Heidelberg Retina Angiograph 2HRA 2Operation ManualRevision 1.1-1E, March 2003 Heidelberg Engineering GmbHPrinted in GermanyTechnical Specifications are Subject to change without noticeArt.No. 97 039-0021

The manufacturer hereby declares that this product conforms to the requirements of Directive 93/42/EEC of the Council of the European Community dated14 June 1993 regarding medical products (MDD 93/42/EEC).This product is manufactured under one or more of the following patents:US 5,170,276; DE 41 03 298 C2; EP 0 498 280 B1.Heidelberg Engineering GmbHGerhart-Hauptmann-Strasse 3069221 DossenheimTelFax06221 / 64 63 - 006221 / 64 63 62Internet: http://www.HeidelbergEngineering.deInternet: http://www.HeidelbergEngineering.comIn the United States of America:Heidelberg Engineering, Inc.Sales and Marketing1499 Poinsetta Avenue, Suite 160Vista, CA, 92083Tel (760) 598 3770 (800) 931-2230Fax (760) 598 30602Heidelberg Engineering, Inc.Technical Support410 Harris RoadSmithfield, RI 02917-1301Tel(401) 349-0500Fax(401) 349-0504

Heidelberg Retina Angiograph 2HRA 2Operation Manual

Contents12345Introduction . 31.1 Intended use . 31.2 The Heidelberg Retina Angiograph 2 . 3Contraindications, Warnings, Precautions and Adverse Events . 42.1 Contraindications. 42.2 Warnings . 42.3 Precautions. 5Installation and Safety Information . 63.1 Components of the Instrument . 63.2 Scope of delivery. 73.3 Installing the Instrument . 83.4 Instrument Safety . 93.4.1General Information. 93.4.2Laser Safety. 93.5 Care . 10General Operating Information . 114.1 Turning the Instrument On and Off. 114.1.1Turning On . 114.1.2Turning Off . 114.2 Controls. 114.2.1Touch Panel. 114.2.2Foot switch . 234.2.3Keyboard . 234.2.4Mouse . 234.2.5Focus knob . 234.2.6Filter Lever. 234.2.7Sensitivity Knob. 24Image Acquisition . 255.1 Preparation. 255.1.1Preparing the Patient. 255.1.2Preparing the Instrument . 255.2 Image Acquisition . 255.2.1Creating a new patient record . 255.2.2Creating a new examination. 265.2.3Touch Panel Settings and Patient Alignment. 275.2.4Displaying and Changing Acquisition Parameters . 285.2.5Acquiring Images. 295.3 Image Acquisition Setup. 315.3.1Scan Parameter Setup . 315.3.2Resetting the injection timers. 311

6Image Inspection and Analysis . 326.1 Image Viewing . 326.1.1Image Display . 326.1.2Image Enhancement. 336.1.3Movie Display. 346.1.4Expanding a Movie. 356.2 Image Processing. 366.2.1Computing Composite Images. 366.2.2Computing Mean Images . 376.2.3Eye Movement Correction . 386.3 Printing. 387 Technical Data . 407.1 Model Type and Manufacturer. 407.2 Environmental Specifications. 407.3 Power Supply and fuses . 407.4 Isolation Transformer for PC- components . 417.5 Laser Source . 417.6 Scanning Specifications . 427.7 PC Requirements . 437.8 Service, Maintenance and Cleaning . 437.9Labels . 447.10Disposal. 462

