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RetCam 3 Service Manual.book

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1. AWB a Figure 13 Front panel showing the lamp assembly drawer 6 Grip the handle on the lamp assembly drawer Pull the drawer out slowly Stop when the light bulb is fully exposed 7 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 Figure 14 Removing the illumination lamp RetCam3 Service Manual PN 21 100357 Rev A 42 Maintenance bulb which is located in the center of the reflector nor the inner concave surface of the reflector Skin oils will adhere to the bulb and reflector which reduces the cooling efficiency of the bulb and thereby creates a hot spot leading to premature burnout Handle by the outside of the lamp only as shown CAUTION Only touch the exterior surface of the illumination lamp Do not touch the 8 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 9 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 10 Push the lamp assembly drawer back in carefully U
2. released in 1987 and updated in 1988 that 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 and thoroughly if contaminated with blood or other bodily fluids Hands should be washed immediately after gloves are removed Health care workers who have exudative lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment until the condition resolves Pregnant health care workers are not known to be a greater risk of contracting HIV infection than health care workers who are not pregnant however if a health care worker develops HIV infection during pregnancy the infant is at risk of infection resulting from perinatal transmission Because of this risk pregnant health care workers should be especially familiar with and strictly adhere to precautions to minimize the risk of HIV transmission accordance with these recommendations disposable gloves should be readily available for all ophthalmic med
3. 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 100357 Rev A Maintenance 27 ae AMERICAN ACADEMY Information Statement realer The Eye M D Association Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Introduction This document 1 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 5 Department of Labor for health care workers Bloodborne pathogens mav be present in blood blood contaminated products or other bodily fluids especially if contaminated with or mixed with bl
4. 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 HCV and surface infectious agents e g herpes simplex virus adenovirus etc likely to be encountered in patients presenting for eye examinations Recommendations Handwashing Handwashing represents the single most effective means of avoiding the risk of transmitting or acquiring infections in the course of examination The CDC recommends that ophthalmic medical personnel performing eye examinations or other procedures involving contact with tears should wash their hands immediately after a procedure and between patients Handwashing should be encouraged when there is any doubt about the necessity for doing so For routine handwashing a vigorous rubbing together of all surfaces of the lathered hands is recommended for at least 10 seconds followed by a thorough rinsing under a stream of water Plain soap can be used for handwashing for most routine activities Gloves may be used as an extra margin of safety When gloves are worn handwashing is still recommended because gloves can become perforated and bacteria can grow rapidly on gloved hands If there are cuts scratches or dermatological lesions e g weeping lesions on the hands then use of gloves 1s advisable B Eyedrops The
5. SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF U S TWO HUNDRED FIFTY DOLLARS U S 250 00 Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineer decompile or disassemble the SOFTWARE except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS You may permanently transfer rights under this EULA only as part of a permanent sale or transfer of the DEVICE and only if the recipient agrees to this EULA If the SOFTWARE is an upgrade any transfer must also include all prior versions of the SOFTWARE EXPORT RESTRICTIONS You acknowledge that SOFTWARE is subject to U S export jurisdiction You agree to comply with all applicable international and national laws that apply to the SOFTWARE including the U S Export Administration Regulations as well as end use and destination restrictions PN 21 100357 Rev A License Agreements 67 issued by U S and other governments For additional information see http www microsoft com exporting RetCam3 Service Manual PN 21 100357 Rev A 68 License Agreements RetCam3 Service Manual PN 21 100357 Rev A Appendix Guide 69 10 Append
6. 100357 Rev A 58 Troubleshooting Guide RetCam3 Service Manual PN 21 100357 Rev A Block Diagrams 59 12 10N 100 3NON rre 8222 S3HONI 9 ya qaivadn sci EN 33NI9N3 NYHOVIG ONIMIM WILSAS Sjubisu Buibuug IN zv SND S3HONI NI SNOISN3MIG 031312395 SST1NN 850 80 20 p109 J9MOd IV J9MOd V4 uuo 45 xog Ajddns OV 6 001 17 V 133HS U 440404 Qvov p109 4 IV AHVS 8 ACT 64000T TZ xz seueneg JHVS 8 AZT ETTOOT TZ ssouJeH Al9yeg 1X3 ZIZOOT TZ SISSEUJ SS9UJEH punog 09EFA PSA dH Jeydepy IV p409 OV p409 J9MOd PZZOOT TZ 8 0000 8T 49juld 8 V e qe asn 8 V 5192 asn Joyuow 0000 8T 31989 IAG 9ZO00T 1Z asn qnH asn age asn CEEOOT TZ SNOW 91925 asn 7 0000 8T Z 0000 8T paeog gsn 34014 9142 asn b9000T TZ age 323IdPULH N 2880 m xog sondo o4323 3 8 000T Tc pued bLZ00T TZ LOEOOT TZ add uonnquisiq J9Mod age 9 qe5 Assy MOT3H 335 LO NOISIAIY OL INJIVAInO3 35 3138 NOLLOndOMd v __ ava 0530 u SNOISIAJY 600 1 2 6 Block Diagrams P
7. F 10710 3576 __ 20710 122 F 295 to 507 Relative Humidity 30 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 Service Manual PN 21 100357 Rev A 52 Technical Specifications RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Troubleshooting Guide 53 5 Troubleshooting Guide This section lists common issues for the RetCam3 Ophthalmic Imaging System and provides suggested corrective actions for each issue If corrective actions do not resolve the issue contact Clarity Technical Support at 800 215 6005 or email service retcam com RetCam 3 Troubleshooting Guide Troubleshooting Recommendations No power to RetCam 3 system Verify power cord is connected Verify power source is correct voltage for system and is functioning correctly Verify the main power switch in the back of the RetCam system turned on If the system has not been plugged into the wall for at least 4 hours before the intended use plug the system in to let the battery charge then press the power button on the control panel No display The display will be dark initially while the program is loading If the display is still dark after five minutes verify that the m
8. Handpiece connector USB connector PN 21 100357 Rev A RetCam3 Service Manual Notices and Labels 13 Head 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 100357 Rev A RetCam3 Service Manual Date of Manufacture eas Keep away from rain Product Label a N Clarity medical systems 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 MEN 100 240V 50 60 Hz 700W 2X TIGA 250 MediMark Europe BP 2332 F 38033 Grenoble Cedex 2 France No 5608472 5822036 P N 21 100222 Rev 21 100357 Rev A RetCam3 Service Manual Introduction 15 2 Introduction The RetCam 3 Wide Field Imaging System system is designed using state of the art digital technology to allow the quick and easy capture of wide field high resolution ful
9. TO DETERMINE THAT THE SOFTWARE 1 SUITABLE FOR SUCH USE PN 21 100357 Rev A 66 License Agreements RetCam3 Service Manual WITH THE EXCEPTION OF THE LIMITED WARRANTY PROVIDED BY CLARITY MEDICAL SYSTEMS THE SOFTWARE IS PROVIDED AS IS AND WITH ALL FAULTS THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE 15 WITH YOU ALSO THERE 15 NO WARRANTY AGAINST INTERFERENCE WITH YOUR USE OF THE SOFTWARE OR AGAINST INFRINGEMENT IF YOU HAVE RECEIVED ANY WARRANTIES OTHER THAN THE LIMITED WARRANTY PROVIDED BY CLARITY MEDICAL SYSTEMS REGARDING THE DEVICE OR THE SOFTWARE THOSE WARRANTIES DO NOT ORIGINATE FROM AND ARE NOT BINDING ON MS OR CMS 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
10. and the cleaning of instruments should be performed in such a way that accidental perforation of the gloves 1s 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 surgery if possible and cleanse the wound for five minutes with an antiseptic solution PN 21 100357 Rev A Maintenance 33 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 su
