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Retina Workplace

Software Version 1.0

Instructions for Use

About these Instructions These Instructions for Use form part of the delivery package.

• Please read carefully before using the product.

• Keep them in the same location as the software.

• Retain them throughout the service life of the software.

• Pass them on to any subsequent owner or user of the software.

The example patient data shown is fictitious. Any similarity to living persons is therefore purely coincidental.

Guidance – The list of chapters at the beginning of the Instructions for Use provides an overview of all topics.

– The index at the end helps you find specific terms.

Scope These Instructions for Use apply to Retina Workplace, Version 1.0.

Information about themanufacturer

Subject to change in design and scope of delivery and as a result of ongoing technical development. Printed in Germany.

© Carl Zeiss Meditec AG 2015

Carl Zeiss Meditec AGGöschwitzer Str. 51-5207745 JenaGermany

E-mail: [email protected]: www.meditec.zeiss.com

Retina Workplace

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Chapter overview

Safety measures 5

Hazard symbols in these Instructions for Use 5

Security measures for IT systems and networks 6

Data protection and information security 6

Usage information 7

Calibrated recording devices and monitors 8

Intented Use 9

Normal Use 9

Introduction 11

Software description 11

CE conformity 12

Symbols 12

Installation and licensing 13

General guidelines 13

System configuration requirements 14

Requirements of the hardware platform 15

Installation 16

Licensing 18

Getting started 19

Starting the program 19

Work area 21

TripleView 22

Tools 26

Retina Workplace

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Basic functions 31

Navigation 31

Views 33

Open/close OCT images 35

Analysis results 36

Editing functions 45

Correcting fovea position 45

Fundus registration 48

Edit segmentation 53

Macula analyses 55

Macular Thickness Analysis – MTA 55

Macular Change Analysis – MCA 56

Raster Scans 65

Configuration 67

System settings 67

User settings 68

Troubleshooting 69

General information 69

Malfunctions 69

Error Messages 70

Shortcuts 71

Index 73

Retina Workplace Safety measures: Hazard symbols in these Instructions for Use

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Safety measures

Hazard symbols in these Instructions for Use

The following safety instructions are included in the Instructions for Use. Observe the safety instructions and be especially careful in these cases.

CAUTION Identification of a hazard that could lead to slight injuries if it is not prevented.

NOTE Identification of a hazard that could lead to material damage if it is not prevented.

Safety measures: Security measures Retina Workplace

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Security measures for IT systems and networks

RA01

Data protection and information security

– The user and/or the person responsible for IT must be responsible for observing national data protection laws and regulations.

– The operators of IT systems and IT networks are responsible for defining the necessary safety standards, i.e. for creating the necessary technical and organizational framework conditions.

– Misuse exists if protected personal data is collected, processed, or otherwise used without corresponding permission.

CAUTION – The Retina Workplace software may be operated only in virus protected networks. The operator of the network is responsible for the security of the network.

– The consequences of virus attacks cannot be foreseen.

– The user of Retina Workplace is responsible for ensuring that external stor-age media (for example, USB thumb drives) that are used for data exchange are free from viruses.

– There is a risk of data corruption or data loss if devices are connected that do not meet the requirements of the FORUM DICOM Conformance State-ment (DICOM: Digital Imaging and Communication in Medicine).

– The user should carry out a risk analysis and risk evaluation and take the appropriate counter-measures if necessary. This must be updated after each change to the (data) network.

– The operator is responsible for safety and integrity of the software and network infrastructure.

– Suitable measures must be taken to ensure that only authorized users can access computers on which Retina Workplace is installed (e.g. by locking the computer).

NOTE The operator of the software is responsible for regular data backup.

Retina Workplace Safety measures: Usage information

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Observe the following definitions:

– Personal data: Personal data means information concerning the per-sonal or material circumstances of an identified or identifiable individ-ual. All data (e.g., name, age, gender, ...) that can be directly assigned to a person (patient, employee, customer, supplier) must be protected.

– Data processing: The storage, transfer (transmission to third parties outside of the organization), modification (including anonymization and pseudonymization), deletion, and blocking (identification to restrict further processing or use) of data.

– Use: Use of data (e.g., company-internal transfer).

– Recipients: Persons or entities that receive data.

– Third parties: Persons or entities that receive data and do not belong to the responsible (legal) entity. Transfer of data to third parties is con-sidered data transfer.

Usage information

• Make sure you are thoroughly familiar with the contents of the Instruc-tions for Use before starting the software. Also read the Instructions for Use of any devices and systems to be connected.

• Keep the Instructions for Use easily accessible to the users at all times.

• Retina Workplace may only be used by appropriately trained and instructed personnel. The operator operating the software is responsible for providing training and instruction of operating personnel.

• Retina Workplace may only be used by medical experts.

• Familiarize yourself with the user settings in the software.

• Use the software only for the intended purpose as described.

• The manufacturer does not accept any liability for damage caused by unauthorized persons tampering with the product. Furthermore, any rights to claims under warranty would be null and void.

Safety measures: Calibrated recording devices and monitors Retina Workplace

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• Modifications to this product are not permitted. Performing any modifica-tions to the device not described in these Instructions for Use makes you a legal manufacturer of a medical device as defined under national regulations.

• Refer to the latest Release Notes for the installed software version. These form part of the delivery package when the software is supplied. After a software update, you will receive the latest version.

• Please observe the legal regulations on accident prevention and occupa-tional safety applicable in the particular country.

Safe functioning

The Retina Workplace product is a supporting system and does not assume any diagnostic functions that are critical to safety. Treatments can be per-formed without the aid of Retina Workplace at any time.

Should a failure occur that cannot be corrected using the "Troubleshooting" section, label the product as malfunctioning, and contact ZEISS Service.

Calibrated recording devices and monitors

Stored images and reports may only be used for medical purposes if the recording device and viewing monitor are calibrated. If the recording device and monitor are not calibrated, the reproduced images may contain devia-tions with respect to scale, form and color.

