Before Use; Scope Of Application; Contraindications - Eighteeth Fast-Pack pro User Manual

3. Before Use

3.1Scope of application

Fast-Pack pro is intended for warming and softening gutta-percha master cones and
searing off gutta-percha cones.
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.

3.2Contraindications

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.
Read the following warnings before use:

The device must not be placed in humid surroundings or anywhere where it can
come into contact with any type of liquids.

Do not expose the device to direct or indirect heat sources. The device must be
operated and stored in a safe environment.

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-Pack pro,
including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

If the package is damaged before opening, contact the agency.

Do not charge, operate or store at high temperatures. Comply with the specified
operating and storage conditions.

Gloves and a rubber dam are compulsory during treatment.

If irregularities occur in the device during treatment, turn it off. Contact the agency.
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