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2 Safety notices
2.14 Care and cleaning instructions for the practice team
20
2.14
Care and cleaning instructions for the practice
team
DANGER
Inappropriate care and cleaning of the device can result in
malfunction or damage. Qualified personnel must be trained in the
handling of medical devices.
2.15
Modifications and extensions of the system
Use only original Dentsply Sirona parts or parts approved by Dentsply
Sirona. Safe operation is not guaranteed for parts that have not been
approved by Dentsply Sirona. In the event of unintended modifications,
Dentsply Sirona is not liable for resulting damages.
DANGER
All devices connected to this product must comply with the applicable
standards:
• IEC 60601-1, Medical electrical equipment
• IEC 60950-1, Information technology equipment
• IEC 62368-1, Audio/video, information and communication
technology equipment
2.16
Cybersecurity
The treatment center is protected against security threats from the
network by the following features:
● connections are encrypted with SSL/TLS and are only established
with a valid certificate
● connections must be allowed by the user on the Smart Touch
● only software signed by Dentsply Sirona can be installed on the
treatment center
Despite these measures, we recommend:
● only allow devices that you know to establish a connection to the
treatment center (Connection request on the Smart Touch)
● restrict physical access to the IT infrastructure of your practice or
clinic and the treatment center
● have the cybersecurity of your internal network checked by a data
processing specialist
2.17
Electromagnetic compatibility
Medical electrical devices are subject to special precautionary
measures with regard to electromagnetic compatibility (EMC). They
must be installed and operated as specified in the document
"Installation Requirements".
Portable HF communication equipment (including its accessories), as
well as diathermy and HF surgical devices should not be used in the
Instructions for Use Treatment Center Axano Pure
D3685.201.02.01.02 2023-12
Dentsply Sirona
68 29 514 D3685
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