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Stratus OCT User Manual - Clarity Medical Systems

1. Complete EXPO GE 81 vil Lu eege 82 e Networking a RetCam Shuttle 85 e Configuring Permanent Access to Network File Ghares 86 POGUAINGLWORIG e E 86 e Accessing the Network Klee desteertsgesg e Eesen enges baw einnueanadevserdeuecenanes 91 PN 20 000106 Rev C e Removing a Network Place uk 92 e Connecting RetCam Devices to an Existing Network 92 T OUO S oone 95 ME 95 System ldentification cccecccccsseeceeeceeseeececeeseeececeueeeeceeseeeeeceeeeeesseuseeessueeesessages 95 E Ee ag MOM OM EE 96 Networking Connechons cccccsssseccccessecceceeeecececeeeeeeeeeuueeeecsuaueesesaaeeeesenaneesessages 96 AGIUSE Dale EIERE 96 EE EE ege Ehe 96 EENEG e EEN 96 t DISK Manage meNon a E AE 97 8 Maintenance and Gupport 98 e Recommended Maintenance Schedule nnnennnsennesenensnnnsrnrnenrensrrresnnesennne 98 EE later EE 98 Cleaning tne EE 98 e Cleaning the Rest of the System ccceecseeeeeeeceaeeneeeeeeeeeaaaaeeeeeeeeaaaaseeeeeeeaaaaes 99 FUSE Hepnlacement 109 e Replace Illumination Lamp 110 KEY VallGavlOn DE 112 Technical SUD DOM EE 114 HOWTO GeV SUDDOR EE 114 e Technical Support Contact Ioiormaton 114 Returning Parts i0r Repar ee EE 115 e Service Information EE 115 d e Eet en EE 116 Leite E 116 s e 116 S EICC IC E 116 ET EE 116 CUSTOM d Le nh lge 116 e Handheld Imager EE 116 Notebook eine EE 117 s GONW E 117 Environmental Co
2. During procedures a When cleaning used instruments When disposing of used needles and When handling sharp instruments after procedures To prevent needlestick injuries ophthalmic medical personnel should be instructed in the proper handling of needles Le needles should not be recapped or purposely bent or broken by hand removed from disposable syringes or otherwise manipulated by hand Health care workers should be instructed to place disposable syringes and needles scalpel blades and other sharp items in puncture resistant containers following their use Puncture resistant containers should be provided and should be located as close as practical to the area where needles and syringes are in use Newer devices have engineering controls such as injury protections and needleless systems to Minimize injuries RetCam Shuttle User Manual OSHA s revised Occupational Exposure to Bloodborne Pathogens Standard now requires that the employers governed by this rule review annually and update to reflect changes in technology that could reduce exposure to bloodborne pathogens and maintain a sharps injury log OSHA s Bloodborne Pathogens Standards applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials However workplaces with 10 or fewer employers are exempt from OSHA recordkeeping requirements including a Sharps Injury Log B Fluorescein and Indocyanine gr
3. Cancel Figure 34 Sample Print Information dialog The Printer and Paper Size fields display the default printer and paper size for printing either a report or an image based on the screen from where you click Print Use the Printer and Paper Size drop lists to select from the available options Be mindful to select the appropriate printer and paper size for printing either images or a report RetCam Shuttle User Manual PN 20 000106 Rev C 62 Review and Compare Images Print Information Notices The Print Information dialog provides reminder messages based on your printer setup to help you use the correct paper size since images and reports are intended to be printed on different sizes of paper Report information will not fit on image sized paper and printing images on larger paper will use an unduly large amount of ink The example below shows the two possible messages that may appear depending on whether you are printing a report or an image and whether or not you have separate printers selected for image and report printing i Print Information x Frinter Vvalley Canon iRSS O iIR6570 PCL6 Basil Paper Size Letter MM Printer Options A Notice 1 Please check if the printer has the correct size paper in ithe tray or cassette D Notice 2 Please choose Letter or A4 for the best fitting report i printing Cancel Print Figure 35 Sample Print Information dialog showing both possible mess
4. IEC 61000 4 2 material the relative humidity should be at least 30 Electrical fast 2 kV for power supply 2 kV for power supply Mains power quality should be that of a typical transient burst commercial or hospital environment IEC 61000 4 4 Surge 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical IEC 61000 4 5 2 kV line s to earth 2 kV line s to earth commercial or hospital environment Voltage dips short gt 95 0 5 cycles gt 95 0 5 cycles interruptions and 60 5 cycles 60 5 cycles voltage variations on power supply input Mains power quality should be that of a typical commercial or hospital environment If the user of the RetCam Shuttle requires continued operation during power mains interruptions it is recommended that the RetCam Shuttle be powered from an uninterruptible power supply 30 25 cycles 30 25 cycles lines gt 95 250 cycles gt 95 250 cycles IEC 61000 4 11 UPS Power frequency 3 A m 3 A m Power frequency magnetic fields should be at 50 60 Hz magnetic levels characteristic of a typical location ina field typical commercial or hospital environment IEC 61000 4 8 Conducted RF 0 15 80 MHz 3 Vrms 0 15 80 MHz 3 Vrms Portable and mobile RF communications IEC 61000 4 6 80 1 KHz AM equipment should be used no closer to any z part of the RetCam Shuttle including cables Radiated RF 80 2500 MHz 3 m 3 V m than the
5. Changing Image Type Click on the Image Type drop list to select Retina Anterior Segment or Other during this imaging session All selections record the images in color Image type is saved with the image Changing Lens You can also select a different lens piece during imaging Click on the Lens drop list to select 1300 ROP 1200 Children s 800 Posterior 300 High Mag or Other Lens piece selection is saved with the image RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 53 Video Mode lt gt Note The video buffer can capture about 30 seconds of video Depending on the current state of the system the size of the video buffer may vary Clarity Image 12345 Age This Session 3 years 11 months Session Items O Doctor Eye Doctor Gender Male Disk Space Usage Estimated space for 92347 images Mode O Still video Eye Right Eye OD Image Type Retina Lens 1300 Stop Recording Save Video Save Still Reset Video 3 Rd Cancel Session Cancel Sessio 42 50 sec remaining a DI gt K a P P RetCam Shuttle 9 18 2007 10 23 AM Figure 28 Live imaging screen in video mode In video mode the following buttons are available on screen e Start Recording Starts recording video e Stop Recording Stops recording video e Save Still Saves a still image to the hard drive e Save Video Saves the re
6. Click Print to print the two images displayed on this screen one on top of the other Printing The Print button appears near the top right of screens when printing is available VG 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 RetCam Shuttle to a network or any externally powered devices or peripherals during imaging Printing Images You can print images from the e Review Screen Prints the single image currently displayed e Compare Screen Prints the two displayed images one above the other e Process Screen Prints the processed image currently displayed For the image printer the default paper size is set to 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 Reports You can print reports from the e Patient Select Screen Prints the displayed list of patients e History Screen Prints a detailed report for the selected patient e Gives the option to print Patient History report or an ROP report Reports are formatted to fit on US Letter or A4 paper Recommended Printers and Supplies ve Note Clarity recommends that you use only those printers that Clarity supplies with or has identified for use with the RetCam Shuttle Clarity also sells printer supplies photo paper and ink for the printers it supports
7. EE 44 TAI SLO SOV CIN ee 45 Patient SESSION Gelechor 46 e Print Patient History Or ROP Hepnort 47 NEW SESSION SCCM ME 49 Slat MA GINO EE 50 Elle EE 51 Ee lee 53 EE 56 Review and Compare Images nnnonnnnennsnnenenenrnnesnrnsnrenerrnennnne 57 REVIEW SCLC CM EE 57 SSES ee Ee EE aces 59 Compare SCLOEIN sec ancewdt eege ee 59 PINT AM AG OS aie a a aaa a a E cauuekeee seen iursuedesecass 60 FEMME oa e a 60 e Printing leet e LEE 60 Printing FRC DOMS se a sawed te cast odes a eel eee aden eee 60 e Recommended Printers And Supplies nnnnnenenensennensennnessrrenesrrrrnsrrrrnsrnrrrnsnrrrenn 60 e Set Default Image and Report Printers cccccsscccceessseecceeeeseeeeseeseeecsnaneeeeesaaes 61 Include on gute L ieler 61 atc lol de Weg nde Lee EE 61 Process IMAGES EE 64 va RER EE 64 SESSION NEES geeeebeegegeeegsdekteehtegegtee geed eege DEE EES deEEe EE 65 FRO tate E 65 lt PANNOALS IMAG LEE 66 e Adjust Image Display Harameteres un 67 EECH 68 e Save and Export Processed Images 68 ala TANSICN essers Getewireadauetontinmeteazeciniecnnes 72 PUMDOSES Sharing and BACKUD secsccsseeneloeseere ts cdegsteteswesenee reste va cdaseeelneuees 72 e Backup Recommendation Network or Removable USB Mass Storage Device 72 e Recommended Scenario for Multiple RetCam Gvstems 73 TRAN STO SCTE ancs a 74 EX DOM EE 75 Select Images Tor EXPOrt EE 75 Select Export Optons 77
8. Figure 42 Transfer screen Use the Transfer screen to perform data transfer both export and import When it opens most of the screen displays thumbnails for the current session of the selected patient R Eye L Eye and All tabs and the Show Hidden checkbox appear above the images at left with All shown by default These enable you to display only right or left eye images and whether to display hidden items not shown by default On the right the Transfer To area includes the Select drop list and the Deselect All and Export buttons the Transfer From area provides the Import button The current patient and session information appear as usual at the top You can change the selection at any time using the Patient Session Selector icon at upper left See Patient Session Selector on page 46 for details on its use RetCam Shuttle User Manual PN 20 000106 Rev C visible Items Flagged Items Entire Session Entire Patient Today s Items All Patients Last 7 Days Items Al Patients Search Result Using Patient Select options Figure 43 Select drop list Data Transfer 75 Export You can export data to any accessible location There are three general steps to complete export with several options within each one 1 Select Images for Export below 2 Select Export Options page 77 3 Complete Export page 81 WARNING Never connect the RetCam Shuttle to a network or any externally powered devices or perip
9. Folder dialog appears Import Folder RetCam supported files hdr mit aml amis mrli files are going to be imported from the source location Source location WeledServer ImageShare 20061201 0704005 Included subfalders C Delete source files and subfolders after import C Overwrite existing records Im po rt Figure 50 Import Folder dialog By default it shows the Source location path and all the options last used VG Note If you follow the recommendations here importing from a single patient subfolder in the main export or backup folder each time you will find the desired patient subfolder in the same path but have to browse to select the specific desired patient subfolder 2 To change the source location click Browse A standard Browse dialog appears open to the last import folder used BZ Tip for Network Import The first time you specify the source location for network import in the Browse dialog look for the source server by selecting My Network Places gt Entire Network gt Microsoft Windows Network gt computer name gt standard export folder where computer name is the name of the source computer and standard export folder is a folder in the root directory where you regularly export files The source computer may be a server or another RetCam station 3 In the Browse dialog find the location from where you want to import files and click Open The path will be automatically entered
10. Ge RetCam Viewing mls Wo My Computer E J My Network Places C Open Standard bmp sml o Entire Network Image 9 Image 10 l Recycle Bin Make New Folder Figure 62 Accessing the network place created All subfolders of the network place can then be accessed as permitted by the privileges associated with the user name used to create the network file share RetCam Shuttle User Manual PN 20 000106 Rev C 92 Data Transfer Networking Connections RetCam Shuttle User Manual Removing a Network Place There is no limit to the number of network places which can be added Should you want to remove a network place to eliminate access for a given user account follow these steps 1 Click the Connections button in the Utilities Screen see page 95 to open the Network Connections dialog EER s Network Connections ar File Edit Mem Favorites Tools Advanced Help ba Search ee Folders gt Ki E Address S Network Connections kl EJ co LAN or High Speed Internet e Local Area Connection E Connected Firewalled r t ES Intel R PRO 100 YE Network Wizard wit New Connection Wizard Zu Network Setup Wizard a 5 Figure 63 Network Connections dialog 2 Inthe address bar type in My Network Places and press Enter Address W My Network Places bk E 3 In the list that appears select the network place you wish to remove and press the Delete key A dialog will prompt you to
11. Gender Male Gestation 4ge 34 weeks Date of Birth 2 22 2007 Retinitis pigmentosa Sample Patient Notes Creation Date Doctor Note 8 27 2007 Pleasanton This is just a test Session List Number Right Eye OD Items Left Eye OS Items RetCam Shuttle 8 29 2007 5 57 PM Figure 21 History screen For the currently selected patient the History screen displays patient notes and a session list that includes a list of images items for each session by eye Columns in the session list provide the following data e Session Number e Session Date e Image type and quantity in that session under Right Eye OD Items and Left Eye OS Items RetCam Shuttle User Manual PN 20 000106 Rev C 46 Start Patient Select New Session Patient Session Selector Click on this icon to e select another session for this patient or e select another patient The Patient List tab appears sorted by last name mm oe Patient List Filter Patents Patient ID Last Name FirstName 2 SG 121212 Smith John i 10 04 2004 2 10 11 2004 Patient ID Last Name First Mame 28586 Smithi Ling w 27289 Smith Mary E 24313 Souder Zack Figure 22 Patient List tab The Patient List displays all patients from the last source you selected resident patients or other media If you have a very large database the list may take a while to appear Scroll the list to find and select the desired patient Use the expandable
12. Live imaging screen in still mode In still mode the following buttons are available on screen e Eye OD or OS Drop list enables you to change to other eye e Image Type Current type Drop list enables you to specify image type e Lens Current lens type Drop list enables you to specify lens type in use e Freeze Image Freezes image on screen but does not save image e Show Live Unfreezes image and returns to live video e Save Still Saves the current image to the hard drive FIFO buffer e Cancel Session Ends the imaging session Footswitch Capture You can also save an image by pressing the central Snap button on the footswitch In still mode each press of the button saves one image Keyboard Capture You can press S for save on the keyboard to save the current image This is especially useful to save still images while viewing a recorded video RetCam Shuttle User Manual PN 20 000106 Rev C 52 Start Patient Select New Session Changing Right Eye OD Left Eye OS To image the other eye in the same session click on the drop list for Eye and select the other eye OD or OS Eye is saved with the image a gt Note Since you have this option it is important to be careful that you select the correct eye before you save the image Be particularly aware if both eyes are captured in one video clip and then you save still images from it You must select the correct eye before you save each still image from the video
13. ON OFF Figure 6 Main power switch VG Note Do not switch off or disconnect main power during live imaging If you do the live image stream will stop and the system will not restart image acquisition when main power is restored Therefore before removing main power it is best to end a live imaging session first Start a new live imaging session only after reconnecting the AC power Turning on the RetCam Shuttle 1 Plug the main power cord from the RetCam Shuttle system into a properly grounded hospital grade electrical outlet and turn on the main power switch RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 27 2 For imaging if it is not already on switch on the electro optical box inside the lower door This supplies power to the camera and other system components The notebook computer power outlet is always live when the main power is on and the power cord is plugged in pt vip d e E A e a we k D p NM e D ev d an i LH A E Tr r ai Electro optical box power switch f a Figure 7 Lower door open showing electro optical box 3 If not already connected connect the notebook computer to the power supply and the USB video input cable USB video input cable Notebook power DE d P L 4 Power on the notebook If the Shuttle software does not start automatically double click its desktop icon to start the system software When the Her am Shuttle softwa
14. RetCam Shuttle system Resident patients will be noted with a v mark When you select Other Media the Add New Patient and Edit Patient buttons are not available That is you cannot add a new patient record nor edit a patient record while Other Media is selected Add to Resident Buttons When you select Other Media and the system finds RetCam records on any installed media the buttons Add Selected Patient and Add All Patients appear above the patient list The patient list displays all patients found on the installed media by default though you can Search for Patients as explained on page 42 e Add Selected Patient Select the desired patient in the list and then click Add Selected Patient to add this patient to the resident database e Add All Patients Click Add All Patients to add all patients from an installed removable media to the resident database RetCam Shuttle User Manual PN 20 000106 Rev C 42 Start Patient Select New Session lt gt Note When you begin a new imaging session for a non resident patient the system automatically adds this patient to the current RetCam Shuttle site as a resident patient A floppy disk icon lel on a thumbnail in the Review Compare Process and Transfer screens indicates that the image can be found on media that is not currently installed in the system Adding RetCam 120 Data to the FIFO Buffer The RetCam Shuttle software provides a way to add RetCam 120 data to the hard drive FIF
15. THAN 15 MINUTES Immersing more or longer than this causes corrosion of the lens piece and voids the lens warranty Use water bleach 3 hydrogen peroxide or isopropyl alcohol Permissible immersion depth is illustrated in Figure 69 below It is important not to immerse the joint where the polished metal tip meets the painted housing since it is susceptible to corrosion o_O Figure 69 Inverted lens piece showing permissible depth of immersion Cleaning the Rest of the System As with any medical device use good public health practices when handling 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 directly on the computer or other modules spray the cloth instead The cart and side panels also cannot be sprayed but only the cloth with which you wipe to avoid introducing spray or mist inside the system Use only a mild soap and or water solution RetCam Shuttle User Manual PN 20 000106 Rev C 100 Maintenance and Support The lens piece should be checked before each use for damage to the front contact lens and surrounding surface The interconnect cable and connectors should be checked for damage to the end connectors and protective covers A N WARNING Always inspect the lens before use for damage such as chips cracks or roughness that could injure the patient s eye RetCam Shuttle
16. User Manual PN 20 000106 Rev C Maintenance and Support 101 _ e AMERICAN ACADEMY Information Statement eng Cora reueg The Eye M D Association Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Introduction This document is intended to provide guidance to ophthalmologists and their staff about minimizing transmission of infection in their offices and operating rooms This document addresses prevention of bloodborne pathogens such as human immunodeficiency virus HIV hepatitis B virus HBV and hepatitis C virus HCV and other viruses such as adenovirus and herpes simplex virus These recommendations are mainly based on broad guidelines issued by the U S Department of Health and Human Services DHHS and the U S Department of Labor for health care workers Bloodborne pathogens may be present in blood blood contaminated products or other bodily fluids especially if contaminated with or mixed with blood Percutaneous injuries e g a needlestick or cut with a sharp object represent the greatest risk of transmission of bloodborne pathogens to health care workers Universal precautions apply to blood and other body fluids containing visible blood but not to tears unless they contain visible blood The use of universal precautions including handwashing and barriers reduces contact with blood and bodily fluids thus reducing exposure of health care workers t
17. click on a title toggles the sort between ascending and descending order alphabetically and or numerically Numbers precede letters in ordering Select Data Source The Data Set area at upper left enables you to specify whether to display resident patients from the local database or patients found on removable media installed on the notebook computer The default is resident patients You can apply all Her am Shuttle functions to the patient records and images found on the source you select but you cannot add or edit a patient record while Other Media is selected Resident Patients Selected by default Resident Patient includes every patient whose records were created or added to the database while attached to this RetCam Shuttle notebook while the current site was selected see Establish Site Awareness on page 28 for details Note All patient and image data is associated with the site under which it is acquired You cannot access data created while any other site was selected except by adding non resident records to the local database or using Data Transfer see page 72 When you select Resident Patients the Add New Patient and Edit Patient buttons are available That is you can create and edit resident patient records Also you can add the records of non resident patients from installed media thus making them resident patients whose records you could then edit For details see Add to Resident Buttons on page 41 Other