11. 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 Service 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 level disinfection kills all organisms and is performed suing a germicide which is regulated by the Food and Drug Administration The 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 has recommended the following which are proven to inactivate infectious HIV herpes simplex virus and adenovirus s Wiping clean and then disinfecting with bleach is recommended by the 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 tono
12. control unit a halogen illumination lamp and the control circuitry for light intensity focus image capture and system logic PN 21 100357 Rev A RetCam3 Service Manual Introduction 17 Battery Backup The battery backup helps to protect against accidental loss of images due to sudden power loss The battery backup can store enough energy to power the computer and display for several minutes allowing the system to be unplugged from the electrical outlet and moved from room to room or bed to bed without having to reboot the system Footswitch The footswitch is a rocker style unit with a function switch on each side and a push button in the middle The pedal on the left side controls focusing Rock this pedal to the left to focus closer and to the right to focus more distant The pedal on the right controls illumination light intensity Rock this pedal to the left to decrease intensity and to the right to increase intensity The push button in the middle is called the snap switch An image is captured and stored each time the snap switch is depressed In video mode this switch can be used to alternately start and stop video recording Storage Drawers Two storage drawers are supplied on the system for lenspieces and accessories The upper drawer contains a mounted external DVD drive Image and Report Printer A high resolution inkjet printer can print images using 5 x 7 photo paper or reports on 8 5 x 11 paper Fluorescein
13. counseling treatment and follow up of occupational exposures to bloodborne pathogens Health 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 Procedures for protection of the ophthalmologist Ophthalmologists might be at risk of acquiring HIV HBV or HCV infection in their professional activities from two major sources 1 the patient examination and 2 the setting of surgical intervention General Precautions Against Infection Office The ophthalmologist personally should follow the same procedures designed to protect office staff and described in Section II These include handwashing wearing of gloves where appropriate and taking precautions to prevent injuries caused by needles scalpels and other sharp instruments Avoid touching one s own eyelids or contact lenses with the fingers without thorough hand washing In the normal ophthalmic office setting gowns masks and protective eyewear are usually unnecessary except in situations when splashing with blood or blood contaminated Fluids may be anticipated Minor Office Surgical and Diagnostic Procedures The universal precautions should be observed whe
14. 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 Tonometers 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 alcohol soaked sponge since it may occasionally touch the eye Digital Pneumotonometer Tips of pneumotonometers should be cleaned with an alcohol sponge taking care that the surface is dry before using it again It is important to allow the alcohol to evaporate completely to avoid damage to the corneal epithelium Diagnostic Contact Lenses Goldmann etc The lens is inverted so that the contact lens surface is uppermost The outer casing and inner surface of the lens are then vigorously wiped with an alcohol sponge 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 importa
15. e mail messages to customer support at the address below service retcam com Our technical support staff responds to your questions as soon as a staff member is available In most cases you will 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 engineering charges Please ask for an hourly quotation before incurring charges Returning Parts for Repair If a part or component is defective or damaged and is to be returned to Clarity Medical Systems for repair or replacement a Service Ticket number must be issued by CMS The Service Ticket number must be noted on the return shipping documents so that the disposition of the part is known when it is received at CMS offices PN 21 100357 Rev A RetCam3 Service Manual License Agreements 65 9 License Agreements CMS Software Restricted Rights This Software and accompanying written materials are provided with Restricted Rights Use duplication or disclosure by the U S Government is subject to restrictions applicable to commercial computer software under FAR 52 227 19 and DFARS 25 227 7013 Contractor manufacturer is Clarity Medical Systems Inc This Agreement is governed in and by the laws of the State of California U S A This statement gives you specific legal rights you may have others whi
16. i sata inira anuli C 20 Lens Piece Selection sessiles nennen nennen nenne nnns nnn nnns 20 COMUO BANE E RR TS mx 21 Installing a lens piece on the 24 Handpiece COMME CONS cina ax dada yd Padova m ui xev Red dee 24 Inverted lens piece showing permissible depth of immersion 26 Removing TN ION panel 36 Automatic black balance test 37 Automatic white balance test 38 Light box cover removed nennen nennen nnn nnne 40 Front panel showing the lamp assembly drawer 41 Removing the illumination 41 Power MOQUE sense 43 Opening the fuse holder cover ee 43 REMOVING the tuse Nolder u 44 TT 44 FUSE 2 9 2 TEINS CHC s ul esse ie 45 Key Validation dialog nennen nnns 46 F llo uttheIDeropuc Cable ana 72 FUIOUT ING ont COV seat ee E a moa 73 Removing tont om tad Ras Dea 73 Remove handpiece MONT BOX 592 au ee ve tea eee ie 74 Threading cables through the front 74 UT 75 I
17. 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 and ICG angiography wear gloves and adhere to the procedures as outlined in this section C Contact lens fitting Ophthalmic medical personnel involved in the fitting of contact lenses should be instructed in the precautions outlined by the CDC for disinfection of lenses D Minor office surgical and diagnostic procedures During the performance of minor surgical and diagnostic procedures particularly where contact with blood or blood contaminated fluids may occur gowns disposable gloves and masks and protective eyewear should be worn 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
18. 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 recommendations for ophthalmic practice in relation to HIV The Committee noted that there were two distinct patients 1 Transmission of ocular surface infectious agents such as adenovirus or herpes virus Prevention of transmission of these pathogens requires good hygienic techniques such as routine hand washing tonometry cleaning and trial contact lens disinfection 2 Transmission of bloodborne pathogens such as HIV or HBY Prevention of transmission of these agents requires the use of bloodborne pathogen precautions which include the proper use of gloves needle disposal and other precautions such as administering hepatitis B vaccine in workers exposed to bloodborne pathogens Recommendations The Committee recommended specific measures that would provide adequate protection for the patient for health care workers in the ophthalmic care setting and for the o
19. 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 1 Use single use surgical instruments 2 Avoid mixing instruments used on tissues of high infectivity vs no infectivity 3 Destroy re usable instruments where possible 4 If destruction is not possible decontaminate instruments The Risk of Acquiring HIV Infection from Ophthalmic Medical Personnel The risk of patients being infected by an ophthalmologist or ophthalmic medical personnel who has been infected with the HIV is considered extremely remote Standard office practices as discussed above will minimize even the unlikely risk of contamination of patients Surgical patients are protected by the routine use of barriers e g gloves Certainly an instrument that punctures the skin of an ophthalmologist or the surgical assistant must be removed from the operating field and sterilized The surgeon or assistant must reglove after all bleeding has stopped and any residual blood has been removed The Guideline for Infection Control in Healthcare Personnel also provides advice about management of patient contact and other situations when health care personnel hav
