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1. 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 However 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 RetCam3 User Manual biomicroscope has been used for a patient who is suspecte
2. AC powered AC DC indicator ON light solid to assure backup battery is fully charged Burned out bulb Replace illumination bulb Blown fuse Replace system fuses Cleaning Procedures For cleaning purposes the RetCam3 is divided into two categories The Lens Piece that contacts the patient e The rest of the system Cleaning the Lens Piece The patient contact area lens should be cleaned immediately after use to prevent the coupling gel from hardening 1 Wipe away debris from the front lens piece surface with a soft dry tissue sterile water soaked tissue or combination 2 Then using a clean soft cloth such as sterile gauze saturated in a fresh solution of 7096 IPA isopropyl alcohol gently wipe the front of the lens piece being sure to pay special attention to the concave contact lens area to remove any remaining debris at least 11 wipes with a clean saturated cloth Pre packaged 70 IPA swabs such as ReliOn Alcohol swabs or BD Alcohol Swabs may be used 3 Rinse surface thoroughly using sterile water PN 21 100277 Rev C 58 Maintenance and Support RetCam3 User Manual 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 CAUTION Do not autoclave any part of the system Autoclaving cause
3. This could damage the precision optics and sealing 2 DO NOT AUTOCLAVE any part of the device 3 Appropriately power down and unplug the unit and allow the light source bulb to cool before replacing it 4 Always return the handpiece to the holster when not imaging You can drape the handpiece cable over the cord wrap post but do not wrap it tightly or damage to the fiber optic may result 5 Do not block access to the holster 6 The system is not intended to be transported outdoors 7 Newly acquired data may be lost if power is interrupted during live imaging Note backup battery power is available for at least 15 minutes after interrupt RetCam3 User Manual PN 21 100277 Rev C 14 Introduction 8 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 Labels and Symbols 8 e LEPORO RetCam3 User Manual System Power Switch Focus Focus Controls Lamp Illumination Intensity Controls SNAP capture switch Read instructions Caution Do not look directly into light source Caution Electrical hazard High voltage in the FA unit Chassis ground Protective earth ground PN 21 100277 Rev C RetCam3 User Manual Introduction 15 Alternating current AC System contains 2 fuses of indicated type Do not use any other type Backup bat
4. progress 5 A Select Import Data to save dialog will appear If not all items were imported you may select Show Detailed Log for the explanation It could be because some files are duplicates already in the destination database or the file is not found or it is corrupt or the destination is write protected PN 21 100277 Rev C 50 Import and Export Images View imported data and select thumbnails you need to save Select Import Selection You can also select Import All to save all images Select Imported Data to save Expand All bi Collapse All Select All Deselect All FirstMame LastName Gender Pathology Classification Selector b Brad JR Nordstrom Male ROP ROP 3 ExamDateTime Selector 09 24 2008 MEZ EI LastName Gender Pathology Classification Selector New new ExamDateTime Selector 11 15 2008 3 3 E T Ff rwn ecu e und an Sa I ey ECL eR i Tegs D ut OT 3 I D COI Ipt Images nr are of an unsu eS exui e erwritten Total Patients Count 2 TotalMediaCount 4 ES Windows 0 X acted Images Count 4 Figure 38 Import successful The system will notify you when the import is completed successfully RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Printing Images 51 5 Printing Images The Print button appears at the lower right of screens when printing is available Note Print is only available if there is a printer attached to the system either directly or through the network
5. s EX DOMINGMIMAGSS autasettidat nail ato ratios Yada anclicedan Saateseds haus duci Red eade 43 s Select Images Tor EXPO ione eo mte timeam tuta eee eC Luo US 44 scSelecb Export ODHIOLIS e auct copiato tuta dtes sitim ete remet Cte Dada o Enzo aum a acest 45 Selec ne Fe Foma RR ERR eh eat Ae ens dalek tal a ee a ata 45 EEX OOLEIMAGEF OFIMALS sericea hes oacckwastnamcai ee doucecace Geant cieetnuetesecantensadees 46 EXPO Data F OlMalSisi2m Mr 46 s Complete EXPO se siz iiintede duce Nea E 47 Iripohtld JB S ennaa fecondi ame Rd tomo fletus itia uu EU eoque Gusta cibis 47 PN 21 100277 Rev C SE xni RIS UNS o1 e Printing Images and REPOlts ccccccsseseeceeeeeceeeeeeseeeeeeeeecsaeeeseeeeeseeeeeness 51 Recommended SUDpll6S 2 bestes Per ste etna E tbe ueri leer uso el lap a 52 6 EluorescelnjAngiogr apriyesmaseeiinsidedas is duet iqa atem tds qeu Parecidos dU 53 e THEORY Of OCA RT T cm 53 e Using Fluorescein Angiography FA Mode ccccccsseseeeecesseeeeaaeeeeeeaaeeees 53 Gontiguring the FA TMe T Er 55 7 Maintenance and Support cccccsseccecseeceeceeeeeeseeeeeseseeesseaeees 57 e Recommended Maintenance Schedule eeeesseses 57 Cleaning PIoCedUf6S tetto tmi rette oett et oou ad utet ixi leaden 57 Cleaning the Lens PieGE senpre a 57 e Cleaning the Rest of the System ccccccccceccssssseeeeeeeeeeeeeeeeeeaeaeeeseeeeeeeeeesesaeaaeas 59 Disposal
6. 100277 Rev C Using the RetCam 3 19 2 Using the RetCam 3 This chapter explains how to use the RetCam 3 system after it is properly installed at your site The activities described include e Turning the System ON from Stand by Mode on page 19 e Turning the System OFF Stand by Ready on page 21 Using Hard Shutdown on page 22 e Turning OFF the Main Power on page 23 e Managing Patient Records on page 23 Performing Exams on page 26 Using Helpful Features on page 30 e Adding Exam Notes on page 33 Turning the System ON from Stand by Mode New systems are installed by Clarity trained personnel The installation includes installing main power attaching the handpiece and adjusting the monitor Upon request full installation instructions are available from the Clarity Service Department The instructions in this chapter are for using an installed system which has the main power printer and monitor turned ON the monitor height adjusted and software installed and configured for the site Note After software is installed the system requires an Authorization key to initiate the system The key is available through Clarity MSI service CAUTION Never block any RetCam 3 System vents CAUTION Never block access to the handpiece holster To turn the system ON from the Stand by mode 1 Carefully pull out the input shelf until it is fully extended 2 Depress the System Power Stand by button located on the Contro
7. OP Maternal coiere odd e eap E iuit odfeea 59 Fuse TRE DIACEINE EET ETE OT DEO 68 e Replace Illumination Ali secuestro iO eb cumini Seas kat usa unn Pe sedxieiec n es 70 di mule LE 72 a NECMAIGAl SUD DON norras o o m S OTT 73 e Technical Support Contact Information esses 73 dE viaje IMPOR MAN ON D ED 74 9 User PEIeletere Suunto iret eeaise uice dades ceu suits 75 OF MVS UNTO sac ee MET ICM 77 d ACT ee cet eee ee 77 BP FNC St oe MC E EN AA PE PE E E E EE E E E E E A 78 s MIdoWs CONT OUI AU OM ecs 0 eh a a epo Ra e circa a 78 9 T chnical SDecITIGatlOlIS ucro eoi taxed att eene Ope ex etude vem es uc edet 79 AOWA e T IMMER 79 Exit c Em 79 NEIO CIC alas n eee a eee nee Wel beri SE 79 e Environmental Conditions 2cssseicsicusevongsicceaaedaaaseiaerdgataswrrudtecivess Waresgreniuie oneness 79 10 LICENSE AOTeelmTiefilS s ees euati Int OR ue eet cad Dade 81 e CMS Software Restricted RIGNts cccccsseeceeeeseeeeeeaeeeeeeeseeseeeseeeeeesaaaeeees 81 e RetCam3 Software End User License Agreement 81 lige zs d PETER ERRORI REN 83 RetCam3 User Manual PN 21 100277 Rev C List of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22
8. Operating Storage and Transport 50 10 95 F 1021035 C 209 to 122 F 295 to 50 C Relative Humidity 3096 to 90 non condensing 10 to 85 non condensing Atmospheric 20 7 to 31 3 inches Hg 70 to 14 7 to 31 3 inches Hg 50 to Pressure 106 kPa 106 kPa Altitude 1255 to 9882 feet 382 to 1255 to 18288 feet 382 to 3012 meters 5574 meters Note Specifications subject to change without notice RetCam3 User Manual PN 21 100277 Rev C 80 Technical Specifications RetCam3 User Manual PN 21 100277 Rev C License Agreements 81 10 License Agreements CMS Software Restricted Rights This Software and accompanying written materials are provided with Restricted Rights Use duplication or disclosure by the U S Government is subject to restrictions applicable to commercial computer software under FAR 52 227 19 and DFARS 25 227 7013 Contractor manufacturer is Clarity Medical Systems Inc 5 75 West Las Positas Boulevard Pleasanton CA 94588 This Agreement is governed in and by the laws of the State of California U S A This statement gives you specific legal rights you may have others which vary from state to state and from country to country Clarity Medical Systems Inc reserves all rights not specifically granted in this statement Any attempt to decompile reverse engineer or otherwise copy this software shall be considered a breach of this agreement RetCam3 Software End User License Agreement Yo
9. a stop or reset e Reset Set the timer to zero again You can also configure the following options e Capture video and images in color or greyscale e Set the frame rate e Frame number e Elapsed time Tip You can move the timer display to any location on the image capture window Tip You can user the timer when you are not in FA mode Using Video Controls in FA Mode When you are in FA mode the timer is controlled separately from the video For example when you pause or stop the video video capture is interrupted but the timer continues uninterrupted When you pause video capture the video images acquired up to that point are not yet saved to the hard drive Images are saved automatically to the hard drive when you stop video capture The video display shows the percentage of the available 2GB hard drive space already used PN 21 100277 Rev C RetCam3 User Manual Maintenance and Support 57 7 Maintenance and Support This section addresses maintenance and support under the following topics e Recommended Maintenance Schedule below Cleaning Procedures below Fuse Replacement page 68 e Replace Illumination Lamp page 70 Key Validation page 72 Technical Support page 73 e Service Information page 74 Recommended Maintenance Schedule Between patients Clean and inspect lens piece Weekly Wipe down the system Monthly Inspect cables and connections for wear System powered for at least 8 hours
