Transcription

SpectralisSpectralis HRA OCTSpectralis HRASpectralis OCTHardwareOperating InstructionsVersion 001, August 2007 Heidelberg Engineering GmbH 2007Art.No. 19963

0482The manufacturer hereby declares that this product conforms to the requirementsof Directive 93/42/EEC of the Council of the European Community dated 14June 1993 regarding medical products (MDD 93/42/EEC).Caution! Do not use the Spectralis without reading this manual.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.Corporate HeadquartersHeidelberg Engineering GmbH Tiergartenstr. 15 69121 Heidelberg GermanyPhone 49 6221 6463-0 Fax 49 6221 646362 www.HeidelbergEngineering.deUS Main OfficeHeidelberg Engineering, Inc. 1499 Poinsettia Avenue, Suite 160 Vista, CA 92081Phone 760 598-3770 Fax 760 598-3060 www.HeidelbergEngineering.comUS Service CenterHeidelberg Engineering, Inc. 410 Harris Road Smithfield, RI 02917Phone 401 349-0500 Fax 401 349-0504 www.HeidelbergEngineering.com2

Contents1General Information. 51.1Intended Use . 51.2Principles of the Technology . 61.2.1Confocal Laser Scanning. 61.2.2Optical Coherence Tomography (OCT). 71.2.3Use of Several Devices, Registration Link . 71.321.3.1General Safety Information . 81.3.2Contraindications for Performing Angiography. 81.3.3Warnings . 81.3.4Precautions . 101.3.5Laser Safety. 111.4Components of the Instrument, Scope of Delivery. 121.5System Installation. 131.6Maintenance, Cleaning and Service. 14General Operating Information. 152.1Turning the Instrument On and Off . 152.1.1Start Up Procedure . 152.1.2Shut Down Procedure. 152.23Safety Information, Cautions and Warnings. 8Operating the Hardware . 162.2.1Spectralis Camera and Headrest. 162.2.2Exchanging Objectives. 172.2.3Focus Knob. 172.2.4Filter lever . 172.2.5External Fixation Target Lamp . 182.2.6Control Panel. 182.2.7Foot Switch. 192.2.8Keyboard . 202.2.9Mouse . 20Technical Specifications. 213.1Recommended Isolation Transformers for PC-Components . 253.2User Training . 253.3Labels . 263.4Disposal. 273

4

1 General InformationThis is an introduction to the Heidelberg Spectralis family of devices (Spectralis HRA,Spectralis OCT and Spectralis HRA OCT). These operation instructions also containimportant safety information.1.1 Intended UseThe Spectralis devices are a diagnostic devices for imaging theretina of the human eye and for aiding in the assessment andmanagement of various diseases of the posterior segment, suchlike age-related macular degeneration, diabetic retinopathy, andglaucoma.The Spectralis HRAis a confocal laser scanning angiography system. It offers thefollowing imaging modes:- Fluorescein angiography (FA)- Indocyanine green angiography (ICGA)- Infrared reflectance imaging (IR)- Blue or “red-free” reflectance imaging (RF)- Fundus autofluorescence imaging (AF)- Simultaneous FA and ICGA- Simultaneous FA and IR- Simultaneous ICGA and IR- Simultaneous AF and IRIn each of the above imaging modes, single images or image sequences can be acquired andstored.The Spectralis OCTis a spectral-domain (also called Fourier-domain) optical coherence tomography system thatallows high-speed, high-resolution cross-sectional imaging of the retina, offering thefollowing imaging modes:- Simultaneous OCT and infrared reflectance imaging- Infrared reflectance imaging aloneOCT imaging can be single cross sections of the retina (“B-scans”), patterns of single crosssections, or complete three-dimensional images.The Spectralis HRA OCTis a combination of the Spectralis HRA and Spectralis OCT, allowing angiography, reflectanceimaging, autofluorescence imaging, and OCT cross sectional imaging, alone or in variouscombinations. The imaging modes of the Spectralis HRA OCT comprise all imaging modeslisted above for the Spectralis HRA and for the Spectralis OCT, plus:- Simultaneous OCT and FA imaging- Simultaneous OCT and ICGA imaging- Simultaneous OCT and BR imaging- Simultaneous OCT and AF imaging5