20. 61 RetCam3 Service Manual PN 21 100357 Rev A Are ee 61 GORmponefilb 61 o TECHNICA SUDO ON u ea 63 HOWTO gm MR DES 63 e Support Within the US 63 s Telephone SUPPOR 63 S AK M MIC Hcr 63 e M 63 s MA ars ee 64 ROTOR IIOP arte TOF ee een 64 9 License AGFECMENIS zu 65 e CMS Software Restricted Rights nennen nennen 65 e RetCam3 Software End User License 65 TO ADOCNOIX O 69 O EE 1 e RetCam Handpiece 71 RetCam3 Service Manual 21 100357 Rev A List of Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 RetCam3 Service Manual RetCam 3 Ophthalmic Imaging System Front 18 RetCam 3 Ophthalmic Imaging System Rear 19 Hangdplecesand Lens PIece sues dde Cone Aratus
21. Angiography Source optional A blue exciter light source is available complete with green barrier filter for the handpiece for doing Fluorescein Angiography F A digital photography with the RetCam 3 PN 21 100357 Rev A 18 Introduction Display contains 4 USB ports Transport Handle Handpiece with gt Interchangeable Input Shelf Lens Piece extended Holster Keyboard 8 Mouse DVD writer 25 inside drawer USB port andpiece Cable with Connectors FA Intensity Control Cord Wrap Post gt both sides FA Light Connector FA Light Switch Storage Drawers Printer on _ 5064 Extended Shelf Lockable Front Casters Footswitch Storage Pocket Footswitch Figure 1 RetCam 3 Ophthalmic Imaging System Front View Shown with optional FA Fluorescein Angiography feature RetCam3 Service Manual PN 21 100357 Rev A Introduction 19 a Ethernet Port Product Label Main Power Switch and Power Cord Connection Figure 2 RetCam 3 Ophthalmic Imaging System Rear View RetCam3 Service Manual PN 21 100357 Rev A 20 Introduction Handpiece Lens piece Clarity T Figure 3 Handpiece and Lens Piece High Magnification High Contrast Children s and Adults Standard Baby 200 Premature Infant Figure 4 Lens Piece Selection Lens Model Application Common Field of View D1300 Premature Infant 130 De
22. RetCam program is displayed on the monitor but no numbers appear on the control panel for light intensity then press the intensity button to turn the lamp on Because the operating system of the RetCam 3 is embedded not all USB sticks will be recognized If the USB stick is not recognized in the Utilities screen then use the USB stick provided by Clarity If repairs to the computer have been performed recently then verify the keyboard cable is inserted into the keyboard connection at the CEO box This can happen when the battery is in a low charge condition The normal time a system can be unplugged from the power source with the program running can be from 10 to 20 minutes on a fully charged battery It is best to leave the RetCam 3 plugged in when not in use so the battery can charge PN 21 100357 Rev A Troubleshooting Guide 57 RetCam 3 Troubleshooting Guide Troubleshooting Recommendations No light from the FA Verify that the fiber optic cable from the handpiece is fully inserted in the fiber port of the FA If no blue light can be seen while the light switch on the front of the FA is turned on the module must be returned to the factory for service Contact Clarity Technical Support at 800 215 6005 or email service retcam com No network connection Contact your Information Technology IT department The machine does not move freely Check the locks on the front wheels RetCam3 Service Manual PN 21
23. RetCam z Ophthalmic Imaging System Service Manual PN 21 100357 Rev A Clarity medical systems Copyright 2008 Clarity Medical Systems Inc All rights reserved Trademarks All other trademarks used in this document are the property of their respective owners Clarity Medical Systems Inc 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 474 2093 Toll free 800 215 6005 www claritymsi com www retcam com service retcam com EC REP MediMark Europe S A R L 11 rue Emile Zola 38100 GRENOBLE France Tel 433 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 e mail info medimark europe com RetCam3 Service Manual PN 21 100357 Rev A Contents 1 INOUCES and ESD6ele aired ho od iun ne eacus onu 7 VIE RENT TERES 7 and pone ch E nn 7 e Electrical Safety Information nennen 8 Important User Safety 5 e ose 10 Labels and Symbols 11 Product essen ee 14 2 eie ee ehe 15 Storage and TAaAsPoll sirka PP 15 gt syst m eee 16 gt Panels 21 8 LTEM 23 e Recommended Maintenance 23 Eens gt
24. ULIIM 1 wWEIIO 50000 8 pued Jesy 9 0000 8T 91925 Skry EOEOOT TZ aged VLYS SEEOOT TZ eaud VLVS 1105 5155209 912001 1Z age Jomod 2d EOTOOT TZ 00Z001 TZ 251003 UD3MS1004 SNALSAS TWOIGSW 30 NOISSIAM3d NILLIYM JHL LNOHLIM 3NOANV OL 19 NI XO 310HM NI 035072510 30 d3sn q3ondodsd3s 38 OL LON SI SW31SAS 1VOIQ3A 30 AlM3dOMd ABVIIMdOHd JHL SI HLIIM3N3H NO NI343H Q3NIVINOO VIVO 3HL LN3WNDOC SIHL PN 21 100357 Rev A RetCam3 Service Manual 60 Block Diagrams RetCam3 Service Manual PN 21 100357 Rev A Replacement Parts 61 7 Replacement Parts opare parts and supplies can be ordered by calling or faxing the part description and part number to Customer Service Customer Service Contact Information Phone 925 463 7984 Fax 925 474 2093 Toll free 800 215 6005 Consumables Part Description Part Number Illumination Bulb halogen 02 04 501 USB STICK 03 12 025 Fuses 3AG 10A 250V slo blo 5 x 15 000053 20 mm Printer paper HP Premium 5x 7 03 12 012 inches Components Flat Panel Display 21 100224 21 100194 Standard Baby lens 120 High Magnification lens 30 01 00 014 1 09 00 015 woos FALightoox 85100885 RetCam3 Service Manual PN 21 100357 Rev A 62 Replacement Parts RetCam3 Service Manua
25. a ad een 24 e Cleaning Procedures 25 Cleaning the Lens 25 e Cleaning the Rest of the System nennen nnns 26 gt Disposal OP RERO hio RTD 26 e Fluorescein Angiography Frequently Asked Questions 35 e Camera Color Balance nn 36 e Automatic Black Balance 37 e Automatic White Balance AWB 38 s Lap ____________ 40 c 43 45 e Servicing the Interior of the 47 4 Technical rn 49 le 49 pec 49 ONERE OR RERO TEETH EET 49 RED 49 Handheld Mage ea een 50 Computer dnd EIBEITO OBlIes ee ana 50 e Fluorescein Angiography Light Source Optional 50 s COOC PIME 50 TU T EE 50 Environmental 51 Troubleshooting ee 53 BIOCK atis au 59 e RetGam 3 Internal Wing ze edet tod cce ee te 59 4 Meplacementl 61 e Customer Service Contact Information
26. ce slowly after that Some users have been performing successful FA imaging up to 200 hours of lamp time Q Can the bulb be replaced in the field A It is not designed for field replacement Return the unit to the factory if the output is reduced or the lamp will not illuminate Call Customer Service for assistance Q How much does a replacement bulb cost A It depends on the circumstances and what else is out of specification at the time of service You will be quoted the costs for repair of your FA Light Box before any work is begun Can get a replacement barrier filter if mine is lost or broken A Yes contact Customer Service for a quotation Q Can the FA Light Source be returned for service without returning the whole RetCam 3 A Yes the FA Light Source is a module that is removable by a person with the skill level of a nominal biomedical technician Be sure to package it as a sensitive medical instrument with at least 3 of padding on all sides in a sturdy box sealed well shipped insured for USD 20 000 NOTE Clarity can send appropriate packaging material to you if needed PN 21 100357 Rev A 36 Maintenance Camera Color Balance Adjustment You must remove the front panel as illustrated below to access the color balance buttons E Pull from bottom outward and remove Figure 9 Removing the front panel When to Adjust Color Balance Clarity Medical performs these procedures at the factory before s
27. ch vary from state to state and from country to country Clarity Medical Systems Inc reserves all rights not specifically granted in this statement Any attempt to decompile reverse engineer or otherwise copy this software shall be considered a breach of this agreement RetCam3 Software End User License Agreement You have acquired a RetCam3 DEVICE that includes software licensed by Clarity Medical Systems Inc CMS Inc from Microsoft 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 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
