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Ophthalmic Imaging System International User Manual

1. EN 61000 4 2 8 kV air tile If floors are covered with synthetic material the relative humidity should be at least 30 2 kV for power supply lines Mains power quality should be that of a typical Electrical Fast Transients commercial or hospital environment AC Power AC Power electronic disturbances transients may cause I O Lines the system s display to scroll continuously If EN 61000 4 4 this occurs imaging should not processed until the disturbance has ceased Surge Line to Line 1 kV line s to line s Mains power quality should be that of a typical AC Power 2 kV line s to earth commercial or hospital environment I O Lines EN 61000 4 5 gt 95 dip in Ut 0 5 cycle If the user of the RetCam system requires 60 dip in Ut 5 cycles continued operation during power mains Voltage dips and interruptions 30 dip in Ut 25 cycles interruptions it is recommended that the EN 61000 4 11 gt 95 dip in Ut 5 seconds RetCam system be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Hz 3 A m Power frequency magnetic fields should be at magnetic field levels characteristic of a typical location in a EN 61000 4 8 typical commercial or hospital environment Radiated Immunity 80MHz 2 5GHz Portable and mobile RF communications EN 61000 4 3 3V m 80 1kHz equipment should be used no closer to any 0 15 80MHz part of the RetCam system including cables 3 Vrms 80 1kHz than the recommended separatio
2. RetCam3 User Manual When key validation is necessary the Key Validation dialog appears when you start the system and each time thereafter until you complete this step before the Site Awareness dialog Key Validation Call Clarity Medical Systems tall free at 800 215 6005 U S and Canada or direct at 825 463 7984 to get an authorization key for this installation Read the license number below to customer support and enter the authorization key they give you in the field below Then press Validate Key 71339298 Validate Key Figure 53 Key Validation dialog Follow the instructions on screen Call Clarity and provide to the customer support representative the large license number in the dialog 71339298 in the example above which is unique for your system You will be provided in turn a unique authorization key Tip You may also send the license number via email to service retcam com and receive the authorization key by return email You must enter the authorization key in the field and click Validate Key to access the system software If you call to make sure you enter the number correctly we recommend you do not hang up until the number is accepted Technical Support Technical Support Contact Information Customers outside the US please contact your distributor for technical support In the US you have the following options Telephone Toll free 800 215 6005 Fax 925 251 0078 Telephone
3. This format uses compression to reduce file size which results in loss of resolution or quality in proportion to the amount of compression You can select the image quality before you save Export Data Formats co Extensible markup language format Comma separated values format Generic text format PN 21 100375 Rev A Import and Export Images 47 Complete Export Select Export to initiate Exporting or Cancel A dialog opens to show export progress Please wait for work to complete Export C RetCam e xporthtest 420061117_193204aaa test 1000 ml ES Elapzed Time 00 00 03 Remaining Time 00 00 04 Cancel Figure 33 Export progress dialog Importing Images Except for data backup the export destination on the network is an intermediate location To complete the data transfer and make the images available for viewing on another RetCam system you must use the RetCam software to import the transferred images into the target system database WARNING Never connect the RetCam3 to a network or any externally powered devices or peripherals during imaging Note We recommend that you do not import more than 2000 images in one batch because the import will take a long time One way to limit batch size is to import only the files from which you or someone else exported a limited number of images In general we recommend you import images from one patient at a time RetCam3 User Manual PN
4. with Connectors FA Intensity Control Cord Wrap Post both sides FA Light Connector FA Light Switch Storage Drawers Printer on mam Extended Shelf Lockable Front Casters Footswitch Storage Pocket Footswitch Figure 1 RetCam3 Ophthalmic Imaging System front view Shown with optional FA Fluorescein Angiography feature RetCam3 User Manual PN 21 100375 Rev A Introduction 9 Ethernet Port Product Label Main Power Switch and Power Cord Connection Figure 2 RetCam3 Ophthalmic Imaging System rear view Main Hardware Components Display A flat panel display is standard with the system Control Panel A membrane control panel turns the system on with one button and has controls for illumination intensity camera focus and snap capture an image or start stop video recording Handpiece Contains the camera Lightweight and easy to position it has a long cable for easy reach Use with changeable lens pieces RetCam3 User Manual PN 21 100375 Rev A 10 Introduction Chassis Contains the control systems and connections Footswitch Provides optional means to control illumination intensity camera focus and snap Storage Drawers All units have two storage drawers for lens pieces tools and supplies Fluorescein Angiography Module or FA optional An optional blue exciter light source is available for FA digital photography It comes complete with a yellow barrier filter for the ha
5. 21 100375 Rev A 48 Import and Export Images Follow these steps to import RetCam images 1 Return to the start screen by selecting Clear from the Patients and Exams screen Select Import Figure 34 Start screen The Import Folder dialog appears Import Folder aM RetCam supported files hdr mli mlv mls mrl files are e going to be imported from the source location Source lacation E 20081113_104047 Include subfolders Delete source files and subfolders after import Cancel Figure 35 Import Folder dialog By default it shows the Source location path and all the options last used 2 To change the source location select the arrow M to expand the path list or select Browse Selecting the red reverse arrow 5 resets the source location to the default setting 3 Once the desired Source location is showing you can select import options RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Import and Export Images 49 Include subfolders check box Check if you want to import images in all subfolders of the source location If not checked you will import only the files found in the source location folder itself and no images in its subfolders If you want files from a specific patient subfolder only select that subfolder as the Source location Delete source files and subfolders after import check box To manage the size of the export destination select this check box to delete the source
6. Patients and Exams Screen Patient Directory From the Patients and Exams Screen you can use the buttons shown in Figure 15 to sort the results Expand Patients Collapse All Check A Uncheck All Figure 15 Patients and Exams screen navigation buttons Performing Exams You can use the RetCam 3 to capture still images or video after selecting a patient Select the green arrow E on the right side of a patient name or select the New Exam button To start an exam you can select a Preset Configuration which can be easily edited or Manual Configuration PN 21 100375 Rev A Using the RetCam 3 27 New Exam Configuration Current weight Select an Imaging Configuration Preset Configuration 1 Preset Configuration 2 Preset Configuration 3 Manual Configuration Cancel Figure 16 New Exam configuration screen The following Information can be defined in the Preset or Manual Configuration Unspecifed Unpeied 1300 IN UE Once the new exam is configured select the green arrow E to enter the New Exam screen Select Show Thumbnails at the bottom of the Exam screen to maximize the available features Full Screen Show Thumbnails Enable mouse over image Figure 17 Show Thumbnails button The Show Thumbnails button toggles between Show Thumbnails and Hide Thumbnails RetCam3 User Manual PN 21 100375 Rev A 28 Using the RetCam 3 RetCam3 User Manual Capturing Still Images F F F S
7. SUG OWI DUI OMA RE OG 22 were ireegerere cim T E naenunes 22 O cLan t tcu Ra can vU n eee 23 PCG MEW pallet scleel aiite trie cer tad a Asia iade ur aec rd diei ade tu E esae 24 Edit Pallenbfecord SCKeeli so cedit Lem a ER eu han ER ua diu Cal ede du aii ke 25 Dal Cl DUTIOMS aee ra e o eo ae pictae ue putat telaiielat deest octe Eolaicsc testo 25 F ati entsearch ODUONS al 25 Patients and Exams Screen Patient Directory oooccccccoonccncccccnnnononnnnnonanencnonaness 26 Patients and Exams screen navigation DU LONS cccoocccoccccconncconnconnnononnnnnnnononoss 26 New Exam configuration Screen lr a ic 27 Snow Thumbnails DUO le me rates meee 27 New Exali Sof eel susci ecco Geta c Uo ecd duo bae o Fut Duke be db Lv be dvd Ue Uude Duc uu 28 Onscreencapltife CoDttols eus e eee pe enge 28 Video and image capture controls occccoonncconcnnccnnncnnonnnconcnnnnanononnrnnononnnonannnnnanonss 29 Video TCE OITA rd tv teak ud luu tuU 31 VIGESO SECOND AM CONT ON Po E 31 Select options for image capture occccoonccncccconcncccnoconocnnanonononannncnnnnnnnnnnnnnnnnnnoncnnnnnnns 32 Enable MOUSSE cT 33 Exam Notes dialog visa ta ca dpa ado a ua Ub cuo a Dg Ryu dra mea xod aU cote ve ARES 33 Mage REVIEWS usce did ee dle dotes a Savant coc p eu Du uU oa cdd a Cu 35 Compare Irades Sere ell aout e a dite tton ed 38 Select patients and exams for ExPOlcooocccccconncnccccnconncnnoncnononanonnnonancnnnnnnnnnnonnncnnnnnnns 44 gt 4 016 g
