the Microsoft Windows Start button , and then click Shut Down.

4. Wait until the computer and the monitor power off, and then turn off the CIRRUS instrument.

WARNING: Data loss and system corruption may occur if the system is turned off without first logging out of CIRRUS and shutting down Microsoft Windows.

Patient Records

Add New Patients

Scanning and analysis are disabled until you identify a patient. The ID Patient screen will list any currently retrieved patients. This is the default screen that appears following system start and login. You can identify a patient using any of the three tabs provided, or you can query archived data to display a list of patients scheduled for exams (see Chapter 11

"Data Management").

The ID Patient screen has three tabs. These are discussed in the sections that follow.

Once you identify the patient, click Acquire in detail in

To add a new patient:

NOTE: The patient date of birth must be entered in the correct format that matches your Windows regional settings, and always appears this way in the software and printouts.

screen appears. Specifying scan type and acquiring data for that scan is discussed

Chapter 6 "Acquiring Scans"

1. Sel ect t he Add New Patient tab from the ID Patient screen ("Basic Screens" on

page 3-3). The Patient Edit dialog will appear as shown in Figure 5-1.

2. Enter the patient’s first and last name in the fields provided as well as their date of birth.

3. Select the patient’s gender from the drop-down list.

Acquire

to initiate a new exam for that patient. The

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Patient Records

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5-3

4. Click Generate ID to have the system automatically create a unique ID for this patient. CIRRUS generated ID’s all start with the prefix “CZMI”. If your institution has its own Patient ID protocol, type that in here. A Patient ID is required for all patient files. No patient data can be saved without a patient ID.

5. Select Normative database of interest from the Normative Data drop-down list. For information on CIRRUS HD-OCT normative databases, see Appendix A

"Normative Data Results".

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6. Enter the Patient Refractive Error (optional). You may enter the refractive error in spherical equivalents (Diopters) for each eye on the patient demographic entry screen if desired. During scanning if you have entered a refractive error for a patient, the CIRRUS HD-OCT will automatically set the focus based on this information. While you may not need to use the Auto Focus feature if you entered a refractive error, you may need to use the focus arrows to manually adjust the focus for optimal clarity (see

"Acquire Screen and Controls" on page 6-19.

7. Cl i ck More (optional), to enter a comment, or add Categories to a Patient Record. The dialog will appear.

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Patient Records

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8. Click Add to add a category to the patient’s record. Remove to remove it.

9. Click Save. The new patient information is saved to the database and to the list of today’s patients. If data is missing from required fields, the Save button will not be enabled.

Find Existing Patients

To search a database (or DICOM archive) for a patient by name or ID:

1. Sel ect t he Find Existing Patient tab from the Patient screen ("Basic Screens" on

page 3-3). The ID Patient screen will appear as shown in Figure 5-4.

2. Type in the patient’s last name and/or Patient ID in the fields in the upper portion of the screen.

3. Click Search. The record will appear in the large patient list viewport. If you have only searched by last name, and you have more than one patient with that last name, the patient records will appear in alphabetical order.

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Patient Records

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To search a database (or DICOM archive) for a patient using additional criteria:

1. Sel ect t he Find Existing Patient tab from the Patient screen ("Basic Screens" on

page 3-3). The ID Patient screen will appear as shown in Figure 5-4.

2. Select Advanced Search.

3. The Advanced Search screen appears as shown in Figure 5-5. You may now select a large number of additional search criteria, as discussed in full below.

5-5

Advanced Search

Click Advanced Search if you want to search for patients using additional parameters besides those provided in the basic search screen For example, you can search on Scan Type for a patient to bring up all the particular scan types associated with the patient using Advanced Search. (See "Find Existing Patients" on page 5-4). The Advanced Search dialog appears (Figure 5-5). If the Use Import Date checkbox is checked, you can also search for patients or exams imported on a specific date. Check the Use Import Date checkbox, then click the From and Through date drop–down menus below to select dates from a popup calendar.

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Zeiss

Carl

Patient Records

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1. Using the available fields, enter or select search parameters and then click Search.

See "Data Management" on page 11-1 for information on the Obscured ID field.

NOTE: The following parameters are disabled in Advanced Search when in DICOM Archive mode:

•Obscured ID •Gender

• Category • Age at time of exam (years)

• Exam Protocol • Use Import Date

• Exclude Obscured Patient

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Patient Records

Search parameters you type in are not case–sensitive, except for Patient ID and Issuer of Patient ID. The Search Preview dialog (Figure 5-6) returns all matching

patients, sorted alphabetically by last name.

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2. In the Search Preview dialog, select the patients of interest.

• Click to select one patient; Ctrl–click to select multiple patients; Shift–click two

patients to select all intervening patients; Ctrl–Shift–click to select all intervening patients plus those already selected.

• Click Select All to select all patients in the Search Preview dialog; the button then

toggles to Deselect All, in case you wish to start selecting again.

• Click Back to return to the Advanced Search dialog.

• Click Cancel to return to the ID Patient screen.

3. After you select patients, click OK. The selected patients will appear in the patient list where you started.

4. Select the patient of interest. The Acquire and Analyze buttons at the bottom of the screen will be activated.

5-7

Add or Remove Categories for Existing Patient Records

Categories are created by the System Administrator (see "System Administration" on

page 4-1). Once patient categories are set up, they may be used in the clinical

environment to assist in grouping patients and organizing records. Categories may be added by clinicians who have been properly trained.

To Add/Remove Categories for an Existing Patient Record:

1. Select a patient in the Patient List viewport of the Patient screen.

2. Select from the Toolbar, Edit > Patient Record. The Patient Edit dialog appears (see

Figure 5-7). The name of the selected patient appears in the title bar of the dialog.

3. Select the Add/Remove Categories tab. Available categories are displayed on the left and applied categories on the right.

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Patient Records

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4. Add the categories of interest to the patient record or Remove them.

5. Click Save.

View Today’s Patients

To select patients who have either been scheduled to be scanned, or have been scanned today (DICOM mode only), select the View Today’s Patients (Figure 5-8) tab.

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Patient Records

How Today’s Patients List Is Populated

Today’s patients list is populated automatically with the following:

• New patients added today on local CIRRUS instrument.

• Patients with new exams completed today. If in DICOM Archive mode, and FORUM is being used as the DICOM Archive, this includes exams completed today from all CIRRUS instruments connected to your network.

