COMPOSITION

COMPOSITION The cutting surface of these instruments is made of a nickel-titanium alloy. (1) INDICATIONS FOR USE RCS GP FILE is a dental instrument for root canals used to mechanically condense gutta-percha in the root canal after instrumentation, cleaning and disinfection is complete. (2) CONTRAINDICATIONS •The product contains nickel, so it should not be used for any patient with allergies to this material. •Should not be used in cases of severe and sudden apical curvatures due to heightened risk of separation. (3) WARNING •The files are non-sterile products and should be sterilized before use •The files are single-use only. They are not to be reused as this can cause deformation defects (bending, stretching), fractures, corrosion or markings
identification, etc., which would mean the instruments cannot meet the level of safety required for the intended use. (4) PRECAUTIONS FOR USE •Never use the GP FILE in anticlockwise rotation (due to danger of getting stuck in the canal or bone). •Do not penetrate the tip of the instrument into the canal to less than 2 mm from the apex. •Do not oppose strong resistance when the GP FILE is backing out of the canal. (5) ADVERSE REACTIONS •In the case of multicuspid mandibular teeth, an overfilling reaching the inferior dental nerve can provoke irreversible damage, such as dysesthesia, paresthesia, anaesthesia, or paralysis with a possible labiodynisis. •GP FILE is not recommended for use in patients with a known allergy to nickel. The use of this product in these patients may cause difficulty breathing, swelling of the face or eyes, hives or rash. If any of these symptoms occur, patients should be advised to contact a medical professional immediately.



(6) STEP-BY-STEP INSTRUCTIONS FOR USE OF RCS GP FILES •The rotation of this instrument against the gutta- percha plasticizes this material by heat produced usingfriction. In this plastic state, the gutta-percha advances apically and condenses. •In order to obtain sufficient heat to plasticizethe gutta-percha, the GP FILE must be used at a low speed with a high torque instrument capable of rotating at a speed 8’000 min-1 with a high torque. For a complete obturation of the root canal system, bring the instrument to 2 mm from the apex of the canal which has already been prepared. The penetration depth of the GP FILE can be checked using the graduations marked on the shaft of the instrument or by using a silicone stopper.

(1) Establish the working length and apical stop of the root canal. (2) Insert the gutta-percha point and the RCS GP FILE into the canal and press the RCS GP FILE against the gutta-percha. (3) Descend the RCS GP FILE into the canal, rotating clockwise at 8’000 min-1. Do not penetrate it to less than 2 mm from the apex. (4) Back the files out of the canal, without opposing strong resistance.

(7) STERILISATION
Dental instrument reprocessing procedure. 1. Scrub the instruments with soap and warm water 2.Rinse thoroughly with distilled or deionized water 3. Allow to air dry 4. Place the instruments, unwrapped, in the autoclave tray 5. Use fresh distilled or deionized water Steam Autoclave at 134°C for 20 minutes 6. RCS GP Files are single patient use instruments 7. 7. Recommended File Disposal (place used files in a Biohazard Sharps container) (8) TRANSPORT •To prevent the medical device from being damaged during transport, the use of specific racks, trays, or rigid containers may be recommended. (9) STORAGE AND EXPIRY •Avoid storing in places with high temperatures, humidity and/or direct sunlight. Keep liquids away. Store at ambient temperature. •Do not damage or puncture the packaging materials. •This product is subject to improvement without prior notice. Apply the “first in, first out” approach to inventory management. •Do not store under a germicidal lamp to prevent deterioration. •The shelf life of endodontic files is 5 years. (10) DISPOSAL •This product should be disposed of as medical waste. •For correct disposal, always respect national laws and recommendations from authorities. (11) PACKAGING •Minimum packaging unit: 4pcs/pack in blister.