CAUTION Rules of common medical sense must be applied when using Retina Workplace.

Retina Workplace Safety measures: Intented Use

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Intented Use

The Retina Workplace is a FORUM application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomogra-phy and fundus photography.

Normal Use

The Retina Workplace is an optional, additional application to FORUM, which is offered separately. It integrates the following complementary functions into FORUM:

– Processing and displaying optical coherence tomography data

– Generating reports that contain results from optical coherence tomogra-phy, and fundus photography

– Providing CIRRUS algorithms and databases for macular thickness measurements

– The Retina Workplace aids trained healthcare professionals in the detec-tion, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.

Safety measures: Normal Use Retina Workplace

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Retina Workplace Introduction: Software description

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Introduction

Software description

Retina Workplace is software that is integrated into FORUM as a plugin. The software serves to interactively display and analyze OCT data and fundus images from retina examinations.

Retina Workplace supports doctors in analysis and monitoring of (pathologi-cal) changes in the macula. The analysis occurs on the basis of OCT images and fundus images of the patient.

The central function of the Retina Workplace is visualization of OCT images in a TripleView, consisting of the fundus image, B-scan, and analysis data. Up to three TripleViews can be displayed simultaneously in the Retina Workplace work area.

OCT images and fundus images recorded by the following devices can be displayed and analyzed with Retina Workplace:

– ZEISS CIRRUS OCT devices

– Fundus cameras.

Retina Workplace provides its own presets but can also be used to open one or more OCT images directly. Appropriate scans are macular cube images and raster images of the macula. When using suitable OCT images, fundus images can be added and registered to them.

Introduction: CE conformity Retina Workplace

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CE conformity

The product meets the essential requirements stipulated in Annex I of the 93/42/EEC Directive governing medical devices. The product bears the follow-ing marking:

Symbols

The following symbols are used in these Instructions for Use:

Additional information and tips. This symbol indicates useful additional information, not a hazard.

The following symbols are used on the DVD label:

Follow Instructions for Use.

Manufacturing date

Manufacturer

Retina Workplace Installation and licensing: General guidelines

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Installation and licensing

General guidelines

All installation work described in this chapter should only be performed by a system administrator.

Prerequisite The Retina Workplace installation file is available.

The FORUM server is installed and started.

The computer on which Retina Workplace is to be installed (FORUM server) has at least 60 GB of free hard drive space.

NOTE If the computer where Retina Workplace is installed does not meet the mini-mum hardware requirements, Retina Workplace may not run as intended. Ensure that the hardware requirements are met.

Installation and licensing: General guidelines Retina Workplace

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System configuration requirements

– Retina Workplace is executed together with FORUM. Both applications must be installed and executed.

– You need FORUM 4.0. in order to be able to execute Retina Workplace 1.0.

– The computers and other ZEISS devices used in your office run on a net-work. As the customer, you are responsible for setting up the network.

– A ZEISS Service technician performs the installation or update of your system to FORUM 4.0.

– Retina Workplace 1.0 can be installed by customers themselves. This pre-supposes that the customer has comprehensive knowledge of IT systems. Otherwise, a ZEISS Service technician can perform the installation. If your office does not have the necessary expertise in IT systems, or if you prefer to have a ZEISS Service technician install Retina Workplace, contact ZEISS Service.

The customer’s own on-site personnel must meet the following prerequisites in order to be able to install and configure Retina Workplace 1.0:

– Knowledge of configuration and administration of software medical products as a system administrator with corresponding permissions

– Familiarity with the local hardware, software, and IT networks

– System administrator rights for the relevant IT system components

– Knowledge of the configuration of local firewalls, including administering and enabling ports, with corresponding permissions

– Knowledge of the configuration of the local antivirus software, including permissions to deactivate this software during the installation and to exclude particular folders

Retina Workplace Installation and licensing: General guidelines

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Requirements of the hardware platform

The use of inappropriate hardware platforms can impair the function of the software. As the operator, you are responsible for selecting the correct hard-ware and for the proper functioning of the hardware.

Your system must fulfill the following minimum requirements in order to function properly:

Server

– Intel Core i5-750 or comparable processor

– 3 GB of RAM in addition to the RAM set aside for FORUM (recommended: 4 additional GB)

– At least 4 GB of free hard drive space for the installation and an additional 50 GB of hard drive space as cache for precomputed data

– Network connection

– Operating systems supported:Windows Server 2008 R2 (64 Bit) with Service Pack 1Windows Server 2012 R2 (64 Bit)Windows 7 (64 Bit) with Service Pack 1Windows 8.1 (64 Bit)

Client

– Intel Core i5-750 or comparable processor

– Minimum screen resolution: 1280 x 800 pixels. Retina Workplace 1.0 has been optimized for a screen resolution of 1680 x 1050 or higher. A screen resolution of 1680 x 1050 is recommended.

– Operating systems supported:OS X 10.8 (Mountain Lion)OS X 10.9 (Mavericks)Windows Server 2008 R2 (64 bit)Windows Server 2012 R2 (64 bit)Windows 7 (64 bit)Windows 7 (32 bit)Windows 8.1 (64 bit)

Installation and licensing: Installation Retina Workplace

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Installation

The Retina Workplace software must be installed on the FORUM Server.

Actions • Double-click on the setup file.

• Confirm the license agreement.

• Select an installation folder and confirm with <Install>.

• Confirm any prompts that appear to perform updates.

Retina Workplace Installation and licensing: Installation

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The installation is performed.After the installation, you will be prompted to restart the computer.

• Confirm the prompt.

A message that the installation has been performed successfully appears.

• Close the window and restart the computer.

Result After the restart, Retina Workplace is completely installed and can be licensed (see section "Licensing" on page 18).

Installation and licensing: Licensing Retina Workplace

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Licensing

Prerequisite Retina Workplace is installed.

The necessary license files are available on the FORUM server.

