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STRATUS OCTTM

Networking Guide

Copyright

Copyright © 2006 Carl Zeiss Meditec, Inc. All rights reserved.

Trademarks

Stratus OCTTM is a trademark of Carl Zeiss Meditec, Inc. All other trademarks used in this document are the property of their respective owners.

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Contents

Contents

(1) Version 4.0 Networking Guidelines................................................. 5 ·Introduction................................................................................................... 5 ·Notice ............................................................................................................ 5 ·Network Capabilities ..................................................................................... 5 ·Warning: Risks of Internet Connectivity......................................................... 6 ·Prohibited Activities ...................................................................................... 7 ·Network Activities Not Supported ................................................................. 7 ·Not Recommended ........................................................................................ 8 ·Network File Server Minimum Requirements................................................. 8 ·Network File Server Recommendations ......................................................... 8 ·Using The Network File Server....................................................................... 9 ·Configuration for Direct Export to a Personal Computer ............................. 11 ·Save or Export Analysis as a PDF File .......................................................... 12 ·Export JPEG ................................................................................................. 12 ·Password Protection and User Accounts ..................................................... 12 (2) Archive, Retrieve & Backup .............................................................17 ·Chapter Overview .........................................................................................17 ·The Patient Database....................................................................................17 ·Data Maintenance Requirements ................................................................ 18 ·Recommendations For Automated Data Maintenance ................................ 19 ·Archive Registration and Management ....................................................... 21 ·Manual Archive ........................................................................................... 25 ·Care of DVD Archives................................................................................... 28 ·Duplicating an Archive Disk......................................................................... 28 ·Format DVD-RAM Disks............................................................................... 29 ·Retrieve Scan Data ...................................................................................... 31 ·Manual Backup............................................................................................ 34 ·Clear Archived Exams .................................................................................. 36 (3) Export and Import Scan Data........................................................ 39 ·Chapter Overview ........................................................................................ 39 ·Privacy and Data Integrity Features............................................................. 39 ·Export Data ................................................................................................. 40 ·Import Data ................................................................................................. 43 Index ................................................................................................. 45

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Version 4.0 Networking Guidelines

(1) Version 4.0 Networking Guidelines Introduction

Note: This is one in a series of networking guides that compiles from the current user documenation all instructions relevant to networking this product.

Notice

Users are responsible for network setup and maintenance, including installation and configuration of all necessary hardware and software. Carl Zeiss Meditec Technical Support is limited to testing network connectivity of the Stratus OCT. Technical Support cannot troubleshoot or repair problems with network connectivity. Please observe the following guidelines regarding networking of the Stratus OCT instrument. Note: These guidelines apply to version 4.0 of Stratus OCT system software.

Network Capabilities

The Stratus OCT is networkable. Version 4.0 software supports the following.

· Windows and Novell networks. · Creation of user accounts · Networking via a local area network or intranet. · Users can archive to and retrieve from a network file server, and synchronize with other Stratus

OCT instrument databases via the network file server.

· Users can backup to and restore from a network file server. Users can configure the instrument

for automatic backup. If you opt for manual backup, we strongly recommend that you use the Stratus OCT backup utility as described in the Stratus OCT user manual, rather than Microsoft Windows backup or a third party backup utility.

· Users can import from and export to a network file server. · Users can export data from a Stratus OCT instrument to a remote personal computer either via

a local area network or by direct cable connection. Data can be exported in Stratus database format or you can export individual scan images as JPEG files, or an individual analysis output as PDF file.

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Warning: Risks of Internet Connectivity

Networking is to be limited to a local area network, intranet or a direct cable connection. We strongly recommend that you do not access the Internet with the Stratus OCT, nor expose the Stratus OCT to the Internet through its connection to the local area network. Accessing the Internet with the Stratus OCT can disable or degrade system performance. When exposed to the Internet, the Stratus OCT is 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 operating system updates to be downloaded to your system, either automatically or intentionally. Installation of any unapproved software, including drivers and operating system updates, could degrade the performance of the instrument and/or lead to corrupted diagnostic or therapeutic information and may void the instrument warranty.

Note: Stratus OCT Software Version 4.0 is compatible with Windows 2000 Service Pack 4, which is primarily a security update to the Windows operating system. Therefore, if you connect the Stratus OCT to an office network, we encourage you to install Service Pack 4.

· It may be possible to install printer drivers for network printing, but this is not supported by

Carl Zeiss Meditec. See the section: Network Activities Not Supported below.

Approved Third Party Software

Note: Carl Zeiss Meditec does not provide technical support for the use of approved third party software.

Please refer to the Stratus OCT Technical Support section of our website (www.meditec.zeiss.com) for the current list of approved software, including approved updates and patches to the Windows operating system. As of this writing, the following software has been validated to work with the Stratus OCT:

· Norton AntiVirus® 2004 (configured for Automatic LiveUpdateTM if used in a network setting)

and Norton Personal Firewall® 2004, both of which are part of the Norton Internet Security® 2004 software package. Other elements of this package have not been validated to work with the Stratus OCT. Also note that Norton Personal Firewall must be properly configured, usually by an information technology specialist, so that it permits desired communications while blocking undesired communications.

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Prohibited Activities

The following activities are prohibited using the Stratus OCT instrument.

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

· Do not relocate the Stratus OCT database to a network file server. · Do not share Stratus OCT folders with other computer systems via the network. · Do not share the Stratus OCT system printer on the network. Network Activities Not Supported

Carl Zeiss Meditec does not support the following network activities, although they may be possible.

Note: The user bears responsibility for any system performance degradation or any other change or defect resulting from the attempt to perform the following activities. Carl Zeiss Meditec is not responsible for software repairs or upgrades necessitated by the attempted performance of the following network activities.

· Network printing, i.e., printing with a printer other than the Stratus OCT system printer. If you

wish to use a third party printer, seek technical support from your printer manufacturer. Repairs necessitated by the attempt to print using a non-system printer are not covered under warranty.

· The default paper size setting for Stratus OCT printouts is set to A4. If the network printer

being used recognizes the paper size of a document, there may be compatibility problems when using letter-sized paper. If necessary, you can change the paper size setting from within the Stratus OCT software, as follows.

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· In

the MAIN WINDOW, select Preferences from the Options menu (click Options >

Preferences). The Preferences dialog opens to the Data Management Tab: Click the Printer Page Setup Tab, and there select the Letter radio button. Once you change this setting, try to print again. This setting is retained until you change it again.

Not Recommended

It is not recommended to print to any black and white printer because the printouts depend on color codes to convey information.

Network File Server Minimum Requirements

The network file server must meet the following minimum requirements:

· Server class 800 MHz processor with 128 KB cache · 256 MB RAM · Windows, Unix or Linux server operating system · NTFS drive partition(s) for Stratus OCT data. Stratus OCT is compatible only with NTFS on

network drives.

Note: You can use SAMBA with Unix and Linux file servers.

· 100 GB available disk space for data storage · Tape backup unit Network File Server Recommendations

In addition to the minimum requirements listed above, we recommend the following for the network file server:

· A mirrored RAID array for data storage--strongly recommended.

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· An uninterruptible power supply (UPS)--strongly recommended. · Backup drive: AIT 50 GB native/130 GB compressed or DLT 40 GB native/80 GB compressed · It is the user's responsibility to protect their exam data from loss by frequent backup of

the network server. Backup media should be of archival quality, and the media should be stored in a secure, remote location.

Warning: Failure to backup the network file server may result in the loss of medical exam data.

· The file server must be started prior to networked Stratus OCT instruments and shut down after

Stratus OCT instruments.

· Strongly recommended that the file server not be used for interactive programs, such as web

browsing or word processing.

Using The Network File Server

Using a network file server is recommended in offices that have a local area network, especially if you have multiple Stratus OCT instruments. Once you have set up the instrument(s) on the network, the benefits are:

· You can use the network file server for routine archive and backup, export and import, without

the need for using and managing multiple DVD-RAM disks.

