Digital Retinal Camera CR-1 Operation Manual Before using the instrument, be sure to read this manual thoroughly. Keep the manual where it is easily accessible.
PLEASE NOTE 1. Please contact a Canon representative or distributor to have the instruments installed. 2. Computer, monitor, or other equipment used in the CR-1 fundus imaging system must be conforming to the IEC60601-1/UL60601-1 or IEC60950/UL60950. Furthermore all configurations shall comply with the system standard IEC 60601-1-1. If in doubt, consult the technical services department or your local representative.
Safety Information Regulations This instrument conforms to IEC 60601-1-2:2001. For U.S.A. and Canada • When the CR-1 is going to be operated at a voltage of 240V in USA or Canada, be sure to connect the instrument to a center tapped voltage source. • This instrument is a CLASS I EQUIPMENT according to UL60601-1.
Safety Information Guidance and Manufacturer’s Declaration for EMC Directive Electromagnetic Emissions The CR-1 is intended for use in the electromagnetic environment specified below. The user of the CR-1 should assure that it is used in such an environment.
Safety Information Electromagnetic Immunity The CR-1 is intended for use in the electromagnetic environment specified below. The user of the CR-1 should assure that it is used in such an environment.
Safety Information Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Portable and mobile RF communications equipment should be used no closer to any part of the CR-1, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separations distance d = 1.2 P Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz d = 1.
Safety Information Recommended Separation Distances The CR-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CR-1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CR-1 as recommended below, according to the maximum output power of the communications equipment.
Safety Information General Safety Information Follow the safety instructions in this manual and all warnings and cautions printed on the warning labels. Ignoring such cautions or warnings while handling the product may result in injury or accident. Be sure to read and fully understand the manual before using this product. Keep this manual for future reference.
Safety Information Installation and Environment of Use ! WARNING Do not use or store the instrument near any flammable chemicals such as alcohol, thinner, benzine, etc. If chemicals are spilled or evaporate, it may result in fire or electric shock through contact with electric parts inside the instruments. Also, some disinfectants are flammable. Be sure to take care when using them. ! CAUTION Do not use or store the instrument in a location with the conditions listed below.
Safety Information Power Supply ! WARNING 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. ! WARNING 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 cable may be damaged, which may result in fire or electric shock.
Safety Information Handling ! CAUTION To ensure cleanliness, replace the chin rest paper whenever changing patients. ! CAUTION When adjusting the forward position of the main 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 contact of the objective lens with patient. ! CAUTION Do not place your hand or fingers between the stage and base.
Safety Information Labels and Markings on the Instrument The CR-1 has a label on it. The label contents and its position are indicated below.
Contents Safety Information..........................................................................................(1) Regulations ............................................................................................(1) Guidance and Manufacturer’s Declaration for EMC Directive ...............(2) General Safety Information ....................................................................(6) Labels and Markings on the Instrument ..............................................(10) 1. Features.......
Contents 6.6 Attaching and Removing the EOS Digital Camera .......................... 33 6.6.1 Attaching the EOS Digital Camera ........................................ 33 6.6.2 Removing the EOS Digital Camera ....................................... 34 6.7 Connecting the USB Cable .............................................................. 36 6.8 Carrying the Instrument ................................................................... 37 7. Service Information .........................................
1. Features The Canon CR-1 digital retinal camera is used to take digital photographic retinal images of patient’s eyes across a wide range (photographic angle of view of 45 degrees) in a naturally dilated state without the use of mydriatics. It has the following features. Compact size and superior operability Compact dimensions and a light weight. Since the main unit can be raised and lowered by the operation lever, and the chin rest became motordriven, the alignment procedure has dramatically improved.
2. Notes for Using the Instrument Before Use • Check and clean the objective lens before taking an image, as any stains or scratches on it will appear as white spots. • Sudden heating of the room in cold areas will cause condensation to form on the objective lens or on optical parts inside the instrument. In this case, wait until condensation disappears before performing photography.
2. Notes for Using the Instrument Environment of Use • Do not install or store the camera or leave it standing in an adverse environment such as where the temperature and humidity levels are high. Doing so may cause trouble and/or malfunction. Be sure to observe the points on page (7) when selecting the installation location. • Dust in the air will not only attach to the objective lens, but will also attach onto the optical parts inside the instrument. You cannot take a good image when dust is on them.
3. Description 3.1 Main Unit f a b c g h i d j e Symbol k Name Function a Diopter compensation lever Used when the target is not brought into focus by turning the focus knob. b Height adjustment mark Adjust so that the height of the patient’s eye is aligned with this mark. This is used for adjusting the height of the chin rest. c Focus knob Used for focusing on patient’s eye. d Panel lighting Illuminates the operation panel (see page 6) area.