8. See Figure 8 Footswitch placed horizontally in footswitch storage pocket Place footswitch cord on top of footswitch Figure 8 Footswitch pocket Note To re start the system see Turning the System ON from Stand by Mode on page 19 Using Hard Shutdown N WARNING Do not use the hard shutdown method unless necessary because data corruption can occur RetCam3 User Manual PN 21 100375 Rev A Using the RetCam 3 23 In the event that hard shutdown is required continuously press the System Power button on the control panel for at least 6 seconds to force the system including the backup battery to shut down Turning OFF the Main Power Flip the main power switch located on the rear of the system to OFF All Control Panel indicators will be OFF except the AC DC indicator The AC DC indicator will flash green while the backup battery continues to supply power at least 15 minutes Managing Patient Records This section describes how to add a new patient and locate the records for an existing patient The software is ready to use when you see the start screen shown in Figure 9 Add a new patient Import data from CD USB network etc Find existing patient Figure 9 Start screen RetCam3 User Manual PN 21 100375 Rev A 24 Using the RetCam 3 Add a New Patient Record To create a new patient record the following information is required First Name e Last Name Date of Birth e Patient ID Patient
9. We Giana a a O 44 Export destriadohn ODI ONS uoce ede the queo t cu ex mee sae eod uta etna ete oa ton ee te pa ose 45 Selectie TOf suits teas ect ai danos 45 oelecrimage and data TO Mali 46 EXPO progress ala lOs sullivan dad ad 47 A A eee 48 MHO Folder dialogi llanto ide 48 Import SUCCESSTUI ccccceecccceseccceeseeceececceeeeeceaueeceseessageesseueeeseaeeessueeessneeessneeeseass 50 A E A EN E A E N E E A T E A E 5 Front panel of FA Module csictsas a sean eau debi Ra feet eae eealent tt 53 Bamer THIER MIStAN AON sse tauchen is laa 54 FATIME eo nire mtr c MM 55 PN 21 100375 Rev A Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 Figure 58 Figure 59 Figure 60 RetCam3 User Manual Inverted lens piece showing permissible depth of immersion 58 Power Entry Modules a a 59 Opening the Tuse holder Cover s aan ar EE ep ean aioe aa 59 REMOVING the use holder cs lasse coa don oe does m Manda etui mm dos oi eue 60 Fe CLS SFTW Claes LR 60 F use holderre Inserted uci ete ip in a ba ua id bb ime ui ua atio Cita e mi ei cow ee 61 Front panel showing the lamp assembly drawer eeeeeeeeeeeeeeese 62 Open ME IA LC 62 Removing Me BUND evocando 63 e 63 Place new DUD IM SO e ave Tote ees seek baer eases 64 Close drawer and replace connections c
10. information is repeated in several of the screens The patient name and Patient ID are always shown in the upper left corner of every screen Mew Patient Last Hane Prom MD Bh rr Pherricians Technici n Select OK to proceed Enter information manually or use menus where available Figure 10 Add new patient screen Editing a Patient Record Highlight the patient s record from the Patients and Exams screen Select Edit Patient You can edit the following information First Name e Last Name Gender Male Female Other or Unknown Date of Birth Weight in grams Note Any fields on the Edit Patient Screen are editable RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Using the RetCam 3 25 Figure 11 Edit Patient record screen Finding Existing Patient Records You can search the directory to locate specific patient records Find Patients Figure 12 Search buttons From the Start screen select the icon to display the entire patient directory or select the plus sign to locate patient records using one or more of the search features see Figure 13 Figure 13 Patient search options Select Clear to clear all search fields Search Results When you select the to display the entire patient directory the results are displayed as shown in Figure 14 PN 21 100375 Rev A 26 Using the RetCam 3 RetCam3 User Manual LasPalmas Ch Ld LANDRE 2 25 Figure 14
11. notify you when the import is completed successfully RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Printing Images 51 5 Printing Images The Print button appears at the lower right of screens when printing is available Note Print is only available if there is a printer attached to the system either directly or through the network if so connected WARNING Never connect the RetCam3 to a network or any externally powered devices or peripherals during imaging You can Print Images from the Image Review Screen Compare Screen Patient list or Patients and Exams screen Print images reports or both The default image size is 5 x 7 For optimal resolution Clarity recommends printing images 5 x 7 or smaller This also avoids the rapid depletion of printer ink Printing Images and Reports You can print both images and reports from the patient list or Patients and Exams screen 1 Select or highlight patient 2 Check the desired session patient or image 3 Select EXT The following dialog appears Report Printing Selection E Print Only Selected Patients no patient selected Patients Information I Frints the list of selected patients Patients Exams Information M Print as ROP report Prints the list of selected patients and their exams Patients Exams Images Information Prints the list of all patients from search and their exams and images M Print
12. switch on the control panel for 6 seconds until the system powers down then press the switch again to power the system back on WARNING This equipment may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating the system or shielding the location WARNING To avoid the risk of electric shock this equipment must be connected to a supply mains with protective earth WARNING For continued protection against risk of fire replace only with same type and rating fuse N Important User Safety Notices 1 Never contact the front of the lens piece with hard or sharp objects This could damage the precision optics and sealing 2 DO NOT AUTOCLAVE any part of the device 3 Appropriately power down and unplug the unit and allow the light source bulb to cool before replacing it 4 Always return the handpiece to the holster when not imaging You can drape the handpiece cable over the cord wrap post but do not wrap it tightly or damage to the fiber optic may result 5 Do not block access to the holster 6 The system is not intended to be transported outdoors 7 Newly acquired data may be lost if power is interrupted during live imaging Note backup battery power is available for at least 15 minutes after interrupt RetCam3 User Manual PN 21 100375 Rev A 14 Introduction 8 The system comes protected from viruses worms an
13. the equipment based on CDC guidelines In addition as with typical office equipment a gentle wiping with a cloth moistened with mild soap and or water is recommended Do not spray cleaning solutions on any part of the system Disposal of Materials Dispose of waste materials according to local and national requirements Contact Clarity Service if additional assistance is required Fuse Replacement Locate the power entry module on the lower right side of the rear of the cart Make sure to remove the power cord before proceeding any further See Figure 42 Figure 42 Power Entry Module Using a flat blade screwdriver gently pry open the cover of the fuse holder at the top of the power entry module See Figure 43 Figure 43 Opening the fuse holder cover RetCam3 User Manual PN 21 100375 Rev A 60 Maintenance and Support Remove the fuse holder See Figure 44 Figure 44 Removing the fuse holder Remove the blown fuse or fuses from the fuse holder and replace it with a new fuse of same type and rating See Figure 45 Re insert the fuse holder Figure 45 Fuses removed N CAUTION For continued protection against risk of fire replace only with same type and rating fuse Replacement fuses are available from Clarity Customer Service RetCam3 User Manual PN 21 100375 Rev A Maintenance and Support 61 Figure 46 Fuse holder re inserted Replace Illumination Lamp Bulb N WARNING Appropriately pow
14. the Control Panel or keyboard controls do not respond check that the Footswitch Controls are not activated Capturing Video Up to 2 minutes of Video capture is available per session A progress bar is enabled each time video is started to let you know the percentage of time used Footswitch Operation Pause Recording Switch to FA Video Recording Stop Recording Pause Timer Save Snapshot re Tu 2 0 Minutes Configure Figure 20 Video and image capture controls Video is captured at full resolution 30 frames per second The following controls are available on screen e Record Video Starts recording video to stop recording video select Stop Recording or Pause Recording Freeze Live Freeze an image during image capture Switch to FA Change the image type to Fluorescein Angiography See Chapter 6 Fluorescein Angiography Module Start Timer Start a timer to record the time elapsed during the exam e Save Still Saves a still image to the hard drive Footswitch Operation options Use the button to pause and continue video recording Note The storage capacity of the system hard drive is a maximum of 140 minutes of total video for example 70 videos of two minutes duration each or 280 videos of 30 seconds each Saving a combination of videos and stills PN 21 100375 Rev A 30 Using the RetCam 3 LIS mi n am I F E E oom qm Radeon RetCam3 User Man
15. 5 minutes after an AC main power loss In the event of an AC power loss we strongly suggest that you complete the imaging session and save images to prevent potential data loss Start a new live imaging session only after reconnecting the AC power RetCam3 User Manual PN 21 100375 Rev A Using the RetCam 3 33 Enable mouse over image preview Check this box to see an existing image on screen during a live imaging session Full Screen Show Thumbnails Enable mouse over image reer Figure 24 Enable mouse over Adding Exam Notes When you select the Exit Exam Add Note button at the bottom right corner of the image capture screen the Exam Notes dialog appears For each eye it provides a field where you can type in notes Exam Notes Exam date 24 11 08 11 06 AM Date Created By Left Eye Note Right Eye Note Note Date Created By Left Eye Note Right Eye Note 2000 chars max 2000 chars max Return to Exam Exit Exam amp Go To Patient List Exit Exam amp Go To Image Review Figure 25 Exam Notes dialog To add notes 1 Select New Note to activate the notes fields 2 Inout Created By information 3 Type new notes in the fields titled Left Eye Note and Right Eye Note 4 Select Save Note to add notes you have typed to the notes above Note You cannot change a note after you select Save Note e Select Reset to clear all fields Select Return to Exam to save note and return to Li
