Digital Retinal Camera Operation Manual Make sure you read this manual before using the instrument. Keep this manual safely so that you can use it in the future.
Thank you for purchasing the Canon Digital Retinal Camera CR-2 (referred to as “CR-2” in this manual). The operation manuals for this instrument consist of the “Digital Retinal Camera CR-2 Operation Manual” and the “Retinal imaging control software NM 2 Operation Manual.” Be sure to read these manuals thoroughly before using the instrument, and apply the information that you learn. Important • The CR-2 must only be used by a doctor or a legally qualified person.
Contents 1 Introduction.................................................................................................. 4 Features....................................................................................................... 4 Indications for Use...................................................................................... 4 Components . ............................................................................................. 5 Conventions Used in This Manual .........................
1 Introduction Features The Canon Digital Retinal Camera CR-2 takes digital photographic retinal images of patient’s eyes across an angle of view of 45 degrees, in a naturally dilated state without using mydriatics. The CR-2 has the following features. Reduced flash intensity The CR-2 can take images at ISO 1600 at the standard flash intensity, and ISO 6400 in low flash intensity mode. This reduces patient discomfort caused by light glare.
1 Introduction Components Digital Retinal Camera CR-2 Main unit Video cable Use to connect an external monitor. Digital camera Digital camera specialized for the CR-2. Digital camera cover Protects the cable that is connected to the digital camera. Power cord Connects the CR-2 to an AC outlet. (3 m) USA and Canada only: Plug type: VM0275 HospitalGrade Chin rest paper 100 sheets provided. Camera mount cap Initially covers the camera mount on the retinal camera.
1 Introduction Conventions Used in This Manual This manual uses the following symbols to indicate safety precautions that are important for using the CR-2 safely. Always follow the advice in these safety precautions. WARNING CAUTION CAUTION A warning that incorrect operation may result in death or serious injury. A caution that incorrect operation may result in serious injury. A caution that incorrect operation may break the CR-2 or damage other devices.
2 Safety Regulatory Information The following sections list the classifications applicable to the CR-2 and the directives and standards that the CR-2 complies with.
2 Safety European Union 93/42/EEC Medical Device Directive EN 60601-1 Ed. 3.
2 Safety Safety Precautions To prevent injuries and data loss, operate the CR-2 correctly by following the safety precautions. Do not damage the power cord WARNING Prohibited • Do not place anything heavy onto the power cord. • Do not damage or modify the power cord. • Do not forcibly bend, twist or pull the power cord. • Do not hold the power cord when removing it from the AC outlet. Be sure to hold the plug. • Do not use an extension cable with the power cord. Connect it directly to the AC outlet.
2 Safety Do not plug or unplug the power plug with wet hands WARNING Prohibited Do not plug or unplug the power plug or handle any other parts with wet hands. Otherwise, fire or electric shock may result. Unplug the plug periodically and remove any dust or dirt around the plug and the AC outlet If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture, and this may cause insulation failure which may result in a fire.
2 Safety Do not place your hands or fingers on the base CAUTION Prohibited Your hand or fingers may be pinched and injured when the stage moves to either side. Similarly, instruct the patient not to place the patient’s hands and fingers there. Be sure to turn off the power before moving the CR-2 Before moving the CR-2, make sure that the power is turned off, the power plug is unplugged from the AC outlet, and any cables that are connected to other devices are disconnected.
2 Safety Be sure to turn off the power when not in use CAUTION For safety reasons, be sure to turn off the power of all the devices when the CR-2 is not being used. Also, unplug the power plug from the AC outlet and put on the cover when the CR-2 is not going to be used for a long time. Otherwise, dust or any foreign matter may accumulate and result in fire.
2 Safety Notes on Using CR-2 Digital camera • The attached digital camera is designed for the CR-2. The specifications differ from commercially available Canon digital cameras, so it can be used only for observing and taking photographs of peoples' eyes. Do not use the digital camera separately detaching from the main unit or it may cause failure on the CR-2.