1.2 Principles of the Technology1.2.1Confocal Laser ScanningFor acquisition of the digital confocal images, a laser beam is focused on the retina. The laserbeam is deflected periodically by means of oscillating mirrors to sequentially scan a twodimensional section of the retina. The intensity of the reflected light or of the emittedfluorescent light at each point is measured with a light sensitive detector. In a confocal opticalsystem, light reflected or emitted outside of the adjusted focal plane is suppressed, resulting inhigh contrast images. Furthermore (especially during indocyanine green angiography), theconfocal optical system allows to acquire a layer-by-layer three-dimensional image.The confocal imaging system allows to image the retina with non or poorly dilated pupils.This is especially important for diabetics because they typically do not dilate very well andaccount for a large number of patients seen in the retina clinic.Fluorescence dyes are excited in relatively narrow wavelength bands. Using a laser is the mostefficient means for excitation, since all the energy is concentrated at one specific wavelengthrather than in a broad continuum as with ordinary flash photography light. Therefore, theretinal light exposure required for angiography with the Spectralis HRA is considerably lessthan that required with a photographic system, thus allowing for safer and more patientfriendly examination.The laser sources of the Spectralis HRA emit laser light with three different wavelengths:1. For excitation of fluorescein, a blue solid state laser (wavelength 488 nm) is used. Abarrier filter at 500 nm separates excitation and fluorescence light. The samewavelength (but without the barrier filter) is used to create blue reflectance images(also called red-free images). Furthermore, the Spectralis HRA is capable of highquality autofluorescence (488 nm) imaging.2. For excitation of indocyanine green, a diode laser at 790 nm wavelength is used,together with a barrier filter at 830 nm to separate excitation and fluorescence light.3. A second diode laser at 820 nm wavelength serves to produce infrared reflectance (IR)images.6

In the simultaneous imaging modes , each image line is scanned twice subsequently withalternating lasers. For example, during simultaneous fluorescein and indocyanine greenangiography, only the 488 nm laser is switched on for the first scan of a line, while during thesecond scan only the 790 nm laser is switched on.In every acquisition mode, individual images, temporal image sequences, or a focal series ofimages (layered three-dimensional images) can be acquired.1.2.2Optical Coherence Tomography (OCT)The Spectralis OCT and the Spectralis HRA OCT use spectral domain optical coherencetomography (SD-OCT) technology, alsoreferred to as Fourier domain OCT (FDOCT). The beam of a super luminescencediode (SLD) scans across the retina toproduce a cross sectional B-scan image. Tocreate three dimensional images of theretina, up to 768 equally spaced B-scans canbe sequentially acquired. The infrared beamof the SLD has an average wavelength of870nm1.2.3Use of Several Devices, Registration LinkAll Heidelberg Engineering imaging products use the Heidelberg Eye Explorer (HEYEX)software platform and database to store patient information and images. Image acquisition andanalysis is controlled by HEYEX plug-in software modules that are specific to each device.Network connections between devicesof the Spectralis family allow access tothe common HEYEX database, as wellas registration of OCT images toangiography images taken withsimultaneous IR images on a separateHRA2, Spectralis HRA or SpectralisHRA OCT system. Thesimultaneously acquired IR imageserves as the registration link betweenthe images obtained at separate devices.For simultaneous use of the software on several computers within a network, additionalnetworking licenses can be obtained. One network license can cover all modules installed inthe network.In addition to the complete operating software (image acquisition and viewing) provided witheach device, optional HEYEX viewing software is available for each module. This viewingsoftware enables users to open E2E files and to review images and patient data on PCs whichare not connected to the Spectralis or HRA device.Furthermore, the optional Image Capture Module software enables the import of digitalimages or documents from other devices (fundus cameras, perimeters etc.) into the HEYEXpatient file.7