18. disorders incorporates PN 20 000106 Rev C Maintenance and Support 103 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 3 the application of good public health principles and specialized precautions Since the infection was first recognized in 1981 there has been no evidence to indicate that the HIV has been transmitted through any of the diagnostic or surgical procedures performed by ophthalmologists According to the CDC the likelihood of transmission through contact with tears is extremely remote However because the virus is potentially lethal is present in surface epithelia in the eye and in low titers in tears and ocular fluids of infected individuals and can in theory at least be transmitted through mucous membranes public health officials have recommended that reasonable precautions be taken Furthermore because many HIV carriers may be unaware of their infection and show no sign of the disease the following recommendations should be routinely used for all patients Recommendations for the safe usage of ophthalmic instruments and contact lenses are provided These guidelines represent good general ophthalmic technique because they reduce the risk of transmitting both bloodborne pathogens HIV HBV and HCY and surface infectious agents e g herpes simplex virus adenovirus etc likely to be encountered in patients presenting for eye examina
19. immune globulin or hepatitis B vaccine in appropriate cases preferably within 24 hours RetCam Shuttle User Manual For personnel exposed to HCV the Public Health Service does not recommend immune globulin or antiviral agents as PEP However there have been studies outside the United States that have utilized interferon early in the course of acute hepatitis C to prevent the establishment of chronic hepatitis C 27 In case of percutaneous or mucosal exposure to blood the CDC recommends that health care institutions have policies to follow up for HCV infection which could include testing of the source person for anti HCY antibodies and follow up testing for anti HCV antibodies of the affected personnel if the source person is found positive for HCV If there is exposure to blood fluid containing visible blood or other potentially infectious fluid not including tears then the status of the source person should be evaluated tor HIV HBV and HCV infection as soon as possible It is recommended that health care organizations have systems in place for prompt reporting evaluation counseling treatment and follow up of occupational exposures to bloodborne pathogens Health care personnel should be educated to report occupational exposures immediately after they occur because treatment can be most effective if administered as soon as possible after the exposure Employers subject to OSHA regulations are required to establi
20. in the Source location field If necessary use the up folder icon to the right of the address field to go up to higher levels of the drive or device directory ch RetCam Shuttle User Manual PN 20 000106 Rev C 84 Data Transfer Included subfolders checkbox Select this checkbox if you want to import images in all subfolders of the source location If not selected 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 in the Browse dialog Delete source files and subfolders after import checkbox To manage the size of the export destination select this checkbox to delete the source files and subfolders after import is complete Note Do not select this checkbox 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 Overwrite existing records checkbox This option is to be used only when you wish to replace previously existing files Select this checkbox to overwrite existing records If not selected duplicate records will not be imported 4 After selecting the desired options click Import A dialog opens to show import progress Work in progress please wa
21. lower portion Showing Connectors 32 Electro optical box drawing upper portion showing color balance buttons 33 Instructions for installing a lens piece to the handpiece nnnannannannnnnnnnnnnnnnnnnnnne 36 Det am Shuttle Splash SCree n ccccccseeccceseeeccaeeeeceeeeeseeeceseeeeesseeeesseeeeeseeeeeeas 38 Patent Select E EE 39 Patient Select screen accessing removable mecdha 41 Patient Information dialog nk 43 PSION SCEN asaina a as sass a ext edie er anak ag eee 45 UCT ISU ebe 46 NOOSE Report CIAO WE 47 Example of an ROP report printout cccccsecccseeeceeeeeseeeecaeeeseueeseneeseueeseueeesaees 48 NEW SESSIONS ChOCN E 49 Select options for eye image type and lens piece o nnnannnonnnennnnnnennennennnrennnnnnne 50 Live imaging screen in Still mode 51 Live imaging screen in video mode 53 Save video IN DEEG 55 Add View Session Notes dalog 56 PROV ICW lt GCIC ER eene 57 Compare Images Scree EE 59 Include on Printout dialog for image printing ccceececeeeeceeeeeeeeeeseeeeseeeeneeeeneaees 61 Sample Print Information dialog A 61 Sample Print Information dialog showing both possible messages 62 Standard PHM OIIO NEE 63 Beie EE 64 Annotate Image dialog eiss a 66 Import open Image dialog ccccceeccceseeceeeeeceeeeceececeueeseeecsueeeseeeeseeeeseueeseeseseees 69 EXPO ODIONS GAl EE 70 PN 20 000106 Rev C Figure 41 Figure 42 Figure 43 Figure 44 Fig
22. recommended separation distance IEC 61000 4 3 80 1 KHz AM calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 12JP 150 kHz to 80 MHz d 1 2 P_ 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 21 WARNING Interference may occur in the A vicinity of equipment marked with this 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 e Increase the separation between the equipment e Connect the equipment into an outlet on a circuit different from that to which the other device s are connected e Consult the manufacturer or field service technician for help Input and Fuse 100 240V 50 60 Hz 250VA T 3A 250V 4 4 A N CAUTION For cont
23. select Last 7 Days Items All Patients e Visible Items Selects all images currently displayed Selects all right eye items in this session if the R Eye tab is selected Selects all left eye items in this session if the L Eye tab is selected Selects all items in this session if the All tab is selected RetCam Shuttle User Manual PN 20 000106 Rev C 76 Data Transfer Visible Items does not select hidden items unless the Show Hidden checkbox is selected Flagged Items Selects all flagged images in this session e Entire Session Selects all images in this session Entire Patient Selects all images in all sessions for this patient e Today s Items Selects all images acquired on today s date e Last 7 Days Items Selects all images acquired on today s date and the six previous dates e Search Result Using Patient Select options Selects all images from all patients found in the last search result BZ Tip for Backup To perform a full backup first search in the Patient Select screen with all search fields blank so the search returns all patients in the database Then in the Transfer screen select Search Result Using Patient Select options in the Select drop list This will result in all images for all patients being exported to the backup destination You can click Deselect All at any time to clear all selections and start over 2 When you have selected the desired items for export click Export The Ex
24. soiled with such fluids and for performing venipuncture and other vascular access procedures Gloves should be changed after contact with each patient Hands and other skin surfaces should be washed immediately and thoroughly if contaminated with blood or other bodily fluids Hands should be washed immediately after gloves are removed Health care workers who have exudative lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment until the condition resolves Pregnant health care workers are not known to be a greater risk of contracting HIV infection than health care workers who are not pregnant however if a health care worker develops HIV infection during pregnancy the infant is at risk of infection resulting from perinatal transmission Because of this risk pregnant health care workers should be especially familiar with and strictly adhere to precautions to minimize the risk of HIV transmission In accordance with these recommendations disposable gloves should be readily available for all ophthalmic medical personnel and they should be instructed regarding the rationale for wearing gloves and their appropriate usage It should be noted particularly that gloves Are not a substitute for handwashing and Are for single use only and should be discarded after each patient encounter C Gowns and Masks Gowns and masks are unnecessary in the normal ophthalmi
25. surface and thus could conceivably be transmitted to other patients Therefore if an instrument such as a slit lamp RetCam Shuttle User Manual biomicroscope has been used for a patient who is suspected of having an ocular infectious disease it is strongly recommended that the surfaces on the instrument be cleaned with alcohol or bleach Trial Fitting Contact Lenses Contact lenses need to be disinfected between patients Rigid gas permeable and hard contact lenses can be disinfected using a hydrogen peroxide or a chlorhexidene containing disinfectant system Soft contact lenses can be disinfected with either hydrogen peroxide or a heat disinfection system E Tissue Transplantation The Eye Bank Association of America has strict criteria in place to screen corneal and scleral tissue for transplantation to prevent transmission of diseases There have been no confirmed cases of occupational transmission of transmissible spongiform encephalopathies such as Creutzfeld Jakob disease The CDC recommends use of stringent chemical and autoclave sterilization methods for heat resistant instruments that come into contact with high infectivity tissues in patients with suspected or confirmed CJD For infection control of transmissible spongiform encephalopathies the World Health Organization recommends the following in situations where there is contact with high infectivity tissues in patients with suspected or confirmed CJD 1
26. these if none is selected an error indicator will display if you try to start imaging Select Lens Plece Select Eye Select Image Type O Right Eye OD Left Eye 035 O Unspecified O Retina O Anterior Segment Other 1300 1200 800 300 O Other Start Imaging Session Figure 26 Select options for eye image type and lens piece Follow these steps to start imaging 1 In the Select Eye area select the radio button for Right Eye OD Left Eye OS or Unspecified 2 Inthe Select Image Type area choose Retina Anterior Segment or Other 3 In the Select Lens Piece area select the lens you are using 1300 ROP 1200 Children s 800 Posterior 300 High Mag or Other 4 When you have made all 3 selections click Start Imaging Session If the electro optical box is on and operating correctly a live image appears on screen 5 In the Mode area at upper right select Still or Video mode These modes are explained in more detail next RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 51 Still Mode Clarity Software 123456789 Doctor Pleasanton Gender Male Disk Space Usage Age This Session 6 months 0 weeks Session Items O 91392 images Estimated space for l E Mode Still Ovideo Eye Right Eye OD Image Type Retina Lens 1200 Freeze Image Cancel Session RetCam Shuttle 8 29 2007 6 07 PM Figure 27
27. to the patient list To either acquire or view images you must select or add a patient Patient Select Screen The Patient Select screen appears first after the Splash screen You can access it any time by clicking its tab or pressing F1 on the keyboard Patient Select New Session H rocess Transfer Utilities Barrer Add N Patient Edit Patient Resident Patient Click any column title to sort O Other Media Last Name First Name Pathology Last Seen 123456789 Clarity Software Pleasanton Retinitis pigmento 1 14 2004 Search Options 3456 Picker Ryan Harbour Software 9 9 2004 Patient ID Last Name Sessions Between From any To any EI Doctor Name Pathology LY Search AND Show All Check this box to show only RetCam patients RetCam Shuttle 8 29 2007 5 29 PM Figure 18 Patient Select screen The Patient Select screen opens showing the complete list of resident patients Click anywhere on the row of the desired patient and then select the History tab to show that patient s history see History Screen on page 45 Patient List Columns The patient list has the following columns Patient ID Patient Last Name Patient First Name Doctor Pathology Last Session Date RetCam Shuttle User Manual PN 20 000106 Rev C 40 Start Patient Select New Session Data Set Resident Patient other Media Sort List by Columns Click on any column title to sort the data by that parameter Each
28. use a backup solution there is no automatic backup You can implement backup using the RetCam Shuttle Data Transfer functionality via your office network or USB connection to an removable USB mass storage device see page 72 for details Backup Recommendation Network or Removable USB Mass Storage Device For long term backup we recommend backing up to another computer on your office network preferably a server class computer with large capacity and redundant storage functionality Redundant Array of Independent Disks or RAID Since USB devices can be directly addressed like a network location and USB devices can have very large capacity we also recommend the use of a removable USB mass storage device For secondary backup in this scenario you may consider using a second removable USB mass storage device Compatible Removable Media For transfer or backup of smaller amounts of data you can use a USB memory stick Like any Windows XP computer the Shuttle computer supports nearly all USB devices While the RetCam Shuttle can read from all standard kinds of CDs DVDs and USB devices it can write only to USB devices during data transfer It cannot write to CD R CD RW DVD R nor DVD RW VG Note From the RetCam Shuttle software you can write transfer data to network folders or USB devices you cannot write to CD R CD RW DVD R nor DVD RW VG Note Clarity Medical Systems has successfully tested many SanDisk brand USB memor
29. 0 on page 43 When selected you can further select the format from among XML extensible markup language format CSV comma separated values format and TXT generic text format This option is offered to facilitate transfer of patient data with standard format images to a PACS system picture archiving and communications system Include Data Complete Export 6 Click Export to export the files to the specified destination e Click Cancel to cancel the export before completion When you click Export a dialog opens to show export progress Please wait for work to complete Esport F 200r0s29_1827086 03200e8d f687 4747 86169 1a16ebdc4233 16 ml O So Elapsed Time 00 00 01 Cancel Remaining Time Figure 48 Export progress dialog RetCam Shuttle User Manual PN 20 000106 Rev C 82 Data Transfer When export is complete an Export Report dialog provides a summary amp Export Report Ka Successfully exported Srecord s out of 5 bema Details Timing Total TimelS items 08 min Speed 9 sec sitem Figure 49 Export successful If not all the selected items were exported the Details pane explains why It could be because some files are duplicates already present in the destination directory or the export file is not found or it is corrupt or the destination is write protected or there is not enough space on the destination disk or media Indexing Delay VG Note If an installed remova
30. Date of Birth e Session Date e Image Number e Pathology e Classification e Image Type e Eye Right Left e Lens Used e Institution PN 20 000106 Rev C Process Images 67 e Department Annotation Placement In the Annotation Placement area in the middle of the dialog click the desired button to select the corner of the image where the annotation will appear Choose from e Top Left e Top Right e Bottom Left e Bottom Right Image Preview The annotations appear in the Image Preview pane for review before saving e Click Set Defaults to set the current selection of annotation fields and placement as the default e Click Save to save all your annotation selections e Click Cancel to quit annotation without saving your changes The annotations you select will remain on the Process Image display until you change the selection Adjust Image Display Parameters Standard Process The right side of the Process screen provides controls to adjust the following image display parameters Re se A d j u stm ents 100 j 100 e Brightness e Contrast e Red e Green e Blue a 2 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 click on the bar to the right or left of the slider changes the parameter value by 10 Standard Process Button The Standard Process button en
31. EG Change The XXX Change button where XXX stands for the current format JPEG Change in the example enables you to change the file format in which images are saved To change the image format in which you will save an image 1 Click XXX Change The Export Options dialog appears Export Options Estimated Size 36 54 KB The JPG image formatis a compressed format with variable quality More compression results in lower quality and smaller files JPG images are viewable on any computer with a web browser Image Quality Low Medium High Preview Figure 40 Export Options dialog You can select from the following image formats e BMP The bitmap format saves images at full resolution without any quality loss It results in the largest files e JPEG JPG This format uses compression to reduce file size which results in loss of quality in proportion to the amount of compression Select the image quality before you save e PNG Portable Network Graphic is a newer format which uses compression to reduce size about half the size of a bitmap but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications 2 Click the desired tab to select JPEG BMP or PNG e If desired click Set Default to make the current selection the default format each time you save an image from the Process screen 3 Click OK to save your choi
32. It is possible to print using other printers not supplied by Clarity or not identified by Clarity for use with the RetCam Shuttle but this is not recommended RetCam Shuttle User Manual PN 20 000106 Rev C Review and Compare Images 61 Set Default Image and Report Printers The Utilities Screen enables you to select the default printer to be used for image printing and for report printing See Printers on page 96 for details Include on Printout for Images When printing images the Include on Printout dialog appears first when you click Print It gives you the option to include the name and patient ID on the image printout Include on Printout Select the fields you wish to include on the printout These will be Included with the session date lens and image type Include on Printout Name Patient ID After the application gets done printing it may take a minute for your image to come out of the printer Cancel Figure 33 Include on Printout dialog for image printing Select the desired checkboxes and click OK to proceed Print Information Dialog The Print Information dialog appears each time you initiate a print operation It gives you the option to select which printer to use as well as the paper size i Print Information E Printer walley Canon iIRSS70 iR6570 PCL Basili Paper Size Letter e A Notice 1 Please check if the printer has the correct size paper in ithe tray or cassette
33. Media Click Other Media to access RetCam images on removable media e g USB device installed on the RetCam Shuttle notebook You can install removable media in either the CD DVD drive or a USB port The RetCam Shuttle can read from all standard kinds of CDs DVDs and USB devices The patient list displays all RetCam data and images found on the installed disks or devices provided that automatic indexing is enabled No patient data will appear if automatic indexing is off Note Automatic indexing is off by default To turn on automatic indexing go to the Utilities screen and select the Auto Index External Media Checkbox see page 97 RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 41 Patient Select ew Session Leview rocess Transfer Utilities Add to Resident SE E Add Selected Patient Add All Patients e External USB CRUZERMICRO Data Set OResident Patient ID Resident Last Name First Name Doctor Pathology Last Seen 34534535 Anterior Testing Doctor M Clarity 3 9 2007 123456789 Clarity Software Pleasanton Retinitis pigment 1 14 2004 Search Options Patient ID Last Name Sessions Between From lany To any Doctor Name Pathology EN Search AND Show All Check this box to show only RetCam patients RetCam Shuttle 8 29 2007 5 45 PM Figure 19 Patient Select screen accessing removable media These images may or may not be from patients resident on this
34. New Site 28 Specify Destination Location 77 Splash Screen 14 38 Standard Process Button 67 RetCam Shuttle User Manual Index 123 Start Imaging 50 Start Imaging Session 50 Start Recording 53 Status Bar 30 Still Mode 51 Stop Recording 53 Storage 16 Storage and Backup 36 Storage Compartment s 12 System Hardware 10 T Technical Support 114 Technical Support Contact Information 114 Telephone 114 Today s Items 76 Transfer Screen 74 Transfer To area 77 Transport 16 Transport Handle 12 Turning Off for Extended Periods 32 Turning off the RetCam Shuttle 31 U UL Label 25 Unflag Image 58 Unhide Image 58 User Safety Notices 22 Utilities 95 Utilities Screen 95 V video clips 58 Video Mode 53 Visible Items 75 X XXX Change button 80 PN 20 000106 Rev C 124 Index RetCam Shuttle User Manual PN 20 000106 Rev C T S m Clarity medical systems 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 251 0078 Toll free 1 800 215 6005 RetCam Shuttle User Manual www claritymsi com PN 20 000106 Rev C
35. O buffer area that eliminates the need to insert old RetCam 120 disks If you have RetCam 120 data you wish to add to your RetCam Shuttle contact technical support for assistance Search for Patients The Search Options area on the left side enables you to search for patients using one or more of the available search fields Patient ID Patient Name Sessions Between date range Doctor Name and Pathology Enter search criteria in a field and click Search to populate the patient list with all patients who match the entered text for all criteria you used e Click the Show All button to display all resident patients at any time e Click Clear to clear all search fields so you can start a new search Search by Patient ID Type in the whole patient ID or just the first few characters usually numbers and click Search The list will display all entries that start with the characters entered Search by Last Name Type in the whole last name or any portion of it The list will display all patients whose last name contains the text you entered Search by Date range To specify a date range under Sessions Between click on the down arrow next to the From field and the To field and select a date for each The list will display all patients with imaging sessions created within the date range specified Search by Doctor Select from the drop list or type in a name Only doctors of resident patients are included in the drop list Search by Patholog
36. 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 e 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 e NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE IS PROVIDED AS IS AND WITH ALL FAULTS THE ENTIRE RISK AS TO SATISFACTORY RetCam Shuttle User Manual PN 20 000106 Rev C 120 License Agreements RetCam Shuttle User Manual QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYJENT OF THE SOFTWARE OR AGAINST INFRINGEMENT 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 aircra