Actions • Save the license files (.lic) to the installation directory (if FORUM has been installed in the default installation directory, the path is: C:\Programs\CZM\FORUM).

• Start the FORUM Service Tool (see FORUM Instructions for Use).

• Select <Tools><Read License Files>.

• Confirm by clicking on <Yes>.

Result The licenses are read. Retina Workplace can be started.

Retina Workplace Getting started: Starting the program

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Getting started

Starting the program

Retina Workplace provides additional presets that appear in the "Retina Workplace" section. Opening one of these presets automatically starts Retina Workplace. The OCT images defined in the preset are loaded into the work area.

Prerequisite Retina Workplace is installed on the FORUM server.

Use of Retina Workplace is enabled for the user logged in to FORUM.

When the user logs in to FORUM, an unlocked user license is available.

In order to be able to use Retina Workplace, each user needs a user license. This license is requested when the user logs in to FORUM and is released when he or she logs off. Therefore, the number of users who can work with Retina Workplace simultaneously is limited by the number of available user licenses.

Actions • Click the "Retina Workplace" entry in order to make the retina presets visible if they are not already.

Getting started: Starting the program Retina Workplace

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In the list that is now available, the following presets are displayed:

• Click on the desired preset.

Result The documents corresponding to the preset are opened in the Retina Workplace work area.

Retina Workplace Getting started: Work area

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Work area

The maximum number of OCT images displayed simultaneously depends on the preset used: At most 2 images are displayed for Macular Change Analysis and at most 3 for all other presets.

The OCT images are arranged in chronological order from left to right.

– Depending on the user settings (see section "User settings" on page 68), the start screen may differ from the illustration above.

– The laterality of the current scan has the same laterality as the display by default.

– If multiple OCT images were made and stored in FORUM in one visit, the scan with the highest signal strength is displayed. Scans marked as favorites are given preference regardless of the signal strength. If fewer than three OCT images are available, those images are displayed in the work area.

Getting started: TripleView Retina Workplace

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TripleView

The TripleViews are structured as follows:

– Fundus image (with selectable overlay).

– B-scan of the OCT image.

– Analysis area with analysis results.

Depending on the user settings, the analysis area of the TripleViews may be covered by a chart upon startup:

Retina Workplace Getting started: TripleView

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Fundus image

Depending on the user settings, the fundus image may be displayed as follows after a preset is opened:

– with navigator (left)

– with an additional overlay in the OCT scan area (right).

The yellow frame marks the OCT scan area. The turquoise line of the navigator indicates which B-scan (see section "B-scan" on page 24) is selected. The pur-ple line is for orientation. It is in the same location here and in the B-scan.

Getting started: TripleView Retina Workplace

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B-scan

Depending on the user settings, the horizontal B-scan of the OCT image is dis-played in color, in gray scale, or in inverted gray scale after a preset is opened.

The scan type of the OCT image determines the resolution of the B-scan displayed. OCT images of the following scan types can be displayed:

– Macular Cube 512x128

– Macular Cube 200x200

– HD 5 Line Raster

Retina Workplace Getting started: TripleView

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Analysis area

Various analysis formats for the OCT images can be displayed in the analysis area (the example shows "Overlays").

The following analysis area tabs are displayed on the left edge of the analysis area. They can be used to select what is displayed in the analysis area.

Depending on the user settings, one of these three options is selected when a preset is opened.

Chart

Display of two selectable thickness and/or volume values for each visit as a chart.

Overlays

Selection of a display of analysis results in the form of overlays superimposed over the fundus image.

Table

Display of a table with analysis results and any further details on the OCT image.

Getting started: Tools Retina Workplace

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Tools

Buttons and information for working with the documents displayed are available for you in the toolbar of the work area and in the TripleViews.

Toolbar

The buttons of the lower toolbar are described in the following table.

The tools displayed in the lower toolbar depend on the current preset.

The FORUM-wide buttons of the upper toolbar are described in the FORUM Instructions for Use.

Hide overlays Displaying/hiding the overlays of a TripleView or, if the "Synchronize" function is activated, of all TripleViews (blue = activated).

Lossy compression

Indicates that the B-scans have been compressed with lossy compression. Image compression is activated in the system settings (see section "System settings" on page 67).

Retina Workplace Getting started: Tools

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Synchronize on/off

All navigation and visualization functions in one TripleView are also performed synchronously in the other TripleViews (blue = active).

CAUTION Retina Workplace does not show exactly the same position during synchro-nized navigation through the B-scans. Instead, the function serves to find sim-ilar areas.

Generation of reports:

Overview report: An over-view report of the TripleViews is generated.

OCT report: The selected OCT image is printed or stored as a PDF report according to the selected analysis.

Save overview report in FORUM The overview report is saved in FORUM.

Save overview report as The overview report can be saved at a selectable location.

Save OCT report in FORUM The OCT report is saved in FORUM.

Save OCT report as The OCT report can be saved at a selectable location.

Print overview report The overview report is sent to a printer.

Print OCT report The OCT report is sent to a printer.

Zoom and pan

The zoom and pan function is activated/deactivated.

Zoom automatically

The fundus image or B-scan is displayed in a way optimized with respect to the relevant image section and its maximum magnification.

Brightness and Contrast

Change of the brightness and contrast of the selected B-scan or fundus image.

Transparency of overlay

Setting for the transparency of the overlays.

Display HD B-scan

Display of a high-resolution B-scan.


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Align navigator to center

The navigator is positioned in the center of the scan area.

Align navigator to fovea

The navigator is positioned on the fovea.

Display and correct fovea position

Display/hide the fovea position (fovea positioner) (blue = activated).

Reset fovea to auto-fovea

Set/reset the fovea-position.


The fovea is reset to the fovea position determined by the system.

Place fovea in navigator position

The fovea is reset to current position of the navigator.

Display segmentation lines

Hide the ILM/RPE segmentation lines (blue = activated).