28. d the file transfer fails Verify you have successful connectivity to network Share directory Verify you are successfully logged on to your network Verify network share file parameters Verify printer power indicator lights are on Verify printer cable connections are properly connected Observe any printer error codes displayed Verify printer media is properly installed PN 21 100357 Rev A Troubleshooting Guide 55 RetCam 3 Troubleshooting Guide Troubleshooting Recommendations No light from hand piece Verify the fiber optic cable from the handpiece is inserted in the fiber optic port of the CEO box and the lamp button on the control panel is turned on Leave the lamp off for 10 minutes to allow the lamp to cool down and then turn it back on If after these measures are taken the lamp does not turn on then replace the illumination bulb See Lamp Replacement on page 40 Light intensity does not increase or Press the light intensity button on the decrease control panel first and then press the light intensity pedal on the footswitch Observe the intensity of light coming out of the handpiece If the intensity does not change with either action contact customer service Live image problem If the color of the live image is not balanced perform the Automatic White Balance procedure in the User or Service manuals If there are color streaks in the live image the handpiece must be sent in for
29. dpiece cable can be draped over the side cord wrap post but do not wrap it tightly or damage to the fiber optic may result For storage of the system when not in use disconnect the power cord and store it in one of the drawers Remove all loose objects from the top surface Wipe down the surfaces with a soft cloth Lock the casters The system can be easily moved between operations or between beds in the NICU while it is running To relocate the system while it is running disconnect the power cord at both ends release the front caster locks and gently roll the system to the new location The internal batteries will keep the computer and monitor running for several minutes Once in the new position lock the casters reconnect the power PN 21 100357 Rev A 16 Introduction RetCam3 Service Manual cord at both ends and continue with imaging If the floor is uneven move the system carefully to avoid damage from excessive vibration The system is not intended to be transported outdoors from building to building For information on how to safely transport the system out of doors or in anything but an upright position please contact Customer Service The RetCam 3 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 Inspection and testing of the system by a factory trained technician after transport outdoors or in a non upright c
30. e State needle safety legistation www cdc 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 Occupationally acquired HIV infections and failures of PEP 1 800 893 0485 HIV AIDS treatment information service www hivatis org Date issued March 1 2002 Approved by Quality of Care Secretariat Acknowledgements The Academy gratefully acknowledges the valuable time expertise and effort of the following individuals in reviewing this document Gary Holland M D Elaine Chuang M D Jay Pepose M D Alice Matoba M D Douglas Jabs M D and Eric Donnenfeld M D of the Ocular Microbiology and Immunology Group PN 21 100357 Rev A RetCam3 Service Manual Maintenance 35 Fluorescein Angiography Frequently Asked Questions WARNING There are high voltages within the FA module and the cover of the module is not to be removed by customers or distributors Q Can the FA Light Source generate other colors and wavelengths of light A No it is designed for 471 nanometer blue excitation exclusively Q How long does the Xenon bulb last A The bulb is a special order and extensive testing data does not exist However a guideline is that the intensity may reduce to one half the original value after 50 hours of use and then continue to redu
31. e HIV and other illnesses which could be transmitted to patients PN 21 100357 Rev A Maintenance 31 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 5 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 and HUV Bloodborne pathogen precautions further reduce the unlikely risk of contamination of the ophthalmic medical personnel and patient alike Employers under OSHA s rule with health care workers who are exposed to bloodborne pathogens are required to establish a program that informs employees and employers of the risks of occupational exposure to bloodborne pathogens and how to reduce those risks Human tears are not considered to contain significant amounts of bloodborne pathogens and thus do not require OSHA s bloodborne pathogen precautions but exposure to human tears does require good office hygiene practices such as handwashing However contact with tears contaminated with blood such as in minor surgery requires the use of bloodborne pathogen precautions As the prevalence of HIV infection continues to increase throughout the United States it is inevitable that patients carrying HIV will be more commonly encountered in e
32. em may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as 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 wait 6 seconds 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 Important User Safety Notices 1 Never contact the front of the lens piece with hard or sharp objects This could damage the precision optics and sealing 2 DO NOT AUTOCLAVE any part of the device 3 Appropriately power down and unplug the unit and allow the illumination lamp to cool before replacing it 4 Always r
33. erwise 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 Service Manual For personnel exposed to HCV the Public Health Service does not recommend immune globulin or antiviral agents as PEP However there have been studies outside the United States that have utilized interferon early in the course of acute hepatitis C to prevent the establishment of chronic hepatitis 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
34. es that may damage the eye WARNING To mitigate the potential for excess light exposure always start at the lowest light intensity level and increase if necessary Use only the shortest amount of exposure time necessary no greater than 5 minutes WARNING Use care when contacting the eye i e use the least amount of pressure and or movement necessary WARNING A risk benefit ratio must be assessed before confirming a patient for RetCam imaging if they are photosensitive concomitantly exposed to photosensitizing agents or aphakic WARNING To avoid the risk of electric shock the equipment must be connected to a supply mains with protective earth WARNING To mitigate the potential for excess light exposure the user should avoid looking directly at the illuminated light source PN 21 100357 Rev A 8 Notices and Labels WARNING There are high voltages within the FA module and the cover of the module is not to be removed by customers or distributors Electrical Safety Information The system has been designed inspected and tested to comply with the safety requirements of IEC60601 1 with respect to fire shock and mechanical hazards only if used as intended Class I Type BF Electrical Equipment Rated for Continuous Operation Electromagnetic Emissions Compliance Level Group 1 Class A Test Type Complamelew Mole Conducted Emissions The RetCam system uses RF energy for its internal CISPR 11 function Nearby elec
35. eturn the handpiece to the holster when not imaging You can drape the handpiece cable over the cord wrap post on the side 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 PN 21 100357 Rev A Notices and Labels 11 8 he 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 lt gt exe OB B RetCam3 Service 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 100357 Rev A 12 Notices and Labels RetCam3 Service Manual Alternating current AC oystem contains 2 fuses of indicated type Do not use any other type Backup battery Computer network Non ionizing electromagnetic radiation FA Fluorescein Angiography FA Intensity increase clockwise FA light OFF FA light ON Light source fiber optic connector
36. grees B1200 Standard Baby 120 Degrees E800 High Contrast Children s amp Adults 80 Degrees C300 High Magnification 30 Degrees PL200 Portrait Lens RetCam3 Service Manual PN 21 100357 Rev A Introduction 21 Control Panel The control panel is located at the front edge of the keyboard tray It provides controls and indicators of system status System Power AC DC indicator indicator Relative intensity Illumination ON green green Focus indicator indicator amber System power Focus Controls SNAP Intensity Controls Lamp Illumination button capture ON OFF button Figure 5 Control Panel RetCam3 Service Manual PN 21 100357 Rev A 22 Introduction RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Maintenance 23 3 Maintenance This section addresses maintenance and support under the following topics Recommended Maintenance Schedule below Installing Lens Pieces page 24 Cleaning Procedures page 25 Camera Color Balance Adjustment page 36 Lamp Replacement page 40 Fuse Replacement page 43 Key Validation page 45 Servicing the Interior of the Cart page 47 Recommended Maintenance Schedule Between patients Clean and inspect lens piece Weekly Wipe down the system Monthly Inspect cables and connections for wear oystem powered for at least 8 hours AC powered AC DC indicator ON light solid to assure backup battery is fully charged Burned out bulb Rep
