64 94 954 D3632
16
D3632
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201.03.08
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23 07.2018
2 Safety information
Dentsply Sirona
2.16 Changes to the unit
Operating Instructions Orthophos SL 2D / 3D
2.16
Changes to the unit
Modifications to this unit 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 Dentsply Sirona accessories or third-party accessories expressly
approved by Dentsply Sirona. The user is responsible for any damage
resulting from the use of non-approved accessories.
2.17
Structural alterations
If structural changes are made in the vicinity of the X-ray unit which result
in the device being exposed to very high levels of vibration or even
impact, the device must be inspected by a service engineer and re-
adjusted and re-calibrated if necessary.
2.18
Electromagnetic compatibility
The acquisition unit complies with the requirements of the standard IEC
60601-1-2.
Medical electrical devices are subject to special precautionary measures
with regard to electromagnetic compatibility (EMC). It must be installed
and operated as specified in the “Installation Requirements” document.
Portable and mobile RF communications equipment may affect medical
electrical equipment.
If the installation requirements and the following recommendations are
not observed, there is a risk that the X-ray images will not have the correct
exposure.
The correctness of the radiation parameters and the repeatability of the
dose values in particular may be affected.
Only operate units approved by Dentsply Sirona at a distance of < 30 cm
from the X-ray unit. The Dentsply Sirona intraoral sensors are approved
for this.
In the case of repairs, only use replacement parts approved by Dentsply
Sirona.
Only use disinfectants approved by Dentsply Sirona so as not to damage
electrical insulation.
Portable HF equipment must not be placed within a 30 cm radius of the
X-ray unit.
HF surgery units and X-ray units must not be operated at the same time.
Summary of Contents for Orthophos SL 2D
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