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Stratus OCT User Manual - Clarity Medical Systems

1. 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 Operating Storage and Transport BO 10 95 F 1510 35 C A o 122 F 20 to 509 C Relative Humidity 1096 to 95 non condensing 1096 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 Notebook Computer Intel Pentium M 2 1 GHz processor e 2GB Random Access Memory e 80 GB hard drive e DVD R RW drive 3 USB connections e Audio e 10 100 Ethernet Adapter Intel 128MB Video Adapter Note Specifications subject to change without notice RetCam Shuttle User Manual PN 20 000225 Rev A 82 Technical Specifications This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A License Agreements 83 11 License Agreements CMS Software Restricted Rights This Software and accompanying written materials are provided with Restricted Rights Use duplication or disclosure by the U S Government is subject to restrictions applicable to commercial computer software under FAR 52 227 19 and DFARS 25 227 7013 Contractor manufacturer is Clarity Medical Systems Inc This Agreement is governed in and by the laws of the State of California U S A This statement gives you
2. Turn the power switch OFF for 10 minutes and then turn it ON This will allow the lamp to cool If after these measures are taken the lamp does not turn on then replace the illumination bulb See Replace Illumination Lamp Bulb on page 71 No live image Check connections Is the USB cable from EO box to the notebook connected Verify the cables are properly plugged in Is the camera cable securely connected to the EO box Verify the camera cable is inserted and threaded on RetCam Shuttle User Manual PN 20 000225 Rev A Service 79 Troubleshooting Steps Unable to SNAP image Is the USB cable from EO box to the notebook from footswitch connected Verify the cables are properly plugged in Close the RetCam Shuttle program and reboot the notebook Images do not transfer Verify the Export path and subfolder match the intended destination No network connection Contact your Information Technology IT department RetCam Shuttle User Manual PN 20 000225 Rev A 80 Service This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A Technical Specifications 81 10 Technical Specifications Hardware Physical e 19 483 mm wide x 19 483 mm deep x 34 864 mm high Approximately 65 lbs 30 Kg Electrical Power consumption 250 VA maximum e Input Power 100 240V 50 60 Hz Fuse T 3A 250V Software e MS Windows XP SP2 operating system Environmental Conditions
3. or direct at 825 463 7984 to get an authorization key for this installation Read the license number below to customer support and enter the authorization key they give you in the field below Then press Yalidate Key 71339298 Validate Key Figure 57 Key Validation dialog Follow the instructions on screen Call Clarity and provide to the customer support representative the large license number in the dialog 71339298 in the example above which is unique for your system You will be provided in turn a unique authorization key Tip You may also send the license number via email to service retcam com and receive the authorization key by return email You must enter the authorization key in the field and select 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 000225 Rev A 76 Maintenance and Support Technical Support Technical Support Contact Information Customers outside the US please contact your distributor for technical support In the US you have the following options Telephone Toll free 800 215 6005 Fax 925 251 0078 Telephone 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 E mail service retcam com
4. footswitch storage i front casters Footswitch Figure 1 RetCam Shuttle Imaging System Image representative only RetCam Shuttle User Manual PN 20 000225 Rev A Introduction 9 Hardware Components e Notebook Computer Pre loaded with Her am system software The notebook computer includes a DVD R RW drive integrated network adapter and USB ports Handpiece Contains the camera Lightweight and easy to position it has a long cable for easy reach Use with changeable lens pieces Handpiece Interconnect Harness Comprises three separate cables the lamp fiber optic cable for subject illumination the camera controller cable and the focus motor cable Note Always return the handpiece to the holster when not in use The handpiece cable can be draped over the transport handle but do not wrap it tightly or damage to the fiber optic may result Electro Optical EO Box Contains the camera control unit illumination lamp and the control circuitry See The Electro Optical Box EO Box on page 21 for more details Footswitch Provides optical means to control illumination intensity camera focus and SNAP e Storage Compartment s All units have storage compartments for lens pieces tools and supplies Transport Handle Extends to tilt and roll the cart to another location i Handpiece __ m Set Interconnect harness cable Figure 2 Handpiece and Lens Piece RetCam Shuttle User Manual PN 20 000225 Rev A 10
5. 10 Carefully push the lamp assembly drawer back Use caution to avoid pinching wires in the area 11 Replace the two screws on the lamp assembly drawer and replace the fiber optic cable Figure 56 Replace lamp assembly drawer and fiber optic cable RetCam Shuttle User Manual PN 20 000225 Rev A Maintenance and Support 75 Key Validation Note New RetCam Shuttle systems ship with their license key already registered and validated However significant changes to the system hardware or a re load of the system software for any reason including software upgrade may require you to perform the key validation process as described below Key validation requires that you get a license key from Clarity to use the revamped system and you cannot request this key until after installation is complete Since it may take up to two 2 business days to obtain a license key after submitting a request we recommend that you affect system or software upgrades when you can manage two business days without use of the system Note To ensure the preservation of your patient data and images we strongly recommend that you perform a complete backup of the system s images before you begin any software installation When key validation is necessary the Key Validation dialog appears when you start the system and each time thereafter until you complete this step Key Validation Call Clarity Medical Systems tall free at 800 215 6005 U S and Canada
6. Figure 10 Add a new patient Import data from USB network etc Find existing patients Click on Magnifying glass to view the patient directory Figure 10 Start screen Add a New Patient Record To create a new patient record the following information is required e First Name e Last Name Date of Birth e Patient ID Patient information is repeated in several of the screens The patient name and Patient ID are always shown in the upper left corner of every screen RetCam Shuttle User Manual PN 20 000225 Rev A 26 Using the RetCam System Mew Patient Laat Name uc uj Select OK to proceed Enter information manually or use menus where available Figure 11 Add new patient screen Editing a Patient Record Highlight the patient s record from the Patients and Exams screen Select Edit You can edit the following information First Name Last Name Gender Male Female Other or Unknown Date of Birth Weight in grams Note Any fields on the Edit Patient Screen are editable RetCam Shuttle User Manual PN 20 000225 Rev A Using the RetCam System 27 Figure 12 Edit patient record screen Finding Existing Patient Records You can search the directory to locate specific patient records Find Patients Figure 13 Search buttons From the Start screen select the icon to display the entire patient directory or select the plus sign to locate patient records using one or more of the sea
7. Our US technical support staff will respond to your questions as soon as a staff member is available In most cases you should receive an answer within 48 hours Complex questions that require testing or special research may take longer Note Questions about products no longer under warranty and questions other than to explain ordinary use of the product may incur service charges Please ask for an hourly quotation before incurring charges RetCam Shuttle User Manual PN 20 000225 Rev A Service 77 9 Service CAUTION This section is intended for use by qualified technical personnel only If in doubt please contact the Clarity Service before proceeding Spare parts and supplies can be ordered by calling or faxing the part description and part number to Customer Service Consumables Part Description Part Number Illumination Bulb halogen 02 04 501 Fuses 3 amp 250 VAC 5x20mm slo blo 20 000097 USB stick 03 12 025 User Manual Software v 4 x 20 000106 User Manual Software v 5 x 20 000225 Components Notebook Computer Durabook 20 000067 Handpiece metal shell 01 00 201 Handpiece plastic shell 21 100064 EO box 20 000008 Portrait Lens PL100 for use with the PL100 metal shell handpiece Portrait Lens PL200 for use with the PL200 plastic shell handpiece Standard Baby Lens B1200 Premature Infant Lens D1300 High Contrast Lens E800 High Magnification lens C300 Servicing the Cart The notebo
8. a specific patient subfolder only select that subfolder as the Source location Delete source files and subfolders after import check box To manage the size of the export destination select this check box to delete the source files and subfolders after import is complete Note Do not select this check box 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 RetCam Shuttle User Manual PN 20 000225 Rev A 52 Import and Export Images Note This does not affect any working RetCam database but only the intermediate location where files are exported to and imported from 8 Select to initiate importing or A dialog opens to show import progress 9 A Select Import Data to save dialog will appear If not all items were imported you may select Show Detailed Log for the explanation It could be because some files are duplicates already in the destination database or the file is not found or it is corrupt or the destination is write protected View imported data and select thumbnails you need to save Select Import Selection You can also select Import All to save all images The system will notify you when the import is completed successfully RetCam Shuttle User Manual PN 20 000225 Rev A Printing Images 53 6 Printing Images The Print button appears at the lower right of screens when printing is available No
