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

2660021156446 B2660021156446 B

CIRRUS HD-OCT

User Manual – Models 500, 5000

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

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

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

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

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

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

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

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

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

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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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

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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

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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.

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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.

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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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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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+ 322 hidden pages

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

Specifications and Main Features

Frequently Asked Questions

User Manual

Symbols and Labels

Warning and Caution Definitions

Warnings

Cautions

Protection of Patient Health Information

Safety

Record and Data Safety

Networking Guidelines

Electromagnetic Compatibility (EMC)

RoHS Compliance

Intended Use

Indications for Use

Usage

Intended Operator Profile

Demographic

Occupational Skills

Job Requirements

Data Analyst Profile

Demographic

Occupational Skills

Job requirements

Subject Profile

Installation and Setup

User Documentation

Accessing PDF Versions

Organization