· If you have multiple Stratus OCT instruments on the network, you can synchronize each of the

instruments with the others via the network, so you can access all Stratus OCT exam data acquired in your office.

Set Up Network Archiving

Note: Configuring the server and the instrument for archiving to a network file server should be attempted only by a network administrator or system administrator, and the following instructions are intended only for personnel with such expertise. Users are responsible for network setup and maintenance. Carl Zeiss Meditec Technical Support is limited to testing network connectivity of the Stratus OCT. Technical Support cannot troubleshoot or repair problems with network connectivity.

1. On the network file server, create a folder named "Stratus OCT Archive" or the like. Make this a shared folder. 2. To ensure access to the shared folder on the network file server:

· On the Stratus OCT, create a new administrator account for use as the default account. (See

the instructions to create new accounts under Password Protection in Chapter 1.)

· On the server, create a new account with the same username and password as on the Stratus

OCT.

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3. On the Stratus OCT, map a network drive to the shared folder you have created on the server. A. Open Windows Explorer: Right-click the Windows Start button and select Explore. B. In Windows Explorer, select Map Network Drive from the Tools menu (click Tools > Map Network Drive). The Map Network Drive dialog appears. C. Select a drive letter. D. Click Browse to find and select the shared folder you created on the network file server. You will have to first find the file server name (machine name), and then the folder. (Do not clear the Reconnect at logon checkbox, which is selected by default.) E. When you have selected the correct folder and returned to the Map Network Drive dialog, click Finish. You have now mapped a network drive to the shared folder. 4. On the Stratus OCT instrument, you must register the new archive on the network file server to make it current. A. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options menu (click Options > Register Archive). The Archive Registration dialog appears. B. In the Archive Registration dialog, click New. The New Archive Registration dialog appears. C. In the New Archive Registration dialog, the Archive Name field is made up of two parts. The first part is generated automatically and cannot be changed; it is composed of the model number, serial number and archive sequence number. You can add a suffix to the name using the second part of the field, if you wish.

· ·

The Mark as current checkbox is selected by default. Do not change this selection if you wish to use the archive you are about to register as the current archive. The Disabled checkbox is not selected by default. Select the Disabled checkbox if you do not wish to archive to or synchronize from this archive.

D. Click the Browse button next to the Local Path field to find and select the local drive letter you have mapped to the shared archive folder on the network file server. When you select the local drive letter, the Network Path field is completed automatically. E. If you wish, you can enter up to about 85 characters in the Description field to describe the archive you have registered. F. When finished, click Save to register the new archive. It will now be the current archive to which scan data is copied when you save scans.

Data Transfer Over the Network

Once you have configured the instrument and the server for archiving, you can perform all data transfer functions as explained in the respective sections of this manual. See Chapter (0), Archive, Retrieve & Backup, and Chapter (2), Export and Import Scan Data, for instructions to archive, retrieve, backup, import, export and synchronize Stratus OCT data.

Note: If you attempt a data transfer function when the network is down or the server is down, the function will fail and the instrument will notify you that a connection could not be established. In this case, if auto-archive is on, all scans saved while the network/server

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is down will not be archived automatically. You must archive these scans manually when service is restored. See the instructions to perform Manual Archive on page 15.

Configuration for Direct Export to a Personal Computer

It is possible to export data from a Stratus OCT to a personal computer (PC) via either a local area network or a direct cable connection. To accomplish this, it is necessary to configure both the Stratus OCT and the PC. To view and analyze data on the PC, you can use compatible third-party software. Terminology The "source system" is the Stratus OCT system, from which you will export; the "target system" is the remote computer to which you will export data.

Note: The choice and use of third party software on the target system for viewing and analysis is at the user's discretion. Carl Zeiss Meditec does not specify compatible third party software, nor support its use. Note: Carl Zeiss Meditec does not provide technical support for direct export to a personal computer. The following configuration requirements pertain to the example of direct export from the Stratus OCT to a PC running Windows 2000. We intend these requirements for information technology (IT) specialists, who will understand how to implement them. The user bears responsibility for any source or target system performance degradation or any other change or defect resulting from the attempt to perform these tasks. Note: The requirements below are for a target system running Windows 2000 or XP. If your intended target system is running another operating system, it may be possible to configure it to import from the Stratus OCT, but the configuration requirements may be different and are not explained here. Configuration requirements

1. If transferring data via a network, connect both the source and target systems to the network using a standard cable. If transferring via direct connection between source and target, connect the two using a crossover cable. The Stratus OCT system has a network connector (ethernet port) on the rear of the computer. 2. The source and target systems must have computer names, and these must be different. If necessary, create a computer name of your choice for one or both computers. 3. Both source and target systems must share the same set of networking protocols, as follows. (The Stratus OCT is shipped with the following protocols properly configured.)

· Client for Microsoft Networks · File and Printer Sharing for Microsoft Networks · Internet Protocol (TCP/IP)

4. On the target system, create a shared folder that will receive the imported data and enable access to the target system from the source system.

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5. On the source system, map a network drive to the shared folder you created on the target system in step 4. If the target system is password protected, you must access it with a user account having either Standard User or Administrator privileges in Windows 2000, or having Computer administrator privileges in Windows XP. 6. The Stratus OCT is configured by default to use DHCP. If the source system is connected to a network that uses static IP addressing, the following TCP/IP parameters must be configured: IP address, Subnet, and Default gateway.

Save or Export Analysis as a PDF File

You can print any analysis output to a PDF file by selecting Print to PDF File from the File menu (click File > Print to PDF File). Use the Save dialog that opens to name and save the file anywhere on the C: drive, on DVD or on the network server. The PDF printout looks exactly like the paper printout.

Export JPEG

The Export JPEG button is found on the ANALYSIS WINDOW and the SELECTION WINDOW. It enables you to export the currently selected scan image in JPEG format.

· Click the Export JPEG button to export the selected scan image. You can save it locally or to any

mapped network drive on another computer.

Note: JPEG compression entails loss of image data. Exported JPEG images are not intended for diagnostic use, but for use in presentations. In addition, they do not contain patient information. It is the clinician's responsibility to associate patient information with exported images.

Password Protection and User Accounts

It is the user's responsibility to implement whatever instrument and data security measures are desired or appropriate. This section instructs you how to use the Windows operating system to require users to enter a password before they can access the Stratus OCT computer. The Stratus OCT is shipped with Windows password protection turned off, so that upon system startup, any user has administrator privileges (access to all functions) via the default user account.

Note: If you establish password protection, the Stratus OCT software will not launch automatically upon system startup. You will be required to log on to the computer by entering a valid user name and password combination. After logging on, you will have to launch the Stratus OCT software by double-clicking on the STRATUS OCT Host desktop icon. User Types and Privileges

Note: The following information and instructions are intended for the use of the Stratus OCT in a standalone setting. If you have installed the Stratus OCT in a network environment, we assume that you will apply your own user account management procedures. We do not offer recommendations or instructions for password protection in a

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network environment. In general, we recommend that you use good practices in creating, administering and securing passwords.

You implement password protection in Windows by turning on password protection and then creating one or more new user accounts that have a user name and password. When you create user accounts, you must select a user type among three choices: Standard user, Restricted user, and Other--Administrator. For purposes of working with the Stratus OCT, the privileges afforded to each kind of user are explained below: Administrators belong to the Administrators Group by default. The default user account is an administrator account.

· Users in the Administrators Group can use all Stratus OCT functions. · Administrators can modify the computer and install programs--and thereby implement Stratus

OCT software upgrades.

· Only administrators can create new user accounts, manage network settings and read the files

of other users. Standard users belong to the Power Users Group by default.

· Users in the Power Users Group can use all Stratus OCT functions. · Standard users can modify the computer and install programs--and

Stratus OCT software upgrades.

thereby implement

· Standard users cannot create new user accounts, cannot manage network settings and cannot

read the files of other users. Restricted users belong to the Users Group by default.