Edit segmentation

Editing the segmentation.

Display B-scan in color

Color display of the B-scans (blue = activated).

Display B-scan in gray scale

Gray scale display of the B-scans (blue = activated).

Display B-scan in inverted gray scale

Inverted gray scale display of the B-scans (blue = activated).

Retina Workplace Getting started: Tools

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Right mouse clickfunctions

TripleView header

The following describes only the buttons and icons specific to Retina Workplace. You can find the description of the other buttons and icons in the Instructions for Use of FORUM or other relevant plugins.

On a fundus image

Copy fundus image to clipboard as image.

On a B-scan Current display of a B-scan as a standard display.

Copy B-scan to clipboard as image.

In the analysis area

on the empty area (chart selection)

Copy chart to clipboard as image.

on an overlay (overlay selection)

Use the overlay that was clicked on for this analysis type by default.

on a table (table selection)

Copy table values to clipboard.

Date/time Date and time of the OCT image.

MTA/MCA/Raster Analysis currently used.

Notification indicator

The number in the indicator gives information on the number of notifications available. Clicking on the indica-tor displays the available notifications.


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Tools and displays in the B-scan

Signal strength of the B-scan displayed (maximum signal strength is 10).

Scale of the B-scan.

Scan direction (here: Scan direction N to T):

– N = Nasal (nose)

– T = Temporal (temple)

[scrollbar] Scrollbar (on the right and bottom) to display any areas of the B-scan that are not visible.

Start and stop layer slideshow (video function).

Speed control for the layer slideshow (to the left = slower, to the right = faster).

Retina Workplace Basic functions: Navigation

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Basic functions

Navigation

Navigator

You can navigate horizontally and vertically in the section of the OCT scan in the yellow box with the navigator (turquoise/purple crosshairs). The numbers on the navigation lines indicate the current B-scan position. The correspond-ing B-scans for the positions selected in this way are displayed in the B-scan.

Prerequisite The navigator can be positioned manually ( "Zoom and pan" button is deactivated).

Actions • Click on any position within the OCT scan area and hold down the mouse button.

The crosshairs of the navigator are aligned to the cursor position.

• Drag the cursor to the desired position.

Result The B-scan is displayed at the selected scan position (horizontal line for B-scan).

Basic functions: Navigation Retina Workplace

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Video function

Using the video function, you can start a layer slideshow of all the horizontal B-scans.

Actions • Click the symbol in the B-scan to start the layer slideshow.

• If desired, change the speed of the layer slideshow with the "Speed Controller".

Result The layer slideshow repeats until you stop it with the symbol. The turquoise line of the navigator shows the current position in the fundus image analogously.

Retina Workplace Basic functions: Views

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Views

Full-screen view

In the full-screen view, either the fundus image or the B-scan is scaled to the maximum size.

Actions • Double-click on a fundus image or a B-scan.

Result

In the full-screen view, all the functions of the work area are available to you with the exception of "Chart" and "Table".

The fundus image or B-scan is displayed in full-screen.

Basic functions: Views Retina Workplace

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In addition, the following buttons are hidden (in the toolbar) in the full-screen view:

HD B-scan

A high-resolution B-scan is displayed instead of the normal B-scan. This is indicated on the bottom left with "HD".

Actions • Click the button ("Display HD B-scan").

Result

The functionality and labeling of the HD B-scan corresponds to the "normal" B-scan and is described there (see section "Tools and displays in the B-scan" on page 30).

Close Back to the work area.

Previous scanCurrent scanNext scan

The TripleViews displayed in the work area can be opened in sequence directly in full-screen mode.

Large fundus image The fundus image with overlay is displayed in full-screen mode.

Large B-scan The B-scan is displayed in full-screen mode.

The HD B-scan is displayed.

Retina Workplace Basic functions: Open/close OCT documents

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Open/close OCT images

You can close the TripleViews displayed in the work area at any time and open new OCT images.

At most 3 OCT images can be displayed simultaneously in the work area. In the Macular Change Analysis, the maximum is 2 OCT images.

Close

Remove a TripleView from the work area by clicking the close button.

Open

You can open an OCT image in the document area in the work area as follows:

– by dragging and dropping to an empty position in the work area. The OCT image is inserted as a TripleView.

– by dragging and dropping to a TripleView in the work area. The TripleView in the work area is replaced.

The TripleViews are then arranged in chronological order from left to right.

Section "Chart" on page 37 describes how you open OCT images directly from the "analysis area".

Section "Fundus registration" on page 48 and section "OCT to OCT registration" on page 60 describe how you open fundus images or OCT images in the work area for registration.

Basic functions: Analysis results Retina Workplace

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Analysis results

The following options are available to you in the analysis area:

– Display of analysis results across all visits within the treatment period as a chart.

– Display/selection of analysis results in the form of overlays of the OCT scan area in the fundus image.

– Display of a table with analysis results and any further details on the OCT image.

You can switch between these with the analysis area tabs. The activated tab is highlighted in blue.

CAUTION Analysis results depend on the correct registration and segmentation of OCT data. The user should check the results of the automatic registration and segmentation process and correct them if needed.

Retina Workplace Basic functions: Analysis results

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Chart

The "Chart" function displays two selected thickness/volume values across the entire visit period as line charts.

Overview

Actions • Click the analysis area tab ("Chart").

Result Two selected thickness or volume values are displayed as line charts across the entire visit period. Each symbol in the line chart corresponds to a visit in which at least one OCT image was made. The position of the symbol corresponds to the left or right axis label. "Central Subfield (μm)" and "Average Cube Thickness (μm)" are selected by default for the display.

The connecting line between the individual values is exclusively for visualization.

The colors (ocher and green) of the two line charts correspond to the values selected in the left (ocher) and right (green) menus. The corresponding scale is displayed on the left and right analogously to the color of the charts. The time axis on the lower edge displays the visit period.