1 Introduction1.1 Intended useThe Heidelberg Retina Angiograph 2 is a diagnostic device for the human eye.Intended use is for the examination of the retina by laser scanning either with or without contrastagent, resp. fluorescence agent). The purpose of the angiography testing is to assist in the diagnosis of eye diseases. The diagnostic result shall provide help to the physician for adequate therapy.1.2 The Heidelberg Retina Angiograph 2The Heidelberg Retina Angiograph 2 is a confocal laser scanning system for digital fluoresceinand indocyanine green angiography. Fluorescein and indocyanine green angiography can be performed either separately or simultaneously.For acquisition of the digital confocal images, a laser beam with a wavelength suitable to excitethe fluorescent dye is focused on the retina. The laserbeam is deflected periodically by means of oscillatingmirrors to sequentially scan a two-dimensional section of the retina. The intensity of the emitted fluorescent light at each point is measured with a lightsensitive detector. In a confocal optical system, lightemitted outside of the adjusted focal plane is suppressed. This suppression increases with the distancefrom the focal plane, and results in a high contrastimage. Furthermore (especially during indocyaninegreen angiography), the confocal optical system allows the user to acquire three-dimensional imageslayer by layer, which is comparable to laser scanningtomography.The laser sources contained in the Heidelberg RetinaAngiograph 2 emit laser light of three different wavelengths: for fluorescein angiography, the blue line ofa solid state laser (488 nm) is used to excite the fluorescein. A barrier filter at 500 nm edge wavelengthseparates excitation and fluorescent light. The samewavelength (but without barrier filter) is used to create red free reflectance images. For indocyanine green angiography, a diode laser at 795 nm wavelength is used to excite the dye, while a barrier filter at 810 nm edge wavelength separates excitation and fluorescent light. A second diodelaser at 830 nm wavelength serves to produce infrared reflectance images.Several image acquisition modes are provided, i.e. pure fluorescein angiography, pure indocyanine green angiography, and simultaneous fluorescein / indocyanine green angiography. In thesimultaneous mode, each image line is scanned twice. During the first scan, fluorescein is excitedand its fluorescence is measured; during the subsequent second scan, indocyanine green is excitedand its fluorescence is measured. In every acquisition mode, individual images, time resolved image sequences, or a focal series of images (layered, three-dimensional images) can be acquired.The images are immediately digitized with a resolution between 384 x 384 and 1536 x 1536 pixels. The digitized images are stored in the computer's main memory and then saved on the computer's hard disk. The size of the field of view can be set to 15 x 15 degrees, 20 x 20 degrees, or30 x 30 degrees.3

2 Contraindications, Warnings, Precautions andAdverse Events2.1 Contraindications Be aware of possible allergic reactions when contrast or dye fluid is injected. Asked the patient for known allergies and compare it with the contraindications of thecontrast or dye fluid.2.2 Warnings4 Carefully read the instructions for use before operating the device. Misuse of the devicemay lead to hazards for patient or user or lead to wrong diagnostic results. Do not open the device component housings. Doing so can lead to the possibility of electrical shock and laser radiation. See also subsection “3.4 Instrument Safety” and “3.4.2Laser Safety” Do not use the device outside of the “Intended use” scope. Doing so may lead to malfunctions or damage of the device Do not use PCs, components or accessories that have not been approved by HeidelbergEngineering. Do not install other software programs as they may interfere with the functionality of the Heidelberg Engineering software or equipment. This could include damage to the system as well as incorrect measurement results. Do not operate the system without connecting the PC and components to an IEC 60601-1proven isolation transformer. Doing so could lead to electrical shock to the user and patient in the case of a failure of the PC or to a PC accessory. Do not use a network connection without network isolation in accordance toIEC 60601-1. In case of a failure in the network, there could be a hazard of electricalshock to the user and patient. Make sure that the environmental requirements are met when the system is operated. Exceeding environmental conditions might damage the system or lead to wrong measuringresults. (See subsection 7 “Technical Data”). Make sure the scanners are working (high pitched sound) before installing a patient infront of the device. No laser beam should be visible, when the scanners are off. A hazardfor an injury of the retina would exist if the laser beam hits the retina without beingscanned. Make sure the patient is correctly placed in front of the camera before starting the examination. Wrong positioning may lead to poor images and wrong diagnostic results. Artifacts on the images might falsify the measured results. Do not use the measured results for further treatment if there are artifacts in the images. Do make a diagnostic decision on one single examination. Always use alternativeinformation; history data etc. to assist in a final diagnostic determination.