· Users in the Users Group can use all Stratus OCT functions. · Restricted users cannot modify the computer and install programs--and therefore cannot

implement Stratus OCT software upgrades.

· Restricted

users cannot create new user accounts, cannot manage network settings and

cannot read the files of other users.

How to Activate Password Protection

To activate password protection, follow these steps: 1. Power up the system. Exit the Stratus OCT program (click File > Exit or click the right) to enter the Windows environment. 2. Click Windows Start > Settings > Control Panel. In the Control Panel, double-click Users and Passwords. at upper

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3. In the Users and Passwords dialog box, select the checkbox near the top that says "Users must enter a user name and password to use this computer." This activates the Add, Remove and Properties buttons.

cáÖìêÉ=N=rëÉêë=~åÇ=m~ëëïçêÇë=aá~äçÖ=^Åíáî~íÉÇ

Warning: Do not attempt to remove, edit the properties or edit the passwords of the "Administrator" and "Tech Support" accounts. Failure to observe this warning could disable access to the system.

4. Click the Add button. The Add New User dialog box appears. Enter a user name and record it. The user name is not case sensitive. (The other information is optional.) Click Next. 5. You will be prompted to enter and to confirm a new password for this user name. The password is case sensitive. Record the password you have entered. When finished, click Next. 6. The Add New User dialog box now lets you select the level of access of the new user account. A. For the first new user account, we strongly recommend that you select the Other radio button and then select Administrators from the drop down list, as in the example below. You must have access to an administrator account to retain full control of your system, particularly the ability to create new user accounts. When you create the first new user account, you lose access to the default administrator account, since you do not know its

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password. (If the default account password were changed and then lost, access to the system would be disabled.) Therefore, it is advisable that the first new account be an administrator account whose password you will create.

cáÖìêÉ=O=pÉäÉÅí=líÜÉêI=^Çãáåáëíê~íçêë B. For additional new user accounts, we suggest that you select the Restricted user radio button. In this way, you can prevent unauthorized changes to the Stratus OCT software and the computer. 7. Click Finish. You will return to the Users and Passwords dialog box, and the new account you created will be listed by User Name and Group.

· To add more user accounts, repeat steps 4 through 7.

8. When finished adding accounts, click OK to implement your changes and exit. You can restart the Stratus OCT software by double-clicking on the STRATUS OCT Host desktop icon.

Log On after Restart

Note: If the Stratus OCT is connected to a network file server, you may be required to log on to the server as well as the instrument. Check with your network administrator for the required log on procedures.

The first time you restart the system after implementing password protection, you will have to do the following: 1. The Select Netware Logon dialog box will appear. Click Cancel. A Netware Network dialog box will appear. Click Yes. 2. The Windows Logon dialog box will appear with "Administrator" in the User Name field. Delete "Administrator" and type in the user name you wish to use. Then enter the corresponding password in the Password field. The password is case sensitive. Click OK. 3. The Getting Started with Windows 2000 dialog box will appear. Uncheck the box at lower left that says, "Show this screen at startup." Then click Exit. 4. We recommend that you set the Windows taskbar properties to auto hide. Right-click on the taskbar and click Properties. In the Properties dialog box, select the checkbox next to Auto hide. Then click OK.

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5. We recommend that you create a desktop shortcut to format DVD-RAM disks. To do this, click Windows Start > Programs > DVD-RAM, and right-click on DVDForm and select Create Shortcut. Then drag the new DVDForm shortcut to the desktop. After the first time you log on with a new user name, you will be prompted to enter the user name and password only. The system will open to the Windows desktop. Double-click the STRATUS OCT Host desktop icon to launch the Stratus OCT software.

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Archive, Retrieve & Backup

(2) Archive, Retrieve & Backup Chapter Overview

The Stratus OCT offers several functions that together enable you to preserve your valuable patient data and maintain excellent database performance. Archive and backup are the core functions required to preserve and recover your data in case of computer malfunction. These functions can be set to occur automatically, or you can perform them manually.

Advisory: If you do not follow the instructions in this chapter, paper records are the only way to confidently retain patient information.

Topics covered include:

· The Patient Database, below · Data Maintenance Requirements, page 18 · Recommendations For Automated Data Maintenance, page 19 · Data Management Preferences, page 20 · Manual Archive, page 25 · Care of DVD Archives, page 28 · Duplicating an Archive Disk, page 28 · Format DVD-RAM Disks, page 29 · Retrieve Scan Data, page 31 · Manual Backup, page 34 · Clear Archived Exams, page 36 The Patient Database

The Stratus OCT patient database contains two kinds of stored data:

1

Scan Data

2

Index Database · Scan data reference locations

Scan data includes the OCT images generated during an examination, along with the associated patient, visit and exam data. The index database identifies each saved scan--by patient, visit, scan acquisition protocol and location where the scan images are saved.

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Data Maintenance Requirements

Archive and Backup

Two actions must occur to protect your data from permanent loss:

1

Archive

2

Backup

Scan Data

Index Database

To enable excellent database performance along with long-term data protection, the patient database separates data-intensive scan data from the index database. The complete index database always remains on the Stratus OCT computer hard drive (unless you delete individual patient data). You must backup (copy) the index database to a second location to protect it from a computer malfunction that would otherwise render it inaccessible. Backup is therefore a data protection function. Archiving, on the other hand, serves both to protect data and to maintain database performance. Scan data has unique and persistent identifiers that link it to the correct patient information in the index database. Because of this, scan data can be safely removed from the Stratus OCT computer hard drive. You must archive (copy) scan data to a second location to protect it from permanent loss due to a computer malfunction. You can readily retrieve archived scan data when the Stratus OCT is connected to the correct archive volume.

Clearing Scan Data

Scan data remains on the instrument hard drive as long as possible, or until you choose to remove it. Only when the hard drive gets too full must you clear enough hard disk space to allow you to save more scans. With a new instrument, it takes many months up to a few years before the Stratus OCT prompts you to clear scan data. If you do not clear (delete) scan data when prompted, eventually the hard disk will reach capacity and prevent you from saving new scans. At that point, you must clear scan data to save new scans.

Warning: We recommend that you do not clear scan data unless it has been archived. If you attempt to clear un-archived scan data, the Stratus OCT will prompt you to confirm your choice before permanently deleting the scan data.

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Media Requirements

You can archive and backup either to a removable DVD-RAM disk installed in the Stratus OCT, or to a network file server. The Stratus OCT archives to the current archive. See Set Current Archive on page 25.

Note: For archive and backup to a network file server, configuring the server and the instrument should be attempted only by a network administrator or system administrator. Instructions for network administrators to set up network archive and backup can be found in Version 4.0 Networking Guidelines. Users are responsible for network setup and maintenance. Carl Zeiss Meditec Technical Support is limited to testing network connectivity of the Stratus OCT. Technical Support cannot troubleshoot or repair problems with network connectivity.

Brand: Carl Zeiss Meditec has qualified the following brands to work with the Stratus OCT:

· Verbatim 4.7 GB DVD-RAM Type 2 · Panasonic 4.7 GB DVD-RAM Type 2 · OptoDisk 4.7 GB DVD-RAM Type 2 · Imation 9.4 GB double-sided DVD-RAM

We recommend that you use one of these brands. Quantity: Adherence to the Recommendations For Automated Data Maintenance initially requires one DVD-RAM disk per instrument. Two more disks are required each time you fill up an archive disk: one to duplicate the archive disk, and another to continue the archiving process.

Warning: You must not use the same archive or backup disk in more than one Stratus OCT instrument. Use of an archive or backup disk in more than one instrument could cause the incorrect identification of patient data. We strongly advise that you physically label disks with the serial number of the instrument to which it is dedicated. Wait after Installing a DVD

When you install a DVD into its drive, it requires approximately 30 seconds for the DVD to be ready for reading or writing. When the light on the DVD drive changes to green, the DVD is ready. Please do not attempt operations that require reading from or writing to the DVD until it is ready.