37. RetCam Shuttle Wide Field Digital Imaging System User Manual PN 20 000106 Rev C For use with software version 4 1 ATTN Clarity medical systems Copyright 2007 Clarity Medical Systems Inc All rights reserved RetCam Shuttle User Manual PN 20 000106 Rev C Contents T Vue e Ue e EE 9 Indications Eeer 9 e Purpose and Organization of this Manual 9 System HardWare socieda ia DE EE EEE E EE DN EEDE 10 e Hardware COMPONCINS x seccicccgnensicrd ovcsiscedlweaetaacsdnsmanddendbasedagtads doveesenthdenecustecaaeiecsaad 11 e Software Overview RetCam Shuttle Screens and Funchons 14 w SPAS gro 1 2 eebe 14 EA EE 14 History Sereen wisc westenecesincazeccetczcedceduceddstseodaciddadeesacgbleSaciaumcactandenctcsaemeteacteeseks 14 New Session Screen Ei 14 e Foon Sere FA E 15 Compare S ren glo EE 15 Proc ss Beren E 15 iransier Zeene e chwedpsbaeawarecbeleenuncensxntanddieamainemcante 15 Wie ee A a E 16 e Software Note Reboot to Refresh Drop Lists cccccccesseeeeeeseeeeeeceeeeeeesseeees 16 REENEN 16 TM Le EE 16 e Electrical Safety Information cccccseecccsseeeeseeeeeseeeeeeeeeeesseeeeesaneeeseeeeesaaes 18 e Electromagnetic Emissions kA EEN 19 e Electromagnetic Immunity EE 20 MUU ana A GE 21 ale Ly MOMAN EE 21 e European Authorized Representative Address cccceccseeseeeeeeeeeeseeeaeees 21 MA ee 22 e Important User Safety Notic
38. STRUCTIONS FOR INSTALLING LENS PIECE TO HANDPIECE Figure 16 Instructions for installing a lens piece to the handpiece Instructions for Installation of All Lens Pieces 1 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 2 Twist the lens piece clockwise as shown until you hear a click indicating that the lens piece is locked in place AN WARNING Always inspect the lens before use for damage such as chips cracks or roughness that could injure the patient s eye Storage and Backup The hard drive on the RetCam Shuttle notebook computer serves as the initial storage media Images taken directly from RetCam Shuttle are stored on a partition of the hard drive for easy access This area on the hard drive is called the FIFO buffer which stands for First In First Out Its capacity is about 10 GB less than the full hard drive capacity If the partition becomes full the oldest files are deleted to RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 37 make room for the new files This is done without warning Each RetCam still image takes about 600 KB of disk space Depending on usage the FIFO buffer can contain several years of data A N WARNING Permanent data loss is possible if no backup solution is employed To preserve data before it starts to be removed from the FIFO buffer we recommend you
39. U S and Canada or direct at 925 463 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 E Validate Key Figure 76 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 BZ 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 RetCam Shuttle User Manual PN 20 000106 Rev C 114 Maintenance and Support Technical Support How to Get Support The User Manual and Service Manual have been written to answer the majority of questions that arise with the product Please consult these manuals before calling for service The in house technical staff of Clarity Medical Systems Inc CMS is dedicated to helping our users with any specific problems and questions you may have with the RetCam Shuttle Please have your serial number ready and include the serial n
40. Use single use surgical instruments 2 Avoid mixing instruments used on tissues of high infectivity vs no infectivity 3 Destroy re usable instruments where possible 4 If destruction is not possible decontaminate instruments The Risk of Acquiring HIV Infection from Ophthalmic Medical Personnel The risk of patients being infected by an ophthalmologist or ophthalmic medical personnel who has been infected with the HIV is considered extremely remote Standard office practices as discussed above will minimize even the unlikely risk of contamination of patients Surgical patients are protected by the routine use of barriers e g gloves Certainly an instrument that punctures the skin of an ophthalmologist or the surgical assistant must be removed from the operating field and sterilized The surgeon or assistant must reglove after all bleeding has stopped and any residual blood has been removed The CDC Guideline for Infection Control in Healthcare Personnel also provides advice about management of patient contact and other situations when health care personnel have HIV and other illnesses which could be transmitted to patients PN 20 000106 Rev C Maintenance and Support 105 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 5 I Procedures for Protection for the Staff Protection of the ophthalmic medical personnel invalves preventive measures to a
41. V infections and failures of PEP 1 800 893 0485 HIV AIDS treatment information service www hivatis org Date issued March 1 2002 Approved by Quality of Care Secretariat Acknowledgements The Academy gratefully acknowledges the valuable time expertise and effort of the following individuals in reviewing this document Gary Holland M D Elaine Chuang M D Jay Pepose M D Alice Matoba M D Douglas Jabs M D and Eric Donnenfeld M D of the Ocular Microbiology and Immunology Group PN 20 000106 Rev C Maintenance and Support 109 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 70 Figure 70 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 71 Figure 71 Opening the fuse holder cover Remove the fuse holder See Figure 72 Cover open Gently pry at edges to start removal Finish removal with fingers Figure 72 Removing the fuse holder RetCam Shuttle User Manual PN 20 000106 Rev C 110 Maintenance and Support Remove the blown fuse from the fuse holder and replace it with a new fuse of same type and rating See Figure 73 Figure 73 Blown fuse removed lt gt Fuse Type T 3A 250V A N CAUTION For continued protection against risk of fire replace only with
42. Video Replay Video replay enables you to identify and save the optimal still images from the session Follow the steps below to save still images during video replay Ve Note To save still images during video replay you must first pause the video playback Clicking Save Still or pressing S on the keyboard will not save a still image during video replay 1 Start playback by clicking Play gt or Reverse lt f 2 Click Pause when you see an image you want to save 3 To find the most favorable video frame to save click Advance One Frame id or Go Back One Frame lt a You can choose from approximately 30 frames per second 4 When the preferred image is displayed click Save Still or press S on the keyboard 5 Click Play gt lt to resume video replay and repeat the process if desired or Reverse RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 55 Saving Video Clips A N WARNING Recall that the FIFO buffer on the notebook hard drive has limited capacity and when it becomes full the oldest files are deleted to accommodate new images Therefore because video files are so large saving video often can trigger deletion of files from the notebook s FIFO buffer If deleted files are not backed up they are lost permanently For this reason we do not recommend saving whole videos Rather we recommend saving still images from recorded video and then cli
43. Windows Explorer Right click the folder and select Sharing In the Sharing tab of the folder Properties dialog select the options to share the folder Create Subfolder Checkbox Select the Create subfolder checkbox to create a subfolder for the exported files within the default export path The system automatically generates a unique name for the subfolder composed of the current date and time To provide the name with a more recognizable meaning for example a patient name you may add text to it retaining the unique date and time or change it completely RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 79 LZ Tip for Backup When performing routine backup to the backup location make sure you select the RetCam Viewing mIx radio button so you save the images in a format accessible by a RetCam system Then clear the Create subfolder checkbox and select the Organize patients into subfolders checkbox When you export the system will create a subfolder for each patient whose images are exported The name of each patient subfolder is composed of last name first name and patient ID for example Wingate David 12345 If the Create subfolder checkbox is cleared you have created a condition where routine backup results in one recognizable folder for each patient being present in the backup location If the Create subfolder checkbox is selected each incremental backup will create its own subfolder and files for the same patie
44. ables you to either apply the currently saved display settings to the image or to save the new display adjustments you have made When you click Standard Process a dropdown menu gives you two choices e Apply Saved Settings Applies the currently saved settings for Brightness Contrast and Red Green and Blue Image display adjustments are applied to RetCam Shuttle User Manual PN 20 000106 Rev C 68 Process Images all images in the current image processing session until you save new settings or click the Reset Adjustments button which resets all parameters to zero e When you leave the current session the display settings are reset to zero e Save Current Settings Saves the current settings for Brightness Contrast and Red Green and Blue Now the settings can be applied when you select Apply Saved Settings Reset Adjustments Button Click Reset Adjustments to reset all display parameters to zero lt gt Note Images you save from the Process screen will reflect image display adjustments and all other changes you make but the original images in the database will not be changed Print Image Click Print to print the current image processed or not Save and Export Processed Images You can use the Process screen to save images in the standard JPEG BMP and PNG formats in any accessible network location The group of three buttons at lower Open i Save right enable you to access images from and save images to these lo
45. ages The two possible messages are RetCam Shuttle User Manual e Please check if the printer has the correct size paper in the tray or cassette e Please choose Letter or A4 for the best fitting report printing PN 20 000106 Rev C RetCam Shuttle User Manual Review and Compare Images 63 Printer Options Click Printer Options to open the standard Print dialog where you can adjust print options for this job like number of copies or access the printer Properties dialog Printer Name Deskjet D4100 series Properties Status Type HP Deskjet 04100 series Where USBOO1 Comment Print to file Print range Copies e All Humber of copies H 2 z CC w CED Cancel Figure 36 Standard Print dialog Print When you have made your selections and installed the correct paper if necessary click Print in the Print Information dialog to print the image or report PN 20 000106 Rev C 64 Process Images 5 Process Images The Process screen enables you to perform image processing on saved images and then to save and export them in standard image formats for viewing on third party systems lt gt 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 This section covers the following e Process Screen below e Session Notes
46. and from the system and the multiple locations where it may be used With the exception of a fluorescein angiography light source and attached printers the RetCam Shuttle offers the same basic functionality as the RetCam Il the leading choice for wide field pediatric retinal imaging The imaging system including camera and lens choices is identical as are the image viewing processing and other utilities The system is designed for easy operation by either a clinician or trained staff members Using the integrated notebook computer you have point and click access to all functions via the system software You can use the RetCam Shuttle to quickly capture display process and transfer high resolution digital images Indications for Use For general ophthalmic imaging including retinal corneal and external Purpose and Organization of this Manual This manual serves as a usage and reference guide for the RetCam Shuttle It first provides introductory and safety information Chapter 1 Introduction and then system level information Chapter 2 System Functions page 26 It is then organized according to the expected sequence of use as follows e Chapter 3 Start Patient Select New Session page 38 e Chapter 4 Review and Compare Images page 57 e Chapter 5 Process Images page 64 e Chapter 6 Data Transfer page 72 e Chapter 7 Utilities page 95 Succeeding chapters cover Maintenance and Support Specifications and License Agreem
47. ate a separate destination location the first time you transfer data for backup purposes Then when performing routine data backup always select the same path for backup Also make sure the Create subfolder checkbox is clear and the Organize patients into subfolders checkbox is selected For details see the Tip for Backup under the Create Subfolder Checkbox on page 78 VG Note For simplicity in performing data transfer and finding exported files we recommend you use a single destination location for all export operations except that you should use a separate location for backup To distinguish exported files you can use the Create Subfolder Checkbox the use of which is explained on page 78 VG Note If exporting to a network location the system must be connected to the network to see it in the Browse dialog If using removable media check the amount of space available to make sure there is enough room before you export The size of data in MB selected for export appears in the Transfer To area of the Transfer screen 4 In the Browse dialog find the location where you want to export the files and click Open The path will be automatically entered in the Path field Ki e If necessary use the up folder icon to the right of the address field to go up to higher levels of the drive or device directory RetCam Shuttle User Manual PN 20 000106 Rev C 78 Data Transfer i P e To create a new folder where you will export the ima
48. ated in the center of the lamp socket s opening 9 Push the lamp assembly drawer back into the EO box carefully Use caution to avoid pinching wires in the area 10 Replace the two screws on the small front panel Key Validation VG Note New RetCam Shuttle systems ship with their license key already registered and validated However significant changes to the system RetCam Shuttle User Manual PN 20 000106 Rev C Maintenance and Support 113 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 affect system or software upgrades when you can manage two business days without use of the system lt gt 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 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 toll free at 800 215 6005
49. atic White Balance AWB on page 34 for instructions When to Adjust Color Balance Clarity Medical performs these procedures at the factory before shipment You should have to adjust the camera color balance only rarely and then only in the following circumstances e The colors of the live image are very different from the real object e If you suspect that the AWB or ABB button was pressed accidentally When one of these circumstances apply we recommend you perform first a black balance and then a white balance in that order If you find that you must adjust the color balance frequently without having accidentally pressed one of the buttons please contact Clarity Customer Service See page 114 for Technical Support Contact Information Automatic Black Balance ABB The automatic black balance adjustment corrects the camera controller to display black accurately To adjust the automatic black balance follow these steps 1 With the RetCam Shuttle running initiate a new imaging session and check on screen to see that the camera is working receiving an image Note To start a new imaging session you must select or create a patient record 2 Disconnect the lamp fiber optic cable from the EO box The handpiece should now not be projecting any light 3 Hold the front of the handpiece with or without a front lens against a towel or soft cloth to block all light from entering the camera 4 Press the ABB button on the f
50. ble media already has data on it the system may need to index the data before export When indexing an I appears in the status bar along the bottom of the screen I 10 11 2004 7 40 PM T means indexing is ongoing During indexing system functions may be a little slow and the system will complete indexing before initiating the export In this case it may take a while for the export to complete VG Note Automatic indexing is off by default To turn on automatic indexing go to the Utilities screen and select the Auto Index External Media Checkbox see page 97 Import 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 lt gt Note We recommend that you do not import more than 15 000 images in one import operation because it may take a long time One way to be sure is to RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 83 import only the files from a folder to which you or someone else exported a limited number of images In general we recommend you import images from one patient at a time as described in the Recommended Scenario for Multiple RetCam Systems on page 73 Follow these steps to import RetCam images 1 On the Transfer screen click Import The Import
51. c infection The risk of developing clinical hepatitis from exposure to the blood that was both hepatitis B surface antigen HbsAg and hepatitis E antigen HbeAg positive was 22 to 31 Any person who is seropositive for hepatitis B surface antigen can be infectious The CDC recommends that health care personnel who have routine contact with blood and bodily fluids be vaccinated For applicable settings the OSHA standard requires that hepatitis B vaccine be made available to personnel with occupational exposure to blood at the employer s expense American Academy of Ophthalmology 906 HO Box J424 San Francisco CA 94120 7424 415 561 8500 http aao ong RetCam Shuttle User Manual PN 20 000106 Rev C 102 Maintenance and Support Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 2 HCY is the cause of most parenterally transmitted cases of non A non B hepatitis in the U S There is no vaccine currently available and postexposure prophylaxis has not appeared effective in preventing infection HCV ts thought to be transmitted relatively rarely through occupational exposure to blood The incidence of seroconversion after percutaneous exposure to an HCV positive source is estimated to be 1 8 Hepatitis C virus HCV has been isolated in tears and aqueous humor Adenovirus has been the main cause of nosocomial outbreaks of conjunctivitis These
52. c office setting PN 20 000106 Rev C 106 Maintenance and Support Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 6 D Protective eye wear In situations when splashing with blood or blood contaminated fluids may be anticipated protective eyewear Is indicated E Handling of tissue In the course of assisting in the examination of eye patients ophthalmic medical personnel may be required to handle the eyelids and surrounding facial skin and thus may come in contact with tears and the conjunctival membrane To minimize direct contact with these tissues particularly if the patient has a known or suspected eye infection ophthalmic medical personnel should be instructed in the use of gloves or in no touch techniques involving the use of cotton tipped applicators to stabilize the tissues whenever possible F Hepatitis B vaccination Ophthalmic medical personnel who frequently come in contact with needles blood or blood products are advised to receive hepatitis B vaccine to avoid infection with the virus OSHA regulations require that the employer make hepatitis B vaccine available to all employees who have occupational exposure Procedures A Handling of sharp instruments The CDC has recommended that all health care workers adopt precautions to prevent injuries caused by needles scalpels and other sharp instruments or devices
53. cations When you save to removable media or a network location you are in effect exporting the images there JP E G fe ha r ge e The XXX Change button where XXX stands for the current format JPEG Change in the example enables you to change the file format in which images are saved e The Open button opens image files from outside the Her am Shuttle database for processing e The Save button saves and exports image files to the location you choose Each of these functions is explained in more detail below RetCam Shuttle User Manual PN 20 000106 Rev C Process Images 69 _ Open an Image from Outside the RetCam Database JPEG Change The Open button at lower right enables you to open images from outside the Open Save RetCam Shuttle database for processing When you click Open the Open Image dialog appears Import image JEJ Look m B Retcam e 2 Temp R Mu Recent Documents 3 Desktop Mu Documents omputer Mu Network File name ClarityLogo bop Places x i Files of type All Images Tonga po bmp el Cancel Figure 39 Import open Image dialog This is a standard Windows dialog that enables you to find and open JPG PNG and BMP image files but not those in the proprietary RetCam format You can select image files from any accessible location RetCam Shuttle User Manual PN 20 000106 Rev C 70 Process Images Change the Format for Saving Images JP
54. ce RetCam Shuttle User Manual PN 20 000106 Rev C Process Images 71 Save and Export an Image You can save one image at a time To save the current image processed or not RIETSER CEET 1 Click Save The Export to image dialog appears ia gt Program Files Mu Recent S WINDOWS Documents Save Desktop Mu Documents Ee Mu Computer Mu Network File name Ps Places Save as tyne A Images Cancel Figure 41 Export to image dialog This is a standard Windows dialog that enables you to find and select the location where you will save the image file You can select any location on the hard drive on a connected network location or on removable media 2 Find the desired location where you want to save the image Ki e f necessary use the up folder icon to the right of the address field to go up to higher levels of the drive or device directory Ca e To create a new folder where you will save the image click on the new folder icon Type in the name of the new folder such as Smith 03 24 05 3 Inthe File Name field enter the name of the image file you will save e The file extension jpg omp or png is added automatically according to the format selected in the Export Options dialog 4 Click Save to save the file RetCam Shuttle User Manual PN 20 000106 Rev C 72 Data Transfer A 6 Data Transfer Data transfer means copying RetCam data including patient data and or imag
55. ch Result Select transfer destination and folder options Batch transfer as MLX file RetCam image file for RetCam viewing Batch transfer as BMP JPEG or PNG with or without patient data Annotate and batch transfer BMP JPEG or PNG files Transfer patient data as CSV XML or Text files N O GO A OW Utilities Screen F8 1 Change system institution name and department View software version information Access Windows Network Connections dialog Adjust speaker volume Adjust system date time Select default printer s for images and reports Manage installed removable media ONO o KR Go DD Enable or disable Auto Indexing option Software Note Reboot to Refresh Drop Lists For several kinds of drop lists you must reboot the system to display new items you add For example when you add a new doctors name a new pathology or a new patients name the new items will not appear in the applicable drop lists until you reboot the system Storage For storage of the system when not in use disconnect the power cord and store it inside the cart Stow the handpiece in its compartment behind the upper door and the footswitch in its compartment behind the lower door Remove all loose objects from the work surfaces Close the notebook computer and consider removing it to a secure location Wipe the surfaces with a soft cloth Apply the brakes to the front casters to keep it in place Transport The system is design
