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3. Before Use
3.1
Intended Use
Fast-Fill is intended for heating and extruding Gutta-percha into cleaned and
shaped canals during root canal treatment.
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
This device must not be used in cases where a patient has been fitted with an
implanted heart pacemaker (or other electrical equipment) and has been cautioned
against the use of small electrical appliances (such as electric shavers, hair dryers,
etc.)
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. The device requires special precautions with regard to electromagnetic
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 Fast-Fill, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result. Do not charge, operate or store at high temperatures.
Comply with the specified operating and storage conditions.
4. Gloves and a rubber dam are compulsory during treatment.
5. If irregularities occur in the device during treatment, switch it off. Contact the
agency.
6. Never open or repair the device yourself, otherwise, void the warranty.
7. Cautions should be exercised when use the device to fill the teeth with thin dentinal
root walls.
Summary of Contents for Fast-Fill
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