Prepare safeguards to ensure that only authorized personnel can access the patient data.Data loss impedes follow up analyses and may result in wrong diagnostic decision. Be sure to perform periodic data backup procedures. Check the success of the backup toavoid data losses caused by backup errors. Do not operate the system directly after obvious climate changes. Let the device acclimate itself for a minimum of 2 hours to avoid device damage or wrong measurement results.2.3 Precautions The operator shall be sure that the device settings and adjustments are correct before examination and diagnostic decision. Wrong settings and adjustments may lead to poor image quality or wrong examination information. The physician shall be sure to have the correct patient data before a diagnostic decision.Mismatched patient data may lead to wrong diagnostic decisions. Read chapter “5.1 Preparation” carefully before starting the examination. Incorrect preparation of the patient may lead to poor image quality and incorrect diagnoses. Do not start an examination without informing the patient about the examination procedure. Wrong patient behavior during the examination may lead to poor image quality andincorrect diagnoses. Clean and disinfect chin rest and head rest after each examination. Contaminated partsmay lead to infections or disease contraction. Read chapter “7.8 Service, Maintenance and Cleaning” carefully. Missing maintenance orincorrect adjustment of the device may lead to poor image quality and incorrect diagnoses. Do not perform more than 1 examination per day on the same patient. Multiple injectionsof the contrast or dye fluid may lead to allergic reactions or shock. Before starting the system check the regional power supply specifications to verify thatthey fit the required tolerances (100V U 240V; 50Hz f 60Hz). Wrong powersupply conditions might lead to malfunctions of the system. Be aware that the influence of other physical effects (vibrations, strong electromagneticfields as caused by big machines etc. running close-by), might disturb the proper operating of the device. A computer failure during picture acquisition or analysis could lead to incorrect results.5

3 Installation and Safety Information3.1 Components of the InstrumentThe HRA2 system applies to the applicable standards of IEC 60601-1, IEC 60601-1-2, UL2601,and IEC 60825.The basic components of the Heidelberg Retina Angiograph 2 are the: Laser scanning cameraCamera mount with headrestTouch panelPower supply with Laser moduleComputerIsolation TransformerOperation software.The laser scanning camera is the core of the Heidelberg Retina Angiograph 2. It contains thethree-dimensional scanning system, the detector and the main part of the electronics. The solidstate 488nm laser source is located in the laser module and is coupled to the camera via an opticalfiber. The diode lasers for infrared and indocyanine green angiography are located in the laserscanning camera. The scanning laser beam emerges from the objective on the front of the camera.The intensity of the emitted fluorescent light is also measured through this objective.The laser scanning camera is mounted on a special camera mount which also contains the headrest for the patient. The camera mount is designed so that the measuring position on the ocularfundus can be selected by rotating the camera around two orthogonal axes.The control panel is used to control image acquisition. Here, the basic image acquisition parameters such as angiography type, laser intensity, detector sensitivity, size of the scanning field andposition of the focal plane are specified. The image acquisition itself is initiated from the controlpanel.The laser module contains one solid state laser. The laser light is transmitted into the laser scanning camera via one fiber optic. The laser scanning camera contains two diode lasers.The power supply supplies voltage to the laser scanning camera. The on/off switch is located onthe front panel. With the switch in position O, the power supply is turned off.The Heidelberg Retina Angiograph 2 is operated by a PC-compatible personal computer in combibnation with a IEC 60601-1 proven isolation transformer. The computer receives the image datagenerated by the laser scanning camera and performs the entire image analysis. For this purpose,special hardware is installed in the computer in addition to the Heidelberg Retina Angiograph 2operation software.The operation software includes functions to communicate with the user, to control image acquisition, to store images and data, to process and analyze the acquired images, and to document theexamination results.6

3.2 Scope of deliveryThe scope of delivery for this instrument consists of the following parts: Laser scanning cameraTouch panelFoot switchCamera mount with integrated headrestPower supply with Laser moduleFrame grabber module for installation in the personal computerCable - touch panel to power supplyCable - frame grabber module to power supplyCable - frame grabber module to cameraCD containing operation softwareSoftware protectorOperation manualPersonal computer with hard disk, floppy drive, magneto-optic drive, VGA board, colormonitor, keyboard, mouse, Microsoft Windows 2000/XP operating system.Isolation transformer with connector cables.7