16. H 1d50a3a S ystem Xml Mersion 2 0 0 0 Culture neutral PublicK ev T oken b77a5c561934e089 Infragistics wn v 2 Version 2 20072 61 Culture neutral PublickeyT akenz dd5c3153fr2cd ch Infragisticez Shared v7 2 Versianz 7 2 20072 61 Culture neutral PublicheyT oken ddSc31 63f2cdOcb Infragistics2 Win Ultra inGrid v 2 Versianz7 2 20072 61 Culture neutral PublickeyToken dd5c3163RcdMOcb Clarity RetCam WebService Versione 0 0 0 Culture neutral Public evyT oken null Figure 55 About Clarity software PN 21 100375 Rev A 70 User Preferences Select User Preferences User Preferences Configurations Live Imaging Mew Exam Notification Printers Windows Configuration Imaging Adjustment configuration does not have a Ul Figure 56 User Preferences screen Select from the following options Imaging Adjustment Not available Institution Add the name of the Institution Department and Location Live Imaging Not applicable New Exam Set the Pre set Imaging Configurations for new exams Notification Not applicable Set the Default Image and Report Printer Windows Configuration Set Date and Time Display Network Connections Printers and Faxes Region and Language Security Center and Sound RetCam3 User Manual PN 21 100375 Rev A User Preferences 71 Institution User Preferences Configurations Imaging Adjustment institution Live Imaging Mew Exam Not
17. INGEMENT IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE THOSE WARRANTIES DO NOT ORIGINATE FROM AND ARE NOT BINDING ON MS Note on Java support The SOFTWARE may contain support for programs written in Java Java technology is not fault tolerant and is not designed manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail safe performance such as in the operating of nuclear facilities aircraft navigation or communications systems air traffic control direct life support machines or weapons systems in which the failure of Java technology could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U S TWO HUNDRED FIFTY DOLLARS U S 250 00 Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineer decompile or disassemble the SOFTWARE except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limita
18. Image to print the two images displayed on this screen one above the other RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Image Review and Compare Mode 39 Edit Image Click Edit Image to display the Image Adjustment window End Compare Click End Compare ito return to the display of a single image Exam Notes Click Exam Notes to review or append text to the exam notes for that image You cannot alter saved notes Notes are identified by date time and person creating the note Exit Review Click Exit Review to return to the Patients and Exams screen Image Adjustment To adjust an image select the image from the Image Review screen and click Edit Image The Image Adjustment window appears To exit the Image Adjustment window click the X in the upper right corner of the window PN 21 100375 Rev A 40 Image Review and Compare Mode Image Adjustment Brightness H Contrast Rotate 180 Reset Save T Apply Saved Settings Save Settings SS Insert Point Insert Ellipse Insert Line Insert Note Rotate Measurement Delete RetCam3 User Manual 43 Image Adjustment Parameters Controls to adjust the image display parameters are e Brightness e Contrast e Red e Green Blue All parameters have a default setting of zero 0 and range from 100 to 100 e Each click on the right or left arrow at the end of the slider bar changes the parameter value by 1 e Each c
19. NEWER soi 71 A A A A 72 s Midows CONT OUI AU OM xis seen doe cu ay sd ee ate eco e toca 72 9 Technical Specification vene uc edes 73 A IMMER 73 Exit c Em 73 A O 73 e Environmental Conditions qc e res rn a S oe IE ade 73 10 LICENSE AOTeelmiefilS s essent dint OR ue eetu Dus ide bate on 75 e CMS Software Restricted RIghtS ccoonccccccccccncccooncnconancnnnononcnncnnanoncnnnonons 75 e RetCam3 Software End User License Agreement 75 gle gt d ie o PU E PEO re ree eee 77 RetCam3 User Manual PN 21 100375 Rev A List of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 RetCam3 User Manual RetCam3 Ophthalmic Imaging System front ViCW ccccccceesseseeeeeeseeeeeeeeeseaaeees 8 RetCam3 Ophthalmic Imaging System rear VieW ooooccccccconocccnncnnnnnnncnncnononcninnnnnnnos 9 Handpiece and Lens piece sibl vu que liada 10 CONMIGO DANG RR D e n 20 Installing a lens piece on the NANADPIECE cccceeececseeeeceeeeeceeeeeseeeeeseeeeseeeeesaees 20 Handpiece connections RE UU T 21
20. RetCam Ophthalmic Imaging System International User Manual PN 21 100375 Rev A For use with software version 5 1 Caution Federal law US restricts this device to sale a y t y by or on the order of a physician or licensed l medical systems medical practitioner Copyright 2009 Clarity Medical Systems Inc All rights reserved EC REP MediMark Europe S A R L 11 rue Emile Zola 38100 GRENOBLE France Tel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 e mail info medimark europe com RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Contents al gele 8 e ie Naci E 7 selezione 7 WINNS and GIUI Seri ni iio oso E T 7 Main Hardware Components ooccccnnnnnnccccccccccnonnnnnnnnonnnnnonononnnnnnnnnnnnnnnnnnnnnnanannnnnnnenenons 9 e Electrical Safety Informiallol a 10 e Important User Safety Notices cccoooncncccconcnccononnonononncncononennnonanonnnonanonoos 13 Labels and intero Si DS 14 uiseeub io te E ER 18 Using the RetCam 8 oocccccnncnncccncnnccnoncnccnanonononnnnonnnnnnonononnnnnnononnns 19 e Turning the System ON from Stand by Mode cceeeeeseeeeeeeeeeeseeeeees 19 Installing ESAS Piece S usse dico 21 e Turning the System OFF Stand by Ready ooccccccccccncccoonononnononconanonnnonanons 21 Dsirng Hard ShbltdoWIT ratillo 22 e Turning OFF the Main POWEL cccccssccecsseeeeeeeseeeeeseeeeeeseeeeeesaaee
21. Rev A 78 Index RetCam3 User Manual PN 21 100375 Rev A Clarit medical Ay Clarity Medical Systems Inc 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 251 0078 Toll free 1 800 215 6005 RetCam3 User Manual www claritymsi com PN 21 100375 Rev A
22. and is strongly not recommended WARNING Unauthorized modifications or additions to the RetCam system including hardware and software etc could adversely affect system function and will void the warranty WARNING Carefully inspect and clean the lens piece before each use DO NOT USE if the lens piece has nicks breaks scratches or rough surfaces that may damage the eye WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of exposure time necessary no greater than 5 minutes WARNING Use care when contacting the eye i e use the least amount of pressure and or movement necessary WARNING A risk benefit ratio must be assessed before confirming a patient for RetCam imaging if they are photosensitive concomitantly exposed to photosensitizing agents or aphakic WARNING To avoid the risk of electric shock the equipment must be connected to a supply mains with protective earth WARNING To mitigate the potential for excess light exposure the user should avoid looking directly at the illuminated light source PN 21 100375 Rev A 8 Introduction Display contains 4 USB ports Transport Handle Handpiece with Interchangeable Input Shelf Lens Piece extended Holster Keyboard amp Mouse DVD writer da inside drawer USB port a andpiece Cable
23. anual PN 21 100375 Rev A Maintenance and Support 65 Figure 52 Close drawer and replace connections AN euros Only touch the exterior surface of the illumination lamp Do not touch the bulb which is located in the center of the reflector nor the inner concave surface of the reflector Skin oils will adhere to the bulb and reflector which reduces the cooling efficiency of the bulb and thereby creates a hot spot leading to premature burnout Handle by the outside of the lamp only as shown Key Validation Note New RetCam3 systems ship with their license key already registered and validated However significant changes to the system hardware or a re load of the system software for any reason including software upgrade may require you to perform the key validation process as described below Key validation requires that you get a license key from Clarity to use the revamped system and you cannot request this key until after installation is complete Since it may take up to two 2 business days to obtain a license key after submitting a request we recommend that you effect system or software upgrades when you can manage two business days without use of the system Note To ensure the preservation of your patient data and images we strongly recommend that you perform a complete backup of the system s images before you begin any software installation RetCam3 User Manual PN 21 100375 Rev A 66 Maintenance and Support
24. are three ways to locate and save a still image PN 21 100375 Rev A Using the RetCam 3 31 1 Scroll through the thumbnails using the arrows at the right and left ends of the strip at the bottom of the screen Figure 21 Video thumbnails Use the arrow at the right 3 to scroll forward through the video and the arrow at the left PY to scroll back e Stop when the image you want to save is highlighted e With the image highlighted select wr or press S on the keyboard or press the e button on the footswitch 2 Use the scrollbar at the top of the video controls to scroll through the video and find a frame Figure 22 Video scrollbar control Move the slider to the right or left to scroll forward or back through the video e Stop the slider when you see an image you want to save E e Select E footswitch or press S on the keyboard or press the button on the 3 Use the playback controls at the top of the screen to locate a still image e Start playback by selecting Play La or Reverse E f e Select Pause LL when you see an image you want to save e Select wm or press S on the keyboard or press the button on the footswitch RetCam3 User Manual PN 21 100375 Rev A 32 Using the RetCam 3 Changing Image Capture Options During an Exam Before you start imaging verify that the options displayed for eye image type and lens piece are correct If necessary you can edit options f
