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Dentsply Sirona
Operating Instructions Xios AE Sensor USB interface and sensors
67 29 433 D3780
D3780.201.01.01.02 09.2019
Modifications and extensions of the system
2.8
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 Dentsply Sirona accessories or third-party accessories
expressly approved by Dentsply Sirona. The user assumes the risk of
using non-approved accessories.
If any devices not approved by Dentsply Sirona are connected, they
must comply with the applicable standards, e.g.:
● IEC 60950-1 or IEC 62368-1 for information technology equipment
(e.g. PC) and
● IEC 60601-1 for medical electrical equipment.
In case of doubt, contact the manufacturer of the system components.
Combination with other units
2.9
Permissible combinations are specified in the Declaration of Conformity
by the system integrator.
Additional instructions
2.10
2.10.1
Operate Sensor as Directed
Always use the sensor and in accordance with the directions and
recommendations contained in these operating instructions. Do not
attempt to modify the sensor or use it in system configurations not
specified in this document.
Before each usage, check the outer surface of the sensor and cable for
any signs of physical damage or defect. Sensor surfaces should have a
smooth finish with no evidence of chipping or damage. If detected,
contact your local distributor of Dentsply Sirona products for further
instructions.
2.10.2
Do Not Touch Exposed Connectors on Non-Medical
Equipment and the Patient at the Same Time
When the sensor is in use, avoid touching exposed connectors on non-
medical electrical equipment and the patient at the same time. The
human body is capable of conducting electrical current and may cause
a shock hazard to patients if appropriate safety practices are not
observed.
2.10.3
RF Interference Considerations
Although the sensor is designed to provide a reasonable degree of
protection from electromagnetic interference, according to IEC
International regulations, they must be installed at an adequate distance
from electricity transformer rooms, static continuity units, two-way
amateur radios and cellular phones. To ensure proper operation, the
latter (meaning, electricity transformer rooms, static continuity units,
two-way amateur radios and cellular phones) can be used only at a
minimum distance of 5 feet (1.5m) from any part of the sensor.
2 Safety instructions
2.8 Modifications and extensions of the system
13
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