Digital Retinal Camera Operation Manual Make sure you read this manual before using the instrument. Keep this manual in a safe place 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 Checking Included Items ........................................................................... 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 800/1600 at the standard flash intensity, and ISO 3200/6400 in low flash intensity mode. This reduces patient discomfort caused by light glare.
1 Introduction Checking Included Items Digital Retinal Camera CR-2 Main unit Digital camera cover Protects the cable that is connected to the digital camera. Digital camera Digital camera specialized for the CR-2. Chin rest paper 100 sheets provided. Power cord Connects the CR-2 to an AC outlet. (3 m) USA and Canada only: Plug type: VM0275 HospitalGrade Objective lens cap Initially covers the objective lens. Camera mount cap Initially covers the camera mount on the retinal camera.
1 Introduction Conventions Used in This Manual Symbols to indicate safety precautions 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: 1990+A1: 1993+A2: 1995 EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for safety IEC 60601-1-1: 2001 Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic compatibility – Requirements and tests IEC60601-1-4: 1996
2 Safety Safety Precautions To prevent injuries and data loss, operate the CR-2 correctly by following the safety precautions. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Do not damage the power cord. • Do not place anything heavy onto the power cord. Prohibited • 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.
2 Safety WARNING Prohibited Do not use a power supply voltage other than that specified on the rating label. Do not use any power cord other than the one supplied. Use the power voltage specified on the rating label. Otherwise, fire or electric shock may result. The supplied power cord is designed exclusively for this product. Do not use any other power cord. Do not plug or unplug the power plug with wet hands. Prohibited Do not plug or unplug the power plug or handle any other parts with wet hands.
2 Safety Do not install in locations exposed to water, steam, moisture or dust. CAUTION Prohibited Doing so may cause problems or malfunctions. Do not install in locations exposed to salt, sulfur or corrosive gas. Prohibited Doing so may result in corrosion of the instrument, problems or malfunctions. Do not install in locations that are unstable or exposed to vibration.
2 Safety Keep the forehead rest and chin rest clean. CAUTION To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient. To ensure cleanliness, replace the chin rest paper for each patient. If the chin rest paper is not being used, be sure to disinfect the chin rest for each patient. For details on how to disinfect, consult a specialist. The forehead rest may be corroded if a disinfectant other than those above is used.
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. Use only for observing and taking photographs of peoples’ eyes. Do not detach the digital camera from the main unit to use separately. Otherwise, failure of the CR-2 may result. • If any problems occur or repairs are needed with the CR-2’s digital camera, contact your sales representative or local Canon dealer.
2 Safety Environment of use • Use, store, and transport the CR-2 in an environment that is within the range of the following conditions. Use the original packaging to store or ship it. Temperature Environment of use 10 to 35°C Storage and transportation –30 to 50°C environment Humidity Atmospheric pressure 30 to 90% RH (no condensation) 700 to 1060 hPa 10 to 95% RH (no condensation) 700 to 1060 hPa • Do not install, store, or leave the CR-2 in a very hot or humid environment.
2 Safety Disposal Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment. Therefore, when disposing of this product, be absolutely certain to follow the procedure which conforms with the laws and regulations applicable to 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 3 4 12 5 13 6 7 8 14 9 15 16 10 17 11 18 1 2 3 4 Digital camera Power switch for the digital camera Digital camera cover Observation monitor 5 6 7 Operation lever Shutter release button Alignment button For viewing the anterior segment and retina. 12 13 14 15 16 17 18 Height adjustment mark Main unit Operation panel USB connector AC power connector Power switch for main unit Stage Switches between a view of the anterior segment and the retina.
3 Names of Parts 19 20 26 21 22 a 23 b c 24 d 27 25 19 20 21 22 23 24 25 18 Connector for external eye fixation lamp (with cap) 26 Diopter compensation knob a No diopter compensation Connector for the external eye fixation lamp (sold b Negative compensation separately).