56. ck Reset Video to delete it VG Note Saving a 15 second video clip can take a minute or more You cannot cancel saving once you begin Saved video is compressed and stored in AVI format You can no longer save still images from a video after it is saved When you click Save Video a progress dialog asks you to wait and shows progress of saving oO Please wait while the task you requested is being performed aweien Frame 5S of 174 O Elapsed Time Beracge Te Figure 29 Save video in progress The progress dialog displays the number of frames saved the elapsed time and the time remaining RetCam Shuttle User Manual PN 20 000106 Rev C 56 Start Patient Select New Session Session Notes When you exit live imaging the Add View Session Notes dialog appears For each eye it provides a field where you can type in notes Add View Section Noles Creapon Date Right Eve OD Rote Left Eye 05 Note Add 2 Naw Note Dochor Mame Smat New Right Eye OD Hate Hewi Left Eye OS Note Laser treatment performed Ho further abnormality a Return Fo Session Figure 30 Add View Session Notes dialog The notes list field at the top tracks all notes entered by creation date doctor and eye To add notes 1 Type new notes in the fields titled New Right Eye OD Note and New Left Eye OS Note 2 Click Add to add notes you have typed to the notes list above e You cannot change a note after you click Add e Clic
57. ck to highlight the drive then click the desired function Auto Index External Media Checkbox This checkbox is unselected by default When you select it it turns on automatic indexing of external media when you connect to them This means that when the Other Media option is selected on the Patient Select screen you must wait for indexing to occur before patients appear in the patient list See Select Data Source on page 40 lt gt Note When you select or deselect this checkbox you must reboot the system for the change to take effect Eject Click the Eject button next to the desired drive to safely remove the installed media RetCam Shuttle User Manual PN 20 000106 Rev C 98 Maintenance and Support A 8 Maintenance and Support This section addresses maintenance and support under the following topics e Recommended Maintenance Schedule below e Cleaning Procedures below e Fuse Replacement page 109 e Replace Illumination Lamp page 110 e Key Validation page 112 e Technical Support page 114 e Service Information page 115 Recommended Maintenance Schedule Between patients Clean and inspect lens piece Weekly Wipe down the system Monthly Inspect cables and connections for wear Burned out bulb Replace illumination bulb Blown fuse Replace system fuses Cleaning Procedures For cleaning purposes the RetCam Shuttle is divided into two categories e The Lens Piece that contacts the patient e The rest o
58. confirm deletion 4 Select Yes to confirm deletion 5 Close the My Network Places dialog Connecting RetCam Devices to an Existing Network RetCam Il and RetCam Shuttle are shipped with Dynamic Host Configuration Protocol DHCP active to automatically obtain the computers IP address for TCP IP communications This will work for most networks If however the network does not contain a DHCP server usually on smaller networks a static IP address must be specified The network administrator must specify the appropriate IP address subnet mask and default gateway server addresses Once these are determined follow the steps below to apply them PN 20 000106 Rev C Data Transfer 93 Networking 1 Click the Connections button in the Utilities Screen see page 95 to open the e Network Connections dialog s Network Connections File Edit view Favorites Tools Advanced Help ae A KA Y p e P Ko yp Search ar Folders icy 4 X i Address e Network Connections v Ej o LAN or High Speed Internet Local Area Connection Connected Firewalled aie A Intel R PRO 100 YE Network Wizard New Connection Wizard Zou Network Setup Wizard Figure 64 Network Connections dialog 2 Right click Local Area Connection and select Properties The Local Area Connection Properties dialog appears Local Area Connection Properties General Authentication Advanced Connect using BH Broadcom Nel treme Gigabit E
59. corded video to the notebook s FIFO buffer e Reset Video Erases the recorded video and prepares to start again e Cancel Session Ends the imaging session lt gt Note When you end a video session by clicking Cancel Session and then close the Add View Session Notes dialog that automatically appears afterward you will erase the video buffer which means you can no longer replay the video nor capture additional stills from it However you will not erase any video clips or still images you already saved you can view these in the Review screen RetCam Shuttle User Manual PN 20 000106 Rev C 54 Start Patient Select New Session Recording Live Video and or Saving Stills In video mode press the Snap button on the footswitch to start and stop live video recording The button toggles between start and stop When you pause the live video you can click Save Still or press S on the keyboard to save the current image from the video clip As you record live video the status bar displays recording time left in seconds Video Replay When you stop live recording the playback buttons are enabled lt it gt Reverse pause and play HI Go to the beginning of the recorded video al Go back one frame id Advance one frame i Go to the end of the recorded video BZ Tip Using the left and right arrow keys on the keyboard will also move the video back or forward one frame at a time Saving Still Images During
60. creen displays the images acquired in the session just completed When you access the Review Screen by other means it displays the images for the last patient and session you selected You can change J the selection at any time using the Patient Session Selector icon at upper left This icon appears on several screens and has similar functionality See Patient Session Selector on page 46 for details on its use RetCam Shuttle User Manual PN 20 000106 Rev C 58 Review and Compare Images By default thumbnails for all images acquired in the selected session appear along the left side You can click on the tabs for R Eye L Eye or All above the thumbnails to display only right eye images only left eye images or all images from an imaging session The currently selected image the first one by default appears full size Click ona thumbnail to display the full resolution image or use the up and down arrow keys on the keyboard to select a thumbnail Thumbnails of video clips have a symbol Ji indicating it is a video Click on the thumbnail to bring the video to the display area Video navigation buttons will then be visible and enabled The buttons have the same functions as for live imaging gt Click Play to start playing video The following options are available on the Review Screen Session Notes Click Session Notes to review or append text to the session notes in the Review screen You cannot alter saved notes Notes ar
61. d Figure 60 Type a name for the new network place RetCam Shuttle User Manual PN 20 000106 Rev C 90 Data Transfer 9 Type in the name to be used for the new network file share from the RetCam for example Image Store as shown Then click Next The Wizard Complete dialog appears Add Network Place Wizard Completing the Add Network Place Wizard You have successfully created this network place Siw Test shortcut for this place will appear in My Network Places To close this wizard click Finish Figure 61 Completing the Add Network Place Wizard 10 Clear the Open this network place when I click Finish checkbox Then click Finish You will return to the Network Connections dialog 11 Close the Network Connections dialog RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 91 Accessing the Network Place When using the RetCam import or export features from the Transfer screen the network place you added will be visible in the Browse for Folder dialog as in the example below lect Transfer PS eM SSS Rein ECKE ee Dtislkjl Qyfl 12345 Doctor Lfdks Age This Session 3 years 11 months Gender Male Of 17 2007 1 45 32 PM R Eye LEye All Show Hidden Specify destination location Path Create subfolder Video 1 SS CO Image 5 e SE R C Overwrite existing data C Organize patients into subf Desktop 18 B My Documents
62. d See Chapter 6 Data Transfer for instructions to implement backup Adjust Date Time In the Current Date Time area click Set to adjust the system date and time Note When you change the time zone you must reboot the system for the time zone change to take effect Adjust Volume In the Volume area at right click the arrows or click above or below the slider or drag the slider to adjust the speaker volume Printers In the Printers area at left use the drop lists in the Image Printer and Report Printer fields to select the printer to be used for each application Note Clarity recommends that you use only those printers that Clarity supplies or has identified for use with the RetCam Shuttle RetCam Shuttle User Manual PN 20 000106 Rev C Utilities 97 Printers and Faxes Click Printers and Faxes in the Set Default Preferences area to open the Printers and Faxes dialog where you can add a new printer or set default printing preferences for printers attached to the system gt Printers and Faxes DER Le Pie Edit View Favorites Tools Help SD 2 Search K Folders ae ig EK Address he Printers and Faxes gt BEE HP Deskjet D4100 series KL MITSUBISHI CP770D LPT Add Printer 8 e J NE 0 5 Ready 5 Ready Figure 68 Printers and Faxes dialog Disk Management In the Disk Management area at lower center the list displays all drives for removable media currently installed in the system Cli
63. ddresses must be specified by your network administrator Then click OK Local Area Connection Properties dialog reappears 6 Click OK again in the Local Area Connection Properties dialog Network Connections dialog reappears 7 Close the Networking Connections dialog 8 If prompted allow the system to restart for your changes to take effect PN 20 000106 Rev C 7 Utilities Utilities 95 The section describes the utilities available in the Utilities screen including e System Identification page 95 e Version Information page 96 e Networking Connections page 96 e Adjust Date Time page 96 e Adjust Volume page 96 e Printers page 96 e Disk Management page 97 Utilities Screen The Utilities screen appears when you select its tab or press F8 on the keyboard Patient Select istory New Session oing oe e a E Utilities Shutdown System Identification Institution Clairy msi EI AYA Department 4 1 1 release Version Information RetCam 4 1 1 NET 2 0 50727 db4o 6 1 401 Infragistics 5 3 20053 73 Networking e ae Current Date Time Thursday August 16 2007 5 1 set Printers ImagePrinter Set Default Preferences Volume buttons right of each description you can format eject and rename your disks MITSUBISHI CP77O0D LPT z ae Report Printer HP Deskjet D4100 series sl Disk Managem
64. dicular to the paper Hold the tip of the lens approximately 2 50 mm from the paper so that the center of the image on the screen appears uniformly bright The outer area or ring of the image may be slightly gray or yellow in color Press the AWB button on the front panel of the EO box for about 1 second The characters AWB will appear superimposed and blinking on the live white image The characters AWB will stop blinking and the characters AWB OK will appear for approximately 1 second White balance adjustment is successful If the characters AWB NG LEVEL NG appear automatic white balance adjustment cannot be performed because the light level is too high or too low Adjust the light level up or down as indicated and repeat steps 4 and 5 again If AWB OK still does not appear try adjusting the ambient room lighting up or down or vary the distance from the front lens tip to the paper If the problem persists please call the manufacturer or your authorized representative RetCam Shuttle User Manual PN 20 000106 Rev C 36 System Functions Lens Installation The diagram below illustrates how to install all lens pieces The instructions are also repeated below ALIGN 3 RADIAL PINS ON HANDPIECE FRONT WITH SPACES BETWEEN TABS OF SPRING RING ON LENS PIECE SPRING RING OF LENS PIECE TWIST LENS PIECE CLOCKWISE UNTIL A CLICK IS HEARD AS SHOWN TWIST COUNTER CLOCKWISE TO REMOVE IN
65. e Ward 90 Accessing the network place created 91 Network Connections dalog 92 Network Connections GialOg cccccccccseeeeecseeeceeseeeceseeeceuseeseseessaseeesenseesaaeeessags 93 Local Area Connection Properties dialog ccccccccseeeeeseseeeeeeseeeneeeeseeeeeseneeesnees 93 Internet Protocol TCP IP Properties dialog nnannnnnnnannnannonnnnnnnannnnnnonnrennnnnnnnne 94 BW 95 Printers and Faxes dial0g WEE 97 Inverted lens piece showing permissible depth of mmersion 99 POWER ENY e el 109 Opening the fuse holder cover 109 REMOVING The fuse le e TEE 109 BIOWN MUSE l CIMOV CG EE 110 Front panel of the EO box showing the lamp assembly drawer nn0nnn0nnannnnann 111 Removing the illumination Lamp ek 112 KEY VaAllQATION GIAIOG ME 113 PN 20 000106 Rev C RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 9 1 Introduction The RetCam Shuttle from Clarity Medical Systems is an integrated mobile wide field digital imaging system Clarity designed the RetCam Shuttle to be maneuverable in constrained areas and for total system transport within and between hospitals and clinics The RetCam Shuttle is made to have site awareness which means it is made to be aware of the physical location where it is being operated Thus it prompts you at start up to identify the operating location and it identifies saved data according to location It also offers networkability to support data transfer to
66. e identified by date and the doctor s name Hide Hem Click Hide Item to hide the current image Hidden items are not deleted Their thumbnails do not appear unless the Show Hidden box above the All tab is checked Show Hidden Default is unchecked Only thumbnails of non hidden images are listed When checked thumbnails for hidden images appear grayed out signalling they are unavailable for full size viewing Unhide Item When Show Hidden is checked and you click on the thumbnail of a hidden image the Hide Item button toggles to Unhide Item which you can click to make the image available again for full size viewing Flag Item Click Flag Item to flag the current image as an image of special interest A small red flag appears at the top left corner of the thumbnail On the Transfer screen there is a Select Flagged option you can use to select flagged items for transfer Unflag Item When you click on the thumbnail of a flagged image the Flag Item button toggles to Unflag Item which you can click to remove the flag RetCam Shuttle User Manual PN 20 000106 Rev C Patient Select REye LEye All Image 16 Print Image Review and Compare Images 59 Click Print to print the current image displayed Compare Screen The Compare screen appears when you select its tab or press F5 on the keyboard Use the Compare screen to compare any two images You can compare among a patient s images or between patients Histo
67. ed Once a name is entered it becomes part of the drop list Only doctors of resident patients are included in this list Gender Click radio button to select PN 20 000106 Rev C lt gt Note The system does not prevent you duplicating patient information In other words you can create multiple patient records with the same name and patient ID if you wish Optional Fields You can also add data in the following optional fields e Pathology Select a pathology from the drop list or type in a new pathology All pathologies previously saved to a patient record appear in the drop list Only pathologies of resident patients are included Classification Enter in this field a specific category for the pathology in the field above Select a classification from the drop list or type in a new classification which will become a part of the drop list Patient Notes To add notes for the patient click Add Patient Note A new note entry will open with a date stamp and doctor identified You can begin typing notes at the cursor in the Note Body column You cannot change notes after typing them in e To add more notes later edit the patient record as explained in Edit a Patient Record on page 44 and click Add Patient Notes Additional Optional Fields for ROP Patients The following data fields appear when the patient is under one year of age according to the birth date entered e Birth Count Select single twins triplets etc e Ges
68. ed retina Ridge at 3 o clock Zone 2 Spock Spock Figure 24 Example of an ROP report printout RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 49 New Session Screen The New Session screen appears when you select its tab or press F3 on the keyboard Use the New Session screen to start a new imaging session whether for still images or video recording Patient Select istory New Session review Compare Process Transfer Utilities Shutdown Doctor Pleasanton Gender Male Gestation 4ge 34 weeks Clarity Software 123456789 Birth Weight 2000 grams Retinitis pigmentosa Sample Date of Birth 2 22 2007 Session Parameters New Imaging Session For Clarity Software Select Eye Select Lens Piece Right Eye OD Retina 1300 Left Eye 0S Anterior Segment 1200 Unspecified Other 800 Select Image Type _ 300 Other Start Imaging Session RetCam Shuttle 8 29 2007 6 00 PM Figure 25 New Session screen lt gt Note Before imaging make sure you have selected the correct name for the patient If images are stored under the wrong patient s name it is not possible to change later RetCam Shuttle User Manual PN 20 000106 Rev C 50 Start Patient Select New Session Start Imaging Before you can start imaging you must select options for eye image type and lens piece For each of
69. ed to be transportable both within and between hospitals clinics and offices Note The system has no internal power supply no battery to support image acquisition while disconnected from a wall outlet The notebook computer can operate using its own battery RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 17 To relocate the system within a building 1 Power down the system through the software by clicking the Shutdown button which can be found at upper right on most screens Switch off mains power on the back of the unit Unplug the power cord from the wall outlet and drape it over the transport handle Secure the camera handpiece in its external holster on the work surface or internally Drape the handpiece cable over the transport handle or place the excess inside the upper storage compartment 4 Release the front caster brakes Now you can gently roll the system on all four wheels to the new location If the floor is an uneven or tiled surface move the system slowly to reduce damage from excessive vibration Once in the new position apply the front caster brakes plug in the power cord and restart the system To transport the system to another location 1 Power down the system through the software by clicking the Shutdown button which can be found at upper right on most screens Switch off mains power on the back of the unit Unplug the power cord from the wall outlet and drape it ove
70. een ICG angiography It is recommended that photographers and other health care workers who may come in contact with blood while performing fluorescein and ICG angiography wear gloves and adhere to the procedures as outlined in this section C Contact lens fitting Ophthalmic medical personnel involved in the fitting of contact lenses should be instructed in the precautions outlined by the CDC for disinfection of lenses D Minor office surgical and diagnostic procedures During the performance of minor surgical and diagnostic procedures particularly where contact with blood or blood contaminated fluids may occur gowns disposable gloves and masks and protective eyewear should be worn Ophthalmic medical personnel assisting at eye surgery should be instructed to avoid the direct handling of needles and those parts of instruments that have come into contact with body tissues and fluids Thus needles should be manipulated with forceps or needle holders rather than by the gloved fingers instruments should be held by the handle rather than by the tips and the cleaning of instruments should be performed in such a way that accidental perforation of the gloves is avoided If an instrument punctures a glove or the skin it must be removed from the operating field and sterilized These practices should be incorporated into standard operating room infection control procedures and should be monitored for compliance as are o
71. eliminate most or all pathogenic microorganisms from inanimate objects such as medical devices or equipment This is usually performed using chemicals known as germicides or disinfectants High level disinfection kills all organisms and is performed suing a germicide which ts regulated by the Food and Drug Administration The CDC recommends that if there are questions about high level disinfectants or how to disinfect a particular medical device the office should contact the manutacturer of the product The CDC has recommended the following which are proven to inactivate infectious HIV herpes simplex virus and adenovirus sg Wiping clean and then disinfecting with bleach is recommended by the CDC as an effective way to inactivate HIV Remove the entire prism from the tonometer and place it in a suitable receptacle that allows the applanating surface and adjacent 2 3 mm of the tonometer to be immersed in a 1 10 dilution of household bleach sodium hypochlorite One method uses a Petri dish with small holes drilled in the lid which allows just the tonometer tip to be partially immersed in the solution After a five minute period of soaking the tip should be washed under running water and dried before use Two tonometer prisms should be available so that one can be used while the other is being disinfected Soaking the entire tip may eventually remove the coloring of the etched calibration marks These disinfecting solutions sh
72. en Site Advanced gt gt T Figure 10 Specify Site Information dialog RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 29 2 Enter a name for the Institution and the Department and then press the Tab key When you press the Tab key the Site name will be completed automatically by combining the two names above it You can override the automatic site name by typing in a name you choose 3 In the Secure Access Options area we strongly recommend you enter and then re type a password in the indicated fields If you do not your system and its data will not be password protected VG Note It is strongly recommend that you record the password you create in a safe separate location to maintain access to the data associated with your site WARNING If you lose the password you will not be able to access any data associated with the site under which it was acquired If you do lose the password contact Clarity or your authorized distributor to assist you with its recovery See Technical Support Contact Information on page 114 4 When finished click Open Site The RetCam Shuttle splash screen see page 38 below will appear giving you access to the system software You can access the Site Awareness dialog and create a new site only by starting the system software If you wish to create multiple sites you can exit and restart the system software and follow the same procedure Select a Site After the first t