1.3 Safety Information, Cautions and WarningsPlease read this section carefully and always heed its contents!1.3.1General Safety InformationIMPORTANT Before you start working with the instrument, make sure that you know thecorrect procedures for turning the instrument on and off (Chapter 2 “GeneralOperating Information”).IMPORTANT Carefully read the instructions for use before operating the device. Misuse ofthe device may lead to hazards for the patient or the operator or can lead towrong diagnostic results. Use outside the “intended use” scope may also leadto instrument damage.IMPORTANT Never leave the patient alone with the instrument during the examination.The instrument must not be used if there is a mechanical, electrical, or optical defect.Modifications or additions lead to loss of conformity. Heidelberg Engineering does not takeresponsibility for modified Spectralis devices.Any repair, especially of the instrument's electric and electronic systems, and any servicework on the instrument components, must only be carried out by appropriately qualified andauthorized staff.CAUTION1.3.2Unusual 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 notattempt to repair any faults with the instrument yourself.Contraindications for Performing Angiography Always ask the patient for known allergies and compare it with the contraindicationsof the contrast or dye fluid. Be aware of possible allergic reactions when contrast or dye fluid is injected.1.3.3WarningsIMPORTANT Do not make a diagnostic decision on one single examination. Always usealternative information, history data etc. to assist in a final diagnosis.CAUTIONDo not use PCs, components or accessories that have not been approved byHeidelberg Engineering. Do not install other software programs as they mayinterfere with the functionality of the Heidelberg Engineering software orequipment. This could include damage to the system as well as incorrectmeasurement results.CAUTIONMake sure that the environmental requirements are met when the system isoperated. Exceeding environmental conditions might damage the system orlead to decreased image quality. (See chapter 3 “Technical specifications”).8

CAUTIONMake sure the patient is correctly placed in front of the camera before startingthe examination. Incorrect positioning may lead to poor images and abnormaldiagnostic results.CAUTIONThis equipment was tested in accordance to 60601-1-2, Electro MagneticCompliance (EMC). Nevertheless it might be influenced by strongelectromagnetic fields. Portable high frequency communication devices mightinfluence the device.CAUTIONArtifacts (e.g. reflexes) on the images might be misleading. Do not useimages with artifacts.WARNINGDo not operate the system without connecting the System over an IEC 606011 approved isolation transformer. Do not place the isolation transformer onthe floor and do not operate other devices that are not part of the HeidelbergEngineering system with the same isolation transformer.WARNINGDo 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 ofelectrical shock to the user and patient.WARNINGDo not open the device component housings. Doing so can lead to thepossibility of electrical shock or exposure to harmful laser radiation.WARNINGTo avoid the risk of electric shock, this equipment must only be connected toa grounded power supply.WARNINGTo avoid the risk of electric shock, do not touch conductive parts ofconnectors and the patient simultaneously.WARNINGDo not use the device outside of the scope of intended use. Doing so maypose a risk to the patient or operator and may lead to malfunctions or damageof the device.For the United States of America only:CAUTIONFederal law restricts this device to sale by or on the order of a Physician orPractitioner.9