9. correspondence 76 E Electrical 81 Electrical Safety Notices 11 Electro Optical EO Box 9 Electro Optical Box 21 E mail 76 EMI Information 12 EO box 21 F Flag Image 38 Footswitch 9 Fuse Replacement 70 H Handpiece 9 Hardware 81 Hardware Components 9 Hide Image 38 How to Get Support 76 RetCam Shuttle User Manual Index 85 Image Display Parameters 42 Immunity Test Summary 12 Indications for Use 7 Interconnect Harness 9 Introduction 7 K Key Validation 75 L Lens Installation 23 Lens Model 10 Lens Piece 9 N Notebook Computer 9 O Operating Environment 81 P Physical 81 Power Connector 19 Power Cord 19 Print Images 40 H Recommended Maintenance Schedule 59 Reset Adjustments Button 42 Review Images 37 S Service Information 76 ooftware 81 ooftware Overview 10 opecifications 81 otorage 10 System Hardware 8 PN 20 000225 Rev A 86 Index T Technical Support 76 Technical Support Contact Information 76 Telephone 76 Transport 10 Transport Handle 9 Turning Off for Extended Periods 21 Turning off the RetCam Shuttle 20 RetCam Shuttle User Manual U UL Label 17 Unflag Image 39 Unhide Image 38 V video clips 38 PN 20 000225 Rev A Clarity medical systems Clarity Medical Systems Inc 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 251 0078 RetCam Shuttle User Manual Toll free 1 800 215 600
10. different lens piece during imaging Expand the Lens menu EM to select 1300 Premature Infant 1200 Standard Baby 800 Posterior 300 High Mag or Unspecified The lens piece selection is saved with the image Changing Image Type Expand the Image Type menu MM to select Retina Anterior Segment or Other during an imaging session All selections record the images in color The Image type selection is saved with the image WARNING System power from a fully charged battery is available for at least 15 minutes after an AC main power loss In the event of an AC power loss we strongly suggest that you complete the imaging session and save images to prevent potential data loss Start a new live imaging session only after reconnecting the AC power RetCam Shuttle User Manual PN 20 000225 Rev A 34 Using the RetCam System Enable mouse over image preview When hovering over thumbnail images a larger image will appear By default this feature is selected on and may be turned off Full Screen Show Thumbnails Enable mouse over image rere Figure 23 Enable mouse over Adding Exam Notes When you select the Exit Exam Add Note button at the bottom right corner of the image capture screen the Exam Notes dialog appears For each eye it provides a field where you can type in notes Exam Notes Exam date 24 11 08 11 06 AM Created By Left Eye Note Right Eye Note Note Date Created By Left Eve Note Right Eye
11. encounter C Gowns and Masks Gowns and masks are unnecessary in the normal ophthalmic office setting PN 20 000225 Rev A Maintenance and Support 67 Minimizing Transmission of Bloodbome 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 precautio
12. is contact with high infectivity tissues in patients with suspected or confirmed C D 1 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 000225 Rev A 66 Maintenance and Support Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 5 IT Procedures for Protection for
13. of video recorded You can also depress the spacebar on the Notebook computer to Start and Pause Recording Note You can capture still images by depressing the ki button during video recording 4 Select the Stop Recording button to STOP recording video RetCam Shuttle User Manual PN 20 000225 Rev A Using the RetCam System 31 5 A 2 by 2 block of pictures appears in your thumbnail if the show thumbnails option is enabled The video is automatically marked for deletion 6 To save the video deselect the red X below the video thumbnail Figure 19 Deselect the red X to save video Note The storage capacity of the system hard drive is a maximum of approximately 100 000 still images or a maximum of 140 minutes of total video for example 70 videos of 2 minutes duration each or 280 videos of 30 seconds each Saving a combination of videos and stills will affect the total number of each that can be saved Saving images with annotations reduces the total number of images that can be saved Recommended Procedure Because saving video consumes a great deal of disc space to maintain optimal system performance we recommend that you capture video of the entire exam save stills from the video and delete the video To do this 1 Capture video see Capturing Video but DO NOT SAVE the video Instead double click the video in the thumbnail display the hover over image feature must be disabled to go to the Review Screen 2
14. remote Although HIV has been 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 httpz www cdc gov ncidod hip 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 htt p Awww osha slc gov OshDoc Additional html Occupational Safety and Health Bloodborne Infectious Disease www cdc gov niosh bbppg html State needle safety legistation www cde gov niosh ndl law html Exposure management resources National Clinicians Postexposure Prophylaxis Hotline PEPline 1 888 448 4911 Needlestick www needlestick mednet ucla edu Hepatitis hotline 1 888 44
15. the connector sleeve and pull out RetCam Shuttle User Manual PN 20 000225 Rev A System Functions 23 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 INSTRUCTIONS FOR INSTALLING LENS PIECE TO HANDPIECE Figure 9 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 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 User Manual PN 20 000225 Rev A 24 System Functions This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A Using the RetCam System 25 3 Using the RetCam System Managing Patient Records This section describes how to add a new patient and locate the records for an existing patient The software is ready to use when you see the Start Screen shown in
16. the usual ophthalmic examination D Disinfection procedures Disinfection is a process to 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 is 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 manufacturer 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 eve
17. to locate a still image e Start playback by selecting Play E or Reverse ke e Select Pause when you see an image you want to save Select Save Still or press S on the keyboard or press the Snap button on the footswitch RetCam Shuttle User Manual PN 20 000225 Rev A Using the RetCam System 33 Changing Image Capture Options During an Exam Before you start imaging verify that the options displayed for eye image type and lens piece are correct If necessary you can edit options from the image capture screen Gendel Unspecifie late of BI 05 15 2007 Age 1 Years 7 31 2008 10 50 A irrent Weight Kg 0 000 ROP rin Left Eye 05 Lens 1700 Retina Figure 22 Select options for image capture FE Chanaina Right Eye OD Left Eye OS To image the other eye in the same session expand the Eye menu EM and select the other eye Right Eye OD or Left Eye OS The Eye selection is saved with the image Note When using this option be careful that you select the correct eye before you save the image This is especially important when both eyes are captured in one video clip and you save still images from the video Make sure you select the correct eye before you save each still image from the video Note Images and video can be selected for deletion only during the imaging session Once the session has been exited the images will be saved for that session Ig Changing Lens You can also select a
18. to show export progress Please wait for work to complete 3 E port tolo EMMTafT52 d107 45b3 bhib fibaefbSal Za E mlx g3x Elapsed Time 00 00 09 Remaining Time 00 00 01 Cancel Figure 33 Export progress dialog Importing Images Except for data backup the export destination on the network is an intermediate location To complete the data transfer and make the images available for viewing on another RetCam system you must use the RetCam software to import the transferred images into the target system database WARNING Never connect the RetCam Shuttle to a network or any externally powered devices or peripherals during imaging Note We recommend that you do not import more than 2000 images in one batch because the import will take a long time One way to limit batch size is to import only the files from which you or someone else exported a limited number of images In general we recommend you import images from one patient at a time RetCam Shuttle User Manual PN 20 000225 Rev A 50 Import and Export Images Follow these steps to import RetCam images 1 On the screen shown in Figure 34 select Figure 34 Start screen The Import Folder dialog appears Import Folder sf RetCam supported files hdr mli mlv mix mrl files are E going to be imported from the source location Source lacation E 420081113_104047 Include subfolders E Celte source files and subfolders after import Can
19. 3 7232 Reporting to CDC Occupationally acquired HIV infections and failures of PEP 1 800 893 0435 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 000225 Rev A 70 Maintenance and Support 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 47 Figure 47 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 48 29 9 an e 1 Figure 48 Opening the fuse holder cover Hemove the fuse holder See Figure 49 Cover open Gently pry at edges to start removal Finish removal with fingers Figure 49 Removing the fuse holder RetCam Shuttle User Manual PN 20 000225 Rev A Maintenance and Support 71 Remove the blown fuse from the fuse holder and replace it with a new fuse of same type and rating See Figure 50 Reinsert the fuse holder Figure 50 Blown fuse removed N CAUTION For co
