Canon CX-1 manuale d’uso

Before using the instrument, be sure to read this manual thoroughly . Keep the manual where it is easily accessible. Digital Retinal Camera CX-1 Operation Manual[...]

PLEASE NOTE 1. Please cont act a Canon represe ntative or distributor to have the instrument s installed. 2. Use the computer , monitor , and other equipment that co nforms to the system standard IEC 60601-1/ UL 60601-1 or IEC 609 50-1/UL 60950- 1 for the Digit al Retinal Camera CX-1. Be sure that the entir e system conform to IEC 60601-1-1 /UL 606[...]

(1) Safety Information Regulations This instrument conforms to IEC 60 601-1-2:2001. For U.S.A. and Canada • When the CX-1 is going to be operated at a voltage of 240V in USA or Canada, be sure t o con- nect the instrument to a center t apped voltage source. • This instrument is a CLASS I EQUIPMENT according to UL 60601-1 and CAN/CSA C22.2 No. 6[...]

(2) Safety Information General Safety Information Follow the safety instructions in this manual and all warnings and cautio ns printed on the warning labels. Ignoring such cautions or warnings while handling the product may re sult in injury or accident. Be sure to read and fully understand th e manual before using this product. Keep this manual fo[...]

Safety Information (3) Safety Precautions Be sure to follow the safety in structions below to ensure corr ect operation of the instrument. Installation and Environment of Use W ARNING Do not use or store the instrument ne ar any flammable chemic als such as alcohol, thinner , benzine, etc. If chemicals are spilled or evaporate, it may result in fir[...]

(4) Safety Information W ARNING Be sure to hold the plug to disconnect the power cable. If you pull the cable, the core wire may be damaged, resulting in fire or electric shock. W ARNING Do not cut or process the cables. Also, do not place anything heavy , including the instrument on it, step on it, pull it, bend it, or bundle it. Otherwise, the ca[...]

Safety Information (5) CAUTION T o ensure clean liness, replace the chin rest paper whenever changing patient s. CAUTION When adjusting the fo rward position of the ma in unit, be sure to move the main unit slowly toward the patient while looking from the side of the patient, so as to prevent accidental cont act of the objective lens with the patie[...]

(6) Safety Information System Use W ARNING Do not place multiple port able socket-outlets on the floor . Other wis e, it may result in fire or electric shock. W ARNING Do not connect an additional multiple port a ble socket-outlet or extension cord to the system. Otherwise, it may result in fire or electric shoc k. W ARNING Do not connect instrumen[...]

Safety Information (7) Label on the Instrument The CX-1 has a label on it. The label contents and its position are indicated below .[...]

(8) Component s Optional Units Internal eye fixation target Stereo unit Chin rest paper (500 sheets) Digital Retinal Camera CX-1 ............. ............................ .... 1 Digital camera ............. ........................ 1 Camera cover ............ .......................... 1 Power cable (3 m, Non-shielded) .... ............... .......[...]

(9) Contents Safety Information ..... ............................................................... ............... .............. ............ .( 1 ) Components ................. .............................. ........................................................ .............. .. (8) 1. Features ........... ..................................[...]

Contents (10) 7. Daily Inspection and Maintenance... ............... .................................................. ............. 38 7.1 Inspection ................................................... ............................................................. ............. 38 7.1.1 Before Turning ON the Power ............... ... .............[...]

-1- 1. Features The Digital Retinal Camera CX-1 is used to observe the retinas of patients ’ ey es and take photographs of them. The camera has th e following features. Both mydriatic and non-mydriati c modes in a single unit The CX-1 includes a mydriatic mo de and non-mydriatic m ode, and each mode can be selected with a single switch. In the my[...]

-2- 2. Notes for Using the Instrument Digital camera • The digital camera installed on the Digit al Retinal Camera CX-1 is designed for the CX-1 . • The specifications differ from the typical commercia lly-available Canon dig ital cameras. It cannot be used for purposes other than observing and taking p hot ographs of peoples’ eyes. Do not us[...]