10. 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 P O Box 7 424 san Francisco CA 94120 7424 415 561 8500 http aao org RetCam3 User Manual PN 21 100277 Rev C Maintenance and Support 61 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 1 875 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 surfac
11. cccccssccecsseeeeeeeseeeeeseeeeeeseeeeeesaaeeeesseaeseeeas 23 e Managing Patient RECOIdS cccccccsssseecceeeeeeceeeseeeeseeeeessaeeseeeseeeeeessaeeess 23 Adda New Patient Record ione rm Ice oce Se esie kel ee 24 Vl GING al Patent FO seio MR ER 24 e Finding Existing Patient RECOIrdS cccccsecccccessseeeeeceeceeeeeececeessaaeneeeeeeseeaeeeeeseaas 25 e Pertorfritid9EXSltis sid nasiemonEcs a Ui Quest be tp wu E Eco bine iUd 26 Capturing Still IMAGES sxc sere Xen 28 s Capto VIdBO iiii u cites edant N 29 Video PAV DAK eic C T 30 Deleting a VIC CO sce m e 30 e Using Helpful Eeatules etr otro E rec ete ERE e ret e ro denen hens 30 JShorte Ub IBS zs tet asd attaadedr e Utente Postes Nicene fi aasse ipsa Paotetudoisa t du deae tees 30 dee inte smnimde E 30 e Changing Image Capture Options During an Exam eeeesseeeeeeeneeenn 32 Adding Exam INOIBS senio od aee tta oo e EE i eot ehe 33 Review and Compare IMAGES viene etur n ied tbt ts 35 diuum 35 Grenelle 38 NAGS AGIOS MINS AI siecics se Sei P m 39 e Adjust Image Display Parameters cccccccssssseeeceeceeeeseeeeeeeeaeeseeceeeesaueaeeeeessasaaees 40 ANNOIN NAG SS ete RT TC MEER EHE REI 41 IMPOR and EXPO IMAGES aiu mins occt dite PEL Csta TEE IUD P RogiacNE 43 Backing WD IMACS scc ian conten iseni uias i aS 43
12. dip in Ut 0 5 cycle If the user of the RetCam system requires 60 dip in Ut 5 cycles continued operation during power mains Voltage dips and interruptions 30 dip in Ut 25 cycles interruptions it is recommended that the EN 61000 4 11 gt 95 dip in Ut 5 seconds RetCam system be powered from an uninterruptible power supply or a battery Power Frequency 50 60 Hz 3 A m Power frequency magnetic fields should be at magnetic field levels characteristic of a typical location in a EN 61000 4 8 typical commercial or hospital environment Radiated Immunity 80MHz 2 5GHz Portable and mobile RF communications EN 61000 4 3 3V m 80 1kHz equipment should be used no closer to any 0 15 80MHz part of the RetCam system including cables 3 Vrms 80 1kHz than the recommended separation distance AC Mains calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 E P 80 MHz to 800 MHz d 7 E JP 800MHz to 2 5 GHz where P is the maximum output power rating of Conducted Immunity the transmitter in watts W according to the P transmitter manufacturer and d is the EN 61000 4 6 recommended separation distance in meters m E4 is 3 V m Conducted Immunity d 3 5 V4 P where V is 3 Vrms Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of e
13. in this section C Contact lens fitting Ophthalmic medical personnel involved in the fitting of contact lenses should be instructed in the precautions outlined by the CDC for disinfection of lenses D Minor office surgical and diagnostic procedures During the performance of minor surgical and diagnostic procedures particularly where contact with blood or blood contaminated fluids may occur gowns disposable gloves and masks and protective eyewear should be worn 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 and should be monitored for compliance as are other infection control procedures If an ophthalmic medical personnel does accidentally sustain a skin puncture the following actions should be taken The individual should temporarily discontinue participation in surger
14. page 38 Review Screen The Review screen appears optionally when you exit live imaging You can also access it by clicking the Exam Review button on the patient list screen IVFA post laser ROP ID Unspecifie 05 15 2007 5 15 2007 4 08 PM 0 000 ROP Unspecified 30 Exam Date 7 4 Lo i i um vae ae I uae am S ide Thumbnails Show hidden mages Print image Fit image Compare Figure 27 Exam Review screen When you exit live imaging the Review screen displays the images acquired in the session just completed When you access the Review Screen by other means it displays the images for the last patient and session you selected To review exams for a different patient exit to the Patients and Exams page and select another patient By default thumbnails for all images acquired in the selected session appear along the bottom of the screen RetCam3 User Manual PN 21 100277 Rev C 36 Review and Compare Images RetCam3 User Manual Video playback controls appear in the upper left corner of the screen The currently selected image the first one by default appears full size Click on a thumbnail to display the full resolution image You can use the arrows at the left and right edges of the thumbnail strip or the up and down arrow keys on the keyboard to scroll through the thumbnails or select a thumbnail Thumbnails of video clips show four images first last and two intermediate images in the video in the
15. pressure and or movement necessary WARNING A risk benefit ratio must be assessed before confirming a patient for RetCam imaging if they are photosensitive concomitantly exposed to photosensitizing agents or aphakic WARNING To avoid the risk of electric shock the equipment must be connected to a supply mains with protective earth WARNING To mitigate the potential for excess light exposure the user should avoid looking directly at the illuminated light source PN 21 100277 Rev C 8 Introduction Display contains 4 USB ports Transport Handle Handpiece with Interchangeable Input Shelf Lens Piece extended Holster Keyboard amp Mouse DVD writer da inside drawer USB port a andpiece Cable with Connectors FA Intensity Control Cord Wrap Post both sides FA Light Connector FA Light Switch Storage Drawers Printer on mam Extended Shelf Lockable Front Casters Footswitch Storage Pocket Footswitch Figure 1 RetCam3 Ophthalmic Imaging System front view Shown with optional FA Fluorescein Angiography feature RetCam3 User Manual PN 21 100277 Rev C Introduction 9 Ethernet Port Product Label Main Power Switch and Power Cord Connection Figure 2 RetCam3 Ophthalmic Imaging System rear view Main Hardware Components Display A flat panel display is standard with the system Control Panel A membrane contro
16. 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 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 mus
17. provides a field where you can type in notes Exam Notes Exam date 24 11 08 11 06 AM Date Created By Left Eye Note Right Eye Note Note Date Created By Left Eye Note Right Eye Note 2000 chars max 2000 chars max Return to Exam Exit Exam amp Go To Patient List Exit Exam amp Go To Image Review Figure 26 Exam Notes dialog To add notes 1 Click New Note to activate the notes fields 2 Type new notes in the fields titled Left Eye Note and Right Eye Note 3 Click Save Note to add notes you have typed to the notes above Note You cannot change a note after you click Save Note Click Reset to clear all fields Click Return to Exam to return to Live Imaging Click Exit Exam amp Go to Patient List to return to the patient list display Click Exit Exam amp Go to Image Review to return to the image review screen RetCam3 User Manual PN 21 100277 Rev C 34 Using the RetCam 3 You can add notes also from the Review screen Once saved the text cannot be modified You can append text to notes from the Review Compare and Image Process screens by clicking Exam Notes Notes are identified by date time and person creating the note RetCam3 User Manual PN 21 100277 Rev C Review and Compare Images 35 3 Review and Compare Images Having acquired images they are available for review and comparison This section covers the following topics e Review Screen below Compare Mode
18. 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 Changing Image Type Expand the Image Type menu 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 Changing Lens You can also select a different lens piece during imaging Expand the Lens menu to select 1300 Premature Infant 1200 Standard Baby 800 Posterior 300 High Mag or Unspecified The lens piece 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 PN 21 100277 Rev C Using the RetCam 3 33 Enable mouse over image preview Check this box to see an existing image on screen during a live imaging session Full Screen Show Thumbnails Enable mouse over image rere Figure 25 Enable mouse over Adding Exam Notes When you click 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
19. to initiate Exporting or Cancel A dialog opens to show export progress Please wait for work to complete Export C RetCam e xporthtest 420061117_193204aaa test 1000 ml Ba Elapsed Time 00 00 03 Remaining Time 00 00 04 Cancel Figure 35 Export progress dialog Importing Images Except for data backup the export destination on the network is an intermediate location To complete the data transfer and make the images available for viewing on another RetCam system you must use the RetCam software to import the transferred images into the target system database WARNING Never connect the RetCam3 to a network or any externally powered devices or peripherals during imaging Note We recommend that you do not import more than 2000 images in one batch because the import will take a long time One way to limit batch size is to import only the files from which you or someone else exported a limited number of images In general we recommend you import images from one patient at a time RetCam3 User Manual PN 21 100277 Rev C 48 Import and Export Images Follow these steps to import RetCam images 1 On the screen shown in Figure 36 click Import Figure 36 Start screen The Import Folder dialog appears Import Folder am RetCam supported files hdr mli mlv mls mrl files are m going ta be imported fram the source location Source location E 420081113_104047 Include subfolders E Delete source fi
20. wear n situations when splashing with blood or blood contaminated fluids may be anticipated protective eyewear Is indicated E Handling of tissue In the course of assisting in the examination of eye patients ophthalmic medical personnel may be required to handle the eyelids and surrounding facial skin and thus may come in contact with tears and the conjunctival membrane To minimize direct contact with these tissues particularly if the patient has a known or suspected eye infection ophthalmic medical personnel should be instructed in the use of gloves or in no touch techniques involving the use of cotton tipped applicators to stabilize the tissues whenever possible F Hepatitis B vaccination Ophthalmic medical personnel who frequently come in contact with needles blood or blood products are advised to receive hepatitis B vaccine to avoid infection with the virus OSHA regulations require that the employer make hepatitis B vaccine available to all employees who have occupational exposure Procedures A Handling of sharp instruments The CDC has recommended that all health care workers adopt precautions to prevent injuries caused by needles scalpels and other sharp instruments or devices 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 b
