HyFlex™ CM NiTi Files

Root Canal Shaping

Like a Phoenix from the ashes... the regenerative NiTi File!

No shape memory + Extreme flexibility = Superior canal tracking

HyFlex™ Controlled Memory NiTi Files have been manufactured utilizing a unique process that controls the material's memory.

• The files are extremely flexible but without the shape memory of conventional NiTi Files.
• This gives the file the ability to follow the anatomy of the canal very closely, reducing the risk of ledging, transportation or perforation.
• Furthermore the files can be pre-bent, similar to the way of stainless steel.
• Particularly in root canals with abrupt curvatures this can help avoid the creation of steps.

Regains shape after heat treatment = Multi-use

• HyFlex™ CM NiTi files respond to excessive resistance with straightening of the spirals, which avoids binding to the walls and therefore increases fracture resistance.
• This form adaptation can be reversed quickly by heat treatment (during autoclaving or with a glass bead sterilizer) returning the instruments back to their original shape.
• Furthermore it will strengthen the files making them a lot more resistant to cyclical fatigue.
• Also it provides a clear visual opportunity to verify safe continuation of file use.

• Pack of 6 files

Instructions For Use - HYFLEX®CM NiTi Files Indications for Use: For dentin removal and root canal shaping. Contraindications: None known.

WARNING! • Files are provided non-sterile, and must be sterilized before use. • This product consists of a Nickel Titanium alloy and chromium. Do not use for individuals with known allergic sensitivity to these metals.

• A new file should be used for each procedure to reduce the risk of file separation.

Instructions:

The number of times the instruments can be re-used is dependent on treatment and procedure. Instruments need to be inspected before and after use.

Hyflex CM Files may respond to pressure, torque and resistance with a lengthening of the spirals, which allows the file to avoid binding to the walls and therefore increases fracture resistance. Unlike normal NiTi instruments, this can be reversed. During autoclaving (or treatment in a glass bead heater for 10 seconds), the instruments can regain their shape. However, care has to be taken, if the instruments start to rewind in the opposite direction during use, the files will not regain their shape and should be discarded. If after autoclaving, a file has multiple spirals which appear lengthened or otherwise seems not functional, the file should be discarded.

• Sterilize files prior to use. See sterilization instructions below.

• Use of a slow speed hand piece required. Operate the hand piece at 500 RPM (revolutions per minute). Recommended torque setting up to 2.4 N·cm (24 mN·m). • Irrigate/lubricate the canal frequently when using the file.

• Clean file flutes after each insertion into the root canal.

• Recapitulate between each step. Files may be used with Crown-down and Step-back techniques, or in the recommended Hybrid technique as follows. Step by Step instructions: Coronal Patency: After gaining a straight-line coronal access, create an apical glide path to a 02/20 hand file size.

STEP 1 - Start with the 08/25 file. Use as an orifice opener. Move slowly forward without pressure in a pecking motion. Once resistance occurs go to step 2. Check patency with 02/20 hand file, irrigate and lubricate. Optional Step: If working length is reached in large canals it may be possible to go directly to step 4.

STEP 2 - Use the 04/20 file for apical enlargement to the working length. Move slowly forward without pressure in a pecking motion. In case resistance occurs use an 02/20 hand file to check patency. Irrigate and lubricate.

STEP 3 - Insert 04/25 file for apical enlargement to the working length. Move slowly forward without pressure in a pecking motion. If resistance occurs, go back to the previous step. Use an 02/20 hand file to check patency. Irrigate and lubricate.

STEP 4 - Use the 06/20 file to shape middle part of the root canal. This file can also be taken to working length. Move slowly forward without pressure in a pecking motion. If resistance occurs, go back to the previous step. Use an 02/20 hand file to check patency. Irrigate and lubricate.

STEP 5 - Take 04/30 file to working length to enlarge the apical part of the canal. Move slowly forward without pressure in a pecking motion. If resistance occurs, go back to the previous step. Use an 02/20 hand file to check patency. Irrigate and lubricate. STEP 6 - Finish treatment with 04/40 file to working length. Move slowly forward without pressure in a pecking motion. If resistance occurs, go back to the previous step. Use an 02/20 hand file to check patency. Irrigate and lubricate. Cleaning Instructions: • Soak all instruments immediately after use in a detergent and disinfecting solution combined with proteolytic enzyme if possible. • In case of having debris left on the file, use a soft toothbrush for cleaning. • An ultrasonic cleaner shall be used with a general purpose cleaner for 30 minutes. • Visually inspect that the file is clean. • Follow instructions below under “Sterilization Instructions”.