Recommendations For Automated Data Maintenance

To maximize data security and long-term database performance with minimal effort, we recommend that you automate data maintenance. To do this, use the Data Management Tab of the Preferences dialog, as described next.

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Archive, Retrieve & Backup

Warning: It is the user's responsibility to protect their exam data from loss. New scans acquired since your last archive, and changes to the scan index database since your last backup are subject to permanent loss in case of computer malfunction. We recommend that you automate data maintenance, as described in this section. Data Management Preferences

Follow these steps to automate data maintenance: 1. In the MAIN WINDOW, select Preferences from the Options menu (click Options > Preferences). The Preferences dialog opens to the Data Management Tab:

cáÖìêÉ=P=qÜÉ=a~í~=j~å~ÖÉãÉåí=q~Ä=áå=íÜÉ=mêÉÑÉêÉåÅÉë=aá~äçÖ 2. By default the Auto Archive checkbox is empty and the others are selected. Select all four checkboxes, as in Figure 3 above. These selections have the effects described next.

Automated Data Maintenance Behavior

Auto Backup index database on shutdown When selected, on shutdown the Stratus OCT will automatically backup (copy) the index database to the current archive location, which is the DVD-RAM disk by default. If you do not select this option, you must perform Manual Backup (see page 34) on a regular basis to preserve changes to the index database. Auto Clear on startup/shutdown When selected, on startup and shutdown the Stratus OCT checks the hard disk space indicator. If it is not green, a dialog will inform you that the Stratus OCT will clear--delete--archived exams. Un-archived exams will not be cleared. Click OK to proceed with deletion of archived scan images, or Cancel to not clear.

20

Note: The Stratus OCT hard drive can hold several thousand scans before it will prompt you to clear scan data. Scan data clearance is for long-term database maintenance.

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Archive, Retrieve & Backup

To preserve it and ensure fast access to it, the Stratus OCT tries to retain exam data, and clears only enough exams to forestall the reappearance of the yellow or red indicator for several days or weeks, depending on the acquisition rate of new exams. Exams are cleared by last modification date, oldest first. For detailed information, see Clear Archived Exams on page 36. Auto Archive When selected, each time you save a new scan, the Stratus OCT will automatically archive (copy) the scan to the current archive location, which is the DVD-RAM disk by default.

Note: The Stratus OCT will archive scans only to the current archive volume. (For details, see Set Current Archive on page 25.) If an error occurs that prevents a successful automatic archive, the Stratus OCT will notify you of the failure and Auto Archive will be suspended until the error condition is removed. In such cases, you must archive scans manually when the error condition is removed. (See Manual Archive on page 25 for instructions.) You will be prompted to archive the un-archived scans on startup and shutdown, if the Archive Check option (described next) is active.

Archive Check on startup/shutdown When selected, on startup and shutdown the Stratus OCT checks for un-archived scans. If any are found, it reports the number found and prompts you to archive them. Click OK to proceed with archiving, or Cancel to not archive. If you do not select this option, it is possible for un-archived scans to accumulate without your knowledge. Such accumulation is possible even if Auto Archive is active, when error conditions prevent successful automatic archiving.

Archive Registration and Management

Archive registration is the process used to create and manage archive volumes. Archive volumes may be either DVD-RAM disks or network file server directories. Each archive volume on DVD or a network file server must have a unique name. When an archive is registered, its name is added to a list of archives your Stratus OCT can access.

Access Archive Registration

You can access the Archive Registration dialog in three ways: 1. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options menu (click Options > Register Archive). 2. From the Stratus OCT Browser, select Register Archive from the Utilities menu (click Utilities > Register Archive).

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3. On startup, the Stratus OCT checks the remaining disk space of the current archive volume. When an archive volume nears capacity, the Stratus OCT prompts you to create a new one. If you click Yes to proceed, the Archive Registration dialog appears.

cáÖìêÉ=Q=qÜÉ=^êÅÜáîÉ=oÉÖáëíê~íáçå=aá~äçÖ It shows all registered archives, both network and DVD archives. (DVD archives have a local path of D: and do not have a network path.) The current archive is indicated on the left with an arrow.

DVD Archive Registration

A DVD-RAM archive volume can be registered in two ways:

· When you create a new DVD archive volume, you register the archive as part of the process. · When you retrieve scan data from an archive created on another Stratus OCT, that archive

volume is registered automatically.

Create a New DVD Archive

The Stratus OCT will prompt you when you need to create a new archive volume, or you can create a new DVD archive at any time through the Archive Registration dialog. On startup, the Stratus OCT checks the remaining disk space of the current archive volume. When an archive volume nears capacity, the Stratus OCT prompts you to create a new one.

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· If the archive volume is full and you must create a new one, you receive the following message:

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· With either of the above dialogs, when you click Yes, the Archive Registration dialog appears.

To create a new DVD archive at any time through the Archive Registration dialog:

· From the MAIN WINDOW, select Register Archive from the Options menu. · From the BROWSER, select Register Archive from the Utilities menu. In either case, the Archive

Registration dialog appears. 1. To create a new DVD archive, insert a new, formatted DVD-RAM disk into its drive. See Format DVD-RAM Disks on page 29 for instructions. 2. In the Archive Registration dialog, click New. The New Archive Registration dialog appears:

cáÖìêÉ=T=kÉï=^êÅÜáîÉ=oÉÖáëíê~íáçå=aá~äçÖ 3. In the first part of the Archive Name field, the system automatically generates a unique archive name, based on your instrument serial number and increasing the final number by one each time you create a new archive. You cannot edit this portion of the field. If you wish, you can edit the second part of the field.

· The Mark as Current checkbox is selected by default. Do not change this selection if you wish

to use the archive you are about to create as the current archive. 4. In the Local Path field, type d: or click Browse to find and select the d: drive.

· If desired, you can type a description in the Description field.

5. When finished, click Create. The Stratus OCT will create a new archive on the DVD. Unless you de-selected the Mark as Current checkbox, newly acquired scans will be archived to this DVD.

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Create a Network Archive

To create a network archive, an information technology specialist must first configure the server and the Stratus OCT to communicate. See the instructions to Set Up Network Archiving in Version 4.0 Networking Guidelines.

Register Existing Network Archive(s)

If archive volumes created on different Stratus OCT instruments exist on the same network file server, any Stratus OCT can access the scans of any other Stratus OCT instrument. This is a process called synchronization. (See Synchronize With All Registered Network Archives on page 24 for instructions to do this.) First you must register the network archive(s) of the other instruments. To do so follow these steps: 1. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options menu (click Options > Register Archive). (From the Stratus OCT BROWSER, click Utilities > Register Archive.) The Archive Registration dialog appears. 2. In the Archive Registration dialog, click Add Existing. The Browse dialog appears. Only archive volumes on the network file server will appear in the dialog. Find and select the desired archive volume. Click OK. 3. Back in the Archive Registration dialog, the newly selected network archive will appear in the list of registered archives. 4. Click Save to save the change and close the dialog. You can now access scan data from the network archive folder you registered, when you synchronize as described below. Synchronization Disabled For each network archive, it is possible to disable synchronization. To make sure a newly added network archive is available for synchronization, select the archive and click Edit. The Edit Archive Registration dialog appears, as in Figure 8. If the Disabled checkbox is selected, you cannot synchronize from that archive.

· You can select or de-select the Disabled checkbox. If you make changes, click Save to save your

changes and return to the Archive Registration dialog.

Synchronize With All Registered Network Archives

Once you have registered the desired network archives on your Stratus OCT, you can access the scans saved in those archives, after you synchronize. To synchronize, follow these steps: 1. From the MAIN WINDOW, select View from the Data menu (click Data > View). 2. With the BROWSER in View mode, click the Refresh button or select Refresh Patient List from the Record menu. The Stratus OCT adds all index database references from all registered and available network archives to the system database. You will see the names of new patients appear in the Patient List. You can now access their exams as if they were created on your Stratus OCT, when the source archive is available.