21. 678 Lr EIL E m e H m e uL 5 E 1 m e o e H m P Figure 30 Select patients and exams for export 2 Check the white boxes on the right side of the display to select files for Export You can select Check All to select all patients records and exams 3 Click the Export button at the bottom of the screen 4 The Export dialog appears Export P Export Patients Exams and Media e Supported Formats MLX DCM PNG BMP JPG XML CSV amp TAT Specify destination location Path C RetCam Export Create subfolder ExamDate EsamTime s LastName FirstName Haspita x 9 20081125 i23 018 DoeJahn HID1234 File Name Format ExamID S5eqNum Y Overwrite existing data d846419c 604b 1 File Format ML File Format B Split File Format Text Data XML Image BMP Export Figure 31 Export dialog By default the dialog shows the source location path and options used for the last export RetCam3 User Manual PN 21 100277 Rev C Import and Export Images 45 Note The Minimum Required Space for Export is displayed Verify that the export destination has sufficient free space to accept the exported files JL Note Regarding File Size Capacity We recommend that you do not export more than 2000 images in one batch because the export will take a long time We recommend that multiple smaller transfers be executed Select Export Options 1 To change the destination locat
22. 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 21 100277 Rev C Maintenance and Support 63 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 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
23. Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 RetCam3 User Manual RetCam3 Ophthalmic Imaging System front ViOW cccccesseceeeceseceetseeeeeeeaneeees RetCam3 Ophthalmic Imaging System rear view ccccsesecccsseeeeeeeeeseeeeeaeeeeeaaaeeees Handpiece and Pens piece sibl vu que pia b oa r fena buta endi Rad CONMIGO DANG RR D e n Installing a lens piece on the NANADPIECE cccceeececseeeeceeeeeceeeeeseeeeeseeeeseeeeesaees Handpiece connections RE UU T SUG OWI DUI OMA RE OG were ireegerere cim T E naenunes SAN S CL SCM esos se sno cate tea douce intota bam dtum face detta ol me cLan t tcu Ra can vU n eee Add new pallet ScKeel aisi tectis c tad lee iade Der ecd deli itia du tu E esae Edit Patlent Tecord SCIeell dett elena teeta a n dui elus iuuat dE C caeno Deal c DittolS cca re epe ote sede eu ae pios at ue putat teal vsu octe Eolaicsc aito F ati entsearch ODOMS sixties tussi divo VudtsUu adam aM tU a a Patients and Exams Screen Patient Directory eeeeeeseeessseeeeeeee Patients and Exams screen navigation buttons eeeeeeeeeeeeeeeeeeee New Exam conftg ratlorisScEeeliissiieupn is husecuc ep cev etu dev bu a voa eared VO e kon co iw iov ev ats Show Thumbnails DUIEOTI 5 petia oiii orit iat ee acta ele
24. Ophthalmic Imaging System system is designed to allow the quick and easy capture of wide field high resolution fully digital images and videos of the eye Indications for Use For general ophthalmic imaging including retinal corneal and external Warnings and Cautions CAUTION Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner WARNING Prior to using the system read all user safety information WARNING Before using this equipment to acquire images from patient eyes users must be trained in proper clinical technique by personnel authorized by Clarity WARNING The RetCam system is designed and tested as a system Omission or substitution of RetCam components may adversely affect system performance and is strongly not recommended WARNING Unauthorized modifications or additions to the RetCam system including hardware and software etc could adversely affect system function and will void the warranty WARNING Carefully inspect and clean the lens piece before each use DO NOT use if the lens piece has nicks breaks scratches or rough surfaces that may damage the eye WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of exposure time necessary no greater than 5 minutes WARNING Use care when contacting the eye i e use the least amount of
25. PN 21 100277 Rev C RetCam3 User Manual User Preferences 75 8 User Preferences The section describes the User Preferences available including System Identification Institution e Setting Pre configuration Imaging defaults for New Exams Changing Date Time Changing Speaker Volume Setting Printer defaults Setting Network connections Select the cog icon in the lower right hand corner to access the User Preferences About Status Monitor Trace Window User Preferences Exam Review Import xiii us Unlock Maintenance Made Displayed Patients 13 Selected Patients 1 Selected Media 6 Figure 52 Access User Preferences Click About to identify the RetCam software version Click OK to exit About RetCam User RetCamn Institution Department HetLam Version 5 1 17 Computer Name CLARITY PBAYEA NET Framework 2 0 50727 Windows OS Windows sP Microsoft Windows MT 5 1 2600 Service Pack 2 Assembly Versions mecorlib Yersion 2 0 0 0 Culture neutral PublicheyT okenzb abche18348 083 Clarity RetCam Version 5 1 17 0 Culture neutral PublicK eu T oken null System Yersion 2 0 0 0 Culture neutral PublicheyT oken b r abcb5613348083 Clarity Common V ersian B 1 17 0 Culture neutral PublickeyT oken rull System Windows Forme V ersionz2 D D 0 Culture neutral PublickeyT oken b7 a5c561 9346089 System Drawing Yersion 2 0 0 0 Culture neutral PublicheyT okenzb 3rbfF H 1d50a3a Clari
26. RetCam Ophthalmic Imaging System User Manual PN 21 100277 Rev C For use with software version 5 1 Caution Federal law US restricts this device to sale C a r t y by or on the order of a physician or licensed l medical systems medical practitioner Copyright 2008 Clarity Medical Systems Inc All rights reserved EC REP MediMark Europe S A R L 11 rue Emile Zola 38100 GRENOBLE France Tel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 e mail info medimark europe com RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Contents al gele 8 e ie 9 er E 7 selezione 7 WINNS aNd AU ONS TEE A RE E T 7 Main Hardware Components cccccssesseeeeeeeeeeeecceeeaeaeeeeseeceeceeeeeeseeeeeeeeeeeeeeeeeeeeeesaas 9 e Electrical Safety Informiallol ecco odo E n tede Eno Rae esae e o Cim Got tva ceu nEus 10 e Important User Safety Notices eessseessseseeeneeeeennnnnnnn nnn 13 Labels and Sy MDO entr DS 14 e Product Lael sera wists E E A ER 18 WSING TNC TROLG AN Ss ert 19 e Turning the System ON from Stand by Mode cceeeeeseeeeeeeeeeeseeeeees 19 Installing LenS Piece S usse aaaeei 21 e Turning the System OFF Stand by Read y ccccecssseeceeseseeeeseeeseeeseaeees 21 Dsirng Hard SMUT O WI ssmieitscocih Nea eere Ios oed i ede Feud e d om tdeo e Dee Eis p dae 22 Turning OFF the Main POWEL
27. a printer driver supported by Windows XP Note Be aware that you must change the paper in the printer when switching between printing images and reports See the User Preferences section for information on setting printer defaults RetCam3 User Manual PN 21 100277 Rev C Fluorescein Angiography 53 6 Fluorescein Angiography This chapter covers acquisition of still or video images using the fluorescein angiography FA option These functions are provided through the Image Capture Screen Theory of Operation The FA generates a narrow band blue excitation light centered at approximately 471 nanometers The barrier filter inserted in the handpiece has a cutoff wavelength at 510 nanometers or shorter The FA dye absorbs the blue light and emits green light longer than 510 nanometers so the RetCam3 camera can image the green fluorescence without being overwhelmed by the blue excitation light Using Fluorescein Angiography FA Mode Note The internal backup battery never powers the FA Therefore the system must be plugged into wall power to operate in FA mode 1 Switch ON FA power The FA lamp requires a few minutes to stabilize Power switch Fiber Optic lamp connector Adjust FA intensity Figure 40 Front panel of FA 2 Carefully install the barrier filter into the handpiece A Remove the lens piece if present B Insert the barrier filter into the cavity of the handpiece observing the orientation as shown in Figur
28. am3 User Manual 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 DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U S TWO HUNDRED FIFTY DOLLARS U S 250 00 Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineer decompile or dis
29. anual PN 21 100277 Rev C User Preferences 77 Institution User Preferences Configurations Imaging Adjustment institution Live Imaging Mew Exam Notification Institution Printers Windows Configuration Department Location Figure 55 User Preferences Institution New Exam User Preferences Configurations d Imaging Configuration One Imaging Adjustment Institution Title Preset Configuration 1 Live Imaging 7 l New Exam Image Type Retina e Lens 1300 Eye Right Eve OD Notification m men n PC Printers windows Configuration Imaging Configuration Two Title Preset Configuration E Image Type Reina Lens 1300 Eye Right Eye 0D v Imaging Configuration Three Title Preset Configuration 3 Image Type Retina Lens 1300 Eye Right Eve OLD Figure 56 User Preferences New Exam Once the New Exam preset configurations are adjusted click Apply to initiate the change or Cancel Click OK to exit the screen RetCam3 User Manual PN 21 100277 Rev C 78 User Preferences Printers User Preferences Configurations Imaging Printer Imaging Adjustment Institution Live Imaging Default Imaging Printer New Exam Notification Printers Windows Config
30. assemble 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 21 100277 Rev C Index B Backup Frequency recommended 43 Backup Recommendation 43 C CE Label 18 Changing Image Type 32 Changing Lens 32 33 Class 1 10 Compare Screen 38 E Electrical Safety Notices 10 EMI Information 11 F Flag Image 36 H Handpiece 10 Hardware Elements 9 Hide Image 36 Image Display Parameters 40 Indications for Use 7 Introduction 7 RetCam3 User Manual Index 83 K Key Validation 72 L Lens Model 10 Lens Piece 10 O Operating Environment 79 P Print Images 39 R Hecord Video 29 Reset Adjustments Button 40 Review Images 35 Rotat
31. ation 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 RetCam3 User Manual us Gowns masks and protective eve wear Gowns masks and protective eyewear are unnecessary for the usual ophthalmic examination D Disinfection procedures Disinfection is a process to 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 le