• Patients scheduled for this CIRRUS instrument today.

•Imported exams (see Chapter 11 "Data Management").

The list is sorted alphabetically by last name.

NOTE: If the selected patient is retrieved from the DICOM server and has more than one visit scheduled today, a study selection dialog (Figure 5-9) asks the user to select the desired visit from the list.

5-9

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Patient ID Search Conflicts

When two patients—one saved in DICOM Archive and one saved in a local database — have the same Patient ID and Issuer of Patient ID, CIRRUS considers them to be the same patient, regardless of name, birth date or gender.

When a patient search is performed in DICOM Archive mode that results in a patient ID conflict, as show in Figure 5-10, you may:

•Click the Update Local Data button to save the patient information from the local database, over–riding the patient information in DICOM Archive; or,

•Click Close to exit the dialog. No data is saved.

If there are multiple conflicts in the patient list, you must confirm each patient individually.

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Patient Preparation

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Patient Preparation

Optional Dilation of Patient’s Eye(s) (Posterior Segment)

In preparation for all patient visits, first clean Instrument Surfaces and adjust table height.

1. Wipe the chin rest and forehead rest with an alcohol pad, and allow the assembly to dry.

2. Adjust the table so the embossed line on the ocular cover is approximately at the same height as the patient’s eye.

NOTE: The table adjustable height switch is mounted on the rear underside of the table, on the operator's right side.

3. After adjusting the table height, instruct the patient to sit back and relax.

The minimum pupil size for CIRRUS HD-OCT is 2 mm. This can usually be achieved without dilation. If dilation is performed on a subject for an exam, we recommend that dilation be used on subsequent visits if quantitative comparisons will be made. Dilation should not directly affect the quantitative measurements, but it may affect them indirectly by allowing more variability in how the OCT beam enters the eye. Although such an effect should be small, optimal repeatability will be achieved by imaging the patient in the same way at every visit.

Position the Patient on the Chinrest

NOTE: Before the patient puts his or her head in the chinrest, click to select the desired scan type for either eye as described in Chapter 6 "Acquiring Scans". Once the scan has been selected, the automated chinrest will go to the default position for the selected scan type and eye. By selecting an anterior segment scan, the CIRRUS HD-OCT will bring

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Patient Preparation

In the ACQUIRE screen, have patient sit back before you click Finish or ID Patient.

the internal lens into position (you may hear a click while this occurs) and dim the illumination to avoid pupillary constriction by default.

The patient’s exam experience with the CIRRUS HD-OCT is normally brief and comfortable. An experienced operator can acquire several scans from each eye in the space of 5–7 minutes. An exam usually requires the patient to look inside the imaging aperture for 1–3 minutes at a time for each eye, depending on the number of scans desired. The instrument acquires most scans in 1–5 seconds. The additional time is required to align the patient before scanning and to optimize scan quality. The patient may sit back between scans as needed. Note that the CIRRUS HD-OCT is never to contact the patient’s eye.

Selecting a scan type moves the chinrest into the default or saved position for the scan. Wait until the chinrest automatic positioning is complete before instructing the research subject to place his or her chin on the chinrest.

If you are using a prior scan (see Patient Preparation on page 5-10) on a patient, the patient must wait until the prior scan has been selected and the chinrest motions are complete before placing their head in the chinrest. Reducing the amount of time the patient spends in the chinrest improves patient comfort.

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Optional Eyelid Elevation

To get a scan unobstructed by the eyelids, especially for vertical scans, you may find it necessary to tape the eyelids of either eye or manually elevate the eyelid during scan acquisition in accordance with standard medical practice. For many patients, it is sufficient to ask them to open their eyes wide during scan acquisition. In certain cases however, it may be necessary to tape the patient’s eyelids in order to get an unobstructed scan.

Precautions

CAUTION: When you complete scan acquisition and before you click the Finish or ID Patient button in the A head away from the chinrest. Clicking either of these buttons in the A the chinrest to reposition itself beyond the point where the patient’s face would contact the lens if the head remained in the chinrest. Failure to observe this warning could result in injury to the patient.

CQUIRE screen, always prompt the patient to sit back and move the

CQUIRE screen causes

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Patient Preparation

Patient Instructions

1. Instruct the Patient to Focus on the Fixation Target.

Ensure the corneal scans are centered on the corneal vertex

Instruct the patient to fixate on the center of the fixation target, even though it may

not appear to be in focus.

• The internal fixation target is centered. For all anterior segment scans, the

• The iris illumination is dimmed by default to avoid causing pupillary constriction.

• The internal lens audibly clicks as it is brought into position.

The HD Angle is the preferred scan for imaging the anterior chamber angle. It gives the highest resolution and greatest detail of the iridocorneal angle. Wide Angle to Angle and Anterior Chamber scans may also be used for anterior chamber angle analysis.

2. Instruct the research subject to focus on the green star fixation target in the imaging

3. With the subject’s eye aligned with the scan beam in three dimensions and image

Of Special Note for Anterior Scans

patient sees the green fixation target against a black background. The flashing red lines showing the scan pattern of the selected scan type are blurry.

aperture and blink naturally throughout the alignment process.

tools applied, instruct the research subject to blink and then open eyes wide during acquisition.

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Patient Preparation

You will begin to see an image once the patient is positioned in the chinrest. The image may be poorly resolved until properly focused (see "Acquiring Scans" on page 6-1). Alignment progresses through a series of steps, although the order in which many of the steps are performed (and whether they are repeated) will vary depending on the cooperativeness of the patient (e.g., whether patients can fixate steadily at a requested location, opacity of their eye, etc.). In general, the sequence of user steps for non–repeat visits is as follows.

4. If necessary, remind the patient not to press against the head rest too firmly, so the forehead glides more easily across it during X-Y movements of the chinrest. The video image of the eye is clearest when the (Z alignment) is correct.

5. Instruct the Patient to relax after capture.

6. After the capture is complete, instruct the subject to relax but maintain chinrest position while the technician reviews the scan.

7. If necessary, repeat steps 4 through 6 above, until the technician is satisfied with the scan quality.

8. When the session is complete, instruct the subject to relax and move away from the chinrest.

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NOTE: Clicking the Finished or ID Patient button moves the chinrest into the default or saved position. Instruct the research subject to move away from the chinrest before clicking the Finished or ID Patient button.

CIRRUS automatically names the file to include patient name, ID number, gender, type of scan, date of exam, eye examined, type of report, and date of report.