73. ent Below is a list of all compatible data storage devices You can only format previously unformatted media Disks currently connected to this system By clicking the marked with a lock icon are read only in this system C Suto Index External Media Indexes external HD CD DVD USB Drives as they are connected May add significant processing time Figure 67 Utilities screen System Identification RetCam Shuttle 8 29 2007 5 29 PM In the System Identification area click Change to edit the Institution and or Department fields This will not change the combination institution department RetCam Shuttle User Manual PN 20 000106 Rev C 96 Utilities name used to identify the site in the Site Awareness dialog see Establish Site Awareness on page 28 which you can only change through that dialog Version Information The Version Information area at upper center displays the current version information the details of which may be useful when communicating with Clarity Customer Service about your system Networking Connections Click the Connections button in the Networking area on the right side as a shortcut to open the Windows Network Connections dialog where you can configure the Shuttle notebook for network access For details see Networking a RetCam Shuttle on page 85 WARNING There is no automatic backup of data on the FIFO buffer which means that permanent loss of data is possible if no backup solution is employe
74. ents Finally this manual provides an Index to assist you with finding desired information The Introduction covers the following topics e System Hardware below RetCam Shuttle User Manual PN 20 000106 Rev C 10 Introduction e Software Overview RetCam Shuttle Screens and Functions page 14 e Storage page 16 e Transport page 16 e Electrical Safety Information page 18 e FDA USA Notices page 22 e Important User Safety Notices page 22 e Labels and Symbols page 23 System Hardware The RetCam Shuttle system consists of modules mounted in a stable high quality integrated mobile cart for easy safe transport from one location to another The four casters allow for easy maneuverability and positioning Figure 1 and Figure 2 below illustrate the system hardware AN WARNING Unauthorized modifications or additions to the software or hardware of the system will void the warranty and could adversely affect the system function RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 11 Notebook computer 3 chip CCD camera handpiece and lens piece LEIF Holster we 2 EY E E e a Ss gt we yn Work surface Extendable transport y handle Secondary work surface Interconnect harness Container for tools and supplies Lens storage box Internal handpiece storage compartment Upper door open f iy d ei BE Lower door electro optical box footswitch stora
75. ents into subfolders checkbox 79 Other Media 40 Overwrite existing data checkbox 79 P Patient List Columns 39 Patient List tab 46 Patient Select Screen 39 Patient Session Selector 46 Physical 116 PNG 70 80 Power Connector 26 Power Cord 26 Print Images 60 Printers 96 Printing 60 Printing to the Mitsubishi Image Printer 61 Process Screen 64 Purposes of Data Transfer Sharing and Backup 72 R Recommended Backup Scenarios 73 Recommended Maintenance Schedule 98 Recommended Scenario for Multiple RetCam Sys tems 73 Recording Video 54 Reset Adjustments Button 68 Reset Video 53 PN 20 000106 Rev C Resident Patients 40 RetCam 120 Data 42 RetCam Shuttle Software End User License Agree ment 119 RetCam Viewing 80 Hei am Viewing mlx 80 Returning Parts for Repair 115 Review Screen 57 Rotate 180 65 S Save and Export Processed Images 68 Save and Export an Image 71 Save Still 51 53 54 Save Video 53 55 Screens and Functions 14 Search Options 42 Search Result Using Patient Select options 76 Select a Site after first use 29 Select Export Options 77 Select Image Format 80 Select Images for Export 75 Select Lens 50 Select 74 Service Information 115 Session Notes 56 58 60 65 Show Hidden 58 Site Awareness 28 Edit a Site 30 Site Awareness specify a site 28 Snap 54 Snap switch central push button 12 Software 117 Software Overview 14 Sort Displayed Data 40 Specifications 116 Specify a
76. es to a new location network removable media etc Data transfer occurs in two steps export and import both from the Transfer screen You can transfer data to any accessible and writable location This chapter explains the purposes of data transfer and how to perform it It covers the following topics e Purposes Sharing and Backup page 72 e Transfer Screen page 74 e Export page 75 e Import page 82 e Networking a RetCam Shuttle page 85 Purposes Sharing and Backup Data transfer has four purposes 1 To make RetCam data available on other RetCam stations which include both RetCam Il and RetCam Shuttle systems and PCs running RetCam Review Software 2 To implement data backup that is to make a backup copy of the original image data kept on the FIFO buffer of your hard drive 3 To export for viewing with standard image software 4 To import to third party imaging systems WARNING Permanent data loss is possible if no backup solution is employed Recall that the RetCam Shuttle does not automatically make a backup copy when you acquire new images Images are stored only on the hard drive of the computer so removal of data becomes an absolute necessity to avert the possibility of data loss due to loss of the computer It is the responsibility of the user to preserve data from permanent loss due to computer loss theft or failure of the computer by making appropriate backup copies Backup Recommendation Netwo
77. es AAA 22 Labels ANd Gvmbole 23 Jan E 25 2 DY SIC EE HON tee 26 e Power Cord and Power Connechor 26 e Turning on the RetCam Shuttle cc ccecccccsseceeeeeeeeeeeeeeseeeeessegeesseeeeeeaees 26 e Establish Site Awareness 28 Specify a New Gite ceccccseseeceeeeeceeeeeeeeeeeesseeeeaeeeesseeeeessaeeessuseessseeeseeeesaaeees 28 Select a Site oo cece ceeccecesseeceeeeeceeeesseuceeseueeesaeecessaeesseaeesseaeeeseaeeeseeeessseeessaaees 29 oe le E 30 Sats EE 30 e Turning Off the RetCam Shuttle cc ceccccecceceeeeeeeeeeeseeeeeseeeeeeseeeeseees 31 e Turning Off for Extended Periods ccccccssecccesseeceeeeeeceeeeeseuseessseeeeeaeeeseaeeesaaeees 32 e The Electro Optical BOX E 32 e Camera Color Balance Adusiment 33 Lens Installation cee ccccceeccceecceeeeeeeeceeeceueeaueeceeecaueeseeseeesaueeseeeseueeaeeesaeees 36 e Instructions for Installation of All Lens Pieces cccccccceeccceeeeeceeeeeeeeeeeeaeeeeaaeees 36 Storage ANd Backup 36 e Backup Recommendation Network or Removable USB Mass Storage Device 37 e Compatible Removable Mecda 37 RetCam Shuttle User Manual PN 20 000106 Rev C RetCam Shuttle User Manual Start Patient Select New Geseion 38 Stalls SOlaSM Oo ChOGM eege eege eeng 38 Patient EE Le EE 39 Patent d Ee Un EE 39 Select Data Gource reenn 40 Search Be ge En 42 e Add a New Patient Hecor uk ENEE 43 Edit as atlent RECO ees 44 Print Palen REDOM
78. etwork When you backup in this scenario we recommend you follow these tips e Clear the Create subfolder checkbox see page 78 and associated tips e Select the Organize patients into subfolders checkbox see page 79 and associated tips In this way you will create a single shared repository for all patients accessible to all RetCam systems and avoid creation of multiple patient records for the same patient Each patient will have a separate subfolder in the backup folder made up of last name first name and patient ID as in the example Sayers Gale 12345 When you wish to extend the record of a patient not created on the current system go to the backup folder and import the images from the patient subfolder of the desired patient RetCam Shuttle User Manual PN 20 000106 Rev C 74 Data Transfer Transfer Screen The Transfer screen appears when you select its tab or press F7 on the keyboard Patient Select History New Session review rocess Transfer Utilities Shutdown DT Gender Male Birth Weight 2000 grams Doctor Pleasanton Clarity Software 123456789 Age This Session 2 weeks Gestation 4ge 34 weeks Retinitis pigmentosa Sample 1 14 2004 1 17 11 4M REye LEye All Show Hidden Transfer To Deselect All Image 16 Image 17 Image 18 Image 19 Items Selected 0 Size of Data 0 bytes O IER Image 20 Transfer From S RetCam Shuttle 8 29 2007 6 25 PM
79. ew D1300 ROP amp Anterior Segment E800 130 Degrees High Contrast Children s amp Adults PL100 egrees Portrait Lens C300 High Magnification 30 Degrees RetCam Shuttle User Manual PN 20 000106 Rev C 14 Introduction Software Overview RetCam Shuttle Screens and Functions This section provides an outline of the primary functions available with the RetCam Shuttle The system provides access to each major function on a separate screen The same tabs present at the top of all screens provide easy navigation from one function to another Just click on the tab to access the screen Alternatively you can access each screen using the function keys F1 through F8 on your keyboard which give access to screens in the same left to right order as the on screen tabs Key Target Screen ne History New Session Review Fa Dem Fo Pre oo FT ae Fees Splash Screen Click Start Using the RetCam Shuttle which opens to the Patient Select screen Patient Select Screen F1 View and search patient list add and edit patient records 1 Select data source resident patients or data saved on other media 2 For resident patients manage patient information e Add new patients e Edit patient data 3 Add patient data from other media to resident data 4 Search for patients by name ID doctor pathology or date last seen History Screen F2 Displays detailed history for a selected patient with session information for OD ri
80. ews Lamp assembly drawer handle Figure 74 Front panel of the EO box showing the lamp assembly drawer 5 Grip the handle on the lamp assembly drawer Pull the drawer out slowly from the EO box Stop when the light bulb is fully exposed RetCam Shuttle User Manual PN 20 000106 Rev C 112 Maintenance and Support 6 Just above the socket and rising from the rear of the illumination lamp is a thick gray wire the lamp ejector indicated in the picture below Be prepared to grab or catch the illumination lamp unit as you gently rotate this wire toward you rotate it toward the right from the front or counterclockwise which ejects the lamp Remove the old illumination lamp Lamp ejector Figure 75 Removing the illumination lamp AN CAUTION 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 7 Holding the new lamp only on the outside as shown replace it in the assembly aligning the two pins in the rear with the corresponding tracks in the socket and pushing it gently and evenly into place 8 Check the position of the new bulb to make sure that the reflector of the bulb is loc
81. f the system Cleaning the Lens Piece The Lens Piece should be cleaned thoroughly between patients to prevent the spread of infectious disease AS recommended by the American Academy of Ophthalmology the cleaning liquid of choice is 70 isopropyl alcohol Moisten a clean towelette with the solution and use a gentle wiping action across the front of the lens piece being sure to pay special attention to the concave contact lens area To prevent irritation to the next patient from residue left on the lens rinse the tip of the lens piece thoroughly with disinfected distilled water WARNING To avoid damage do not autoclave any part of the RetCam system The American Academy of Ophthalmology also recommends disinfecting with 1 10 dilution of bleach for 5 minutes Refer to the AAO page inserts starting on page 101 RetCam Shuttle User Manual PN 20 000106 Rev C Maintenance and Support 99 WARNING To handle chemicals safely consult Material Safety Data Sheets MSDS before using isopropyl alcohol or bleach Note If you disinfect with bleach you must rinse the frontmost part of the lens piece with disinfected distilled water and make sure the lens piece is wiped completely clean before using on a patient lt gt Note Never immerse the entire lens piece or handpiece in any liquid or solution For disinfection purposes you can immerse no more than 4 mm about 1 6 of the tip of the lens piece in an inverted position FOR NO MORE
82. fect the system function DO NOT AUTOCLAVE any part of this device Refer to Chapter 8 Maintenance and Support for cleaning recommendations Do not use the white light source for longer than 5 cumulative minutes on the same eye during an exam Appropriately power down and unplug the unit and allow the light source bulb to cool before replacing it Refer to the instructions to Replace Illumination Lamp on page 110 Never connect the RetCam Shuttle to a network or any externally powered devices or peripherals during imaging Before using this equipment to acquire images from patient eyes users must be trained in proper clinical technique by personnel authorized by Clarity 10 The RetCam Shuttle is for use by or on the order of a health care professional RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 23 Labels and Symbols CAUTION DO NOT LOOK DIRECTLY INTO LIGHT SOURCE BEFORE CONNECTING READ INSTRUCTIONS Protective earth ground Le Alternating current AC Type BF Equipment applied part is handpiece Do not use if dropped RetCam Shuttle User Manual PN 20 000106 Rev C 24 Introduction Clean lens piece after use IPX1 Footswitch in accordance with IEC 60529 Separate collection of waste at end of life as required by European directives eVO Equipment suitable for direct current DC only using the indicated terminal Notebook computer can be powered
83. fety requirements of IEC60601 1 with respect to fire shock and mechanical hazards only if used as intended Model RetCam Shuttle Manufactured by Clarity Medical Systems Inc dba Massie Laboratories Inc Pleasanton CA Made in USA Class 1 Type BF Electrical Equipment Rated for Continuous Operation IEC 60601 1 1995 Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards i e IEC6950 for data processing equipment and IEC 60601 1 1 for medical equipment Furthermore all configu rations shall comply with the system standard IEC 60601 1 1 Anyone who con nects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible to ensure the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt consult the technical services department or your local representative A N WARNING This equipment should be connected using the power cord supplied by Clarity A N WARNING To avoid risk of electric shock this equipment must be connected to a supply mains with protective earth RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 19 Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions Emissionstet Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The RetCam Shuttle uses RF ene
84. from this terminal RetCam Shuttle User Manual PN 20 000106 Rev C Label RetCam Shuttle User Manual Clarity medical systems Clarity Medical systems Inc dba Massie Laboratories Inc Pleasanton California Made in USA Model RetCam Shuttle Serial No eege Mfg Date OOo Input 100 240V 50 60 Hz 250VA T3A 250V LEC REP MediMark Europe BP 2332 F 38033 Grenoble Cedex 2 France CCOR Patent No 5608472 5822036 20 000123 Rev A Introduction 25 PN 20 000106 Rev C 26 System Functions 2 System Functions This section addresses system level attributes and functions that are important to understand for general operating purposes including e Power Cord and Power Connector below e Turning on the RetCam Shuttle page 26 e Establish Site Awareness page 28 e Status Bar page 30 e Turning Off the RetCam Shuttle page 31 e Lens Installation page 36 e The Electro Optical Box page 32 e Storage and Backup page 36 e Compatible Removable Media page 37 kd OT Oo Oo E g D A o e Man WW Power Cord and Power Connector Power for the RetCam Shuttle enters the unit through the main power inlet located i on the lower right side of the rear panel of the Shuttle cart The cart is wired for universal voltage input o o a D 689 6 GA e A G o o o KH H q The main power switch is located above the power cord inlet It must be in the ON position to operate the Shuttle
85. ft 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 limitation 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 tha
86. ge e O casters with brakes on front Focus control Light intensity Tri function foot control Snap Capture image video Figure 1 RetCam Shuttle Imaging System Hardware Components e Notebook Computer Pre loaded with Her am Shuttle system software it comes as part of the system Offers a large LCD display for real time video and still imaging image processing and data transfer A Pentium based system running Windows XP Professional it includes a DVD R RW drive integrated network adapter and USB ports RetCam Shuttle User Manual PN 20 000106 Rev C 12 Introduction VG Note For information on the rechargeable battery of the notebook computer please see the manufacturer s user manual found on the RetCam Shuttle CD e Handpiece Contains the 3 chip CCD camera Lightweight and easy to position it has a long cable for easy reach Use with 3 changeable lens pieces See details in Figure 2 and Figure 3 VG Note Always return the handpiece to the holster on the work surface when not imaging The handpiece cable can be draped over the transport handle but do not wrap it tightly or damage to the fiber optic may result e Handpiece Interconnect Harness Comprises three separate cables the lamp fiber optic cable for subject illumination the camera controller cable and the focus motor cable e Electro Optical EO Box Contains the CCD camera control unit a halogen illumination lamp and the control circuitry f
87. ge click on the new folder icon Type in the name of the new folder such as Smith 03 24 05 The folder must be shared with write permission Tip 1 for Network Data Transfer The first time you specify the destination location in the Browse dialog look for the desired target server by selecting My Network Places gt Entire Network gt Microsoft Windows Network gt computer name gt standard export folder where computer name is the name of the desired target computer on the network and standard export folder is a folder in its root directory where you will regularly export files The target computer may be a server or another RetCam station Browse For Folder Desktop E3 My Documents Hoy My Computer EI a My Network Places H e Entire Network ERG B Microsoft Windows Network fy Claritymsi E3 Ka BackUp on rrouthukumard emmtbukumar Si Recycle Bin Make New Folder Figure 46 Finding the export destination on the network P Tip 2 for Network Data Transfer When using a network location for export use the same export destination folder each time and for all attached RetCam systems and give it a recognizable name like FileShare This will simplify finding the folder from which you will import images to other systems Tip 3 for Network Data Transfer To access the export destination folder it must be shared To share a folder on the target computer from that computer locate the desired folder to share using
88. ge 180 e Annotate an image e Adjust image display parameters brightness contrast and color e Save and export images in standard image formats Session Notes Click Session Notes to review or append text to the session notes in the Process screen You cannot alter saved notes Notes are identified by date and the doctor s name Rotate 180 Click this button to rotate the image 180 RetCam Shuttle User Manual PN 20 000106 Rev C 66 Process Images Annotate Image Annotate Image is useful to identify and provide information about images especially when you intend to save them The annotation text is overlaid on the image Click the Annotate button to open the Annotate Image dialog Annotate Image Wl Session Date i Image Number Wl Pathology i Classification w Image Type Wl Eye OD OS Wl Lens Used kl Institution Placement Top Left a ES Top Right Bottom Left 93 f 2 Bottom Right Image Preview image 16 imaged on 1 14 2004 Image Type Retina Eye Right Eye OD Lens 800 Retinitis pigmentosa sample Massie Labs Ophthalmology Set Defaults Cancel Figure 38 Annotate Image dialog RetCam Shuttle User Manual Annotation Fields In the Annotation Fields list at the top select the desired checkboxes to overlay the indicated information on the image You can select checkboxes for the following items scroll down to see all items e Patient ID e Name e Patient Initials e
89. ght eye and OS left eye 1 View patient history New Session Screen F3 Live imaging session for the selected patient 1 Save still images 2 Record video RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 15 3 Save still images from recorded video 4 Erase video 5 Enter session notes Review Screen F4 View all images taken for the selected patient 1 Navigate through images for all sessions 2 Display and enter session notes 3 Hide or skip over image 4 Flag image Compare Screen F5 Compare two images side by side Compare any two images for the same patient from any session or compare images from different patients 1 Compare hidden images 2 Compare flagged images 3 Print 2 images Process Screen F6 Apply image processing functions 1 Rotate 180 Annotate images Adjust Brightness Contrast Red Green Blue Save and export files as BMP JPEG or PNG Open BMP JPEG or PNG file Display and enter session notes O oa A WB N Transfer Screen F7 Transfer images to any accessible location May be used to share or back up images 1 Select individual image s for transfer 2 Select multiple images for transfer e Visible Items Flagged Items e Entire Session e Entire Patient e Today s Items RetCam Shuttle User Manual PN 20 000106 Rev C 16 Introduction Pao Clarity Figure 4 Shuttle with all items stowed JE e Last 7 Days Items e Sear
90. he new network place 6 Type in the path of the new network file share to be accessed for example enter MedServer RetCam Images including the backslashes as shown Then click Next lt gt Note You can also map to a subfolder of the file share for example MedServer RetCam Images RetCam RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 89 Now the system will prompt you to enter the username and password with which you will logon to access the network file share on the target system the server Connect to med Server LE Connecting to bigserver User name medserver userID EI Password eeescees eene Figure 59 Connect to target system 7 In the indicated fields enter a valid user name prefaced by the domain name and a backslash with no spaces and the corresponding password for the target system VG Note The user name UserID in the example must be prefaced by the domain name and backslash in the format DomainName UserlID as shown 8 Be sure to select the Remember my password checkbox to ensure the target drive will be accessible automatically for future access Then click OK The wizard will now ask you What do you want to name this network place Add Network Place Wizard What do you want to name this place Create a name for this shortcut that wall help you easily identity this network place WoigserverSottware S W Test Type a name for this network place Image Store
