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GDxVCC™

User Manual

ii

GDxVCC™ User Manual Revision Control Part Number

Rev

Software Version

Description

Release Date

58655-1

A

5.5.0

GDxVCC™ User Manual English

2005.04

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PLEASE Read this entire manual before setting up and operating your GDxVCC™. Important Information WARNING: User Changes to Software or Hardware The GDxVCC is a medical device. The software and hardware have been designed in accordance with U.S., European and other international medical device standards designed to protect clinicians, users and patients from potential harm caused by mechanical, diagnostic or therapeutic failures. Unauthorized modification of GDxVCC software or hardware (including peripherals) can jeopardize the safety of users and patients, the performance of the instrument, and the integrity of patient data; it also voids the instrument warranty. Disclaimer: Clinicians Responsible for Diagnostic Interpretation Carl Zeiss Meditec does not offer advice in the diagnostic interpretation of GDxVCC scans. We do provide with the instrument a primer on clinical application of scanning laser polarimetry using the GDxVCC. It is the clinician’s responsibility to make diagnostic interpretations of GDxVCC scans. WARNING: Accessory Equipment Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. General Warnings & Precautions • Do not insert a lens, mirror or other optically active device between the system and the patient. (The patient may wear prescription contact lenses.) Doing so may result in a higher than normal energy density in the eye that could injure the patient. • Use of controls, or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. • Always clean the patient contact surfaces of the face mask with alcohol pads prior to each use.

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iv • To maintain patient safety, peripheral devices must be placed at least 1.5 meters (4.9 feet) away from the patient, such that the patient cannot touch a peripheral device with any part of his or her body while being examined. In addition, the instrument operator must not attempt to touch the patient and a peripheral device at the same time while examining the patient. • Do not attempt to open the protective housing of the GDxVCC for any reason. There are no user-replaceable parts inside the instrument covers. (Users may replace fuses, which are located by the power cord inlet--see page 6-2.) Only Zeiss authorized technicians should disassemble or service this instrument. In case of malfunction, error messages or operational problems, call Carl Zeiss Meditec customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. • In case of emergency related to the instrument, unplug the power cord from the wall outlet and call for service immediately. • For the replacement of any component, accessory, or peripheral, call Carl Zeiss Meditec customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. • The GDxVCC weighs approximately 45 pounds (21 kg). To avoid injury, exercise proper lifting techniques when lifting or moving the GDxVCC. • Allow the system to acclimate to room temperature before turning on the power. • Be sure not to apply power to the GDxVCC until all connections are secure and the instructions specifically advise you to apply power. System lockup may occur and require a power down/power up sequence if all connections are not made as described in this manual. • Remove the foam protector from in front of the objective lens and unlock the scan head before turning on the power (See Setup). • Confirm that the objective lens is clean before imaging patients (See Cleaning the Objective Lens ). • Although this instrument is designed for continuous operation, it should be turned off when not in use for an extended period. • This instrument may cause ignition of flammable gases or vapors. Do NOT use in the presence of flammable anesthetics such as nitrous oxide, or in the presence of pure oxygen. • To prevent electric shock, the instrument must be plugged into an earthed ground outlet. Do not remove or disable the ground pin. • Connecting electrical equipment to a multiple portable socket-outlet could result in a shock hazard to the user or patient. • The equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided herein. • Portable and mobile RF communications equipment can affect medical electrical equipment.

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v • The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment. • The equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Equipment Classifications • Type of protection against electric shock: Class I equipment • Degree of protection against electric shock: Type B equipment • Degree of protection against harmful ingress of water: IPXO—ordinary equipment. • Mode of operation: Continuous operation equipment Indications The Carl Zeiss Meditec GDxVCC is used for diagnosing and monitoring diseases and disorders that manifest themselves in the posterior pole of the eye, e.g. for diagnosing and monitoring of glaucoma and other optic neuropathies. Contraindications The GDxVCC may not produce reliable results for patients in the following categories: • Patients with cornea retardance greater than 120 nm. The system will provide an error message when such a retardance measurement is detected. • Patients with dense cataracts. Patients with cataracts will have a dark fundus image and low image quality score. • Patients who are unable to fixate on a target with the subject eye. These typically are patients with loss of central vision. • Patients with refractive errors outside the following ranges: +5 D to -10 D (for earlier VCC Systems) or +7 D to -15 D (for later VCC Systems). • Patients less than 18 years of age; such patients can be imaged, but they are not supported by the normative database. International Customers Please contact your CZM Sales Representative for a listing of printers that CZM has approved for use with this product.

Embedded Windows License Each instrument is issued with an embedded Windows license located on the hard drive tower under the hard drive access door.

Product Compliance 0297 93/42/EEC Medical Device Directive

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CSA C22.2 No. 601.1-M90 (Canada) + UL60601-1 (1st Edition, US)

Indicates this equipment contains Type B applied parts.

Symbols Defined Indicates that there are important operating and maintenance instructions found in the manual.

Indicates risk of electrical shock due to the presence of uninsulated high voltage inside the instrument. Do not remove the instrument cover or parts.

Indicates a fuse is present near this symbol. Protective Packing Symbols Handling Requirements Fragile

Keep Dry

This end up

Transport and Storage Conditions Relative Humidity: 10% to 85%, excluding condensation

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Temperature: -20 to +50 deg. C Atmospheric Pressure: 500 hPa to 1060 hPa

Instrument Disposition When it comes time to upgrade the device, please contact Carl Zeiss Meditec to inquire about trade-in or upgrade values we may offer. Should you not wish to trade in the instrument, please dispose of it in accordance with local and national requirements.

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Contents ix Contents Important Information.................................................................................. -iii WARNING: User Changes to Software or Hardware ............................................. -iii Disclaimer: Clinicians Responsible for Diagnostic Interpretation ........................... -iii WARNING: Accessory Equipment ........................................................................ -iii General Warnings & Precautions ......................................................................... -iii Equipment Classifications..................................................................................... -v Indications .......................................................................................................... -v Contraindications................................................................................................. -v International Customers....................................................................................... -v

Embedded Windows License ......................................................................... -v Product Compliance....................................................................................... -v Symbols Defined........................................................................................... -vi Protective Packing Symbols ................................................................................. -vi

Instrument Disposition ................................................................................ -vii (1) Introduction .....................................................................................1-1 Overview........................................................................................................1-1 Purpose Of This User Manual ........................................................................1-1 Setup ............................................................................................................ 1-2 Visual Guide to System Features..........................................................................1-5 Unlocking the System .........................................................................................1-5 Power Up ...........................................................................................................1-5 Power Down.......................................................................................................1-5 The AccessCard ..................................................................................................1-6 Data Entry ..........................................................................................................1-6 Time and Date Setup .......................................................................................... 1-7 Security Mode Setup........................................................................................... 1-7 Importing and Exporting Data............................................................................. 1-7

(2) Exam Procedures............................................................................ 2-1 Quick Start Guide.......................................................................................... 2-1 Setup New Patient........................................................................................2-2 Select Existing Patient ..................................................................................2-3 Scan Procedure.............................................................................................2-4 Refraction Settings............................................................................................. 2-4 Positioning the Patient....................................................................................... 2-4 Patient Fixation.................................................................................................. 2-5 Image Acquisition.............................................................................................. 2-5

Image Quality ............................................................................................... 2-7 Modifying the Macular Ellipse.............................................................................2-7 Cornea Measurement Image Check ................................................................... 2-10 RNFL Measurement Image Check......................................................................2-11

Calculation Circle.........................................................................................2-12 To Resize the Calculation Circle ......................................................................... 2-13

Retaking Exams ...........................................................................................2-15

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Contents Results.........................................................................................................2-16 (3) Record Management...................................................................... 3-1 Select Patient Record.................................................................................... 3-1 Direct Patient Search...........................................................................................3-1 Scrolling the Full List.......................................................................................... 3-2

Manage Patient Information ........................................................................3-3 Full Exam .......................................................................................................... 3-3 Screen ............................................................................................................... 3-3 Review .............................................................................................................. 3-3 Edit Patient Information ..................................................................................... 3-3 Delete Patient and Exams .................................................................................. 3-3

Manage Patient Exams .................................................................................3-4 Select Measurements ......................................................................................... 3-4 On Screen Exam Review..................................................................................... 3-5

Print/Export Exams .......................................................................................3-6 Export Raw Data................................................................................................ 3-6

(4) Reports ............................................................................................ 4-1 Report Content ............................................................................................. 4-1 Calculation Circle................................................................................................4-1 Fundus Image.....................................................................................................4-1 RNFL Thickness Map...........................................................................................4-1 TSNIT Graph ...................................................................................................... 4-2 TSNIT Symmetry Graph....................................................................................... 4-2 TSNIT Comparison Graph ................................................................................... 4-2 TSNIT Serial Analysis Graph................................................................................ 4-2 Trend Analysis with Probability Graph................................................................. 4-2 Deviation from Normal Map............................................................................... 4-2 Deviation from Reference Map........................................................................... 4-3 TSNIT Parameters............................................................................................... 4-3 Difference from Baseline .................................................................................... 4-3 NFI (Nerve Fiber Indicator) ................................................................................. 4-3 Extended Parameters ......................................................................................... 4-4

Report Formats.............................................................................................4-6 Nerve Fiber Analysis .......................................................................................... 4-6 Serial Analysis ................................................................................................... 4-6 Advanced Serial Analysis.....................................................................................4-7

Alignment Options........................................................................................ 4-7 (5) System Management ..................................................................... 5-1 Using Security Mode..................................................................................... 5-1 To Enable Security Mode for the First Time ..........................................................5-1 To Setup User Names and Passwords ..................................................................5-1 To Change the Password for the Current User ..................................................... 5-3 To Log Out......................................................................................................... 5-4 To Disable Security Mode ................................................................................... 5-4

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System Tests .................................................................................................5-5 Automatic System Test ....................................................................................... 5-5 User Initiated Tests............................................................................................. 5-5

Disk Backup Options..................................................................................... 5-7 Database Options .........................................................................................5-8 Optimize............................................................................................................ 5-8 Merge ............................................................................................................... 5-8 Sync Disks ......................................................................................................... 5-9 Recalculate Data ............................................................................................... 5-9 Export Data ....................................................................................................... 5-9 Import Data....................................................................................................... 5-9

Software Update......................................................................................... 5-10 Alignment Options...................................................................................... 5-10 (6) Care, Maintenance & Transportation ........................................... 6-1 What to do for GDxVCC ................................................................................ 6-1 Other Recommendations.....................................................................................6-1