32. c patient records Find Patients Figure 12 Search buttons From the Start screen click the icon to display the entire patient directory or click the plus sign J to locate patient records using one or more of the search features see Figure 13 Figure 13 Patient search options Click Clear to clear all search fields Search Results When you click the to display the entire patient directory the results are displayed as shown in Figure 14 PN 21 100277 Rev C 26 Using the RetCam 3 RetCam3 User Manual LasPalmas Ch Ld LANDRE 2 25 Figure 14 Patients and Exams Screen Patient Directory From the Patients and Exams Screen you can use the buttons shown in Figure 15 to sort the results Expand Patients Collapse All Check A Uncheck All Figure 15 Patients and Exams screen navigation buttons Performing Exams You can use the RetCam 3 to capture still images or video after selecting a patient Click 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 PN 21 100277 Rev C Using the RetCam 3 27 Mew Exam Configuration Current weight Select an Imaging Confiquration Preset Configuration 1 Preset Configuration 2 Preset Configuration 3 Manual Configuration Cancel Figure 16 New Exam configuration screen The following Information can be de
33. ce connections Always return the handpiece to the holster when it is not in use You can drape the handpiece cable over the cord wrap post but do not wrap it tightly or damage to the fiber optics may result WARNING Carefully inspect and clean the lens piece before each use DO NOT use if the lens piece has nicks breaks scratches or rough surfaces that may damage the eye PRINTER Extend the printer shelf fully and verify that sufficient paper is installed in the printer The shelf can be pushed back in 6 When the software is ready you will see the message Not Displaying Patients 7 For FA operation if available see Chapter 6 Fluorescein Angiography for instructions If the illumination lamp is OFF press the illumination lamp button located on the right side on the Control Panel to turn illumination ON The amber indicator light is illuminated when the lamp is ON Turning the System OFF Stand by Ready Note We strongly suggest that you backup and store your data prior to turning OFF the system See Exporting Images on page 43 for details PN 21 100277 Rev C 22 Using the RetCam 3 1 To turn OFF the system leaving the Stand by Ready hover over the red Shutdown button at the bottom of the Patients and Exams screen Mew Exam Exam Heview Import Export Print Displayed Patients 0 Selected Patients 0 Selected Media 0 r o Sh utdown button Figure 7 Shutdown button The shutdown optio
34. center of the reflector nor the inner concave surface of the reflector Skin oils will adhere to the bulb and reflector which reduces the cooling efficiency of the bulb and thereby creates a hot spot leading to premature burnout Handle by the outside of the lamp only as shown 7 Holding the new lamp only on the outside as shown replace it in the assembly aligning the two pins in the rear with the corresponding tracks in the socket and pushing it gently and evenly into place 8 Check the position of the new bulb to make sure that the reflector of the bulb is located in the center of the lamp socket s opening 9 Push the lamp assembly drawer back in carefully Use caution to avoid pinching wires in the area 10 Replace the two screws on the small front panel Key Validation Note New RetCam3 systems ship with their license key already registered and validated However significant changes to the system hardware or a re load of the system software for any reason including software upgrade may require you to perform the key validation process as described below Key validation requires that you get a license key from Clarity to use the revamped system and you cannot request this key until after installation is complete Since it may take up to two 2 business days to obtain a license key after submitting a request we recommend that you effect system or software upgrades when you can manage two business days without use of the sy
35. cted a puli tdi meee sStilkimage SCLC CIN EE C rr eh La Ae oe Onscreen caplure COnDtlols snis ne Diss esso Git uet ictu va erede a Progress o RT T Video and image capture controls ccccceececceseeceeseeceeececseeeeecegeeesaneeeseueesseseeess Videc TALIM GIS zeros esi Ros CukadiietasiusveRedu a acad ecu datu a ue de adiudantaf Boii Video ScrollBar CONTO usitas dense cu Eae aevo ten edad puc t o tavta bat ufi Select options Tor image captille oie acie vitae evene ue edebat EE Ue IN bdo euo bdo pa vaa s Enable mollsesoVOl isto odia stets tetes dte eated e oec a mas ecd codd ttt euncie doi osos Exam INOTES CIAO Mtm Exam REVIEW SCION essiri aa a e a e mbt luu uguds Compare Images screen cecccccceeeceecaeeeeeeeeeeeeeeseseeeeseeeeeeeseeeeeseeaeeeesaaeeeessaeess zeli pare ze 0 g eter c TNT Select patients and exams for export cccccccseeceeessseceeceeeeeeeeseeeeeeeaeeeeessaeeeeeseness EXPO Clalit 5 saan a EE M Export destination OPllONS sercsidtoiieener b I N Goo e Pene PEDIR v Eos DM des Select TIE TOMMY se ace eR T m Select image and data format esses nennen nnns Export progress dlalogssssiesededndicoe essteru a dna ddp Monte driver dra up sini Gaule idun Start clel fici RT TRE PONE OIME FGIAlOG aa LE IMPORE SUCCES SIU eer miele T m FON Dane Bou T T ro UNT PN 21 100277 Rev C Figure 41 Figure 42 Figure 43 Figure 44 Figure 45 Figur
36. d 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 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 dec
37. der to the right or left to scroll forward or back through the video e Stop the slider when you see an image you want to save Click Save Still or press S on the keyboard or press the Snap button on the footswitch 3 Use the playback controls at the top of the screen to locate a still image e Start playback by clicking Play La or Reverse sd won mm Click Pause LL when you see an image you want to save Click Save Still or press S on the keyboard or press the Snap button on the footswitch RetCam3 User Manual PN 21 100277 Rev C 32 Using the RetCam 3 RetCam3 User Manual 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 hysicia Left Eye 05 Lens 1700 Retina Figure 24 Select options for image capture Changing Right Eye OD Left Eye OS To image the other eye in the same session expand the Eye menu 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
38. e 180 40 S Save Still 29 Service Information 74 U Unflag Image 37 Unhide Image 36 User Safety Notices 13 V video clips 36 PN 21 100277 Rev C 84 Index RetCam3 User Manual PN 21 100277 Rev C Clarity medical systems Clarity Medical Systems Inc 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 251 0078 Toll free 1 800 215 6005 RetCam3 User Manual www claritymsi com PN 21 100277 Rev C
39. e 41 C Reattach the lens piece before moving the handpiece RetCam3 User Manual PN 21 100277 Rev C 54 Fluorescein Angiography F ai Lens piece Bi Rubber O ring toward lens piece Barrier filter Beveled edge toward handpiece Handpiece Figure 41 Barrier filter installation Note If lenses are exchanged during an FA session hold the camera upright to avoid having the barrier filter fall out during the exchange 3 Select Switch to FA from the live image screen and SNAP a red free image recommended 4 Attach the fiber optic lamp connector from the handpiece into the FA fiber optic port See Figure 40 5 Select Start Timer Dye can now be injected Note The timer can be paused or stopped at any time 6 Adjust FA light intensity using the FA intensity knob shown in Figure 40 Note You cannot adjust the FA lamp intensity using the footswitch or control panel controls 7 You can take still photos or video during the FA session and you can SNAP still photos during video replay RetCam3 User Manual PN 21 100277 Rev C Fluorescein Angiography 55 RetCam3 User Manual 8 When the FA session is completed A Stop the timer B Move the fiber optic cable back to the white light port and switch OFF the FA power C Remove and store the barrier filter in the special clear plastic box provided or in a manner that prevents damage Clean the filter with compressed air and optica
40. e 46 Figure 47 Figure 48 Figure 49 Figure 50 Figure 51 Figure 52 Figure 53 Figure 54 Figure 55 Figure 56 Figure 57 Figure 58 RetCam3 User Manual Bamer fiter IMStAN AON ustedes n lente ce beni dap bets Gu en Eta bus tud s aou bdo 54 FA TIMP ele gio cR T Tm E 55 Inverted lens piece showing permissible depth of immersion 58 POWER ENV MOQUIS 68 Opening the fuse holder cover reeden e a E 68 Removing the fuse holdel secet onse ia eee ee oiii eese tan tels uss 69 Fuses removed EM RE RR IR E 69 Fuse holderTesinserted oaa coma cerae a aM M Aidan D aD cM MS ALMAE 70 Front panel showing the lamp assembly drawer eeeeeeeeeeeeeeese 71 Removing the illumination lamp 1 seeeeeeeeeeeeeenrnnnenm nnn 71 KEY ValiGallon GINO eet EE mI T 73 Access User Preferences coiere oi deter bul csi leui uc Lad cese eae aceelegiecnaceds 75 About Clarmy SOWA E setts eee E tou ce eee dup ea dues Po uto ce 75 User Prerer nces SCre Oll nos isre dine etaed A si essen inre anes 76 User Preferences Institution cccccccssececeesceeeeeeeceeceeseueecseueeeseaeceeeeeeessaeeesaaaees 77 User Preferences New EXA a a a 77 User Preferences Printers aciei n an 78 User Preferences Windows Configuration ccccccccseceecaeeeeeeeeeeseeseesseneeesaeeeenees 78 PN 21 100277 Rev C RetCam3 User Manual Introduction 7 1 Introduction The RetCam3
41. e 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 RetCam3 User Manual OSHA s revised Occupational Exposure to Bloodborne Pathogens Standard now requires that the employers governed by this rule review annually and update to reflect changes in technology that could reduce exposure to bloodborne pathogens and maintain a sharps injury log OSHA s Bloodborne Pathogens Standards applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials However workplaces with 10 or fewer employers are exempt from OSHA recordkeeping requirements including a Sharps Injury Log B Fluorescein and Indocyanine green ICG angiography It is recommended that photographers and other health care workers who may come in contact with blood while performing fluorescein and ICG angiography wear gloves and adhere to the procedures as outlined
42. ect the image from the Exam Review screen and click Edit Image E Show hidden images Show annotations Full Screen Hide Thumbnails Print Image Edit Image Figure 29 Edit Image button The Image Adjustment window appears The upper portion of this window provides image adjustment tools The low portion of this window provide tools for annotating an image To exit the Image Adjustment window click the X in the upper right corner of the window RetCam3 User Manual PN 21 100277 Rev C 40 Review and Compare Images Image Adjustment x Adjust Image Display Parameters Wines o AA right side of the Process screen provides controls to adjust the following image m aMilidisplay parameters Brightness e Contrast e Red Rotate 130 Reset e Green Save As e Blue Apply Saved Settings Save Settings E MESE All parameters have a default setting of zero 0 and range from 100 to 100 Insert Point Insert Ellipse e Each click on the right or left arrow at the end of the slider bar changes the Insert Line Insert Hote parameter value by 196 ix om e Each click on the bar to the right or left of the slider changes the parameter Delete value by 1 Rotate 180 Click this button to rotate the image 180 Reset Button Click Reset to reset all display parameters to zero Save Settings Click to save the current settings for Brightness Contrast and Red Green and Blue The saved settings can be applied when y
