Contraindications; Adverse Reactions; Direction For Use - Dentsply Maillefer ProTaper Universal Gebrauchsanweisung

FOR DENTAL USE ONLY
ProTaper instruments for endodontic treatment:
®
- ProTaper shaping fi les
®
- ProTaper ® fi nishing fi les
COMPOSITION: the cutting part of these instruments is made of a nickel-titanium alloy.
1. INDICATIONS FOR USE:
These instruments are to be used only in a clinical or hospital environment, by qualifi ed users.
Application fi eld: shaping and cleaning of the root canal system.

2. CONTRAINDICATIONS:

None known.
3. WARNINGS:
None known.
4. PRECAUTIONS:
- Multiple use disinfection and resterilization cycles may lead to increased risk of fi le separation.
- These instruments should not be immersed in a sodium hypochlorite solution.
- Instrument decontamination: strictly follow decontamination instructions from the manufacturer.
- Irrigate abundantly and frequently
- Establish a reproducible glide path using hand fi les, at least an Iso 015 size.
- Use in a constant rotation at a speed of 150-350 rpm with light apical pressure.
- Clean fl utes frequently and check for signs of distortion or wear.
- For optimal usage, torque control devices are recommended.
- Use the Shaping Files (S1, S2 and SX) with a brushing action on the withdrawal stroke in order tocreate
straight line radicular access.
- Use the Finishing Files (F1, F2, F3, F4 and F5) with no brushing action.
- Use the appropriate fi nishing fi les to passively follow the canal to the working length, and thenwithdraw
immediately.

5. ADVERSE REACTIONS:

In the present technical state, no adverse reaction has been reported so far.
6. STEP BY STEP INSTRUCTIONS FOR PROTAPER
1) Create straight line access to canal orifi ce
2) Always irrigate and confi rm a reproducible glide path with an ISO 015 hand fi le.
3) Protocol of use:
- Locate the orifi ce.
- Use passively an ISO 015 hand fi le to resistance.
- Use Shaping File S1 with brushing action until the same depth as the ISO 015 hand fi le is reached.
- Repeat this sequence until the working length is determined with an ISO 015 hand fi le and reached with
S1.
- Use shaping fi le S2 with brushing action until the working length is reached.
- reconfi rm working length.
- Use fi nishing fi le F1 (non-brushing motion) with each insertion deeper than the previous insertion until the
working length is reached.
- Gauge the foramen with hand fi les.
- Use the appropriate fi nishing fi le (F2, F3, F4, F5) with the same non-brushing motion to working length if
additional enlargement is required or if foramen is larger.
If necessary, use the SX with a brushing motion to move the coronal aspect of the canal away from thefurcation
and / or to create more coronal shape.
Directions for use ProTaper
2 / 45
® Universal
FILES:
®
GB