2 Safety Environment of use • Use, store, and transport the CR-2 in an environment that is within the range of the following conditions. Temperature Environment of use 10 to 35°C Storage and transportation –30 to 60°C environment Humidity Atmospheric pressure 30 to 90% RH (no condensation) 800 to 1060 hPa 10 to 60% RH (no condensation) 700 to 1060 hPa • Do not install, store, or leave the CR-2 in a very hot or humid environment. Also, do not use the CR-2 outside.
2 Safety Disposal Disposal of this product in an unlawful manner may have a negative impact on health and on the environment. When disposing of this product, therefore, be absolutely sure to follow the procedure which is in conformity with the laws and regulations applicable in your area. European Union (and EEA*) only This symbol indicates that this product is not to be disposed of with your household waste, according to the WEEE Directive (2002/96/EC) and your national law.
2 Safety Rating Label Display The position and contents of the label attached on the CR-2 is shown below. Follow the information on the label to use the CR-2 appropriately. The following table describes the marks and indications on the rating label.
3 Names of Parts Retinal Camera 1 2 12 3 4 13 5 6 7 8 14 9 15 16 1 2 3 10 17 11 18 Digital camera Digital camera cover Observation monitor For viewing the anterior eye and retina. 4 5 6 7 Power switch for the digital camera Operation lever Shutter release button Alignment button Switches between a view of the anterior eye and the retina. 8 Main unit vertical movement ring 9 Focus ring Turn to focus the image.
3 Names of Parts 19 20 26 21 22 a 23 b c 24 d 27 25 19 Connector for external eye fixation lamp (with cap) Connector for the external eye fixation lamp (sold 20 21 22 23 18 24 25 26 Chin rest Indentation for lifting Diopter compensation knob separately).
3 Names of Parts Operation Panel 1 2 6 3 4 7 5 8 1 2 Flash intensity button/lamp 5 Top: Raises chin rest. –: Flash intensity decreases. Bottom: Lowers chin rest. Observation light brightness button/lamp 6 +: Observation light brightness increases. x2 photography button/lamp 7 Small pupil photography button/lamp Enables small pupil photography function. (See Set button/lamp Internal eye fixation lamp blinks. Enables x2 photography function.
3 Names of Parts Observation Monitor During anterior eye observation 1 2 1 4 2 5 3 6 Pupil alignment circles Photography ready lamp 4 Green: Ready to shoot Red: Not ready to shoot 3 Left/right eye indicator R: Right eye L: Left eye 5 Observation light brightness indicator Diopter compensation knob position indicator : Anterior eye photography 6 Flash intensity indicator During retinal observation (with x1.
4 Basic Operations Flow of Operation The flow of operations for retinal photography is as follows. Connect the cables if necessary as described in “Connecting Cables” (see page 22).
4 Basic Operations Connecting Cables Connect the CR-2 to a computer in which the Rics NM 2, the supplied software, has been installed. • Do not plug or unplug the power plug with wet hands. WARNING • Do not use any power cord other than the supplied. Otherwise, fire or electric shock may result. 1 Make sure that the power switch for the CR-2 is turned off. 2 Connect the power cord and the USB cable to the retinal camera. 3 Insert the power plug all the way into an AC outlet.
4 Basic Operations 3 Remove the objective lens cap, and turn the retinal camera's power switch to the ON position. The POWER lamp lights and the set lamp blinks. The CR-2 automatically does an initialization sequence (internal check and initialization of driving parts). After the initialization the parts of the main unit stop in their center positions. CAUTION The main unit and the chin rest move to the center position when the CR-2 is turned on.
4 Basic Operations 7 Disinfect the forehead rest and replace the chin rest paper. If chin rest paper is not being used, disinfect the chin rest also. • To prevent the risk of infection, wipe the forehead rest with ethanol solution or any other disinfectant whenever changing patients. For details on how to disinfect, consult a specialist. CAUTION • To ensure cleanliness, replace the chin rest paper whenever the patient is changed. Setup for Patient 1 Start an examination on the Rics NM 2.
