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Digital Retinal Camera CX-1 Instructions for Use For Euporean Union...
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Important Information • This product must only be used by a doctor or a legally qualified person. • 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.
Introduction Features The Canon Digital Retinal Camera is used to observe the retinas of patients’ eyes and take photographs of them. Indications for Use The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.
Member State in which the user and/or patient is established. Electronic Instructions for Use Instructions for use are available on the website for viewing and download by customers. • https://global.canon/en/ifu/medcom/index.html For details, please contact your sales representative or local Canon dealer.
Also, when other equipment is going to be connected to the instrument using the connector for interface, be sure that leakage current is within the tolerable value. For details, please contact your sales representative or local Canon dealer. Do not place your hands or fingers on the base.
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IEC 60601-1 when a computer or monitor conforming to IEC 60950-1 is used. Otherwise, electric shock may occur. For details, please contact your sales representative or local Canon dealer. Make sure that the patient’s name, ID, birth date, and sex match those that are entered for the patient.
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If you add, change or update the OS, driver, or other software after installing the control software, the control software may not function properly. Contact your sales representative or local Canon dealer beforehand. Do not change the Windows Update settings.
• The attached digital camera is designed for this product. 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 this product may result.
• This product needs to be protected from vibration and shocks when it is transported in a vehicle or over long distances. For details, contact your sales representative or local Canon dealer. Disposal Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment.
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2 Safety Symbols on the labels and their meanings. Alternating current Type B Product that WEEE directive, Directive on Waste Electrical and Electronic Equipment, requires separate collection. The directive is effective in the European Union only. Symbol for “Consult instructions for use”. This symbol indicates medical device which complies with the Regulation (EU) 2017/745 This mark shows a certification mark in European Economic Area.
Basic Operations Connecting Cables Make sure that the power switch for this product is turned off. Connect the power cord and the USB cable to the retinal camera. Insert the power plug all the way into an AC outlet. Preparing for an Examination Turn on the computer and start the control software.
Maintenance Daily Inspections Checks before turning on the power Check the following items before turning on the power. Cables 1) The power cord and connection cable are not damaged and their insulation is not torn. 2) The power cord is fully and securely inserted into the AC connector on the main unit and the AC outlet.
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.
These parts cannot be replaced by the user. If these parts are found to be worn out or to have deteriorated during daily or regular inspection, contact your sales representative or local Canon dealer for repairs. • Baseboard (USB connector) •...
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