37. he colors of the live image are very different from the real object follow the Camera Color Balance Adjustment method in the Maintenance section of the Service Manual If the color balance is similar to the real object then proceed to the next step 6 4 Restore the System to original condition RetCam3 Service Manual PN 21 100357 Rev A 76 Appendix 1 6 4 1 When testing is complete and the system is not being used then press the power button to turn off 7 0 For the Handpiece to be returned to Clarity 7 1 Place the handpiece to be returned to Clarity in the box as shown Figure 28 Place handpiece in shipping box 7 2 Ship the handpiece to Clarity RetCam3 Service Manual PN 21 100357 Rev A 777 lt Clarity medical systems 5775 W Las Positas Blvd Pleasanton CA 94588 USA Phone 925 463 7984 Fax 925 251 0078 Toll free 1 800 215 6005 RetCam3 Service Manual www claritymsi com PN 21 100357 Rev A
38. hipment You should have to adjust the camera color balance only rarely and then only when the colors of the live image are very different from the real object If this occurs we recommend you perform first a black balance and then a white balance in that order If you find that you must adjust the color balance frequently please contact Clarity Customer Service RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Maintenance 37 Automatic Black Balance ABB The automatic black balance adjustment corrects the camera controller to display black accurately To adjust the automatic black balance follow these steps 1 With the system running initiate a new imaging session and check on screen to see that the camera is working receiving an image Note To start a new imaging session you must select or create a patient record 2 Disconnect the fiber optic lamp cable The handpiece should now not be projecting any light 3 Hold the front of the handpiece with or without a front lens against a towel or soft cloth to block all light from entering the camera 4 Press the ABB button on the front panel for about 1 second until characters ABB appear and release button Figure 10 Automatic black balance test button The characters ABB will stop blinking and the characters ABB OK will appear for approximately 1 second Black balance adjustment is successful If the characters ABB NG appear it means
39. hite balance test button The characters AWB will stop blinking and the characters AWB OK will appear for approximately 1 second White balance adjustment is successful PN 21 100357 Rev A Maintenance 39 If the characters AWB NG LEVEL NG appear automatic white balance adjustment cannot be performed because the light level is too high or too low Adjust the light level up or down as indicated and repeat steps 4 and 5 again If AWB OK still does not appear try adjusting the ambient room lighting up or down or vary the distance from the front lens tip to the paper If the problem persists please call customer service RetCam3 Service Manual PN 21 100357 Rev A 40 Maintenance Lamp Replacement N WARNING Appropriately power down and unplug the unit and allow the illumination lamp to cool before 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 Disconnect the main power cord from the wall Unplug the fiber optic cable from the front panel Remove the light box cover Be Je Figure 12 Light box cover removed RetCam3 Service Manual PN 21 100357 Rev A Maintenance 41 5 Remove two screws from the lamp assembly drawer the smaller panel with the black handle on the front Hemove 2 screws Lamp assembly drawer Lamp assembly drawer handle
40. ical 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 100357 Rev A 32 Maintenance Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 6 D Protective eye wear n situations when splashing with blood or blood contaminated fluids may be anticipated protective eyewear 15 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
41. in 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 must be remembered that these precautions will be effective against other more infectious agents than may be encountered in patients with HIV infection These OSHA and CDC guidelines are intended to help protect the public and ophthalmic medical personnel and minimize transmission of bloodborne pathogens and surface infectious agents RetCam3 Service Manual Additional Resources Further information on the guidelines can obtained by viewing the 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 Diseas
42. ix Guide Appendix Table Appendix Procedure Number Number Revision Document Title 30 000071 RetCam 3 Handpiece Replacement RetCam3 Service Manual PN 21 100357 Rev A 70 RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Appendix 1 Field Replacement Procedure 30 000071 Rev A RetCam 3 Handpiece Replacement Rev ECO Revision History Appendix 1 71 PN 21 100357 Rev A 72 1 RetCam3 Service Manual 1 0 Purpose 1 1 To provide instructions on how to replace a Handpiece in a RetCam 3 System 2 0 Scope 2 1 This procedure provides the step by step process to replace the Handpiece 3 0 References 3 1 Plastic Housing Handpiece 21 100064 3 2 RetCam 3 Service Manual 21 100357 4 0 Eguipment and Tooling 4 1 NA 5 0 Material and Supplies 5 1 NA 6 0 Handpiece Replacement Procedure 6 1 Remove the handpiece from the RetCam 3 6 1 1 Power down the system according to the RetCam 3 User Manual 6 1 2 Disconnect the system power cord from the base of the system 6 1 3 Lock the front casters 6 1 4 Pull out the fiber optic cable Figure 21 Pull out the fiber optic cable 6 1 5 Pull out the front cover PN 21 100357 Rev A Appendix 1 73 Front cover being pulled out Focus connection Figure 22 Pull out the front cover 6 1 6 For focus connection insertion and removal be aware of the red alignment dots on the connections To remove the focus connec
43. l PN 21 100357 Rev A RetCam3 Service Manual Technical Support 63 8 Technical Support How to Get Support The User Manual and Service Manual have been written to answer the majority of questions that arise with the product Please consult these manuals before calling for service Clarity Medical Systems Inc s CMS in house technical staff is dedicated to helping our users with any specific problems and questions you may have with the RetCam 3 Please have your serial number ready and include the serial number on all correspondence The serial number is located on a sticker affixed to the base of the cart at the back just above the power cord connection Please be as specific and give as much information as possible If you encounter a system malfunction of any kind please record the exact steps taken leading to the failure so that our staff can replicate the problem Customers in the rest of the world outside the US please contact your distributor Support Within the US Telephone Support Direct dial 925 463 7984 Toll Free 800 215 6005 FAX Support 925 474 2093 Telephone support is typically available between the hours of 9am and 5pm Pacific Time Write to Clarity You can send written requests to Clarity at the address below Clarity Medical Systems Inc 5775 West Las Positas Blvd Pleasanton CA 94588 USA PN 21 100357 Rev A 64 Technical Support RetCam3 Service Manual E mail Support Send
44. lace illumination bulb Blown fuse Replace system fuses PN 21 100357 Rev A 24 Maintenance Installing Lens Pieces 1 Fit the lens piece on the handpiece aligning the 3 radial pins on the front of the handpiece with the spaces between the tabs of the spring ring on the lens piece 2 Twist the lens piece clockwise as shown in Figure 6 until you hear a click indicating that the lens piece is locked in place Align lens piece to fit over pins alignment pins on handpiece Carefully tighten clockwise until it clicks in place Do not overtorque Figure 6 Installing a lens piece on the handpiece 3 Verify that the handpiece is connected to the system as shown in Figure 7 Figure 7 Handpiece connections RetCam3 Service Manual PN 21 100357 Rev A Maintenance 25 Cleaning Procedures For cleaning purposes the RetCam3 is divided into two categories he Lens Piece that contacts the patient 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 t