1.3.410Precautions The operator shall be sure that the device settings and adjustments are correct beforeexamination and diagnostic decision. Incorrect settings and adjustments may lead topoor image quality or abnormal examination information. Make sure the scanners are working (high pitched sound) before sitting a patient infront of the device. No laser beam should be visible, when the scanners are off. Ahazard for an injury of the retina would exist if the laser beam hits the retina withoutbeing scanned. The physician shall be sure to have the correct patient data before a diagnosticdecision. Mismatched patient data may lead to incorrect diagnostic decisions. Read chapter “Preparing the patient“ of the Software Operation Instructions carefullybefore starting the examination. Incorrect preparation of the patient may lead to poorimage quality and incorrect diagnoses. Do not start an examination without informing the patient about the examinationprocedure. Incorrect patient behavior during the examination may lead to poor imagequality and incorrect diagnoses. Clean and disinfect chin rest and headrest after each examination. Contaminated partsmay lead to infections or disease contraction. Read chapter 1.6 “Maintenance, Cleaning and Service” carefully. Missingmaintenance or incorrect adjustment of the device may lead to poor image quality andincorrect diagnoses. Prepare safeguards to ensure that only authorized personnel can access the patientdata. Data loss impedes follow up analyses and may result in wrong diagnosticdecision. Be sure to perform periodic data backup procedures. Check the success of the backupto avoid data losses caused by backup errors. Do not operate the system directly after large temperature changes. Let the deviceacclimate itself for a minimum of 2 hours to avoid device damage or incorrectmeasurement results. For the application of contrast or dye fluid, closely follow the package informationleaflet. Because of possible adverse effects of drug injections (as allergic reactions orshock), we recommend to limit the number of angiography examinations per day tothe minimum necessary. In most cases one injection will be sufficient. Before starting the system check the regional power supply specifications to verifythat they fit the required tolerances (100V U 240V; 50Hz f 60Hz). Incorrectpower supply conditions might lead to malfunctions of the system. Be aware that the influence of other physical effects (vibrations, strongelectromagnetic fields as caused by big machines etc. running close-by) might disturbthe proper operating of the device. Note that a computer failure during picture acquisition or analysis could lead toincorrect results.

1.3.5Laser SafetyThis instrument contains a solid-state laser and two diode lasers as well as a superluminescence diode. The instrument emits visible and invisible laser light through theobjective lens on the front of the laser scanning camera. TheSpectralis is a Class 1 laser system. It does not pose any safetyLASER CLASS 1hazard whatsoever. The laser class label is located on the rearpanel of the camera housing and the rear panel of the lasermodule.However, hazardous laser radiation may be accessible when the camera housing or thehousing of the laser module is open.WARNINGNever open the housing of the laser scanning camera or the laser module.When the camera housing or the laser module housing is open, visible and/orinvisible laser radiation of Class IIIB is accessible and can lead to injuries. Thecamera housing and laser module housing must only be opened by qualifiedservice staff.Laser warning labels to this effect are positionedon the cover of the camera housing (underneath theelectronics card which is located there) and on theback side of the laser module.WARNINGLASER BEAM CLASS 3B WHENOPEN AVOID DIRECTEXPOSURE TO BEAMTo guarantee the safety of the user and the patientat all times, a limit has been imposed on the maximum period of time for which the laserbeam can be switched on. If this limit is exceeded, the screen shows the message: 'LaserSafety; laser timed out'. Image acquisition is automatically interrupted and can only becontinued after a specified waiting period (about 3 hours). However, this will not usuallyoccur during normal use of the instrument.11

1.4 Components of the Instrument, Scope of DeliveryThe Spectralis conforms to all applicable safety standards such as IEC 60601-1, IEC 60601-12, IEC 60601-1-4, UL 60601, and IEC 60825.The basic components of the Spectralis are: Laser scanning camera Control Panel (also called Touch Panel) Foot switch Camera mount with integrated headrest Power supply / laser box (PSW PS410 or PWS/FW) Cable connecting Control Panel and power supply Power Supply Model PWS / FW, IEEE 1394 cable to PC CD containing operation software Software protector Operation Manuals Hardware Operation Instructions (this document) Software Operation Instructions (Spectralis QuickGuide) Manual “Installation and System Configuration”The Spectralis is operated by a personal computer, in combination with an IEC 60601-1approved isolation transformer (see chapter 1.5 “System Installation”, as well as chapter 1.3.3“Cautions and Warnings” for further details). The computer receives the image data generatedby the laser scanning camera and performs the entire image analysis.The operation software includes functions to communicate with the user, to control imageacquisition, to store images and data, to process and analyze the acquired images, and todocument the examination results.12