4 Basic Operations Alignment 1 CAUTION Align the retinal camera with the eye to be photographed. When adjusting the position of the retinal camera in the front-back direction, slowly bring the main unit closer to the patient while looking at the patient’s eye from the side. The patient’s eye may be injured if the objective lens makes contact with it. 1. Move the stage until the eye to be photographed appears in the observation monitor. 2.
4 Basic Operations 2 Tilt the operation lever forward or backward to unify the top and bottom of the image of the pupil. When the pupil is smaller than the inner pupil alignment circle Darken the room further to dilate the patient's pupil more. If the patient's pupil does not dilate enough, use the small pupil photography function (see page 30). 3 Press the alignment button. 4 Adjust the observation light brightness with the observation light brightness button.
4 Basic Operations 5 Have the patient stare at the internal eye fixation lamp to fix the part for the photograph. Take the following steps to guide the patient’s eye. Press the FIX TARGET buttons up, down, left, and right to move the internal eye fixation lamp to your desired position and then press the set button to make it blink. If the eye cannot be guided by the internal eye fixation lamp, use the external eye fixation lamp (sold separately).
4 Basic Operations Photography 1 Do a preliminary check before taking photos. a. b. c. d. The photography ready lamp lights green. The working distance dots appear sharpest. The working distance dots are on the extension line of the WD guides. The split lines form a single line. a b, c d Photography ready lamp • Green: Ready to shoot. • Red: Preparing to shoot. Wait until the lamp lights green. • None: Cannot access the Rics NM 2. The retina observation mode is not established.
4 Basic Operations Finishing an Examination 1 CAUTION Save the images on the Rics NM 2 and end the examination. The set lamp starts blinking and the observation monitor turns off. The main unit and the chin rest moves to the center position when a study is finished with the control software. Do not touch the main unit and the chin rest while they are moving. 2 Align the stage with the base and slide the stage lock to LOCK side to lock the stage.
5 Photography Auxiliary Functions The section describes how to use x2 photography, small pupil photography function, diopter compensation, and anterior eye photography and how to connect an external monitor when one is used. x2 Photography You can take and save images that are within the x2 photography range on the observation monitor. 1 Press the x2 photography button.
5 Photography Auxiliary Functions 2 Take the image. Press the small pupil photography button again to finish the small pupil photography. • Do not use the small pupil photography function if the patient's pupil is large enough. The image will be overexposed. • The image may contain flare around the edges of the image outside the photography range.
5 Photography Auxiliary Functions Anterior Eye Photography This function makes it possible to photograph the anterior eye. It is also possible to use the x2 photography function at the same time. Do not allow external light that contains infrared to enter the position being photographed. 1 Switch the diopter compensation knob to the anterior eye photography position. The anterior eye photography mark appears on the observation monitor.
5 Photography Auxiliary Functions 1 Remove the digital camera cover. 2 Connect the video cable to the digital camera. 1. Securely insert the supplied video cable into the VIDEO OUT terminal on the digital camera. 2. Fit the ferrite core of the video cable into the space in the cover, and place the video cable in the notch. Notch Ferrite core 3 Attach the digital camera cover. 1. Hook the digital camera cover hook onto the strap mount of the digital camera. 2.
6 Maintenance This section describes the CR-2's daily inspections, cleaning, disinfection, as well as refilling the chin rest paper, and removing and installing the digital camera. CAUTION • Before using the CR-2, for safety reasons, be sure to perform the daily inspection. • Have a regular inspection performed for the CR-2 at least once a year by the representative that is designated by Canon.