25. arity trained personnel The installation includes installing main power attaching the handpiece and adjusting the monitor Upon request full installation instructions are available from the Clarity Service Department The instructions in this chapter are for using an installed system which has the main power printer and monitor turned ON the monitor height adjusted and software installed and configured for the site Note After software is installed the system requires an Authorization key to initiate the system The key is available through Clarity MSI service CAUTION Never block any RetCam 3 System vents CAUTION Never block access to the handpiece holster To turn the system ON from the Stand by mode 1 Carefully pull out the input shelf until it is fully extended 2 Depress the System Power Stand by button located on the Control Panel to turn ON system power The System Power Stand by indicator light solid green should be illuminated The software should initialize RetCam3 User Manual PN 21 100375 Rev A 20 Using the RetCam 3 The membrane control panel is located at the front edge of the keyboard tray It provides controls and indicators of system status System Power AC DC indicator indicator Relative intensity Illumination ON green green Focus indicator indicator amber i System power Focus Controls SNAP Intensity Controls Lamp Illumination Stand by button capture ON OFF button b
26. as ROP report Figure 37 Print dialog PN 21 100375 Rev A 52 Printing Images Select the desired option s Reports are formatted to fit on US letter size or A4 paper Recommended Supplies Clarity sells printer supplies photo paper and ink for the printer supplied with the system Note Network printers used with the system must have a printer driver supported by Windows XP Note Be aware that you must change the paper in the printer when switching between printing images and reports See the User Preferences section for information on setting printer defaults RetCam3 User Manual PN 21 100375 Rev A Fluorescein Angiography Module 53 6 Fluorescein Angiography Module This chapter covers acquisition of still or video images using the fluorescein angiography FA module option These functions are provided through the Image Capture screen Theory of Operation A narrow band blue excitation light centered at approximately 470 nanometers is generated from the FA module The barrier filter inserted in the handpiece has a cutoff wavelength at 510 nanometers or shorter Fluorescein dye absorbs the blue light and emits green light longer than 510 nanometers so the RetCam3 camera can image the green fluorescence without being overwhelmed by the blue excitation light Using Fluorescein Angiography FA Module i Note The internal backup battery never powers the FA module Therefore the system must be plugged i
27. ble including System Identification Institution e Setting Pre configuration Imaging defaults for New Exams Changing Date Time Changing Speaker Volume Setting Printer defaults Setting Network connections Select the cog icon in the lower right hand corner to access the User Preferences About Status Monitor Trace Window User Preferences Exam Review Import xiii us Unlock Maintenance Made Displayed Patients 13 Selected Patients 1 Selected Media 6 Figure 54 Access User Preferences Click About to identify the RetCam software version Click OK to exit About RetCam User RetLam Institutions Department HetLam Version 5 1 17 Computer Name CLARITY PBAYEA NET Framework 2050727 Windows OS Windows xP Microsoft Windows MT 5 1 2600 Service Pack 2 Assembly Versions mecorlib Yersion 2 0 0 0 Culture neutral PublicheyT oken b7a5c561 934e0089 Clarity RetCam Yersion 5 1 17 0 Culture neutral PublickepT oken null System Yersion 2 0 0 0 Culture neutral Publick epT oken b77a5c561934e089 Clarity Common Wersion 5 1 17 0 Culture neutral PublickeyT oken null System Windows Forme V ersionz2 D D 0 Culture neutral Publick eyT oken b77a5c561934e089 System Drawing Yersion 2 0 0 0 Culture neutral PublicheyT okenzb 3rbfF H 1d50a3a Clarity RetCam Core Version 1 17 0 Culture neutral PublickeyT oken null System Configuration Yersion 2 0 0 0 Culture neutral PublickepT oken b03f57
28. ccccoccncccnnnnconncnnccnnncnnonnnononcnononononnncnnnnnnos 65 Key Validation dialog ia 66 Access User Prior o E Cr Leda 69 About Clarity software seeessssssssssseseeeeeene nennen nennen nnne nnns nnn nnns 69 User PreterericesSCEIOO aac iue aoa dos ratu ett N be A cod US EE 70 User Preferences Institution seerder E 71 User Preferences New Exam cccccccccsseccecesceceeeeeceeeeseuseeseueeesseeeseeeessaeeessaaees 71 User Preterences Printers anal 72 User Preferences Windows ConfiguratiON cccoonccccooncnccccnncooncnonnncnconanoconncononanononos 72 PN 21 100375 Rev A RetCam3 User Manual Introduction 7 1 Introduction The RetCam3 Ophthalmic Imaging System system is designed to allow the quick and easy capture of wide field high resolution fully digital images and videos of the eye Indications for Use For general ophthalmic imaging including retinal corneal and external Warnings and Cautions CAUTION Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner WARNING Prior to using the system read all user safety information WARNING Before using this equipment to acquire images from patient eyes users must be trained in proper clinical technique by personnel authorized by Clarity WARNING The RetCam system is designed and tested as a system Omission or substitution of RetCam components may adversely affect system performance
29. censing Inc or its affiliates MS Those installed software products of MS origin as well as associated media printed materials and online or electronic documentation SOFTWARE are protected by international intellectual property laws and treaties The SOFTWARE is licensed not sold All rights reserved IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT EULA DO NOT USE THE DEVICE OR COPY THE SOFTWARE INSTEAD PROMPTLY CONTACT CMS INC FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE OR A REFUND ANY USE OF THE SOFTWARE INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA OR RATIFICATION OF ANY PREVIOUS CONSENT GRANT OF SOFTWARE LICENSE This EULA grants you the following license e YOU MAY USE THE SOFTWARE ONLY ON THE DEVICE NOT FAULT TOLERANT THE SOFTWARE IS NOT FAULT TOLERANT CMS INC HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND MS HAS RELIED UPON CMS INC TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE IS PROVIDED AS IS AND WITH ALL FAULTS THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK RetCam3 User Manual PN 21 100375 Rev A 76 License Agreements RetCam3 User Manual OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR USE OF THE SOFTWARE OR AGAINST INFR
30. ck the Hide Image icon below the highlighted thumbnail to hide the current image You can click this icon beneath any thumbnail to hide that image You can use the icon to toggle between hidden 3i and unhidden Hidden items are not deleted Their thumbnails do not appear unless the Show hidden images box is checked Unhide Item When Show hidden images is checked select the Hide Image icon p to unhide an image The hidden image icon appears in the upper right corner of the thumbnail for a hidden image Flag Image Click the Flag Image icon me to flag the current image as an image of special interest A small red flag appears at the top left corner of the thumbnail To unflag an image click the icon again The icon toggles between flagged and unflagged PN 21 100375 Rev A RetCam3 User Manual Image Review and Compare Mode 37 Full Screen Click Full Screen to display a full screen view of the current image with no thumbnails visible Hide Thumbnails Click Hide Thumbnails to remove the thumbnail display without changing the display of the current image Print Image Click Print Image to print the current image displayed Edit Image Click Edit Image to edit the current image Compare Click Compare to view two images side by side on the screen See Compare Mode for details Exam Notes Click Exam Notes to review or append text to the session notes in the Review screen You cannot alter saved notes Notes are i
31. d spyware with Microsoft s anti malware Please refer to your warranty prior to adding any additional software or contact Clarity Service Labels and Symbols System Power button Focus Focus Controls Lamp Illumination button Intensity Controls SNAP capture switch or button Warning or Caution Warning Do not look directly into light source Warning Dangerous Voltage used in FA Chassis ground P 9o e im 9 S RetCam3 User Manual PN 21 100375 Rev A O P KC i RetCam3 User Manual Introduction 15 Protective earth ground Alternating current AC System contains 2 fuses of indicated type Do not use any other type Backup battery Computer network Non ionizing electromagnetic radiation FA Fluorescein Angiography FA light Intensity increase clockwise FA light OFF FA light ON Light source fiber optic connector Handpiece connector PN 21 100375 Rev A 16 Introduction f S Bora A ES RetCam3 User Manual USB connector Read accompanying user documentation Fragile contents This side of carton up Temperature limits Authorized representative in the EU Type BF equipment applied part is handpiece To prevent damage to lens piece carefully store handpiece in holster when not in use Clean lens piece after use Separate collection of waste at end of life as required by European directives Contact Clarity for equipment disposal ins
