General Description; Certification; Intended Use - Dentsply Sirona CEREC AF Notice D'utilisation

Dentsply Sirona
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
66 37 487 D3652
D3652.201.01.14.02 10.2017
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General description

3.1

Certification

CE mark
This product bears the CE mark in accordance with the provisions of
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
NOTICE
CE mark for connected products
Further products which are connected to this unit must also bear the CE
mark.
Compliance
Anyone creating or changing a medical electrical system through a
combination with other devices in accordance with standard EN 60601-1-
1:2001 based on 60601-1-1:2000 (specification for the safety of medical
electrical systems)/UL 60601-1 Part 1: first edition 2003 is responsible for
ensuring that the requirements of these standards are met to the full
extent in order to ensure the safety of patients, operators and the
environment.
3.2

Intended use

In combination with the milling unit, the CEREC AF/CEREC AI/CEREC
AF Connect/CEREC AI Connect unit is used to manufacture dental
restorations, e.g. from a natural-appearing ceramic material. The unit
may be operated only by medically trained and qualified personnel.
This unit must not be used for any other purpose. If the unit is used for
any purpose other than the one mentioned above, it may be damaged.
Intended use also includes compliance with these Operating Instructions
and the relevant maintenance instructions.
CAUTION
Follow the instructions
If the instructions for operating the unit described in this document are
not observed, the intended protection of the user may be impaired.
3 General description
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