20. 4 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 Image representative oniv 8 Handpiece and Lens Hece 9 Shuttle withal tems SLOWS EE 10 Transporting the Shuttle 0 0 0 ccccceecseeeeeeeeeeeeeeeeeeseeeseeeeeeeseeeeeesaeaeeeesaageeessaaees 11 IAIN power SwWIte EE 19 Computer power and USB video cables cccccseeeceeseeeeeeseaeeeeeeaeeeeeesaaeeeessness 19 EO DOK E 20 EO box drawing lower portion showing connectors sss snssennereenneneenreesenrennne 21 Instructions for installing a lens piece to the handpiece 23 El e M e T Ee 25 ACG new patient SCIGeL Sa deci ica cc EM e Gadd oat e ea hun Ee die ute tui custo 26 Edit patient record ecreen nennen nennen nennen nnns nnn nnns 27 SEELEN 27 Patentsearch OpUONS E 27 Patients and Exams Screen Patient Directory cccceccccseseeeeeeseeeeeeeeeeeeeeaaaeees 28 Patients and Exams screen navigation buttons 28 New Exam configuration screen 29 Ell El E 30 Deselect the red X to save video 31 Video playback controls 31 Video controls and SCKOMDAN EE 32 Select options for image capture cccseeeeccceeeeceecseeeeeccaeeeeeseeeeeeesseeeeeeessaaeeeeseaees 33 Enable tolse OVOlL asado scodtiaeiti beds etel taut de bia senti
21. 5 Hepatitis C virus HCV has been isolated in tears and aqueous humor Adenovirus has been the main cause of nosocomial outbreaks of conjunctivitis These outbreaks have mostly occurred in eye clinics or offices Adenovirus can survive for long periods on environmental surfaces and aphthalmic 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 The 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 uni
22. 5 D Culbgesngeual Pr s ent i a2 00000 Cuburesrasutrel PubcKeyT akene bTTs c1 Mes Culue nesunal onan aa r UD Lobgrereata PulicEnylc Sopris 73 5E Saal 2000 Cuiuresraesuisel Pubsck dua hee Ere Ven core 1E 0 Cubre m semi Tap omm Veigerez 0 QU Cul prm ian Aer Vei Sa is ppm TE eres H 3 arra zw a Probie ear ena debe TIEJE2E Inher haai KE r Veni inet 220072 CN palate Publick Toib rd isque We Ue na nid 7 2 Wenn Z 20072 EI Culturesneutsl Puika oka S lay Hei zs a eb ervaers Vacant TOU Dikter Publ eng T ok erm a Hee Pateri Edi Patsch Figure 40 About Clarity software RetCam Shuttle User Manual PN 20 000225 Rev A 56 User Preferences Select User Preferences User Preferences Configurations Live Imaging Mew Exam Notification Printers Windows Configuration Imaging Adjustment configuration does not have a Ul Figure 41 User Preferences screen Select from the following options Imaging Adjustment Not available Institution Add the name of the Institution Department and Location Live Imaging Not applicable New Exam Set the Pre set Imaging Configurations for new exams Notification Not applicable Set the Default Image and Report Printer Windows Configuration Set Date and Time Display Network Connections Printers and Faxes Region and Language Security Center and Sound RetCam Shuttle User Manual PN 20 000225 Rev A Institution User Preferences Confi
23. 5 PN 20 000225 Rev A www claritymsi com
24. AS RELIED UPON CMS INC TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE RetCam Shuttle User Manual PN 20 000225 Rev A 84 License Agreements RetCam Shuttle User Manual NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE IS PROVIDED AS IS AND WITH ALL FAULTS THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR USE 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 aircraft navigation or communications systems air traffic control direct life support machines or weapons systems in which the failure of Java technology could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DA
25. Gatch the e WEE 73 inser new 617 o RE RENT 74 Replace lamp assembly drawer and fiber optic cable 74 Key Validation dialog t 75 PN 20 000225 Rev A Introduction 7 1 Introduction The RetCam Shuttle Ophthalmic Imaging System system is designed to allow the quick and easy capture of wide field high resolution fully digital images and videos of the eye Indications for Use For general ophthalmic imaging including retinal corneal and external N Warnings and Cautions CAUTION Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner WARNING Prior to using the system read all user safety information WARNING Before using this equipment to acquire images from patient eyes users must be trained in proper clinical technique by personnel authorized by Clarity WARNING The RetCam system is designed and tested as a system Omission or substitution of RetCam components may adversely affect system performance and is strongly not recommended WARNING Unauthorized modifications or additions to the RetCam system including hardware and software etc could adversely affect system function and will void the warranty WARNING Carefully inspect and clean the lens piece before each use DO NOT USE if the lens piece has nicks breaks scratches or rough surfaces that may damage the
26. In the Review Screen use the video playback features to replay the video and FT See DID ers es Ei p WK ME LL EU ol m e DI AHC Bee imaging and recardieg 3 Select this button to return to the New Exam screen Figure 20 Video playback controls 4 In the New Exam Screen the viewed video is marked for deletion unless you saved the video as shown in Figure 19 View the exam thumbnails and select any other images for deletion RetCam Shuttle User Manual PN 20 000225 Rev A 32 Using the RetCam System Video Playback Video playback buttons are Reverse pause and play Fast forward Go to the beginning of the recorded video Go back one video Advance one video UL Go to the end of the recorded video Control the rate of playback or search Use the buttons or the scrollbar to locate images of interest Adam Jones ID 555 55 5555 LE dd E eee el Rate Wx Figure 21 Video controls and scrollbar Tip Using the left and right arrow keys on the keyboard will also move the video back or forward one frame at a time Using Helpful Features The RetCam software includes some useful features to streamline your work Shortcut Keys An underlined letter indicates a quick key To use a quick key press ALT and the letter key simultaneously Note Do not use Windows shortcut keys for example Copy Ctrl C Paste Ctrl V Undo Ctrl Z and others Use the playback controls at the top of the screen
27. Introduction Lens Model Application Common Field of View Premature Infant 130 Degrees Standard Baby 120 Degrees D1300 B1200 E800 C300 High Contrast Children s amp Adults 80 Degrees High Magnification 30 Degrees PL200 Portrait Lens M te Figure 3 Shuttle with all items stowed 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 designed 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 To relocate the system within a building 1 Power down the system through the software by selecting and then Shutdown 2 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 3 Secure the handpiece in its holster or inside the storage compartment 4 Unlock the caster brakes Now you can gently roll the system on all
28. MAGES 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 that apply to the SOFTWARE including the U S Export Administration Regulations as well as end use and destination restrictions issued by U S and other governments For additional information see http www microsoft com exporting PN 20 000225 Rev A Index B Backup Frequency recommended 45 Backup Recommendation 45 C Changing Image Type 33 Changing Lens 33 Class 1 11 Cleaning Procedures 59 Cleaning the Rest of the System 60 Compare Screen 39
29. Note 2000 chars max 2000 chars max Return to Exam Exit Exam amp Go To Patient List Exit Exam amp Go To Image Review Figure 24 Exam Notes dialog To add notes 1 Select New Note to activate the notes fields 2 Inout Created By information 3 Type new notes in the fields titled Left Eye Note and Right Eye Note 4 Select Save Note to add notes you have typed to the notes above Note You cannot change a note after you select Save Note e Select Reset to clear all fields Select Return to Exam to save note and return to Live Imaging RetCam Shuttle User Manual PN 20 000225 Rev A RetCam Shuttle User Manual Using the RetCam System 35 e Select Exit Exam amp Go to Patient List to save note and return to the Patients and Exams screen e Select Exit Exam amp Go to Image Review to save note and return to the image review screen You can add notes also from the Review screen Once saved the text cannot be modified You can append text to notes from the Review Compare and Image Process screens by selecting Exam Notes Notes are identified by date time and person creating the note PN 20 000225 Rev A 36 Using the RetCam System This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A Image Review and Compare Mode 37 4 Image Review and Compare Mode Having acquired images they are available for review and comparison This section covers the following topics e Ima
30. OSHA regulations are required to establish exposure control plans that include post exposure follow up and to comply with incident reporting requirements III Procedures for protection of the ophthalmologist Ophthalmologists might be at risk of acquiring HIV HBV or HCV 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 II 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 000225 Rev A Maintenance and Support 69 Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 8 eyewea
31. RetCam Shuttle Ophthalmic Imaging System User Manual PN 20 000225 Rev A For use with software version 5 2 Caution Federal law US restricts this device to sale by or on the order of a a r T physician or licensed medical practitioner medical systems Copyright 2009 Clarity Medical Systems Inc All rights reserved European Authorized Representative address Ec nep i MediMark amp Europe S A R L 11 rue Emile Zola 38 100 Grenoble France Tel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 e mail info medimark europe com RetCam Shuttle User Manual PN 20 000225 Rev A Contents E Late goe UO pP 7 aMiteleion aeq 7 Waris and CAUVIN reni A Q 7 Le Ee TEE 8 Hardware Rieger EE 9 EE eebe 10 EIERE ee 10 e Electrical Safety Information cccccccccecseesececeeeeeeesaeeeeeeeseseesseaeeeseseeeeseas 11 e Electromagretic EImisSSIOETS EE 12 v Immunity Test SUMIMANY Geol Save daaeican otra ta eta eg 12 e Important User Safety Notices sseeeessesesssseseeennneennm nnne 14 kabels AOSV INDO enee 15 le EE 17 2 SYVSIEM PUNCH ONS EE 19 e Power Cord and Power Connechor enne 19 e Turning ON the Hei am System ccccccccseeeeeeseeeeeesaeeeeeseeeeeeseeeeeeseaeeeeeeas 19 e Turning OFF the RetGam SyStem c cccccccccseeeeescseceesesseeececeeseeeceeeeeeees 20 s Usina Hard SIMULA OWI EE 21 e Turning Off for Extended Periods cccecccececceese