45. lenspieces Computer and Electro optics e Adjustable intensity iris Automatic black and white balance functions L emo focus motor connector Custom fiber optic interlock Easy access bulb replacement Embedded Computer 2 16 GHz Intel Processor 2 GB memory e Hard drive storage Fluorescein Angiography Light Source Optional Continuous arc xenon lamp Narrow line blue excitation filter 471 nm Iris intensity control Fiber optic safety interlock Green emission blocking filter for handheld imager 510 nm Color Printer Software The software allows for networkability MS Windows XP Embedded operating system with service pack 2 Proprietary image acquisition storage and processing Live color image display Integrated patient database otill and video capture modes Heview functions Compare functions Transfer functions Backup functions Image export as MLX DICOM or open standard i e jpeg bmp or png RetCam3 Service Manual PN 21 100357 Rev A Technical Specifications 51 Image annotation Data export as XML CSV or TXT e Image import of RetCam supported files hdr mli mlv mlx Fluorescein Angiography mode 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 Operating Storage and Transport BO 10 95
46. ly digital images and videos of the eye The system is designed for easy use and operation by either a physician or trained staff members High resolution digital images and videos can be quickly captured stored displayed for review transferred and or printed by simply using the mouse to point and click The system as delivered is intended for use indoors at normal room temperatures 50 F to 95 F or 10 C to 35 C non condensing humidity range 3096 to 9096 upright on a level surface with the front casters locked This manual contains maintenance instructions specifications and service instructions Only those modules identified within this service manual are authorized for replacement by the customer Any service outside the scope of this manual shall void the warranty and may compromise the safety efficacy of the system This manual is meant to be used in conjunction with the RetCam 3 User s Manual The supplier will make available on request component part lists descriptions or other information which will assist the user s appropriately qualified technical personnel to replace those parts of the equipment which are designated by the manufacturer as replaceable CAUTION Use of this manual is intended for qualified technical personnel only If in doubt please contact the manufacturer before proceeding Storage and Transport Note Always return the handpiece to the holster on the top surface when not imaging The han
47. meter 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 s As an alternative the CDC recommends that a similar approach with a 5 to 10 minute exposure to a fresh solution of either 3 hydrogen peroxide 70 ethanol or 70 isopropanol can be followed These solutions need to be changed at least twice daily Galdmann type Tonometers A recent study compared several methods of disinfecting Goldmann tonometer tips which were inoculated with hepatitis C virus The methods that resulted in the greatest decrease in concentration of HCV were a 5 minute soak in 3 hydrogen peroxide or 70 isopropyl PN 21 100357 Rev A 30 Maintenance Minimizing Transmission of Bloodborne Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 4 alcohol following by washing in cold water 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
48. n performing minor procedures and intravenous fluorescein angiography In addition to gloves and masks protective PN 21 100357 Rev A 34 Maintenance 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 procedures Adopt universal precautions for all patients s Wear gloves when performing all injections a Handle suture needles with needle holders only Develop techniques for safe 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 rema
49. n 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 7 4 800 MHz to 2 5 GHz where P is maximum output power rating of Conducted Immunity the transmitter in watts W according to the rS 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 Vrms Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 2 RetCam3 Service Manual PN 21 100357 Rev A 10 Notices and Labels RetCam3 Service Manual WARNING Interference may occur in the vicinity of equipment marked with the following symbol gt This equipment syst
50. nstall front cover and fiber optic cable 75 Place handpiece in shipping box nnns 76 PN 21 100357 Rev RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Notices and Labels 7 1 Notices and Labels The RetCam3 Ophthalmic Imaging System system is designed to allow the quick and easy capture of wide field high resolution fully digital images and videos of the eye Indications for Use For general ophthalmic imaging including retinal corneal and external Warnings and Cautions CAUTION Federal law US restricts this device to sale by or on the order of a physician or licensed medical practitioner WARNING Prior to using the system read all user safety information WARNING Before using this equipment to acquire images from patient eyes users must be trained in proper clinical technique by personnel authorized by Clarity WARNING The RetCam system is designed and tested as a system Omission or substitution of RetCam components may adversely affect system performance 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 surfac
51. nt 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 Service Manual biomicroscope has been used for a patient who is suspected of having an ocular infectious disease it is strongly recommended that the surfaces on the instrument be cleaned with alcohol or bleach Trial Fitting Contact Lenses Contact lenses need to be disinfected between patients Rigid gas permeable and hard contact lenses can be disinfected using a hydrogen peroxide or a chlorhexidene containing disinfectant system Soft contact lenses can be disinfected with either hydrogen peroxide or a heat disinfection system 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
52. o 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 owabs may be used 3 Rinse surface thoroughly using sterile water 4 Air dry 5 Verify that the lens surface is free of debris and coupling gel Repeat above steps if necessary 6 Inspect the lens for damage and clarity Do not use the lens if there are chips cracks or rough edges on the lens which may injure the patient s eye CAUTION Do not autoclave any part of the system Autoclaving causes irreparable damage and voids the warranty CAUTION Never immerse the entire lens piece or handpiece in any liquid or solution If necessary only the distal 4 mm can be immersed See Figure 8 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 RetCam3 Service Manual PN 21 100357 Rev A 26 Maintenance RetCam3 Service Manual NAP __ 4 0 16 Figure 8 Inverted lens piece showing permissible depth of immersion
53. onfiguration is necessary to insure continued compliance with all safety standards System Description The RetCam 3 system consists of several modules mounted in a stable high quality integrated mobile cart for easy safe transportation from one location to another The front pair of lockable casters allow for easy maneuverability and positioning See Figure 1 on page 18 Display A high resolution LCD flat panel display is standard with the system Control Panel A control panel turns the system on with one button and has controls for illumination intensity camera focus and snap capture an image or start stop video recording Handpiece The handpiece contains a 3 chip CCD It is light weight and easy to use The front lens pieces are removable and allow quick and easy exchange Interconnect Cable The interconnect harness contains three separate cables the fiber optic cable for transmission of illumination light the camera cable and the focus motor control cable Power Supply Box The power supply box contains the input power converter power to charge the battery backup power for the computer camera controller and the electro optic circuits CEO Box Computer Electro Optical Box The computer is a Pentium based system running a specialized Embedded Windows XP with an external DVD drive and proprietary software The system has an integrated network adapter and USB hub The Electro Optical box contains a CCD camera