91. herals during imaging Select Images for Export Note Regarding Export Size Capacity You can use the system while export is ongoing as long as the number of images selected for export is less than 10 000 While you cannot directly select a specific number of images for export you can be confident of exporting less than 10 000 images by exporting saved images in three month blocks To do this first go to the Patient Select Screen see page 39 and perform a Search by Date range see page 42 specifying a three month block Then back in the Data Transfer Screen click the Select button and choose Search Result Using Patient Select options To select images for transfer follow these steps 1 Click on a thumbnail to select the image To select multiple items click and drag over multiple contiguous items or hold down the Ctrl key and click Ctrl click on individual items Selected items are highlighted To select items in pre defined groups use the Select button its options are described below BZ Tip The options you select under the Select button are additive To make sure you select only the single option desired first click the Deselect All button before you use the Select button BZ Tip for Backup The Select button is particularly useful if you are performing a regular data backup For example if you back up items daily you would select Today s Items All Patients if you back up weekly you would
92. ime you specify a site the Site Awareness dialog will appear showing all created sites Site Awareness Site Awareness enables data to be organized into separate data repositories based onthe site selected on this screen site identifies a particular institution and department which uses this RetCam device Select the appropriate site to be used or create a new site if one does not exist for your institution and department Pleasanton Neonatal Intensive Care Dublin General Hospital Infant Care Figure 11 Site Awareness dialog after first use RetCam Shuttle User Manual PN 20 000106 Rev C 30 System Functions To access the system you must select a site from the list in the Site Awareness dialog or you may create a new site if you wish For details see Specify a New Site on page 28 VG Note All patient and image data is associated exclusively and irrevocably with the site under which it is acquired When you select a site click OK to continue to the RetCam Shuttle splash screen see page 38 below Edit a Site To edit site information for the currently selected location 1 Click Edit in the Site Awareness dialog The Edit Site Information dialog appears which is visually and functionally the same as the Specify Site Information dialog see Figure 10 on page 28 2 Edit the fields as desired and click Save You will return to the Site Awareness dialog from where you can select a site and continue Sta
93. ing 1 Click the Connections button in the Utilities Screen see page 95 to open the ae zonnections Network Connections dialog s Network Connections File Edit wiew Favorites Tools Advanced Help ka ps Search i Folders __LAN or High Speed Internet E Local Area Connection 4 z d Firewalled Connected s A Intel R PRO 100 YE Network Wizard win New Connection Wizard Network Setup Wizard KZ Figure 54 Network Connections dialog RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 87 2 Select Map Network Drive from the Tools menu click Tools gt Map Network Drive The Map Network Drive dialog appears Map Network Drive Windows can help you connect to a shared network Folder and assign a drive letter to the connection so that you can el access the folder using My Computer eg kee Specify the drive letter For the connection and the Folder that you want to connect to Drive Y w rit Example server share V Reconnect at logon Connect using a different user name Sion up For online storage or connect bo a network server Finish Figure 55 Map Network Drive dialog 3 Near the bottom of the dialog click Sign up for online storage or connect to a network server The Add Network Place Wizard appears Add Network Place Wizard Welcome to the Add Network Place Wizard This wizard helps you sign up for a serice that offers online storage space You can use thi
94. inued protection against risk of fire replace only with same type and rating fuse Safety Information This medical equipment is in compliance with UL60601 1 CAN CSA C22 2 No 601 M90 This medical equipment is IPX1 labeled and in accordance with IEC 60529 European Authorized Representative address EC REP MediMark Europe Sarl 11 rue Emile Zola BP 2332F 38033 Grenoble Cedex 2 FranceTel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82e mail info medimark europe com RetCam Shuttle User Manual PN 20 000106 Rev C 22 Introduction FDA USA Notices This device is listed with the United States of America USA Food and Drug Administration FDA for commercial distribution Device Trade Name RetCam Shuttle Product Code 86 HKI Classification Name Ophthalmic Camera Classification Regulation Number 886 1120 Medical Device Classification Risk Class II Important User Safety Notices Mi Remove the lens and store it in the lens box and secure the handpiece in its storage compartment inside the cart before moving the cart to a new site Carefully inspect and clean the lens piece before each use DO NOT use if the front lens of the lens piece is nicked or scratched Never contact the front of the lens piece with hard or sharp objects This could damage the precision optics and sealing Unauthorized modifications or additions to the software or hardware of the system will void the warranty and could adversely af
95. ion in these circumstances appears to be extremely remote precautions by health care employers and employees are justified as recommended by the OSHA and the CDC The following recommendations for hygienic procedures to be used in the delivery of eye care to patients are effective ways to minimize this risk as well as the risks of contracting or transmitting other much more common infectious diseases encountered in patients Because it is impractical to identify all patients who may be carrying these infectious agents these recommendations should be the routine for all patient encounters General Precautions Against Infection Office A Handwashing The hands should be washed with soap and water and thoroughly dried on a fresh or disposable towel between each eye examination Fingernails should be kept short and clean The hands and fingers should be inspected frequently for cuts abrasions and breaks in the skin or paronychia RetCam Shuttle User Manual B Gloves The CDC suggests in its recommendations for the prevention of HIV transmission in health care setting released in 1987 and updated in 1988 that All health care workers should routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with the blood or blood contaminated fluids of any patient is anticipated Gloves should be worn for touching blood and blood contaminated fluids for handling items or surfaces
96. it e Import CG C Documents and GettngekuserMw Documents 20061122 151954 Drab ina io J Elapsed Time Remaining Time Figure 51 Import progress dialog RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 85 When import is complete an Import Report dialog provides a summary Y Import Report Successfully imported 11 file s outof 11 ad Details Figure 52 Import successful If not all the items were imported the details pane explains why It could be because some files are duplicates already present in the destination database or the file is not found or it is corrupt A sample report with error messaging appears below import Report Failed to import 1 file s outof4i1 v Imported nofilesfrom 41 requested Skipped overwriting 40 existing file s Details Main message Imported no files fram 41 requested Failed to import 1 file s out of 41 Skipped overwriting 40 existing file s Check transter logs for each file failure status Check transfer logs to see which files already exist Figure 53 Import Report dialog Successfully imported files go into the local database and are available immediately in the patient list The original identifying information always remains associated with the images so you can determine their source Networking a RetCam Shuttle If you wish to exchange data to and from other RetCam stations which may be other RetCam II or Shuttle sys
97. itten 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 5775 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 RetCam Shuttle Software End User License Agreement You have acquired a RetCam Shuttle DEVICE that includes software licensed by Clarity Medical Systems Inc CMS Inc from Microsoft Licensing 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
98. k Clear to clear both fields before saving e Click Return to Session to return to live imaging 3 When finished click on Close to close the window The Review screen opens displaying the current patient and session just imaged 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 tabs by clicking Session Notes Notes are identified by date and the doctor s name RetCam Shuttle User Manual PN 20 000106 Rev C Review and Compare Images 57 4 Review and Compare Images Having acquired images they are available for review and comparison This section covers the following topics e Review Screen below e Compare Screen page 59 e Printing page 60 Review Screen The Review screen appears automatically when you exit live imaging You can also access it by clicking its tab or pressing F4 on the keyboard Patient Select History ssior Review Compare Process Transfer Utilities Print Shutdown Clarity Software 123456789 Age This Session 2 weeks Doctor Pleasanton Gestation Age 34 weeks Gender Male Lens 800 Birth Weight 2000 grams Right Eye OD Retina 1 14 2004 1 29 AM Retinitis pigmentosa Sample M Show Hidden All Session Notes R Eye LEye Image ip RetCam Shuttle 8 29 2007 6 09 PM Figure 41 Review screen When you exit live imaging the Review s
99. l 128MB Video Adapter Software e MS Windows XP SP2 operating system e Proprietary image acquisition storage and processing e Live color image display e Integrated patient database e Still and video capture modes e Review functions e Compare functions e Transfer backup functions e Data export as XML CSV or TXT with automatic patient organization e Image export as bitmap jpeg or png e Image annotation Environmental Conditions The system as delivered is intended for use indoors at normal room temperatures upright on a level surface with the brakes applied to the front casters Condition Operating Storage and Transport 592 to 95 F 152 to 352 C 4 to 122 F 202 to 502 C Relative Humidity 10 to 95 non condensing 10 to 85 non condensing Atmospheric 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 VG Note Specifications subject to change without notice RetCam Shuttle User Manual PN 20 000106 Rev C 118 Specifications RetCam Shuttle Dimensions Illustrated Dimensions in brackets are millimeters 20 7 526 19 0 483 46 9 1191 35 4 899 All casters swivel under base RetCam Shuttle User Manual PN 20 000106 Rev C License Agreements 119 10 License Agreements CMS Software Restricted Rights This Software and accompanying wr
100. lacement a Return Materials Authorization Number RMA must be issued by CMS The RMA number must be noted on the return shipping documents so that the disposition of the part is known when it is received at CMS offices Should your CMS product prove defective during the period covered by warranty please call fax or write to CMS at the numbers and address listed above for an RMA number Each separate part must be securely packaged and returned to CMS in its original shipping container or an equivalent Please clearly mark the outside of each returned package with the RMA number CMS will at its option repair or replace any defective or damaged part or component Determination regarding whether service and repairs are completed at the customer site or the defective or damaged part s are returned to CMS s facilities for repair shall be made by CMS on a case by case basis Costs incurred to complete service or repair including parts labor travel and shipping not covered by warranty will be billed to the customer upon successful completion of the service or repair For repairs not under warranty a purchase order PO will be required to cover the evaluation Service Information Service information is available separately in the RetCam Shuttle Service Manual RetCam Shuttle components are typically return to factory components and can be repaired by only Clarity personnel and or our qualified distributors The Service Manual contains inf
101. ll resolution without any quality loss It results in the largest files e JPEG JPG 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 e PNG Portable Network Graphic is a newer format which uses compression to reduce size about half the size of a bitmap but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications Video clips are always saved and exported in AVI format Include Images checkbox Select this checkbox to include image data in the standard non proprietary formats JPG BMP or PNG PN 20 000106 Rev C Data Transfer 81 e Annotate Image checkbox Select this checkbox to include image annotations on all images you export Videos are not annotated When selected the Annotation Settings button becomes available When you click Annotation Settings the Annotate Image dialog opens For further instructions see Annotate Image on page 66 amp Note You must clear all annotation checkboxes to exclude all annotations from the exported images Clearing the Annotate Image checkbox does not ensure that no annotations will be exported e Include Data checkbox Select this to export the patient data associated with each image which includes all the data entered on the Patient Information dialog see Figure 2
102. m any other health care occupation In June 1988 the CDC further clarified their recommendations particularly as they relate to the protection of health care workers by stressing the far greater risk of bloodborne viral infections e g HIV and HBV posed by blood and blood contaminated bodily fluids than by such bodily secretions as tears In that document they noted that Universal precautions do not apply to nasal secretions sputum sweat tears unless they contain visible blood Thus normal tear exposure does not require bloodborne pathogen precautions In June 2001 the U S Public Health Services updated RetCam Shuttle User Manual recommendations for the management of occupational exposures to HBV HCV and HIV In March 1992 the Occupational Safety and Health Administration OSHA issued a set of regulations entitled Occupational Exposure to Bloodborne Pathogens which requires that employers establish safeguards which protect workers against hazards related to bloodborne pathogens These regulations require identification of who is at risk of occupational exposure the communication of hazards to employees at risk for exposure exposure prevention control measures and what to do if an exposure occurs In April 2001 the Needlestick Safety and Prevention Act became effective revising the bloodborne pathogens standard to require employers identify and make use of safer medical devices which can be u
103. make contact with the cornea or tears but may cause micro aerosol formation The front surface may be wiped with an alcohol soaked sponge since it may occasionally touch the eye Digital Pneumotonometer Tips of pneumotonometers should be cleaned with an alcohol sponge taking care that the surface is dry before using it again It is important to allow the alcohol to evaporate completely to avoid damage to the corneal epithelium Diagnostic Contact Lenses Goldmann etc The lens is inverted so that the contact lens surface is uppermost The outer casing and inner surface of the lens are then vigorously wiped with an alcohol sponge As an alternative the inner cup may be filled to the rim or partly immersed within a fresh 1 10 dilution of household bleach After five minutes the bleach is removed and the device ts briskly irrigated with running water and dried This method allows cleansing of the outer surface of the lens as well as the contact portion without exposing the anti reflective coating on the operator surface of the contact lens to the bleach It is important to rinse to avoid corneal de epithelialization that might be caused by residual disinfectant solution Other Instruments That May Come Into Contact With Patients The HIV is a fragile virus and there is no evidence of casual spread from surfaces of ophthalmic instruments However it is known that other viruses such as adenovirus may persist for many hours on a dry
104. n isolated from tears and other ocular fluids the titer is extremely low and is considered by many authorities to be below an inoculating dose To date there is no evidence that the infection has been acquired from contact with tears However it must be remembered that these precautions will be effective against other more infectious agents than may be encountered in patients with HIV infection These OSHA and CDC guidelines are intended to help protect the public and ophthalmic medical personnel and minimize transmission of bloodborne pathogens and surface infectious agents RetCam Shuttle User Manual Additional Resources Further information on the CDC guidelines can be obtained by viewing the CDC website for Division of Healthcare Promotion http www cde gov ncidod shipy Further details on the OSHA regulations including regulations governing HIV and HBV research laboratories and production facilities can be obtained by viewing the OSHA website http www osha gov or ordering publications online http Avww osha sic 2ov OshDoc Additional hbtml Occupational Safety and Health Bloodborne Infectious Disease State needle safety legistation www cde gov niosh ndl law ron Exposure management resources National Clinicians Postexposure Prophylaxis Hotline PEPline 1 888 448 4911 Needlestick www needlestick mednet ucla edu Hepatitis hotline 1 888 443 7232 Reporting to CDC Occupationally acquired HI
105. nditions nnne a neha 117 10 License Agoreements uk 119 e CMS Software Restricted Hobte 119 e RetCam Shuttle Software End User License Agreement 119 WNC SX E 121 RetCam Shuttle User Manual PN 20 000106 Rev C 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 RetCam Shuttle User Manual List of Figures RetCam Shuttle Imaging System ccccccseseececeeeeeecceeeeececeueeeecseeeseessaeeeesesaeeeees 11 Handpiece and Lens PieCescs ccu 13 Lens Piece SEIS CON EE 13 Shuttle with all items stowed c cece cecccceeeeceeeeceeeeeeeeeeeeeeesee seca eeseaeeseeeesaeeesaeeeees 16 TRrANSOOMING ING lt 17 M in DOWER SWIC EE 26 Lower door open showing electro optical box 27 Computer power and USB video cables cccccceccccceeceeeeeeeeeceeeeeseeeesseneeesaeees 27 Site Awareness dialog on first use 28 Specify Site Information dialog cccccccssesceeceeeeeeeeeeeeeeseeeeeeeseeeeeeesseeseeeeeseeeeseas 28 Site Awareness dialog after first use 29 Her am Shuttle status bar 30 Sh tdowm Options E e EE 31 Electro optical box drawing
106. nt will be scattered over many export subfolders BZ Tip for Export of a Few Images When exporting not for backup purposes but to share a few images from one or a few patients with another RetCam system use the standard destination location but select the Create subfolder checkbox and give the export subfolder a highly recognizable name This way the export subfolder will be easy to find in the usual directory but with a clearly purposeful name Also make sure you select the RetCam Viewing mix radio button so you save the images in a format accessible by a RetCam system Overwrite existing data checkbox This option is to be used only when you wish to replace files previously exported to the same destination Select this checkbox to overwrite existing records If not selected duplicate data will not be exported again This speeds export by exporting only new data When performing routine backup you normally want to have this checkbox clear so that only new data is exported saving time and making backup incremental Organize patients into subfolders checkbox Select this option to create a subfolder for each patient whose images are exported When you export the system will create a subfolder for each patient whose images are exported The name of each patient subfolder is composed of last name first name and patient ID for example Wingate David 12345 This is especially useful for incremental backup as described in the Tip for Backu
107. o bloodborne pathogens The use of safety devices and techniques to reduce handling of sharp instruments also reduces the number of percutaneous Injuries Exposure to HIV in health care settings has been of major concern As of June 2000 the Centers for Disease Control and Prevention CDC received reports of 56 U S health care personnel with HIV transmission associated with occupational exposure and another 138 reports of possible transmission to date For health care personnel exposed through percutaneous means to HIV infected blood the estimated risk for HIV infection is 0 3 Risks associated with a mucous membrane exposure are estimated to be 0 09 Risks for HIV seroconversion after a percutaneous exposure have been found higher for those exposed to a larger quantity of blood De a device visibly contaminated with blood a needle being placed directly in a vein or artery or a deep injury or when the source patient was terminally ill with AIDS Transmission of HBV poses a risk to health care workers In 1994 approximately 1 000 health care workers were infected with HBV from occupational exposure Since implementation of routine preexposure vaccination of health care personnel and precautions to prevent exposure to blood there has been a significant decrease in HBV infection among health care personnel HBV is transmitted by mucosal or percutaneous exposure to blood and serum derived body fluids trom persons with acute or chroni
108. or light intensity camera focus image capture and system logic The front panel has outlets for computer power DC DC power and USB video the footswitch and the three interconnect camera handpiece harness cables See The Electro Optical Box on page 32 for more details Footswitch A rocker pedal on each side and a push button in the middle e Focus control left pedal Rock to the left to focus closer to the right to focus more distant e Light intensity right pedal Rock to the left to decrease intensity to the right to increase intensity e Snap switch central push button Press to capture and store the current still image or in video mode to start and stop recording e Storage Compartment s Particularly useful for safe transport compartments inside the upper cart door provide storage for the handpiece the lens pieces and a container for tools and supplies Inside the lower door on the right is a compartment for the footswitch e Transport Handle Extends to tilt and roll the cart to another location RetCam Shuttle User Manual PN 20 000106 Rev C Introduction 13 Handpiece Lens piece Frontmost tip or Contact lens Quick removal connector Interconnect cable Figure 2 Handpiece and Lens Piece LENS PIECE SELECTION CHART gt High Magnification High Contrast Children s amp Adults ROP amp Anterior Segment Figure 3 Lens Piece Selection Lens Model Application Common Field of Vi
