Intended Use; Target Group; Indications For Use; Contraindications - Dentsply Sirona X-Smart Pro Instructions For Use Manual

1 General information

1.7 Intended use

10
1.7 Intended use
The device is used in dentistry to drive endodontic instruments for the
mechanical preparation of the patient's root canal and cavity.
Some models incorporate an electronic apex locator that assists the
operator to locate the file tip inside the root canal.
1.8

Target group

This product is intended for use only by trained dental personnel in
dental practices.
WARNING
Injury to user and patients caused by improper use or user's lack of
information.
This product is intended for use only by trained dental personnel in
dental practices.
1.9

Indications for Use

The device is indicated for use when endodontic procedures are
required.
1.10

Contraindications

None known.
1.11

Obligation to notify authorities

In the European Union, operators or users must report all serious
events related to medical devices to the competent authority of the
Member State in which they are established.
1.12

Cyber security

The device is protected against security threats via the network using
the following features:
● Network connections are only possible after the network (WLAN) is
actively turned on by the user at the device.
● Network connections to the server are password protected and
encrypted.
● The device will only allow software that is specific to the device, and
with a valid checksum, to be installed.
In addition, we recommend:
● Turning off the network connection when not in use.
● Restricting physical access to the IT infrastructure of your practice or
clinic.
Dentsply Sirona
Instructions for Use X-Smart
67 98 487 D3778
D3778.201.01.02.02 2023-05