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Safety
Regulatory Information
CE marking
This device complies with the following:
•
Regulalation (EU) 2017/745
•
Directive 2011/65/EU
For European Union
Notification of Serious Incident
Any 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.
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.
EU_BT8-1756-EN01_CR-2_AF.indb 4
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