43. ed even when you modify the image displayed on the screen You can save processed images only outside the RetCam database and in a non proprietary format PN 21 100277 Rev C 42 Review and Compare Images RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Import and Export Images 43 4 Import and Export Images You can import or export images e To make RetCam data available on other RetCam stations which include RetCam3 RetCam Il and RetCam Shuttle systems and PCs running RetCam Heview Software o make a backup copy of the original image data kept on the hard drive o view with standard image software o use RetCam images with third party imaging systems Backing Up Images The RetCam system stores all images to the local hard drive It is highly recommended to create a central repository on a network of all data from the RetCam device for long term data backup Recommended Backup Frequency Each day you acquire new images Exporting Images You can export data to any accessible location There are three general steps to complete export These are 1 Select Images for Export below 2 Select Export Options page 45 3 Complete Export page 47 PN 21 100277 Rev C 44 Import and Export Images Select Images for Export 1 Go to the Patients List screen and highlight the desired patient Click the arrow on the left side to show all the exams for the selected patient Danville Robert ID 455
44. ed for Continuous Operation RetCam3 User Manual PN 21 100277 Rev C Introduction 11 Electromagnetic Emissions Compliance Level Group 1 Class A Test Type Compliance Levl NOS Conducted Emissions Class A The RetCam system uses RF energy for its internal CISPR 11 function Nearby electronic equipment may be EN 55011 affected Radiated Emissions Class A CISPR 11 EN 55011 Harmonic emissions Complies IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 FCC Part 158 RetCam3 User Manual PN 21 100277 Rev C 12 Introduction Electromagnetic Immunity Test Type IEC 60601 1 2 test and Electromagnetic Environment Guidance compliance level Electrostatic Discharge ESD 6 kV contact Floors should be wood concrete or ceramic EN 61000 4 2 8 kV air tile If floors are covered with synthetic material the relative humidity should be at least 30 2 kV for power supply lines Mains power quality should be that of a typical Electrical Fast Transients commercial or hospital environment AC Power AC Power electronic disturbances transients may cause I O Lines the system s display to scroll continuously If EN 61000 4 4 this occurs imaging should not processed until the disturbance has ceased Surge Line to Line 1 kV line s to line s Mains power quality should be that of a typical AC Power 2 kV line s to earth commercial or hospital environment I O Lines EN 61000 4 5 gt 95
45. eletion when you exit the exam The delete icon toggles that is clicking it again before exiting the exam means the video is no longer marked for deletion Note Images and video can be selected for deletion only during the imaging session Once the session has been exited the images will be saved for that session Using Helpful Features The RetCam 3 software includes some useful features to streamline your work Shortcut Keys An underlined letter indicates a quick key To use a quick key press ALT and the letter key simultaneously Note Do not use Windows shortcut keys for example Copy Ctrl C Paste Ctrl V Undo Ctrl Z and others Still Images From Video During video replay you can identify and save still images from the exam There are three ways to locate and save a still image PN 21 100277 Rev C Using the RetCam 3 31 1 Scroll through the thumbnails using the arrows at the right and left ends of the strip at the bottom of the screen Figure 22 Video thumbnails Use the arrow at the right to scroll forward through the video and the arrow at the left to scroll back e Stop when the image you want to save is highlighted e With the image highlighted click Save Still or press S on the keyboard or press the Snap button on the footswitch 2 Use the scrollbar at the top of the video controls to scroll through the video and find a frame Figure 23 Video scrollbar control Move the sli
46. en view of the current image with no thumbnails visible PN 21 100277 Rev C RetCam3 User Manual Review and Compare Images 37 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 PN 21 100277 Rev C 38 Review and Compare Images 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 05 15 2007 Uneefined T Unspecified T Otlver Undefimed Urispecified te SHSOOD 4 08 PM T SHSAT 4 08 PM 7 ES ET hidden imagea Primi image Fuit Image Frid Compare Fam Hates Figure 28 Compare Images screen The last image displayed on the Review screen will appear on the left side of the Compare screen On the right side by default the first image of the first session for the same patient appears Identifying information for eac
47. eo click Stop Recording or Pause Recording Freeze Live Freeze an image during image capture Switch to FA Change the image type to Fluorescein Angiography See Chapter 6 Fluorescein Angiography Start Timer Start a timer to record the time elapsed during the exam Save Still Saves a still image to the hard drive Footswitch Operation options Use the SNAP button to pause and continue video recording Note The storage capacity of the system hard drive is a maximum of 140 minutes of total video for example 70 videos of two minutes duration each PN 21 100277 Rev C 30 Using the RetCam 3 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 Video Playback When you stop live recording the playback buttons are enabled LS mF Reverse pause and play A Fast forward Go to the beginning of the recorded video Go back one video RetCam3 User Manual i a Advance one video ET SEE Go to the end of the recorded video Control the rate of playback or search Tip Using the left and right arrow keys on the keyboard will also move the video back or forward one frame at a time Deleting a Video To delete a video in the thumbnail view click the delete icon red x at the bottom of the frame This marks the video for d
48. es 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 universal 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 re
49. fined in the Preset or Manual Configuration Unspecified Unspeciied 139 00 C jUmewed Once the new exam is configured select the green arrow to the right to enter the New Exam screen Select Show Thumbnails at the bottom of the Exam screen to maximize the available features Full Screen Show Thumbnails Enable mouse over image Figure 17 Show Thumbnails button The Show Thumbnails button toggles between Show Thumbnails and Hide Thumbnails RetCam3 User Manual PN 21 100277 Rev C 28 Using the RetCam 3 RetCam3 User Manual Capturing Still Images Ld Fi Ld Shem fiction images abba atte creer TLS pis Figure 18 Still image screen The recommended procedure is to capture video of the entire exam and grab still images from the video then delete the video prior to exiting still image session after the exam is finished You can take still images from the New Exam screen using the following Keyboard and Mouse Some utility buttons are displayed on the monitor use the mouse to select them Immature ROP ID Click to save still c ur Still LL rur Peepers Footswitch Operation Record Video Switch to FA L Video Recording Freeze Live Start Timer Save Snapshot Click to use EE footswitch for stills capture Figure 19 Onscreen capture controls Use the S key to SNAP images Footswitch Select Save Snapshot from the monitor display see Figure 21 on page 28 Then use t
50. h 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 RetCam3 User Manual PN 21 100277 Rev C Review and Compare Images 39 The following controls available on the image display screen are not available on the Compare screen Hide Image and Flag Image icons e Full Screen e Hide Thumbnails Compare This button is replaced by End Compare on this screen The Compare screen provides buttons 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 Edit Image Click Edit Image to display the Image Adjustment window End Compare Click End Compare to 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 and the doctor s name Exit Review Click Exit Review to return to the Patients and Exams screen Image Adjustment To adjust an image sel
51. he footswitch SNAP button to SNAP images PN 21 100277 Rev C RetCam3 User Manual Using the RetCam 3 29 Control Panel Press the SNAP button Note Saving video can take significant time and consumes a great deal of disc space To maintain optimal system performance select the images of interest from the video then delete the video prior to exiting Image Capture Note The storage capacity of the system hard drive is a maximum of approximately 250 000 still images Saving a combination of videos and stills will affect the total number of each that can be saved Saving images with annotations reduces the total number of images that can be saved Note If the Control Panel or keyboard controls do not respond check that the Footswitch Controls are not activated Capturing Video Up to 2 minutes of Video capture is available per session A progress bar is enabled each time video is started to let you know the percentage of time used Footswitch Operation L Video Recording Stop Recording Pause Timer Save Snapshot EC 20 ites nee Pause Recording Switch to FA Figure 20 Progress bar Video is captured at full resolution 30 frames per second a videa MENTE EA Footswitch Operation ME MILLE Freeze Live start Timer Save Snapshot i y i 200 cs Figure 21 Video and image capture controls The following controls are available on screen e Record Video Starts recording video to stop recording vid
52. if so connected WARNING Never connect the RetCam3 to a network or any externally powered devices or peripherals during imaging You can Print Images from the e Exam Review Screen Compare Screen Patient list or Patients and Exams screen Print images reports or both The default image size is 5 x 7 For optimal resolution Clarity recommends printing images 5 x 7 or smaller This also avoids the rapid depletion of printer ink Printing Images and Reports You can print both images and reports from the patient list or Patients and Exams screen 1 Select or highlight patient 2 Check the desired session patient or image 3 Select Print The following dialog appears Report Printing Selection B Print Only Selected Patients no patient selected Patients Information I Prints the list of selected patients Patients Exams Information Prints the list of selected patients and their exams Bl Print as ROP report Patients Exams Images Information E Prints the list of all patients from search and their exams and images E Print as ROP report Figure 39 Print dialog PN 21 100277 Rev C 52 Printing Images Select the desired option s Reports are formatted to fit on US letter size or A4 paper Recommended Supplies Clarity sells printer supplies photo paper and ink for the printer supplied with the system Note Network printers used with the system must have