What not to do for GDxVCC.......................................................................... 6-1 Cleaning the Objective Lens ........................................................................6-2 Model and Serial Number Information .........................................................6-2 Replacing the Main Fuse .............................................................................6-2 Removing Hard Disk Drives ..........................................................................6-3 Other Maintenance, Safety Labels ................................................................6-4 Laser Safety ..................................................................................................6-5 AccessCards and Supplies.............................................................................6-6 AccessCards ...................................................................................................... 6-6 Ownership:........................................................................................................ 6-6 Ordering Additional Supplies.............................................................................. 6-6

Transporting ................................................................................................6-6 (7) Troubleshooting ............................................................................. 7-1 GDxVCC Will Not Start Up................................................................................... 7-1 GDxVCC Locks Up ............................................................................................... 7-1 Keyboard Does Not Work.................................................................................... 7-1 External Color Printer Does Not Work .................................................................. 7-1 What to do when an Error Message is displayed.................................................. 7-1 Acquisition Mode is Suspended...........................................................................7-2

(A) Screening Exams ............................................................................ A-1 To Perform a Screening Exam ....................................................................... A-1 For an Existing Patient ........................................................................................A-1 For a New Patient...............................................................................................A-1

(B) Directly Attaching a PC to the GDxVCC ....................................... B-1 To Attach a PC to the GDxVCC ...................................................................... B-1 What if ‘Test Connection’ Fails?.......................................................................... B-6

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Contents (C) Importing, Exporting, & Printing Data via a Network .............. C-1 Overview....................................................................................................... C-1 Importing and Exporting Data.............................................................................C-1 The Relationships between Doctors, Clinics, and Networks ................................. C-2

Data Files and Folders ..................................................................................C-4 Tab-Delimited Text Files...................................................................................... C-5 HTML and SVG (Scalable Vector Graphics) Files .................................................. C-5

Configuring the System for Network Import/Export .....................................C-6 To Configure the Network Connection ................................................................ C-6

Basic Networking Procedures .......................................................................C-8 To View the Currently Selected Doctor/Clinic ....................................................... C-8 To Change the Currently Selected Doctor/Clinic................................................... C-9 To Convert an SVG File to Another Graphic Format (JPG, BMP, etc.).................... C-10

Exporting Data Over a Network.................................................................. C-10 To Export Selected Exams for a Single Patient .................................................... C-10 To Send Exam Reports as Email Attachments .....................................................C-11 To Export the Complete Database...................................................................... C-12

Importing Data Over a Network ..................................................................C-15 To Import Data Over the Network...................................................................... C-15 To Import Data from Another GDxVCC............................................................... C-15

Importing and Exporting Data to a Floppy Disk ..........................................C-16 To Export Patient Data to a Floppy Disk ............................................................. C-16 To Export Error Logs.......................................................................................... C-17

Using a Fixed IP Address for the GDxVCC....................................................C-17 To Specify a Fixed IP Address for a GDxVCC ....................................................... C-17

Printer Setup................................................................................................C-19 To Convert a Desktop Printer into a Network Printer.......................................... C-20

(D) The AccessCard Log File ................................................................D-1 To Print or Export the AccessCard Log File................................................... D-2 (E) Image Check Messages.................................................................. E-1 (F) Specifications ................................................................................. F-1 Environmental Conditions ................................................................................... F-1

(G) Legal Notices...................................................................................G-1 Limited Warranty ..........................................................................................G-1 Service Contract........................................................................................... G-2 Software Copyright...................................................................................... G-2 Software License Agreement ....................................................................... G-2 (H) Microsoft End User License Agreement ......................................H-1 (I)

Electromagnetic Compatibility Information ............................... I-1 Index ..................................................................................................i-i

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Introduction 1-1 (1) Introduction Overview The GDxVCC™ employs patented GDx Scanning Laser Polarimetry (SLP) technology to provide quantitative information about the retinal nerve fiber layer (RNFL). The near infrared laser beam passes the retinal nerve fiber layer twice. Due to an optical property of the RNFL called birefringence, part of the beam is phase-shifted. This phase shift (retardation) directly correlates to the thickness of the RNFL. The GDxVCC compares the patient’s retinal nerve fiber layer (RNFL) distribution with that of the nerve fibers of healthy eyes from a normative database. This information, in conjunction with other diagnostics, assesses the patients’ ocular health, in particular with respect to glaucoma.

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Note: For conceptual clarity, the output of the GDxVCC analysis is expressed in polarimetric microns and called Polarimetric Thickness. However, the actual quantity being measured through polarimetry is birefringence, which is affected by not only thickness but also by retinal tissue structure. Therefore, Polarimetric Thickness is not to be compared to anatomical thickness measured by other devices. A unique feature of the GDxVCC is its Variable Corneal Compensation. When using this feature, the system will measure the birefringence of each cornea and then optically cancel the corneal birefringence when imaging the RNFL for each eye. We recommend you use this feature due to variations in the cornea characteristics in the patient population. However, the system is also able to perform exams using fixed compensation, which may be useful if you have used a previous version of the GDx technology. Notes specific to this option are designated by “FCC” in this manual. For Fixed Mode operation, refer to the User Manual for the Access system. The GDxVCC allows you to take exams consisting of measurements (scans) for one or both eyes of a patient at a given office visit. Each measurement contains images representing the RNFL of one eye and analysis based on those images. You may also create a variety of reports based on one or more measurements for a given patient.

Purpose Of This User Manual Zeiss designed this User Manual to instruct you in the procedures for imaging the patient, creating and managing patient records, reviewing measurements, and creating reports. We assume that users are clinicians or technicians with professional training or experience in the use of ophthalmic diagnostic equipment, and in diagnostic interpretation of the images generated. Carl Zeiss Meditec does not offer advice in the diagnostic interpretation of GDxVCC scans. We do provide with the instrument a primer on clinical application of scanning laser polarimetry using the GDxVCC. It is the clinician’s responsibility to make diagnostic interpretations of GDxVCC scans.

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Setup The GDxVCC contains sensitive electronic, mechanical and optical components, as well as an internal computer. Handle it gently.

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Note: The GDxVCC weighs approximately 45 pounds (21 kg). To avoid injury, exercise proper lifting techniques when lifting or moving the GDxVCC.

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Note: Do not turn power on until all connections are made and all steps are completed.

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1. Place the GDxVCC on a sturdy table, preferably one that is height adjustable. 2. Connect the keyboard to the keyboard connector on the underside of GDxVCC (Figure 1-4). 3. To export reports to a network server or PC, connect a crossover cable from the network server or PC to the network connector on the underside of the GDxVCC (Figure 1-4). Refer to Appendix B: Directly Attaching a PC to the GDxVCC and Appendix C: Importing, Exporting, & Printing Data via a Network for detailed instructions. 4. Connect the external color printer data cable to the printer connector located on the underside of GDxVCC (Figure 1-4). Plug the printer power cord into the power outlet. Be sure the ink cartridges and paper are installed per the manufacturer’s directions. 5. Grasp the end of the plastic bag/foam objective lens shipping protector and pull it out and away from the face mask. Place the protector in a safe place for future transport. Remove the lens cap. 6. Read and remove the Caution label from the LCD Display. 7. Unlock GDxVCC scan head optics using the screwdriver and instructions provided in the accessory kit. See Unlocking the system section in this chapter for more information (Figure 1-5). Note: Be sure to remove the objective lens foam block protector and unlock the scan head optics before applying power to GDxVCC. System warm up and self tests will fail if the scan head optics are not unlocked with power applied. 8. Position and insert the AccessCard into the card slot located to the left of the LCD Color Display. See AccessCard section in this chapter for more information (Figure 1-6). 9. Connect the female end of the power cord into the power cord connector on the underside of GDxVCC (Figure 1-3). Plug the power cord male end into the power outlet.

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Figure 1-1 Operator Console

Figure 1-2 Patient Console Front and Right Side

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Introduction

Figure 1-3 Underneath from Right Side

Figure 1-4 Underneath from Left Side

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Introduction 1-5 Visual Guide to System Features Unlocking the System If the Shut Down for Transport procedure was performed the last time the system was powered down, or if it is unknown, the procedure for unlocking the scan head optics should be performed as a precaution before powering up the system. Insert the Phillips screwdriver, included in the GDxVCC accessory kit, into the optics lock down screw hole (larger of the air vent holes) on the right side of the unit, engage the spring loaded screw

Figure 1-5 Unlocking scan head optics and turn the screw counterclockwise to insure that it is loosened and moves freely. This will ensure that the optic assembly is unlocked and it is safe to power up the system (Figure 1-5). Power Up Confirm that the system is unlocked (see above). Make sure the power cord is plugged in as described in Setup. The power on/off switch is located on the underside of the unit by the power cord inlet. Power up the system by flipping the switch to the on position (I = on, O = off).

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Note: It is recommended to leave the system running during daily use and to power down at the end of each day.

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Note: Some (rare) units do not have a power on/off switch. For these units, you may plug and unplug the power cord to power up and power down the system. At power-up, GDxVCC will run a warm up test procedure. The test usually takes several minutes. If the unit is cold (e.g. if the unit was transported from another office), allow it to acclimate to normal room temperature before turning on the power. It may take up to 30 minutes for GDxVCC to “warm-up” and pass the system test. As the test is being performed, there will be a screen indicated that the test is in progress. If there are no errors, the system will start up normally. See Disk Backup Options on page 5-7 for more information. Once the GDxVCC Logo screen is displayed, the system is ready for operation. Power Down CAUTION: Only power down your system from the LOGO screen or the SHUT DOWN FOR TRANSPORT screen. Whenever the system will be left idle for more than 6-8 hours, it is recommended to turn off the power. To do so, first turn off the external printer, if connected, at the printer’s power switch. Power down the system by flipping the power switch to the off position (I = on, O = off).

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The AccessCard To perform scans with GDxVCC, an AccessCard must be inserted into the slot located to the left of the LCD Display. Insert the card with the GDxVCC logo side facing left, placing the end with the gold smart chip and black arrow into the slot (Figure 1-6). The system will not take images if an AccessCard is not inserted. It is best to leave the AccessCard inserted at all times, however, if it must be removed (for example, to transport), return to the LOGO screen (press Cancel/Go Back (8) until the LOGO screen is displayed) before removing the AccessCard.

Figure 1-6 AccessCard

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Note: Never remove or insert the AccessCard during scan acquisition or processing. See AccessCards and Supplies on page 6-6 for more AccessCard information. Data Entry You will use the keyboard when entering initial setup data and patient information. After that, most inputs are made by pressing the two operation and six function buttons on the operator console. The buttons are backlit when active. The six function buttons below the LCD Display change function depending upon which screen is displayed. The current function of each button is indicated on the LCD Display just above the respective button. The two operation buttons to the right of the LCD Display are marked 9 and 8.

9 is the OK button. Pressing this button accepts the current screen and any data entered and moves to the next screen.

