61 93 556 D3509
15
D3509
.
201.01.02
.
02
19.09.2008
2 Safety information
Sirona Dental Systems GmbH
Modifications and extensions of the system
Operating Instructions TENEO
2.13
Modifications and extensions of the
system
Modifications to this system which might affect the safety of the system
owner, patients or other persons are prohibited by law.
For reasons of product safety, this product may be operated only with original
Sirona accessories or third-party accessories expressly approved by Sirona.
The user assumes the risk of using non-approved accessories.
If any devices not approved by Sirona are connected, they must comply with
the applicable standards, e.g.:
z
IEC 60950 for information technology equipment (e.g. PC) and
z
IEC 60601-1 for medical electrical equipment.
The treatment center monitor must fulfill the requirements of IEC 60950 and
IEC 60601-1.
The loudspeaker port of the monitor may be connected only to a device that
complies with IEC 60950 (e.g. a PC) or
IEC 60601-1. Under no circumstances may it be connected e.g. to a stereo
system, etc.
If a system is created during the installation process, the requirements of IEC
60601-1-1 must be fulfilled.
2.14
Electromagnetic compatibility
Medical electrical equipment is subject to special precautionary measures
regarding electromagnetic compatibility (EMC). It must be installed and
operated as specified in the document "Installation Requirements."
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of such devices (e.g. mobile
phones) in practice or hospital environments must be prohibited.
The presence of electromagnetic interference in the vicinity of the treatment
center may cause image degradation and interruptions in the data
transmission via the USB interface to the PC. In those cases, repeat the
image acquisition or other actions.
In the event of heavy interference, it may be necessary to restart the PC. It is
therefore not recommended to use the PC for controlling other devices that
provide essential performance components.
2.15
HF surgery
This dental treatment center is available with a high-frequency surgical
device.
Only in the Federal Republic of Germany: The system owner is obliged to
keep a “Medical Product Log” if any HF surgical equipment is installed! For
more information, refer to "Safety tests for systems with HF surgical
equipment" [