2. Notes for Using the Instrument -3- • Never use disinfecting ethanol, glutaraldeh yde or ot her solvents to clean the cover of the instrument, except the forehead rest and th e chin rest. This could damage the cover of the instrument. • If the chin rest paper will not be used, b e sure to di sinfect the chin rest in the same way as the forehe[...]

-4- 3. Names of Part s 3.1 Main Unit 1 External eye fixation lamp (see p age 17, 27) 2 Face rest 3 Forehead rest (see p age 45) 4 Objective lens (see page 44 ) 5 Objective lens cap 6 Chin rest (see page 15) 7 Diopter com pensation le ver (see page 34) 8 Focus kn ob (see page 17 , 27) 9 Pan T ilt gr ip (see page 35) 10 Finger guard 1 1 Carrying inde[...]

3. Names of Parts -5- 12 Viewfin d er (see page 7) 13 Digital camer a (see page (8 )) 14 Digital camera cover (see page 48) 15 Observation monitor (see page 7) 16 Digital camera power switch (see pag e 1 1) 17 Shutter release button (see p age 18, 21, 22, 28) 18 Oper ation leve r (see page 12, 15, 16) 19 S tage unit (see p age 12, 15, 19, 29) 20 He[...]

3. Names of Parts -6- 3.2 Operation Panel 1 Brightness adjuster (see p age 16) 2 Focus indicator switch/lamp (see pag e 33) 3 × 2 switch/lamp (see page 33) 4 Small pupil photography switch/lamp (see pag e 34) 5 BA switch/lamp (see pa ge 30) 6 Flash intensity indicator (see page 19) 7 Flash intensity switches (see page 19) 8 TIMER/C switch/lamp (se[...]

3. Names of Parts -7- 3.3 Observation Moni tor and V iewfinder Observation monitor (with x1.3 magnification) 1 Photography mode indica tion COLOR: Color ( see page 14) RED FREE: Red free (see p age 20) COBAL T : Cobalt (see pa ge 21) FLUO: Fluorescein an giography (see pag e 21) F AF: Fundus autofluorescence (see pag e 23) 2 Focus indicator (se e p[...]

-8- 4. Prep aration Please ask a Canon representative or distributor to perform install ation of this instrument. 4.1 Power Cable Connections 1 Check that the power switch of the retina l camera is set to the O position (OFF). 2 Connect the power cable to the retinal camera. Insert the power cable conn ector firmly into the AC power connector while[...]

4. Prep aration -9- 4.2 Connecting to a Computer Connect the retinal camera to a computer wher e the supplied software has been installed. 1 Check that the power switches for the retinal camera and digit al camera are set to the OFF position. 2 Connect the USB cables to the main unit. Insert the USB cable connect ors firmly into the USB connectors [...]

4. Prepar ation -10- 4.3 Carrying the Instrument This is the procedure when car rying the instrument by hand. 1 T urn off the powe r of the retinal camera. Press the power switch of the retinal camera to the O side (OFF ). 2 Remove the connecte d cables. Remove all power cables and USB cables. 3 Secure the part s in place. T ighten th e panning loc[...]

-1 1- 5. Basic Photography 5.1 Before T aking Photographs 5.1.1 T urn On the Power 1 Remove the dust cover and the ob jective lens cap. 2 T urn on the computer . T urn on the computer , and star t the control software. 3 T urn on the power switch of the digit al camera. Set the power switch of the digital camera to or . 4 T urn on the power of the [...]

5. Basic Photography -12- 5.1.2 Move the S tage Unit to Get S tarted Press the sta ge unit lock button to release the lock. Grasp the operation lever , and pull the stage all the way to the right front, and then press the stage lock button to lo ck it in place. 5.1.3 Adjust the Viewfinder Note: Be sure to adjust the diopter of the viewfi nder so it[...]