8

is the Cancel/Go Back button. Pressing this button will cancel current activity on the current screen and return the display to the previous screen.

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Introduction 1-7 The operation and function buttons provide for simple quick operation; the keyboard is necessary only for inputting patient and initial setup data. However, each function on the LCD Display above the six function buttons has one letter in its label that is underlined. Holding down the “Alt” key on the keyboard, while simultaneously pressing the keyboard letter that corresponds to the underlined letter in the label, will select that function just as if the related function button had been pressed. Use the Tab key to advance through the input fields, and the Shift+Tab keys to go back. Time and Date Setup At the LOGO screen, select System and then More. When the ADDITIONAL SYSTEM OPTIONS screen is displayed, select Set Time & Date. Update the fields as needed. When the correct time and date are displayed, press OK (9) and the display will return to the LOGO screen. Security Mode Setup The GDxVCC provides an optional security mode feature which helps to protect the privacy of patient data, and also helps to prevent unauthorized access to the system. When security mode is enabled, each user (e.g. doctor, operator, or administrator), must log onto the GDxVCC by entering a user name and password. In this case, a doctor (or operator designated by the doctor) will only be able to view data and access patient records for those patients that are assigned to the doctor. When security mode is disabled, user names and passwords are not required to log onto the system, and all users can access all patient data. Security mode is disabled by default. If you wish to enable security mode, you should first appoint a single Administrator for the system. It is the Administrator’s responsibility to enable security mode, and to setup user accounts for the doctors who use the GDxVCC. Only the Administrator has complete access to all of the patient data and user accounts on the GDxVCC. If a GDxVCC will only be used by a single doctor, you may still wish to enable security mode in order to safeguard the system against unauthorized access. In this case, the doctor can serve as the Administrator. To use security mode, see Using Security Mode on page 5-1. Importing and Exporting Data You can connect a GDxVCC directly to a Windows PC or network server via the Ethernet network card in your PC. Alternatively, if you have a local area network (LAN) in your office, you can attach a GDxVCC to the LAN allowing it to communicate with any of the networked Windows PCs or printers within your clinic. Using either of these methods, you can import and export the following types of data: • Exam reports (measurement data, calculations, formatting, patient and doctor information) can be printed to network printers and imported or exported to and from Windows PCs. • Raw measurement data (without formatting) can be imported or exported to and from Windows PCs. There are several reasons that you might want to perform data imports and exports. For example, you can export measurement data to a PC in order to back up the data, or to analyze it with software tools. Later the data can be imported again, possibly to a different GDxVCC. This might be useful in a practice where doctors perform exams on multiple GDxVCCs, since this allows patient data to be easily transferred from one GDxVCC to another as needed. You can even place the

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exported data on removable media such as floppy disk or CD, and transport it to another clinic where it can be imported from a networked PC to any GDxVCCs resident at that clinic. In this way, doctors who see the same patients at different clinics can easily transfer data from clinic to clinic. The security features of the GDxVCC can be employed to keep patient information private, even when several doctors transfer data among a number of different GDxVCCs. To use the data importing and exporting features, see Appendix B: Directly Attaching a PC to the GDxVCC, or Appendix C: Importing, Exporting, & Printing Data via a Network. Appendix C also describes how to set up a network printer.

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Note: These procedures are similar. Essentially, attaching a PC directly to a GDxVCC is a special case of the more general procedure where the GDxVCC is attached to a LAN that may host multiple PCs. Although these two procedures are independently described in Appendix B and Appendix C, if you are simply attaching a GDxVCC directly to a single PC, you may still find some of the general overview information from Appendix C to be useful.

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Exam Procedures 2-1 (2) Exam Procedures

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Note: This chapter describes Full exams. See Appendix A: Screening Exams for information on Screening (abbreviated) exams.

Quick Start Guide 1. With the GDxVCC and peripherals properly connected and the optics unlocked, switch the system on. If there is a printer connected, turn its power switch to the “on” position. Insert the AccessCard into the slot to the left of the LCD display. 2. When the warm-up test is complete, the LOGO screen will be displayed. Select New Patient or Existing Patient. Follow the prompts and enter patient information (or recall patient information if this is a returning patient). 3. Enter the patient’s refractive error. Position the patient in front of the GDxVCC with her/his face placed comfortably against the mask. 4. Select Full Exam, enter patient refraction manually and press OK (9). When the ACQUISITION or ACQUISITION - CORNEA MEASUREMENT screen appears and the Please Wait caption has disappeared, you are ready to scan.

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IMPORTANT: For a patient’s first scan only, steps 5 through 10 will be performed for the cornea measurement, and then repeated for the RNFL measurement. 5. Ask the patient to gaze at the blinking fixation target in the red field; the right eye will be first and the target will be on the patient’s left. 6. Move and rotate the joystick to center the yellow crosshairs on the pupil, then move the joystick forward or back to center the white focus dot on the horizontal red line. 7. With the patient’s eye and focus dot properly aligned, press the Image Acquisition button on top of the joystick to scan the eye. The system will automatically switch to the other eye. Repeat steps 4 through 6. 8. If the ellipse is not well centered on the optic nerve head (ONH) or on the macula (for cornea measurement), reset the position of the ellipse. Press OK (9) to return to IMAGE CHECK. 9. Review the scans on the IMAGE CHECK screen. If the images are not acceptable, select Retake Image and repeat steps 5 through 8. (On the IMAGE RETAKE SELECTION screen, choose Retake Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye as appropriate.) 10.When ellipse placement and image quality are satisfactory, select Accept. If this is a cornea scan, the ACQUISITION screen will reappear for the compensated RNFL scan (go to step 5). Otherwise, REVIEW CALCULATIONS will appear. 11.At the REVIEW CALCULATIONS screen, select Print, Export, Print & Export Options, Serial Analysis, or Save Only, as appropriate. If desired, enter operator initials and comments.

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Exam Procedures Setup New Patient To image a new patient with no previous exams stored in the database, you must first create a new patient record. At the LOGO screen (Figure 2-1), select New Patient to display the PATIENT IDENTIFICATION screen. Enter a unique ID number (e.g. medical record number) in the Patient ID field. Use the Tab key to move to each subsequent input field on the screen. Patient ID, Last Name, First Name and Doctor-Clinic fields are required data. If you attempt to skip these mandatory fields, a message will appear on the screen before you may continue. If the desired doctor is not listed in the Doctor—Clinic field, select Doctor Information to add a new doctor. If Security is enabled, only the Administrator will be able to add a new doctor. (See Chapter 5: System Management) Input the Date of Birth information (required). Use the Tab key to move to the appropriate field and the keyboard (input value or use up and down arrow keys) to enter the correct value for the Month, Day and Year fields and press OK (9) to continue. At the ANCESTRY screen (required), select the appropriate ancestry from the drop-down list and click OK (9) to continue. At the GENDER (OPTIONAL) screen, select Female or Male.

Figure 2-1 Logo Screen

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Exam Procedures 2-3 At the PATIENT INFORMATION SCREEN (Figure 2-2), review all the patient information. If the information is not accurate, select Edit to change any or all of the information for this patient. Otherwise, proceed to Scan Procedure on page 2-4.

Select Existing Patient To perform an exam on a patient whose data is already stored in the system, you must locate and highlight the patient record in the database. At the LOGO screen, select Existing Patient. Please refer to Chapter 3: Record Management for instructions on searching for an existing patient record. When the patient of interest is highlighted, either on the PATIENTS LIST screen or on the SEARCH FOR PATIENT screen, press OK (9) and you will see the PATIENT INFORMATION screen. To begin the scan procedure, see Scan Procedure on page 2-4.

Figure 2-2 Patient Information Screen

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Scan Procedure

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IMPORTANT: The GDxVCC quantifies the RNFL by first measuring the value of corneal birefringence contribution for each eye imaged. The corneal contribution only needs to be measured once per eye and only on the first exam performed on each eye (excluding patients with LASIK or cataract surgery). The corneal compensation value for each eye is stored in a database and will then be used for all subsequent exams for that eye. The scan procedure described in this section applies to both cornea measurement scans and compensated RNFL scans. The procedure is the same except as indicated. On the PATIENT INFORMATION screen (Figure 2-2), select Full Exam. To perform a screening exam instead, select Screen (see Appendix A: Screening Exams for information on screening exams). The scan procedure described in this section applies to both types of exams. Refraction Settings You must enter patient refraction manually.

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Note: The refractive correction settings are stored in a database and are used for subsequent exams. Repeat the refraction setting if patient refraction has changed (for example, if the patient has had refractive surgery, cataract surgery, or is wearing contact lenses). At the SELECT REFRACTION screen, use the Up Right (OD), Down Right (OD), Up Left (OS), Down Left (OS) buttons to select the correct spherical equivalent refraction for the appropriate eye. Alternatively, you may use the Tab key to highlight a refraction value box and then use the up and down arrow keys to select or use the keyboard to enter the correct value. The spherical equivalent (SE) is calculated by algebraically adding ½ the cylinder value to the sphere value from the spectacle refraction. Examples: If patient’s spectacle refraction is +1.00 –1.00 x 90, SE = +1.00 + ½ (-1.00) = +1.00 – 0.50 = +0.50. If patient’s spectacle refraction is –1.00 –1.00 x 120, SE = -1.00 + ½ (-1.00) = -1.00 – 0.50 = -1.50. GDxVCC uses the refraction information to set the best focus for scanning the eye. Before pressing OK (9), position the patient in front of the face mask, and prepare to perform the exam (as described earlier in this chapter).

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Note: When the previous step is completed, the system will automatically activate the scanning laser and the scanning laser active light at the top-right of the operator console. Positioning the Patient Clean all patient contact surfaces of the face mask with an alcohol pad before each patient. Allow the alcohol to evaporate before positioning the next patient. Seat the patient in front of the system as shown in Figure 2-3, Adjust the table or patient chair to allow the patient to lean forward and place his/her face comfortably into the mask. Make sure that

the patient’s forehead and cheeks are centered, gently and evenly touching the mask, and the

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Exam Procedures 2-5 patient is comfortable. The patient should remain stationary; head movement interferes with the quality of the acquired image.