53. 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 21 100277 Rev C Maintenance and Support 67 Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 8 eyewear 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
54. ion path select the arrow to expand the path list or click Browse Clicking the red reverse arrow resets the source location to the default setting Export images to a new subfolder Specify file name format Specify destination location Path C RetCam Espart gt Browse Create subfolder ExamDate ExamTime LastName FirstName Hospita 9 ox 20081125 123 01i58 Daoe JJohn HID1234 File Name Format ExamID SeqNum Overwrite existing data d8a8419c 604b 1 Overwrite existing data Create a subfolder for one feature Create a subfolder for multiple features Figure 32 Export destination options 2 Select the destination options e Export images to a new subfolder Create a subfolder for one feature such as exam date exam time last name etc Create a subfolder for multiple features e Specify a file name format for the exported files Overwrite existing data Select the File Format File Format MLX File Format B Split File Format Text Data XML Image BMP Figure 33 Select file format Select MLX DICOM or Split File format RetCam3 User Manual PN 21 100277 Rev C 46 Import and Export Images RetCam3 User Manual Clarity s proprietary encrypted data format DICOM DCM is the filename extension for patient data files that are DCM compatible with the DICOM Digital Imaging and Communications in Medicine standards for ophthalmology Split File If you select this format you wi
55. l 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 unvaccinated person and provide PEP with hepatitis B immune globulin or hepatitis B vaccine in appropriate cases preferably within 24 hours RetCam3 User Manual For personnel exposed to HCV the Public Health Service does not recommend immune globulin or antiviral agent
56. l Panel to turn ON system power The System Power Stand by indicator light solid green should be illuminated The software should initialize RetCam3 User Manual PN 21 100277 Rev C 20 Using the RetCam 3 The membrane control panel is located on the lower front part of the keyboard tray It provides controls and indicators of system status System Power AC DC indicator indicator Relative intensity Illumination ON green green Focus indicator indicator amber 4 System power Focus Controls trols SNAP Intensity Controls Lamp Illumination Stand by button capture button Figure 4 Control panel 3 Attach the desired lens piece to the Handpiece as shown in Figure 5 and Installing Lens Pieces on page 21 Align lens piece e to fit over pins alignment pins on handpiece Carefully tighten clockwise until it clicks in place Do not overtorque Figure 5 Installing a lens piece on the handpiece RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Using the RetCam 3 21 Installing Lens Pieces A Fit the lens piece on the handpiece aligning the 3 radial pins on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece B Twist the lens piece clockwise as shown in Figure 5 until you hear a click indicating that the lens piece is locked in place 4 Verify that the handpiece is connected to the system as shown in Figure 6 Figure 6 Handpie
57. l 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 After hours Please leave a message as the messages are checked during the evening hours PN 21 100277 Rev C 74 Maintenance and Support RetCam3 User Manual Send correspondence to Clarity Medical Systems Inc 5775 West Las Positas Blvd Pleasanton CA 94588 USA Email service retcam com Our US technical support staff will respond to your questions as soon as a staff member is available In most cases you should receive an answer within 48 hours Complex questions that require testing or special research may take longer Note Questions about products no longer under warranty and questions other than to explain ordinary use of the product may incur service charges Please ask for an hourly quotation before incurring charges Service Information Service information is available separately in the RetCam3 Service Manual RetCam3 components are typically return to factory components and can be repaired by only Clarity personnel and or our qualified distributors The Service Manual contains information on user replaceable parts and or instructions to remove components for return for factory repair
58. l cleaner and tissue as required When the Image Type selected is Fluorescein the video and images are displayed and stored in grayscale by default To view and store FA images and videos in color select FA from the Image Type menu instead of using the Switch to FA button WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of light necessary no greater than 5 minutes WARNING Do not look directly at the fiber optic port WARNING If the light from the illumination source is not blue DO NOT USE IT because there may be a filter failure WARNING Do not attempt to override the interlock switches or to operate in FA mode with the cover off The FA contains internal sources of high voltage high current heat and moving parts Only authorized technicians may attempt any service or repairs to the FA Failure to observe this warning could result in injury to operator or patient Configuring the FA Timer To configure the FA timer click Configure at the top left of the screen Record Video Switch to Color Freeze Live Restart Figure 42 FA timer controls The drop down menu offers the following timer options e Start Start the timer e Pause Pause video capture but keep the timer running PN 21 100277 Rev C 56 Fluorescein Angiography RetCam3 User Manual 0 e Restart Restart the timer following
59. l panel turns the system on with one button and has controls for illumination intensity camera focus and snap capture an image or start stop video recording Handpiece Contains the camera Lightweight and easy to position it has a long cable for easy reach Use with changeable lens pieces RetCam3 User Manual PN 21 100277 Rev C 10 Introduction Chassis Contains the control systems and connections Footswitch Provides optional means to control illumination intensity camera focus and snap Storage Drawers All units have two storage drawers for lens pieces tools and supplies Fluorescein Angiography Source optional An optional blue exciter light source is available for FA digital photography It comes complete with a yellow barrier filter for the handpiece You can agjust illumination intensity only through the FA intensity control Printer Color images and reports can be printed Handpiece Lens piece we Figure 3 Handpiece and Lens piece Lens Model Application Common Field of View D1300 Premature Infant 130 Degrees B1200 Standard Baby 120 Degrees E800 High Contrast Children s amp Adults 80 Degrees C300 High Magnification 30 Degrees PL200 Electrical Safety Information The system has been designed inspected and tested to comply with the safety requirements of IEC60601 1 with respect to fire shock and mechanical hazards only if used as intended Class I Type BF Electrical Equipment Rat
60. late 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 RetCam3 User Manual recommendations for the management of occupational exposures to HBV HCV and HIV In March 1992 the Occupational Safety and Health Administration OSHA issued a set of regulations entitled Occupational Exposure to Bloodborne Pathogens which requires that employers establish safeguards which protect workers against hazards related to bloodborne pathogens These regulations require identification of who is at risk of occupational exposure the communication of hazards to employees at risk for exposure exposure prevention control measures and what to do if an exposure occurs In April 2001 the Needlestick Safety and Prevention Act became effective revising the bloodborne pathogens standard to require employers identify and make use of safer medical devices which can be used to reduce worker exposure In 1992 the American Academy of Ophthalmology Public Health Committee developed updated recomme
61. les and subfolders after import Cancel Figure 37 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 click Browse Clicking 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 RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Import and Export Images 49 Included subfolders check box oelect 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 If you want files from a specific patient subfolder only select that subfolder as the Source location Delete source files and subfolders after import check box To manage the size of the export destination select this check box to delete the source 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 Note This does not affect any working RetCam database but only the intermediate location where files are exported to and imported from 4 Click Import to initiate importing or Cancel A dialog opens to show import
62. ll have additional options for the Format Export Image and Export Data formats Export gt Export Patients Exams and Media em Supported Formats MLS DEM PNG BMP JPG XML CSV amp TXT Specify destination location Path CiRetCam Export test26x Browse Create subfolder ExamDate ExamTime LastName FirstName Hospita m 20081125 1803544Do6 John HID1234 File Name Format ExamID SeqNum E Overwrite existing data d8a8419c 604b 1 File Format MLX File Format B DICOM File Format E Split File Format Test Data XML Image BMP Export Images Export Data o L n Cancel Figure 34 Select image and data format Export Image Formats Portable Network Graphic uses compression to reduce file size about half the size of a bitmap file but without loss in quality or resolution It can be viewed in a standard web browser and used in image processing or viewing applications The bitmap format saves images at full resolution without any quality loss It results in the largest files or JPEG 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 E Extensible markup language format Comma separated values format Generic text format PN 21 100277 Rev C Import and Export Images 47 Complete Export Select Export