3.3 Installing the Instrument(1) Assemble the headrest according to the separate set of instructions. The headrest should bemounted firmly on the table top.(2)Place the camera mount onto the sliding platform of the headrest.(3)Install the frame grabber board into the computer.(4)Assemble the computer and connect the monitor, keyboard and mouse.(5)Connect all the power cables (PC, Monitor, Printer and Power Supply) to the isolationtransformer.Caution:Do not operate the system without an isolation transformer. Doing so will void the warranty !It is not allowed to operate PC components in the patients environment without separation via an isolation transformer.(5)Connect all cables between camera, laser box and PC in accordance to the connectiondiagram shown below.Make sure that all cables are in good condition correctly inserted.8Frame grabber Signals toPC- Frame Grabber BoardRS232 interface to PC-serialport (COM1, COM2)Frame Grabber Signals fromthe cameraTouch panel interfaceCamera power supply connected to the cameraLeft- Right recognition connected to camera mountDebug and Service interface(not connected in normal operation)Expansion Interface(not connected in normal operation)Data Cable connected to thecameraFoot SwitchAC- Power Supply(110 / 230V)Metal shielded fiber connected to the cameraThe picture below shows the cable connections to the back of the Laser Box:

3.4 Instrument SafetyImportant! Before you start working with the instrument, make sure that you know the correctprocedures for turning the instrument on and off (“Chapter 4 General Operating Information”). Do not leave the patient alone with the instrument during the examination.3.4.1 General InformationThe instrument must not be used if there is a mechanical, electrical, or optical defect. Any modifications or additions which are made to the instrument must comply with the relevant legalguidelines. Any repair, especially of the instrument's electric and electronic systems, and any service work on the instrument components, must only be carried out by appropriately qualified andauthorized staff.Caution!Unusual noises and/or vibrations may be symptoms of a fault in the instrument.Please turn the instrument off and contact your local service office. Do not attempt torepair any faults with the instrument yourself.3.4.2 Laser SafetyThis instrument contains a solid state laser and two diode lasers. The instrument emits visible andinvisible laser light through the objective lens on the front of the laser scanning camera. The Heidelberg Retina Angiograph 2 is a Class 1 laser system. It does not pose any safety hazard whatsoever. The laser class label is located on the rear panel of the camera housing and the rear panel ofthe laser module:LASER CLASS 1However, hazardous laser radiation may be accessible when the camera housing or the housing ofthe laser module is open.Caution!Never open the housing of the laser scanning camera or the laser module. When thecamera housing or the laser module housing are open, visible and/or invisible laserradiation of Class IIIB is accessible and can lead to injuries. The camera housing andlaser module housing must only be opened by qualified service staff.Laser warning labels to this effect are positioned on the cover of the camera housing (underneaththe electronics card which is located there) and on the rear side of the laser module:WARNINGLASER BEAM CLASS 3B WHENOPEN AVOID DIRECTEXPOSURE TO BEAM9

To guarantee the safety of the user and the patient at all times, a limit has been imposed on themaximum period of time for which the laser beam can be switched on. If this limit is exceeded,the screen shows the message: 'Laser Safety; laser timed out'. Image acquisition is automaticallyinterrupted and can only be continued after a specified waiting period (about 3 hours). However,this will not usually occur during normal use of the instrument.3.5 CareThe Heidelberg Retina Angiograph 2 is a precision optical instrument. Please protect the instrument from dust and moisture, and avoid subjecting it to shocks or strong forces.The lens surface on the front of the camera should be carefully cleaned at regular intervals (possibly every day). For this purpose, it is best to use acetone and a soft cotton ball.The non-optical surfaces of the instrument can be cleaned and/or disinfected as usual whenevernecessary. Before doing this, please turn the instrument off and pull out the power plug.10

