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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.
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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. • The user is responsible
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Contents 1 Introduction ................................................................................................. 4 Features ...................................................................................................... 4 Indications for Use ..................................................................................... 4 Components .............................................................................................. 5 Conventions Used in This Manual ............
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Introduction 1 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. Compact, user-friendly design The CR-2 is designed t
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1 Introduction Components Digital Retinal Camera CR-2 Video cable Main unit Use to connect an external monitor. Digital camera Digital camera cover Digital camera specialized for Protects the cable that is the CR-2. connected to the digital camera. Power cord Chin rest paper Connects the CR-2 to an AC 100 sheets provided. outlet. (3 m) USA and Canada only: Plug type: VM0275 Hospital- Grade Camera mount cap Objective lens cap Initially covers the camera Initially covers the objectiv
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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. A warning that incorrect operation may result in death or serious injury. WARNING A caution that incorrect operation may result in serious injury. CAUTION A caution that incorrect operation may break the CR-2 or damage other CAUTION devices. This symbol indicates things tha
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Safety 2 Regulatory Information The following sections list the classifications applicable to the CR-2 and the directives and standards that the CR-2 complies with. Device Classification Protection against electric shock Class I equipment Degree of protection against electric shock Type B applied parts Degree of protection against ingress of water IPX0 Degree of safety of application in the presence of a Not suitable flammable anaesthetic mixture with air or with oxygen or nitrous oxide Mode
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2 Safety European Union 93/42/EEC Medical Device Directive EN 60601-1 Ed. 3.0: 2006 Medical electrical equipment – Part 1: General requirements for safety EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic compatibility – Requirements and tests EN 60601-1-6: 2004 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability IEC 62304: 2006 Medical device software – Software life-cycle processes EN 62366:
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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 • 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. Be sure to hold the plug. • Do not use an extension cable with the power cord. Connect it directly to the
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2 Safety Do not plug or unplug the power plug with wet hands WARNING Do not plug or unplug the power plug or handle any other parts with wet hands. Prohibited 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. Insert t
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2 Safety Do not place your hands or fingers on the base CAUTION Your hand or fingers may be pinched and injured when the stage moves to either Prohibited 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. Do not hold the fa
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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. Do not touch the main unit and the chin rest while they are CAUTION moving Prohibited The main unit and the chin rest move to the cente
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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. • If any problems with the CR-2's digital camera occur or repairs are needed, contact the Canon representative or distributor from
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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 Humidity Atmospheric pressure Environment of use 10 to 35°C 30 to 90% RH (no 800 to 1060 hPa condensation) Storage and transportation –30 to 60°C 10 to 60% RH (no 700 to 1060 hPa environment condensation) • Do not install, store, or leave the CR-2 in a very hot or humid environment. Also, do not use the CR-2 outside. Doing so may cause a ma
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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. This product
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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. Alternating current Type B Class I device indicating manufacturer’s declaration of conformance with the Annex VII of the Medical Device Directive, 93/42/EEC Certification mark that shows the product has passed the tests by TUV Rheinland of conformi
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Names of Parts 3 Retinal Camera 1 2 12 3 4 13 5 6 7 8 14 9 15 16 10 17 18 11 1 Digital camera 9 Focus ring Turn to focus the image. 2 Digital camera cover 3 Observation monitor 10 Stage lock For viewing the anterior eye and retina. 11 Indentation for lifting 4 Power switch for the digital camera 12 Height adjustment mark 5 Operation lever 13 Main unit 6 Shutter release button 14 Operation panel 7 Alignment button 15 USB connector Switches between a view of the anterior eye and 16 AC p
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3 Names of Parts 19 20 26 21 22 a 23 b c 24 d 27 25 19 Connector for external eye fixation lamp 24 Chin rest (with cap) 25 Indentation for lifting Connector for the external eye fixation lamp (sold 26 Diopter compensation knob separately). a No diopter compensation b Negative compensation 20 Forehead rest 21 Objective lens c Positive compensation 22 Objective lens cap d Anterior eye photography 23 Face rest 27 Base 18
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3 Names of Parts Operation Panel 1 2 6 3 4 7 5 8 1 Flash intensity button/lamp 5 CHIN REST button +: Flash intensity increases. Top: Raises chin rest. –: Flash intensity decreases. Bottom: Lowers chin rest. 2 Observation light brightness button/lamp 6 FIX TARGET button +: Observation light brightness increases. Move up, down, right, and left to move internal eye fixation lamp. –: Observation light brightness decreases. 7 Set button/lamp 3 x2 photography button/lamp Internal eye fixation
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3 Names of Parts Observation Monitor During anterior eye observation 1 4 5 2 3 6 1 Pupil alignment circles 4 Left/right eye indicator R: Right eye 2 Photography ready lamp Green: Ready to shoot L: Left eye Red: Not ready to shoot 5 Diopter compensation knob position 3 Observation light brightness indicator indicator : Anterior eye photography 6 Flash intensity indicator During retinal observation (with x1.3 magnification) 1 7 8 2 9 3 10 4 5 6 11 1 Indicator for top limit of position o