Figure 2-3 Positioning the Patient Patient Fixation With the patient in position, instruct him/her that he/she will see a field of thin red horizontal lines. On one side of the field, the patient will see short, bright, blinking, red horizontal lights, similar to an equal (=) sign. This is the patient fixation target. For the right eye, the target will be on the left side of the red field; for the left eye it will be on the right side. Ask the patient to keep his/her gaze fixed at the blinking target (if there are two, the lower of the two). Instruct the patient to hold as

steady as possible, and to blink normally until told to not blink. Image Acquisition The ACQUISITION screen provides a live image of the patient’s eye (Figure 2-4). You will use the joystick to align the eye and focus the instrument, and the image acquisition button to acquire the scan images. For compensated RNFL scan only: If a patient has had refractive or cataract surgery since their last exam, it is recommended to repeat the cornea measurement by selecting Reset Compensation. FCC: Users of earlier versions of GDx systems may wish to select Fixed Compensator in the ACQUISITION screen to produce scans comparable to those produced by earlier systems. Such scans will not benefit from the simplified interpretation provided by custom corneal compensation. Refer to the User Manual for your previous system. The system will initially be in position to scan the right eye first. Right (OD) will be displayed on the top-left of the screen. If you want to skip to the other eye, wait for the Please Wait message to disappear and select Other Eye. Ask the patient to remain still and focus on the fixation target.

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To align focus dot: After approximately centering the pupil on the yellow crosshairs, adjust the joystick forward and backward until the focus dot is centered on the horizontal red line. With the focus dot equally above and below the horizontal red line, GDxVCC is at optimum focus. To align pupil: Use the joystick to center the patient’s pupil with the yellow crosshairs. Rotate the joystick to move the image up and down. Tilt the joystick to the right to move the eye image left; tilt the joystick to the left to move the image right. See Figure 2-4 for an example of correct alignment.

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Note: You may notice two or three additional white areas within the area of the patient’s pupil. These are reflections from the eye and have no bearing on the image and the focus, and should be disregarded. Note: Pupil dilation is not recommended and may make focus dot alignment difficult, since the focus dot is a reflection from the iris. For a partially dilated eye follow the steps below to catch the edge of the iris. Measurements on fully-dilated eyes are not recommended. 1. Use the joystick to adjust the yellow crosshairs slightly off the center of the pupil until the focus dot becomes visible. 2. Adjust the joystick forward and backward until the horizontal red line bisects the focus dot evenly. 3. Adjust the joystick left-right and up-down (twisting motion) to center the partially-dilated pupil on the yellow crosshairs. Small adjustments are often helpful as the image approaches alignment with the red line. You may need to refine alignment of the yellow crosshairs now. Instruct the patient to blink once. Promptly check the pupil alignment and focus dot, make necessary fine adjustments, and press the Image Acquisition button on top of the joystick to acquire the scan, making sure the Please Wait indicator is not displayed.

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The pupil must be centered on the yellow crosshairs and the red line must be centered on the focus dot. Otherwise, the scan may not pass the image quality check and will need to be repeated.

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Ask the patient to blink just before pressing the Image Acquisition button, then not to blink during acquisition (between the first and second beeps, less than 1 second).

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Do not move or push any controls/buttons, including the joystick, during the image acquisition period while the Please Wait indicator is red.

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Exam Procedures 2-7 The system will beep once when the Image Acquisition button is pressed and again as soon as it has completed. At the sound of the second beep, instruct the patient to remain in position and blink

normally.

Figure 2-4 Acquisition Screen, Live Image The scan acquisition takes less than 1 second. While scan acquisition is in progress, a Please Wait indicator at the top-center of the display will turn red. After completion of scan acquisition of the right eye, the system will pause for a few seconds then move to position for the left eye scan. The Please Wait indicator will remain red from the time of pressing the Image Acquisition button until the system is in position for the left eye scan. If you do not want to scan the left eye, press OK (9) and the system will automatically display the IMAGE CHECK screen, otherwise repeat scan acquisition for the left eye. On completion of scan acquisition for the left eye, the IMAGE CHECK will automatically display.

Image Quality When image acquisition (cornea or RNFL) is completed, the system displays the IMAGE CHECK screen. A good image is one that has a scan quality score of 7 or above, OK’s fo Alignment, Fixation, Refraction, and Other, and is well focused. In some cases and for some eyes, it will not be possible to achieve the recommended score value and avoid all warning messages. In those cases, accept the best scan that can be obtained. Strive to obtain the best image possible, and note any problems on the printout. See Appendix E: Image Check Messages for more information on image quality messages. Modifying the Macular Ellipse Following a cornea measurement, the MODIFY ELLIPSE - MEASURING CORNEA screen appears (Figure 2-5), showing how the system automatically placed the cornea measurement ellipse for each imaged eye. A dotted square shows the optimal optic nerve head centering, which allows you to verify correct patient fixation. To ensure accurate cornea measurement, the macular ellipse should be centered directly over the macula “bow tie” pattern.

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Note: For accurate patient fixation, ensure that the ONH is within the dotted square. To change the macular ellipse position, use the arrow buttons. A dot in the center of the ellipse makes it easier to center the ellipse (Figure 2-6). Do not change the size of the macular ellipse. If the macula “bow tie” is not well-defined, press the Irregular Pattern button. When Irregular Pattern is selected, the software uses an alternative cornea calculation based on the macula area within the dotted square which does not require macular ellipse placement, and the position buttons are not available (Figure 2-7). Press the Macula Ellipse button to re-enable the macular ellipse placement options.

ONH located inside dotted square indicates accurate patient fixation

Macular ellipse centered on macula “bow tie” pattern

Dotted Square Indicates Optimal ONH Centering Figure 2-5 Modify Ellipse - Measuring Cornea

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Eye with low

Eye with moderate

Eye with high

corneal birefringence

corneal birefringence

corneal birefringence

Macular “bow tie” pattern well-defined, Macular “bow tie” pattern well-defined, Macular “bow tie” pattern well-defined, macular ellipse well-centered

macular ellipse well-centered

macular ellipse well-centered

Figure 2-6 Proper Positioning of Macular Ellipse

Dotted square indicates that Irregular Pattern is selected, the macula pattern is not well-defined

ONH located inside dotted square indicates accurate patient fixation Figure 2-7 Modify Ellipse - Measuring Cornea When you have optimized the placement of the cornea measurement ellipse, press OK (9) to go to the MODIFY ELLIPSE - MEASURING CORNEA for the next eye and optimize the placement of the cornea measurement ellipse in the same manner as for the first eye.

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Exam Procedures When finished, press OK and then Accept to the IMAGE CHECK—MEASURING CORNEA screen. Cornea Measurement Image Check Two macular images, a fundus image and a thickness (polarization) image, appear at the top of the IMAGE CHECK screen (Figure 2-8) for each eye scanned. The center two images are fundus images. The outer two images are the corresponding uncompensated thickness (retardance) images that are used to determine the amount of corneal compensation required for each eye. The colors appearing on these images will vary greatly across the patient population. Review the scan quality scores and messages for both eyes: if they are not satisfactory, select Retake Image. The IMAGE RETAKE SELECTION screen appears, and allows you to choose Retake Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye. After you make your selection, the system returns to the ACQUISITION screen to obtain new scans. The system will only overwrite the image or images that you retake. For example, if you only retake the image of the right eye, the previous image of the left eye is retained without being overwritten. When satisfied with the information on the IMAGE CHECK MEASURING CORNEA screen, select Accept. The refractive error correction values and cornea measurements are saved and used for subsequent examinations. The ACQUISITION screen will now appear so you can proceed to obtain compensated RNFL images, as described in Scan Procedure on page 2-4. After images of the compensated RNFL have been acquired, the IMAGE CHECK screen will appear (see RNFL Measurement Image Check below).

Dotted square indicates that Irregular Pattern is selected

Figure 2-8 Image Check - Measuring Cornea Screen

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Exam Procedures 2-11 RNFL Measurement Image Check Upon completion of the scan procedure as described in Scan Procedure, review the scan quality scores and messages for both eyes. If they are not satisfactory, select Retake Image. Press OK (9) and the system will return to ACQUISITION to obtain new scans. To obtain a new scan of only the right eye, press OK (9). To obtain a new scan of only the left eye, select Other Eye. The system automatically replaces previous scan(s) with the new scan(s). Potential causes of image quality problems include: • improper ONH ellipse placement. • image out of focus indicates an incorrect refraction setting. • ONH not centered (too close to edge) indicates improper fixation. • uneven illumination indicates incorrect alignment. • an overexposed or black image indicates that the patient blinked during acquisition. • black borders along one or more sides of the image indicate patient eye movement during acquisition.

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IMPORTANT: Proper ONH ellipse placement influences image quality messages. Verify placement is correct before deciding to retake an image. At the IMAGE CHECK screen (Figure 2-9), select Modify Right (OD) Ellipse. The screen displays how the system automatically placed the ONH ellipse. It should be placed such that the ellipse is centered over the ONH.

Figure 2-9 Image Check Screen (RNFL Measurement) To modify the ONH ellipse position, select Set Position. Four positioning buttons will be activated for right, left, up, and down movement. Press the proper positioning buttons to center the ONH ellipse.

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Exam Procedures For continuous movement, press and hold down the direction buttons. Proper placement of the ellipse over the ONH should appear as shown in Figure 2-10. Select Modify Left (OS) Ellipse and position the ONH ellipse.

ONH ellipse not centered

ONH ellipse well-centered

Figure 2-10 Proper Positioning of the ONH Ellipse

Calculation Circle The Calculation Circle is the area between the two outer concentric circles on the IMAGE CHECK screen (Figure 2-11). This area is where measurement data is acquired for the TSNIT and NFI parameters. The Calculation Circle can be resized, if necessary, in order to obtain more meaningful results for patients with parapapillary atrophy (PPA) and scleral crescent. By default, the Calculation Circle is set to the smallest size.

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Exam Procedures 2-13 To Resize the Calculation Circle Use this procedure to modify the size of the Calculation Circle in order to obtain higher quality measurement data for patients with PPA and scleral crescent. (See example below.)

PPA

Figure 2-11 Calculation Circle with Parapapillary Atrophy (PPA) 1. From the IMAGE CHECK screen, select Modify ONH Ellipse for the desired eye. (The IMAGE CHECK screen appears immediately after image acquisition. You can also bring up this screen when you review an image.) The MODIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears, as shown in Figure 2-12.

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Exam Procedures

Figure 2-12 Modify Calculation Circle and ONH Ellipse Screen 2. Select Calculation Circle. The MODIFY CALCULATION CIRCLE AND ONH ELLIPSE screen appears, as shown in Figure 2-13.

Figure 2-13 Thickness Map and Fundus Image, with Small Circle Intersecting PPA Area

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Exam Procedures 2-15 3. Circle Small is the default setting. You can select Circle Medium or Circle Large to expand the Calculation Circle beyond the PPA or affected area in the image. The Calculation Circle is resized accordingly. The currently selected button is deactivated. Figure 2-14 shows examples of small, medium, and large Calculation Circles. 4. You can see the results superimposed on the image, and visually determine whether or not the calculation circle is positioned optimally.