32. all parameters to zero When you leave the current session the display settings are reset to zero Note Images you save from the Image Adjustment window will reflect image display adjustments and all other changes you make but the original images in the database will not be changed RetCam Shuttle User Manual PN 20 000225 Rev A Image Review and Compare Mode 43 Image Adjustment An notat ion You can annotate an image by inserting graphic elements or text notes Click to select any of the following annotation features Insert Point Insert pointer and text on the image Insert Ellipse Draw an ellipse on the image Insert Line Draw a line on the image ud ee Insert Note Add text to the image Save s AEN ENEE e Rotate Rotate the pointer Settings Save Settings e Measurement Display the number of pixels between two points Insert Point Insert Ellipse Delete Remove a selected annotation Insert Line Insert Hote Select the X at the top right to close the screen Rotate Measuremen 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 Delete RetCam Shuttle User Manual PN 20 000225 Rev A 44 Image Review and Compare Mode This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A Import
33. and Export Images 45 5 Import and Export Images You can import or export images e To make Her am data available on other RetCam stations which include Her am 3 and RetCam Il systems and PCs running RetCam Review Software To make a backup copy of the original image data kept on the hard drive To view with standard image software To use RetCam images with third party imaging systems Backing Up Images The RetCam system stores all images to the local hard drive It is highly recommended to create a central repository on a network of all data from the RetCam device for long term data backup Recommended Backup Frequency Each day you acquire new images Exporting Images You can export data to any accessible location There are three general steps to complete export These are 1 Select Images for Export below 2 Select Export Options page 46 3 File name format menu page 48 Select Images for Export 1 Go to the Patients and Exams Screen and check the box next to each image for export You can also use the automatic Expand and Check box features located in the upper menu Jones Adam ID 555 55 5555 Gender bale Last Mame Jones Primary Clinician Location Mayo Age 2 Days Classificatian First Mame Adam Unspecified Unspeciied Add Field Expand Images for Displayed E xam D Collapse Al Check All hi Uncheck All Exams for Checked Patients Exams Images for Current Patient Images for Displayed Exam
34. and should be monitored for compliance as are other 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 000225 Rev A 68 Maintenance and Support Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 7 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 infectious 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 t
35. ards 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 contact Clarity service N WARNING This equipment should be connected using the power cord supplied by Clarity RetCam Shuttle User Manual PN 20 000225 Rev A 12 Introduction WARNING To avoid risk of electric shock this equipment must be connected to a N P supply mains with protective earth Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions Emissions Test Electromagnetic Environment Guidance Radiated Emissions Class A 30 MHz to 1 GHz The RetCam system uses RF energy for its internal CISPR 11 function Nearby electronic equipment may be EN 55011 affected Harmonic emissions IEC 61000 3 2 The RetCam system is suitable for use in all Voltage fluctuations flicker emissions Complies establishments other than domestic and may be IEC 61000 3 3 used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warnin
36. cel Figure 35 Import Folder dialog By default it shows the Source location path and all the options last used 2 o change the source location select the arrow to expand the path list or select Browse Selecting the red reverse arrow resets the source location to the default setting 3 Once the desired Source location is showing you can select import options 4 Select to initiate importing 5 A Select Import Data to save dialog will appear RetCam Shuttle User Manual PN 20 000225 Rev A Import and Export Images 51 6 View imported data Check Selector on the images or patient data you would like to import Seisi On Db TA age L 1 BE Ld Figure 36 Select Import Data dialog 7 Select one of the options on the bottom menu Show Detailed Log Hide Summary Cancel Import Selection Import All Figure 37 Import options Show Detailed Log Provides details regarding the processed files selected for import Hide Summary Hides Summary Information Cancel Importing Import Selection Allows importation of data only from checked items Import All Allows all processed files to be imported The system will notify you when the import is completed Included subfolders check box Select this check box 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 To import files from
37. covers are also available Non contact lLonometers The non contact tonometer may not make contact with the cornea or tears but may cause micro aerosol formation The front surface may be wiped with an alcahol 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 1s 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 Howeve
38. ed person and provide PEP with hepatitis B immune globulin or hepatitis B vaccine in appropriate cases preferably within 24 hours RetCam Shuttle User Manual For personnel exposed to HCY 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 77 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 It 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
39. eeeeeeeceaeeeceeeeeesaeeeeeeeesaeeeeeeeeeenas 21 e The Electro Optical Box EO Box 21 kens STAAL OM E 23 e Instructions for Installation of All Lens Pieces eeeeeeeeeeeeeeeeeeee 23 3 Using the RetCam System sikieni R 25 e Managing Patient REcords sesiiieone a e a E E 25 Adda New Patient Record EE 25 Editing a Patent Record EE 26 e Finding Existing Patient Hecords urere os ek hal een 27 Penorming EE ee 28 Reide Le IIBages us etal Sa oto ve ted dup Dodo ode e ced ite d dub alee iva Suy Reduu xe aao 29 EC Uem ioo MC HH W 30 Recommended Procedure o e Loose ren Evo us Ret ae uev se aetna aw OE ae 31 vided Play BACK EE 32 e Using Helpful EE 32 SNCT E 32 e Changing Image Capture Options During an Exame 33 lt Adding let 34 4 Image Review and Compare Mode 37 e Image Review Gcreen nennen nnne nnns nnns nna nnns 37 COMPIE MOOG e P 39 MIJE AGIBDSITIG EE 41 e Image Adjustment Parameters E 42 CANOU DE 43 RetCam Shuttle User Manual PN 20 000225 Rev A 5 Import and Export Image S aseri ee 45 e Backing Morlem m UNUM 45 v EXDOFUIg Images ege eege ico ba toe Duel so nM ere 45 Select Images for Otter 45 OEEC Export ODONIS E 46 SEI onte p p E P 47 EEX DOM Image eu EE 47 diodes creased ee 47 Select Advanced ODOM EE 47 OMDIC E e 49 IMbOrIng Runen 49 6 Prnig dnades susvicdcs ipud a aa nri Gnd o3 e Printing Images and H
40. efore replacing it 5 Newly acquired data may be lost if power is interrupted during live imaging 6 The system comes protected from viruses worms and spyware with Microsoft s anti malware Please refer to your warranty prior to adding any additional software or contact Clarity Service 7 It is possible during the connection of any cable or device into any of the Notebook computer ports the computer may lock up This is an indication that a source of High Electrostatic Discharge 6 Kv was discharged into one of the ports of the computer If this should occur please reset the Notebook computer s power To perform a system reset press the power ON button on the Notebook computer for a few seconds until the system powers down then press the power button ON again to power the Notebook back ON This does not present a safety risk to the patient user or environment RetCam Shuttle User Manual PN 20 000225 Rev A Introduction 15 Labels and Symbols gt RetCam Shuttle User Manual Focus Controls Intensity Controls SNAP capture switch Head instructions Caution Do not look directly into light source Protective earth ground Alternating current AC System contains fuse of indicated type Do not use any other type Non ionizing electromagnetic radiation Head accompanying user documentation Fragile contents PN 20 000225 Rev A 16 Introduction This side of carton up Temperature
41. epnorts 53 T NISCMPIGIClE CCS OE 55 B MISTI A pec 57 BIN EE 57 OT BITS eer T cpu 58 WINDOWS Eiere Le EE 58 8 Maintenance and Support seisseen tinana ea E 59 e Recommended Maintenance Schedule nnennnnnnnennnenennennrnnnrnrornrrsnnrrnnnen nne 59 Cleaning PFOCCOUNES dee EE 59 Cleaning the LenS E 59 Cleaning the Rest of the System ccccccccccccsssseseeeeeeeeeeeeeeseeseeaeeeseeeseeeeeeeseaeaeaas 60 Disposal of dE EE 61 LIS CF YC PC CICS wrest es 70 e Replace Illumination TL amp PBulb 71 vvh Valldal Osse 75 Eeler ele e Ree 76 e Technical Support Contact Information 76 SOI IC EE 77 COMSUIMA La 77 E COmMDONGMIS ee 77 s OGNINI Ue E GE 77 e Notebook Computer Information cccccccccsssssssseeceeeeeeeeeeseeaeeeeeseeeeeeeeessesaaeeseness 78 TrOUDIESHOOLING Rellene rS 78 10 Technical Gpechficatons message aa a 81 ximciell Tm TT T DU UTILE 81 iuit PER 81 ii eile EE 81 S DO MWA EE 81 Environmnental GoHdilloliSsesn EE 81 Notebook Ren ue EE 81 11 License el EE 83 e CMS Software Restricted Hobes 83 e RetCam Software End User License Agreement 83 f CC TT 85 RetCam Shuttle User Manual PN 20 000225 Rev A 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 2