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Patient Preparation

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Overview of Scan Types

6 Acquiring Scans

Overview of Scan Types

CIRRUS HD-OCT software provides a large set of scan acquisition options that provide the basis for in depth analysis of ocular features and possible abnormalities. These are shown in Table 6-1 and discussed in the sections of this chapter which follow.

Anterior Segment Scan Acquisition

Anterior Chamber Scan

Anterior Segment Cube Scan 512 x12 8

HD Angle Scan

HD Cornea Scan

Pachymetry Scan

Wide Angle-to-Angle Scan

6-1

Anterior Segment 5-Line Raster Scan

Posterior Segment Scan Acquisition

CIRRUS OCT Angiography Angiography Scan

3x3 / 6x6 / 8x8

Montage Angio Scan 6x6 / 8x8

ONH Angiography Scan

4.5x4.5

Macula Macular Cube Scan

200x200 / 512x128

Macula and Optic Nerve (Integrated View)

Optic Nerve Optic Disc Cube Scan

Visualization Macular Cube Scan

Macular Cube Scan 200x200 / 512x128

- and -

Optic Disc Cube Scan 200x200

200x200

200x200 / 512x128

- or -

Optic Disc Cube Scan 200x200

All Raster Scans

Table 6-1 Scan types available with the CIRRUS HD-OCT

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Posterior Segment Scans

CIRRUS OCT Angiography

CIRRUS OCT Angiography is a method that uses differences between B-scans to generate contrast associated with motion, in particular the motion of blood through the vasculature. CIRRUS OCT Angiography can be subject to several of the same artifacts seen in OCT structural imaging, and may also have some artifacts particular to this type of imaging. To minimize errors and artifacts, acquire Angiography Cube scans with FastTrac on.

The scans used for CIRRUS OCT Angiography are: Angiography scan, Montage Angio scan, and ONH Angiography scan.

NOTE: CIRRUS OCT Angiography is not intended as a substitute for fluorescein angiography.

NOTE: Vascular findings on fluorescein angiography may be absent, poorly defined, or variably defined on CIRRUS OCT Angiography. Additionally, leakage, staining, and pooling are not features of CIRRUS OCT Angiography.

Angiography Scan

Scanning results in either a 3x3 mm, 6x6 mm, or 8x8 mm square cube, and is similar to the Macular 512x128/200x200 cubes but uses an intensity-based frequency filtering technique to generate images with detailed vasculature. To image vascular flow, each B-scan in the scan pattern is repeated several times consecutively. Comparisons of contrast on consecutive B-scans in the same location reveal some areas with contrast change over time and some areas with constant contrast. Temporal contrast change in a specific location is thought to be due to erythrocyte motion and hence indicates a vessel location.

Montage Angio Scan

The 6 6x6 mm or 5 8x8 mm scans increase the Field of View (FOV) of Cirrus OCTA through the use of a montage to 10x14 mm and 14x14 mm respectively. The FOV, which is now fixed, is comparable to traditional imaging systems such as mydriatic and non-mydriatic fundus cameras. Wide-field montage images enable high-resolution vascular imaging over a larger region of the retina to further expand the applicability of OCT angiography.

The Montage Angio acquisition workflow is unique from the other Angiography scan acquisitions because you can acquire all the Angiography scans consecutively without going to the Quality Check screen each time. You review all of the scans at the end of the last scan you acquired. This ability shortens the time for both the patient and the operator.

ONH Angiography Scan

The 4.5x4.5 mm ONH Angiography scan expands the capability of CIRRUS, which enables the use of OCTA in the vascular assessment of the optic nerve.

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Macula

Posterior Segment Scans

The scans used for viewing the macula are: Macular Cube 200x200 and Macular Cube 512x128.

Macular Cube 200x200

This scan generates a cube of data through a 6 mm square grid by acquiring a series of 200 horizontal scan lines each composed of 200 A-scans and a central horizontal HD B-scan.

Macular Cube 200x200

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Optic Nerve

Macular Cube 512x128

This scan generates a cube of data through a 6 mm square grid by acquiring a series of 128 horizontal scan lines each composed of 512 A-scans and a central horizontal HD B-scan. The Macular Cube 512x128 is the default scan. Compared to the 200x200, this scan has greater resolution in each line from left to right, but the lines are spaced further apart, giving less resolution from top to bottom. This scan can be used to measure macular thickness (corneal thickness for anterior segment scans), and create a 3–D image of the data.

Macular Cube 512x128

The scan used for viewing the optic nerve is the Optic Disc Cube 200x200 scan.

Optic Disc Cube 200x200

The Optic Disc Cube 200x200 generates a cube of data through a 6 mm square grid by acquiring a series of 200 horizontal scan lines each composed of 200 A-scans The fixation target is offset to one side to allow the center of the optic nerve to move to the center of

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Posterior Segment Scans

the scan pattern. In addition, the scan pattern overlay consists of concentric rings to assist in the alignment of the optic disc (see Figure 6-17).

Optic Disc Cube 200x200

Integration

For an integrated view, both the Macular Cube scan and Optic Disc Cube scan are used.

Macular and Optic Disc Cube Scans

For an integrated view, the Macular Cube (512x128 mm or 200x200 mm) and Optic Disc Cube (200x200 mm) scans are generated by combining a series of A-scans taken at varying depths. Macular and Optic Disc Cube scans provide information about disc and fovea parameters including (but not limited to):

Visualization

•Size

• Cup, disc, rim area and volume

• Nerve fiber layer thickness

• Ganglion cell layer thickness (macular cube)

In turn, the post processing tools available for scan analysis Chapter 8 "Analysis" provide tools for RNFL and Ganglion cell layer estimation, which provide the earliest warnings of glaucoma and other, neuro-ophthalmic conditions.

Cube scans are the most common acquisition types, and are used as the basis for the largest number of CIRRUS HD-OCT analyses (see Tab le 8 -1).

Depending on your requirements, you can specify cube scans based on several geometries:

For a visualized view, either the Macular Cube scan or Optic Disc Cube scan is used.

Macular or Optic Disc Cube Scans

For an visualized view, either the Macular Cube (512x128 mm or 200x200 mm) or Optic Disc Cube (200x200 mm) scan is generated. See the previous sections for information about the two scans.