Small calculation circle intersecting PPA area

Medium calculation circle intersecting PPA area

Large calculation circle expands, avoiding PPA area

Figure 2-14 Examples of Small, Medium, and Large Calculation Circles

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Note: When performing a serial analysis, the software overlays the circle size from the baseline image onto each subsequent image to calculate change. If it becomes necessary to resize the calculation circle for previously imaged patients, you must also resize the calculation circle on the baseline scans prior to performing serial or advanced serial analysis

Retaking Exams

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Note: Once an exam has been saved it cannot be retaken. During an exam, the system may alert you to reset compensation (obtain a new measurement for the corneal contribution), or you may choose to remeasure the corneal contribution to reestablish or update its value (for example, following cataract or refractive surgery) prior to a new RNFL exam. To retake an exam, select Retake Image. The IMAGE RETAKE SELECTION screen appears, and allows you to choose Retake Both Eyes, Retake Right (OD) Eye, or Retake Left (OS) Eye. After you make your selection, the system returns to the ACQUISITION screen. Select Reset Compensation and the ACQUISITION—MEASURING CORNEA screen appears. Refer to the Image Acquisition section on page 2-5 to re-measure the cornea. When satisfied with the image quality on the IMAGE CHECK screen, select Accept. The REVIEW CALCULATIONS screen appears (Figure 2-15).

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Results The REVIEW CALCULATIONS screen (Figure 2-15) provides an abbreviated summary of the exam results including the TSNIT, RNFL image and parameter table. Refer to Chapter 4: Reports for greater detail.

Print, Save and Export options will automatically save the exam and display the OPERATOR INFORMATION (OPTIONAL) screen where you may enter the operator’s initials and Tab to the Comments Box to enter comments. The comments are stored with the exam file and can be viewed on screen (see Chapter 3: Record Management), but are not printed on the reports. In addition to saving exam results, the REVIEW CALCULATIONS screen allows you to print and export reports (see Chapter 3: Record Management).

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Note: If you are using an AccessCard with a plan that does not have unlimited use, you will be debited one full exam when you press Accept. Your exam is now complete, the system will automatically return to the LOGO screen.

Figure 2-15 Review Calculations Screen

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Record Management 3-1 (3) Record Management The GDxVCC saves patient information and exam results. This chapter describes how to access and manage this information.

Select Patient Record This section describes how to select a patient record previously stored in the GDxVCC database. Once a patient is selected, the patient’s information may be viewed and changed as described in Manage Patient Information (page 3-3), and exams for that patient can be selected for reviewing, printing, exporting, and deleting, as described in Manage Patient Exams (page 3-4). Select Existing Patient at the LOGO screen. At the SEARCH FOR PATIENT screen (Figure 3-1), click View Full List and you will see a display of all patients currently stored in the database. You can scroll through the list until you find a patient or search for a patient directly. Direct Patient Search If you know the patient name or ID, the quickest way to select the patient is to enter this information into fields on the SEARCH FOR PATIENT screen. Use the Tab and Shift-Tab keys to move between fields. The currently selected field is shaded reddish-brown. As each character is entered, the database will sort to and display the first of all the patients that meet the criteria defined by the input so far. As each additional character is entered, the database will be sorted more specifically until sufficient characters have been entered to display the specific patient of choice.

Figure 3-1 Search for Patient Screen

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Record Management While entering characters in any of the fields, the View Full List button may be selected. The system will automatically display the PATIENTS LIST screen, starting with the first patient meeting the criteria of the characters entered up to that point. If the information on the SEARCH FOR PATIENT screen is not what is desired, select Clear to begin the selection process again. Once the desired patient is selected, press OK (9) and the system will display the PATIENT INFORMATION screen. Scrolling the Full List If you wish to scroll through the entire list, select View Full List to display the PATIENTS LIST screen (Figure 3-2). Select Previous, Next, Page Up, Page Down to move through the list until you select the patient of interest. You may also use the up and down arrow keys and the Page Up and Page Down keys on the keyboard. You may select Sort By to change the field by which the list is ordered (Patient ID, Patient First Name, Patient Last Name, or Doctor). The PATIENTS LIST screen will remain in this sort order until a new sort is performed. Once the desired patient is selected, press OK (9) to display the PATIENT INFORMATION screen.

Figure 3-2 Patient List Screen

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Record Management 3-3 Manage Patient Information The PATIENT INFORMATION screen presents the patient information stored in the database (Figure 2-2). From this screen, the options are Full Exam, Screen, Review, Edit and Delete. Full Exam For a Full Exam, a full analysis of results will be performed and the exam will be saved. The number of remaining Full Exams on the AccessCard may be debited, depending upon what plan you purchased. See Scan Procedure on page 2-4 for details on conducting a full exam. Screen For a Screening Exam, an abbreviated analysis of results will be performed, and the exam will not be saved. The number of remaining Screenings on the AccessCard may be debited, depending upon what plan you purchased. See Appendix A: Screening Exams for details on conducting a screening exam. Review At the PATIENT INFORMATION screen, select Review to display the MEASUREMENTS LIST screen for the selected patient. Each measurement is of one eye. The next step is to select one or more measurements. For a typical exam, you will select one right and one left eye. The following section explains how to select measurements and what can be done with them. Edit Patient Information At the PATIENT INFORMATION screen, select Edit to display the PATIENT IDENTIFICATION screen. To select the information fields you wish to edit, use the Tab key to move down the screen, and the Shift+Tab keys to move up the screen. Use the keyboard to correct/update information. When you have completed editing the PATIENT IDENTIFICATION screen, press OK (9) and the subsequent patient information screens will be displayed for editing. Continue to edit as appropriate. Refer to Setup New Patient on page 2-2 for additional details on editing the patient information. When you have completed all the desired editing by completing all the screens available to edit, or you have pressed Done, confirm or reject the changes. You will return to the PATIENT INFORMATION screen. Delete Patient and Exams At the PATIENT INFORMATION screen select Delete and press OK (9) to delete the selected patient and all of that patient’s exams. The system will return to the LOGO screen.

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Record Management Manage Patient Exams Select Measurements The MEASUREMENTS LIST screen (Figure 3-3) allows you to select one or more patient measurements. You can review these on screen, create reports, export, or delete. To select measurements, first highlight one by using the Previous or Next buttons to scroll up and down the list. A highlighted measurement is indicated by a surrounding dotted box and a selected measurement has a blue background. Only one measurement is highlighted at a time. Use Select/Deselect to change whether or not the highlighted measurement is selected. This allows you to select more than one measurement. As a measurement is highlighted, a thumbnail image is displayed in the upper right of the display. This display shows a larger image area than is visible in other screens, including the macula area as well as the ONH, and thus may be helpful in understanding the patient’s exam printout as discussed in Chapter 4: Reports. You can also review full images in the MODIFY ELLIPSE screen. On the MEASUREMENTS LIST screen, measurement types are identified by a small icon at the left of the screen. Standard (cornea compensated--VCC) image icons are green; Fixed compensation (FCC) icons are gray with the word “Fixed” to the right; and Cornea image icons are yellow.

Figure 3-3 Measurements List Screen

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Record Management 3-5 On Screen Exam Review Select up to two measurements for on-screen review. Usually one right (OD) and one left (OS) measurement from the same visit will be selected, representing a patient exam. It is also possible to select a single eye, or two left or two right eyes.

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Note: You cannot review together images of different types, e.g., VCC images cannot be reviewed with Cornea images. Select Review and the system will display the selected measurement results on the REVIEW CALCULATIONS screen (Figure 3-4).

Figure 3-4 Review Calculations Screen At the REVIEW CALCULATIONS screen you may select: • Print to print a standard (default) report for the displayed exam (see Report Formats). • Export to export the displayed exam to a computer over the network, as described under Print/Export Exams on page 3-6. • Print & Export Options to select options including print two copies, extended report, and export raw data. • Serial Analysis Options to go to the Measurement List dialog to create a Serial Analysis or Advanced Serial Analysis report (based on the type of images selected) without having to close the current patient session.

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At the IMAGE CHECK screen you may review the TSNIT graphs and the thickness maps, as well as the parameter table of values computed from the thickness maps and how they compare to the normative database (see Chapter (4) Reports for detailed information). Press OK (9) to return to the MEASUREMENTS LIST screen.

Print/Export Exams GDxVCC provides multiple report formats for printing and exporting. See Chapter 4: Reports for information on different report formats and their components. With the desired measurements selected at the MEASUREMENTS LIST screen (see Select Measurements page 3-4), you may print and/or export the measurements without reviewing them on screen, or review the measurement(s) on screen and then print and/or export them. If you wish to review the exam on screen before print and/or export, select Review. The REVIEW CALCULATIONS screen will be displayed for RNFL measurements, and the IMAGE CHECK - MEASURING CORNEA screen will be displayed for cornea measurements. When finished reviewing, select either Print, Export, Print & Export Options, Serial Analysis, or Save Only (for newly-acquired images) or Image Check (for previously-acquired images).

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Note: If a network destination has not been set up or selected, see System Tests on page 5-5 before exporting. Otherwise, export to a floppy disk or system directory. If you wish to print and/or export exam(s) without review, at the MEASUREMENTS LIST screen select Print and Export Options. If you have selected two, three or four exams of the same eye, you will receive a Serial Analysis or Advanced Serial Analysis when you select Print or Export.

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Note: You can create a Serial Analysis or Advanced Serial Analysis report from the MEASUREMENTS LIST screen. The MEASUREMENTS LIST screen is accessible from the REVIEW CALCULATIONS screen or by selecting Review from the PATIENT INFORMATION screen. Each exported report includes several files with various formats. One .jpg file is provided for each fundus image and thickness map in the report. The .svg and .html files contain the entire report for viewing. These files can be viewed by installing SVGViewer, a free application provided by Adobe. For additional information or to obtain the software, contact a Carl Zeiss Meditec service representative or Adobe on the Internet: http://www.adobe.com. Export Raw Data The Export Raw Data option will export the data files to a Windows PC. The raw data files will be exported to the currently selected network location under a subfolder labeled ‘DatabaseExport.’ If the network is not configured, the user can save the files to the hard drive or floppy. For more information about using a network destination, see Appendix (C): Importing, Exporting, & Printing Data via a Network.

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Reports 4-1 (4) Reports This chapter presents explanations of report content (Report Content) and information about report formats (Report Formats). For assistance with interpretation of results, refer to your GDxVCC Primer.