32. dentified by date and created by Exit Review Click Exit Review to exit the current review session and return to the Patients and Exams screen Compare Mode The Compare screen appears when you click Compare Use the Compare screen to compare any two images You can compare images for one or more exams for a single patient PN 21 100375 Rev A 38 Image Review and Compare Mode 05815007 Undefined T Unspecified T Other l Undefimed Unspeci iod EET DIR EE EINE T AMARO 4 08 PM Exam Selector Shaw hidden imagea Primi image Fuit Image Figure 27 Compare Images screen The last image displayed on the Image Review screen will appear on the left side of the Compare screen On the right side by default the first image of the first session for the same patient appears Identifying information for each image appears above it Below each image at the bottom thumbnails appear for all images in the same session The Exam Selector displays the dates for all the current patient s exams above the thumbnails The highlighted date is the exam date for the current thumbnails To view images from a different exam select another exam date from the Exam Selector The video playback controls are not displayed on this screen because It is not possible to compare videos The Compare screen provides a toolbar for the following options Show hidden images The check box for displaying hidden images is available Print Image Click Print
33. eesseaeseeeas 23 e Managing Patient RECOIdS cccccccsssseecceeeeeeceeeseeeeseeeeessaeeseeeseeeeeessaeeess 23 Adda New Patient Record ione rm Ice eE a ee 24 Vl GING al Patent FO seio MR ER 24 e Finding Existing Patient RecordS ccccccccccononconccccnononononnnononanonononnnnonnnnnncnnonanennnnnss 25 e Pertorfritid9EXSltis sid nasiemonEcs doi 26 Capturing Still IMAGES sxc sere Xen 28 s Capto VIdBO iiii u cites edant A 29 Video PAV DAK eic C T 30 MUA A E a aAa Oaa 30 e Using Helpful Feature ctra 30 JShorte Ub IBS zs tet int ipsa Paotetudoisa t du deae tees 30 Sul inte smnimde E 30 e Changing Image Capture Options During an Exam oooonnnnnncnnnnncccccnncnnnnncnnnnnonnninnnos 32 Adding Exam NOS cercanos E nen Era uo er e obese tunes 33 Image Review and Compare Mode sseeeees 35 Image Review eei P 35 COMPare MOE ERR TRU 37 Image sre b zug cim ER er athe See ceeds nea Gade eden E 39 e Image Adjustment Parameters ccccccsssecccccceseeeseeeccceeeeeeeceeeeseueaeeeeeesseaeeeeeeeesaaas 40 FAIA LAO eect ects et totes ata cee ace ta ep a cae es todos tte mE gu eae dep d ttc d 41 IMPOR and EXPO IMAGES sersan ea 43 ui silo dne UDINE Sir 43 s EX DOMINGMIMAGSS static diia 43 s Select Images Tor EXPO ione eo mte timeam tuta eee eC Luo US 44 scSelecb Export ODHIOLIS e auct ala acest 45 Selec ne Els Foma RR ERR ts es los ae ee a ata 45 EEX OOLEIMAGEF OFIMALS sericea c
34. er down and unplug the unit to allow the bulb to cool before replacing it Replacement bulbs are available from Clarity Follow these steps to replace the bulb 1 If not already OFF turn OFF the main power 2 Disconnect the power cord from the wall 3 Unplug the fiber optic cable from the front panel RetCam3 User Manual PN 21 100375 Rev A 62 Maintenance and Support 4 Remove the two screws from the lamp assembly drawer Remove 2 screws ZEN Lamp assembly drawer Lamp assembly drawer handle Figure 47 Front panel showing the lamp assembly drawer 5 Grip the handle on the lamp assembly drawer Pull the drawer out slowly Stop when the light bulb is fully exposed Figure 48 Open the drawer RetCam3 User Manual PN 21 100375 Rev A Maintenance and Support 63 RetCam3 User Manual 6 Push the lamp ejector as shown i r Figure 49 Removing the bulb 7 Carefully slide the bulb out of the socket slots 8 Pick up the bulb Socket slots Figure 50 Catch the bulb PN 21 100375 Rev A 64 Maintenance and Support 9 Holding the new bulb only on the outside align the two pins of the bulb with the two slots in the socket Push it all the way in Figure 51 Place new bulb in socket 10 Carefully push the lamp assembly drawer back Use caution to avoid pinching wires in the area 11 Replace the two screws on the lamp assembly drawer and replace the fiber optic cable RetCam3 User M
35. files and subfolders after import is complete Note Do not check if you or others want to import the same data to another RetCam station which would be the case especially if you are importing from the backup repository Note This does not affect any working RetCam database but only the intermediate location where files are exported to and imported from 4 Click Import to initiate importing or Cancel A dialog opens to show import progress 5 A Select Import Data to save dialog will appear If not all items were imported you may select Show Detailed Log for the explanation It could be because some files are duplicates already in the destination database or the file is not found or it is corrupt or the destination is write protected PN 21 100375 Rev A 50 Import and Export Images View imported data and select thumbnails you need to save Select Import Selection You can also select Import All to save all images Select Imported Data to save Expand All Collapse All Select All FirstName LastName Gender Pathology Chorioretinitis Male Chorioretinitis ExamDateTime Selector 05 15 2007 ivi FirstName LastName Gende Pathology Classification Selector Corneal Abrasion Paper Cut ExamDateTime Selector Show Detailed Log Hide Summary Cancel Import Selection Import All Total Patients Count 3 Total Media Count 24 Selected Patients Count 3 Selected Images Count 24 Figure 36 Import successful The system will
36. ge Select the X at the top right to close the screen Insert Ellipse Draw an ellipse on the image Insert Line Draw a line on the image Insert Note Add text to the image Rotate Rotate the pointer Delete Remove a selected annotation Measurement Display the number of pixels between two points Note The original images in the database are never changed even when you modify the image displayed on the screen You can save processed images only outside the RetCam database and in a non proprietary format PN 21 100375 Rev A 42 Image Review and Compare Mode This page left intentionally blank RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Import and Export Images 43 4 Import and Export Images You can import or export images e To make RetCam data available on other RetCam stations which include RetCam3 RetCam ll and RetCam Shuttle systems and PCs running RetCam Heview Software o make a backup copy of the original image data kept on the hard drive o view with standard image software o use RetCam images with third party imaging systems Backing Up Images The RetCam system stores all images to the local hard drive It is highly recommended to create a central repository on a network of all data from the RetCam device for long term data backup Recommended Backup Frequency Each day you acquire new images Exporting Images You can export data to any accessible locat
37. hem fiction images A Figure 18 New Exam screen The recommended procedure is to capture video of the entire exam and grab still images from the video then delete the video prior to exiting the New Exam session You can take still images from the New Exam screen using the following Keyboard and Mouse Some utility buttons are displayed on the monitor use the mouse to select them Select to save still Save Still Images Footswitch Operation o e a Video Recording Freeze Live start Timer Save Snapshot Select to use 2 GB footswitch for stills capture Record Video Switch to FA Figure 19 Onscreen capture controls Use the S key to SNAP images Footswitch Select Save Snapshot from the monitor display see Figure 19 on page 28 Then use the footswitch button to SNAP images PN 21 100375 Rev A RetCam3 User Manual Using the RetCam 3 29 Control Panel Press the button Note Saving video can take significant time and consumes a great deal of disc space To maintain optimal system performance select the images of interest from the video then delete the video prior to exiting Image Capture Note The storage capacity of the system hard drive is a maximum of approximately 250 000 still images Saving a combination of videos and stills will affect the total number of each that can be saved Saving images with annotations reduces the total number of images that can be saved Note If
38. iclo 46 EXPO Dala F OlMalSisi2m Mr 46 s Complete EXPO se siz iiintede duce Nea io iia 47 IMPOR JB S urna 47 PN 21 100375 Rev A SE xni RIS UNS o1 e Printing Images and REPOlts ccccccsseseeceeeeeceeeeeeseeeeeeeeecsaeeeseeeeeseeeeeness 51 Recommended SUDpll68 esie Perte eta eee 52 6 Fluorescein Angiography Module seseesseusssss 53 e THEON OrOpEralo m Rr T m 53 e Using Fluorescein Angiography FA Module sseeeeeesss 53 e Configuring the FA Module Timer occcccccnccccccccccconnccnncnnnnnnoncnonononnnnncnnnnnnnnononononnnnos 56 7 Maintenance and Support cccccssecceecseceeceeeeeeseeeeeseeeessaaeees 57 e Recommended Maintenance Schedule occoooccccccnoccccccncccnconnnccnnnnnanancnnancnnnos 57 Cleaning Procedures sonrisa 57 Cleaning the Lens PieGE senpre a 57 e Cleaning the Rest of the SySteM oooonnnncncccnncoccccnnnnononnccnnnnnnnnnnononononanennnnnnnnnonnnnnss 59 Disposalor Material o aria 59 Fuse Replacements rl ca 59 e Replace Illumination Lamp Bulb sees eee 61 uii mule Le 65 a TecnNCalLSUDPON norras o ad 66 e Technical Support Contact Information esses 66 Service IMPOR MAN ON zu ioco ere e et SU oie eda ada Ee gue io su teeth egeta eee deve ca edens 67 9 User IP RCTS KCNC Suerte reels uice ddadeds ce ui su inel 69 SCD WONTON TT MET CEREREM 71 e
39. ification Institution Printers Windows Configuration Department Location Figure 57 User Preferences Institution New Exam User Preferences Configurations d Imaging Configuration One Imaging Adjustment Institution Title Preset Configuration 1 Live Imaging 7 l New Exam Image Type Retina e Lens 1300 Eye Right Eve OD Notification m men n PC Printers windows Configuration Imaging Configuration Two Title Preset Configuration E Image Type Reina Lens 1300 Eye Right Eve 0D v Imaging Configuration Three Title Preset Configuration 3 Image Type Retina o Lenz 1300 Eye Right Eve OLD Figure 58 User Preferences New Exam Once the New Exam preset configurations are adjusted click Apply to initiate the change or Cancel Click OK to exit the screen RetCam3 User Manual PN 21 100375 Rev A 72 User Preferences Printers User Preferences Configurations Imaging Printer Imaging Adjustment Institution Live Imaging Default Imaging Printer New Exam Notification Printers Windows Configuration HP Deskjet D4200 series Copy 1 HP Deskjet 04200 seres Report Printer Default Report Printer HP Deskjet D4200 series Copy 1 Figu