3. Description l q r m s n o p t Symbol Name Function l External eye fixation unit terminal Accepts the external eye fixation unit (sold separately). m Objective lens Lens used for photography. n Stage unit lock button Locks and unlocks the stage unit. o Power switch The power turns ON when pressed to the I side, and the power turns OFF when pressed to the O side. p AC power connector The supplied power cable is connected.
3. Description 3.2 Operation Panel a f b g c h d e i Symbol Name Function a Brightness adjuster Used for adjusting brightness in field of view for observation. b ×2 switch Switches the ×2 photography function ON and OFF. c SP (Small pupil photography) switch Switches the function for photographing small pupil diameters ON and OFF. d Flash intensity switch Pressing the left switch reduces the flash intensity. Pressing the right switch increases the flash intensity.
3. Description 3.3 Monitor Display Screens R a b g R h c i d j LOW e STEREO Anterior eye observation screen Symbol f STEREO Retina observation screen Name Function a Photographic status The photographic preparation status (see page 18) is indicated by colors. b ×2 photography Appears when the ×2 photography function is ON. c SP Appears when the small pupil photography function is ON. d Flash intensity mode “LOW” is displayed under low flash intensity conditions.
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4. Operation Concerning the power-saving function The power-saving function is activated under the following circumstances. • When none of the switches on the operation panel has been operated, when the stage unit has not been switched to the left or right or when the diopter correction slider has not been operated for 10 or more minutes while power is supplied to the camera When the power-saving function has been activated, the POWER lamp on the operation panel blinks.
4. Operation 3 Unlock the stage unit. Press the stage unit lock button to release the lock. 4 Adjust the height of the main unit. Turn the operation lever, and align the main unit with the center position of the height adjustment mark. Center of height adjustment mark 5 Darken the room. Darken the room so that there is barely enough light (approx. 5 lux) by which to read a newspaper. 6 Input the study information into the computer. Use the control software to input the study information.
4. Operation 4.2 Adjusting the Position and Focusing 1 Have the patient sit down. Have the patient place his or her chin against the chin rest and his or her forehead against the forehead rest. 2 Align the height of the patient’s eye. Move the chin rest up or down so that the patient’s eye is aligned with the height adjustment mark by operating the CHIN REST switches. Height adjustment mark 3 Display the patient’s eye to be photographed on the monitor.
4. Operation 4 Align the position of the pupil. ! CAUTION When adjusting the position of the main unit in the front-back direction, slowly bring the main unit closer to the patient while looking at the patient’s eye from the side. You may injure the patient’s eye if the objective lens makes contact with it. ! CAUTION Do not put your fingers or hands between the sliding part and base of the stage unit . Similarly, do not allow patients to put their hands in these places.
4. Operation Concerning the SP function Use the SP (small pupil photography) function if the pupil of the patient’s eye fails to become larger than the inside pupil position alignment mark even after waiting for a while in the darkened room. This function enables pupils with a diameter down to 3.7 mm to be photographed. (1) Press the SP switch on the operation panel. (2) Press the ALIGNMENT switch, and display the retinal image on the monitor. The photography range is now R displayed.
4. Operation 5 Display the retina observation screen. Press the ALIGNMENT switch. The internal eye fixation lamp flashes for 3 seconds. R Note: When the stage unit is slid toward the other eye on the retina observation screen, the anterior eye observation screen is displayed. Concerning the stereo mode The stereo mode can be set to ON or OFF using the [Set menu] .Refer to 5. Settings (see page 21). When this mode is ON, “STEREO” is displayed on the observation screen.
4. Operation 8 Decide on the area to be photographed. Have the patient stare at the green internal eye fixation lamp. If necessary, while viewing the monitor, press the FIX TARGET switch to move the internal eye fixation lamp, and guide the patient’s eye. The internal eye fixation lamp moves up and down and toward the left and right.
4. Operation 10 Bring the eye into focus. Turn the focus knob and align the split lines into a single straight line. Split lines Working distance dots In the event of the following: When the split lines are not visible: If this is the case, refer to 6.2.1 Troubleshooting (see page 26). When the split lines are not aligned into a single straight line: If the split lines are not aligned: Use the diopter compensation lever to insert the diopter compensation lens, and take the photographs.
4. Operation Note: When operating the diopter compensation lever, set it precisely to the 0, “–” or “+” position. If the lever is set to a position midway between two settings, fundus images will not be taken properly. 11 Adjust the position of the retinal image. Tilt the operation lever forward or backward so that the left and right working distance dots are made as small as possible.