63. nd 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 21 100277 Rev C 68 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 44 Figure 44 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 45 Figure 45 Opening the fuse holder cover RetCam3 User Manual PN 21 100277 Rev C Maintenance and Support 69 Remove the fuse holder See Figure 46 Figure 46 Removing the fuse holder Remove the blown fuse or fuses from the fuse holder and replace it with a new fuse of same type and rating See Figure 47 Re insert the fuse holder Figure 47 Fuses removed N CAUTION For continued protection against risk of fire replace only with same type and rating fuse Replacement fuses are available from Clarity Customer Service RetCam3 User Manual PN 21 100277 Rev C 70 Maintenance and Support A RetCam3 User Manual Figure 48 Fuse holder re inserted Replace Illumination Lamp WARNING Appropriately power down and unplug the unit and allow the illumination lamp to cool before
64. nd thoroughly if contaminated with blood or other bodily fluids Hands should be washed immediately after gloves are removed Health care workers who have exudative lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment until the condition resolves Pregnant health care workers are not known to be a greater risk of contracting HIV infection than health care workers who are not pregnant however if a health care worker develops HIV infection during pregnancy the infant is at risk of infection resulting from perinatal transmission Because of this risk pregnant health care workers should be especially familiar with and strictly adhere to precautions to minimize the risk of HIV transmission In accordance with these recommendations disposable gloves should be readily available for all ophthalmic medical personnel and they should be instructed regarding the rationale for wearing gloves and their appropriate usage It should be noted particularly that gloves Are not a substitute for handwashing and Are for single use only and should be discarded after each patient encounter C Gowns and Masks Gowns and masks are unnecessary in the normal ophthalmic office setting PN 21 100277 Rev C Maintenance and Support 65 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 6 D Protective eye
65. ndations 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 of the Patient Protection of patients from exposure to the HIV during examination and treatment of eye disorders incorporates PN 21 100277 Rev C 62 Maintenance and Support Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Opera
66. ns screen appears Select Shutdown Computer 2 f the system stops responding wait at least one minute because it may be busy If the system does not respond after one minute depress the System Power button on the Control Panel once 3 All Control Panel indicators except for the green AC DC indicator will turn off 4 f FA is available verify that the FA light switch is OFF 5 Remove the lens from the handpiece Carefully inspect and clean the lens piece Store the lens in the lens box 6 Return the handpiece to the holster 7 Return the footswitch to the footswitch pocket See Figure 8 Footswitch placed horizontally in footswitch storage pocket Place footswitch cord on top of footswitch Figure 8 Footswitch pocket Note To re start the system see Turning the System ON from Stand by Mode on page 19 Using Hard Shutdown N WARNING Do not use the hard shutdown method unless necessary because data corruption can occur RetCam3 User Manual PN 21 100277 Rev C Using the RetCam 3 23 In the event that hard shutdown is required continuously press the System Power button on the control panel for at least 6 seconds to force the system including the backup battery to shut down Turning OFF the Main Power Flip the main power switch located on the rear of the system to OFF All Control Panel indicators will be OFF except the AC DC indicator The AC DC indicator will flash green while the backup battery co
67. nt GR FM 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 The 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 reduce
68. ntinues to supply power at least 15 minutes Managing Patient Records This section describes how to add a new patient and locate the records for an existing patient The software is ready to use when you see the start screen shown in Figure 9 Add a new patient Import data from CD USB network etc Find existing patient Figure 9 Start screen RetCam3 User Manual PN 21 100277 Rev C 24 Using the RetCam 3 Add a New Patient Record To create a new patient record the following information is required First Name e Last Name Date of Birth e Patient ID Patient information is repeated in several of the screens The patient name and Patient ID are always shown in the upper left corner of every screen Mew Patient Last Hane Prom MD Bh rr Pherricians Technici n Click OK to proceed Enter information manually or use menus where available Figure 10 Add new patient screen Editing a Patient Record Highlight the patient s record from the Patients and Exams screen Select Edit You can edit the following information First Name e Last Name Gender Male Female Other or Unknown e Date of Birth Weight in grams Note Any fields on the Edit Patient Screen are editable RetCam3 User Manual PN 21 100277 Rev C RetCam3 User Manual Using the RetCam 3 25 Figure 11 Edit patient record screen Finding Existing Patient Records You can search the directory to locate specifi
69. ontaminate 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 21 100277 Rev C 64 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 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
70. ou 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 Adjustments button which resets all parameters to zero When you leave the current session the display settings are reset to zero Note Images you save from the Process screen will reflect image display adjustments and all other changes you make but the original images in the database will not be changed RetCam3 User Manual PN 21 100277 Rev C Image Adjustment Rotate 180 Reset Save T Save Settings Settings Insert Point Insert Ellipse Insert Line Insert Hote Rotate Measurement Delete RetCam3 User Manual Apply Saved Annotating Images Review and Compare Images 41 You can annotate an image by inserting graphic elements or text notes Click to select any of the following annotation features Insert Point Insert pointer and text on the image Select the X at the top right to close the screen Insert Ellipse Draw an ellipse on the image Insert Line Draw a line on the image Insert Note Add text to the image Rotate Rotate the pointer Delete Remove a selected annotation Measurement Display the number of pixels between two points Note The original images in the database are never chang
71. 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 Lll to start playing video The following options are available on the Review Screen Exam Date 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 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 and unhidden Hidden items are not deleted Their thumbnails do not appear unless the Show hidden images box is checked Unhide Item When Show hidden images is checked and you click on the thumbnail of a hidden image the Hide Image button toggles to Unhide Item which you can click to make the image available again for full size viewing Flag Image Click the Flag Image icon to flag the current image as an image of special interest A small red flag appears at the top left corner of the thumbnail To unflag an image click the icon again The icon toggles between flagged and unflagged Full Screen Click Full Screen to display a full scre
72. quipment marked with the following symbol 2 RetCam3 User Manual PN 21 100277 Rev C Introduction 13 WARNING Interference may occur in the vicinity of N equipment marked with the following symbol gt This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as e Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help An error message may be displayed which then may require a system reset To perform a system reset press the system power switch on the control panel for 6 seconds until the system powers down then press the switch again to power the system back on WARNING This equipment may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating the system or shielding the location WARNING To avoid the risk of electric shock this equipment must be connected to a supply mains with protective earth WARNING For continued protection against risk of fire replace only with same type and rating fuse N Important User Safety Notices 1 Never contact the front of the lens piece with hard or sharp objects
73. replacing it Replacement illumination lamps are available from Clarity Follow these steps to replace the illumination lamp 1 If it is not already turned OFF turn OFF the instrument according to the instructions found under Turning the System OFF Stand by Ready on page 21 Disconnect the main power cord from the wall Unplug the fiber optic cable from the front panel PN 21 100277 Rev C RetCam3 User Manual Maintenance and Support 71 4 Remove the two screws from the lamp assembly drawer the smaller panel with the black handle on the front Remove 2 screws Lamp assembly drawer Lamp assembly drawer handle uc ABB AWB m Figure 49 Front panel showing the lamp assembly drawer 5 Grip the handle on the lamp assembly drawer Pull the drawer out slowly Stop when the light bulb is fully exposed 6 Just behind the socket and extending from the rear of the illumination lamp is a thick gray wire the lamp ejector indicated in the picture below Be prepared to grab or catch the illumination lamp unit as you gently rotate this wire toward you rotate it up or counterclockwise which ejects the lamp Remove the old illumination lamp Lamp ejector Figure 50 Removing the illumination lamp PN 21 100277 Rev C 72 Maintenance and Support RetCam3 User Manual CAUTION Only touch the exterior surface of the illumination lamp Do not touch the bulb which is located in the
74. rocedures 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 RetCam3 User Manual B Gloves The CDC suggests in its recommendations for the prevention of HIV transmission in health care setting released in 1987 and updated in 1988 that All health care workers should routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with the blood or blood contaminated fluids of any patient is anticipated Gloves should be worn for touching blood and blood contaminated fluids for handling items or surfaces 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 a
75. s 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 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 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