Report Content The following are descriptions of the components used in various reports. Results are based on data extracted from the area defined by the Calculation Circle. Calculation Circle The Calculation Circle defines the area where data is acquired for the TSNIT parameters. The data acquired in this area also affects the NFI calculation. The Calculation Circle appears on reports, and is described in Calculation Circle on page 2-12. Fundus Image The Fundus Image is a reflectance image depicting a 20° x 20° image of the posterior pole of the eye. GDxVCC utilizes more than 16,000 data points from the scan area to produce and display the Fundus Image showing the optic nerve head. This image allows the initial quality evaluation of the scan to determine if it is adequate for further analysis and is used for centering the ONH ellipse. For information on image quality, refer to Image Quality on page 2-7. RNFL Thickness Map The Retinal Nerve Fiber Layer (RNFL) Thickness Map is a color map depicting the different RNFL Polarimetric Thickness levels in the 20° x 20° area surrounding the optic nerve head (ONH). This image presents the unique results provided by scanning laser polarimetry—the retardance of the RNFL measured during a scan. Polarimetric Thickness is represented using a rainbow color scale, with dark blue being thinnest (less retardance) and generally bright red being thickest (more retardance).

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Note: For conceptual clarity, the output of the GDxVCC analysis is expressed in polarimetric microns and called Polarimetric Thickness. However, the actual quantity being measured through polarimetry is birefringence, which is affected by not only thickness but also by retinal tissue structure. Therefore, Polarimetric Thickness is not to be compared to anatomical thickness measured by other devices. A typical normal pattern is characterized by bright yellows and reds (thicker) in the superior and inferior sectors, and greens and blues (thinner) in the nasal and temporal sectors. Deviations from normal may reflect: • Lack of the typical RNFL distribution. • A diffuse loss of RNFL resulting in blue areas where you would normally expect yellow or red. • Focal defects, or areas of concentrated dark colors. • Asymmetry between the superior and inferior quadrants. • Asymmetry between right and left eye.

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TSNIT Graph The Temporal-Superior-Nasal-Inferior-Temporal (TSNIT) graph displays the normal range (shaded area) and the patient’s values (dark line) of Polarimetric Thickness developed from the data obtained along the Calculation Circle. The left side of the TSNIT graph starts the plot from the Calculation Circle, beginning at the temporal side of the retina. As the map progresses to the right it plots the Polarimetric Thickness values obtained by tracing around the Calculation Circle, passing through the Temporal, Superior, Nasal, Inferior, and then back to the Temporal positions.

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Note: Although the TSNIT graph provides a quick, easy look at how a patient compares to normal, it must be recognized that this analysis is based only on the data points within the Calculation Circle. TSNIT Symmetry Graph This graph matches and overlays the individual TSNIT graphs of the right and left eye to allow for better visualization of asymmetry. On this graph, look for differences between the right and left eye with regard to Polarimetric Thickness and TSNIT shape and placement. TSNIT Comparison Graph This graph matches and overlays the individual TSNIT graphs of two right or two left eye scans to allow for analysis of change between visits. On this graph, look for the degree of overlap between the two scans on the same eye. TSNIT Serial Analysis Graph This graph matches and overlays the individual TSNIT graphs of the same eye (either right or left) of the patient scanned at two, three, or four different visits to allow for visualization of change over time. On this graph, look for the presence (or lack) of change in Polarimetric Thickness, as well as the amount of thinning, if present, over time. Trend Analysis with Probability Graph The Trend Analysis with Probability graph presents an analysis of the changes over time of the TSNIT measurements and the NFI, over two, three or four different visits. It is designed to facilitate interpretation of the rate of change between visits. Deviation from Normal Map This map shows how the patient’s RNFL measurements compare with values derived from the normative database. Small color-coded squares indicate the amount of deviation from normal at each given location and are presented over a black-and-white fundus image to provide a visual frame of reference. A color legend defines the statistical significance of deviation from normal using p-values.

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Reports 4-3 Deviation from Reference Map This map highlights change in RNFL measurements since the first visit in a series for a given eye. Points or areas highlighted in color indicate possible clinically significant changes. The color legend defines change in 20 micron increments.

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Note: In Advanced Serial Analysis, this same map has the name Difference from Baseline. TSNIT Parameters This table presents parameters computed from the Calculation Circle and compared to similarly computed values from the normative database. They are color coded to indicate deviation from normal (based on p-values).

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Note: The parameters listed on the first page of the printout were determined to be the most effective in helping doctors differentiate glaucoma patients from normal patients. These values should be evaluated together and in conjunction with all other clinical information for the patient. The TSNIT Parameters Table is populated by the following parameters: TSNIT Average: This parameter evaluates the average Polarimetric Thickness in the Calculation Circle. Superior Average: This is the average of all pixels in the superior 120 degrees of the Calculation Circle. Inferior Average: This is the average of all pixels in the inferior 120 degrees of the Calculation Circle. TSNIT Standard Deviation: This number represents the standard deviation of the values contained in the Calculation Circle. The higher the number, the greater the modulation of the double-hump pattern. Inter-Eye Symmetry: This is the correlation of corresponding points in the TSNIT data for right and left eyes. The closer the ratio is to 1.0, the more symmetric the nerve fiber layer. Because this is a right-left eye comparison, there is only one resulting value, rather than one for each eye as in the other parameters. Therefore, if two right, two left, or only one eye is evaluated, this value is not shown. Difference from Baseline These values appear in the NFL Analysis table of the change analysis reports (Serial Analysis and Advanced Serial Analysis). The Diff. (Difference) column in the NFL Analysis table reports the absolute change from baseline value for each TSNIT parameter. Change % from Baseline These values appear in the NFL Analysis table of the Advanced Serial Analysis report only. The Change column in the NFL Analysis table reports the percent change from baseline for each TSNIT parameter. NFI (Nerve Fiber Indicator) The NFI is an indicator of the likelihood that an eye has glaucoma. Image data from normal and glaucomatous eyes were used to train an artificial intelligence algorithm designed to optimize the difference between eyes with normal and abnormal RNFL.

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Reports Patient scan data obtained from within and outside the Calculation Circle are evaluated based on these criteria to generate the NFI. The NFI is displayed as a number between 0 - 100. The higher the NFI, the more likely the patient has glaucoma. This is not an indicator of disease severity or progression. While there are exceptions, generally the following scale can be used as a guideline in considering the NFI: < 30 30 – 50 > 50

low likelihood of glaucoma glaucoma suspect elevated likelihood of glaucoma

The NFI is dependent upon proper ellipse placement centered over the ONH. Change in the ellipse position may affect the NFI. Extended Parameters The Extended Parameters include alternative parameters that are generally less frequently used in clinical practice than those presented in the TSNIT Parameters Table. They are provided to allow comparison to data from exams conducted with earlier versions of the GDx. These parameters are available only by selecting Extended Print on the PRINT & EXPORT OPTIONS screens. These parameters will appear as a second page of the active report format. (* indicates parameters that also appear on Page 1.) *The Number: see NFI (Nerve Fiber Indicator). Symmetry: Ratio of the average of the 210 thickest measurements in the superior quadrant over the average of the 210 thickest measurements in the inferior quadrant. The closer the ratio is to 1.0, the more symmetric the nerve fiber layer of the superior and inferior quadrants (Superior quadrant ÷ Inferior quadrant). Superior Ratio: Ratio of the average of the 210 thickest measurements in the superior quadrant over the average of the 210 median measurements in the temporal quadrant (Superior quadrant ÷ Temporal quadrant). Inferior Ratio: Ratio of the average of the 210 thickest measurements in the inferior quadrant over the average of the 210 median measurements in the temporal quadrant (Inferior quadrant ÷ Temporal quadrant). Superior/Nasal: Ratio of the average of the 210 thickest measurements in the superior quadrant over the average of the 210 median measurements in the nasal quadrant (Superior quadrant ÷ Nasal quadrant). Max. Modulation: This parameter provides an indication of the difference between the thickest parts of the nerve fiber layer and the thinnest parts. The higher the number, the greater the difference between the thickest and thinnest parts of the nerve fiber layer. In a normal eye, where the superior and inferior nerve fiber layer is much thicker than the nasal or temporal nerve fiber layer, the modulation number will usually be greater than 1. Superior Maximum: The average of the 210 thickest measurements in the superior quadrant. Inferior Maximum: The average of the 210 thickest measurements in the inferior quadrant. Ellipse Modulation: Like Max Modulation, Ellipse Modulation is an indication of the difference between the thickest and thinnest parts of the retinal nerve fiber layer. Rather than using all of the

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Reports 4-5 points in the image, Ellipse Modulation uses only the data points along the data ellipse surrounding the optic nerve. Normalized Superior Area: This parameter examines the modulation in the data ellipse, but only in the superior portion. A high value represents high modulation as seen in normal eyes; a low value represents low modulation as seen in eyes with RNFL loss. Normalized Inferior Area: This parameter examines the modulation in the data ellipse, but only in the inferior portion. A high value represents high modulation as seen in normal patients; a low value represents low modulation as seen in patients with RNFL loss. *Ellipse Standard Deviation: see TSNIT Standard Deviation. Discriminant Analysis: Only available for Fixed Mode exams, refer to your previous manual for information. *Ellipse Average: see TSNIT Average.

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Report Formats This section describes the various report formats available with GDxVCC, the details of each component are described in Report Content. Two basic types of report exist: Nerve Fiber Analysis and Serial Analysis. Space for comments, signature and date are provided. Format Nerve Fiber Analysis (Single Eye or Symmetry)

Serial Analysis (FCC or SCC scans)

Advanced Serial Analysis (VCC scans only)

OD or OS or both

OD or OS

OD or OS

RNFL thickness map

9

9

9

TSNIT graph

9

9

9

Deviation from normal map

9

9

9

Deviation from reference (baseline) map

9

9

9

TSNIT parameters table and NFI

9

9

9

9

9

Format Content Fundus image

Difference from Baseline % Change from Baseline

9

Trend Analysis with Probability Graph

9 Table 4-1 Printout Format Contents

Nerve Fiber Analysis Nerve Fiber Analysis reports include a Fundus Image, RNFL Thickness map, TSNIT Parameters Table, NFI, TSNIT graph and Deviation from Normal map for each eye. Figure 4-1 presents an example of a report showing a patient’s right and left eyes. The middle TSNIT graph contains data from both eyes to facilitate assessment of symmetry between the two eyes. The Inter-Eye Symmetry parameter appears only in this report. Figure 4-2 presents an example of a report for a single eye, showing exam results and how they compare with the normative database. Serial Analysis The Serial Analysis printout (Figure 4-3) displays a selection of up to four scans of the same eye chronologically (from top to bottom) to help track RNFL changes over time. This report presents an RNFL thickness map, Deviation from Normal map, Deviation from Reference map, TSNIT Parameters Table and NFI for each eye. In addition, a combination TSNIT graph provides an overlay showing the TSNIT values for each eye as a different colored line. The exam at the top of the report is considered the baseline measurement for the selected serial analysis. The Deviation from Reference map for each additional measurement (after baseline) illustrates changes from baseline. The TSNIT Parameter Table also contains a difference column (from baseline).

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Note: If the comparison scans do not align well, see Alignment Options on page 5-10.

