Indications For Use; Contraindications; Warnings - Denstply Sirona X-Smart IQ Protocole D'utilisation

Indications for Use

1 INDICATIONS FOR USE
The X-Smart IQ
operate endodontic files in both reciprocating and continuous rotation mode during an
endodontic procedure.
The device must only be used in hospital environments, clinics or dental offices by
qualified persons.
Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for
dental instruments and equipment. X-Smart IQ
and intended for single patient use only.
2

CONTRAINDICATIONS

Read the following contraindications before use.
• The X-Smart IQ
heart pacemaker (or other electrical equipment) or cautioned against the use of
small electrical appliances (such as electric shavers, hair dryers, etc.).
• Safety and effectiveness have not been established in pregnant and breastfeeding
women or in children.
• Clinical judgment needs to be exercised by the end user of the X-Smart IQ
Handpiece.
3

WARNINGS

Read the following warnings before use.
Some sections / texts of this DFU are dedicated uniquely to readers from a specific
territory. When this happens the section / text will be clearly identified with a sentence
similar to: For US / EU readers. If nothing is indicated, the text is applicable to all of the
intended territories.
Dentist
• The X-Smart IQ
used by trained and qualified dentists.
• Do not use the X-Smart IQ
outside endodontics.
END-IFU-X-SMART-IQ-V16-WEB-EUR-Multilingual-2021-01
®
Handpiece is a cordless motor handpiece with torque control used to
®
Handpiece must not be used in patients fitted with an implanted
®
Handpiece is intended for endodontic treatment and shall only be
®
Handpiece for implants or any other dental procedure
®
Disposable Barrier Sleeve is non-sterile
®
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