European Authorized Representative; Disposal Of The Product; Reporting Of Incident To Manufacturer; Technical Characteristics - Dentsply Sirona X-Smart Apex Locator User Manual

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European Authorized Representative

European Authorized Representative who has been empowered to
enter into commitments in our behalf:
CEpartner4U B.V.
ESDOORNLAAN 13, 3951 DB MAARN, THE NETHERLANDS.
Contact Person: Mr. Ton Pennings
Tel. +31 343 442 524, Fax +31 343 442 162
Email: office@cepartner4u.com
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Disposal of the Product

Recycling: PLEASE DO NOT THROW AWAY! This product and all
its components must be recycled through your supplier.
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Reporting of Incident to Manufacturer

Users shall report to the Manufacturer any serious incident related
to the device, using this email: info@forumtec.net. Any personal
information contained in this email is considered confidential and is
accessible only by authorized personnel.
Any serious incident that has occurred in relation to the device
should be also reported to the competent authority of the Member
State in which the user and/or patient is established.
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Technical Characteristics

X-Smart
electrical medical device, belongs to the following category of
medical devices:
Internally powered equipment
Type BF Applied Parts
Not suitable for use in the presence of flammable
anesthetic mixtures with air, oxygen or nitrous oxide
Continuous operation
Expected service life: 3 years
Ingress of liquids – not protected
® Apex Locator electronic apex locator is a programmable
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