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Provide indications for observing and recording retinal fundus images without contact for diagnosis, plus product composition and safety guidance. Includes regulatory compliance details (EU 2017/745 and EU 2011/65/EU), serious incident reporting requirements, and electronic instruction access. Safety precautions cover authorized use, maintenance responsibility, network connection risks, cleaning and disinfectant handling, electrical safety, installation environment limits, and patient identification and hygiene.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/digital-retinal-camera-cr-2-af-instructions-for-use/645992/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/digital-retinal-camera-cr-2-af-instructions-for-use/645992.png","ImageObject",300,407,{"name":92,"@type":93},"Kurz","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-10","2026-10-23",true,{"@type":102,"interactionType":103,"userInteractionCount":81},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Who is allowed to use the device?","Question",{"text":112,"@type":113},"The product must only be used by a doctor or a legally qualified person.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What are the indications for use of the Digital Retinal Camera?",{"text":117,"@type":113},"It is intended to observe and record retinal fundus images through the pupil without making contact with the patient’s eye for diagnostic purposes.",{"name":119,"@type":110,"acceptedAnswer":120},"What safety precautions are given for cleaning and disinfecting?",{"text":121,"@type":113},"Turn off power and unplug the cord before cleaning; do not use flammable solvents such as alcohol, benzine, thinner, or similar chemicals, and use appropriate disinfectant ethanol for wiping the forehead rest while replacing/disinfecting chin rest paper as instructed.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},645992,1793064333,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":81,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":46,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":31,"preview_page_count":4},2336478945635,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Digital Retinal Camera  \nCR-2 AF  \nCR-2 Plus AF  \nInstructions for Use  \nFor European Union  \nImportant Information  \n• This product must only be used by a doctor or a legally qualified person.  \n• The user is responsible for managing the usage and maintenance of medical equipment. We suggest that a dedicated individual is assigned responsibility for maintenance to ensure that this product is kept in good condition and can be used safely.  \n• Connection of a system that uses this product to a network could result risks to patients, operators, or third parties. A dedicated individual who is assigned responsibility for maintenance should assess these risks in advance. The responsible person should also assess the risks when changes to the network (including changes in the network configuration, addition or disconnection of items to the network, or update or upgrade of equipment connected to the network) occur after connection.  \n1 Introduction  \nFeatures  \n\n| The Canon Digital Retinal Camera takes digital photographic retinal images of patient’s eyes across an angle of view of 45 degrees.\u003Cbr>Indications for Use |\n| --- |\n| This medical device is intended to observe and record images of retinal fundus through the pupil without making contact with subject’s eye for the purpose of diagnosis by way of producing fundus image information.\u003Cbr>Composition |\n\n• Digital Retinal Camera  \n• Digital camera  \n• Control Software  \nOptional products  \nExternal eye fixation lamp unit EL-1 Chin rest paper—500 sheets  \n2 Safety  \nRegulatory Information   \nCE marking  \nThis device complies with the following:  \n• Regulation (EU) 2017/745  \n• Directive 2011/65/EU  \nFor European Union  \nNotification of Serious Incident  \nAny serious incident (defined in Article 2(65) of the Regulation (EU) 2017/745) that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.  \nElectronic Instructions for Use  \nInstructions for use are available on the website for viewing and download by customers.  \n• [https://global.canon/en/ifu/medcom/index.html](https://global.canon/en/ifu/medcom/index.html)  \nFor details, please contact your sales representative or local Canon dealer.  \nSafety Precautions   \nTo prevent injuries and data loss, operate this product correctly by following the safety precautions.  \n\n| Do not leave alcohol, thinner, or any flammable chemicals near the instrument.\u003Cbr>Do not place this product near a flammable solvent. Fire may result if the solventspills or evaporates and makes contact with the internal electric parts. Some disinfectants are flammable. Be sure to take precautions when using them. |\n| --- |\n| Do not clean this product with flammable solvent.\u003Cbr>For safety reasons, before cleaning this product, be sure to turn off the power of all the devices and unplug the power cord from the AC outlet. Do not use alcohol, benzine, thinner or any other flammable solvent.\u003Cbr>Otherwise, fire or electric shock may result. |\n| Do not touch conductive parts of non-medical equipment and the patient simultaneously.\u003Cbr>Otherwise, electric shock may result. |\n| Use an isolation transformer when this system is connected to a network.\u003Cbr>Connect an isolation transformer conforming to IEC 60601-1 for networks between the computer and HUB.\u003Cbr>Otherwise, there is a risk of electric shock if the network is faulty. |\n| Do not install in locations exposed to water, steam, moisture or dust.\u003Cbr>Doing so may cause problems or malfunctions. |\n| Do not install in locations exposed to salt, sulfur or corrosive gas.\u003Cbr>Doing so may result in corrosion of the instrument, problems or malfunctions. |\n| Do not install in locations that are unstable or exposed to vibration.\u003Cbr>The vibration may knock over the instrument or the instrument may become unbalanced and fall, resulting in a malfunction or injury. |\n| Do not place your hands or fingers on the base.\u003Cbr>You","cbCaiu3mmmbif1PU","https://ap.wps.com/l/cbCaiu3mmmbif1PU","pdf",580454,"English","# 1 Introduction\n## Features\n## Indications for Use\n## Composition\n## Optional Products\n# 2 Safety\n## Regulatory Information\n## Notification of Serious Incident\n## Electronic Instructions for Use\n## Safety Precautions","[{\"question\":\"Who is allowed to use the device?\",\"answer\":\"The product must only be used by a doctor or a legally qualified person.\"},{\"question\":\"What are the indications for use of the Digital Retinal Camera?\",\"answer\":\"It is intended to observe and record retinal fundus images through the pupil without making contact with the patient’s eye for diagnostic purposes.\"},{\"question\":\"What safety precautions are given for cleaning and disinfecting?\",\"answer\":\"Turn off power and unplug the cord before cleaning; do not use flammable solvents such as alcohol, benzine, thinner, or similar chemicals, and use appropriate disinfectant ethanol for wiping the forehead rest while replacing/disinfecting chin rest paper as instructed.\"}]","Digital Retinal Camera - CR-2 AF - Instructions for Use | PDF",1792744731]