54. onitor is turned on Verify monitor power indicator light is on Verify monitor cable and power cord are connected properly Verify monitor functionality Connect monitor to alternate system Connect alternate monitor to system No RetCam 3 program Restart the system Verify RetCam splash screen displays Verify error messages displayed Obtain details If system is connected to network disconnect from network and restart the system PN 21 100357 Rev A 54 Troubleshooting Guide RetCam 3 Troubleshooting Guide Troubleshooting Recommendations No camera image Unable to save image Unable to transfer an image Unable to print report or image file RetCam3 Service Manual Verify connections are secure Verify the hand piece camera cable is connected to the CEO box Verify the camera cable is connected securely If there is still no image contact the Clarity service department at 800 215 6005 Verify destination location of file to be saved local USB network etc Verify there is sufficient available space at the destination location Observe any error messages displayed while saving Obtain details Check the file transfer destination location If networking the system verify settings and permissions Verify that the destination device or network location is resident in RetCam program Verify that the device is recognized in File Explorer If network location is available an
55. ood Percutaneous injuries e g needlestick or cut with sharp object represent the greatest risk of transmission of bloodborne pathogens to health care workers Universal precautions applv to blood and other bodv 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 reduces the number of percutaneous injuries Exposure to HIV in health care settings has been of major concern As of June 2000 the Centers for Disease Control and Prevention CDC received reports of 56 U S health care personnel with HIV transmission associated with occupational exposure and another 138 reports of possible transmission to date For health care personnel exposed through percutaneous means to HIV infected blood the estimated risk for HIV infection is 0 3 Risks associated with a mucous membrane exposure are estimated to be 0 09 Risks for HIV seroconversion after percutaneous exposure have been found higher for those exposed to a larger quantity of blood 1 e a device visibly contaminated with blood needle being placed directly in a vein or arterv or a deep injury or when the source patient was terminally ill with AIDS Transmission of HBV poses a ri
56. ovided 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 PN 21 100357 Rev A RetCam3 Service Manual Maintenance 47 Servicing the Interior of the Cart WARNING Removing the back panel should be done by qualified technical personnel only Maintenance personnel should be familiar with the usual precautions regarding the service of electronic and electrical equipment Contact Technical Service for help troubleshooting problems to the module level If it is determined that a module needs to be replaced guidance from Technical Service will be given in the form of a written procedure or verbal instruction No repairs are to be performed by the customer within the modules with the exception of the lamp within the CEO box as stated in the contents The modules comprising this system are Display Handpiece Lens piece CEO box FA option Power Supply box Footswitch Batteries WARNING When doing this level of service Electrical Safety Retesting of the system is required to maintain compliance with IEC requirements Contact Customer Service before beginning Only those mod
57. phthalmologist This document updates four areas s Procedures for protection of the patient s Procedures for protection of the staff Procedures for protection of the ophthalmologist Responsibilities toward patients with known or suspected HIV infection Procedures for Protection of the Patient Protection of patients from exposure to the HIV during examination and treatment of eye disorders incorporates PN 21 100357 Rev A Maintenance 29 Minimizing Transmission of Bloodbome Pathogens and Surface Infectious Agents in Ophthalmic Offices and Operating Rooms Page 3 the application of good public health principles and specialized precautions Since the infection was first recognized in 1981 there has been no evidence to indicate that the HIV has been transmitted through any of the diagnostic or surgical procedures performed by aphthalmologists 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
58. rgery 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 0 5 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 still be effective If a person has been exposed to a source person already known to be seropositive for HIV or there is a strong likelihood that the source person is HIV infected then postexposure prophylaxis PEP can be initiated as soon as possible in consultation with physicians with expertise in antiretroviral therapy and HIV transmission If the source person s HIV status is not known the use of PEP can be decided on a case by case basis All persons with occupational exposure to HIV should receive follow up counseling testing and medical evaluation For HIV PEP recommendations include a basic 4 week regimen of drugs if tolerated and an expanded regimen for exposures that pose an increased risk for transmission If the source person is seronegative for HIV then baseline testing or further follow up of the exposed health care personnel is not necessary Oth
59. rom 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 relate to the protection of health care workers by stressing the far greater risk of bloodborne viral infections e g HIV and HBV posed by blood and blood contaminated bodily fluids than by such bodily secretions as tears In that document they noted that Universal precautions do not apply to nasal secretions sputum sweat tears unless they contain visible blood Thus normal tear exposure does not require bloodborne pathogen precautions In June 2001 the 0 5 Public Health Services updated RetCam3 Service 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
60. se caution to avoid pinching wires in the area 11 Replace the two screws on the small front panel RetCam3 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Maintenance 43 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 15 Figure 15 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 16 Figure 16 Opening the fuse holder cover PN 21 100357 Rev A 44 Maintenance Remove the fuse holder See Figure 17 Figure 17 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 18 Re insert the fuse holder Figure 18 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 Service Manual PN 21 100357 Rev A RetCam3 Service Manual Maintenance 45 Figure 19 Fuse holder re inserted 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
61. service If live image freezes start and stop video Image does not focus Check the lenspiece for cleanliness If there is dried gel on the lenspiece clean off with sterile water Verify that the handpiece focus cable is connected to the CEO box correctly When the focus button is pressed listen for the sound of the motor turning within the handpiece Verify footswitch pedals are not jammed If you cannot hear the motor contact Clarity Medical Systems For further assistance please contact Clarity Technical Support at 800 215 6005 or email service retcam com RetCam3 Service Manual PN 21 100357 Rev A 56 Troubleshooting Guide RetCam 3 Troubleshooting Guide Troubleshooting Recommendations Image capture is not working No numbers displayed on control panel for light intensity USB stick is not recognized Keyboard does not work The system turns off when it is unplugged and moved RetCam3 Service Manual If you can capture a live image using the software verify that an image can also be captured using the control panel button If you can capture an image using the control panel button then take an image using the snap button on the footswitch If you can capture an image using the snap button on the footswitch but not using the control panel the control panel must be replaced Contact Clarity Technical Support at 800 215 6005 or email service retcam com If the system is turned on and the
62. sk to health care workers In 1994 approximately 1 000 health care workers were infected with 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 antigen HbsAg and hepatitis E antigen HbeAg positive was 22 to 31 Any person who is seropositive for hepatitis B surface antigen can be infectious The 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 Box 7424 san Francisco 94120 7424 415 561 8500 http aao org RetCam3 Service Manual PN 21 100357 Rev A 28 Maintenance 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 curren
