3 Before Use
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3. Before Use
3.1 Intended Use
Use for dental root canal treatment using endodontic instruments
in torque controlled continuous rotation and in reciprocating
movement.
This device must only be used in hospital environments, clinics or
dental offices by qualified dental personnel and not used in the
oxygen-rich environment.
3.2 Contraindications
The E-xtreme is contraindicated in cases where patient/user carry
medical implants such as pace makers or cochlear implants etc.
Do not use the device for implants or other non-endodontic dental
procedures.
Safety and effectiveness have not been established in pregnant
women and children.
WARNING
Read the following warnings before use:
1. The device must not be placed in humid surroundings or anywhere
where it can come into contact with any type of liquids.
2. Do not expose the device to direct or indirect heat sources. The
device must be operated and stored in a safe environment.
3. Do not use the equipment in the presence of free oxygen,
anesthetic gas or combustible materials. The equipment must be
operated, used and stored in a safe environment.
4. The device requires special precautions with regard to electrom-
agnetic compatibility (EMC) and must be installed and operated in
strict compliance with the EMC information. In particular, do not use
the device in the vicinity of fluorescent lamps, radio transmitters,
remote controls and do not use this system near the active HF
Surgical Equipment in the hospital. Portable RF communications
equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to
any part of the E-xtreme, including cables specified by the manu-
facturer. Otherwise, degradation of the performance of this equipm-
ent could result.
5. Please do not charge, use or store this equipment at high temp-
erature. Please pay attention to the use and storage conditions.