The various symbols have the following meanings:

The OCT image of scan type 512x128 is located in the work area. The TripleView selected in the work area is displayed in blue.

The OCT image of scan type 200x200 is located in the work area. The TripleView selected in the work area is displayed in blue.

The OCT image of scan type 512x128 is not displayed in the work area.


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Chart-specific functions

The following functions are available to you for generating and displaying the line charts:

Menus

Buttons

The OCT image of scan type 200x200 is not displayed in the work area.

The OCT image is not included in the chart (see section "Document-specific functions" on page 39).

Left selection menu for left scale

Selection of a measurement (ocher chart).

If "none" is selected, no chart is displayed. Values that have already been selected in the right selection menu are blocked (grayed out).

Right selection menu for right scale

Selection of a measurement (green chart).

If "none" is selected, no chart is displayed. Values that have already been selected in the left selection menu are blocked (grayed out).

Zoom in/out

Zooming in or out on the time axis.

Shift time axis to the left/right

Move time axis.


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Document-specific functions

You have the options of:

– excluding OCT images from the analysis,

– moving OCT images displayed in the chart into the work area.

Right mouse clickfunctions

Drag & dropfunctions

Mouseoverfunctions

Select values

Actions • Click on a value in the left or right selection menu or on a subfield of the ETDRS grid in the "Thickness values of ETDRS subfields" submenu.

Result The selected values are displayed as a chart across the visit period.

On a filled circle The OCT image is not included in the chart and is displayed as an empty circle.

On an empty circle

The OCT image is included in the chart and is displayed with the corresponding symbol.

Move circle into the work area by dragging and dropping it

Open the OCT image belonging to the circle in the work area if it is not already open.

Mouseover over a circle Tool tip with information on the OCT image is shown.


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Overlays

You have the option of superimposing analysis results over the OCT scan area in the fundus image. Such a superimposition is called an "overlay".

Overview

Prerequisite The "Hide overlays" button is deactivated (see section "Toolbar" on page 26).

Actions • Click the analysis area tab ("Overlays").

Further specific overlays are described in section "Overlays" on page 57.

The following overlays are available to you:

OCT Fundus An OCT Fundus image is overlaid on the fundus image.

ILM-RPE A thickness map is overlaid on the fundus image. The color scale on the bottom edge of the fundus image indicates the values of the colors.

ETDRS An ETDRS grid with numerical and normative color values is overlaid on the fundus image. The color scale on the bottom edge of the fundus image indi-cates the values of the colors.

CAUTION ETDRS grid results depend on the patient age and the fovea position. Incorrect values can lead to incorrect analysis results.


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Select overlay

Actions • Move the cursor over the available overlays (mouseover).

When the cursor touches an overlay, the overlay is temporarily displayed in the associated fundus image.

or

• Click on an overlay.

Result The overlay is permanently displayed in the associated fundus image.

You can adjust the transparency of the overlay with the button ("Transparency of overlay").

You can select one overlay as the standard display with the right mouse button. The selected overlay is then displayed for the analysis (MTA, MCA) for this user by default.


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Table

The "Table" function displays a selection of the thickness and volume values for every OCT image.

Actions • Click the analysis area tab ("Table").

Result

The meanings of the colors highlighting the values is described in the CIRRUS Instructions for Use.

Depending on the values determined, one of the following symbols is dis-played at the end of the table. These symbols show additional information when pressed.

A selection of thickness/volume values is shown in various colors:

All values are in the normal range.

One or more values are on the boundary to a normative reference limit.

No symbol displayed No normative data are available. The reason may be a missing license for the normative database, the age of the patient (under 18 years old), or missing age information.


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You can show detailed values with the respective icon displayed:

Actions • Click on the icon.

Result

The "Normative Data Details OD/OS" window opens with all relevant values.


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Retina Workplace Editing functions: Correcting fovea position

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Editing functions

Correcting fovea position

Retina Workplace generally detects the fovea position automatically. When Retina Workplace starts, the crosshairs of the navigator are positioned on the fovea.

Due to anatomical peculiarities or pathological changes, it is possible that Retina Workplace will not determine the fovea position correctly or not detect the fovea.

If the system has not detected the fovea, an error message is output. The crosshairs of the navigator are positioned in the center of the OCT scan area.

Tools

You can change the fovea position determined by the system by using the fovea positioner. To do so, activate the fovea positioner with the button ("Display and correct fovea position").

The fovea positioner is displayed in the form of an inner pink circle and outer black circle. The inner circle defines the position of the fovea.

Editing functions: Correcting fovea position Retina Workplace

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The fovea positioner can be positioned with the mouse or with the help of the navigator and the following buttons:

Align navigator to center

The navigator is positioned in the center of the scan area.

Align navigator to fovea

The navigator is positioned on the fovea.


Set/reset the fovea position.


The fovea is reset to the position determined by the system.

Place fovea in navigator position

The fovea is reset to current position of the navigator.

Retina Workplace Editing functions: Correcting fovea position

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Correction

Prerequisite The fovea positioner is shown (button ("Display and correct fovea posi-tion")).

Actions • Use the mouse and/or the buttons described previously to position the inner circle of the fovea positioner at the fovea location you have detected.

Result The manual change to the fovea position is saved automatically. The man-ual change is displayed in the header of the TripleViews with the icon.

Using the mouse or the buttons described, you can also reset or redefine the newly determined fovea position.

Editing functions: Fundus registration Retina Workplace

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Fundus registration

With the "Fundus registration" function, you can register additional fundus images to an OCT image. From the header of the function, you can select which available or additionally registered fundus images are displayed. The information about which fundus images have been additionally registered to an OCT image is saved automatically with the OCT image.

The registration is first performed automatically. The result can be checked in the "Register fundus image to OCT" window. If the automatic registration was not successful, the registration can be performed manually.

Automatic registration

Actions • Move a fundus image from the preview area onto the fundus image in a TripleView while holding the mouse button down.