109. ormation on user replaceable parts and or instructions to remove components for return for factory repair RetCam Shuttle User Manual PN 20 000106 Rev C 116 Specifications 9 Specifications Hardware Physical e 19 483 mm wide x 19 483 mm deep x 34 864 mm high e 75 mm front swivel casters with brakes e 5 mm rear casters e Approximately 65 lbs 30 Kg e Low center of gravity e Temperature range 59 F to 95 F or 15 C to 35 C e Humidity range non condensing 10 to 95 Electrical e Power consumption 250 VA maximum e Input Power 100 240V 50 60 Hz e Detachable hospital grade power cord Cart Features e Two storage containers for lenses and supplies e Internal handpiece holster e Secondary work surface e Tri function footswitch e Dual 5 front locking casters e Extendable handle for system transport Custom Light Source e Adjustable intensity iris e Automatic black and white balance functions e Lemo focus motor connector e Custom fiber optic e Automatic fan speed controller e Easy access bulb replacement Handheld Imager e 3 chip RGB CCD e Full 24 bit color RetCam Shuttle User Manual PN 20 000106 Rev C Specifications 117 e Full resolution capture from video e Quick change front lens piece 5 options Notebook Computer e Intel Pentium M 2 1 GHz processor e 1GB Random Access Memory e 80 GB hard drive e DVD R RW drive e 3 USB connections e Audio e 10 100 Ethernet Adapter e Inte
110. ould be changed at least once daily As an alternative the CDC recommends that a similar approach with a 5 to 10 minute exposure to a fresh solution of either 3 hydrogen peroxide 70 ethanol or 70 isopropanol can be followed These solutions need to be changed at least twice daily Goldmann type Tonometers A recent study compared several methods of disinfecting Goldmann tonometer tips which were inoculated with hepatitis C virus The methods that resulted in the greatest decrease in concentration of HCV RNA were a 3 minute soak in 3 hydrogen peroxide or 70 isopropyl PN 20 000106 Rev C 104 Maintenance and Support Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 4 alcohol following by washing in cold water A 5 second 70 isopropyl alcohol wipe was not as effective and a 5 second wipe with povidone iodine was more effective than the isopropyl alcohol wipe in reducing HCV RNA The washes are important to avoid corneal de epithelialization that might be caused by residual disinfectant solution Schiotz Tonometer The tonometer should be dissembled between each use cleaning the barrel with two pipe cleaners the first soaked in alcohol the second dry and the footplate with an alcohol swab All surfaces must be dried before reassembly Disposable covers are also available Non contact onometers The non contact tonometer may not
111. outbreaks have mostly occurred in eye clinics or offices Adenovirus can survive for long periods on environmental surtaces and ophthalmic instruments can become contaminated and transmit infection Handwashing glove use and disinfection of instruments can all help to prevent or limit the transmission of adenovirus Infected personnel should not provide patient care for the duration of symptoms after onset of adenoviral conjunctivitis Background The National Society to Prevent Blindness in cooperation with the American Academy of Ophthalmology assembled a Task Force to examine the risk of acquiring HIV infection in the course of eye examinations and treatments he Task Force helped develop precautions to reduce spread of pathogens that might be present in tears In August 1987 the Centers for Disease Control and Prevention CDC issued revised recommendations for the prevention of HIV transmission in a health care setting This was followed two months later by a joint advisory notice from the U S Department of Labor and the U S Department of Health and Human Services regarding the protection against occupational exposure to HBV and HIV These documents addressed the risk that health care workers may face in the course of their duties and made broad recommendations labelled universal precautions that all health care workers should follow Neither document distinguished the risks and needs of healthcare workers in ophthalmology tro
112. p on page 79 RetCam Shuttle User Manual PN 20 000106 Rev C 80 Data Transfer Select Image Format 5 Select either RetCam Viewing mIx or Open Standard format for export C RetCam Viewing mils f Open Standard bmp xml Include Images Annotate Image idegulsibiaedet Include Data Figure 47 Selecting the format for export e RetCam Viewing This radio button is selected by default MLX is the proprietary RetCam image format Use this option for routine data backup and to share data with other RetCam stations which include both RetCam II and RetCam Shuttle systems and PCs running RetCam Review Software or the Clarity Viewer program lt gt Note RetCam systems can read only native RetCam data files which are in the MLX format MLX files include images and patient data Images exported in standard formats JPG PNG or BMP do not have any patient data associated with them RetCam Shuttle User Manual e Open Standard Select this radio button to export image data in the standard non proprietary formats JPG BMP or PNG If you select this radio button its further options become available XXX Change button Click XXX Change where XXX stands for the current format JPEG High Change in the example to change the image format for export The Export Options dialog appears see Figure 40 on page 70 You can select from the following image formats e BMP The bitmap format saves images at fu
113. page 65 e Rotate 180 page 65 e Annotate Image page 66 e Adjust Image Display Parameters page 67 e Save and Export Processed Images page 68 Process Screen The Process screen appears when you select its tab or press F6 on the keyboard Print DEET Clarity Software 123456789 Doctor Pleasanton Gender Male Lens 800 Age This Session 2 weeks Gestation Age 34 weeks Birth Weight 2000 grams Right Eye OD Retina 1 14 2004 1 29 AM Retinitis pigmentosa Sample IT Show Hidden REye LEye All i 3 Annotate Standard Process Reset Adjustments Image 16 0 100 Image 17 Session Notes Rotate 180 Image 18 Image 19 JPEG Change RetCam Shuttle 8 29 2007 6 18 PM Figure 37 Process screen RetCam Shuttle User Manual PN 20 000106 Rev C Process Images 65 Use the Process screen to perform image processing You may often use the Process screen to prepare images for export especially if you must export them using a standard image format like JPEG BMP or PNG You can use the Process screen to save images in these formats in any accessible network location The layout of the Process screen is similar to the Review screen with thumbnails for the currently selected session on the left and the currently selected image full size in the center On the right side the screen provides following options each of which is explained in more detail below e View and append session notes e Rotate an ima
114. port Items To dialog appears i Export 5 items to ameme i Specify destination location Path Fs Create subfolder j20070829_182708 C Overwrite existing data C Organize patients into subfolders C RetCam Viewing mils Ge Open Standard hmp sml iM Include Images S4ynotate Image Annotation Settings Image Format Export Figure 44 Export Items To dialog The title bar of the dialog includes the number of items selected for export 5 in the example shown By default it shows the path and all the options last used RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 77 Select Export Options Use the Export items to dialog to specify where to export the images the image format and what information to include with the images Specify Destination Location 3 In the Specify Destination Location area near the bottom of the Export Images To dialog the Path field indicates the path where the export folder s will be created Specify destination location path WHospitalNetwork FileShare g eea 0061117 _ 112611 O Overwrite existing data O Organize patients into subfolders Figure 45 Specify Destination Location area By default the Path field shows the path last used To change the path click Browse A standard Windows Browse dialog opens enabling you to find and select the desired export path which may be any accessible network location BZ Tip for Backup Cre
115. r the transport handle If you wish you can detach it from the rear of the system and place it inside the cart Remove the lens and store it in the lens box and secure the camera handpiece and the footswitch in their storage compartments inside the cart The camera cable also fits inside the upper and lower storage compartments 4 Remove the notebook computer from the work surface and carry it separately 5 Make sure the cart doors are closed Release the front caster brakes 6 Extend the transport handle upward and use it to tilt the cart and roll it to a vehicle for transport Inside the vehicle you may lay the RetCam Shuitle on the slider bars on its back side with the two front compartment doors facing upward You may also place the Shuttle system upright and apply the front caster brakes It may require more than one person to lift and position the system properly in the vehicle Do not place the system on its work surface not upside down nor on either side with the front compartment doors facing sideways When you unload and place the device at its new work location Figure 5 Transporting the Shuttle apply the caster brakes plug in the power cord unpack the RetCam Shuttle User Manual handpiece and footswitch connect and power on the notebook computer PN 20 000106 Rev C 18 Introduction Electrical Safety Information The RetCam Shuttle System has been designed inspected and tested to comply with the sa
116. re completes its start sequence you will be prompted to establish site awareness for the system Figure 8 Computer power and USB video cables RetCam Shuttle User Manual PN 20 000106 Rev C 28 System Functions Establish Site Awareness After you turn on the notebook computer and it completes its start sequence the Site Awareness dialog appears prompting you to identify the current physical location No sites will appear in the list initially You must create one before you can access the RetCam Shuttle functions Site Awareness a Site Awareness enables data to be organized into separate data a repositories based onthe site selected on this screen A site identifies a particular institution and department which uses this RetCam device Select the appropriate site to be used or create a new site if one does not exist for your institution and department Choose a Site Cancel Figure 9 Site Awareness dialog on first use VG Note All patient and image data is associated exclusively and irrevocably with the site under which it is acquired Specify a New Site To specify a new site follow these steps 1 In the Site Awareness dialog Figure 9 above click New The Specify Site Information dialog appears Specify Site information Describe clinical entity A Institution ke 8 Department Site namefautomatic Secure access Optional Password Retype password Cancel Op
117. rgy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 The RetCam Shuttle is suitable for use in all Harmonic emissions IEC 61000 3 2 establishments other than domestic and may be Voltage fluctuations flicker emissions Complies Usog Ii COMOR IG eS SATEN ANA MOSE aiecky IEC 61000 3 3 connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only 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 re orienting or relocating the RetCam Shuttle or shielding the location RetCam Shuttle User Manual PN 20 000106 Rev C 20 Introduction Electromagnetic Immunity Guidance and manufacturer s declaration electromagnetic immunity The RetCam Shuttle is intended for use in the electromagnetic environment specified below The user should assure that it is used in such an environment Immunity test IEC 60601 1 2 Compliance level Electromagnetic environment guidance test level Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic discharge ESD 8 kV air 8 kV air tile If floors are covered with synthetic
118. rk or Removable USB Mass Storage Device VG Note Consult your network administrator or an information technology professional regarding arrangements to implement a secure long term data backup scheme in your particular situation For details see Networking a RetCam Shuttle on page 85 lt gt Recommended Backup Frequency Each day you acquire new images RetCam Shuttle User Manual PN 20 000106 Rev C Data Transfer 73 Recommended Backup Scenarios Scenario 1 To a Network Server In this scenario you use data transfer to backup data to another computer on your office network preferably a server class computer with large and expandable capacity and internal backup functionality The server must be Windows network compatible which most servers are See Networking a RetCam Shuttle on page 85 for instructions to link a RetCam system to the office network Scenario 2 To a Removable USB Mass Storage Device Removable USB mass storage devices can have very large capacity for secondary backup When not connected to the Shuttle notebook keep the removable USB mass storage device in a secure place Recommended Scenario for Multiple RetCam Systems In the situation where an institution has multiple RetCam systems we recommend that you link each system to your office network and back up every system to the same backup folder on the network See Networking a RetCam Shuttle on page 85 for instructions to link a RetCam system to the office n
119. ront panel of the EO box for about 1 second and release The characters ABB will appear superimposed and blinking on the live black image The characters ABB will stop blinking and the characters ABB OK will appear for approximately 1 second Black balance adjustment is successful If the characters ABB NG appear it means that the automatic black balance cannot be performed NG no good Usually this is due to light leaking into the black image Try blocking ambient light more completely and press ABB again If the problem persists please call the manufacturer or your authorized representative Automatic White Balance AWB The automatic white balance adjustment corrects the camera controller to display colors accurately RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 35 lt gt Note This procedure should be done under minimal room lighting to simulate how a retina being imaged is screened from room lighting by the handpiece To adjust the automatic white balance follow these steps T 2 Perform automatic black balance as described above Connect the lamp fiber optic cable back in its EO box receptacle The handpiece should now be projecting light Adjust the handpiece light level to that of normal usage 3 Attach any front lens if not already present See Lens Installation on page 36 4 Place a blank white piece of paper on a nearby table Hold the handpiece perpen
120. ry New Session Review Clarity Software 123456789 Doctor Pleasanton Lens 800 Age This Session 2 weeks Gender Male S Session Left Eye OS Retina Moes 1 14 2004 1 33 AM IT Show Hidden R Eye L Eye Image 17 Image 18 Figure 32 Compare Images screen Image 16 Utilities Print Clarity Software 123456789 Doctor Pleasanton Lens 800 Age This Session 2 weeks Gender Male Left Eye OS Retina 1 14 2004 1 33 4M Notes All Show Hidden Image 17 Image 18 RetCam Shuttle 8 29 2007 6 16 PM If you access the Compare screen from the Review screen the last image displayed on the 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 Use the Patient Session Selector above either or both images to change the patient and or session on that side It is not possible to compare videos Hide Item and Flag Item are not available from this screen RetCam Shuttle User Manual PN 20 000106 Rev C 60 Review and Compare Images Session Notes Click Session Notes above the desired image to review or append text to the session notes for that image You cannot alter saved notes Notes are identified by date and the doctor s name Print Images
121. s a receptacle for insertion of the handpiece fiber optic line which is part of the camera interconnect cable AN WARNING Do not look directly into the Lamp Fiber Optic opening when the EO box is on The Focus connector is a direct insert receptacle for insertion of the white focus motor cable which is part of the camera interconnect cable e Insert Detach Align the red dot on the connector with the red dot on the Focus port and insert To detach pull back on the connector but not the wire The focus connector is not threaded The Camera Handpiece connector is a receptacle for insertion of the black camera controller cable which is part of the camera interconnect cable e Insert Detach To insert align the slot in the port with the pin on the connector insert and screw in clockwise to secure To detach unscrew counterclockwise the connector sleeve and pull out Camera Color Balance Adjustment The electro optical box provides buttons near the top left by which you can adjust the black and white camera color balance AWB and ABB Buttons UA Figure 15 Electro optical box drawing upper portion showing color balance buttons e The ABB button is for automatic black balance of the camera Refer to Automatic Black Balance ABB on page 34 for instructions RetCam Shuttle User Manual PN 20 000106 Rev C 34 System Functions JE e The AWB button is for automatic white balance of the camera Refer to Autom
122. s space to store organize and share your documents and pictures Using only a Web browser and Intemnet connection You can also use this wizard to create a shortcut to a Web site an FTP site or other network location To continue click Next Figure 56 Add Network Place Wizard welcome dialog RetCam Shuttle User Manual PN 20 000106 Rev C 88 Data Transfer 4 Click Next The wizard will ask you Where do you want to create this network place Add Network Place Wizard Where do you want to create this network place Select a service provider It you do not have a membership with the provider you select the wizard will help you create an account To just create a shortcut click Choose another network location Service providers MSN Communities Share your files with others or store them for your personal uze p Choose another network location Speci the address ol a Web ste network location or FTF site Figure 57 Choose where to create the new network place 5 Select Choose another network location and click Next The wizard will ask you What is the address of this network place Add Network Place Wizard What tt the address of this network place Type the address of the Web site FTP site or network location that this shortcut wall open Internet or network address Whi edserver AetCam Images k View some examples Cancel Figure 58 Specify the address of t
123. same type and rating fuse Replacement fuses are available from Clarity Customer Service Call 800 215 6005 toll free in the US Outside the US contact your distributor The part number for the fuse is 20 000097 See complete Technical Support Contact Information on page 114 When you have replaced the blown fuse reinsert the fuse holder fully and close the cover Replace Illumination Lamp A N WARNING Appropriately power down and unplug the unit and allow the illumination lamp to cool before replacing it The illumination light bulb located in the EO box will need periodic replacement It is a 12 volt 75 watt halogen bulb industry type EKE Replacement bulbs are available from Clarity Customer Service Call 800 215 6005 toll free in the US and ask for replacement part number 02 04 501 See complete Technical Support Contact Information on page 114 Follow these steps to replace the illumination lamp found in the EO box 1 If it is not already turned off turn off the instrument according to the instructions found under Turning Off the RetCam Shuttle on page 31 2 Disconnect the main power cord from the wall 3 Unplug the fiber optic cable from the front of the EO box RetCam Shuttle User Manual PN 20 000106 Rev C Maintenance and Support 111 4 Remove the two screws from the lamp assembly drawer the smaller panel with the black handle on the front of the EO box IG _Lamp assembly drawer gt Remove 2 scr
124. sed to reduce worker exposure In 1992 the American Academy of Ophthalmology Public Health Committee developed updated recommendations for ophthalmic practice in relation to HIV The Committee noted that there were two distinct areas of concern to ophthalmic medical personnel and patients 1 Transmission of ocular surface infectious agents such as adenovirus or herpes virus Prevention of transmission of these pathogens requires good hygienic techniques such as routine hand washing tonometry cleaning and trial contact lens disinfection 2 Transmission of bloodborne pathogens such as HIV or HBV Prevention of transmission of these agents requires the use of bloodborne pathogen precautions which include the proper use of gloves needle disposal and other precautions such as administering hepatitis B vaccine in workers exposed to bloodborne pathogens Recommendations The Committee recommended specific measures that would provide adequate protection for the patient for health care workers in the ophthalmic care setting and for the ophthalmologist This document updates four areas e Procedures for protection of the patient Procedures for protection of the staff Procedures for protection of the ophthalmologist Responsibilities toward patients with known or suspected HIV infection l Procedures for Protection of the Patierit Protection of patients trom exposure to the HIV during examination and treatment of eye
125. sh exposure control plans that include post exposure follow up and to comply with incident reporting requirements Il Procedures for protection of the ophthalmologist Ophthalmologists might be at risk of acquiring HIV HBV or HCY infection in their professional activities from two major sources 1 the patient examination and 2 the setting of surgical intervention General Precautions Against Infection Office The ophthalmologist personally should follow the same procedures designed to protect office staff and described in Section Il These include handwashing wearing of gloves where appropriate and taking precautions to prevent injuries caused by needles scalpels and other sharp instruments Avoid touching one s own eyelids or contact lenses with the fingers without thorough hand washing In the normal ophthalmic office setting gowns masks and protective eyewear are usually unnecessary except in situations when splashing with blood or blood contaminated fluids may be anticipated Minor Office Surgical and Diagnostic Procedures The universal precautions should be observed when performing minor procedures and intravenous fluorescein angiography In addition to gloves and masks protective PN 20 000106 Rev C 108 Maintenance and Support Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page amp eyewear should be used if there is a po
126. ssibility of blood or body fluid splashing Surgery Ophthalmologists are probably most at risk of exposure to HIV and other bloodborne pathogens while performing or assisting in surgery The following procedures are recommended during surgical procedures Adopt universal precautions for all patients Wear gloves when performing all injections a Handle suture needles with needle holders only Develop techniques for sate handling and transfer of sharp instruments a Follow guidelines given in Section II regarding surgery IV Responsibilities Towards Patients with Known or Suspected HIV Infection Like all physicians ophthalmologists have a moral and ethical responsibility for providing care to all patients regardless of whether they are known to be infected with HIV are known to be seropositive or fall within a high risk group Ophthalmologists and ophthalmic medical personnel are at little risk of contracting HIV infection in the course of routine clinical practice Risks may be further minimized when dealing with those known to be seropositive or suffering from clinical AIDS but one should remain cognizant of the fact that many seropositive individuals have not been tested Given the above scenario bloodborne precautions are warranted for all appropriate patients Conclusion The risk of contracting HIV infection in the ophthalmic healthcare setting is estimated to be extremely remote Although HIV has bee