6 Maintenance Cleaning the Objective Lens • Do not wipe or rub the objective lens if there is dirt or dust on it. Doing so could scratch the surface of the lens. • Do not wipe the objective lens with disinfectant ethanol, eyeglass cleaner, or silicone-coated paper. Doing so could corrode the surface of the lens or leave streaks. For information about lens cleaning paper, lens cleaner, and blowers, contact the Canon representative or distributor from whom you purchased the CR-2.
6 Maintenance Cleaning the Image Sensor The digital camera has a self-cleaning sensor unit. Dirt and dust on the front surface of the imaging sensor are automatically removed when the power is turned on or off. This function makes it possible to remove the majority of dirt and dust that may interfere with images. It is not necessary to be aware of this function during normal usage. To use the self-cleaning sensor unit for cleaning, follow the procedure below.
6 Maintenance Disinfecting the Forehead Rest • To prevent the risk of infection, wipe the forehead rest with ethanol solution or any other disinfectant whenever changing patients. CAUTION • The forehead rest may be corroded if a disinfectant other than those above is used or if another disinfectant is added to ethanol. For details on how to disinfect, consult a specialist. Use a sanitized gauze or wipe that includes disinfectant to clean the forehead rest for each patient.
6 Maintenance Removing the digital camera 38 1 Turn off the power to the retinal camera and remove the plug from the AC outlet. 2 Loosen the cover screw and remove the digital camera cover. 3 Remove the cables from the digital terminal and the remote control terminal. 4 Remove the DC coupler. 5 While holding down the lens release button on the digital camera, turn the digital camera counterclockwise to remove it. 6 Attach the caps to the retinal camera and the digital camera mount. 1.
6 Maintenance Installing the digital camera 1 Make sure the following check items. • The power to the retinal camera is off. • The power plug of the retinal camera is not plugged into an electric outlet. 2 Attach the digital camera to the retinal camera. 1. Align the positions of the mounting alignment marks on the retinal camera and the digital camera. 2. Fit the digital camera's lens mount to the retinal camera's mount. 3. Turn the digital camera clockwise until it clicks.
7 Troubleshooting If any of the symptoms listed here occurs or if a warning appears in the Rics NM 2 while using the CR-2, try the relevant remedy described below. If these remedies do not eliminate the symptoms or the warning, turn off the power and contact the Canon representative or distributor from whom you purchased the CR-2. Be ready to provide a detailed description of the symptoms and message. Symptom The power lamp does not light when the power is turned on.
7 Troubleshooting Symptom Cause and remedy The patient's pupil is not dilated enough. Dilate the patient’s pupil. If the pupil is still too small, enable the small pupil photography function. The retinal camera and the eye are not aligned. Align them correctly. Focus the image. Cannot capture good images. Eyebrows or eyelashes are blocking the pupil. Instruct the patient to open their eye wider. The patient's eye is cloudy. Clear images cannot be captured if this is the case.
Appendix Specifications Field angle 45° Photographic magnification 1.1 x (image size on the sensor) Required pupil diameter 4.0 mm or greater (3.
Appendix EMC (Electromagnetic Compatibility) This instrument conforms to the EMC standard IEC 60601-1-2. Guidance and Manufacturer’s Declaration for Electromagnetic Emission The CR-2 is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 should assure that it is used in such an environment.
Appendix Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The CR-2 is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 should assure that it is used in such an environment.
Appendix Guidance and Manufacturer’s Declaration for Electromagnetic Immunity The CR-2 is intended for use in the electromagnetic environment specified below. The customer or the user of the CR-2 should assure that it is used in such an environment.
Appendix Recommended Separation Distances between Portable and Mobile RF Communications Equipment and Devices or the CR-2 The CR-2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Appendix Warranty and Repair Service Service life The service life of this product is eight years if specified inspections and maintenance are done. About repairs If a problem cannot be solved even after taking the measures indicated in “7 Troubleshooting” (see page 40), contact the Canon representative or distributor from whom you purchased the CR-2 for repairs. When requesting repair, please provide us with the following information.
*L-IE-5176* 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 SINGAPORE PTE. LTD.