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Set Current Archive

The current archive is the one to which new scans will be archived (assuming the archive volume is accessible). If you wish to change the archive volume to which new scans will be archived, follow these instructions: 1. From the Stratus OCT MAIN WINDOW, select Register Archive from the Options menu (click Options > Register Archive). (From the Stratus OCT BROWSER, click Utilities > Register Archive.) The Archive Registration dialog appears (see Figure 4). 2. In the Archive Registration dialog, click on the archive you want to make current and then click Edit. The Edit Archive Registration dialog appears.

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Note: The Disabled checkbox appears only when you are editing a network archive.

3. Select the Mark as Current checkbox and click Save to save your changes. Back in the Archive Registration dialog, the archive you selected will be marked as the current archive. 4. Click Close or the at upper right to exit Archive Registration.

Manual Archive

Manual archiving is not required if you follow the Recommendations For Automated Data Maintenance, described above. If you have opted not to use the automated archive feature, follow the instructions below to archive un-archived scans manually. You can archive scan data manually at any time.

Note: It does not affect the instrument or its performance to leave it running overnight for archive or backup purposes.

You can initiate archiving from the MAIN WINDOW or the BROWSER.

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1. A. From the MAIN WINDOW, select Archive from the Data menu (click Data > Archive). The Archive dialog appears as below. You have the option to archive all un-archived exams, or to select which exams to archive.

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· To archive all un-archived exams, click Archive All Exams. Archiving will begin immediately. · To select which exams to archive, click Select Exams for archiving. The BROWSER opens in

Archive mode. Go to step 2. 1. B. From the BROWSER, select Archive from the Data Transfer menu (click Data Transfer > Archive). The BROWSER opens in Archive mode. 2. When the BROWSER opens in Archive mode, it displays the list of patients with un-archived exams. Click the checkboxes to select the patients whose exams you wish to archive. To select specific exams to archive, click on the selected patient's visit date(s), then select the exams.

· Click File > Select All to select all exams at any time. To start over making selections after you

have begun, click File > Deselect All. 3. When you have made your selections, select Archive from the File menu (click File > Archive). Archiving begins and a Progress dialog appears.

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· It can take several seconds to several minutes for the Stratus OCT to finish writing to the

archive volume, depending on the number of exams you selected. When complete, a summary dialog reports the number of exams archived successfully.

· Click Cancel to abort the archive process after the next whole patient record has been

archived. Already archived patients shall not be removed from the archive volume.

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· If you are using a new DVD archive disk, when the archive process is complete, a Notice

dialog will prompt you to write the new label on the archive DVD.

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· Label the disk as instructed and click OK.

4. Store the archive disk in a secure location, according to the recommendations for Care of DVD Archives.

Deselect Exams (Optional)

Deselecting specific exams is an optional step in the data transfer process. You must deselect exams for one patient at a time. If you do so, the BROWSER remembers the exams selected for every patient until you finish or exit the data transfer function. After you begin, if you wish to start over, click File > Deselect All. To Deselect All the Exams From One Visit

· Select one patient and the Visits list shows all his visits with checkboxes selected by default.

(When you select multiple patients, no visits are displayed.) Clear a visit checkbox to deselect all exams from that visit. To Deselect Specific Exams

· Select one or more visits and the Exams list shows all exams for the selected visits with

checkboxes selected by default. Clear an exam checkbox to deselect that exam.

· When only some of a patient's exams are selected, that patient's checkbox will be grayed

and contain a gray checkmark. When only some exams from a specific visit are selected, that visit's checkbox will appear likewise.

Access Archived Scans

If a scan is archived, when you select the scan in the patient list of the Stratus OCT MAIN WINDOW, the Scan Group Images Tab shows you on which archive disk (by label) the scan can be found. If you attempt to view or analyze a scan that is archived, a dialog box prompts you to insert the archive disk where the scan is, as in the example below.:

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To access those scans for review or analysis, install the indicated archive disk in the DVD drive, and then click OK.

Care of DVD Archives

Remember that DVD archive disks contain valuable patient data. Treat them accordingly. Unlike CDs, a sturdy plastic case encloses DVD-RAM disks, because they are more sensitive to damage than CDs. They must be treated with greater care, if you are to preserve your patient data from loss.

Recommendations To Preserve DVD Archives

Observe the following recommendations to maintain long-term access to your DVD archive data:

· Never open the DVD-RAM case and remove the disk. · To distinguish each archive, always label the DVD-RAM case with the unique archive name,

using permanent marker. Do not write on the disk itself.

· We recommend you keep your DVD archives in a cabinet. Do not expose them to bright light or

sunlight for extended periods.

· To protect them from spills and other office accidents, do not leave them out on desks for

extended periods.

· Do not stack DVD-RAM disks on top of each other, nor place anything else on top of a

DVD-RAM, especially cups containing liquids.

Duplicate full DVD archives

For added security, duplicate the full DVD archive disk. See the instructions for Duplicating an Archive Disk on page 28. Keep the original archive disk in a secure location for use with the instrument as needed. Store the duplicate copy off-site in a secure location.

Duplicating an Archive Disk

As soon as an archive disk becomes full (after archiving scans from approximately 200-300 patient visits), you should make a duplicate copy of the archive disk and store it off-site in a secure location. This provides redundancy in case of damage to an archive disk.

Note: Since duplication can take up to 2 hours, plan for it in advance.

Duplication requires that you make a temporary copy of an archive disk on the Windows desktop, then copy the contents of that folder back to a blank, formatted DVD-RAM disk. Follow these steps: 1. Write-protect the full archive disk, for example Archive Disk A1. Locate the small switch at the base of the disk cartridge and push the switch to the "protect" position using a ballpoint pen or an unfolded paper clip. This will help avoid accidental writing over the data on the full archive disk. 2. Format another blank DVD-RAM disk and label it "Archive Disk - A1 Copy" Also write today's date and the numeric label from the A1 disk, which includes the Stratus OCT serial number. 3. Insert the full Archive Disk A1 in the drive.

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4. Exit the Stratus OCT software (click File > Exit or click the Windows desktop.

at upper right) into the

5. Right-click on the desktop (outside all icons) and select New > Folder. The new folder will appear on the desktop. Type the name of the new folder as Archive Copy. 6. Open Windows Explorer: right-click on Start and select Explore. 7. Locate and click on Removable Disk (D:). 8. Select all of the files on Removable Disk (D:) by holding down the Ctrl key and pressing the A key (press Ctrl-A). 9. Using the mouse, drag the selected files to the Archive Copy folder you created on the desktop. Copying will begin immediately. (Duplication time can be up to 2 hours, so plan accordingly).

· As an alternative, you can copy the selected files by pressing Ctrl-C. Then go to the

Archive Copy folder you created on the desktop, open it and press Ctrl-V to paste the selected files 10.When copying is completed, remove archive disk A1 from the disk drive. 11.Insert the newly formatted Archive Disk - A1 Copy into the drive. 12.Double-click to open the Archive Copy folder on the desktop and select all of its files by holding down the Ctrl key and pressing the A key (press Ctrl-A). Drag the selected files to the Removable Disk (D:) drive. This will copy the files to the new DVD-RAM disk. 13.Click on the Removable Disk (D:) in the Explorer window to verify that the files were successfully copied. 14.Remove the duplicate A1 Copy disk from the drive, verify that it is properly labeled, write protect the disk cartridge, and store the duplicate A1 Copy off-site in a secure location. 15.Store the original Archive Disk A1 in a secure location for use as needed.

