Contraindications
5
2
Contraindications
Read the following contraindications before use.
• 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.)
3
Warnings
Read the following warnings before use.
• This device is intended to be used for filling a root canal with gutta-percha and
provide a heated endodontic plugger for packing the root canal filling material
into place and may only be used by trained and qualified dentists.
• Do not use this device for any dental procedure other than root canal obtura-
tion.
• Do not use the device in the presence of free oxygen, flammable anesthetic gas
mixtures or flammable substances.
• The device can cause radio interference or disrupt the operation of equipment
in the vicinity. If this happens, the interference should be reduced by reorienting
or repositioning the device or by screening off the immediate environment. The
electromagnetic radiations emitted by the device are below the recommended
limits specified by the applicable relevant provisions (DIN EN 60601-1-2:2007).
During Treatment
• Gloves and a rubber dam are mandatory during treatment.
• If any irregularities with the device should occur during treatment, turn it off.
Contact Dentsply Sirona by phone or online at the contact information shown
on the back cover page of this manual, or contact your Dentsply Sirona autho-
rized service partner.
• Thermal hazard risk exists for patients.
• When replacing a gutta-percha cartridge during a procedure, the flow heater
sleeve and expended cartridge may be hot to the touch.
• Allow the flow heater to cool before attempting to remove.
• Do not remove a hot gutta-percha cartridge!
• Electric heat plugger tips become hot during use. Turn off unit and allow cool-
ing before exchanging tips.
— Warnings
Summary of Contents for Gutta-Smart
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