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Reports 4-7 Advanced Serial Analysis The Advanced Serial Analysis printout (Figure 4-4) displays a selection of up to four scans of the same eye chronologically (from top to bottom) to track RNFL changes over time. It includes all the features of the Serial Analysis printout, plus a more detailed analysis of change in the parameters from the baseline, in the form of: • A Trend Analysis with Probability graph, which presents an analysis of the changes over time of the TSNIT measurements and the NFI. • Tables for each follow-up scan showing the changes in the TSNIT averages in polarimetric microns and in percent change from the baseline.

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Note: Difference from Baseline, found in this analysis, is the same as Deviation from Reference found in other analyses.

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Note: If the comparison scans do not align well, see Alignment Options on page 5-10.

Alignment Options If scans used for Serial Analysis or Advanced Serial Analysis are not well aligned, you should examine the Compare Alignment Options function. For details, see Alignment Options on page 5-10.

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Reports

Figure 4-1 Symmetry Printout

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Figure 4-2 Nerve Fiber Analysis: Single Eye Printout

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Figure 4-3 Serial Analysis Printout (Simulated)

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Figure 4-4 Advanced Serial Analysis Printout

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System Management 5-1 (5) System Management This chapter presents information about the system management of the GDxVCC, including security options, network configuration, system tests, database management and software upgrades.

Using Security Mode The GDxVCC provides an optional security mode feature which helps to protect the privacy of patient data, and also helps to prevent unauthorized access to the system. For an overview of security mode, see Security Mode Setup on page 1-7. This section contains step-by-step procedures for setting up and using security mode. To setup security mode, the Administrator must first enable security mode, and then setup user names and passwords for all doctors who will use the system. Subsequently, users can log on, possibly change their passwords, and log out. It is possible to disable and re-enable security mode at any time, if desired. The step-by-step procedures for all of these activities are shown in this section. To Enable Security Mode for the First Time Use this procedure to enable security mode, when security mode has never been enabled previously on this GDxVCC. (If you need to re-enable security mode, see the procedure To Re-enable Security Mode on page 5-4.) 1. From the LOGO screen, select System. 2. Select Security Setup. 3. The SECURITY OPTIONS screen appears. Select Security. 4. The SECURITY screen appears. Select Enable. The Security Enabled dialog appears. Press OK (9). 5. The SECURITY OPTIONS screen appears again, Select Log Out. When prompted, “Are you sure you want to log out the current user?”, press OK (9). 6. The LOGON screen appears, with text boxes for User Name and Password. For the User Name, enter ‘admin’. Leave the Password blank. Press OK (9). 7. The Password screen appears, with text boxes for Current Password, New Password, and Reenter New Password. Leave Current Password blank. Choose an administrator password and write it down. Enter the password in the boxes for New Password and Reenter New Password. Press OK (9).

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Note: Make sure you write down the Administrator password and put it in a safe place. If you lose your Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. 8. You are now logged on as the Administrator. At this point, you can setup user names and passwords for all other users of the GDxVCC. See the procedure, To Setup User Names and Passwords below. To Setup User Names and Passwords Use this procedure to setup user names and passwords for the doctors who will use the GDxVCC. When security mode is enabled, each user must enter their user name and password when they log onto the system.

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Note: To setup or modify user names (and initial passwords), you must be logged on as the Administrator. If you lose your Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. 1. If you are not currently logged on as the Administrator, log onto the system by entering ‘admin’ as the user name and specifying the Administrator password. 2. From the LOGO screen, select System. 3. The SYSTEM OPTIONS screen appears. Select Doctor Information. 4. The USER LIST screen appears. If you wish to create a user name and password for a doctor who has already been entered into the system, highlight the name of the doctor in the list and select Modify User. If you wish to enter a user name and password for a new doctor (who isn’t already shown in the user list), select Add User. 5. The USER INFORMATION screen appears. All fields in this screen are required to be filled in. Enter the user name and password, and then re-enter the password, as shown in Figure 5-1 below.

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Note: As the screen indicates, you are specifying the GDx user name and password. This is different from the network user name and password that the Administrator needs to setup in a networked environment (e.g. a clinic where Windows PCs and GDxVCCs are attached to a local area network). The GDx user name and password allows a doctor to log onto the GDxVCC. The network user name and password (which is described in Appendix C: Importing, Exporting, & Printing Data via a Network), allows the GDxVCC to log onto a Windows PC over the network.

Figure 5-1 User Information Screen

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System Management 5-3 6. Optionally, click Clinic Info, and enter or modify the clinic information for the doctor. 7. When you have finished entering the user information, select Save. You are notified “User Logon information was added to the database”. Press OK (9). 8. You must log out before the new user names and passwords will take effect. To Change the Password for the Current User Use this procedure to change your password. 1. Log onto the system using your current user name and password. 2. From the LOGO screen, select System. 3. Select Security Setup. 4. The SECURITY OPTIONS screen appears. Select Password. The Password screen appears, as shown in Figure 5-2 below.

Figure 5-2 Password Screen 5. Enter your current password, and then enter your new password twice, as indicated. Be sure to write down your new password. Press OK (9). 6. If the password was changed successfully, you are prompted “Your password has been updated. Your old password will no longer be valid.” Press OK (9).

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To Log Out Use this procedure to log out, so that no other user can access the GDxVCC without entering a valid user name and password. 1. From the LOGO screen, select System. 2. Select Security Setup. 3. The SECURITY OPTIONS screen appears. Select Log Out. You are prompted, “Are you sure you want to log out the current user?” Press OK (9). To Disable Security Mode Use this procedure to disable security mode. After performing this procedure, users will no longer be required to enter user names and passwords to use the GDxVCC. Also, safeguards will no longer be in place to protect patient data privacy when the GDxVCC is used by multiple doctors.

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Note: To disable security, you must be logged on as the Administrator. If you lose your Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. 1. When you startup the GDxVCC—or when you log on—you are asked for a user name and password. (If you are not asked for a user name and password, then security is not currently enabled.) Enter ‘admin’ for the user name, and then enter the administrator password. 2. From the LOGO screen, select System. 3. Select Security Setup. 4. The SECURITY OPTIONS screen appears. Select Security. 5. The SECURITY screen appears. Select Disable. 6. The SECURITY OPTIONS screen appears again. Press OK (9). To Re-enable Security Mode Use this procedure to re-enable security mode, where you previously enabled security mode and then disabled it. (If you need to enable security mode for the first time, see the procedure To Enable Security Mode for the First Time on page 5-1.)

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Note: You must know either the administrator password and/or the user name and password of a user in order to log onto the system once security mode is re-enabled. If you lose your Administrator password, call CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. If you forget the user name and password for a normal user, ask the Administrator to retrieve that information from the USER INFORMATION screen, shown in the procedure To Setup User Names and Passwords on page 5-1. 1. From the LOGO screen, select System. 2. Select Security Setup. 3. The SECURITY OPTIONS screen appears. Select Security. 4. The SECURITY screen appears. Select Enable. 5. The SECURITY OPTIONS screen appears again, Select Log Out. When prompted, “Are you sure you want to log out the current user?”, press OK (9). 6. The LOGON screen appears, with text boxes for User Name and Password. Enter a user name and password that was setup the last time security was enabled. If you enter ‘admin’ as the user name, you must know the Administrator password. Press OK (9).

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System Management 5-5 System Tests System tests verify that your system is operating correctly. As a part of the tests, the software will verify that the calibration is consistent over time. Some system test measurements are classified as “critical.” Failure of these critical tests will cause image acquisition to be disabled. Automatic System Test The automatic system warm up is set to run each day when the unit is first turned on. If your system is left on overnight (not recommended), it will run at 2:00 am each day. The test usually takes several minutes. If the unit is cold (i.e. if the unit was transported from another office) it may take up to 30 minutes for the system to “warm-up” and pass the system test. During the test, the clock in the upper left of the WARM UP screen counts up the time from the start of the test, and the light blue dot continuously repeats moving across the screen, left to right, indicating the test is in progress. If there are no errors, GDxVCC will start up normally. If there are any errors the startup procedure will stop and a screen will be displayed with a list of the errors. If any of the errors are critical and affect scan acquisition, acquisition mode will be disabled. If this happens you will be directed to the next step through the ERROR LIST screen. User Initiated Tests System Test If you feel your system is not operating properly, it is recommended that you run the System Test prior to calling CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. Information on whether or not the system passed the System Test will be helpful to your CZM service representative. To run the System Test, at the LOGO screen select System, More, System Test, and System Test again. The System Test will run one time and progress during the test is displayed on the LCD Display. The System Test may be stopped at any time by pressing Cancel/Go Back (8). If the test is cancelled before the end of the test, the system may take up to a minute before testing actually stops.

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On completion, if there were no errors the software will display that the test is complete, press OK (9) to return to the LOGO screen. If there were errors or if the test was terminated before completion, errors will be displayed on the SYSTEM ERROR LIST screen (Figure 5-3). Additional information to display is indicated by the scroll bar below the list of errors.

Figure 5-3 System Error List screen Continuous Test If you suspect that your system is intermittently demonstrating a problem, it is recommended to run the Continuous System Test for a period commensurate with the period between suspected problem occurrences. Continuously passing the system test over that suspect period indicates that the system operation is stable. To run the System Test continuously, at the SYSTEM TEST screen select Continuous. The System Test will run until Cancel/Go Back (8) is pressed. If the test is cancelled before the end of a full test sequence, the system may take up to a minute before testing actually stops. Once you end the test, errors will be displayed on the SYSTEM ERROR LIST screen. Additional information to display is indicated by the lightly shaded portion(s) of the horizontal scroll bar below the list of errors. Button Test To test the function and control buttons and their backlights, select Button Test at the SYSTEM TEST screen. When this test is initiated, GDxVCC will step the user through a button test, one button at a time. The system will light each button in sequence, and display an instruction on the LCD Display to press the lighted button. When instructed, press the scan acquisition button on top of the joystick. At the completion of the test the LOGO screen is displayed.

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Note: If you press the wrong button, the test results will be invalid and the failure dialog will appear. The system will return to the LOGO screen and you should repeat the test.

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System Management 5-7 Disk Backup Options The system saves data to both a primary and a backup hard disk drive for data safety. If one of the hard drives fails, it will need to be replaced. While the hard drive is being replaced, GDxVCC may still be used to acquire scans. In this instance, the normal procedure to store the data on two hard drives will be turned off. To turn the Backup Options off, at the LOGO screen select System, then Backup Options. At the BACKUP OPTIONS screen, select Turn Backups Off. The system will display a warning message informing you that exam data acquired in this mode will not be backed up. Press OK (9) and you will return to the LOGO screen.

