Regulatory Information - Canon CXDI-Pro Instructions For Use Manual

7
7.1
Type of protection against
electrical shock
Degree of protection against
electrical shock
7.2
This product complies with the following:
Regulation (EU) 2017/745
Directive 2011/65/EU
Directive 2014/53/EU
Directive 2014/30/EU
Directive 2014/35/EU
7.3
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 product 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.
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Regulatory information

Medical equipment classification
CE marking
For European Union
Internally powered equipment
Class I Equipment, with Power Box
Type B Applied Parts : Detector