5. Basic Photography -13- 5.2 Photography Flow This instrument includes non-mydr iatic and mydriatic observation modes. In each observation mode, photographs can be taken using color , red-free, cobalt, fluo rescein angiography , or fundus autofluorescence. The observation moni tor is used in non-mydriatic mode, and the viewfinder is used in mydria[...]

5. Basic Photography -14- 5.3 Non-Mydriatic Mode The Non-Mydriatic mode is designed for photographing the patient eye without using a mydriatic. T o switch from the mydriatic mode to the non-mydriatic mode, hold down the observati on mode switch for approx. 2 or more seconds. The observation mode lamp Non-Myd turns on. The observation monitor is us[...]

5. Basic Photography -15- 5 Align the height of the patient’s eye. Press the CHIN REST switches to adjust the chin rest up or down so that the patien t ’ s eye is aligned with the height adjustment ma rk. 6 Move the st age positio n. If the stage is locked at th e operator ’ s side, press the stage lock button to unlock the stage. Hold the op[...]

5. Basic Photography -16- The right and left dots (working distance dots) appear sharpest when the retinal camera is at the optimum position. 8 Adjust brightness in the fi eld of view for observatio n. T urning t he brightness adjust er clockwise increases the brightness for observation, and turning it counter- clockwise reduces the brightness for [...]

5. Basic Photography -17- 9 Determine the area to be photographe d. Have the patient stare at the green internal ey e fixation lamp. If necessary , press a FIX T ARGET switch to move t he internal eye fixatio n lamp to g uide the patientís eye. If you press the blin k switch, the internal eye fixation lamp blin ks to make the lamp more noticeable [...]

5. Basic Photography -18- 11 T ake the image. Check that the photograp hy ready lamp li ghts green. Check again that the work ing distance dots appear sharpest and the split lines form a single lin e, and then press the shutter release button. Concerning th e photogra phy ready lamp The ready status of the fundus camera is indicat ed by the color o[...]

5. Basic Photography -19- 12 Review the image. The fundus images and st udy information are d isplayed in the control software. Check the images. T o take images of the other eye, repeat steps 7 and the following. 13 End the study . End the study with the control so ftware. 14 Lock the stage unit. Press the stage unit lock but ton to lock the stage[...]

5. Basic Photography -20- 15 T urn off the powe r of the retinal camera. 5.3.2 Red-free P hotography Mode 1 Enter the study information into the computer . 2 Select the red-fr ee photography mode. Press the RED FREE switch. Or select the photography mode with the con trol software. The RED FREE lamp turns on. RED FREE is displayed on t he observati[...]

5. Basic Photography -21- 5.3.3 Cobalt Photography Mode In this mode, photography using the exciter filter fo r fluorescein angiography is possibl e. 1 Enter the study information into the computer . 2 Select the cobalt photogra phy mode. Press the COBAL T switch. Or select the photography mode with the con trol software. The COBAL T lamp turns on.[...]

5. Basic Photography -22- 9 Roughly determine the area to be photographed. 10 Focus on the patient ’s eye. 11 S tart the timer . Press the TIMER/C switch as soon as the fluorescein medium is injected. The buzzer sounds each second, the lamp lights brightly and the elapsed time is displayed in the control software. 12 T ake the image. Check again [...]

5. Basic Photography -23- 5.3.5 Fundus Auto fluorescence Mode 1 Enter the study information into the computer . 2 Select the fundus autofluorescen ce mode. Press the F AF switch. Or select the photography mode with the con trol software. The F AF lamp turns on. FA F is displayed on the observation monitor . 3 Perform the procedure starting from ste[...]

5. Basic Photography -24- 5.4 Mydriatic Mode The Mydriatic m ode is designed for ph otographing the patient’ s eye that a mydriatic is applied. T o switch from the non-mydriatic mode to the mydriatic mode, ho ld down the observation mode switch for approx. 2 or m ore seconds. The observation mode lamp Myd turns on. The viewfinder is used for reti[...]