Result

A failed automatic registration is indicated by an error message and by the header of the TripleView appearing red. You can perform the registration manually.

The original OCT image and the new fundus image are registered.

Retina Workplace Editing functions: Fundus registration

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After registration, the following buttons are displayed in the header:

Scroll between the available and additionally added fundus images.

X/X Currently displayed fundus image/total number of fundus images.

Expand list of registered fundus images

Display of the fundus images available or added to the OCT image with information on the type (manual/automatic) and success (successful/failed) of the registration.

The following functions can be selected for every fundus image:

Review result The result of the registra-tion is displayed in the "Reg-ister fundus image to OCT" window.

Register manually Start the manual registra-tion.

Register automatically The automatic registration is performed again for the selected fundus image.This function is only availa-ble for manually registered fundus images.

Remove from list The fundus image is removed from the list. This deletes an existing registra-tion.


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Display registration results

You can find details on a registration in the "Register fundus image to OCT" window.

Actions • Click on the button in the fundus image.

The available and added fundus images are listed.

• Choose the menu item <Review result> for the desired fundus image.

Result The "Register fundus image to OCT" window opens with information on the registration.

In the "Register fundus image to OCT" window, you will see (from left to right):

– the OCT Fundus image (reference image),

– the fundus image to be registered (registration image),

– the overlay of the two fundus images (registration result/reference image).

The following functions are available to you:

Scrollbar Change of the transparency of the overlaid reference image. This makes it easier to check the registration results.

Register manually Start the manual registration.

Close Close window.

Retina Workplace Editing functions: Fundus registration

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Manual registration

If the automatic registration has not been performed or has been performed incorrectly, you can also perform the registration manually.

Actions • Click the <Register manually> button in the "Register fundus image to OCT" window

or

• Click on the button in the header of the fundus image and select <Register manually>.

• Set the first (orange) registration point in the "Reference image" by clicking on the desired position with the cursor.

• Set the first (orange) registration point in the "Registration image" at the same position. A magnifying glass with the cursor position shown as a green cross helps you during positioning.

You can move incorrectly set registration points with the mouse or remove them with the <Remove points> buttons.

You remain in or are taken to the "Register fundus image to OCT" window.


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As soon as at least 3 registration points have been set per image, the <Register> button becomes active and can be used.

• Click on the <Register> button.

The registration result is displayed on the right. A message in the window indicates whether the registration was successful.

If the registration was not successful, you can repeat the registration process.

• Save the successful registration with the <Save> button.

Result The registration is saved.

• Set at least 3 or at most 5 corresponding registration points in each image:

Retina Workplace Editing functions: Edit segmentation

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Edit segmentation

With this function, the segmentation can be changed manually.

In the "Edit segmentation" window, you can edit the ILM and RPE lines. The software then recomputes the thickness/volume values between these layers.

Overview

Actions • Select a TripleView in the work area and click on the button ("Edit segmentation").

Result

The fovea position is visualized in the left fundus image with the pink circle. The color coding of the thickness map is explained by the color scale on the bottom edge of the screen. The segmentation line for the ILM is displayed in blue, and the segmentation line of the RPE is displayed in red.

The ILM-RPE thickness map and the B-scan with the segmentation lines are displayed in the "Edit segmentation" window.

Editing functions: Edit segmentation Retina Workplace

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Correct segmentation

Actions • Navigate to the desired B-scan position with the navigator, mouse wheel, or scrollbar.

• Point the cursor at a segmentation line.

The segmentation line is highlighted as a thick line.

• Click the left mouse button and hold it down.

The cursor is displayed as a cross.

• Drag the segmentation line again.

• Complete the edit with <Save>.

Result The "Edit segmentation" window closes. The changes are visible in the work area.

The original automatic segmentation of the OCT image can be restored at any time with <Reset>.

The following functions are available during editing:

Buttons

Additional functions

Previous & copy Transfer RPE/ILM lines to the previous layer and switch to the previous layer.

Next & copy Transfer RPE/ILM lines to the next layer and switch to the next layer.

Reset The original automatic segmentation of the OCT image is restored.

Import from CIRRUS The most recent segmentation, which was performed before with CIRRUS, is imported.

Save The "Edit segmentation" window closes. The modified OCT image is displayed in the work area.

Cancel The changes from the current edit are discarded, and the "Edit segmentation" window closes.

Scrollbar in B-scan Direct navigation through all B-scans.

Retina Workplace Macula analyses: Thickness Analysis

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Macula analyses

Macular Thickness Analysis – MTA

When a "Macular Thickness Analysis" preset is opened, up to three OCT images are displayed in the work area.

Perform your examination with the functions described in the previous sections.

Macula analyses: Change Analysis Retina Workplace

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Macular Change Analysis – MCA

This section describes functions in which the Macular Change Analysis differs from the Macular Thickness Analysis.

When a "Macular Change Analysis" preset is opened, two OCT images are displayed in the work area.

By default, the two OCT images are registered to each other when the preset is opened. This is displayed by the notification indicator in the header of the right TripleView in the form of a notification. The more recent OCT image in the right TripleView is registered to the older OCT image in the left TripleView.

The following additional buttons are displayed in the toolbar:

Turn OCT to OCT registration on/off

Turn current OCT to OCT registration on/off (blue = on).

Registration Menu function for OCT to OCT registration (see section "OCT to OCT registration" on page 60).

Retina Workplace Macula analyses: Change Analysis

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Besides the analysis and processing options described so far, specific functions are available to you in the following areas when using the "Macular Change Analysis" preset:

– Overlays (analysis area)

– Table (analysis area)

– OCT registration (toolbar).

Overlays

The following overlays are available to you for both TripleViews:

OCT Fundus: An OCT Fundus image is overlaid on the fundus image.

ETDRS via ILM-RPE: A thickness map known from the macular thickness analysis is overlaid on the fundus image. In addition, one ETDRS grid per subfield is displayed above it with average thickness values.


