Instructions For Use - HyFlex
®
NT NiTi
Root Canal Instruments
Indication for Use: For dentin removal and root canal shaping.
Contraindications: None known.
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.
This product contains a chemical known to the state of California to
WARNING!
cause cancer.
Instructions:
A new file should be used for each procedure to reduce the risk of file separation.
• Sterilize files prior to use. See sterilization instructions below.
• Use of a slow speed hand piece required. Operate the hand piece at 300 RPM (revolu-
tions per minute). Recommended torque setting up to 2.5 N·cm (25 mN·m).
• Irrigate during and between each step. COLTENE
CanalPro™ EXTRA for irrigation and debridement.
• 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 with the Hybrid
technique below. In curved canals, use of a HyFlex
recommended for preparing the apical curvature.
Step by Step instructions:
Coronal Patency: After gaining a Straight-Line coronal access, create an apical glide path
using HyFlex
®
GPF™ system or 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 a 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 a 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 a 02/20 hand file to check patency.
Irrigate and lubricate.
ENDO recommends the use of
®
CM™ (Controlled Memory) is
®
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 a 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 a
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.
• Follow instructions below under "Sterilization Instructions".
Coltène/Whaledent Inc.
235 Ascot Parkway
Cuyahoga Falls, Oh 44223/USA
Tel. USA/Canadá 1 800 221-3046
+1 330 916-8800
Fax +1 330 645 8704
info.us@coltene.com
Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner.
www.coltene.com
Upon request a hardcopy of the IFU will be supplied free
of charge within 7 days.