1.5 System InstallationAccompanying these operating instructions you will find detailed installation instructions inthe document 'Spectralis – Installation and System Configuration'.IMPORTANTTo ensure the overall safety of the system, only certified staff of yourlocal Heidelberg Engineering distributor must install the Spectralis.All power plugs of the Spectralis system (computer, monitor, printer, Spectralis power supply,table) must be connected to the isolation transformer.WARNING:The system must not be operated without IEC 60601-1 approvedisolation transformer. (please refer to chapter 1.3.3 “Cautions andWarnings”)All cable connections between camera, laser box and computer must be carried out accordingto the following connection scheme. All cables must be in good condition and properlyconnected.13

1.6 Maintenance, Cleaning and ServiceThe Spectralis is a precision optical instrument. Please protect the instrument from dust andmoisture, and avoid subjecting it to shocks or strong forces.The non-optical surfaces of the instrument can be cleaned and/or disinfected whenevernecessary. Any standard cleaning product appropriate for plastic surfaces that does not containacetone or hydrogen peroxide (e.g. ethanol and isopropyl alcohol disinfectants) may be usedfor this purpose. Before doing this, please turn the instrument off and pull out the power plug.The lens surface at the front of the laser scanning camera should be carefully cleaned atregular intervals. For this purpose, it is best to use a cotton swab slightly moistened with pure(99.9%) ethyl alcohol.Please be aware that only authorized service personnel can do service and repair operations ofthe Spectralis. Do not open the device. If the device is opened by someone other than anauthorized service personnel, the warranty will be discontinued. If the device fails please callyour local distributor or the Heidelberg Engineering support department.A yearly inspection of the device by a Heidelberg Engineering service engineer is highlyrecommended to ensure proper and exact operation.14

2 General Operating Information2.1 Turning the Instrument On and Off2.1.1Start Up ProcedureTo turn the Spectralis on, proceed as follows:(1) Turn the computer on. After the boot sequence has beencompleted, the computer will start the Windows operatingsystem.(2) Turn on the power supply of the device. The power switchis located on the front panel of the power supply. The 'On'position is marked I.(3) Start the Heidelberg Eye Explorer software.Use the Heidelberg Eye Explorer shortcut on the desktop to start the application by doubleleft-clicking on the Eye Explorer Icon on your desktopor by using the windows start menu:Start Programs Heidelberg Eye Explorer Heidelberg Eye ExplorerWait until the software opens to the database view.Note:2.1.2It 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 iton in the morning and not to turn it off again until the evening.Shut Down ProcedureTo turn the Spectralis 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 green button at the lower right corner of the Control Panel display.To close the software program, select theoption Exit from the menu item File orby clicking the Exit button at the topright corner of the screen.(2) Turn off the power supply. The power switch is located on the front panel of the powersupply. The 'Off' position is marked 0.IMPORTANT Never turn off the power supply while the scanning laser camera is acquiringimages. This can result in damage to the camera. Never turn the computer offwithout exiting out of the Spectralis operation software first. This can result inthe loss of data stored on the computer's hard disk. Before you turn off yourcomputer, select "Shut Down" from the Windows "Start" menu.15

2.2 Operating the Hardware2.2.1Spectralis Camera and HeadrestThe laser scanning camera is mounted on a special cameramount which also includes the headrest for the patient.Familiarize yourself with handling the camera using thejoystick or micromanipulator adjustment controls (x, y, zmovement of the camera). Confident handling of thecontrols reduces the time required for the examination,increases patient comfort and leads to optimal imagequality.JoystickTurn the joystick clockwise to move the camera up. Turnthe joystick counter-clockwise to move the camera down.Move the joystick left / right and forward / backwards todirect the camera in the same direction.xyz-MicromanipulatorUse the xyz-Micromanipulator for the adjustment of thecamera position: inner knob: Z adjustment (forward/backward) middle knob: Y adjustment (height) outer knob: x adjustment (left/right)To change the camera position in order to examine theother eye of the patient, move the camera backwards, pressthe unlock button and slide the camera mount to the otherside of the headrest.16