76. s irreparable damage and voids the warranty CAUTION Never immerse the entire lens piece or handpiece in any liquid or solution If necessary only the distal 4 mm can be immersed See Figure 43 It is important not to immerse the joint where the polished metal tip meets the painted housing since it is susceptible to corrosion WARNING If you clean or disinfect rinse the lens with sterile water to avoid corneal de epithelialization that may be caused by residual solution Note For disinfection see attached Information Statement from the American Academy of Ophthalmology CAUTION As disinfection solutions may cause corrosion of the lens piece soak times that exceed the recommendation should be avoided Figure 43 Inverted lens piece showing permissible depth of immersion PN 21 100277 Rev C RetCam3 User Manual Maintenance and Support 59 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 on any part of the system Disposal of Materials Dispose of waste materials according to local and national requirements Contact Clarity Service if additional assistance is required PN 21 100277 Rev C 60 Maintenance and Support NT AMERICAN ACADEMY Information Stateme
77. s 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 infection 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
78. stem 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 PN 21 100277 Rev C RetCam3 User Manual Maintenance and Support 73 When key validation is necessary the Key Validation dialog appears when you start the system and each time thereafter until you complete this step before the Site Awareness dialog Key Validation Call Clarity Medical Systems tall free at 800 215 6005 U S and Canada or direct at 825 463 7984 to get an authorization key for this installation Read the license number below to customer support and enter the authorization key they give you in the field below Then press Validate Key 71339298 Validate Key Figure 51 Key Validation dialog Follow the instructions on screen Call Clarity and provide to the customer support representative the large license number in the dialog 71339298 in the example above which is unique for your system You will be provided in turn a unique authorization key Tip You may also send the license number via email to service retcam com and receive the authorization key by return email You must enter the authorization key in the field and click Validate Key to access the system software If you call to make sure you enter the number correctly we recommend you do not hang up until the number is accepted Technica
79. t 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 RetCam3 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 gov OshDoc Additional html Occupational Safety and Health Bloodborne Infectious Disease 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 1 888 443 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 a
80. tery Computer network Non ionizing radiation FA Fluorescein Angiography FA Intensity increase clockwise FA light OFF FA light ON Light source fiber optic connector Handpiece connector USB connector PN 21 100277 Rev C 16 Introduction RetCam3 User Manual Read accompanying user documentation Fragile contents This side of carton up Temperature limits Authorized representative in the EU Type BF equipment applied part is handpiece To prevent damage to lens piece carefully store handpiece in holster when not in use Clean lens piece after use Separate collection of waste at end of life as required by European directives Contact Clarity for equipment disposal instructions European conformity North American compliance certification Serial number PN 21 100277 Rev C Introduction 17 Date of Manufacture Keep away from the rain RetCam3 User Manual PN 21 100277 Rev C 18 Introduction RetCam3 User Manual Product Label Clarit larity Clarity Medical Systems Inc Pleasanton California 94588 Made in USA Model RetCam 3 Class I Equipment Caution Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner E omi 100 240V 50 60 Hz 700W 2X Ti T 1OA 250V MediMark Europe BP 2332 F 38033 Grenoble Cedex 2 France S Patent No 5608472 5822036 P N 21 100222 Rev A PN 21
81. ting Rooms Page 3 the application of good public health principles and specialized precautions Since the infection was first recognized in 1981 there has been no evidence to indicate that the HIV has been transmitted through any of the diagnostic or surgical procedures performed by ophthalmologists According to the CDC the likelihood of transmission through contact with tears is extremely remote However because the virus is potentially lethal is present in surface epithelia in the eye and in low titers in tears and ocular fluids of infected individuals and can in theory at least be transmitted through mucous membranes public health officials have recommended that reasonable precautions be taken Furthermore because many HIV carriers may be unaware of their infection and show no sign of the disease the following recommendations should be routinely used for all patients Recommendations for the safe usage of ophthalmic instruments and contact lenses are provided These guidelines represent good general ophthalmic technique because they reduce the risk of transmitting both bloodborne pathogens HIV HBV and HCY and surface infectious agents e g herpes simplex virus adenovirus etc likely to be encountered in patients presenting for eye examinations Recommendations A Handwashing Handwashing represents the single most effective means of avoiding the risk of transmitting or acquiring infections in the course of examin
82. ty RetCam Core Version 1 17 0 Culture neutral PublicK ey T oken null System Configuration Yersion 2 0 0 0 Cultures neutral PublicheyT akenszb 3fer H 1d50a3a S ystem Xml V ersionz2 D D 0 Culture neutral PublicK ev T akenzb r a5c5b1334a083 Infragistics wn v 2 Version 2 20072 61 Culture neutral PublicKeuT akenz dd5c3153fr2cd ch Infragisticez Shared v7 2 Versianz 7 2 20072 61 Culture neutral PublicheyT okenz dd85c31 amp 3f2cd cb Infragistics2 Win LIH ltrasvv inGrid v 2 Versianz7 2 20072 61 Culture neutral PublicKeyT akenz dd5c3153fr2cd ch Clarity RetCam WebService Versione 0 0 0 Culture neutral Public evyT akenenull Figure 53 About Clarity software PN 21 100277 Rev C 76 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 54 User Preferences screen Select from the following options Imaging Adjustment Not available Institution Add the name of the Institution Department and Location Live Imaging Not applicable New Exam Set the Pre set Imaging Configurations for new exams Notification Not applicable Set the Default Image and Report Printer Windows Configuration Set Date and Time Display Network Connections Printers and Faxes Region and Language Security Center and Sound RetCam3 User M
83. u have acquired a RetCam3 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 HAS RELIED UPON CMS INC TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE IS PROVIDED AS IS AND WITH ALL FAULTS THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK RetCam3 User Manual PN 21 100277 Rev C 82 License Agreements RetC
84. unlikely risk of contamination of the ophthalmic medical personnel and patient alike Employers under OSHA s rule with health care workers who are exposed to bloodborne pathogens are required to establish a program that informs employees and employers of the risks of occupational exposure to bloodborne pathogens and how to reduce those risks Human tears are not considered to contain significant amounts of bloodborne pathogens and thus do not require OSHA s bloodborne pathogen precautions but exposure to human tears does require good office hygiene practices such as handwashing However contact with tears contaminated with blood such as in minor surgery requires the use of bloodborne pathogen precautions As the prevalence of HIV infection continues to increase throughout the United States it is inevitable that patients carrying HIV will be more commonly encountered in eye examining rooms and in surgery Some of these patients will be known to be infected with the HIV but in many it will be unrecognized All health care personnel engaged in delivering ophthalmic care to such patients might in the course of their normal duties be exposed to the blood of individuals who may be shedding the virus Although the risk of 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 p
85. uration HP Deskjet D4200 series Copy 1 HP Deskjet 04200 seres Report Printer Default Report Printer HP Deskjet D4200 series Copy 1 Figure 57 User Preferences Printers Select the default printers then click Apply to initiate the change or Cancel Click OK to exit the screen Windows Configuration User Preferences Configurations Imaging Adjustment Institutian Live Imaging New Exam i A EN i g w Notification t Printers Date and Display Network Time Connections Printers and Region and Security Sound axes Language Center Export Lags Figure 58 User Preferences Windows Configuration Select the desired Windows configuration icon and make changes where needed Click Apply to initiate changes or Cancel Click OK to exit the screen RetCam3 User Manual PN 21 100277 Rev C Technical Specifications 79 9 Technical Specifications Hardware Physical e 26 660 mm wide x 24 610 mm deep x 54 1372 mm minimum height e Approximately 200 lbs 91 Kg fully loaded Electrical Ratings 100 240 V 50 60 Hz 700 VA e Fuses 3AG 10A 250V slo blo 5 x 20 mm Power consumption 700W with all options Detachable hospital grade power cord Environmental Conditions The system as delivered is intended for use indoors at normal room temperatures and humidity upright on a level surface with the brakes applied to the front casters Condition
86. vel 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 Wiping clean and then disinfecting with bleach is recommended by the CDC as an effective way to inactivate HIV Remove the entire prism from the tonometer and place it in a suitable receptacle that allows the applanating surface and adjacent 2 3 mm of the tonometer to be immersed in a 1 10 dilution of household bleach sodium hypochlorite One method uses a Petri dish with small holes drilled in the lid which allows just the tonometer tip to be partially immersed in the solution After a five minute period of soaking the tip should be washed under running water and dried before use Two tonometer prisms should be available so that one can be used while the other is being disinfected Soaking the entire tip may eventually remove the coloring of the etched calibration marks These disinfecting solutions 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
87. y if possible and cleanse the wound for five minutes with an antiseptic solution PN 21 100277 Rev C 66 Maintenance and Support Minimizing Transmission of Bloodborne 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 timely 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 stil

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