3 Before Use
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3. Before Use
3.1 Intended Use
Fast-Pack is intended for heating and cutting Gutta-percha outside the mouth
during root canal treatment.
This device must only be used in hospital environments, clinics or dental
offices by qualified dental personnel.
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. Do not use this device for any dental procedure other than root canal obturation.
2. Do not use the device in the presence of free oxygen, flammable anesthetic gas
mixtures or flammable substances.
3. The device must not be placed in humid surroundings or anywhere where it can
come into contact with any type of liquids.
4. Thermal hazard risk exists for patients.
5. Do not expose the device to direct or indirect heat sources. The device must be
operated and stored in a safe environment.
6. 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, portable or mobile RF
communication devices and do not charge, operate or store at high
temperatures. Comply with the specified operating and storage conditions.
7. Gloves and a rubber dam are compulsory during treatment.
8. If irregularities occur in the device during treatment, switch it off. Contact the
agency.
9. Never open or repair the device yourself
,
otherwise, void the warranty.
Содержание Fast-Pack
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