4 General Operating Information4.1 Turning the Instrument On and Off4.1.1 Turning OnTo turn the Heidelberg Retina Angiograph 2 on, proceed as follows:(1) Turn the computer on. After the boot sequence has been completed, the computer will startthe Windows operating system.(2) Turn on the power supply. The power switch is located on the front panel of the power supply. The 'off' position is marked O.(3) Use the Heidelberg Eye Explorer shortcut on the desktop to start the application.This will start the Heidelberg Eye Explorer software.Note:It is not recommended to turn the instrument on and off frequently. Even if you arenot using the instrument constantly during the course of a day, it is best to turn it onin the morning and not to turn it off again until the evening.4.1.2 Turning OffTo turn the Heidelberg Retina Angiograph 2 off, proceed as follows:(1) If the acquisition dialog is open and the live image is visible on the screen, stop the imageacquisition with the 'freeze' button on the touch panel and leave the acquisition dialog.(2) Turn off the power supply. The power switch is located on the front panel of the power supply. The 'off' position is marked O.Important!Never turn off the power supply while the laser scanning camera is acquiring images. This can result in damage to the camera.Never turn the computer off without quitting the Heidelberg Retina Angiograph 2operation software first. This can result in the loss of data stored on the computer's hard disk. Before you turn off your computer, select "Shut Down" fromthe Windows "Start" menu.4.2 Controls4.2.1 Touch Panel11 “Freeze” ScreenImmediately after switching on the device. “Freeze” Screen:HRA2 Acquisition Module started in Eye Explorer. Press button (0) to go to live mode (andtherefore to main screen).12 Main ScreenFA/Red Free modes are not available during warm-up (approx. ½ minute). Main ScreenFA laser warmed up. Filter in angiography mode.13 Main ScreenFA laser warmed up. Filter in Red Free / IR (reflectance) mode. Target Select ScreenPress button (13) to select this screen. Choose either the external or one of the internal targets. Toswitch off all targets, press the button for the selected target again.14 Target Select ScreenCentral internal target selected. The letters right and left of the internal target buttons show wherethe temporal (T) and the nasal (N) side are. Target Select ScreenThe T-N letters change whenever the camera head is moved to the other eye.15 Main ScreenThe selected target is indicated on the select target button. Acquire Mode ScreenPress button (10) on main screen once (twice if not active) to activate this screen. The buttonsmarked ‘b’ open a respective screen for selection of the respective parameter.16 Select Time for T-Sequence Screen Press button (16b) to get to thisthe screen. Use / to change default # time for ' # a !" & % timeseries. ( ) * Main ScreenThe length of the time series is indicated on button (10) now.17 Select Depth for Z-Sequence ScreenOn this screen the z-scan depth can be changed, similar to the time series before. Select Frames for M-Sequence ScreenChange number of frames that are to be averaged to a mean image.18 Main Screen: 3x3 Composite ModeThe current image number is indicated on button (10). Main Screen: 3x3 Composite ModeAfter acquisition of one frame the target changes automatically.19 Main Screen: 3x3 Composite ModeAcquisition of last image of the 3x3 composite. Main ScreenAfter the last 3x3 composite image, the mode changes back to “single” automatically.20 Main Screen: Injection Button PressedIf an angiography mode is selected and no injection timer was started, button (14) will blink.Press this button to start the injection timer for the current mode. Afterwards, button (14) stopsblinking and stays activated (blue). More ScreenThis screen is reached via button (12) on the main screen. Select high speed or high-resolutionmode here.21 More ScreenA internal myopic lens can be activated here. Freeze Screen: InterlockAn interlock can be triggered if the FA/red free laser power gets to high or if one or both scannersdo not work properly.22

4.2.2 Foot switchThe foot switch is used to acquire images. Its function is identical to pressing the ‘Acquire’ buttonof the touch panel.4.2.3 KeyboardTo use the Heidelberg Retina Angiograph 2 operation software, you need the computer keyboardin order to enter text and to control certain software functions. In the second case, function keysand special keys are often used. In this operation manual, the function keys are identified as 'F1','F2', etc.4.2.4 MouseThe Heidelberg Retina Angiograph 2 operation software is controlled via a graphical user interface (menu). For interaction, use your computer's mouse. To select a specific menu field, use themouse to move the pointer to the field and press the left mouse button.4.2.5 Focus knobThe knob at the backside of the camera head changesthe focus. By turning this knob refractive errors ofthe patients eye can be compensa

HRA 2 Operation Manual Revision 1.1-1E, March 2003 Heidelberg Engineering GmbH Printed in Germany Technical Specifications are Subject to change without notice Art.No. 97 039-002 . 2 The manufacturer h