BRASSELER XP-3D Shaper and Finisher Endo Files with Prokit Instruction Manual

One Brasseler Blvd, Savannah, Georgia 31419
XP-3D + Prokit
Instructions for Use
REF. – 99.XAA.10.09A.EN – notice n°348 – 2022/01
XP-3D + Prokit
Description

XP-3D Shaper and Finisher Endo Files with Prokit

Taper (1) and ISO diameter (2) identification

Instructions for Use

1. Create straight-line coronal and radicular access.

2. Use the ISO 010 K-File to explore the canal.

3. Determine working length using a radiograph and/or an electronic apex locator.

4. Use the mechanized XP-3D Scout instrument to perform glide path until the working length is reached.
   The XP-3D Scouts are used with gentle strokes advancing the instrument 2-3 mm before completely disengaging the file.
   Repeat until the working length is reached. The file should progress easily with light apical pressure. If the file is not progressing remove and clean the instrument, irrigate, recapitulate with the ISO #10 hand file and repeat until the working length is reached.

5. Start the shaping procedure, applying your usual irrigation protocol.

6. Insert the tip of the XP-3D Shaper+ into the canal until resistance (Fig. 1), retract (tip loose) and start the motor.

7. Use long gentle strokes to progress down to working length (WL) (Fig. 2). If WL is not reached in 8 strokes, stop, irrigate, recapitulate, and proceed again. Do not use pecking motion! Never force the instrument and always keep it spinning and moving while in the canal.

8. XP-3D Finisher must only be used only after preparing the canal to at least ISO 25.

9. In multirooted teeth, begin with the largest canal. The canal should always contain irrigant.

10. Fix the canal working length by using the plastic tube (a) to adjust the endo stop (b) (Fig. 3).

11. Place the XP-3D Finisher into the canal by lining up cusp, insert slightly into the canal. Then start the motor and slowly thread the XP-3D Finisher into the canal.

12. Use the XP-3D Finisher for 1 minute (approximately 60 strokes), using slow and gentle 7-8 mm longitudinal movements to contact the full length of the canal (Fig. 4). Make small multidirectional movements and avoid removing the file from the canal.

13. Irrigate the canal to remove the suspended debris. A syringe tip 31G is recommended (or no bigger diameter than 30G).
    Once the cleaning of the canals is completed, proceed to the next phase of treatment:

14. Obturate with gutta percha and sealer. Endo Sequence® BC Points™ and Endo Sequence ® BC Sealer™ are recommended.

Warnings
XP-3D + Prokit instruments are intended for single use only, e.g. 1 tooth (up to 1 molar).
The reuse of instruments labeled as single use increase the risks of breakage and cross contaminations.

• Do not soak nickel-titanium instruments more than 5 minutes in a solution of NaOCl at more than 5%.

• Hydrogen peroxide (H2O2) degrades the instruments.

• Operating an Endodontic File with too high of an RPM may generate undesirable heat and cause patient discomfort, tooth or tissue necrosis, and patient burns.

• Failure to follow these instructions may cause the following : apex perforation, insufficient cleaning of the root canal, preparation site damage, injury to the patient or user, or possible aspiration or swallowing of the file.

• Irrigation with ultrasonics is recommended. Inadequate use of irrigation may generate undesirable heat and cause patient discomfort, tooth or tissue necrosis, or patient burns.

• Always clean the file after every three (3) engagements. Failure to clean the file may cause the file to break or unwind causing patient or user harm or may generate undesirable heat and cause patient discomfort, tooth or tissue necrosis, or patient burns.

• Use a rubber dental dam while using Endodontic Files to avoid possible aspiration or swallowing of the file.

• Do not apply excessive pressure on the Endodontic Files as this could cause undesirable heat or may cause the file to fail and cause patient or user injury.

• Carefully read package labels to ensure use of the appropriate device. Failure to do so may cause patient or user injury.

• Always wear gloves when handling contaminated instruments to avoid possible infection/cross-contamination.

• Do not use Endodontic Files that are worn-out, dull or that exhibit “unwinding” as this could cause undesirable heat or may cause the file to fail.

• Maintain handpieces in good working condition to ensure maximum effectiveness of the
  device. Failure to properly maintain handpieces may lead to patient discomfort, injuryof the patient or user, aspiration or swallowing of the Endodontic File, or damage to the preparation site due to vibration of a worn chuck or turbine.

• Ensure the Endodontic File is fully seated and securely gripped in the handpiece collet prior to use. Failure to do so may cause the file to “walk out” of the handpiece and maylead to injury of the patient or user or aspiration or swallowing of the Endodontic File.

• Never force a file into a handpiece as this could cause damage to the handpiece collet.

• Eye protection must be worn to protect against ejected particles.

• Surgical masks must be worn to avoid inhalation of any aerosol or dust generated.

• This product contains nickel, a chemical known in the state of California to cause cancer, birth defects or other reproductive harm.

| Sterilized by irradiation| Rx Only| Caution : Federal law restricts this device to sale by or on the order of a “dentist/physician” licensed by the lawof the State in which he/she practices to use or order the use of the device
| Expiry date
| Do not re-use

Contraindications

This product contains nickel and should not be used for individuals with known allergic sensitivity to this metal.

Precautions

Sterile products – Use

1. Open the individual blister pack.

2. Extract the instrument (use of gloves imperative) and attach it to the contra-angle.

3. Use the instrument according to the protocol on front page.

4. Always check expiry date.

5. If file sterility is compromised prior to use, please clean and sterilize according to the following the protocol :

6. Pre-disinfection or decontamination
   – Immerse the instruments as soon as possible after use in a disinfectant solution.
   – Thoroughly rinse instruments in water after disinfection.

7. Manual cleaning & disinfection
   – Soak all instruments in a disinfectant/detergent solution and, if appropriate, use an ultrasonic washing device. (Remove the silicone stops if necessary).

8. Rinsing & drying
   Rinse the instruments thoroughly with clean water and dry them.

9. Inspection
   – Check the status of instruments and eliminate those with defects.
   – If the instruments are still dirty, clean them again.
   – If necessary, reassemble the instruments (Mount silicone stops).

10. Packaging
    Place the instruments in “bags for sterilization”, as soon as possible after cleaning.

11. **Sterilization***
    Sterilize with steam at 134°C (273°F) / 2,1 bars / 18 min. for endodontic instruments and filling.
    – Check the success of the sterilization cycle (cycle parameters consistent with the data validation).
    – Use a physicochemical indicator for each sterilization cycle.

*Precautions :

• The methods of sterilization via chemiclave and hot air have not been validated.
• REPROCESSING LIMITS : A process of repeated sterilization has little effect on the instruments. The lifetime of the instruments is determined by wear and damage after use.

Distributed by
Brasseler U.S.A Dental, LLC
One Brasseler Blvd
Savannah, GA 31419 USA

For more information visit www.BrasselerUSA.com

Golden Rules
Speed : 800-1000 rpm
Torque : 1 Ncm

Intended Use
XP-3D + Prokit Files fit into a dental handpiece allowing the user to perform root canal debridement.

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