40. ion There are three general steps to complete export These are 1 Select Images for Export below 2 Select Export Options page 45 3 Complete Export page 47 PN 21 100375 Rev A 44 Import and Export Images Select Images for Export 1 Go to the Patients and Exams screen and highlight the desired patient Click the arrow on the left side to show all the exams for the selected patient Danville Robert ID 455678 Lr EIL E m e H m e uL 5 pom E 1 m e o e H om P Figure 28 Select patients and exams for export 2 Check the white boxes on the right side of the display to select files for Export You can select Check All to select all patients records and exams 3 Click the Export button at the bottom of the screen 4 The Export dialog appears Y Export P Export Patients Exams and Media e Supported Formats ML DCM PNG BMP JPG XML CSV amp TAT Specify destination location Path C RetCam Export Create subfolder ExamDate _ ExamTimel LastHame FirstMame Hospita e 20081125 _123016 0o0e John HID1234 File Name Format ExamID SeqnNum Y wv Overwrite existing data d846419c 604b 1 File Format ML File Format B Split File Format Text Data XML Image BMP Export Figure 29 Export dialog By default the dialog shows the source location path and options used for the last export RetCam3 User Manual PN 21 100375 Rev A Import and Exp
41. lect file format Select MLX DICOM or Split File format RetCam3 User Manual PN 21 100375 Rev A 46 Import and Export Images RetCam3 User Manual Clarity s proprietary encrypted data format DICOM DCM is the filename extension for patient data files that are DCM compatible with the DICOM Digital Imaging and Communications in Medicine standards for ophthalmology Split File If you select this format you will have additional options for the Format Export Image and Export Data formats Y Export Export Patients Exams and Media em Supported Formats MLS DEM PNG BMP JPG XML CSV amp TXT Specify destination location Path CiRetCam Export test26x Browse Create subfolder ExamDate ExamTime LastName FirstName Hospita m 20081125 180354 Doe John HID1234 File Name Format ExamID SeqNum E Overwrite existing data d8a84159c 604b 1 File Format MLX File Format B DICOM File Format E Split File Format Text Data XML Image BMP Export Images Export Data o 0 n Cancel Figure 32 Select image and data format Export Image Formats Portable Network Graphic uses compression to reduce file size about half the size of a bitmap file but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications The bitmap format saves images at full resolution without any quality loss It results in the largest files or JPEG
42. lick on the bar to the right or left of the slider changes the parameter to the end of the range Rotate 180 Click this button to rotate the image 180 Reset Button Click Reset to reset all display parameters to zero Save As select to export the image Save Settings Click to save the current settings for Brightness Contrast and Red Green and Blue The saved settings can be applied when you select Apply Saved Settings Apply Saved Settings Click to apply the currently saved settings for Brightness Contrast and Red Green and Blue Image display adjustments are applied to all images in the current image processing session until you save new settings or click the Reset button which resets all parameters to zero When you leave the current session the display settings are reset to zero Note Images you save from the Image Adjustment window will reflect image display adjustments and all other changes you make but the original images in the database will not be changed PN 21 100375 Rev A Image Adjustment Rotate 180 Reset Save T Save Settings Settings Insert Point Insert Ellipse Insert Line Insert Hote Rotate Measurement Delete RetCam3 User Manual Apply Saved Annotation Image Review and Compare Mode 41 You can annotate an image by inserting graphic elements or text notes Click to select any of the following annotation features Insert Point Insert pointer and text on the ima
43. n distance AC Mains calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 E P 80 MHz to 800 MHz d 7 E JP 800 MHz to 2 5 GHz where P is the maximum output power rating of Conducted Immunity the transmitter in watts W according to the P transmitter manufacturer and d is the EN 61000 4 6 recommended separation distance in meters m E4 is 3 V m Conducted Immunity d 3 5 V4 P where V is 3 Vrms Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 2 RetCam3 User Manual PN 21 100375 Rev A Introduction 13 WARNING Interference may occur in the vicinity of N equipment marked with the following symbol gt This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as e Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help An error message may be displayed which then may require a system reset To perform a system reset press the system power
44. ndpiece You can adjust illumination intensity only through the FA intensity control Printer Color images and reports can be printed Handpiece Lens piece we Figure 3 Handpiece and Lens piece Lens Model Application Common Field of View D1300 Premature Infant 130 Degrees B1200 Standard Baby 120 Degrees E800 High Contrast Children s amp Adults 80 Degrees C300 High Magnification 30 Degrees PL200 Electrical Safety Information The system has been designed inspected and tested to comply with the safety requirements of IEC60601 1 with respect to fire shock and mechanical hazards only if used as intended Class I Type BF Electrical Equipment Rated for Continuous Operation RetCam3 User Manual PN 21 100375 Rev A Introduction 11 Electromagnetic Emissions Compliance Level Group 1 Class A Test Type Compliance Level NOS Conducted Emissions Class A The RetCam system uses RF energy for its internal CISPR 11 function Nearby electronic equipment may be EN 55011 affected Radiated Emissions Class A CISPR 11 EN 55011 Harmonic emissions Complies IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 FCC Pant 158 RetCam3 User Manual PN 21 100375 Rev A 12 Introduction Electromagnetic Immunity Test Type IEC 60601 1 2 test and Electromagnetic Environment Guidance compliance level Electrostatic Discharge ESD 6 kV contact Floors should be wood concrete or ceramic
45. nto wall power to operate the FA module 1 Switch ON FA module power The FA lamp requires a few minutes to stabilize Power switch Fiber Optic lamp connector Adjust FA intensity Figure 38 Front panel of FA Module 2 Carefully install the barrier filter into the handpiece A Remove the lens piece if present B Insert the barrier filter into the cavity of the handpiece observing the orientation as shown in Figure 39 C Reattach the lens piece before moving the handpiece RetCam3 User Manual PN 21 100375 Rev A 54 Fluorescein Angiography Module Lens piece Barrier filter Handpiece RetCam3 User Manual p Pezu E Rubber O ring toward lens piece Beveled edge toward handpiece Figure 39 Barrier filter installation Note If lenses are exchanged during an FA imaging session hold the camera upright to avoid having the barrier filter fall out during the exchange 3 Select Switch to FA and SNAP a red free image recommended 4 Attach the fiber optic lamp connector from the handpiece into the FA module fiber optic port See Figure 38 5 Select Start Timer Dye can now be injected Note The timer can be paused or stopped at any time 6 Adjust FA light intensity using the FA light intensity knob shown in Figure 38 Note You cannot adjust the FA light intensity using the footswitch or control panel controls 7 You can take still photos or video during the FA imaging session and you can SNAP s
46. ort Images 45 Note The Minimum Required Space for Export is displayed Verify that the export destination has sufficient free space to accept the exported files JL Note Regarding File Size Capacity We recommend that you do not export more than 2000 images in one batch because the export will take a long time We recommend that multiple smaller transfers be executed Select Export Options 1 To change the destination location path select the arrow to expand the path list or click Browse Clicking the red reverse arrow resets the source location to the default setting Export images to a new subfolder Specify file name format Specify destination location Path C RetCam Espart gt Browse Create subfolder ExamDate ExamTime LastName FirstName Hospita e ox 20081125 _123016 0o0e John HID1234 File Name Format ExamID SeqNum Overwrite existing data d8a8419c 604b 1 Overwrite existing data Create a subfolder for one feature Create a subfolder for multiple features Figure 30 Export destination options 2 Select the destination options e Export images to a new subfolder Create a subfolder for one feature such as exam date exam time last name etc Create a subfolder for multiple features e Specify a file name format for the exported files Overwrite existing data Select the File Format File Format ML File Format B Split File Format Text Data XML Image BMP Figure 31 Se