4. Operation 4.3 Photography 1 Take a photograph. Check that the photography status display is green. In a flare-free status, check the focus again, and press Shutter release button the shutter release button. A retinal image is now taken, and the anterior eye observation screen is displayed. However, the retina observation screen will remain on the monitor if the stereo mode is established.
4. Operation 2 Review the image. The fundus images and study information are displayed in the control software. Check the images. When the images taken are not clear If this is the case, refer to 6.2.1 Troubleshooting (see page 26). 3 Now take a photography of the other eye. Taking photographs of one eye will cause the pupils of both eyes to contract excessively. Wait at least 5 minutes, and check that the pupils have dilated.
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5. Settings The various settings can be established on the setup menu screen. 1 Display the setup menu screen. Press the SET switch on the anterior eye observation screen. The setup menu screen is now displayed. SET MENU >MONITOR PANEL STEREO FIX RESET LOW FLASH SPLIT 50 4 ON . OFF ON . OFF ON . OFF ON . OFF SET END 2 Change the settings. Press the or FIX TARGET switch to select the items. Press the or FIX TARGET switch to select (or change) the setting.
5. Settings Selection item LOW FLASH Used to select whether to take photographs at low flash intensity levels. ON: Photographs are taken at low flash intensity levels. OFF: Photographs are not taken at low flash intensity levels. SPLIT Used to select whether to display the split lines for focusing. ON: The split lines are displayed. (They are not displayed when diopter correction has been undertaken.) OFF: The split lines are not displayed.
6. Daily Inspection and Maintenance ! WARNING The instrument must be repaired by a qualified engineer only. If it is not repaired properly, it may cause fire, electric shock, or accident. ! CAUTION For safety reasons, be sure to inspect the instrument before using it. 6.1 Inspection In order to ensure that the instrument is used safely and normally, please be sure to inspect the instrument before use.
EOS Digital camera Main unit Location 6. Daily Inspection and Maintenance Result Inspection Month Month Month Remedy Day Day Day Check that the cover and parts are not damaged and are not loose. Pass/ Fail Pass/ Fail Pass/ Fail Hold the operation lever, and check that stage unit moves smoothly when it is moved back and forth and to the right and left. Check that the locking of the stage unit operates properly.
6. Daily Inspection and Maintenance 6.1.2 Turning ON the Power Main unit Location Turn on the power of all the equipment which has been connected as a system. Result Inspection Remedy Month Month Month Day Day Day Check whether the POWER lemp lights. Pass/ Fail Pass/ Fail Pass/ Fail Contact a Canon representative or distributor if the power cable is not connected properly.
6. Daily Inspection and Maintenance 6.2 Before Calling a Service Technician Perform the appropriate remedy when any of the problems below appear in inspection or during operation or a warning is displayed in the control software. If performing the remedy still does not fix the problem, or the warning is still displayed, turn OFF the power, and contact a Canon representative or distributor. Please be sure to describe the problem or warning message in detail. 6.2.
6. Daily Inspection and Maintenance Problem The split lines are not visible. Cause Remedy The split bar is not displayed. Press the focus indicator switch to display the split bar. The pupil is not dilated enough. Make the patient’s pupil dilate. If the pupil is still too small, press the SP switch to activate the SP function. The positioning is not correct. Perform positioning. The image is unfocused. Focus the image. Eyebrows or eyelashes are blocking the pupil.
6. Daily Inspection and Maintenance 6.2.2 What to Do when These Displays Appear If a message fails to be cleared even after taking the remedial action suggested below, contact a Canon representative or distributor, and provide full details of the message which is displayed. Message Cause Remedy DEVICE ERROR (code 001) Trouble in power supply unit BACKUP ERROR (code 003) Backup device failure CHARGER ERROR (code 004) Charging circuit failure Contact a Canon representative or distributor.
6. Daily Inspection and Maintenance 6.3 Cleaning and Disinfection 6.3.1 Objective Lens Note: Do not wipe off or rub the objective lens when there is dust or other substances on it. This could scratch the lens surface. Note: Never wipe the objective lens with disinfecting ethanol, eyeglass lens cleaner, or cleaning paper containing silicon. The lens surface could be damaged or the surface may not be completely wiped off. Note: Do not let the tip of a blower touch the objective lens.
6. Daily Inspection and Maintenance 6.3.2 Forehead Rest CAUTION To prevent the risk of infection, wipe the forehead rest with disinfecting ethanol, glutaraldehyde solution, or other disinfectant whenever changing patients. For more details on the disinfection procedure, please consult a specialist. Please also consult a specialist when using a disinfectant other than those specified above and then adding another disinfectant to ethanol since this could damage the forehead rest.