5. Basic Photography -25- 5 Align the height of the patient’s eye. Press the CHIN REST switches to adjust the chin rest up or down so that the patien t ’ s eye is aligned with the height adjustment ma rk. 6 Move the st age positio n. If the stage is locked at th e operator ’ s side, press the stage lock button to unlock the stage. Hold the op[...]

5. Basic Photography -26- The right and left dots (working distance dots) appear sharpest when the retinal camera is at the optimum position. 8 Adjust brightness in the fi eld of view for observatio n. T urning t he brightness adjust er clockwise increases the brightness for observation, and turning it counter- clockwise reduces the brightness for [...]

5. Basic Photography -27- 9 Determine the area to be photographe d. Use the external eye fixation lamp to guide the patient’ s eye. 10 Focus on p atient’ s eye. T urn the focus knob to focus the image. When using the focus indicat or , ensure that the split lines are aligned into a single straig ht line. When it is difficult to gui de a patient[...]

5. Basic Photography -28- 11 T ake the image. Check that the pho tography ready la mp lights green. In a flare-free condition, check the focus again, and press the shutter release button. Concerning th e photogra phy ready lamp The ready status of the fundus camera is indicat ed by the color of the photography ready lamp. This status differs depend[...]

5. Basic Photography -29- 12 Review the image. The fundus images and st udy information are d isplayed in the control software. Check the images. T o take images of the other eye, repeat steps 7 and the following. 13 End the study . End the study with the control so ftware. 14 Lock the stage unit. Press the stage unit lock but ton to lock the stage[...]

5. Basic Photography -30- 5.4.2 Red-free P hotography Mode 1 Enter the study information into the computer . 2 Select the red-fr ee photography mode. Press the RED FREE swit ch. Or select the photography mode with the control software. The RED FREE lamp turns on. 3 Perform the procedure starting from ste p 3 in 5.4.1 Color Photography Mo de (see pa[...]

5. Basic Photography -31- 10 Focus on p atient’ s eye. 11 S tart the timer . Press the TIMER/C switch as soon as the fluorescein medi um is injected. The buzzer sounds each second, the lamp lights brigh tly and the elapse d tim e is displayed in the control so ftware. 12 T ake the image. In a flare-free condition, ch eck the focus again, and pres[...]

5. Basic Photography -32- 5.4.5 Fundus Auto fluorescence Mode 1 Enter the study information into the computer . 2 Select the fundus autofluorescen ce mode. Press the F AF switch. Or select the photography mode with the con trol software. The F AF lamp turns on. 3 Perform the procedure starting from ste p 3 in 5.4.1 Color Photography Mo de (see page[...]

-33- 6. Photography Auxiliary Functions 6.1 Using the Fo cus Indicator The focus in dicator swit ch on th e operation panel can be used to select whether to use the focus indicator or not. When the focus indicator is be ing used, the focus indicator lamp lights brig htly . 6.2 × 2 photography function Press the × 2 switch. If the × 2 photography[...]

6. Photography Auxiliary Functions -34- 6.3 Small pupil ph otography function The small pupil photograp hy function can be used in the color , red free or cobalt photography mod e. T o activate this function, press the small pupil photo graphy switch on the operation panel. The small pupil photograp hy lamp turns on brightly . During the non-mydria[...]

6. Photography Au xiliary Functions -35- 6.5 Panning Function and T ilting Function 6.5.1 Panning Function This function is used to take photographs of peripheral areas in the side-to-side direction. First, turn the panning lock knob to the position, and then adjust the angle of the retina l camera in the side-to-side direction. Before carrying the[...]

6. Photography Auxiliary Functions -36- 6.6 Using the External Monitor The image on the observation monitor can be viewed on an external m onitor . Please ask yo ur Canon representative or distributo r about which external monito rs can be used. 1 Before connecting or disconnecting th e cable, turn off the power for the retinal camera. 2 Connect th[...]