Raster Scans

• HD 5 Line Raster and HD 1 Line 20x: This is a single scan that generates 5 parallel B-scans composed of 1024 A-scans each, with an option to collapse the 5 lines into a

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single high definition line. The scan can be positioned anywhere on the fundus image and has an adjustable line length of 3, 6, or 9 mm, an adjustable angle of –89 to 90 degree, and adjustable spacing from 0 to 1.25 mm in increments of 0.025 mm.

• 5 Line Raster: This scan is the original version of the 5 line raster with less resolution than the HD 5 Line Raster. The scan can be positioned anywhere on the fundus image and has an adjustable line length of 3, 6, or 9 mm, an adjustable angle of –89 to 90 degree, and adjustable spacing from 0 to 1.25 mm in increments of 0.025 mm.

•

NOTE: HD 1 Line x100, HD 21 Line, HD Cross, and HD Radial scans are offered as an option that may not be available in all markets and,when available in a market, may not be on all instruments. If you do not have this feature and want to purchase it, contact Zeiss. In the U.S.A., call 1-877-486-7473; outside the U.S.A., contact your local Zeiss distributor.

Guidelines for Raster Scans

For HD 5 Line scans, to switch between the HD 1 20x single line and multi–line scanning, click the Toggle Spacing button located below the fundus image.

The toggle button remains available until the Single Line scan pattern is moved in the acquisition window. To move the scan pattern and keep the button active, switch to 5 Line mode before moving the scan pattern, and then switch back to Single Line mode. If you move the Single Line pattern and want to switch back to 5 Line mode, just collapse the scan.

6-5

NOTE: Sometimes switching from Color OCT to black and white ( ) will allow you to see more details in a high–resolution scan.

Scan Pattern Adjustments

Raster scans have adjustable scan patterns. You can use the image pattern controls on the live Fundus image (Fundus Viewport, Posterior Scans) to manually change line length, line spacing, or angle of rotation. You can also use the Custom Scan Pattern dialog box. Adjustments apply to all scan lines.

If you adjust the scan pattern position, check that the retinal OCT B-scan images are not too high in the viewport. When the edges of scan images are near the upper boundary, they tend to fold over, reflecting a mirror image back into the viewport. If this occurs, or if the scan image is completely inverted, adjust the image position using the Center controls.

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Drag blue bar left or right to adjust line length

Drag blue bar up or down to adjust line spacing

Drag rotation icon to adjust the angle of rotation

Anterior Segment Scans

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Enhanced Depth Imaging (EDI)

Enhanced Depth Imaging (EDI) is an optional mode for single and multi–line raster scans that improves visibility of structures at the bottom of B-scans.

The signal to noise ratio in OCT scans varies across the axial range. The default CIRRUS setup is such that the best signal is obtained at the top portion of the scan. Enhanced Depth Imaging allows you to change the acquisition settings for the raster scans so that the best signal to noise ratio is obtained at the bottom of the B-scan. This allows you to obtain an HD image that is optimized in the region that is of interest for a particular scan.

To switch between EDI and standard scanning mode, select the EDI checkbox below the fundus image.

Anterior Segment Scans

Scan Preparation

Instrument Imaging Process

When an anterior segment scan is selected or external lens mounted:

• The LSO illumination of the retina is turned off.

• The internal fixation target is centered. For all anterior segment scans, the patient sees the green fixation target against a black background. The flashing red lines showing the scan pattern of the selected scan type are blurry.

• The iris illumination is dimmed by default to avoid causing pupillary constriction.

• The internal lens audibly clicks as it is brought into position.

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Anterior Segment Scans

Scan Acquisition Controls

Not all posterior scan acquisition controls are available for anterior segment scans. For anterior segment scans:

• There is no fundus image, and therefore the Auto Focus button and Z controls (left– right Focus arrows) are not displayed. However, the Focus bar is still displayed, showing the last focus for the patient.

• FastTrac is not available for anterior segment scans, and therefore the three FastTrac buttons below the Capture button are not displayed.

•The Optimize button is available only for Anterior Segment Cube 512x128 and Anterior Segment 5 Line Raster scans.

•The Auto–Enhance button, the Auto–Center button, and manual–center controls are not available. The OCT display can be centered vertically in the live OCT window by using the chinrest control buttons or the mouse scroll wheel. However, the shift key + mouse scroll wheel does not bring the scan into the acquisition window for anterior scans as it does for posterior scans.

Scan Pattern Adjustments

The scan pattern for anterior scans is displayed on the iris image. The scan pattern cannot be moved, and scan length is not adjustable. Rotation and line spacing are adjustable for the Anterior Segment 5 Line Raster scan. Rotation is adjustable for the HD Angle, HD Cornea, Anterior Chamber, and Wide Angle-to-Angle scans. For more information on adjusting scan patterns, see "Scan Pattern Adjustments" on page 6-5.

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Aligning Scans Corrected for Beam Scanning Geometry and Corneal Refraction

Anterior Chamber, Wide Angle-to-Angle, HD Cornea, HD Angle, and Pachymetry scans are corrected to account for beam scanning geometry and refraction on the corneal surfaces. These corrections are most accurate when acquired corneal scans are centered on the corneal vertex, which generates a strong central reflection line on the live OCT image. Typically the corneal vertex is just to the nasal side of the pupil center.

Center Corneal Scans on the Corneal Vertex

NOTE: HD Angle scans are

1. Instruct the patient to fixate on the center of the fixation target, even though it may not appear to be in focus.

2. Follow the alignment guidelines for each scan to position the scan in the OCT viewport, making adjustments until there is a strong central reflection line indicating the scan is centered on the corneal vertex.

not

aligned to the corneal vertex.

Anterior Chamber and Cornea External Lenses

Four anterior segment scans require an external lens:

Anterior Chamber External Lens:

• Anterior Chamber Scan

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Anterior Chamber Lens

English lens label

Cornea Lens

Lens symbol

English lens label

Lens symbol

Anterior Segment Scans

• Wide Angle-to-Angle Scan

Cornea External Lens:

•HD Cornea Scan

• Pachymetry scan

Attaching an External Lens

To attach an external lens and select a scan

1. Attach the appropriate external lens to the instrument lens mount.

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2. CIRRUS HD-OCT automatically detects the lens, adjusts lens positioning, and displays the scans that require the lens in the scan list.Select the scan from the scan list for the eye you want to scan.