Format DVD-RAM Disks

To archive, backup or export requires a DVD-RAM cartridge formatted in the Universal Disk Format (UDF1.5). Carl Zeiss Meditec provides unformatted DVD-RAM cartridges that must be formatted correctly to work in your DVD-RAM drive. Brand: Carl Zeiss Meditec has qualified the following brands to work with the Stratus OCT:

· Verbatim 4.7 GB DVD-RAM Type 2 · Panasonic 4.7 GB DVD-RAM Type 2 · OptoDisk 4.7 GB DVD-RAM Type 2 · Imation 9.4 GB double-sided DVD-RAM

We recommend that you use one of these brands.

Warning: Formatting erases any data currently on the disk. Be sure that the disk is empty before formatting. Formatting a disk that contains archive or backup data will permanently destroy that data!

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Follow these steps to format a DVD-RAM disk: 1. Power up the system. Exit the Stratus OCT program (click File > Exit or click the at upper right) to enter the Windows desktop. Be sure that the new DVD-RAM disk cartridge is not write-protected: Check the switch near the lower left of the cartridge. Install the new disk cartridge into the DVD drive. 2. Double-click the STRATUS DVD Formatter desktop icon, or click Windows Start > Programs > Zeiss > STRATUS DVD Formatter. The Stratus OCT DVD Ram Format Utility appears.

cáÖìêÉ=NP=qÜÉ=píê~íìë=l`q=asa=o~ã=cçêã~í=ríáäáíó 3. Click Format DVD Ram Disk.

· The utility first checks the installed DVD for the presence of an OCT archive database. If one is

present, the following dialog appears.

cáÖìêÉ=NQ=`~ååçí=Ñçêã~í=~å=~êÅÜáîÉ=Çáëâ You cannot format an archive disk. Click OK and formatting will be cancelled.

· Next, the utility checks if the disk is empty. If it is not, the following dialog appears.

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· Click No if you do not want to erase all files on the DVD; install another DVD instead. Click Yes

to erase all files and proceed with formatting.

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4. When you proceed to formatting, the following dialog appears to remind you to use the UDF1.5 file system format:

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· Click OK to close the dialog and proceed with formatting. The DVDForm dialog appears.

cáÖìêÉ=NT=qÜÉ=asacçêã=aá~äçÖ 5. Click on the down-arrow next to the Format Type field and select Universal Disk Format (UDF1.5).

cáÖìêÉ=NU=pÉäÉÅí=íÜÉ=racNKR=cçêã~í=qóéÉ 6. Click Start. Formatting will begin. The progress bar across the bottom will indicate formatting progress. 7. When finished, click Close or on the to exit the program.

Retrieve Scan Data

To retrieve scan data is to copy all scan data from an archive volume--on DVD or the network file server--to the Stratus OCT hard drive, thereby making it available for viewing and analysis without

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connection to the archive volume. You can retrieve archived scan data made on any Stratus OCT instrument with any OCT software down to version A1.1.

Registration and Retrieval

When you retrieve from a DVD archive volume, it is registered automatically on the Stratus OCT. In contrast, to retrieve from a network archive volume, it must first be registered. If it is not yet registered, see the instructions to Register Existing Network Archive(s) on page 24.

How To Retrieve

To retrieve scan data, follow these steps. 1. Make sure that the archive volume is accessible. If it is a DVD archive, insert the DVD into its drive on the Stratus OCT. If it is a network archive, it must be registered, and the Stratus OCT must have access to the network file server. 2. From the Stratus OCT MAIN WINDOW, select Retrieve from the Data menu (click Data > Retrieve). (From the Stratus OCT BROWSER, click Data Transfer > Retrieve.) The BROWSER opens in Retrieve mode, showing the archive contents in the path from which you last retrieved. (The first time you retrieve, it shows the archive contents of any inserted DVD, by default). If the BROWSER is displaying the desired source archive, skip to step 5.

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· If no archive volume is accessible on the path from which you last retrieved, for example, if you

last retrieved from DVD and no DVD is present in the drive, the Archive Selection dialog will appear automatically, as in Figure 20 below.

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3. To select a different source archive, click the Select Source Archive button, or click File > Select Source Archive. The Archive Selection dialog appears.

cáÖìêÉ=OM=qÜÉ=^êÅÜáîÉ=pÉäÉÅíáçå=aá~äçÖ 4. The Archive Selection dialog shows the name, location and description of all registered network archives. To retrieve from a network archive, select the desired network archive and click OK. To retrieve from the inserted DVD archive, click the Select DVD button. In either case, the BROWSER will display the archive contents of the selected archive. 5. When the BROWSER opens in Retrieve mode, the Patients list shows the names of all patients with exams in the archive. Click the checkboxes to select the patients whose exams you wish to retrieve. To select specific exams to retrieve, click on the selected patient's visit date(s), then select the exams.

· To select all exams at any time, click the Select All/Deselect All button, or click File > Select All.

To start over making selections after you have begun, click the Select All/Deselect All button, or click File > Deselect All.

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6. When you have made your selections, click the Retrieve button, or click File > Retrieve. The Retrieve Options dialog appears.

cáÖìêÉ=ON=qÜÉ=oÉíêáÉîÉ=léíáçåë=aá~äçÖ 7. The Retrieve Options dialog gives you the option to remove references to the source archive media, which will enable you to re-archive the exams to a new or different archive volume. To enable re-archiving, select the Remove reference to the archive media checkbox. When you retrieve with this option selected, the Stratus OCT will no longer recognize that the exam data is on the source archive, although a copy of the data remains. Instead, the Stratus OCT will treat the retrieved exams as un-archived. Click OK to begin retrieval, or click Cancel to cancel retrieval. 8. When you click OK, retrieval begins and a Progress dialog appears.

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· When retrieval is complete, the Stratus OCT notifies you.

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Manual Backup

Manual backup is not required if you follow the Recommendations For Automated Data Maintenance. If you have opted not to use the automated backup feature, follow the instructions below to backup the index database manually.

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Note: It does not affect the instrument or its performance to leave it running overnight for archive or backup purposes.

1. If not on already, turn on the Stratus OCT. 2. Insert a formatted DVD-RAM disk into its drive. 3. Exit the Stratus OCT software (click File > Exit or click the OCT software is running. 4. On the Windows desktop, double-click on the Zeiss Stratus OCT Backup Utility shortcut, or click Windows Start > Programs > Zeiss > Stratus OCT > Backup Utility. The BACKUP-RESTORE UTILITY WINDOW appears. at upper right) into the Windows desktop. The system will not permit you to run the Backup Utility while the Stratus

cáÖìêÉ=OQ=qÜÉ=_^`hrmJobpqlob=rqfifqv=tfkalt 5. Verify that the Database Backup radio button is selected (as in Figure 24). If not selected, click on it to select it.

· You have the option of selecting a new Backup Set Name and Backup Directory

location to store the database copy that you will create. Click the Browse button to select any available location on the hard drive, network file server or the DVD-RAM drive (the default d:\ drive). You can repeat the backup procedure to store multiple copies. However, we recommend that you backup one copy to removable storage media--a DVD-RAM disk--to preserve it from corruption due to computer malfunction.

· The index database remains on the hard drive, and each time you perform a backup, it is

backed up in its entirety. Therefore, it is not necessary to give the backup copy a new name each time. Only the latest copy is required to restore the entire index database since your last backup.

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Warning: The System Backup radio button enables backup of the Stratus OCT system software. This function needs to be performed only once upon installation by the Zeiss service representative who installs the system. Its purpose is to create a backup copy of the system software in case of computer malfunction. Restoration of the system software or the patient database may be done only by or in consultation with a Zeiss service technician.

6. Click the Backup button. Backup will begin immediately. The Status area and the Progress meter indicate progress. Depending on the size of the database, it can take from minutes up to an hour.

· You can click the Abort Backup button to abort at any time.

7. When the Status field reports that backup is complete, click the Quit button to exit to the desktop. 8. Remove the backup DVD-RAM disk and store it in a safe place. To return to the Stratus OCT software, double-click the STRATUS OCT Host desktop icon.