6. Photography Au xiliary Functions -37- 5 Connect the video cable to the exte rnal monitor . Connect the video cab le to the video inp ut terminal on the external mon itor . T urn on the external monitor, a n d get the input selected on the monitor . 6 T urn on the power for the retinal camer a and digital camera. The image is displayed on the c o[...]

-38- 7. Daily Inspection and Maintenance 7.1 Inspection In order to ensure that the instrument is used safely and normally , please be sure to inspect the instrument before use. If the inspection finds a fault, and you are unabl e to correct the problem, please contact a Canon representative or distributo r . It is recommended that you either copy [...]

7. Daily Inspection and Maintenance -39- 7.1.1 Before T urning ON the Power WA R N I N G For safety reasons, be su re to turn OFF the power when the following inspections are going to be performe d. Otherwise, it may result in electric shock. WA R N I N G Clean the plug of the powe r cable periodically by unplugging it from th e AC outlet and remov[...]

7. Daily Inspection and Maintena nce -40- 7.1.2 T urning ON the Power T urn on the power of all the equipment which has been connected as a system. Digital came ra Check that the digital camera is firmly attached and the cables are connected correctly . Pass/ Fail Pass/ Fail Pass/ Fail Contact a Canon representative or distributor if there is any p[...]

7. Daily Inspection and Maintenance -41- 7.2 Before Calling a Service T echnician Perform the appropriat e remedy when an y of the prob lems below appear in in spection or d uring operation or a warning is displayed in the control software. If performing the remedy still does not fi x the probl em, or the warning is still displayed, turn OFF th e p[...]

7. Daily Inspection and Maintena nce -42- The working distance dots are difficult to view . The observation light is too bright. Lower the observation li ght intensity . The working distance dots are not visible. The positioning is not correct. Perform positioning (see pag e 15) . The retinal image is still not visible even when increasing the brig[...]

7. Daily Inspection and Maintenance -43- Sharp images cannot be taken. The pupil is not dilated enough. Make the patient’ s pupil dilate. If th e pupil is still too small , press the small pupil photography switch t o activate the small pupil function. The positioning is not correct. Perform positioning . The image is unfocused. Focus the image. [...]

7. Daily Inspection and Maintena nce -44- 7.3 Cleaning and Disinfection 7.3.1 Objective Lens Note: Do not wipe of f or rub the objective lens w hen there is dust or other sub stances on it. This could scratch the lens surface. Note: Never wipe the objective lens with dis infecti ng ethanol, eyeglass le ns cleaner , or cleaning paper cont aining sil[...]

7. Daily Inspection and Maintenance -45- 5 Wipe off the ob jective lens. Gently wipe the lens with Canon-designated lens cleaning paper that has been slightly wet with the Canon-designated lens cleaner . Starting from the center of the lens, wipe the lens in increasingly larger spirals towa rd the circumference. Change the paper , and wi pe several[...]

7. Daily Inspection and Maintena nce -46- 7.3.4 Retinal Camera and Di gita l Camera Outer Covers Note: Do not clean the cover of th e instrument with lens cleaner . The cover of the instru ment could be damaged. Use the procedure below to clean the cover when it is dirty . 1 T urn OFF the power of the retinal camera. Press the power switch of the r[...]

7. Daily Inspection and Maintenance -47- 7.4 Refilling the Chin Rest Paper Note: If the chin rest paper will not be used, be sure to disinf ect the chin rest whenever the patient is changed in the same way as the forehead rest. Note: The chin rest p aper is a consumable produc t (sold se parately). T o purchase the chin rest paper , please contact [...]

7. Daily Inspection and Maintena nce -48- 7.5 Removing and Installing the Digit al Camera It is not necessary to remove and re-install the digit al camera during normal usage. The procedure below is used to remove and install th e digital camera during m aintenance and inspection of the digital camera or other work. Note: Do not touch the lens part[...]