Anterior Chamber Scan (Chamber View™)

This scan generates a wide field, speckle–reduced raster scan of the anterior chamber at a depth of 5.8 mm, with higher contrast than the Anterior Segment 5 Line Raster scan. It

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Anterior Segment Scans

horizontally. The scan is adjustable from –89 to 90 degrees, though rotation may reduce the field The 5.8 mm scan depth is achieved by allowing the source and mirror images to overlap. Note that in the overlap region (indicated by blue overlay), source image detail may be compromised. This scan requires the Anterior Chamber external lens. The Anterior Chamber Scan provides the data used for Anterior Chamber measurements ("Anterior

Segment Scans" on page 6-6).

The Acquire screen displays the position of the Anterior Chamber scan pattern on the live iris image. The OCT B-scan image on the right displays the cornea and mirror image of the scan. The Anterior Chamber scan requires the Anterior Chamber external lens.

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1 Mirror iris image 2Cornea image

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3 Mirror cornea image 4 Iris image

5 Lens of the eye

Guidelines for Anterior Chamber Scan Acquisition

• Attach the external Anterior Chamber lens to the instrument lens mount, see

"Attaching an External Lens" on page 6-8.

• Instruct the patient to fixate on the center of the fixation target even though it may not appear to be in focus.

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Anterior Segment Scans

• Click the center of the pupil and use the screen X-Y and Z controls or keyboard arrow keys and mouse scroll wheel to center the scan on the corneal vertex with the anterior chamber visible in the B-scan viewport.

A strong vertical central reflection line on the B-scan indicates the scan is centered on the corneal vertex.

• Center the image to see the lens of the eye and the anterior chamber angles.

• If the anterior chamber seems tilted, instruct the patient to shift his/her gaze slightly to the left or right as needed to horizontally orient the anterior chamber.

• Separate the cornea image and mirror image as much as possible, without letting the cornea images touch the iris images.

The correct position of the scan is shown in Figure 6-3. Three incorrectly aligned images are shown in Figure 6-4: one with the iris touching the cornea, one with the cornea too close, and one with an off–center image that obscures the eye lens.

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Anterior Segment Cube Scan

The Anterior Segment Cube 512x128 Scan provides the data used for the Anterior Segment Analysis ("Anterior Segment Scans" on page 6-6)

The Acquire screen displays the position of the Anterior Segment Cube 512x128 scan pattern on the live iris image. The OCT B-scan images on the right correspond to the horizontal and vertical scan lines of the selected slice in the cube, with the smaller images corresponding to the top and bottom horizontal cube slices (see Figure 6-5).

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1 Grey bar for aligning OCT scan

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Guidelines for Anterior Segment Cube 512x128 Scan Acquisition

• Instruct the patient to fixate on the center of the fixation target.

• Use the screen X, Y and Z controls or keyboard arrow keys and mouse scroll wheel to center the scan on the corneal vertex with the anterior chamber visible in the B-scan viewport.to center the scan between the gray bars on either side of the B-scan display, as shown in Figure 6-5.

• If the patient’s cornea is perfectly centered, a strong reflection from the anterior cornea can produce bright artifacts in the HD Cornea display (Figure 6-6). The scan alignment should be slightly offset from the center by adjusting the chinrest to avoid the corneal reflection.

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Anterior Segment Scans

HD Angle Scan

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NOTE: For the Anterior Segment Cube 512x128 and Anterior Segment 5 Line Raster scans, the instrument focuses the OCT beam onto the anterior segment. The OCT beam scans in an arc to allow the curved cornea to better fit into the 2mm scan depth. This will cause the cornea to appear flat in the display during alignment and acquisition. This effect is partially corrected for after acquisition, so the cornea will appear with the expected curvature during review and analysis.

The HD Angle is the preferred scan for imaging the anterior chamber angle. It gives the highest resolution and greatest detail of the iridocorneal angle. Wide Angle-to-Angle and Anterior Chamber scans may also be used for anterior chamber angle analysis. All three scans have an angle measurement tool (see "In HD Angle Analysis" on page 8-53). The HD Angle and Wide Angle-to-Angle scans also have an iridocorneal (IC) angle tool to measure iridocorneal angle features (see "Angle Measurements" on page 8-53).

This scan, available for anterior segment scans only, generates a speckle–reduced raster scan at a depth of 2.9 mm using 20 B-scans, each composed of 1024 A scans. The scan is

6.0 mm in length, with an adjustable angle from –89 to 90 degrees. The scan highlights one iridocorneal angle, which can be measured via specialized angle calipers in the HD Angle Scan Analysis ("In HD Angle Analysis" on page 8-53).

The Acquire screen displays the position of the HD Angle scan pattern on the live iris image and displays the OCT B-scan image on the right.

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Guidelines for HD Angle Scan Acquisition

• For an HD Angle scan, you may need to use the external fixation device if the patient has difficulty fixating without the internal fixation target, which is not in view when the limbus of the scan eye is optimally exposed. The external fixation device may help the patient fixate with the eye that is not being scanned, for correct angle alignment.

• Adjust the area of the eye visible in the Iris viewport until the iris is in clear focus, and make coarse adjustments with the X-Y controls to move the chinrest until the corneoscleral junction is in view.

• Use the mouse scroll wheel to bring the angle into view on the B-scan, centering it in the lower quadrant of the B-scan viewport and maximizing exposure of the cornea.

• If the angle recess in the B-scan appears shadowed by the sclera, move the scan slightly along the limbus to minimize the effect, or ask the patient to adjust fixation further away from center.

• Align the scan at the desired location on the limbus, and then align the B-scan so that the anterior chamber angle falls in the lower left and lower right quadrant, respectively. Figure 6-7 shows a well–aligned scan and live OCT image of an HD Angle scan.

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HD Cornea Scan

Anterior Segment Scans

This (anterior segment) scan generates a single high–definition scan with a depth of 2.0 mm that has a wider field of view than the Anterior Segment 5 Line Raster. The scan uses 20 B-scans, each composed of 1024 A scans. The scan is 9.0 mm in length when oriented horizontally and has a depth of 2.0 mm. The scan is adjustable from –89 to 90 degrees. This scan requires the Cornea external lens. The HD Cornea Scan provides the data for the HD Cornea Analysis ("Corneal Thickness" on page 8-43).

The Acquire screen displays the position of the HD Cornea scan pattern on the live iris image

and displays the OCT image of the scan on the right. The HD Cornea scan requires

the Cornea external lens.