Clear Archived Exams

Manual clearance of hard disk space is not required if you follow the Recommendations For Automated Data Maintenance. If you have opted not to use the automated clearance feature, follow the instructions below to clear hard disk space manually. Scan data remains on the instrument hard drive as long as possible, or until you choose to remove it. With a new instrument, it takes many months up to a few years before the Stratus OCT prompts you to clear scan data. If you do not clear (delete) scan data when prompted, eventually the hard disk will reach capacity and prevent you from saving new scans. At that point, you must clear scan data to save new scans.

Warning: We recommend that you do not clear scan data unless it has been archived. If you attempt to clear un-archived scan data, the Stratus OCT will prompt you twice to confirm your choice before permanently deleting the scan data.

The Stratus OCT retains patient records on the hard drive to preserve exam data and ensure fast access to it. Therefore, you can clear hard disk space only when the database indicator is yellow or red. If you attempt to clear disk space when the database indicator is green, you will receive the following message:

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Note: The exam clearance function, whether automatic or manual, has the same characteristics:

· The Stratus OCT clears only enough exams to forestall the reappearance of the yellow or red

indicator for several weeks or months, depending on the acquisition rate of new exams.

· It does not clear exams that have not been archived, nor does it clear exams of patients for

whom you have not allowed clearance of their exams. (For more information, see Allow Clear Exams on page 108.)

· Among those allowed to be cleared, archived exams are cleared oldest first, based on the last

modification date. The modification date for an exam is changed when you change which scans are selected for inclusion in an analysis and run the analysis. When the database indicator is yellow or red, perform the following steps to clear disk space. 1. From the MAIN WINDOW, select Clear Archived Exams from the Options menu (click Options > Clear Archived Exams). A dialog informs you of the details and asks you to confirm that you wish to clear archived exams.

cáÖìêÉ=OS=`äÉ~ê=^êÅÜáîÉÇ=bñ~ãë=`çåÑáêã=aá~äçÖ 2. Click Yes to clear archived exams now, or click No to cancel exam clearance.

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Export and Import Scan Data

(3) Export and Import Scan Data Chapter Overview

The Stratus OCT offers the capability of exporting data for viewing and analysis on another Stratus OCT instrument. This chapter explains how to export and import Stratus OCT data, but first it details the technical measures employed to ensure patient privacy and data integrity.

Privacy and Data Integrity Features

It is the user's responsibility to observe applicable privacy restrictions and to maintain data integrity. The Stratus OCT incorporates options in its data transfer functions that enable the user to do this.

Patient Privacy

The Stratus OCT gives you the choice to export exam data without information that could identify the patient. When you choose to export data in this way, the Stratus OCT does export the following clinically relevant patient data: gender, ethnic group, axial length, assigned patient categories and diagnoses and physician comments. You have the further option to export a complete date of birth, the month and year of birth only, or no date of birth. The patient name is not exported and neither is the following potentially identifying information: patient ID, insurance company name, telephone numbers and attending and referring physician. Instead, anonymous patient records include a unique Patient Export ID and the originating clinic's Site ID.

Note: When you import patient records that were exported without identifying

information, the Stratus OCT displays those patients with the originating clinic Site ID as the last name and the Patient Export ID as the first name. Users who wish to obtain additional medical information about an anonymous patient must contact the originating clinic to request information using the Patient Export ID. The originating clinic can then search for the patient with the Patient Export ID provided (see Search for Patients on page 103). Data Integrity

Cannot Edit Identifying Information The Stratus OCT applies a permanent electronic tag to patient records that are imported without patient identifying information and treats them as a protected category of data. For these records, you cannot edit the following fields: Last Name, First Name, Middle Names, Gender, Date of Birth, and Patient ID. You can edit other fields of the anonymous patient record, as well as analyze, archive and re-export the data. Data that is imported with identifying patient information can be edited without restriction. Updating Imported Records For all imported patient records, it is possible to import new scan data and update patient data. In the case of records imported without patient identifying information, the Patient Export ID

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enables updating of the patient record. Once created, the Patient Export ID is fixed. It is also unique among those created on all Stratus OCT instruments because part of it is derived from the unique serial number of the Stratus OCT instrument on which it was created. If during import the Stratus OCT encounters information associated with a Patient Export ID already imported, the Stratus OCT does the following:

· imports all scan data (exams) not previously imported, but never deletes nor overwrites any

scan data already imported;

· updates patient data (e.g., axial length, patient categories, etc.) only if it was created on a

later date than the data already imported. This prevents overwriting of newer patient data with older. DVD Disk Use Restrictions The Stratus OCT prevents you from mingling export data with archive or backup data on the same DVD-RAM disk. The Stratus OCT will not write export data to a DVD-RAM disk that already contains archive or backup data. Only one export database can be present on a DVD at a time. If you attempt to export to a DVD disk that already has an export database, you will be asked if you wish to overwrite the previous database before export can continue. Similarly, the Stratus OCT will not write archive or backup data to a DVD-RAM disk that already contains export data.

Note and Warning: It is possible to reuse a DVD disk for export, but you must overwrite--and in the process delete--the current export database. You can also repurpose any dedicated DVD disk, but only if you first delete all files on the disk or reformat the disk--and thereby permanently erase all data on the disk.

Export Data

The Stratus OCT offers the ability to export data to another Stratus OCT instrument.

Export Media & Methods

It is possible to export data in three ways: 1. To DVD-RAM disk. If the PC does not have a DVD-RAM drive, it is possible, but not recommended, to remove a DVD-RAM disk from its case, insert it directly into a writable DVD drive and export to it. It is not recommended because the DVD-RAM disk is susceptible to damage once removed from its case. 2. To a network destination. The export options dialog enables you to select a network destination. Users are responsible for setting up and maintaining their own networks, and for selecting the desired network destination when exporting. 3. Directly to a Stratus OCT instrument. To do this, the sending and receiving platforms must be connected by an RJ-45 crossover cable between their respective ethernet ports. It is the user's responsibility to acquire and install the necessary crossover cable, and to select the correct export path when exporting.

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Export and Import Scan Data

Note: If there is an export database on the intended export media, the Stratus OCT warns you first that it will overwrite it. Click Cancel if you do not wish to overwrite the previously exported data. To successfully export multiple patient records to a single export media, you must select them during a single export session. Stratus Database Export

To export a Stratus database to another Stratus OCT instrument, follow these steps: 1. If you are exporting to DVD-RAM disk, insert a formatted DVD-RAM disk cartridge into its drive. If not, skip to the next step. 2. From the MAIN WINDOW, select Export from the Data menu (click Data > Export) to reach the BROWSER. (If you are in the BROWSER View mode, click Data Transfer > Export.) The BROWSER appears as below. (For details on the BROWSER, see Chapter (7).) The Patients list displays every name in the patient database. Each name has an empty checkbox by it.

cáÖìêÉ=OT=qÜÉ=píê~íìë=l`q=_oltpbo=áå=bñéçêí=jçÇÉ 3. Select the checkboxes next to the patients whose exams (scan groups) you wish to export. If necessary, use the Search Now button and fields to find and select the patients whose data you wish to export. For each selected patient, all his exams are selected by default. If you do not wish to export all the exams of the selected patients, you can Deselect Exams (Optional) (See instructions on page 43.)

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Export and Import Scan Data

4. When you have finished making your selections, select Database Export from the File menu (click File > Database Export). The Export Options dialog box appears:

cáÖìêÉ=OU=qÜÉ=bñéçêí=léíáçåë=aá~äçÖ 5. The dialog prompts you to Enter Medial Label Name. The left field, which is grayed out and unalterable, contains the instrument serial number followed by a dash and an archive number generated automatically, starting with "0001" and increasing by one each time you export. In the right field, you can type up to 11 more characters, including spaces. 6. In the Export Path field, the D: drive appears initially. You can export data to DVD, to any location in a network path or to hard disk. If you choose an export path besides the D: drive, click Browse to find and select the desired export path, or type in the desired export path.