42. eric text format 4 Select MZEE to display advanced features Select Advanced Options The advanced features option allows you to Create subfolders RetCam Shuttle User Manual PN 20 000225 Rev A 48 Import and Export Images Export P Export Patients Exams and Media e Supported Formats ML DEM PNG BMP JPG XML CSV amp TAT e Specify destination location Path Ci RetCam Export Browse Fm Create subfolder LastName File Name Format FirstHama DOB Internal Patien Overwrite existing data Advanced File Format Em MLx File Format B DIcomWw File Format B Split File Format Text Data XML Image BMP Figure 31 Create subfolders menu e Choose a File Name Format Export Export Patients Exams and Media Supported Formats MX DCM PNG BMP JPG XML CSV amp TAT Specify destination location Fath E Browse Create subfolder m File Name Format ExamID Seqnum m D d8a8418c B504b 1 LastName Overwrite existing data FirstName DOB Patient GUID MLx File Format Internal ImageID File Format B CITOM File Format Patient ID SORS Classificatian B Split File Format Text Data XML Image BMP Ss CurrentD ate ExamDate S NONE Cancel Figure 32 File name format menu RetCam Shuttle User Manual PN 20 000225 Rev A Import and Export Images 49 Complete Export Select Export to initiate exporting or sco A dialog opens
43. erpes simplex virus adenovirus etc likely to be encountered in patients presenting for eye examinations 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 is still recommended because gloves can become perforated and bacteria can grow rapidly on gloved hands If there are cuts scratches or dermatological lesions e g weeping lesions on the hands then use of gloves 1s 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 us Gowns masks and protective eve wear Gowns masks and protective eyewear are unnecessary for
44. eye WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of exposure time necessary no greater than 5 minutes WARNING Use care when contacting the eye i e use the least amount of pressure and or movement necessary WARNING To avoid the risk of electric shock the equipment must be connected to a supply mains with protective earth WARNING To mitigate the potential for excess light exposure the user should avoid looking directly at the illuminated light source WARNING A risk benefit ratio must be assessed before confirming a patient for RetCam imaging if they are photosensitive concomitantly exposed to photosensitizing agents or aphakic RetCam Shuttle User Manual PN 20 000225 Rev A 8 Introduction 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 Notebook C t Oe eee ot ed Handpiece with interchangeable lens piece Holster Work surface Transport Handle Secondary work surface Container for tools and supplies Lens storage box Internal handpiece storage compartment poen Upper door open Lower door Electro Optical EO box
45. f the Patient Protection of patients from exposure to the HIV during examination and treatment of eye disorders incorporates PN 20 000225 Rev A 64 Maintenance and Support 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 h
46. four casters to the new location Move the system slowly to minimize vibration Once in the new location apply the 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 selecting and then Shutdown 2 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 or store the power cord inside the cart RetCam Shuttle User Manual PN 20 000225 Rev A Introduction 11 3 Carefully remove the lens and store it in the lens box Secure the handpiece and footswitch in their storage compartments in the cart 4 Remove the notebook computer from the work surface and carry it separately 5 Close the cart doors Unlock the 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 we recommend that you lay the RetCam Shuttle front side up Figure 4 Transporting the Shuttle Electrical Safety Information The system has been designed inspected and tested to comply with the safety requirements of IEC60601 1 with respect to fire shock and mechanical hazards only if used as intended Class 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 stand
47. g This equipment system is intended for use by health care professionals only This equipment 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 system or shielding the location Immunity Test Summary Test Type Test and Compliance Level Electromagnetic Environment Guidance Electrostatic discharge 6 kV contact The RetCam Portable requires ESD ESD 8 kV air exemption See Important User Safety EN 61000 4 2 Notices Electrical Fast 2 kV for power supply lines Mains power quality should be that of a Transients burst typical commercial or hospital environment EN 61000 4 4 Surge 0 5 1 kV Line to Line Mains power quality should be that of a EN 61000 4 5 05 1 2 kV Line to earth typical commercial or hospital environment Voltage dips and gt 95 0 5 Cycles If the user of the RetCam system requires interruptions 60 5 Cycles continued operation during power mains EN 61000 4 11 g interruptions it is recommended that the 30 25 Cycles RetCam system be powered from an gt 95 250 Cycles uninterruptable power supply UPS Power Frequency 50 60 Power frequency magnetic fields should be Hz magnetic field at levels characteristic of a typical location in EN 61000 4 8 a typical commercial or hospital environment RetCam Shuttle User Manual PN 20 000225 Rev A Introduction 13 Immunity Test Summa
48. ge Review Screen below e Compare Mode page 39 e Image Adjustment page 41 Image Review Screen The Image Review screen appears optionally when you exit live imaging You can also access it by selecting the Exam Review button on the Patients and Exams screen IVFA post laser ROP ID Unspecifie 05 15 2007 5 15 2007 4 08 PM EXT ROP Unspecified 30 d b Exam Date 7 b Xe kb l o we ta ED II ha Ei ka a ED ta ES S ide Thumbnails Shaw hidden imagea Print image Fit image Compare Fxam Notes Figure 25 Image Review screen The Image Review screen displays the images acquired in the session just completed When you access the Image Review Screen by other means it displays the images for the last patient and session you selected To review exams for a different patient exit to the Patients and Exams screen and select another patient RetCam Shuttle User Manual PN 20 000225 Rev A 38 Image Review and Compare Mode By default thumbnails for all images acquired in the selected session appear along the bottom of the screen Video playback controls appear in the upper left corner of the screen The currently selected image the first one by default appears full size Select a thumbnail to display the full resolution image You can use the arrows at the left and right 3 edges of the thumbnail strip or the up and down arrow keys on the keyboard to scroll through the thumbnails or select a thumbnail Thumbnails
49. gurations Imaging Adjustment Live Imaging Mew Exam Notification Printers Windows Configuration Institution Department Location User Preferences 57 Figure 42 User Preferences Institution New Exam User Preferences Configurations Imaging Adjustment Institution Live Imaging iNew Exam Notification Printers Windows Configuration Imaging Configuration One Title Preset Configuration 1 Image Type Reina Lens 1300 Imaging Configuration T wo Title Preset Configuration E Image Type Retina Lens 1300 Imaging Configuration Three Title Preset Configuration 3 Image Type Retina EN Lens 1300 EN Eye Right Eve OD Eye Right Eye 0D EN Eye Right Eve OD Figure 43 User Preferences New Exam Once the New Exam preset configurations are adjusted select Apply to initiate the change or Cancel Select OK to exit the screen RetCam Shuttle User Manual PN 20 000225 Rev A 58 User Preferences Printers User Preferences Configurations Imaging Printer Imaging Adjustment Institution Live Imaging Default Imaging Printer New Exam Notification Printers Windows Configuration HP Deskjet D4200 series Copy 1 HP Deskjet 04200 seres Report Pr
50. he use of universal precautions including handwashing and barriers reduces contact with blood and bodily fluids thus reducing exposure of health care workers to 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 1 e 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 infect
51. ight side by default the first image of the first session for the same patient appears Identifying information for each image appears above it Below each image at the bottom thumbnails appear for all images in the same session The Exam Selector displays the dates for all the current patient s exams above the thumbnails The highlighted date is the exam date for the current thumbnails To view images from a different exam select another exam date from the Exam Selector The video playback controls are not displayed on this screen because It is not possible to compare videos The Compare screen provides a toolbar for the following options Show hidden images The check box for displaying hidden images is available Print Image Click Print Image to print the two images displayed on this screen one above the other RetCam Shuttle User Manual PN 20 000225 Rev A Image Review and Compare Mode 41 Edit Image Click Edit Image to display the Image Adjustment window End Compare Click End Compare ito return to the display of a single image Exam Notes Click Exam Notes to review or append text to the exam notes for that image You cannot alter saved notes Notes are identified by date time and person creating the note Exit Review Click Exit Review to return to the Patients and Exams screen Image Adjustment To adjust an image select the image from the Image Review screen and click Edit Image The Image Adjustment wind
52. imely management can be administered Studies 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 after 24 to 36 hours it can be considered because it might still be effective If 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 HIV 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 HBV it is recommended to initiate the hepatitis B vaccine series to an unvaccinat
