Warning And Safety Information; Intended Use; General Safety Information - Sirona C1+ Gebrauchsanweisung

Sirona Dental Systems GmbH
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Warning and safety information

Intended use

General safety information

Combination with other units
59 06 446 D 3386
D 3386.201.01.08.02
1 Warning and safety information
This dental treatment center is intended for therapy,
diagnosis and dental treatment. in humans.
This unit is not intended for operation in areas subject
to explosion hazards.
The 'on-site installation' must be performed according
to our requirements.
As manufacturers of dental medical equipment and in
the interest of the operational safety of your system, we
stress the importance of having maintenance and
repair of your treatment center performed only by our-
selves or by agencies expressly authorized by us. Fur-
thermore components influencing the safety of the
device should always be replaced with original spare
parts upon failure.
When having such work done, we suggest that you
request a certificate stating the type and extent of work
performed, if necessary, including statements concern-
ing any modifications of the rated parameters or of the
operating ranges, as well as the date, name of organiza-
tion and signature.
Changes to this unit which could impair its safety for the
system owner, patients or third parties are forbidden by
legal regulations!
For reasons of product safety, only original Sirona
accessories approved for this product, or accessories
from third parties approved by Sirona, may be used. The
user is responsible for dangers resulting from the use of
non-approved accessories.
If any devices not approved by Sirona are connected,
they must comply with the applicable standards:
EN 60950 for information technology equipment, and EN
60601-1 for medical electrical equipment.
Any person who assembles or modifies a medical elec-
trical system complying with the standard EN 60601-1-1
(Safety requirements for electromedical systems) by
combining it with other equipment (e.g., by connecting it
with a PC) is responsible for ensuring that the require-
ments of this regulation are met to their full extent for the
safety of the patients, operators and environment.
In case of doubt, contact the manufacturer of the system
components.
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