2.2.2Exchanging ObjectivesIn order to remove the Spectralis Standard Objective, rotate theobjective by about 50 to the left (counter clockwise) andremove it (bayonet connector). Make sure that the objective isretained properly; a special wooden box is delivered for thelenses.The optional 55 wide angle lens for IR, RF and angiographywide-field imaging is mounted the same way: it has to beinserted with the red dot orientated upwards (12 o’clock) andthen rotated by about 50 clockwise until it snaps in.The Spectralis automatically detects which lens is mounted on the system. For the standardobjective, the field sizes 15 , 20 and 30 are offered on the Control Panel, whereas with theoptional 55 objective the scan angles 25 , 35 and 55 are displayed.For further information, please refer to the “55 lens” Release Notes.NOTE:2.2.3The optional 55 lens is not suitable for OCT imaging.Focus KnobThe black knob at the backside of the camera head (away fromthe patient) is the Focus knob. By turning this knob, refractiveerrors of the patient’s eye can be compensated. The currentfocus compensation is shown at the lower left side of themonitor in the PC Acquisition screen in diopters.For examination of most patients, an initial focus setting of ‘0’(zero diopters) is suitable. Then make focus adjustments asnecessary. (Note: when imaging high myopes it might benecessary to increase the focusing span – use the Control Panel‘More’ option).Keep in mind that the focal planes for blue and infra-red light differ slightly. Therefore, it isrecommended to check the focus when changing from red free or FA to infrared or ICGAmode or vice versa.2.2.4Filter LeverBy changing the position of this lever at the left side of thecamera head, the filters needed for angiography are brought into position. In the position marked ‘A’ the angiography modes(FA, ICGA) are available, in the position marked ‘R’ onlyreflectance modes (IR, RF) are available.RANOTE:When the filter lever is not properly locked in toone of the above positions, it will not be possible to acquire any images. A notice tothis effect will appear at the bottom of the acquisition screen.17

2.2.5External Fixation Target LampThe flexible external fixation target can be activated fromwithin the Control Panel by double tapping on the 3x3 matrixof blue dots and then selecting ‘External fixation’.2.2.6Control PanelThe Control Panel is used to control image acquisition. Allimage acquisition parameters such as imaging mode, laserintensity, detector sensitivity and size of the scanning field arespecified. Image acquisition itself may be activated from theControl Panel.To switch the laser on and off tap on the square ‘On-Off’ buttonat the lower right corner of the screen on the Control Panel.2.2.6.1 Sensitivity KnobTurning this knob increases (clockwise) or decreases(counterclockwise) the light sensitivity of the camera. Thus byturning the knob the image brightness changes (high sensitivity high brightness, low sensitivity low brightness).The current sensitivity value is displayed on the lower left side ofthe monitor in the PC Acquisition module window.By pressing the sensitivity knob, you can change into the optional ART (Automatic RealTime) modes: ART Composite (Pan Retinal Composite) ART Mean (Noise Reduction) imaging mode2.2.6.2 Starting the LaserImmediately after switching on the device., the ControlPanel display will appear as shown on the right (“SystemStart” Screen).To open the HEYEX Acquisition window on the computer,start the HEYEX. Enter a new patient or open an existingpatient file and start a new examination. (please refer tochapter 2.2 “Patient File” of the Spectralis SoftwareOperating Instructions).18

Once a patient file is open and entries for an acquisition aremade, the Acqusition Window with the li

OCT imaging can be single cross sections of the retina (“B-scans”), patterns of single cross sections, or complete three-dimensional images. The Spectralis HRA OCT is a combination of the Spectralis HRA and Spectralis OCT, allowing angiography, reflectance imaging, autofluorescence imaging, and OCT cross sectional imaging, alone or in variousFile Size: 1MBPage Count: 27Explore furtherSPECTRALIS Training Guide - Heidelberg Engineeringwww.heidelbergengineering.comImaging user manuals Planmecawww.planmeca.comTutorials - SPECTRALIS OCT - Heidelberg Engineeringbusiness-lounge.heidelbergengine Spectralis Quick Guide - Research at St. Michael's Hospitalstmichaelshospitalresearch.caSpectralis Installation Guide - Frank's Hospital Workshopwww.frankshospitalworkshop.comRecommended to you b