Safety Instructions; Product Safety; Combination With Other Units; On-Site Radiation Protection - Dentsply Sirona Orthophos E Installation Requirements

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2 Safety instructions
2.1 Product safety
6
2

Safety instructions

2.1

Product safety

CAUTION
Product safety hazard
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.
Recommendation! If any devices not approved by Dentsply Sirona are
connected, they shall comply with the applicable standards:
- IEC 60950 / IEC 62368-1 for information technology equipment
(e.g. PC)
- IEC 60601-1 for medical electrical equipment
In case of doubt, contact the manufacturer of the system components.
2.2

Combination with other units

Putting together or altering a medical electrical system by combining with
other devices in accordance with IEC 60601-1 (safety requirements for
medical electrical systems) is subject to the obligation to ensure
compliance with the requirements of this provision for patient safety, the
operator and the environment.
2.3

On-site radiation protection

When using the Orthophos E X-ray unit, proper shielding of the room and
operator position is essential.
It is the installer's responsibility to ensure that all local radiation
regulations and safety measures are met.
2.4

Radiotelephones

Mobile RF communication equipment, including accessories, should not
be used at a low level to the unit. Non-compliance can lead to a reduction
in the performance features of the unit.
2.5

Electromagnetic compatibility

The device should not be operated immediately adjacent to other
devices. If this proves to be unavoidable, the unit should be monitored to
ensure that it is operating properly.
For details, see section Electromagnetic compatibility
Dentsply Sirona
Installation Requirements Orthophos E
67 10 532 D3352
D3352.021.04.01.02 03.2019

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