3 Names of Parts Operation Panel 1 2 6 3 4 7 5 8 1 Flash intensity button/lamp 6 +: Flash intensity increases. –: Flash intensity decreases. 2 Observation light brightness button/lamp 7 3 x2 photography button/lamp Set button/lamp Internal eye fixation lamp blinks. +: Observation light brightness increases. –: Observation light brightness decreases. FIX TARGET button Move up, down, right, and left to move internal eye fixation lamp. 8 POWER lamp Lights when power is turned on.
3 Names of Parts Observation Monitor During anterior segment observation 4 1 5 2 6 3 1 Photography ready lamp 4 Green: Ready to shoot Red: Not ready to shoot 2 3 Pupil alignment circles Observation light brightness indicator Left/right eye indicator R: Right eye L: Left eye 5 Diopter compensation knob position indicator 6 Flash intensity indicator : Anterior segment photography 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 supplied software, the Rics NM 2, has been installed. • Do not plug or unplug the power plug with wet hands. WARNING • Do not use any power cord other than the one 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. The main unit and the chin rest move to the center position when the CR-2 is turned on. Do not touch the main unit or the chin rest while they are moving.
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 disinfectant ethanol for each patient. For details on how to disinfect, consult a specialist. CAUTION • To ensure cleanliness, replace the chin rest paper for each patient. Patient Setup 1 Start an examination on the Rics NM 2. 2 Seat and position the patient.
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, images cannot be taken properly. 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. Flash intensity adjustment The flash intensity is set in advance to the standard level.
4 Basic Operations Finishing an Examination 1 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 move 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. CAUTION 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 segment photography. Instructions are also included for connecting an optional external monitor. 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 Segment Photography This function makes it possible to photograph the anterior segment. 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 segment photography position. The anterior segment photography mark appears on the observation monitor.
5 Photography Auxiliary Functions 1 Remove the digital camera cover. 2 Connect the HDMI cable to the digital camera. 1. Securely insert the HDMI cable into the HDMI mini output terminal on the digital camera. 2. Fit the HDMI cable into the space in the cover, and place the cable in the notch. Notch 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 outlines the maintenance instructions for the CR-2: daily inspection, cleaning, disinfecting, refilling chin rest paper, and removing/installing the digital camera. CAUTION • For safety reasons, before using the CR-2, be sure to perform the daily inspection. • Have a periodically inspection performed for the CR-2 at least once a year by a Canon designated representative to maintain its performance and reliability.
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 your sales representative or local Canon dealer.
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 disinfectant ethanol for each patient. CAUTION • The forehead rest may be corroded if a disinfectant other than ethanol is used. 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 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 6 38 1. Open the battery compartment cover on the digital camera, and then slide the battery lock lever to remove the DC coupler. 2. Close the battery compartment cover.
6 Maintenance Installing the digital camera 1 First be sure to check the following 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 your sales representative or local Canon dealer. 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. Cause and remedy The power cord has been disconnected.
7 Troubleshooting Symptom The split lines do not align. Cause and remedy The diopter patient's eye is outside the range of –10 to +15 D. Use the diopter compensation function, turn the focus ring, and focus on the position where the images of the retina look clear at the same time. 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.
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) The CR-2 is designed and tested to comply with IEC 60601-1-2 (EN 60601-1-2), the applicable regulations regarding EMC for medical devices. The CR-2 needs to be installed and put into service according to the EMC information stated as follows.
Appendix 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 your sales representative or local Canon dealer for repairs. When requesting repair, please provide us with the following information.
*L-IE-5176C* CANON INC. Medical Equipment Group 30-2, Shimomaruko 3-chome, Ohta-ku, Tokyo 146-8501, Japan Telephone: (81)-3-3758-2111 Distributed by: CANON U.S.A., INC. Healthcare Solutions Division 15955 Alton Parkway, Irvine, CA 92618, U.S.A. Telephone: (1)-949-753-4160 CANON EUROPA N.V. Medical Products Division Bovenkerkerweg 59, 1185 XB Amstelveen, The Netherlands Telephone: (31)-20-545-8926 CANON SINGAPORE PTE. LTD.