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The following overlays are available to you for the right TripleView:

ILM-RPE difference: A difference map is overlaid on the fundus image. The colors of the difference map represent the change in the thickness in comparison to the OCT image displayed on the left. The color scale on the bottom edge of the fundus image explains the exact meanings of the colors.

An ETDRS grid is displayed above it in addition. The values in the ETDRS grid correspond here to the change in the ETDRS values in comparison to the OCT image displayed on the left.

CAUTION The ILM/RPE difference values are also displayed if the two OCT-images are not registered. However, a missing registration can lead to incorrect values, since the images may not be lined up above one another in exactly the right position.


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Table

The analysis area shows you various values for the TripleViews. The right TripleView additionally displays the difference values in comparison to the left TripleView.

The difference values are also displayed if the two OCT images are not regis-tered. However, a missing registration can lead to incorrect values, since the images may not be lined up above one another in exactly the right position.


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OCT to OCT registration

You can register two OCT images to one another with the "OCT to OCT registration" function.

When the "Macular Change Analysis" preset is opened, this registration is per-formed automatically for the images displayed. The automatic registration is also performed if you drag new OCT images into the work area.

You can check, reset, or repeat the registration or perform it manually at any time.


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The following buttons are available to you in the toolbar for registration:

Automatic registration

Prerequisite Manually registered image pair.

Actions • Click the <Registration> button and select <Automatic>.

Result The registration is performed automatically. A message that can be viewed with the notification indicator reports on the success of the registration.

Turn OCT to OCT registration on/off

Delete/restore registration currently displayed (blue = on).

The difference values are also displayed if the two OCT images are not registered. However, a missing registration can lead to incorrect values, since the images may not be lined up correctly above one another.

Automatic The OCT images currently displayed are registered automatically.

This function is only active for manually registered OCT images.

Manual Start manual registration in the "Register OCT to OCT" window.

Review result The result of the registration is displayed in the "Register OCT to OCT" window.


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Display registration result

You can find detailed information on a registration in the "Register OCT to OCT" window.

Actions • Click the <Registration> button and select <Review result>.

Result The "Register OCT to OCT" window opens. You can find information on the OCT images to be registered here.

The following functions are available:

Register manually Start the manual registration from the "Register OCT to OCT" window (see next section).

Close Close window.


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Manual registration

If the automatic registration has not been performed or has been performed incorrectly, you can also perform the registration manually.

Actions • Click the <Registration> button and select <Manual>

or

• Click the <Register manually> button in the "Register OCT to OCT" window.

You remain in or are taken to the "Register OCT to OCT" window:

• Set the first (orange) registration point in the "Reference image" by clicking on the desired position with the cursor.

• Set the first (orange) registration point in the "Registration image" at the same position.

You can move incorrectly set registration points with the mouse or remove them with the <Remove points> buttons at any time.


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As soon as at least 3 registration points have been set per image, the <Register> button becomes active and can be used.

• Click on the <Register> button.

The registration result is displayed on the right of the image. A message in the window indicates whether the registration was successful.

If the registration was not successful, you can repeat the registration process at any time.

• Save the successful registration with the <Save> button.

Result The registration of the OCT images is saved.

• Set at least 3 or at most 5 corresponding registration points in each image:

Retina Workplace Macula analyses: Raster Scans

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Raster Scans

This section describes functions in which the Raster Scans differ from the Macular Thickness Analysis.

When a "Raster Scans" preset is opened, up to three raster scan OCT images are opened in the work area.

The raster scan consists of one or more B-scans:

Only a limited selection of functions is available to you for the raster scans. The buttons that cannot be used are grayed out. The navigator, the fovea positioner, and the overlays are deactivated.

You can find the following information under ("Table"):

Scan Angle Image angle for the layer image.

Length (mm) Length of the layers.

Spacing (mm) Spacing between the layers.

Macula analyses: Raster Scans Retina Workplace

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Retina Workplace Configuration: System settings

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Configuration

System settings

You can adjust system settings for Retina Workplace in FORUM.

Actions • In FORUM, select <System><Workplace Administration><FORUM Retina Workplace Configuration>.

• Adjust the following system settings:

• Save the modified settings.

Result The modified settings will be available immediately when Retina Workplace starts.

Normative OCT Data Selection of an available database for normative OCT data.

Order of patient names Preference list from the following options for displaying the names: Alphabetically, phonetically, or ideographically.

Activate lossy image compression

Activation/deactivation of image compression. The cache is used more efficiently when image compression is activated.

Directory for cache Cache directory.

Maximum storage space for cache in GB

Maximum storage space for cache.

Include worklist for caching

Activate/deactivate use of worklists ("Modality Worklist") for pre-computing caching entries.

Time window for caching in hours

Time window [1–100 hr] during which the entries in of worklists ("Modality Worklists") should be used for pre-computing caching entries.

CAUTION Lossy compression might lead to blurred or unclear images. This can obscure important image details.

Configuration: User settings Retina Workplace

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User settings

You can adjust user settings for Retina Workplace in FORUM.

Actions • In FORUM, select <System><Workplace Administration><FORUM Retina Workplace Configuration>.

• Adjust the following user settings:

• Save the modified settings.

Result The modified settings will be available immediately when Retina Workplace starts.

Default component for analysis

Selection of the analysis area tab that is preset by default.

Default overlay for MTA Selection of the default overlay in the MTA presets.

Default overlay for MCA Selection of the default overlay in the MCA preset.

Default visualization mode of B-scan

Selection of the default color display of the B-scans.

Automatically zoom in on B-scans

Turns the "Zoom automatically" function on/off for B-scans

Retina Workplace Troubleshooting: General information

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Troubleshooting

General information

Many error conditions can be resolved by checking that you have taken care of all of the following:

• If you have a firewall installed, make sure that the firewall is not blocking the connection between FORUM server and Retina Workplace.

• Make sure you have all the appropriate licenses.