127. t 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 20 000106 Rev C Index A Add a New Patient Record 43 Add All Patients 41 Add New Patient 43 Add Selected Patient 41 Add to Resident Buttons 41 Adjust Volume 96 Annotate Image 66 Annotation Data checkbox 81 Annotation Placement 67 Annotation Settings 81 Automatic Black Balance ABB 34 Automatic White Balance AWB 34 B Backup 79 Backup Frequency recommended 72 Backup Recommendation 37 72 BMP 70 80 C Camera Color Balance Adjustment 33 Cancel Session 51 53 Cart Features 116 Change button 80 Change the Format for Saving Images 70 Changing Image Type 52 Changing Lens 52 Changing Right Eye OD Left Eye OS 52 Class 1 18 Cleaning Procedures 98 Cleaning the Lens Piece 98 Cleaning the Rest of the System 99 CMS Software Restricted Rights 119 Color Balance 34 Compare Screen 59 Compatible Removable Media 37 correspondence 114 Create subfolder 73 RetCam Shuttle User Manual Index 121 Create Subfolder Checkbox 78 Lens 51 Image Type 51 D Data Source Select 40 Data Transfer 72 Date Time 96 Deselect All 74 Disk Management 97 E Edit Patient 44 Eject 97 Electrical 116 Electrical Safety Notices 18 Electromagnetic Immunity 20 Electro Optical EO Bo
128. tational Age Enter gestational age in weeks e Birth Weight Enter patient s birth weight in grams When finished entering information click OK The patient record is created and highlighted automatically on the Patient Select screen Edit a Patient Record When Resident Patients is selected in the Data Set area at upper left the Edit Patient button is available With the desired patient selected click Edit Patient to edit that patient record The Patient Information dialog appears showing the current data in the fields Edit the fields as desired and or use the drop lists to select options for Doctor Name Pathology and Classification When finished editing click OK to save your changes A confirmation dialog appears prompting you to confirm or cancel your changes Print Patient Report Click Print to print the data currently displayed in the patient list on the report printer RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 45 Complete Report prints all the displayed fields plus expanded sessions with individual session numbers and dates History Screen The History screen appears when you select its tab or press F2 on the keyboard Select the desired patient first to display that patient s history Patient Select History New Session Review Compare Process Transfer Utilities Print Shutdown Clarity Software 123456789 Birth Weight 2000 grams Doctor Pleasanton
129. tems or RetCam Review Station computers the information in this section will help you accomplish this lt gt Note Due to the variations possible in network configuration the knowledge of which is important to successfully add systems to a network Clarity RetCam Shuttle User Manual PN 20 000106 Rev C 86 Data Transfer recommends that networking be left to a network specialist who is familiar with the configuration of your local network Configuring Permanent Access to Network File Shares The following information is intended to be understood and implemented by a network specialist familiar with your local network A network file share is a shared accessible folder in a network location on a server This section explains how to configure access to a Windows network file share by a RetCam device that is not part of the domain to which the server belongs VG Note A system administrator network specialist must assign a user account on the domain to access the network file share to be used for network data transfer with write access We suggest you create a separate folder on the server for storage of RetCam images Add A Network Place Follow the steps below to add a network place which will give the RetCam device permanent access to the network file share for data transfer operations relative to the access of the user account used VG Note There is no limit to the number of network places which can be added Network
130. ter Hangs If the computer hangs stops responding you may have to shut it down directly but in doing so you may lose any unsaved data Therefore please wait a sufficient time to make sure it is not simply busy To shutdown the computer directly as with any Windows XP system hold down the computer on off switch for about three to five seconds Emergency Shutdown A N WARNING Do not use the emergency method below unless necessary because data corruption can occur In an emergency turn off the main power switch at the power inlet on the rear of the cart or pull the plug from the wall outlet These actions will remove power from the entire system although the notebook computer may continue to operate using its internal battery RetCam Shuttle User Manual PN 20 000106 Rev C 32 System Functions Camera Handpiece Focus Controller USB Video Out to Computer JE Turning Off for Extended Periods If you are not going to use the system for an extended period eg a day or more it is advisable to turn off the electro optical box to preserve the life of the illumination lamp The electro optical box is found inside the lower door at the left Its power switch is on the right side Note Turning off the power switch on the electro optical box removes power to all system components except for the notebook computer The notebook power outlet on the electro optical box is live whenever the main power is on Alternatively yo
131. theme This connection uses the followang tems Jl QoS Packet Scheduler Y AEGIS Protocol IEEE 802 15 v3 1 6 0 Description Transmission Conitnol Protocolintemet Protocol The default Wide area network protocol that provides communication across diverse interconnected networks Show icon in notihication area when connected Notify me when this connection has limited or no connectivity Figure 65 Local Area Connection Properties dialog RetCam Shuttle User Manual PN 20 000106 Rev C 94 Data Transfer RetCam Shuttle User Manual 3 Click on Internet Protocol TCP IP and select Properties The Internet Protocol TCP IP Properties dialog appears Internet Protocol TCP IP Properties General You can get IP settings assigned automatically if your network supports thie capability Othenvise You need to ask your network administrator for the appropriate IP settings C Obtain an IP address automatically g Use the following IP address IP address 192 168 100 7 Subnet mask 255 255 255 0 1 Default gateway 192 168 100 Use the following DNS server addresses Preferred DNS server l Alternate DHS server l Figure 66 Internet Protocol TCP IP Properties dialog 4 Select the Use the following IP address radio button 5 In the indicated fields enter the assigned IP Address Subnet mask and Default gateway The addresses shown above are for example only The actual a
132. ther infection control procedures If an ophthalmic medical personnel does accidentally sustain askin puncture the following actions should be taken The individual should temporarily discontinue participation in surgery if possible and cleanse the wound for five minutes with an antiseptic solution PN 20 000106 Rev C Maintenance and Support 107 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page The wound should then be dressed with a bandage after rescrubbing If there is no oozing or weeping of the wound the person may reglove and complete the surgery Under experimental conditions it has been reported that oral polio vaccine virus was cultured from the laser plume after excimer laser ablation Another experimental study postulated that intectious virus particles could be aerosolized during excimer laser photoablation Another study using a model system did not find any transmission of virus by the excimer laser plume It seems prudent then to maintain the same procedures in excimer laser surgery procedures as practiced as in other surgical procedures e g masks gloves sterilization of instruments etc Management of Exposures These recommendations are based on the U S Public Health Service Guidelines published in 2001 Occupational exposures are considered urgent medical concerns so that timely management can be administered St
133. tions Recommendations A Handwashing Handwashing represents the single most effective means of avoiding the risk of transmitting or acquiring infections in the course of examination The CDC recommends that ophthalmic medical personnel performing eye examinations or other procedures involving contact with tears should wash their hands immediately after a procedure and between patients Handwashing should be encouraged when there is any doubt about the necessity for doing so For routine handwashing a vigorous rubbing together of all surfaces of the lathered hands is recommended for at least 10 seconds followed by a thorough rinsing under a stream of water Plain soap can be used for handwashing for most routine activities Gloves may be used as an extra margin of safety When gloves are worn handwashing ts still recommended because gloves can become perforated and bacteria can grow rapidly on gloved hands If there are cuts scratches or dermatological lesions g weeping lesions on the hands then use of gloves is advisable B Eyedrops The bottle tip should not come into direct contact with the patient s tears or conjunctiva If the tip does touch the patient the bottle should be discarded RetCam Shuttle User Manual L Gowns masks and protective eve wear Gowns masks and protective eyewear are unnecessary for the usual ophthalmic examination D Disinfection procedures Disinfection is a process to
134. tree structure to select another patient or a different session Click on the boxed plus sign next to the Patient ID to display the list of sessions for this patient Click on a session to highlight the session and access its images When a patient s session list is expanded click on the boxed minus sign to contract it For further search options click on the Filter Patients tab These search options are the same as the options on the Patient Select screen Refer to Patient Select Screen on page 39 for a description RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 47 Print Patient History or ROP Report Click Print to print the currently displayed patient history on the report printer For ROP patients it offers the option to print the ROP report Choose Report Please select which report to run f Patient History Figure 23 Choose Report dialog RetCam Shuttle User Manual PN 20 000106 Rev C 48 Start Patient Select New Session ROP Report Jones Indy 23223 DOB Gender Birth Weight Gestational Age Birth Count 11 01 2003 Male 1500 gms 32 weeks Twins Doctor Pathology Spock ROP Patient Notes Date Notes 11 10 2003 6 weeks premature can be released in 4 weeks Spock 12 12 CLOCK HOURS j ai Se 3 ORA SERRATA E Right Eye 6 e Left Eye Session History Session Date OD Images amp Notes OS Images amp Notes 1 11 1 Retina 1 Retina Detach
135. tus Bar The status bar appears at the bottom of all RetCam Shuttle screens I Al 10 11 2004 7 48 PM Figure 12 RetCam Shuttle status bar It displays the date time and system status information The following status indicators can appear e Indexing The system is reading the data on a media or in the hard drive buffer and checking the data against the system s database e A Caps Lock for the keyboard e 1 Num Lock for the keyboard RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 31 Turning Off the RetCam Shuttle Shutdown To turn off the system use the Shutdown button in the upper right corner of most screens When you click Shutdown the system gives you three options as illustrated below Shutdown Options Please backup export your data on a regular basis You may want to go back to RetCam now to perform export operations Exit to Windows 3 Go back to RetCam SI Figure 13 Shutdown Options dialog This dialog reminds you to backup export your data on a regular basis To backup before shutting down click Go back to RetCam and use the export function see Export on page 75 for details To proceed with shutdown click Shutdown Computer which safely closes the RetCam Shuttle application and powers down the correct components in the normal sequence To exit the RetCam Shuttle application without shutting down the computer click Exit to Windows If the Compu
136. u may turn off the main power switch at the power inlet on the rear of the cart This removes power from the entire system including the notebook which may still run by its internal battery The Electro Optical Box The electro optical box EO box is akin to the central nervous system of the RetCam receiving your input from the footswitch and camera and directing its output to camera computer and notebook display It contains the illumination lamp and light intensity controllers focus camera and footswitch controllers and passes live images from the camera to the screen This section introduces its components and functions you can control with it Lamp Fiber Optic On Off Switch Footswitch Laptop Power always on with main power Figure 14 Electro optical box drawing lower portion showing connectors Note It is not necessary to remove any of the connectors for use storage or transportation RetCam Shuttle User Manual PN 20 000106 Rev C System Functions 33 WARNING Do not remove or insert the camera connector while the RetCam A N Shuttle system is powered on Before connecting or disconnecting the camera connector shut down the system through the software and then switch off the power at the main power switch IT IS NOT SUFFICIENT TO SHUT DOWN THE COMPUTER ONLY YOU MUST SWITCH OFF POWER AT THE MAIN POWER SWITCH You can insert or remove the fiber optic connector at any time The Lamp Fiber Optic connector i
137. udies show that postexposure prophylaxis should be initiated as soon as possible because it is most effective within 24 to 36 hours after exposure However even atter 24 to 36 hours it can be considered because it might still be effective lf a person has been exposed to a source person already known to be seropositive for HIV or there is a strong likelihood that the source person is HIV infected then postexposure prophylaxis PEP can be initiated as soon as possible in consultation with physicians with expertise in antiretroviral therapy and HIV transmission If the source person s HIV status is not known the use of PEP can be decided on a case by case basis All persons with occupational exposure to HIV should receive follow up counseling testing and medical evaluation For HIV PEP recommendations include a basic 4 week regimen of drugs if tolerated and an expanded regimen for exposures that pose an increased risk for transmission If the source person is seronegative for HIN then baseline testing or further follow up of the exposed health care personnel is not necessary Otherwise health care personnel should be tested for HIV within hours of exposure Serologic testing should be made available to all health care personnel who are concerned that they might have been infected For personnel exposed to HEV it is recommended to initiate the hepatitis B vaccine series to an unvaccinated person and provide PEP with hepatitis B
138. umber on all correspondence The serial number is located on a sticker affixed to the base of the cart at the back just above the power cord connection Please be as specific and give as much information as possible If you encounter a system malfunction of any kind please record the exact steps taken leading to the failure so that our staff can replicate the problem 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 support is typically available between the hours of 9am and 5pm Pacific Time 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 VG 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 RetCam Shuttle User Manual PN 20 000106 Rev C Maintenance and Support 115 Returning Parts for Repair lf after consulting with CMS technical support to CMS for repair or rep
139. ure 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 Figure 61 Figure 62 Figure 63 Figure 64 Figure 65 Figure 66 Figure 67 Figure 68 Figure 69 Figure 70 Figure 71 Figure 72 Figure 73 Figure 74 Figure 75 Figure 76 RetCam Shuttle User Manual EXPO tO MAGS ale re BEE 71 Transler Scree eebe eege 74 Select drop EE EEN 75 EXPO tems Todiadlog EE 76 Specify Destination Location area ccccccceccccceececceeceeceueeeceeucecseueeecseeeesseeesssaaees 77 Finding the export destination on the NEtWOFK ccccseeeeseeeeeeeeeeeeeeeeeeeeeeeneaes 78 Selecting the format fOr CXPOFt iina aaa aa aa a ea 80 EXPO PrOOreSS dialo e EEN 81 EXPO SUCCESS FUN esp tee atest acon rel acces aeued ee toncelaaeonsetoneus ee 82 MPO OIG gl le DEE 83 IMPOR DrOQleSS el ee WEE 84 IDOE SUCCCSSIUN EEN 85 IMD OTE IAG Lei CIAO BEE 85 Network Connections e Te e BEE 86 Map Network Drive dialog cccceeceeseeeeeeeeeeeeeeeeeeeeeeeesaeeessaeeseeeeseeeeseeeeseeessneens 87 Add Network Place Wizard welcome dialog s snnsnnnssnnennennennrnsrrnrrrnerrnrrrerrrsrrrn 87 Choose where to create the new network place 88 Specify the address of the new network place 88 Connect to TarOCTSYSICM EE 89 Type a name for the new network Place cccccccseccceeeceeceeeeeseeeceeeeeeeeseeeseeeeseeenes 89 Completing the Add Network Plac
140. void infection with ocular surface contaminants such as adenovirus or herpes simplex virus as well as bloodborne pathogens such as HIV HBV and HCV Bloodborne pathogen precautions further reduce the unlikely risk of contamination of the ophthalmic medical personnel and patient alike Employers under OSHA s rule with health care workers who are exposed to bloodborne pathogens are required to establish a program that informs employees and employers of the risks of occupational exposure to bloodborne pathogens and how to reduce those risks Human tears are not considered to contain significant amounts of bloodborne pathogens and thus do not require OSHA s bloodborne pathogen precautions but exposure to human tears does require good office hygiene practices such as handwashing However contact with tears contaminated with blood such as in minor surgery requires the use of bloodborne pathogen precautions As the prevalence of HIV infection continues to increase throughout the United States it is inevitable that patients carrying HIV will be more commonly encountered in eye examining rooms and in surgery Some of these patients will be known to be infected with the HIV but in many it will be unrecognized All health care personnel engaged in delivering ophthalmic care to such patients might in the course of their normal duties be exposed to the blood of individuals who may be shedding the virus Although the risk of infect
141. x 12 Electro Optical Box 32 Email 114 Emergency Shutdown 31 EMI Information 19 Entire Patient 76 Entire Session 76 EO box 32 European Authorized Representative 21 Export 75 Export of a Few Images 79 F FDA USA Notices 22 Filter Patients 46 Flag Image 58 Flagged Items 76 Focus control left pedal 12 Footswitch 12 Footswitch Capture 51 Format Change Button 70 Freeze Image 51 Function Key 14 Fuse Replacement 109 Fuse Type 110 PN 20 000106 Rev C H Handheld Imager 116 Handpiece 12 13 Hardware 116 Hardware Components 11 Hide Image 58 History Screen 45 How to Get Support 114 If the Computer Hangs 31 Image Display Parameters 67 Image Preview 67 Include Data 81 Include Images 80 Indications for Use 9 Input and Fuse 21 Interconnect Harness 12 Introduction 9 J JPEG JPG 70 80 K Key Validation 112 Keyboard Capture 51 L Labels Symbols 23 Last 7 Days Items 76 Lens Installation 36 Lens Model 13 Lens Piece 13 Lens Piece Selection 13 License Agreements 119 Light intensity right pedal 12 Light Source 116 Live Image 51 M Multiple RetCam Systems 73 RetCam Shuttle User Manual Index 122 N Network Data Transfer 78 New Patient 43 New Session Screen 49 Notebook Computer 11 117 O Eye 51 Open an Image from Outside the RetCam Database 69 Open Standard 80 Operating Environment 117 Organization of this Manual 9 Organize patients into subfolders 73 Organize pati
142. y Select a pathology from the drop list or type in an entry Only pathologies of resident patients are included in the drop list RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 43 Add a New Patient Record When Resident Patient is selected in the Data Set area at upper left the Add New Patient button is available Click it to add a new patient record The Patient Information dialog appears with all fields empty Patient Information Required Fields Patient ID Doctor Last Name First Name Male Female Date of Birth unspecified MMO Dey Pathology Classification Patient Hotes Add Patent Note Created Doctor Note Body Cancel Figure 20 Patient Information dialog Required Fields To create a new patient record enter information at least in the required fields which are RetCam Shuttle User Manual Patient ID Type letters and or numbers usually a unique number to identify the patient Patient Last Name First letter is capitalized automatically when stored Patient First Name First letter is capitalized automatically when stored Patient DOB Enter patient s date of birth Age is displayed automatically e For patients under 2 years age is displayed in months and weeks e For patients over 2 years age is displayed in years and months Doctor s Name Select from the drop list or type in a new name First letter will automatically be capitalized when stor
143. y sticks Some USB sticks require special formatting before use with RetCam systems and we recommend purchasing pre formatted USB sticks directly from Clarity Call 800 215 6005 toll free in the US and ask for part number 03 12 025 If you are experiencing problems with your USB stick contact Clarity Customer Support See complete Technical Support Contact Information on page 114 RetCam Shuttle User Manual PN 20 000106 Rev C 38 Start Patient Select New Session 3 Start Patient Select New Session This chapter covers the functional prerequisites for image acquisition or review which include accessing the system software finding or adding a patient and reviewing the patient s history Then it covers image acquisition itself These functions are provided through the following screens e Start Splash Screen below e Patient Select Screen page 39 e History Screen page 45 e New Session Screen page 49 Start Splash Screen After you have established site awareness the Splash screen appears signaling that the system is ready for use Wide Field Digital Retinal Imaging RetCam Start using RetCam Shuttle P Clarity RetCam Shuttle 5 29 2007 5 27 PM Figure 17 RetCam Shuttle splash screen RetCam Shuttle User Manual PN 20 000106 Rev C Start Patient Select New Session 39 To begin using the system click Start using RetCam Shuttle When you do the Patient Select screen appears providing you access

Stratus OCT User Manual - Clarity Medical Systems

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