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○
Breakage of instrument.
○
Cross-contamination.
○
Heat generation due to insufficient lubrication and irrigation.
○
Swallowing of working part of the instrument.
○
Toxic or allergic reactions caused by processing residues.
●
Similar to all machine-driven root canal instruments, ProTaper Next® instruments should
not be used in a root canal with an abrupt apical curvature due to heightened risk of
separation. In this case, pre-curved hand files should be used in the apical region.
4) PRECAUTIONS
●
Safety and effectiveness of use have not been established in pregnant or breastfeeding
women or in children.
●
Use a rubber dam system during the endodontic procedure.
●
For your own safety, wear personal protective equipment (gloves, glasses, mask).
●
Inspect the packaging before use and do not use the instruments if the packaging is
damaged.
●
Do not use the instruments after expiration date.
●
Check the instrument before each use for signs of defects such as deformations (bent,
unwound), breakage, corrosion, damaged cutting edges, loss of color coding or marking.
With these indications the devices are not able to fulfil the intended use with the required
safety level, instruments should be discarded.
●
Before using any instrument, make sure it is well connected to the contra-angle head.
●
Check instrument and clean working part frequently during instrumentation, inspecting for
signs of distortion, elongation or wear, such as uneven flutes, dull spots. With these
indications that the devices are not able to fulfil the intended use with the required safety
level, instruments should be discarded.
●
Instruments should not be fully immersed in a sodium hypochlorite solution (NaOCl). Only
the working part of the NiTi instrument, which is in contact with the patient should be
immersed in a NaOCl solution concentrate at NOT more than 5%.
●
Exercise caution in the apical area and in canals that divide, and/or exhibit abrupt
curvatures or recurvatures.
●
Irrigate abundantly and frequently the canal throughout the procedure and after each
instrument used (according to good dental practices).
●
Always use minimal apical pressure. Never force the files down the canal.
●
When instrument does not easily progress, clean and inspect the cutting flutes, then
irrigate, recapitulate with a manual file and reirrigate.
●
For shaping extremely curved canals it is safer to use the file only to shape one canal in
order to reduce the risk of breakage. Pay attention to the following good practices:
○
Use a new file and discard it after the canal was treated (single canal use).
○
Use manual instead of rotary files.
○
Use small size, flexible or/and NiTi files (this will help avoid canal transportation).
END-IFU-PROTAPER-NEXT-SINGLE-USE-STERILE-V00-WEB-EUR-Multilingual-2021-05
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