• Make sure you (and other users of Retina Workplace) are configured for Retina Workplace access in FORUM.

Follow the directions in the following tables if an error occurs. If you cannot resolve the error, contact the ZEISS Service.

Malfunctions

Malfunction Cause/Procedure

It is not possible to open the Retina Workplace. The message "No connec-tion to the server could be establis-hed." will be shown.

A possible cause could be that a firewall is blocking the Retina Workplace. This service is installed on the computer that runs the FORUM server.

If your system uses a firewall, the Windows services "CZM-FORUM-Retina-Service" and "CZM-FORUM-Retina-Analysis-Service" must be configured as an exception in the firewall.

Troubleshooting: Error Messages Retina Workplace

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Error Messages

Software area

Error message Cause Procedure

Total No connection to the server could be established. Contact your system administrator

The Retina Workplace server is not available.

The Windows services "CZM-FORUM-Retina-Service" and "CZM-FORUM-Retina-Analysis-Service" must be configured as an exception in the firewall, if there is one.

Total An internal server error has occurred. Contact your system administrator.

An internal error occurred.

Unfortunately it is not possible for the user to solve the problem. Please contact the system admini-strator or the ZEISS Service.

Retina Workplace Shortcuts

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Shortcuts

Switch analysis area Chart

Overlays

Table

B-scan, fundus image Move

Zoom

Brightness/Contrast

B-scan Navigate horizon-tally and vertically

Navigate vertically

Zoom

Scroll through layers

Display/hide overlays

Copy selected components to clipboard

Full-screen view, B-scan Next scan

Previous scan

Open full-screen view

ctrlcmd 1

ctrlcmd 2

ctrlcmd 3

ctrlcmd

ctrlcmd

PgUp

PgDn

ctrlcmd

Space

ctrlcmd C

ctrlcmd

ctrlcmd

ESC

Shortcuts Retina Workplace

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Retina Workplace Index

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Index

A

Address of the manufacturer ...................................................................... 2Analysis area ...................................................................................... 22, 25Analysis area tab ...................................................................................... 25Analysis data and tools ............................................................................. 36Automatic registration

Fundus image ............................................................................... 48OCT to OCT .................................................................................. 61

B

B-scan ................................................................................................ 24, 30Buttons .................................................................................................... 26

C

Caching .................................................................................................... 67CE conformity .......................................................................................... 12Chart ........................................................................................................ 37Conformity (CE) ........................................................................................ 12Correct segmentation ............................................................................... 54

D

Data protection .......................................................................................... 6Difference values ...................................................................................... 59Document area ........................................................................................ 35

E

Edit ILM and RPE lines .............................................................................. 53Error Messages ......................................................................................... 70ETDRS overlay .......................................................................................... 40

F

FORUM Retina Workplace Configuration ............................................ 67, 68FORUM Service Tool ................................................................................. 18Fovea position

correct .......................................................................................... 45display .......................................................................................... 45

Index Retina Workplace

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Fovea positioner ....................................................................................... 45Full-screen view ....................................................................................... 33Fundus image .......................................................................................... 23Fundus registration .................................................................................. 48

H

Hazard symbols .......................................................................................... 5HD B-scan ................................................................................................ 34Horizontal B-scan ..................................................................................... 24

I

ILM/RPE difference values ........................................................................ 58ILM-RPE overlay ....................................................................................... 40Image compression .................................................................................. 67Information security ................................................................................... 6Installation ............................................................................................... 16Installation file ......................................................................................... 13Intented Use .............................................................................................. 9

L

License ..................................................................................................... 19License files .............................................................................................. 18Licensing .................................................................................................. 18Lossy compression ................................................................................... 26Lossy image compression ......................................................................... 67

M

Macular Change Analysis ......................................................................... 56Macular Thickness Analysis ...................................................................... 55Malfunctions ............................................................................................ 69Manual registration


Manufacturer's address .............................................................................. 2Monitors .................................................................................................... 8

N

Navigator ................................................................................................. 31Normal Use ................................................................................................ 9

Retina Workplace Index

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O

OCT Fundus overlay ................................................................................. 40OCT images .............................................................................................. 21

close ............................................................................................. 35insert ............................................................................................ 35open ............................................................................................. 35

OCT report ............................................................................................... 27OCT scan area .......................................................................................... 23Overlays

ETDRS ........................................................................................... 40ILM-RPE ........................................................................................ 40OCT Fundus .................................................................................. 40

Overview report ....................................................................................... 27

P

Presets ............................................................................................... 19, 20

R

Recording devices ...................................................................................... 8Registration


Registration resultFundus image ............................................................................... 50OCT to OCT .................................................................................. 62

Reportsgenerate ....................................................................................... 27print ............................................................................................. 27save .............................................................................................. 27

Retina presets ........................................................................................... 19

S

Scan direction .......................................................................................... 30Security measures for IT systems and networks .......................................... 6Segmentation ........................................................................................... 53Setup file .................................................................................................. 16Speed controller ....................................................................................... 32Starting the program ................................................................................ 19Symbols

DVD label ..................................................................................... 12Hazard symbols ............................................................................... 5

Symbols on the DVD ................................................................................ 12System settings ........................................................................................ 67

Index Retina Workplace

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T

Table ........................................................................................................ 42Time window for caching ......................................................................... 67Toolbar .................................................................................................... 26TripleView ................................................................................................ 22TripleView header .................................................................................... 29Troubleshooting

Error Messages ............................................................................. 70Malfunctions ................................................................................ 69

Turn OCT to OCT registration ................................................................... 60

U

User license .............................................................................................. 19User settings ............................................................................................ 68

V

Video function ......................................................................................... 32

W

Work area ................................................................................................ 21

Y

Yellow frame ........................................................................................... 23

Retina Workplace

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Göschwitzer Str. 51-5207745 JenaGermany

E-mail: [email protected]: www.meditec.zeiss.com

Carl Zeiss Meditec AG

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