1 Upper red line 2 Corneal reflex line

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Guidelines for HD Cornea Scan Acquisition

• Attach the external Cornea lens to the instrument lens mount, see "Attaching an

External Lens" on page 6-8.

• Instruct the patient to fixate on the center of the fixation target even though it may not appear to be in focus

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• Click the center of the pupil and use the X-Y and Z controls to center the scan on the corneal vertex, positioning the anterior corneal surface to the upper red line in the B-scan viewport as shown in Figure 6-8.

NOTE: A strong vertical central reflection line on the B-scan indicates the scan is centered on the corneal vertex.

Wide Angle-to-Angle Scan

This scan (for anterior segments only) generates a wide field, speckle–reduced raster scan with a depth of 2.9 mm. It uses 20 B-scans, each composed of 1024 A scans and is

15.5mm in length when oriented horizontally. The scan is adjustable from –89 to 90 degrees, though rotation may reduce the field The scan simultaneously highlights both 0 and 180 degree iridocorneal angles. This scan requires the Anterior Chamber external lens. The Wide Angle-to-Angle Scan is used as the basis for the Wide Angle-to-Angle Analysis ("Using Wide Angle-to-Angle Analysis" on page 8-43).

The Acquire screen displays the position of the Wide Angle-to-Angle scan pattern on the live iris image and the OCT image of the scan on the right.

Anterior Segment Scans

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Pachymetry

Anterior Segment Scans

Guidelines for Wide Angle-to-Angle Acquisition

• Attach the external Anterior Chamber lens to the instrument lens mount, see

"Anterior Chamber and Cornea External Lenses" on page 6-7.

• Instruct the patient to fixate on the center of the fixation target even though it may not appear to be in focus.

• If the anterior chamber seems tilted, instruct the patient to shift his/her gaze slightly to the left or right as needed to horizontally orient the anterior chamber.

• Click the center of the pupil and use the X, Y and Z controls or keyboard arrow keys and mouse scroll wheel to center the scan on the corneal vertex with both iridocorneal angles, iris, and pupil visible in the OCT scan display area and the anterior of the cornea extending slightly out of the field of view, as shown in

NOTE: A strong vertical central reflection line on the B-scan indicates the scan is centered on the corneal vertex.

NOTE: For the Wide Angle to Wide Angle scan, the iris will be slightly out of focus even when correctly aligned.

Figure 6-9.

This scan consists of 24 radial scan lines with a scan depth of 2.0 mm that are used to generate a color-coded thickness map of the cornea. The scan uses 24 B-scans, each composed of 1024 A scans. This scan requires the Cornea external lens. The Pachymetry scan is used as the basis for the Pachymetry Analysis. (See "In Pachymetry Analysis"

on page 8-44 for more information.)

The Acquire screen displays the position of the Pachymetry scan pattern on the live iris image. The images on the right display the temporal/nasal and inferior/superior scans of the selected meridian. The Pachymetry scan requires the Cornea external lens.

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Guidelines for Pachymetry Scan Acquisition

The Pachymetry scan is similar to the HD Cornea scan, but you must align two scans rather than one.

• Attach the external Cornea lens to the instrument lens mount, see "Anterior

Chamber and Cornea External Lenses" on page 6-7.

• Instruct the patient to fixate on the center of the fixation target even though it may not appear to be in focus.

• Click the center of the pupil and use the X-Y and Z controls to center the scan on the corneal vertex until the cornea is visible in the B-scan viewports.

• Align the images in the two B-scan viewports by fine adjustment of the X-Y controls using the keyboard arrow keys. To center both images, first center the bottom image with the keyboard arrow keys until you see the corneal reflex in the upper image. The up arrow brings the image down and to the right. The down arrow brings the image up and to the left. Press the Ctrl key with arrow keys for finer adjustments.

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• The horizontal B-scan is correctly positioned when it fits between the two red lines on the viewport with the anterior corneal surface aligned with the upper red line, as shown in Figure 6-10.

NOTE: Minimize eyelash and eye interference as much as possible.

Anterior Segment 5–Line Raster Scan

This scan can be positioned anywhere on the Iris image and has an adjustable line length of 3, 6, or 9 mm, an adjustable angle of –89 to 90 degree, and adjustable spacing from 0 to 1.25 mm in increments of 0.025 mm. It is used as the basis for HD Images Analysis ("High Definition Images Analysis" on page 8-55).

The Acquire screen displays the position of the Anterior Segment 5 Line Raster scan pattern on the live iris image. The OCT B-scan images on the right correspond to the 5 scan lines, with the middle scan line corresponding to the larger middle OCT B-scan image.

1 Grey Bar for aligning B-scan

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Available

Toolbar

Fundus

Iris

Live Scan

Scans

Viewport

Acquisition

• Instruct the patient to fixate on the center of the fixation target.

• Use the screen X-Y and Z controls or keyboard arrow keys and mouse scroll wheel to center the scan between the gray bars on either side of the B-scan display, as shown in Figure 6-11.

Acquire Screen and Controls

Once a patient is in your database (see "Patient Records" on page 5-2 for new and existing patient protocol) and the patient is selected, the Scan button at the bottom of the Patient Screen becomes active. Pressing Scan brings up the Acquire Screen (Figure 6-12) from which all operations for scanning from CIRRUS are conducted. The Scan Screen for all but the Montage Angio scan consists of the 5 main portions with associated menus and options to assist in targeting and optimizing scan acquisition.

Acquire Screen and Controls

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Available

Toolbar

Fundus

Iris

Live Scan

Scans

Viewport

Scan Position

Montage

Acquire Screen and Controls

The Scan Screen for Montage Angio scans, as shown in the Figure 6-13, consists of 6 main portions and is discussed in the Montage Angio scan areas of this chapter.

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Acquire Screen Toolbar

As shown below, the Acquire Screen indicates the patient’s name on the left, followed by gender and birthdate. Center right, a green dot indicates which eye is currently being scanned, and to the far right are a set of menus. Only Too ls is of interest during acquisition. A discussion of the other items in the Tool Bar can be found in "Toolbar Options" on

page 3-5.

Toolbar options specific to scan acquisition include:

• Live Fundus Overlay

• Color OCT (F9) allows you to switch between color and grayscale globally, for all viewports. Color OCT is the default.

• Live OCT Center Line

•Auto Repeat

•Tracking

Available Scans List

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At the top of the Acquire Screen, two scan lists contain the list of scans—the left list is for the right eye, and the right list for the left eye.