6. Daily Inspection and Maintenance 6.4 Refilling the Chin Rest Paper Note: If the chin rest paper will not be used, be sure to disinfect the chin rest whenever the patient is changed in the same way as the forehead rest. 1 Pull out the chin rest right and left holding pins. 2 Insert the holding pins in the chin rest paper. Insert the holding pins in the right and left holes of the chin rest paper. About 100 sheets of paper can be mounted. 3 Attach the chin rest paper to the chin rest.
6. Daily Inspection and Maintenance 6.5 Power Cable Connections 1 WARNING Be sure to operate this instrument using the power supply described in the specifications. Otherwise, it may result in fire or electric shock. WARNING Be sure to turn OFF the power before plugging or unplugging the cables as indicated in this manual. Also, do not handle it with wet hands. Otherwise, you may get an electric shock that may result in death or serious injury.
6. Daily Inspection and Maintenance 6.6 Attaching and Removing the EOS Digital Camera 6.6.1 Attaching the EOS Digital Camera Note: Do not touch the lens part of the main unit and the mirror part of the digital camera when attaching and detaching the digital camera from the main unit. If any dirt, fingerprints, dust, and other foreign objects attaches to the lens or mirror part, you cannot take a good image. 1 Turn OFF the power of the main unit. Press the power switch to the O side.
6. Daily Inspection and Maintenance 5 Attach the cable to the EOS digital camera. Open the terminal cover of the EOS digital camera, and connect the respective cables to the digital terminal, PC terminal, remote control terminal and video out terminal. 6 Attach the camera cover to the EOS digital camera. Attach the camera cover to the EOS digital camera. Attach the camera cover screws to the tripod socket on the bottom of the EOS digital camera. 6.6.
6. Daily Inspection and Maintenance 5 Remove the EOS digital camera. Turn the EOS digital camera counter-clockwise while holding down the lens release button on the EOS digital camera to detach the camera. 6 Remove the DC coupler. Open the battery compartment cover on the EOS digital camera, and then slide the battery lock lever to remove the DC coupler. After removing the DC coupler, close the battery compartment cover. 7 Attach the cap to the camera mount. Attach the mount cap to the camera mount.
6. Daily Inspection and Maintenance 6.7 Connecting the USB Cable 1 Turn OFF the power of the main unit. Press the power switch to the O side. 2 Remove the power plug from the AC outlet. 3 Connect the USB cable to the main unit. Insert the USB cable connector firmly into the USB connector while holding down the main unit with your hand. 4 Connect the USB connector at the other end to the computer. Connect the connector at the other end of the USB cable to the computer.
6. Daily Inspection and Maintenance 6.8 Carrying the Instrument This is the procedure when carrying the instrument by hand. WARNING When the instrument is going to be moved, be sure to turn OFF the power, unplug the power cable from the AC outlet, and disconnect other cables. Otherwise, the cable may be damaged, which may result in fire or electric shock.
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7. Service Information Repair If problem cannot be solved even after taking the measures indicated in Section 6, contact a Canon representative or distributor for repair. When requesting repair, please provide us with the following information by referring to the rating label on the main unit. Product name: CR-1 Serial number : 6-digit number indicated on the rating label Phenomenon: In detail.
8. Main Specifications Type Non-Mydriatic type Field angle 45°/43° (digital) Image size on the sensor ø13.7 mm Diameter of pupil required ø4 mm or more ø3.7 mm or more (when using the small pupil photography function) Working distance 35 mm Patient’s diopter range –10 to +15D (Without compensation lens) –31 to –7D (when using negative compensation lens) +11 to +33D (when using positive compensation lens) Flash intensity 5.9 EV (Standard) Linked to photography mode Can be set manually (–1.
9. Components CR-1 main unit ......................................................................................................................... 1 Power cable (3 m, Non-Shielded) ............................................................................................ 1 Chin rest paper.......................................................................................................................... 100 Objective lens cap........................................................................
CANON INC. Medical Equipment Group 30-2, Shimomaruko 3-chome, Ohta-ku, Tokyo, Japan Telephone: (81)-3-3758-2111 CANON U.S.A., INC. CANON MEDICAL SYSTEMS Eye Care Systems Department 15975 Alton Parkway, Irvine, CA 92618, U.S.A. Telephone: (1)-949-753-4000 CANON EUROPA N.V. Medical Products Division Bovenkerkerweg 59-61, 1185 XB Amstelveen, The Netherlands Telephone: (31)-20-545-8926 CANON (CHINA) CO., LTD. Medical Equipment Division 15F. Jinbao Building, No.