63. that the automatic black balance cannot be performed NG no good Usually this is due to light leaking into the black image Try blocking ambient light more completely and press ABB again the problem persists please contact Clarity customer service PN 21 100357 Rev A 38 RetCam3 Service Manual Automatic White Balance AWB The automatic white balance adjustment corrects the camera controller to display colors accurately Note This procedure should be done under room lighting that simulates conditions during actual use To adjust the automatic white balance follow these steps 1 2 Perform automatic black balance as described above Reconnect the fiber optic lamp cable The handpiece should now be projecting light Adjust the handpiece light level to that of normal usage Attach any front lens if not already present See Installing Lens Pieces on page 24 Place a blank white piece of paper on a flat surface Hold the handpiece perpendicular to the paper Hold the tip of the lens approximately 2 50 mm from the paper so that the center of the image on the screen appears uniformly bright Adjust the light intensity on the control panel to read 20 on the indicator as a starting point The outer area or ring of the image may be slightly gray or yellow in color Press the AWB button on the front panel until the characters AWB appear on the screen Figure 11 Automatic w
64. tly 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 8 Hepatitis C virus HCV has been isolated in tears and aqueous humor Adenovirus has been the main cause of nosocomial outbreaks of conjunctivitis These outbreaks have mostly occurred in eye clinics or offices Adenovirus can survive for long periods on environmental surfaces and aphthalmic instruments can become contaminated and transmit infection Handwashing glove use and disinfection of instruments can all help to prevent or limit the transmission of adenovirus Infected personnel should not provide patient care for the duration of symptoms after onset of adenoviral conjunctivitis Background The National Society to Prevent Blindness in cooperation with the American Academy of Ophthalmology assembled a Task Force to examine the risk of acquiring HIV infection in the course of eye examinations and treatments The Task Force helped develop precautions to reduce spread of pathogens that might be present in tears In August 1987 the Centers for Disease Control and Prevention 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 f
65. tor pull back on the metal connector sleeve 6 1 7 To remove the camera cable from the CEO box turn the metal sleeve counterclockwise at least 5 turns and slowly pull out on the connector 6 1 8 Remove the cabling from the front cover Figure 23 Removing the cabling 6 1 9 Carefully set aside the handpiece 6 2 Install the replacement handpiece 6 2 1 Remove the replacement handpiece from the box RetCam3 Service Manual PN 21 100357 Rev A 74 1 Figure 24 Remove handpiece from box 6 2 2 Thread the handpiece focus and camera cables through the front Figure 25 Threading cables through the front cover 6 2 3 To install the focus cable align the red dots on the connectors and insert the metal sleeve 6 2 4 To install the camera cable align the slot on the cable connector with the pin at the 6 o clock position in the port and insert Then thread on the sleeve of the connector clockwise until tight RetCam3 Service Manual PN 21 100357 Rev A Appendix 1 75 2 Focus connection Figure 26 Cable connections 6 2 5 Install the front cover 6 2 6 Install the fiber optic cable Figure 27 Install front cover and fiber optic cable 6 3 Verifying the handpiece works 6 3 1 Plug the RetCam 3 system in and turn it on 6 3 2 Install a lenspiece on the handpiece 6 3 3 Select a test patient and go to new exam 6 3 4 View image for color balance 6 3 5 If t
66. tronic equipment may be EN 55011 affected Radiated Emissions CISPR 11 EN 55011 Harmonic emissions Complies IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 FOC Part 158 RetCam3 Service Manual PN 21 100357 Rev A Notices and Labels 9 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 3096 2 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 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 guality should be that of a typical AC Power 2 kV line s to earth commercial or hospital environment I O Lines EN 61000 4 5 gt 95 dip in Ut 0 5 cycle If the user of the RetCam system requires 60 dip in Ut 5 cycles continued operation during power mains Voltage dips and interruptions 30 dip in Ut 25 cycles interruptions it is recommended that the EN 61000 4 11 gt 95 dip in Ut 5 seconds RetCam system be powered from a
67. ules identified within this service manual are authorized for replacement by the customer Any service outside the scope of this manual shall void the warranty and may compromise the safety efficacy of the system PN 21 100357 Rev A 48 Maintenance RetCam3 Service Manual PN 21 100357 Rev A Technical Specifications 49 4 Technical Specifications Hardware Physical e 26 660 mm wide x 24 610 mm deep x 541372 mm minimum height Approximately 200 lbs 91 Kg fully loaded Electrical Ratings 100 240 50 60 Hz 700 Fuses 3AG 10A 250V slo blo 5 x 20 mm Power consumption 700W with all options Detachable hospital grade power cord Cart Features The RetCam 3 cart includes the following features e System has been designed inspected and tested to comply with the safety requirements of IEC60601 1 Internal Battery Backup Multi function Control Panel Tri function footswitch Waterproof Keyboard Mouse LCD flat panel display Display arm for angle and height adjustment Handpiece cable hanger Integrated cooling ducts Dual Front locking castors Upper Storage drawer within which is mounted external DVD drive Lower Storage drawer with lenspiece holders Color report and image printer on slide out tray USB ports Ethernet port RetCam3 Service Manual PN 21 100357 Rev A 50 Technical Specifications Handheld Imager 3 chip RGB CCD Built in fiber optics Quick change
68. validation process as described below Key validation requires that you get a license key from Clarity to use the revamped system and you cannot request this key until after installation is complete Since it may take up to two 2 business days to obtain a license key after submitting a request we recommend that you effect system or software upgrades when you can manage two business days without use of the system Note To ensure the preservation of your patient data and images we strongly recommend that you perform a complete backup of the system s images before you begin any software installation PN 21 100357 Rev A 46 Maintenance RetCam3 Service Manual When key validation is necessary the Key Validation dialog appears when you start the system and each time thereafter until you complete this step before the Site Awareness dialog Key Validation Call Clarity Medical Systems toll 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 20 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 pr
69. with the virus OSHA regulations require that the employer make hepatitis B vaccine available to all employees who have occupational exposure Procedures Handling of sharp instruments The 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 s When disposing of used needles and When handling sharp instruments after procedures To prevent needlestick injuries ophthalmic medical personnel should be instructed in the proper handling of needles Le needles should not be recapped or purposely bent or broken by hand removed trom disposable syringes or otherwise manipulated by hand Health care workers should be instructed to place disposable syringes and needles scalpel blades and other sharp items in puncture resistant containers following their use Puncture resistant containers should be provided and should be located as close as practical to the area where needles and syringes are in use INewer devices have engineering controls such as injury protections and needleless systems to minimize injuries RetCam3 Service 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
70. ye 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 and the The following recommendations for hygienic procedures to be used in the delivery of eye care to patients are effective ways to minimize this risk as well as the risks of contracting or transmitting other much more common infectious diseases encountered in patients Because it is impractical to identify all patients who may be carrying these infectious agents these recommendations should be the routine for all patient encounters General Precautions Against Infection Office Handwashing The hands should be washed with soap and water and thoroughly dried 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 Service Manual Gloves The CDC suggests in its recommendations for the prevention of HIV transmission in health care setting

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