Figure 5-4 Backup Options screen When the second hard drive is reinstalled and GDxVCC is powered up, the presence of both drives is sensed and the backups are enabled automatically. If data was saved when the system contained only one functioning hard drive, the system will update the replaced hard drive with the data acquired while it was absent. When the system is powered up after replacing the hard drive, you will automatically be prompted to copy the master (top) drive contents to the backup (bottom) drive (see Sync Disks on page 5-9).

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Database Options The Database Options allow the user to optimize database performance, merge the exam files between the two hard drives, and synchronize all data, databases, application files, and the operating system. Optimize As with any computer-based system, the more reading and writing to and from a database, the more the data becomes fragmented on the hard disk. Therefore, the performance of these operations will slow over time. The system is routinely optimized during the system warm up. Only run the Optimize function at the recommendation of the CZM Service department. At the LOGO screen select System, then Database, then Optimize. GDxVCC will optimize the database and return to the LOGO screen automatically.

Figure 5-5 Database Options screen Merge

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IMPORTANT: Merge is not a general purpose, database administration tool. It cannot be used to merge two different databases from two different GDxVCC systems without first contacting CZM. Merge is protected by a password, which can be obtained only by calling CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. Merge is used to merge the database files from the backup drive to the main drive. Normally, the main and backup drives contain identical data. Merge should only be necessary when the backup drive contains data that is not present on the main drive. This could occur if you have multiple GDxVCC units and you wish to have all patient

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System Management 5-9 exams on all units, or if one of the two hard drives was out of service and needed to be updated with the exams stored on the other drive during the out of service period. To perform the Merge operation, at the LOGO screen, select System, then Database, then Merge. You will see the CZM OPTIONS PASSWORD screen. This screen will instruct you to call CZM service for a password. Coordinate with the CZM service representative for the remainder of the Merge operation. If the system is unable to merge a patient record because of differences between the main database and backups on the system, you will be prompted to replace the record. There are four ways to replace that record: • Main Record: The two records belong to the same patient, and the main record is more correct. • Backup Record: The two records belong to the same patient, and the backup record is more correct. • Main Change Patient ID: The two records have the same patient ID, and the main record belongs to different patient. Assign a new patient ID number to the main record. • Backup Change Patient ID: The two records have the same patient ID, and the backup record belongs to different patient. Assign a new patient ID number to the backup record. If during a Merge operation, a patient ID conflict occurs the system will display the UPDATE PATIENT ID – DATABASE MERGE screen. Enter an appropriate ID for the patient. Press OK (9) and the LOGO screen will be displayed. Sync Disks Sync Disks is used to make the backup drive identical to the master drive. This includes databases, application files, and operating system. Everything on the backup drive will be overwritten such that it is contains identical information as the main drive. As a precaution, if the main drive and backup drive contain different versions of GDx software, disk synchronization cannot be performed.

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Note: Sync Disks will overwrite all data on the backup drive with data from the master drive. This feature should not be used unless instructed by an CZM Service Representative. Recalculate Data All records in the database will be updated with the most current version of calculations. This function may be performed after a software update and may take a while depending on the number of records in the database. Export Data Selecting Export Data exports all the information required to regenerate the database. If security is enabled, only the data for the doctor who is currently logged on will be exported. Import Data Selecting Import Data imports the data into the current systems database. If security is enabled the database is imported to the database for the doctor who is currently logged on. Importing only imports updated or new database records. All calculation records are recalculated prior to saving into the database.

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Software Update You may receive update disks from CZM with directions to insert a floppy disk and turn on power. This is the preferred technique for updating software. This technique does not use the Software Update function which appears on the ADDITIONAL SYSTEM OPTIONS screen.

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IMPORTANT: Software Update is not a general purpose function and should not be used without direction from CZM personnel.

Alignment Options If scans used for Serial Analysis or Advanced Serial Analysis are not well aligned, you should examine the Compare Alignment Options function. At the LOGO screen, select System, More, More then Compare Alignment. The COMPARE ALIGNMENT OPTIONS screen (Figure 5-6) is displayed and allows setting up the type of alignment when performing a serial analysis or advanced serial analysis of images of the same eye over time. The default settings are Image Alignment and Image Rotation.

Figure 5-6 Compare Alignment Options screen Difficulty with image alignment may be noted by: • The ONH Ellipse is not positioned in the same location on the different exam fundus images (only if Ellipse Alignment option is selected). • Some Deviation from Reference maps have large black borders on one or more edges, usually thicker at one end of the edge than at the other. • Excessive color appears to be displayed in the Deviation from Reference maps. If you have noticed misalignment of the images on a serial analysis report format, alter the default settings as described below to obtain improved alignment. When finished making your selections, press OK (9), and the selections will be saved until they are changed at a later time. The LOGO screen will be displayed.

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System Management 5-11 The choices on the COMPARE ALIGNMENT OPTIONS screen to select from are: XY Alignment options: • No Alignment to deactivate XY alignment. Only use this option if all other alignment types fail. • Ellipse Alignment to have GDxVCC align the scans based on the position of the ellipse on each scan. As the user sets the position of the ellipse, almost any position of XY alignment may be achieved with this option. • Image Alignment (the default) to have GDxVCC align the scans based on features in the scans. If this option is successful, it provides the best XY alignment automatically. Rotational Alignment options: • No Rotation to deactivate rotational alignment. Only use this option if Image Rotation failed. • Image Rotation (the default) to perform rotational alignment based on features in the scans. If this option is successful, it provides the best rotational alignment, automatically.

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Care, Maintenance & Transportation 6-1 (6) Care, Maintenance & Transportation What to do for GDxVCC Always handle the GDxVCC with care. Always select a location for your GDxVCC that allows easy access for both patient and technician. Always operate the GDxVCC from a power source as specified. This source should be a dedicated line. Use of a power source other than indicated on the unit will shorten the life of the unit and may cause damage in addition to improper operation. Always operate the GDxVCC with the power cord inserted into a standard three-prong power outlet that is correctly grounded through normal wiring. Always route electrical cables with safety as the first concern. Always unplug the GDxVCC before moving the GDxVCC, opening the panels or inserting and replacing the removable hard drive. Always let the GDxVCC reach room temperature before it is powered up. This is particularly important if the GDxVCC was exposed to temperature extremes. Always operate the GDxVCC within the following working ranges of temperature and humidity: • Ambient Temperature: 65° F - 75° F (18° C - 24° C). • Ambient Humidity: 20 - 60% Always unplug the GDxVCC before cleaning the plastic body panels or LCD screen. If the LCD or other body panels require more than a dusting, apply a mild household cleaner to a soft cloth to clean them. Always clean the patient contact surfaces of the face mask with alcohol pads prior to each use. Other Recommendations • • • •

Use a UPS (Uninterrupted Power Supply) to protect data from power failures. Always place the lens cap over the patient lens when not in use. Use the CZM carrying case if transporting the GDxVCC. Wrap the GDxVCC in a plastic bag while the unit is in the carrying case to protect the optics from dust.

What not to do for GDxVCC Never lift the GDxVCC by the face mask or joystick. Never transport the GDxVCC without locking down the optics head. Never subject the GDxVCC to temperatures below 32° F (0° C) for more than 15 minutes. Prolonged exposure to freezing temperatures may require excessive time to warm up that could prolong the System Test procedure at power up beyond 30 minutes. Never position the GDxVCC in direct sunlight or near a direct source of heat. Never position the GDxVCC in a dusty location. Never install any software or utilities on this GDxVCC without prior approval from CZM. Any unauthorized modification to the system will void the warranty and any repair costs for damage to the GDxVCC may be billed to the customer.

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Care, Maintenance & Transportation Never remove any panels except the side panel (which covers the removable hard-drives) and the top panel (which covers the internal printer in some models) from the GDxVCC. Never clean with harsh chemicals or detergents. Never use fluids or aerosol on or near the GDxVCC. These products can damage the GDxVCC surface and affect the delicate optics. Never attempt to change any of the batteries in the system. Attempting to change a battery can cause damage and loss of data.

Cleaning the Objective Lens Clean the objective lens inside the face mask with a small amount of alcohol on a soft cloth, cotton swab, or tissue. Rub gently in a circular motion to remove dirt or foreign matter. Do not use harsh materials or chemicals to clean this lens. Keep the lens covered with the dust cap when the GDxVCC is not in use.

Model and Serial Number Information The label model and serial number of the GDxVCC is shown on the label on the lower left of the left side of the unit (Figure 6-1).

Figure 6-1 GDxVCC Model and Serial Number Label

Replacing the Main Fuse If you have the GDxVCC plugged in to an appropriate and functional wall outlet and cannot obtain power up with the GDxVCC turned on, it is recommended to check the GDxVCC main fuse. Before replacing the main fuse be sure that GDxVCC is powered down (see Power Down on page 1-5), and that the power cord is disconnected from the unit. Gently place the GDxVCC on its left side. The fuse holder is located next to the insertion of the power cord into the power connector underneath the GDxVCC. Compress the outer tabs on the side of the fuse holder to release the fuse drawer and pull the holder out (Figure 6-2). Replace the fuse with the same type as indicated on

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Figure 6-2 Removing the Main Fuse CAUTION: Always replace fuses with fuses of the same type or rating. Failure to do so may create a fire risk.

Removing Hard Disk Drives The two hard disk drives in GDxVCC should not be removed without contacting your CZM service representative.

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Note: Improper removal of one or both Hard Disk Drives may result in loss of valuable data. Do not attempt to remove the Hard Disk Drives in GDxVCC without specific instructions from CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor.

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Note: The Hard Disk Drives have a warning label (Figure 6-3) to guard against removal without first removing the GDxVCC from any power source.

Figure 6-3 Hard Disk Drive Warning Label

Other Maintenance, Safety Labels Upon initial setup of your GDxVCC (Setup on page 1-2), note the caution label on the LCD display (Figure 6-4). CAUTION: Be sure to remove the objective lens foam block protector and unlock the scan head optics before applying power to the GDxVCC. CAUTION: Be sure to remove power from the external printer, if applicable, prior to powering down the GDxVCC.

Figure 6-4 Caution Label on LCD display Remove the caution label from the LCD Display prior to use of the GDxVCC. For any difficulties beyond that described within this manual, please contact CZM customer service: in the U.S., call 800-341-6968; outside the U.S., contact your local CZM distributor. WARNING: Do not open the GDxVCC (Figure 6-5).

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Care, Maintenance & Transportation 6-5 Laser Safety The GDxVCC is equipped with three different low power laser devices: • The Imaging laser - a laser diode, 780 nm wavelength, primary output power of 40mW, that emits directionally variable radiation. • The Fixation laser - a visible laser diode, 635 nm wavelength, primary output power of 5mW, that emits directionally variable radiation. • The Trigger laser - a diode laser, 650 nm wavelength, primary output power of