Sirona Dental Systems GmbH
1 Warning and safety information
Operating Instructions C4
+
59 06 313 D 3382
D 3382.201.01.13.02
7
1
Warning and safety information
Intended use
This dental treatment center is intended for diagnosis,
therapy and dental treatment of humans by properly
trained personnel.
This unit is
not
intended for
operation in areas subject
to explosion hazards
.
On-site installation
The
on-site installation
must have been performed
according to our requirements. The details are described
in the document “Installation Requirements”.
Maintenance and repair
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 unit
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, including statements concerning any modifi-
cations of the rated parameters or of the operating
ranges (if applicable), as well as the date, name of orga-
nization and signature.
Modifications of the system
Modifications of this system which could impair the
safety of the system owner, patients or other persons
are prohibited by law!
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 equipment not approved by Sirona is connected, it
must comply with the applicable standards:
IEC 60950 for information technology equipment (e.g.
PCs), and IEC 60601-1 for medical electrical equipment.
Combination with other equipment
Any person who assembles or modifies a medical elec-
trical system complying with the standard IEC 60601-1-1
(safety requirements for medical electrical equipment)
by combining it with other equipment (e.g., by connect-
ing it with a PC) is responsible for ensuring that the
requirements 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.
