S5 Rotary Files. only. Manufacturer. Packing unit. Batch code. For professional use only (0)

Transcription

1 EN S5 Rotary Files AR Manufacturer 100 Packing unit (0) Batch code only For professional use only Catalogue number Consult instructions for use Sendoline AB Box 7037, Tillverkarvägen 6 SE Täby, SWEDEN NON STERILE Non sterile Do not re-use CE mark and identification number of Notified Body 44

2 AR EN Taper/ISO Marking Torque Ncm Length (mm) RPM 08/30 I /30 II / /30 III / /25 IIII / /20 IIIII / S5 Endo Motor setting File No. 1 Setting 1 File No. 2 Setting 2 File No. 3 Setting 3 File No. 4 Setting 4 File No. 5 Setting 5 45

3 EN S5 Rotary Files - Instruments for root canal treatment Intended use S5 Rotary Files are made from nickel titanium and are intended for mechanical instrumentation of root canals. The instruments are intended to be used with the S5 Endo Motor in accordance with the instructions accompanying the motor. Recommended rotary speed: 300 RPM. Composition The instrument s working part is made from heat-treated nickel titanium alloy, which gives increased flexibility while retaining strength. The shank is type 1 according to EN ISO Warnings The instrument contains nickel and it should not therefore be used in patients with known allergy to this material. The instrument is intended for single use and must not be re-used. Precautions S5 Rotary Files are single-use instruments designed for the preparation of no more than one molar (a tooth with 4 root canals). Check the instruments for defects before and during the treatment. If there are any defects, the instruments must be disposed of. Never work without irrigant in the canal. Be careful in areas with severely curved canals. The instruments must be used cautiously and slowly, using an in and out pecking motion. Work in the canal should be kept as brief as possible. Clean the cutting flutes after every 3 to 4 repetitions during instrumentation. Always apply rubber dam. AR 46

4 AR Before use sterilization Inspection Inspect the instruments for signs of damage. Contact your supplier if defects are identified. Packaging Arrange the instruments in an instrument tray or stand. Use suitable sterilization wrapping material or sterilization pouches compliant with ISO The packaging material must be large enough to ensure that the seal is not under tension. Do not overload the sterilization equipment. Sterilization options - Steam sterilization class B with sterilizers in accordance with EN Sterilization holding time a minimum of 3 minutes at 134 C (273.2 F). - Steam sterilization class S with sterilizers in accordance with EN Sterilization holding time a minimum of 3 minutes at 134 C (273.2 F). - Steam sterilization class N with sterilizers in accordance with EN Gravity displacement sterilizers: 132 C (270 F) for 15 minutes. Do not exceed 277 F (136 C) during sterilization. The operator assumes responsibility for the use of any other sterilization procedures. Maintenance of sterilization equipment Ensure regular servicing and monitoring of the sterilization equipment. Consult the instructions for use provided by the manufacturer. Storage Keep the devices in their sterilization packaging in a dry, dust free and clean environment. EN 47

5 EN General instructions Before the instruments are used, the canals must be located and a glide path created using thin files (min. ISO 15). Abundant irrigation is required throughout the instrumentation. During use, rinse and repeat using a hand file (ISO 15) each time you change instrument. Always fill the canal with irrigant. Apply only light pressure to S5 Rotary Files during instrumentation. If there is any resistance, or if the instrument does not advance, clean the instrument, irrigate and check for possible blockage with a size 10 or 15 hand file. Step-by-step instructions 1. Prepare the pulp chamber to enable good access to the canals to be prepared. 2. Apply rubber dam and disinfect the area. Irrigate using sodium hypochlorite solution throughout the cleaning procedure. Never work in a dry root canal. 3. Locate all canals using a manual file. 4. Determine the working length. This should ideally be done using an apex locator. Always use an X-ray for verification. 5. Use a manual file to create a glide path until the determined working length is reached. 6. Use S5 Rotary Files, applying a Crown Down technique. Start with a no. 1 file. In larger canals, the determined working length is often already reached using a no. 2 file, otherwise continue using the file sequence until the determined working length is reached. In many cases, this is reached with a no. 3 or no. 4 file, though in some cases a no. 5 file will be required. Reverse the file sequence (5-4-3) to the desired size of the canal preparation. In a straight canal, it is recommended that the file sequence is reversed to a no. 2 file. AR 48

6 AR 7. After reaching the working length, the instrument can be used in a brushing movement peripherally in order to remove irregularities in the canal wall and to enlarge the root canal opening. The total working time in each canal should not exceed 15 seconds. 8. Use a hand instrument to check the apical dimension of the final preparation to determine the ISO size achieved. EN 49