Thomas NiTiShaper T1 Manual De Instrucciones página 6

MANUFACTURER
APPLICABLE TO
INSTRUCTIONS FOR USE
WARNING /
CONTRA-INDICATIONS
PRECAUTIONS FOR USE
DESCRIPTION
PACKAGING
Page 1/3
INSTRUCTION MANUAL
FFDM TIVOLY
78-80 Avenue de la prospective
18020 BOURGES Cedex
CHER / CENTRE / France
NiTiShaper : Medical Device
List:
- NiTiShaper T1
- NiTiShaper T2
- NiTiShaper T3
• NiTiShaper is for endodontic treatment
• It enables the cleaning and shaping of root canals
1. Strict medical contra-indication: Heart disease at high risk of infectious endocarditis if the pulp
is necrotic
2. Relative medical contra-indication: Cardiopathy at high risk of infective endocarditis if the tooth
is alive and cardiopathy at lower risk in all cases.
3. This product contains nickel: Do not use on patients with known sensitivity or allergy to Nickel
4. Do not use for any function other than shaping and cleaning root canals
5. Do not use NiTiShaper if an instrument is damaged or contaminated
1. Only dentists are allowed to use these instruments for endodontic treatment
2. These devices are intended for use in hospitals, clinics or dental surgeries
3. Before beginning the clinical procedure, a radiographic examination must be done to evaluate
the anatomy of the canal (width, length, curvature)
4. Ensure sterilisation of products before first use and before reuse
5. Multiple uses and sterilisations can deform the blade and thus weaken it. Using a weakened
instrument can lead to accidental breakage
6. Any serious incident involving the instrument (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.
NiTiShaper is intended for use by dental professionals during the root canal treatment phase. During their
training, these professionals learn how to use these instruments, including associated medical procedures.
NiTiShaper is a kit of 3 instruments whose working parts are in nickel-titanium alloy.
Conicity
(%)
NiTiShaper T1 4%
6%
NiTiShaper T2
NiTiShaper T3 6%
NiTiShaper T1
The part connecting the contra-angle is manufactured in accordance with the current ISO 1797 (diameter
of the counter angle connecting stem: Ø2.35 0 / -0.016 mm)
Supplied with a "stop" silicone washer (silicone USP class 6)
Quantity per set: 3 or 6 identical or different units (assortment). Non-sterile blister.
Tel. :02 48 23 27 37
thomas.dental@ffdm-pneumat.com
Web site : www.thomas-dentaltools.com/
Ø Tip Blade Lgth Colour
(mm) (mm)
0.18 21 / 25
0.20 21 / 25
0.23 21 / 25
NiTiShaper T2
Translated from French to English
NiTiShaper
Markings
Code (mm)
blanc 20, 22
rouge 18,19,20,22
noir 18,19,20,22
NiTiShaper T3
2nd edition : 01/10/2019
Total
Lgth
(mm)
37
37
37