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page 6-21FK

Selecting the scan type populates the Acquire screen with the correct image layout.

NOTE: Only the scans which your institution has licensed will be shown in the Available Scans list. You can check which scans have been licensed by going to Help > View Licenses in the Toolbar (see "Toolbar Options" on page 3-5).

Scan Organizer

The Scan Organizer is accessed from the Toolbar by selecting Tools > S c an Organiz er in ID Patient mode.

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NOTE: You cannot access the Scan Organizer from Review Software.

When Scan Organizer is selected, the dialog shown in Figure 6-15 below appears. All your licensed scans will appear in the left column. If your institution only uses certain scans, select the scans of interest. Select the right arrow, and the scans of interest will appear in the right side of the dialog. Subsequently, only those scan will appear at the top of Acquire screens as shown in Figure 6-16. You may change the set of scans that appear in Acquire screens at any time by using the left and right arrows to change selections.

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Iris Viewport

The Iris Viewport lies in the upper left quadrant of the main Acquire screen Viewport (Figure 6-12). During scanning the iris and pupil of the current patient is shown in real time. Within this viewport you can:

• Select the appropriate lens type from the Lens drop-down menu, depending on the scan type you have selected.

• Adjust the chinrest either automatically or manually.

• Target the patient pupil using the left mouse button to move the fixation target to the center of the pupil image.

• Enhance ( ), adjust brightness and contrast ( ), or reset the pupil target .

Proper alignment of the scan beam to the pupil is required in three dimensions, X, Y (transverse), and Z (axial). CIRRUS provides automated alignment controls by clicking the Iris Viewport as well as manual controls both on–screen and via the keyboard (X-Y). These controls will adjust the chinrest and forehead rest so that the eye is properly aligned for the OCT scan. Start by using the mouse to change depth (mouse wheel), or move left to right. Once you’ve aligned the target as well as possible using the mouse controls, use the manual controls are to fine tune the alignment.

You may also use the keyboard to auto–adjust the alignment by using the keyboard arrow buttons that correspond to the X-Y controls. Press Ctrl with the keyboard arrow keys for finer adjustments. Adjustments occur in discrete steps when you click and release. When you click and hold the arrow, the adjustment motion becomes continuous until you release.

Scan Position Montage

The Scan Position Montage provides a visual representation of the retinal scan location.

6x6 mm Montage Angio Scan

The 6x6 mm Montage workflow includes 6 scans at different positions and the fixation moves 4 times.

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The initial scan location for this type of scan is Superior Nasal (SN), and the scan progression and fixation target automatically flows in the following sequence:

• Superior (S)

• Superior Temporal (ST)

•Inferior Temporal (IT)

•Inferior (I)

• Inferior Nasal (IN)

NOTE: You can skip scan locations or veer from the automatic sequence by clicking the mouse on location(s) you want to use. However, you can click Done after 1 scan is acquired.

8x8 mm Montage Angio Scan

The 8x8 mm Montage workflow includes 5 scans at different positions and the fixation moves 5 times.

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The initial scan location for this type of scan is Central (C), and the scan progression and fixation target automatically flows in the following sequence:

• Superior Nasal (SN)

• Superior Temporal (ST)

•Inferior Temporal (IT)

• Inferior Nasal (IN)

NOTE: You can skip scan locations or veer from the automatic sequence by clicking the mouse on location(s) you want to use. However, you can click Done after 1 scan is acquired.

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Fundus Viewport

The Fundus Viewport lies in the lower left quadrant of the main Acquire screen Viewport as shown in Figure 6-12, and shows a live fundus image from the line scanning ophthalmoscope (LSO). The Fundus Viewport is not available for Anterior scans. As with the Iris Viewport, there are a number of options available for optimizing the patient scan:

• Focus/Auto Focus will attempt to compensate for the patient’s refractive error by automatically changing the focus adjustment. This may help clear up a dim fundus view and will also help clear up the fixation target for a patient whose refractive error is considerable. In addition to improving the overall focus, the Auto Focus feature will do an additional adjustment on the brightness and contrast of the fundus image.

•The Transparency slider is active when a saved scan image overlay is present, which occurs when you are using a prior scan.

• Prior scan will appear as a selectable link, as shown in the margin. If your patient has been scanned previously, selecting this option will open up a small screen with a list of the patient’s previous scans. Once you select a previous scan, the location of that scan will appear as a live link, and serve as a reference as you acquire the current scan. You can change the prior, reference scan, at any time. You can also initiate an exact replica of a prior scan using the Auto Repeat function (Figure 6-20).

• Optimize automatically optimizes first the scan image centering (Z-offset), and then optimizes the scan image quality (polarization). Instruct the patient not to blink during optimization.

• Enhance ( ), adjust brightness and contrast ( ), or reset the fixation target . When you select ( ), one of the following dialog boxes will appear.

• If you have the tracking selection enabled ("Toolbar Options" on page 3-5), tracking on the macula, FastTrac automatically monitors whether the OCT B-scans are

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Click and drag scan pattern and/or fixation target to adjust their placement.

Double–click the point you wish to center. The fixation target moves accordingly.

Auto Focus and Z focus controls

Overlay Transparency control for prior scans

Focus bar

centered vertically–”Z” monitored–and stops the tracking progress when some or all of the tissue is outside the B-scan window. In some patients, it may be difficult to align the tissue within the B-scan entirely, such as those with high myopia or other kinds of atypical anatomies; for example, tilted retinas or posterior staphylomas. For these patients, the user may turn off Z monitoring, as shown in the OCT Tomogram figure on the previous page. To turn this option off, click the wand button next to the B-scan in the lower right of the Acquire Scan screen. If tracking is dialog box includes the Show Alignment checkbox. For any Macular Cube Scan, this checkbox toggles display of an alignment tool that is locked in position relative to the scan pattern; the alignment tool moves when you move the scan pattern and vice versa. This tool is designed to be placed over the optic disc to assist in accurately repeating scan pattern placement for future scans of the same eye. For macular scans, placing the alignment tool over the optic disc results in the scan center being within 1 mm of the fovea for most patients. This tool is helpful when the fovea is difficult to find in extreme edema, cataract, or floater situations.

not

enabled, the

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For optic disc scans, the alignment tool is centered on the scan pattern and on by default.