7. Daily Inspection and Maintenance -49- 4 Remove the digital ca mera. While pressing down on the lens unlock bu tton of the digital camera , slowly turn counterclockwise so that the camera mount index I on the top of the digital camera is aligned wi th the seam of the cover of the retinal camera body . Release the lens unlock button . While holdin[...]

7. Daily Inspection and Maintena nce -50- 5 Remove th e DC coupler . Open the battery compartment cover on the digital camera, and then slide the ba ttery lock lever to remove the DC coupler . After removing the DC coupler , close the battery compartment cover . 6 Attach the cap to th e camera mount. Attach the mount cap to the retinal cam era moun[...]

7. Daily Inspection and Maintenance -51- 3 Mount the digital ca mera to the retinal camera. Set the mount lock lever to the UNLOCK position . Fit the digital camera len s mount onto the camera mount of the retin al camera body . When fitting them together , be sure that the digital camera mount index mark is aligned with the cover seam on the reti [...]

7. Daily Inspection and Maintena nce -52- 4 Attach the cable to the digit al camera. Open the terminal cover of the digital camera, and connect the respective cables to the digital terminal, PC terminal, and remote control term inal. 5 Attach the camera cover to the digital camera. Place the camera cover hook onto the strap mount of the digital cam[...]

-53- 8. Main S pecifications and Performance 8.1 Main S pecifications Note: In the International System of Unit s (SI), the expression 1D (diopter) = 1m -1 . Field angle Mydriatic mode Non-Mydriatic mode 50° 45° Magnification view 1.1 × (Image size on the sensor ) Image magnification of observation (viewfinder) 10 × Diameter of pupil requi red [...]

8. Main S pecifications and Performance -54- 8.2 Functions in th e Observation and Photography Modes The following table shows the availa bility of functions when each of obs ervation modes is used with each photography mode. A vailable option s are indicated w ith the check mark “ 9 ”. Unavailable options are indicated with “N/A.” It also [...]

8. Main S pecifications and Performance -55- 8.3 Guidance and Manufacturer ’s Declaration for EMC Directive Electromagnetic Emissions The CX-1 is intended for use in the elec tro m agnetic environment specified below . The customer or the user of the CX-1 sho uld assure that it is used in such an environm ent. Emission T est Compliance Electromag[...]

8. Main S pecifications and Performance -56- Electromagnetic Immunity The CX-1 is intended for use in the elec tro m agnetic environment specified below . The customer or the user of the CX-1 sho uld assure that it is used in such an environm ent. Immunity T est IEC 60601 T est Level Compliance Level Electromagnetic Environmen t – Guidance Electr[...]

8. Main S pecifications and Performance -57- Immunity T est IEC 60601 T e st Level Compliance Level Electromagnetic Environmen t – Guidance Conducted RF IEC 61000-4-6 3 V rms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF comm unications equipment should be used no closer to any part of the CX-1, includ ing cables, than the recom mended sep arat[...]

8. Main S pecifications and Performance -58- Recommended Sep aration Distances be tween Port able and Mobile RF Communications Equi pment and the CX-1 The CX-1 is intended for use in an ele c tr omagnetic environment in which radiated RF disturbances are controlled. Th e customer or the user of the CX-1 can help prevent electromagnetic interference[...]

-59- 9. Service Information Repair If problem cannot be solved even after taking the measures indicated in Section 7, contact a Canon representative or distrib utor for repair . When requesting repair, please provide us with the following informati on by referring to th e rating label o n the main unit. Name of the inst rument: CX-1 Serial number o[...]

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CANON INC. Medical Equipment Group 30-2, Shimomaruko 3-chome, Ohta-ku, T okyo, Jap an T elephone: (81)-3-3758-21 1 1 CANON U.S.A., INC. CANON MEDICAL SYSTEMS Eye Care Systems Department 15975 Alton Parkway , Irvine, CA 92618, U.S.A. T elephone: (1)-949-753-4000 CANON EUROP A N.V . Medical Product s Division Bovenkerkerweg 59-61, 1 185 XB Amstelveen[...]