Note: If you export to the instrument's hard disk, please be aware that it is possible to completely fill the hard disk, at which point you will be unable to save new exams. The Windows operating system will warn you as you approach hard disk capacity.

7. To export data anonymously, select the Obscure Patient checkbox. The patient name is not exported and neither is the following potentially identifying information: patient ID, insurance company name, telephone numbers and attending and referring physician. Instead, anonymous patient records include a unique Patient Export ID and the originating clinic's Site ID. You will then have the further option of obscuring the date of birth: either fully, partially or not at all. 8. When finished making your selections, click OK to begin exporting data. To abort export, click Cancel. Note that if you are exporting a large set of data, it can take minutes to stop the export process after clicking Cancel.

Note: Stratus OCT enables you to export cleared archive data. If the cleared data is on a network archive, the data will be exported from the archive automatically. If the file server is not connected, you will be prompted to connect with it. If the cleared data is on a DVD archive, you will be prompted to insert the archive disk by its label. If more than one

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Export and Import Scan Data

archive DVD is required, you must attend the instrument during export and insert the indicated archive disk(s) when prompted.

9. When you click OK in the Export Options dialog box, export begins. The Progress dialog box shows export progress. It can take several seconds to several minutes for the Stratus OCT to finish writing to the disk, depending on the number of exams you selected for export.

· At any time, you can click the Cancel button to abort export and no data will be exported.

10.When the export process is complete, a Notice dialog will prompt you to write the label on the export DVD disk. Label the disk as instructed and click OK.

Deselect Exams (Optional)

Deselecting specific exams is an optional step in the data transfer process. You must deselect exams for one patient at a time. If you do so, the BROWSER remembers the exams selected for every patient until you finish or exit the data transfer function. After you begin, if you wish to start over, click File > Deselect All. To Deselect All the Exams From One Visit

· Select one patient and the Visits list shows all his visits with checkboxes selected by default.

(When you select multiple patients, no visits are displayed.) Clear a visit checkbox to deselect all exams from that visit. To Deselect Specific Exams

· Select one or more visits and the Exams list shows all exams for the selected visits with

checkboxes selected by default. Clear an exam checkbox to deselect that exam.

· When only some of a patient's exams are selected, that patient's checkbox will be grayed

and contain a gray checkmark. When only some exams from a specific visit are selected, that visit's checkbox will appear likewise.

Import Data

To import data, follow these steps: 1. If you are importing from DVD-RAM disk, insert the DVD-RAM disk containing the export database into its drive. If not, skip to the next step.

Note: You cannot import an export database created with Stratus OCT 2.0 software to an instrument running Stratus OCT version 4.0.

2. From the Stratus OCT MAIN WINDOW, select Import from the Data menu (click Data > Import) to reach the Stratus OCT BROWSER.

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Export and Import Scan Data

3. When you are in the BROWSER View mode, select Import from the Data Transfer menu (click Data Transfer > Import). An Import Options dialog box appears:

cáÖìêÉ=OV=qÜÉ=fãéçêí=léíáçåë=aá~äçÖ 4. In the Import Path field, the D:\ drive appears initially. You can import data from DVD, the instrument hard drive or from any location in a network path. If you choose an import path besides the D:\ drive, click Browse to find and select the desired import path, or type in the desired import path. When finished, click OK. 5. A Confirm dialog box appears and asks, "Are you sure you want to import from this media: [Serial Number]-[Label]?" Click Yes to proceed or No to abort the import process.

Note: You must import all the exams on a DVD-RAM disk or in the selected folder for a hard drive or network location; you cannot import exams selectively.

6. When you click OK in the Confirm dialog box, data import begins. The Progress dialog box shows import progress. It can take several seconds to several minutes for the Stratus OCT to finish importing to the hard drive, depending on the number of exams on the import disk.

· At any time, you can click the Cancel button to abort import. The import process will stop

after the next whole patient record has been imported. Already imported patient records will not be removed. 7. When the import process is complete, the Progress dialog box disappears and a Summary dialog box appears. The Summary dialog box reports the number of duplicate exam records that were found and not imported and the number of exams that failed to be imported. Click OK to close the dialog.

· Click the Refresh button in the BROWSER to check for imported patient data. The Stratus

OCT displays imported patients in the patient list with the originating Site ID as the last name and the Patient Export ID as the first name.

Note: For patients imported with the date of birth obscured, normative data will not be presented in the RNFL Thickness Average analysis. Note: Imported diagnosis codes do not retain the descriptions created for them on the exporting instrument. For example, exporting instrument A has the description "Retina" for diagnosis code 001, but importing instrument B has the description "Glaucoma" for diagnosis code 001. When you view on instrument B a patient record imported from instrument A with diagnosis code 001 assigned, the description will read "Glaucoma," as if the record were created on importing instrument B.

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Index

Index

A

Access Archived Scans 27 add a network archive 24 Approved Software 6 Archive Check on startup/shutdown 21 Archive Registration 21 archive registration, network 24 Archive Scans & Backup Database 17 archive, current 25 Archive, Retrieve & Backup 17 Archive/Backup Scheme 19 archived scans, access 27 Auto Archive 21 Auto Backup index database on shutdown 20 Auto Clear on startup/shutdown 20 Automate Data Maintenance 20

DVD-RAM drive 29

E

Export And Import Scan Data 39 export archived data 42 Export Data 40 export directly to another instrument 40 Export Label dialog box 42 Export Media & Methods 40 export to DVD-RAM 40 export via network 40

F

File menu Exit 29, 35

Export 42

Format DVD-RAM Disks 29 Formatting--erases DVD disks 29

B

Backup 36 Backup procedure 34

G

gray checkmark 27, 43 grayed checkbox 27, 43

C

Clearing Scan Data 18 current archive, set 25

I

Import Data 43 Imported data

Cannot Edit Identifying Information 39 Data Integrity 39 DVD Disk Use Restrictions 40 Patient Privacy 39 Privacy and Data Integrity Features 39 Updating Imported Data 39

D

Data Management Preferences 20 data management preferences 8, 20 Data menu

Export 41 Import 43

Internet Connectivity Risks 6

Data Protection Requirements 18 Data Protection, Media Requirements 19 Database, Patient 17 Deselect Exams (Optional) 27, 41, 43 Duplicating an Archive Disk 28 DVD, wait after installing 19 DVD_RAM Disks, Format 29 DVD-RAM disk cartridge 41, 43

M

Media Requirements for Data Protection 19

N

Network Activities Not Supported 7 network activities, not supported 7 network activities, proscribed 7 Network Archive Registration 24

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Index

network archive registration 24 Network Capabilities 5 Networking Guidelines 5 Networking Risks 6

O

Options Menu, Preferences 8, 20

P

Patient Database 17 Preferences, Data Management Tab 8, 20 Progress dialog box 43 Proscribed Network Activities 7

Q

Quit button 36

R

Register a Network Archive 24 Restoration of database 36

S

Schedule for Archive and Backup 19 Select exams--deselect 27, 43 Set Current Archive 25 Stratus Database Export 41 System Backup 36

T

Third Party Software 6

V

Validated Antivirus Software 6

W

Wait after Installing a DVD 19

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DRAFT/PRE-RELEASE/CONFIDENTIAL

6/23/06

DRAFT/PRE-RELEASE/CONFIDENTIAL

6/23/06

Carl Zeiss Meditec AG Goeschwitzer Strasse 51­52 07745 Jena Germany Telefon: +49 (0)36 41/2 20-3 33 Telefax: +49 (0)36 41/2 20-2 82 [email protected] www.meditec.zeiss.com

Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA Toll Free: 800-341-6968 Phone: 925 557-4100 Fax: 925-557-4101 Stratus OCT 2006.06 Specifications subject to change [email protected] www.meditec.zeiss.com

0297

Information

Stratus OCT User Manual

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