53. inter Default Report Printer HP Deskjet D4200 series Copy 1 Figure 44 User Preferences Printers Select the default printers then select Apply to initiate the change or Cancel Select OK to exit the screen Windows Configuration User Preferences Configurations Imaging Adjustment Institution Live Imaging E e 2 al le Notification l z Printers Date and Display Network Time Connections Printers and Region and Security Sound Faxes Language Center Export Lags Figure 45 User Preferences Windows Configuration Select the desired Windows configuration icon and make changes where needed Select Apply to initiate changes or Cancel Select OK to exit the screen RetCam Shuttle User Manual PN 20 000225 Rev A Maintenance and Support 59 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 70 Replace Illumination Lamp Bulb page 71 Key Validation page 75 Technical Support page 76 Technical Support Contact Information page 76 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 Cleaning the Lens Piece The patient c
54. ion among health care personnel HBV is transmitted by mucosal or percutaneous exposure to blood and serum derived bodv fluids from persons with acute or chronic 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 3195 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 f 906 HO Box 7 424 san Francisco CA 94120 7424 415 561 8500 http aao org RetCam Shuttle User Manual PN 20 000225 Rev A Maintenance and Support 63 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 is 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 87
55. keeping requirements including a Sharps Injury Log B Fluorescein and Indocyanine green ICG angiography It is recommended that photographers and other health performing fluorescein and ICG angiography wear gloves and adhere to the procedures as outlined in this section ES 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 Surgery 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
56. lectro Optical Box EO Box page 21 Lens Installation page 23 Power Cord and Power Connector Bog 6 od 4 e A 6 G o o o Ka D D KH H a The main power switch is located above the power cord inlet It must be in the ON position to operate the system ON OFF Figure 5 Main power switch Shown OFF Note Do not switch OFF or disconnect main power during imaging as data corruption may occur Turning ON the RetCam System 1 Connect the notebook computer to the notebook power supply cable and the USB video input cable unless already connected USB video input cable Notebook power supply cable A E Figure 6 Computer power and USB video cables RetCam Shuttle User Manual PN 20 000225 Rev A 20 System Functions 2 Switch power ON in the EO box unless already ON AWS Ags E e HANDPIECE EO box power switch Figure 7 EO box 3 Plug the main power cord from the system into a properly grounded hospital grade electrical outlet Turn ON main power The software should start automatically If not power ON the notebook computer The system is ready when you see the message No Patients to Display or Not Displaying Patients Turning OFF the RetCam System Note We strongly suggest that you backup and store your data prior to turning OFF the system 1 Select the red shutdown icon at the bottom right corner of the screen 2 Select Shutdown LIT ud Kies Hase
57. limits Authorized representative in the EU Type BF equipment applied part is handpiece To prevent damage to lens piece carefully store handpiece in holster when not in use Clean lens piece after use separate collection of waste at end of life as required by European directives Contact Clarity for equipment disposal instructions European conformity North American compliance certification Manufacturer SN Serial number RetCam Shuttle User Manual PN 20 000225 Rev A Introduction 17 Label es Clarit Iarity Clarity Medical Systems Inc Pleasanton California 94588 Made in USA Model RetCam Shuttle Class I Equipment Caution Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner SN p Zei Lol 100 240V 50 60 Hz 250VA Le ER MediMark Europe BP 2332 F 38033 Grenoble Cedex 2 France C C n A JUS e Patent No 5608472 5822036 P N 20 000123 rev B RetCam Shuttle User Manual PN 20 000225 Rev A 18 Introduction This page intentionally left blank RetCam Shuttle User Manual PN 20 000225 Rev A System Functions 19 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 System page 19 e Turning OFF the RetCam System page 20 e The E
58. my of Ophthalmology Caution As disinfection solutions may cause corrosion of the lens piece soak times that exceed the recommendation should be avoided Note Permissible immersion depth is illustrated in Figure 46 below It is important not to immerse the joint where the polished metal tip meets the painted housing since it is susceptible to corrosion em E Famm Figure 46 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 RetCam Shuttle User Manual PN 20 000225 Rev A RetCam Shuttle User Manual Maintenance and Support 61 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 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 WARNING Always inspect the lens before use for damage such as chips cracks or roughness that could injure the patien
59. n Auc Colunna 7 Stee He leen D doen o m Note If the computer hangs wait at least one minute to make sure that the system is not busy If the system is still not responding press the power ON button on the Notebook computer for 3 5 seconds until the system powers down Select Shutdown Computer RetCam Shuttle User Manual PN 20 000225 Rev A System Functions 21 Using Hard Shutdown N WARNING Do not use the hard shutdown method unless necessary because data corruption can occur 1 Press the power ON button on the Notebook computer for 3 5 seconds until the System powers down 2 Turn OFF main power switch on the back of the unit or unplug the power cord from the outlet Turning Off for Extended Periods If you are not going to use the system for an extended period such as one day or more it is advisable to switch OFF the EO box only This will help preserve the illumination lamp Note These actions will remove power from the entire system except the notebook computer The Electro Optical Box EO Box The 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 wi
60. ns to prevent injuries caused by needles scalpels and other sharp instruments or devices 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 trom 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 INewer 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 record
61. ntinued protection against risk of fire replace only with same type and rating fuse Replacement fuses are available from Clarity Customer Service Replace Illumination Lamp Bulb N WARNING Appropriately shutdown and unplug the unit to allow the bulb to cool before replacing it Note Replacement bulbs are available from Clarity Service 1 If not already OFF turn OFF the Main Power see page 20 2 Disconnect the power cord from the wall 3 Unplug the fiber optic cable from the front panel RetCam Shuttle User Manual PN 20 000225 Rev A 72 Maintenance and Support 4 Remove the two screws from the lamp assembly drawer Lamp assembly drawer Lamp assembly E 2s isi E Remove 2 screws ON OFF FOOTSWITCH Figure 51 Front panel showing the lamp assembly drawer 5 Grip the handle on the lamp assembly drawer Pull the drawer out slowly Stop when the bulb is fully exposed Figure 52 Open lamp assembly drawer RetCam Shuttle User Manual PN 20 000225 Rev A Maintenance and Support 73 6 Push the lamp ejector as shown Figure 53 Eject the bulb 7 Carefully slide the bulb out of the socket slots 8 Catch the bulb Figure 54 Catch the bulb RetCam Shuttle User Manual PN 20 000225 Rev A 74 Maintenance and Support 9 Holding the new lamp only on the outside align the two pins of the bulb with the two slots in the socket Push it all the way in Figure 55 Insert new bulb
62. ntually remove the coloring of the etched calibration marks These disinfecting solutions should 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 Galdmann 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 5 minute soak in 3 hydrogen peroxide or 70 isopropyl PN 20 000225 Rev A Maintenance and Support 65 Minimizing Transmission of Bloodborne 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
63. o interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as e Reorient or relocate the receiving device Increase the separation between the equipment RetCam Shuttle User Manual PN 20 000225 Rev A 14 Introduction Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help N CAUTION For continued protection against risk of fire replace only with same type and rating fuse Note The notebook computer Hewlett Packard Model 6730B has met all requirements of EN55024 IT Equipment Immunity Requirements and IEC 60601 1 1 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests However this notebook computer does not fully meet Clause 36 202 2 of IEC 60601 1 2 Refer to the Electromagnetic Environment Guidance section in the Immunity Test Summary on page 17 Important User Safety Notices 1 Before moving the system to a new site carefully remove the lens from the handpiece and store it in the case Store the handpiece in the cart 2 Never contact the front of the lens piece with hard or sharp objects This could damage the precision optics and sealing 3 DO NOT AUTOCLAVE any part of the device 4 Appropriately power down and unplug the unit and allow the illumination bulb to cool b
