Changes To The Unit; Structural Alterations; Electromagnetic Compatibility - Dentsply Sirona Orthophos E Ceph Operating Instructions Manual

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2 Safety instructions

2.15 Changes to the unit

14
Changes to the unit
2.15
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.

Structural alterations

2.16
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.

Electromagnetic compatibility

2.17
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.
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.
Dentsply Sirona
Operating Instructions Orthophos E
67 11 001 D3352
D3352.201.12.01.02    03.2019

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