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For Optic Disc Cube 200x200 scans, it is not necessary to precisely center the optic disc in the scan image because the analysis algorithm can correctly place the Calculation Circle around the optic disc even when it is not well centered. Though it is sufficient to keep the optic disc within the outer dashed circle, it is best to center the scan on the optic disc as well as possible. The captured Live OCT fundus image

NOTE: For ONH Angiography scan, it is different than the Optic Disc Scan, in that for ONH angiography, you need to click and drag the scan pattern to be centered over the optic nerve.

Adjust Rotation and Size allows you to rotate the angle of the scan and its length.

opens the Custom Scan Pattern dialog shown below, and allows you to specify a non–

standard scan pattern.

En Face

scan image overlay that shows the area scanned. This is the

•For Rotation, click the up arrow (for counterclockwise rotation) or down arrow (for clockwise rotation) or enter a value to adjust the angle in the ranges of 0 to 360 degrees. Values entered from 91 to 269 are automatically transposed 180 degrees to correspond with scan direction. The default 0 degree position is horizontal.

•For Length, depending on the scan, you can select 3, 6, or 9 mm.

•For line Spacing, depending on the scan, you can select between 0.00 and 1.25 mm in increments of 0.025 mm.

Enhanced Depth Imaging (EDI) is an optional mode for single and multi–line raster scans that improves visibility of structures at the bottom of B-scans. The signal to noise ratio in OCT scans varies across the axial range. The default CIRRUS setup is such that the best signal is obtained at the top portion of the scan. Enhanced Depth Imaging allows you to change the acquisition settings for the raster scans so that the best signal to noise ratio is obtained at the bottom of the B-scan. This allows you to obtain an HD image that is optimized in the region that is of interest for a particular scan. To switch between EDI and standard scanning mode, select the EDI checkbox below the fundus image.

• Capture starts the scan.

• Fa stTrac R etinal Track i ng, is started and controlled by the 2 outer buttons ( ) and () just under Capture. (Green icons are on and gray icons are off.) The FastTrac

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retinal tracking system tracks eye movement and enables tracking of the current scan to the position of a prior scan. The FastTrac retinal tracking system on CIRRUS HD-OCT uses multiple channels of concurrent imaging to monitor the motion of the eye in real–time. During acquisition, motion is automatically detected and tracked to the eye. The motion of the retina is observed at a high rate to ensure higher efficiency in reducing the effects of motion. Most importantly, FastTrac ensures faster data acquisition by only re-scanning data affected by motion. FastTrac also allows precise scanning at follow-up visits to acquire data at the same region of the eye allowing for better progression analysis.

In addition to the selectable options that appear on the Acquisition screen, you can adjust certain system parameters using the left mouse button and scroll wheel, and open additional options by clicking the right mouse button. Mouse controls and options are discussed below.

Mouse Controls

Using your mouse provides a rapid way of accessing most of the controls that are available as buttons or in menus on the CIRRUS screens. During scan acquisition you can adjust scan pattern placement using your mouse for posterior scans by hovering over the fundus image (the mouse cursor will turn into a ), and dragging the scan pattern box area to another position.

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Hover the mouse over the fixation target icon (the mouse icon will turn into ), and then click and drag the fixation target to change the center its location to one of 9 pre-set locations.

Right-clicking the mouse will bring up an option box that allows you to select to Rapid Refresh View (model 500 only). This is a great tool for patients with unsteady fixation as it increases the rate at which the screen refreshes, reducing the affect of unsteady fixation.

Double-clicking anywhere on the fundus image will change the fixation location to bring that point (clicked) into the center of view.

Live Scan Viewports

The right half of the main Acquire Scan Viewport comprises the live data feed based on your current iris and fundus settings. The number of viewports may vary depending on the scan type selected. Each scan view includes a color–coded scan marker at upper left, to identify scan lines. The color and orientation of each marker correspond to the color and orientation of the lines that make up the scan pattern overlay derived from the Fundus Viewport (for posterior segment scans) or the Iris Viewport (for anterior segment scans). Live scans can be adjusted in real time using

• Center Live Scan allows you to adjust the zoom (Z-offset) of posterior segment live scans. Associated up and down arrow buttons enable you to adjust the value manually.

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• Enhance Live Scan allows you to adjust the polarization (X,Y–offsets) of posterior segment live scans. Associated up and down arrow buttons enable you to adjust each manually.

NOTE: HD Angle scans are not aligned to the corneal vertex.

NOTE: If a button or menu option does not appear on the Acquisition screen for your current scan selection then that function is not available for the current scan.

General Acquire Procedure

This section contains information about acquiring scans supported in CIRRUS HD-OCT.

NOTE: Review both the "Acquire Screen and Controls" on page 6-19 and "Set Up

for Maximum Image Quality" on page 6-31 sections prior to acquiring scans.

Once you have selected the patient of interest, the Acquire button at the bottom of the Patient screen becomes selectable.

NOTE: The first scan selection and scan of the day will run slightly slower than all later scans.

NOTE: To minimize errors and artifacts, acquire OCTA Cube scans with FastTrac on.

• HD Line 100x: A single high definition OCT B-scan, using 1024 A-scans, with selectable B-scan averaging 100 frames with an adjustable length from 3 mm to 9 mm and an adjustable angle from 0 to 90 degrees.

To Begin Scan Acquisition:

1. Ensure that the Patient is fully prepared for the scan as described in "Patient Good

Practices" on page 5-1.

2. Select Acquire. The screen will change to indicate the scan types available.

3. Select the scan type of interest

4. Ask the patient to hold their gaze and head steady (as the chinrest will be moving) and select Auto Focus in the Fundus Viewport.

5. Left–click the pupil center of the live image in the Iris Viewport to center the scan beam through the pupil.

6. After Auto Focus, check the Iris Viewport to ensure that the pupil is still centered. If the Fundus Viewport turns dark following Auto Focus, center the pupil, click , then click the Auto B/C button. If additional brightness and contrast changes are necessary, use the appropriate slider controls.

7. Further adjust the chinrest manually, if necessary, by use the circular X-Y control (see

"Iris Viewport (Posterior Segment Scan) and Anterior Segment Scan Patterns" on page 6-29). Use Z controls (left–right arrows or mouse scroll wheel)

to reach the proper working distance by bringing the iris image into focus.

8. Use Enhance (polarization) and Center (Z-offset) (posterior segment scans only) buttons and sliders to the left help you improve the scan image quality and center it vertically.

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