47. ot attempt to override the interlock switches or to operate in FA mode with the cover off The FA module contains internal sources of high voltage high current heat and moving parts Only authorized technicians may attempt any service or repairs to the FA module Failure to observe this warning could result in injury to operator or patient PN 21 100375 Rev A 56 Fluorescein Angiography Module Configuring the FA Module Timer To configure the FA timer click Configure at the top left of the screen You can configure the following e Capture video and images in color or greyscale e Set the frame rate e Frame number e Elapsed time Timer position Timer display Frame numbers etc Note You can use the timer when you are not in FA mode Tip You can move the timer display to any location on the image capture window Tip You can use the timer when you are not in FA mode Using Video Controls in FA Mode When you are in FA mode the timer is controlled separately from the video For example when you pause or stop the video video capture is interrupted but the timer continues uninterrupted When you pause video capture the video images acquired up to that point are not yet saved to the hard drive Images are saved automatically to the hard drive when you stop video capture The video display shows the percentage of the available 2GB hard drive space already used RetCam3 User Manual PN 21 100375 Rev A Re
48. re 59 User Preferences Printers Select the default printers then click Apply to initiate the change or Cancel Click OK to exit the screen Windows Configuration User Preferences Configurations Imaging Adjustment Institutian Live Imaging New Exam i A EN i g w Notification t gt Printers Date and Display Network Time Connections Printers and Region and Security Sound axes Language Center Export Logs Figure 60 User Preferences Windows Configuration Select the desired Windows configuration icon and make changes where needed Click Apply to initiate changes or Cancel Click OK to exit the screen RetCam3 User Manual PN 21 100375 Rev A Technical Specifications 73 9 Technical Specifications Hardware Physical e 26 660 mm wide x 24 610 mm deep x 54 1372 mm minimum height e Approximately 200 lbs 91 Kg fully loaded Electrical e Ratings 100 240 V 50 60 Hz 700 VA e Fuses 3AG 10A 250V slo blo 5 x 20 mm Power consumption 700W with all options Detachable hospital grade power cord Environmental Conditions The system as delivered is intended for use indoors at normal room temperatures and humidity upright on a level surface with the brakes applied to the front casters Condition Operating Storage and Transport 50 10 95 F 1021035 C 20 to 122 F 29 to 50 C Relative Humidity 30 to 90 non condensing 10 to 85 non condensing Atmosphe
49. ric 20 7 to 31 3 inches Hg 70 to 14 7 to 31 3 inches Hg 50 to Pressure 106 kPa 106 kPa Altitude 1255 to 9882 feet 382 to 1255 to 18288 feet 382 to 3012 meters 5574 meters Note Specifications subject to change without notice RetCam3 User Manual PN 21 100375 Rev A 74 Technical Specifications This page left intentionally blank RetCam3 User Manual PN 21 100375 Rev A License Agreements 75 10 License Agreements CMS Software Restricted Rights This Software and accompanying written materials are provided with Restricted Rights Use duplication or disclosure by the U S Government is subject to restrictions applicable to commercial computer software under FAR 52 227 19 and DFARS 25 227 7013 Contractor manufacturer is Clarity Medical Systems Inc 5 75 West Las Positas Boulevard Pleasanton CA 94588 This Agreement is governed in and by the laws of the State of California U S A This statement gives you specific legal rights you may have others which vary from state to state and from country to country Clarity Medical Systems Inc reserves all rights not specifically granted in this statement Any attempt to decompile reverse engineer or otherwise copy this software shall be considered a breach of this agreement RetCam3 Software End User License Agreement You have acquired a RetCam3 DEVICE that includes software licensed by Clarity Medical Systems Inc CMS Inc from Microsoft Li
50. rom the image capture screen Gendel Unspecifie late of BI 05 15 2007 Age iYears 7 31 2008 10 50 A irrent Weight Kg 0 000 ROP rin Left Eye 05 Lens 1700 Retina Figure 23 Select options for image capture FE Changing Right Eye OD Left Eye OS To image the other eye in the same session expand the Eye menu EM and select the other eye Right Eye OD or Left Eye OS The Eye selection is saved with the image Note When using this option be careful that you select the correct eye before you save the image This is especially important when both eyes are captured in one video clip and you save still images from the video Make sure you select the correct eye before you save each still image from the video Note Images and video can be selected for deletion only during the imaging session Once the session has been exited the images will be saved for that session Ig Changing Lens You can also select a different lens piece during imaging Expand the Lens menu KA to select 1300 Premature Infant 1200 Standard Baby 800 Posterior 300 High Mag or Unspecified The lens piece selection is saved with the image Changing Image Type Expand the Image Type menu KM to select Retina Anterior Segment or Other during an imaging session All selections record the images in color The Image type selection is saved with the image WARNING System power from a fully charged battery is available for at least 1
51. s 7 For FA operation if available see Chapter 6 Fluorescein Angiography Module for instructions If the illumination lamp is OFF press the illumination lamp button located on the right side on the Control Panel to turn illumination ON The amber indicator light is illuminated when the lamp is ON Turning the System OFF Stand by Ready Note We strongly suggest that you backup and store your data prior to turning OFF the system See Exporting Images on page 43 for details PN 21 100375 Rev A 22 Using the RetCam 3 1 To turn OFF the system leaving the Stand by Ready hover over the red Shutdown button at the bottom of the Patients and Exams screen Mew Exam Exam Review Import Export Print Displayed Patients 0 Selected Patients 0 Selected Media O r o Sh utdown button Figure 7 Shutdown button The shutdown options screen appears Select Shutdown Computer 2 f the system stops responding wait at least one minute because it may be busy If the system does not respond after one minute depress the System Power button on the Control Panel once 3 All Control Panel indicators except for the green AC DC indicator will turn off 4 f FA is available verify that the FA light switch is OFF 5 Remove the lens from the handpiece Carefully inspect and clean the lens piece Store the lens in the lens box 6 Return the handpiece to the holster 7 Return the footswitch to the footswitch pocket
52. s with a clean saturated cloth 3 Rinse surface thoroughly using sterile water 4 Air dry PN 21 100375 Rev A 58 Maintenance and Support RetCam3 User Manual 5 Verify that the lens surface is free of debris and coupling gel Repeat above steps if necessary 6 Inspect the lens for damage and clarity Do not use the lens if there are chips cracks or rough edges on the lens which may injure the patient s eye CAUTION Do not autoclave any part of the system Autoclaving causes irreparable damage and voids the warranty CAUTION Never immerse the entire lens piece or handpiece in any liquid or solution If necessary only the distal 4 mm can be immersed See Figure 41 It is important not to immerse the joint where the polished metal tip meets the painted housing since it is susceptible to corrosion WARNING If you clean or disinfect rinse the lens with sterile water to avoid corneal de epithelialization that may be caused by residual solution Note For disinfection the American Academy of Ophthalmology recommends 1 10 dilution of bleach soak for 5 minutes CAUTION As disinfection solutions may cause corrosion of the lens piece soak times that exceed the recommendation should be avoided Figure 41 Inverted lens piece showing permissible depth of immersion PN 21 100375 Rev A Maintenance and Support 59 Cleaning the Rest of the System As with any medical device use good public health practices when handling
53. st patient and session you selected To review exams for a different patient exit to the Patients and Exams screen and select another patient RetCam3 User Manual PN 21 100375 Rev A 36 Image Review and Compare Mode RetCam3 User Manual By default thumbnails for all images acquired in the selected session appear along the bottom of the screen Video playback controls appear in the upper left corner of the screen The currently selected image the first one by default appears full size Select a thumbnail to display the full resolution image You can use the arrows at the left and right 3 edges of the thumbnail strip or the up and down arrow keys on the keyboard to scroll through the thumbnails or select a thumbnail Thumbnails of video clips show four images first last and two intermediate images in the video in the quadrants of a square Click on the thumbnail to bring the video to the display area Use the video playback buttons to control the video The buttons have the same functions as for live imaging Click Play to start playing video The following options are available on the Review Screen Exam Date ES Select a different exam to review by clicking the arrow next to Exam Date Show Hidden Images Default is unchecked in which case only thumbnails of non hidden images are displayed When this box is checked thumbnails for hidden images appear and are available for full size viewing Hide Image Cli
54. support is typically available between the hours of 9am and 5pm Pacific Time After hours Please leave a message as the messages are checked during the evening hours PN 21 100375 Rev A Maintenance and Support 67 RetCam3 User Manual Send correspondence to Clarity Medical Systems Inc 5775 West Las Positas Blvd Pleasanton CA 94588 USA Email service retcam com Our US technical support staff will respond to your questions as soon as a staff member is available In most cases you should receive an answer within 48 hours Complex questions that require testing or special research may take longer Note Questions about products no longer under warranty and questions other than to explain ordinary use of the product may incur service charges Please ask for an hourly quotation before incurring charges Service Information Service information is available separately in the RetCam3 Service Manual RetCam3 components are typically return to factory components and can be repaired by only Clarity personnel and or our qualified distributors The Service Manual contains information on user replaceable parts and or instructions to remove components for return for factory repair PN 21 100375 Rev A 68 Maintenance and Support This page left intentionally blank RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual User Preferences 69 8 User Preferences The section describes the User Preferences availa
