Endodontic retreatment
Neoniti
files should be used for endodontic retreatment only if the previous filling material was soft enough (e.g. gutta percha). Insert
Neoniti
C1 into the gutta percha, while using an appropriate solvent for filling resin
,
if needed, and continue the action with
Neoniti
A1
by using the same procedure as for an endodontic treatment.
5- Cleaning, disinfection and sterilisation of instruments before use (EN ISO 17664 standard)
For pre-cleaning and cleaning/disinfection steps, use approved products (CE certified, FDA approved or VAH/DGHM list) for rotary
instruments made of Nickel-Titanium.
Steps
Instructions
Precautions
Pre-cleaning
Carry out pre-cleaning in a suitable container
by soaking the instruments in a disinfectant
solution.
Rinse them thoroughly with running water.
Use a cleaning/disinfectant solution that complies with
the manufacturer's instructions (concentration, contact
duration and water quality appropriate for the products).
Au
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Cleaning
Disinfection
Rinsing
Drying
Place the files on a suitable rack and in a
disinfectant washer device.
Perform one cleaning cycle and then one
disinfection cycle (at least 93°C for 3 minutes:
A0 > 3000).
Dry with hot air
(at least 70°C for 10 minutes).
Use a cleaning/disinfectant solution that complies with
the manufacturer's instructions (concentration, contact
duration and water quality appropriate for the products).
The disinfectant washer device must meet EN ISO
15883-1 standard and be used in accordance with the
device manufacturer's recommendations (load
configuration, positioning, connection, accessories,
pressure, temperature limits).
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Cleaning
Disinfection
Place the instruments on a suitable rack.
Immerse them in a container containing the
cleaning/disinfectant solution and then place
the container in an ultrasonic bath.
Use a cleaning/disinfectant solution that complies with
the manufacturer's instructions (concentration, contact
duration and water quality appropriate for the products).
The ultrasonic bath must be used in accordance with
the manufacturer's recommendations (load
configuration, positioning, connection, accessories,
pressure, temperature limits).
Rinsing
Rinse them thoroughly with demineralised
water for at least 1 minute.
Drying
Dry the files using a single-use lint-free cloth
or compressed air.
Check that the instruments are completely dry.
Packing
Immediately place the instruments (on their
rack) into a sterilisation pouch.
Seal the pouch in accordance with the manufacturer's
recommendations. The pouch must meet EN ISO
11607-1 standard.
Sterilization
Place the pouches in an autoclave.
Sterilise them in accordance with applicable
national requirements. Recommended
sterilisation: 134°C for 18 minutes.
Check that the sterilisation cycle was correctly
performed.
The autoclave must meet EN 13060 (type B) and EN
ISO 17665-1 standards (load configuration, rack and
contents according to manufacturer's instructions).
Use and maintain the autoclave according to the
manufacturer's instructions.
Minimum parameters: 134°C for 3 minutes.
Minimum drying time: 20 minutes.
Storage
Store the pouches
containing the sterilised
instruments in a warm, clean and dry place.
Before use, check the integrity of the pouches and the
sterilization expiration date.
Cleaning agents/disinfectants used to validate this protocol:
•
Pre-cleaning and cleaning/disinfection (manual method): Dentasept® Special Rotative.
•
Cleaning/disinfection (automatic method): neodisher® Mediclean forte and Mediklar special.
6- Elimination
The used files must be discarded in accordance with the local regulation by following a method specific to infectious risk healthcare wastage.
7- Symbols
Read the instruction
manual
Do not re-use
Address of the
manufacturer
Nickel-Titanium
Sterilizable in an autoclave
at 134°C
Non-sterile
Batch number
Product reference
Do not use if the package
is damaged
Clockwise rotation and max.
speed (rpm)
CE mark
Number of files per
packaging
NEOLIX SAS
11 av. Raoul Vadepied - Châtres-la-Forêt
FR-53600 EVRON (France)
@ :
-
+33-2-5374-5007
Class IIa medical device
Year of CE marking: 2013
Document reference: NI-NEONITI-01 EN (K)
Last update: June 2020