64. of video clips show four images first last and two intermediate images in the video in the quadrants of a square Click on the thumbnail to bring the video to the display area Use the video playback buttons to control the video The buttons have the same functions as for live imaging Click Play to start playing video The following options are available on the Review Screen Exam Date Edi Select a different exam to review by clicking the arrow next to Exam Date Show Hidden Images Default is unchecked in which case only thumbnails of non hidden images are displayed When this box is checked thumbnails for hidden images appear and are available for full size viewing Hide Image Click the Hide Image icon left below the highlighted thumbnail to hide the current image You can click this icon beneath any thumbnail to hide that image You can use the icon to toggle between hidden ei and unhidden mag Hidden items are not deleted Their thumbnails do not appear unless the Show hidden images box is checked Unhide Item When Show hidden images is checked select the Hide Image icon p to unhide an image The hidden image icon appears in the upper right corner of the thumbnail for a hidden image Flag Image Click the Flag Image icon me to flag the current image as an image of special interest A small red flag appears at the top left corner of the thumbnail To unflag an image click the icon again The icon t
65. oggles between flagged and unflagged RetCam Shuttle User Manual PN 20 000225 Rev A Image Review and Compare Mode 39 Full Screen Click Full Screen to display a full screen view of the current image with no thumbnails visible Hide Thumbnails Click Hide Thumbnails to remove the thumbnail display without changing the display of the current image Print Image Click Print Image to print the current image displayed Edit Image Click Edit Image to edit the current image Compare Click Compare to view two images side by side on the screen See Compare Mode for details Exam Notes Click Exam Notes to review or append text to the session notes in the Review screen You cannot alter saved notes Notes are identified by date and created by Exit Review Click Exit Review to exit the current review session and return to the Patients and Exams screen Compare Mode The Compare screen appears when you click Compare Use the Compare screen to compare any two images You can compare images for one or more exams for a single patient RetCam Shuttle User Manual PN 20 000225 Rev A 40 Image Review and Compare Mode 05 15 2007 Lincdetined T Unspecified T Other l Umgd tmeg Unispecified EET DIR EE EINE T SHST 4 08 PM Exam Selector Show hidden imagea Prim Image Fuit Image Figure 26 Compare Images screen The last image displayed on the Image Review screen will appear on the left side of the Compare screen On the r
66. ok computer EO Box Handpiece and Footswitch are modules that can be removed from the cart for replacement under the direction of the technical service department Make note of the cable connections before removing a module RetCam Shuttle User Manual PN 20 000225 Rev A 78 Service Contact Clarity Technical Service for specific procedures and help troubleshooting problems to the module level before attempting repairs Notebook Computer Information Note The battery is not fully charged Allow your battery to fully charge before using it i e before disconnecting AC power Calibrating the battery before use is also highly recommended For information on the rechargeable battery of the notebook computer please follow the laptop manufacturer s recommendations For the Durabook http usa twinhead com PRO N15RI For the HPhitp np com Troubleshooting Guide Troubleshooting Steps No power to notebook Check connections computer Is the power cord plugged into the back of the system e If not plug the power cord in Is the main power switch in the back turned on If not then turn the main power on Is the notebook power cable plugged into the notebook and the EO Box e If not plug cable in No light from handpiece Verify the fiber optic cable from the handpiece is inserted in the fiber optic port of the EO box Verify the power switch in the back of the system and on the front of the EO box are turned on
67. ontact area lens should be cleaned immediately after use to prevent the coupling gel from hardening 1 Wipe away debris from the front lens piece surface with a soft dry tissue sterile water soaked tissue or combination 2 Then using a clean soft cloth such as sterile gauze saturated in a fresh solution of 7096 IPA Isopropyl alcohol gently wipe the front of the lens piece being sure to pay special attention to the concave contact lens area to remove any remaining debris at least eleven wipes with a clean saturated cloth Pre packaged swabs such as ReliOn Alcohol swabs or BD Alcohol Swabs may be used 3 Rinse surface thoroughly using sterile water 4 Air dry 5 Verify that the lens surface is free of debris and coupling gel Repeat above steps if necessary 6 Inspect the lens for damage and clarity Do not use the lens if there are chips cracks or rough edges on the lens which may injure the patient s eye RetCam Shuttle User Manual PN 20 000225 Rev A 60 Maintenance and Support gt Pee Caution Do not Autoclave any part of the system Caution Never immerse the entire lens piece or handpiece in any liquid solution If necessary only the distal 4 mm can be immersed See Figure 46 Warning If you clean or disinfect rinse the lens with sterile water to avoid corneal deepithelialization that may be caused by residual solution Note For disinfection see attached Information Statement from the American Acade
68. ould be worn for touching blood and blood contaminated fluids for handling items or surfaces 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
69. ow appears To exit the Image Adjustment window click the X in the upper right corner of the window RetCam Shuttle User Manual PN 20 000225 Rev A 42 Image Review and Compare Mode Image Adjustment Brightness H Contrast Rotate 180 Reset Save s Apply Saved Settings Save Settings Le Insert Point Insert Ellipse Insert Line Insert Hote Rotate Measurement Delete 43 Image Adjustment Parameters Controls to adjust the image display parameters are e Brightness e Contrast e Red e Green e Blue All parameters have a default setting of zero 0 and range from 100 to 100 e Each click on the right or left arrow at the end of the slider bar changes the parameter value by 1 e Each click on the bar to the right or left of the slider changes the parameter to the end of the range Rotate 180 Click this button to rotate the image 180 Reset Button Click Reset to reset all display parameters to zero Save As select to export the image Save Settings Click to save the current settings for Brightness Contrast and Red Green and Blue The saved settings can be applied when you select Apply Saved Settings Apply Saved Settings Click to apply the currently saved settings for Brightness Contrast and Red Green and Blue Image display adjustments are applied to all images in the current image processing session until you save new settings or click the Reset button which resets
70. posed to the blood of individuals who may be shedding the virus Although the risk of infection 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 sh
71. r it is known that other viruses such as adenovirus may persist for many hours on a dry 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 tor 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
72. r should be used if there is a possibility 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 a 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
73. rch features See Figure 14 Figure 14 Patient search options Select Clear to clear all search fields Search Results When you select the to display the entire patient directory the results are displayed as shown in Figure 15 RetCam Shuttle User Manual PN 20 000225 Rev A 28 Using the RetCam System Jones Adam ID 555 55 5555 jonder Male 431 Name nmary Chrecaan Santa Rita Mayo Adam WE Show Hektor Images Autorze Columns O Windows ER Figure 15 Patients and Exams Screen Patient Directory From the Patients and Exams Screen you can use the buttons shown in Figure 16 to sort the results Expand Exams for Checked Patients Collapse All Check A hl Uncheck All Figure 16 Patients and Exams screen navigation buttons Performing Exams You can use the RetCam system to capture still images or video after selecting a patient Select the green arrow on the right side of a patient name or select the New Exam button To start an exam you can select a Preset Configuration which can be easily edited or Manual Configuration RetCam Shuttle User Manual PN 20 000225 Rev A Using the RetCam System 29 New Exam Configuration Current weight Select an Imaging Configuration Preset Configuration 1 Preset Configuration 2 Preset Configuration 3 Manual Configuration Cancel Figure 17 New Exam configuration screen The following Information can be defined in the Preset or Manual Configura
74. rmatted to fit on US letter size or A4 paper Note Network printers used with the system must have a printer driver supported by Windows XP Note Be aware that you must change the paper in the printer when switching between printing images and reports See the User Preferences section for information on setting printer defaults RetCam Shuttle User Manual PN 20 000225 Rev A User Preferences 55 7 User Preferences The section describes the User Preferences available including e System Identification Institution e Setting Pre configuration Imaging defaults for New Exams Changing Date Time Changing Speaker Volume Setting Printer defaults Setting Network connections Select the cog icon in the lower right hand corner to access the User Preferences About Status Monitor Trace Window User Preferences Exam Review Import xiii us Unlock Maintenance Made Displayed Patients 13 Selected Patients 1 Selected Media 6 Figure 39 Access User Preferences Select About to identify the RetCam software version Select OK to exit Jones Adam ID 553 55 5555 Hale Asl Mare Prenar Cliraan Tanta Riia Maryn D a daheim Urk reram Adam About R tt am britia Depatrerd E Es Feit ni m os SF 1h icd pa a r T HET Fiara ZU XIPST MWiesbkwwet DS Wirskaee PIU Microsoft Windows HI 51 2800 Senice Pack 2 Apere Verona Ch Viire D UD nile mah adl D s E eat eoe a eT ALES Cin etre Were 2 1
