Contraindications - Thomas K-File Gebrauchsanweisung

MANUFACTURER
APPLICABLE TO
INSTRUCTIONS FOR USE
WARNING /
CONTRA-INDICATIONS
PRECAUTIONS FOR USE
DESCRIPTION
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INSTRUCTION MANUAL
HAND-HELD INSTRUMENTS FOR ROOT CANAL TREATMENT
FFDM TIVOLY
78-80 Avenue de la prospective
18020 BOURGES Cedex
CHER / CENTRE / France
Hand-held instruments for root canal treatment : Medical Devices
List:
Reamer / Broche - K-File / Lime K
Canal Probe / Canal Probe - Barbed broach /
Finger plugger / Fouloir bout plat
• K-files, reamers, H-files, helixofiles, barbed broaches, and canal probes are instruments for cleaning,
disinfecting and shaping dental root canals in a single patient during a single procedure.
• Paste fillers (finger spreader and finger plugger) are used for filling the root canals with sealing paste (Gutta
Percha) in a single patient during a single procedure.
6. Strict medical contra-indication: Heart disease at high risk of infectious endocarditis if the pulp is
necrotic.
7. Relative medical contra-indication: Cardiopathy at high risk of infective endocarditis if the tooth is
live and cardiopathy at lower risk in all cases.
8. Root instruments with a stainless steel or titanium nickel blade should not be used in cases of known
allergic sensitivity of the patient.
9. Tooth without functional future, which cannot be repaired in a sustainable way.
10. Tooth with insufficient periodontal support.
7. Only dentists are allowed to use these instruments for canal preparation.
8. These instruments are intended for use in hospitals, clinics or dental practices.
9. Endodontic care should only be performed if three conditions are met: sealed operating area [dental
dam], endodontic area is fully accessible, it is performed in one session.
10. Ensure sterilisation of products before first use and before reuse.
11. Multiple uses and sterilisations can deform the blade and thus weaken it. Using a weakened
instrument can lead to accidental breakage.
12. Any serious incident in connection with the device(s) concerned must be notified to the manufacturer
and the competent authority of the Member State in which the user and / or patient is established.
All instruments intended for root preparation, manufactured by FFDM TIVOLY in accordance with the
specifications of the current ISO 3630, are intended to be used by dental professionals during the root canal
treatment phases. During their training, these professionals learn how to use these instruments, including
associated medical procedures.
All these instruments are made from top quality materials and machined according to current ISO 3630
standards.
Illustrations of products:
K-File
Easy identification of products with a triple coding system, according to the current ISO 3630 standard:
Colour code, symbol and number.
Supplied with or without a silicone "stop" washer on the blade.
All manual instruments have a safety hole on the handle ("parachute hole").
Tel. :02 48 23 27 37
thomas.dental@ffdm-pneumat.com
Website : www.thomas-dentaltools.com/
- H-File / Racleur - H-File Flex / Racleur Flex
Tire nerf - Helixofile / Helixofile
Translated from French to English
- K-File "T-Flex" / Lime K "T-Flex"
- Finger spreader / Fouloir bout pointu
Barbed broach
3rd edition : 01/10/2019
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