55. tCam3 User Manual Maintenance and Support 57 7 Maintenance and Support This section addresses maintenance and support under the following topics e Recommended Maintenance Schedule below Cleaning Procedures below Fuse Replacement page 59 e Replace Illumination Lamp Bulb page 61 Key Validation page 65 Technical Support page 66 e Service Information page 67 Recommended Maintenance Schedule Between patients Clean and inspect lens piece Weekly Wipe down the system Monthly Inspect cables and connections for wear System powered for at least 8 hours AC powered AC DC indicator ON light solid to assure backup battery is fully charged Burned out bulb Replace illumination bulb Blown fuse Replace system fuses Cleaning Procedures For cleaning purposes the RetCam3 is divided into two categories The Lens Piece that contacts the patient e The rest of the system Cleaning the Lens Piece The patient contact area lens should be cleaned immediately after use to prevent the coupling gel from hardening 1 Wipe away debris from the front lens piece surface with a soft dry tissue sterile water soaked tissue or combination 2 Then using a clean soft cloth such as sterile gauze saturated in a fresh solution of 7096 IPA isopropyl alcohol gently wipe the front of the lens piece being sure to pay special attention to the concave contact lens area to remove any remaining debris Use at least 11 wipe
56. till photos during video replay 8 When the FA imaging session is completed A Pause or Reset the timer PN 21 100375 Rev A RetCam3 User Manual Fluorescein Angiography Module 55 Record Video Switch to Color Freeze Live Restart Figure 40 FA timer controls The drop down menu offers the following timer options e Start Start the timer e Pause Pause video capture but keep the timer running e Restart Restart the timer following a stop or reset e Reset Set the timer to zero again B Move the fiber optic cable back to the white light port and switch OFF the FA module power C Remove and store the barrier filter in the special clear plastic box provided or in a manner that prevents damage Clean the filter with compressed air and optical cleaner and tissue as required When the Image Type selected is Fluorescein the video and images are displayed and stored in grayscale by default To view and store FA images and videos in color select Fluorescein as the Image Type instead of using the Switch to FA button WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of light necessary no greater than 5 minutes WARNING Do not look directly at the fiber optic port WARNING If the light from the illumination source is not blue DO NOT USE IT because there may be a filter failure WARNING Do n
57. tion SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS You may permanently transfer rights under this EULA only as part of a permanent sale or transfer of the DEVICE and only if the recipient agrees to this EULA If the SOFTWARE is an upgrade any transfer must also include all prior versions of the SOFTWARE EXPORT RESTRICTIONS You acknowledge that SOFTWARE is subject to U S export jurisdiction You agree to comply with all applicable international and national laws that apply to the SOFTWARE including the U S Export Administration Regulations as well as end use and destination restrictions issued by U S and other governments For additional information see http www microsoft com exporting PN 21 100375 Rev A Index B Backup Frequency recommended 43 Backup Recommendation 43 C CE Label 18 Changing Image Type 32 Changing Lens 32 33 Class 1 10 Compare Screen 37 E Electrical Safety Notices 10 EMI Information 11 F Flag Image 36 H Handpiece 10 RetCam3 User Manual Index 77 Hardware Elements 9 Hide Image 36 Image Display Parameters 40 Indications for Use 7 Introduction 7 K Key Validation 65 L Lens Model 10 Lens Piece 10 O Operating Environment 73 P Print Images 38 R Hecord Video 29 Reset Adjustments Button 40 Review Images 35 S Save Still 29 Service Information 67 U Unflag Image 37 Unhide Image 36 User Safety Notices 13 V video clips 36 PN 21 100375
58. tructions European conformity PN 21 100375 Rev A RetCam3 User Manual Introduction 17 North American compliance certification Serial number Date of Manufacture Keep away from the rain Go to next screen Hide image Delete image Flag or select item Reset View patient directory Utilities PN 21 100375 Rev A 18 Introduction RetCam3 User Manual Product Label Clarit larity Clarity Medical Systems Inc Pleasanton California 94588 Made in USA Model RetCam 3 Class I Equipment Caution Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner E omi 100 240V 50 60 Hz 700W 2X Ti T10A 250V A MediMark Europe BP 2332 F 38033 Grenoble Cedex 2 France S Patent No 5608472 5822036 P N 21 100222 Rev A PN 21 100375 Rev A Using the RetCam 3 19 2 Using the RetCam 3 This chapter explains how to use the RetCam 3 system after it is properly installed at your site The activities described include e Turning the System ON from Stand by Mode on page 19 e Turning the System OFF Stand by Ready on page 21 Using Hard Shutdown on page 22 e Turning OFF the Main Power on page 23 e Managing Patient Records on page 23 Performing Exams on page 26 Using Helpful Features on page 30 e Adding Exam Notes on page 33 Turning the System ON from Stand by Mode New systems are installed by Cl
59. ual will affect the total number of each that can be saved Saving images with annotations reduces the total number of images that can be saved Video Playback When you stop live recording the playback buttons are enabled Reverse pause and play Fast forward Go to the beginning of the recorded video Go back one video Advance one video Go to the end of the recorded video Control the rate of playback or search Tip Using the left and right arrow keys on the keyboard will also move the video back or forward one frame at a time Deleting a Video To delete a video in the thumbnail view select the delete icon x at the bottom of the frame This marks the video for deletion when you exit the exam The delete icon X toggles that is selecting it again before exiting the exam means the video is no longer marked for deletion Note Images and video can be selected for deletion only during the imaging session Once the session has been exited the images will be saved for that session Using Helpful Features The RetCam 3 software includes some useful features to streamline your work Shortcut Keys An underlined letter indicates a quick key To use a quick key press ALT and the letter key simultaneously Note Do not use Windows shortcut keys for example Copy Ctrl C Paste Ctrl V Undo Ctrl Z and others Still Images From Video During video replay you can identify and save still images from the exam There
60. utton Figure 4 Control panel 3 Attach the desired lens piece to the Handpiece as shown in Figure 5 and Installing Lens Pieces on page 21 Align lens piece to fit over pins alignment pins on handpiece Carefully tighten clockwise until it clicks in place Do not overtorque Figure 5 Installing a lens piece on the handpiece RetCam3 User Manual PN 21 100375 Rev A RetCam3 User Manual Using the RetCam 3 21 Installing Lens Pieces A Fit the lens piece on the handpiece aligning the 3 radial pins on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece B Twist the lens piece clockwise as shown in Figure 5 until you hear a click indicating that the lens piece is locked in place 4 Verify that the handpiece is connected to the system as shown in Figure 6 Figure 6 Handpiece connections Always return the handpiece to the holster when it is not in use You can drape the handpiece cable over the cord wrap post but do not wrap it tightly or damage to the fiber optics may result WARNING Carefully inspect and clean the lens piece before each use DO NOT use if the lens piece has nicks breaks scratches or rough surfaces that may damage the eye PRINTER Extend the printer shelf fully and verify that sufficient paper is installed in the printer The shelf can be pushed back in 6 When the software is ready you will see the message Not Displaying Patient
61. ve Imaging e Select Exit Exam Go to Patient List to save note and return to the Patients and Exams screen e Select Exit Exam amp Go to Image Review to save note and return to the image review screen RetCam3 User Manual PN 21 100375 Rev A 34 Using the RetCam 3 You can add notes also from the Review screen Once saved the text cannot be modified You can append text to notes from the Review Compare and Image Process screens by selecting Exam Notes Notes are identified by date time and person creating the note RetCam3 User Manual PN 21 100375 Rev A Image Review and Compare Mode 35 3 Image Review and Compare Mode Having acquired images they are available for review and comparison This section covers the following topics Image Review Screen below Compare Mode page 37 Image Review Screen The Image Review screen appears optionally when you exit live imaging You can also access it by selecting the Exam Review button on the Patients and Exams screen IVFA post laser ROP ID Unspecifie 05 15 2007 5 15 2007 4 08 PM _0 000 ROP Unspecified 30 Wh Exam Date Y 4 YE I da e Jd ia ED Ka e 14 EN Ka ER ka ED tag E Mie is rails E Show hidden images Print image Fit image Compare Figure 26 Image Review screen The Image Review screen displays the images acquired in the session just completed When you access the Image Review Screen by other means it displays the images for the la

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