75. ry Test Type Test and Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 0 15 80 MHz 3Vrms 80 1 KHZ Portable and mobile RF communications 61000 4 6 equipment should be used no closer to any part of the RetCam system including cables than the recommended separation distance Radiated Immunity 80MHz 2 5GHz calculated from the equation applicable to EN 61000 4 3 3V m 80 1kHz the frequency of the transmitter Recommended separation distance d 3 5 E1 x square root of P 80 MHz to 800 MHz d 7 E1 x square root of 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 E1 is 3 V m Conducted Immunity d 3 5 V1 x square root of P where V1 is 3 Vrms Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol gt Magnetic Immunity 3A m 50 60 Hz Video display terminals and other electron EN 61000 4 8 beam devices e g X ray image intensifiers may use a justification for lower IMMUNITY COMPLIANCE LEVELS as allowed by 36 202 1 a WARNING Interference may occur in the vicinity of j equipment marked with this symbol This AN equipment system may cause radi
76. s Pork Exams Images for Displayed Patients uru Senke Eka ROP ENE ant ID PrimaryClinician V Pathology Port Sal t Santa Rita p Pear Bill amp bosc San Ramon Unknown p Apple Robert ZGala Pleasanton Unknown Grape Concord Fremont Unknown b Orange Cara Shaval Dublin Unknown Figure 27 Select patients and exams for export RetCam Shuttle User Manual PN 20 000225 Rev A 46 Import and Export Images 2 Select the Export button on the lower menu Export dialog appears Export 7P Export Patients Exams and Media e Supported Formats MX DCM PNG BMP JPG Specify destination location Overwrite existing data Advanced File Format m MLx File Format B CICOM File Format B Split File Format Text Data XML Image BMP Cancel Export Figure 28 Export dialog By default the dialog shows the last destination location path used Note The Minimum Required Space for Export is displayed Verify that the export destination has sufficient free space to accept the exported files Note Regarding File Size Capacity We recommend that you do not export more than 2000 images in one batch because the export will take a long time We recommend that multiple smaller transfers be executed Select Export Options 1 To change the destination location path select Selecting the red reverse arrow resets the source location to the default setting Specify destination location eee ee RetCams E
77. s aa Ei 34 Exam NOES dalog EE 34 MAGS KEE 37 Compare Images screen 40 Select patients and exams for export eeeesssesssessseesseeeeen nennen 45 poro qRe r ee NEN EET m m Tm 46 Export dialog showing closeup of destmnaton 46 xil edant 47 Create subfolders LEE 48 FIG Maine ed un EE 48 Expor Progress el ee EE 49 Stat SChECN E 50 MPO Foder dalog EE 50 Select Import Data dialog ccccccseeceeeceeeeeeceeeseeeseeeeeeeeeeeseeeseeeeeesseeseeesaaaeeeeesness 51 Naa 1 ge 0 Lea 51 PINCO unen a A a 53 Access DUser Preferente EE 55 ele ee ie SOWA EE 55 PN 20 000225 Rev A Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figure 46 Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 RetCam Shuttle User Manual User Prerererices SCre EE 56 User Prererences IMStILUTION iis coat rare dette eee kin eege eegen 57 Wser Preterences New EX aint uestem ese htec Re vae a dede d wee ea ate a 57 Ser Preterences at 58 User Preferences Windows Confguraton 58 Inverted lens piece showing permissible depth of immersion 60 Power Entry Module 70 Obe mng the Tuse holdel COVEN sustine m T VEKU eR Np ce s TU MU DNUS 70 Removing the fuse nee EE 70 Blown fus removed ed 71 Front panel showing the lamp assembly drawer n nssennnennnsrnnnsnneserrnrnresrrrnnnnenne 72 Open lampcasSembly e TEE 72 Ser UII EE 73
78. 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 Software End User License Agreement You have acquired a RetCam 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 OF THE UNUSED DEVICE OR A REFUND ANY USE OF THE SOFTWARE INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA OR RATIFICATION OF ANY PREVIOUS CONSENT GRANT OF SOFTWARE LICENSE This EULA grants you the following license e YOU MAY USE THE SOFTWARE ONLY ON THE DEVICE NOT FAULT TOLERANT THE SOFTWARE IS NOT FAULT TOLERANT CMS INC HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND MS H
79. t s eye Disposal of Materials Dispose of waste materials according to local and national requirements Contact Clarity Service if additional assistance is required PN 20 000225 Rev A 62 Maintenance and Support ae AMERICAN ACADEMY Information Statement Geng Coen SANTO 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 T
80. te 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 You can Print Images from the e Exam Review Screen e Compare Screen Patient list or Patients and Exams screen Print images reports or both The default image size is 5 x 7 For optimal resolution Clarity recommends printing images 5 x 7 or smaller This also avoids the rapid depletion of printer ink Printing Images and Reports You can print both images and reports from the patient list or Patients and Exams screen 1 Select or highlight patient 2 Check the desired session patient or image 3 Select Print The following dialog appears Report Printing Selection E Print nly Selected Patients no patient selected Patients Information E ES Prints the list of selected patients Patients Exams Information Prints the list of selected patients and their exams Bi Print as ROP repart If you select this option for more than 100 images at a Prints the list of all patients fram search and their exams and images time a warning message Print as ROP report appears Patients Exams Images Information Figure 38 Print dialog RetCam Shuttle User Manual PN 20 000225 Rev A 54 Printing Images Select the desired option s Reports are fo
81. th it Camera Handpiece Lamp Fiber Optic Focus Controller ON OFF Switch USB Video Out to Computer Footswitch Laptop Power always ON with main power Figure 8 EO box drawing lower portion showing connectors RetCam Shuttle User Manual PN 20 000225 Rev A 22 System Functions A Note It is not necessary to remove any of the connectors for use storage or transportation WARNING Do not remove any connections while the system is powered ON The main power switch must be OFF prior to connecting or disconnecting any cables from the EO box The Lamp Fiber Optic connector is a receptacle for insertion of the handpiece fiber optic line which is part of the camera interconnect cable WARNING Do not look directly into the Lamp Fiber Optic opening when the EO box is ON The Focus controller is a direct insert receptacle for insertion of the white focus motor cable which is part of the camera interconnect cable 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
82. the Staff Protection of the ophthalmic medical personnel involves preventive measures to avoid 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 ex
83. tion mage Type Retina 300 Right OD 800 Left OS Anterior Segment 1200 Unspecified Unspecified 1300 Unspecified Once the new exam is configured select the green arrow to the right to enter the New Exam screen Capturing Still Images In the New Exam screen you can add the name of the Imaging Technician in the upper right corner of the screen RetCam Shuttle User Manual PN 20 000225 Rev A 30 Using the RetCam System Nancy Zinfandel ID urzgaad Gender Female Dade of Birth 10 04 2000 xam Age 10 Woks Ir 20d AS Carem Weight gi 0 00 Pathology Shaken Hafe m Primary Physician Chabot Classification imaging Technician Oye Righi Eye OD LJ Lens Lens 1100 6 4 Ie Patina E Media Video M Figure 18 Still image screen 1 Set the Footswitch Operation to Save Snapshot default 2 Adjust the focus and light intensity using the footswitch 3 Depress the green SNAP button to capture a still image You can also capture an image using the S key on the Notebook keyboard or by selecting the KL button 4 The saved image appears in your thumbnail display if the show thumbnails option is enabled Capturing Video 1 Set the Footswitch Operation to Video Recording Footswitch Operation Video Recording Save Snapshot 2 Adjust the Focus and Light Intensity using the footswitch 3 Depress the green SNAP button to Start and Pause video recording The progress bar will display the amount
84. vention Act became effective revising the bloodborne pathogens standard to require employers identify and make use of safer medical devices which can be used 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 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 HBY 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 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 o
85. versal precautions that all health care workers should follow Neither document distinguished the risks and needs of healthcare workers in ophthalmology from 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 Pre
86. xport Figure 29 Export dialog showing closeup of destination 2 Select Overwrite existing data This optional feature is useful if you are refreshing backup data 3 Select sg RetCam Shuttle User Manual PN 20 000225 Rev A Import and Export Images 47 File Format ML File Format E DICOM File Format B Split File Format Text Data XML Image BMP Figure 30 File format Format Options MLX Clarity s proprietary encrypted data format DICOM DOM is the filename extension for patient data files that are DCM compatible with the DICOM Digital Imaging and Communications in Medicine standards for ophthalmology oplit File If you select this format you will have additional options for the Format Export Image and Export Data features shown below Export Image Formats Portable Network Graphic uses compression to reduce file size about half the size of a bitmap file but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications The bitmap format saves images at full resolution without any quality loss It results in the largest files or JPEG This format uses compression to reduce file size which results in loss of resolution or quality in proportion to the amount of compression You can select the image quality before you save Export Data Formats Extensible markup language format Comma separated values format Gen

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