General Description; Certification; Intended Use - Sirona CEREC AC Connect Operating Instructions For The Acquisition Unit

Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit CEREC AC Connect
63 20 134 D3492
D3492.201.04.15.02 10.2018
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General description

Certification

3.1
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.
NOTE
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.

Intended use

3.2
This unit allows you to create digital impressions and transmit these to
your dental laboratory. 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.
For the USA only
CAUTION: Federal law (USA) restricts sale of this device to or on the
order of a physician, dentist, or licensed practitioner.
3 General description
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