Directions for use

Endodontic Files Ref. A 0800

Portugus

Nederlands
Suomi

Svenska

Dansk

Polski

Lietuvi k.

Latvieu

Eesti

Este manual de utilizao est tambm disponvel, quando requisitado, nas seguintes
lnguas: Portugus (POR), Holands (NL), Dinamarqus (DK), Sueco (S), Finlands
(FIN), Grego (GR), Polacos (POL) Letnia (LV), Estnia (EE) e Litunia (LT)..
Deze gebruiksaanwijzing is, op aanvraag, eveneens verkrijgbaar in de volgende talen:
Portugees (POR), Nederlands (NL), Deens (DK), Zweeds (S), Fins (FIN), Grieks (GR),
Pools (POL), Lets (LV), Ests (EE) en Litouws (LT).
Kyttohje on saatavana mys seuraavilla kielill: Portugali (POR), hollanti (NL), tanska
(DK), ruotsi (S), Suomi (FIN), Kreikka (GR), Puola (POL), Latvian (LV), Viron (EE) ja
Liettuan (LT).
Denna bruksanvisning finns ven att tillg p fljande sprk: Portugisiska (POR),
Hollndska (NL), Danska (DK), Svenska (S), Finska (FIN), Grekiska (GR), Polska
(POL), Lettiska (LV), Estniska (EE) och Litauiska (LT).
Denne brugsanvisning kan ogs rekvireres p flgende sprog: Portugisisk (POR),
Hollandsk (NL), Dansk (DK), Svensk (S), Finsk (FIN) grsk (GR) Polsk (POL), Lettiske
(LV), Estiske (EE) og Litauiske (LT).
, , :
(POR), Oa (NL), (DK), (S), (FIN),
(GR) (POL), (LV), (EE) (LT).
Ta instrukcja obsugi jest rwnie dostpna, na zamwienie, w nastpujcych wersjach
jzykowych: Portugalski (POR), Holenderski (NL), Duski (DK), Szwedzki (S), Fiski
(FIN), Grecki (GR), Polski (POL), otewski (LV), Estoski (EE) i Litewski (LT).
instrukcij vadov pagal uklaus galima gauti ir iomis kalbomis: Portugal (POR),
Oland (NL), Dan (DK), ved (S), Suomi (FIN), Graik (GR) Latvi k (LV), Est k.
(EE) ir Lietuvi k. (LT) .
rokasgrmata pc pieprasjuma ir pieejama ar ds valods: Portugu (POR),
Holandieu (NL), Du (DK), Zviedru (S), Somu (FIN), Grieu (GR), Pou (POL),
Latvieu (LV), Igauu (EE) un Lietuvieu (LT) valods.
See juhend juhend on saadaval ka taotluse korral jrgmistes keeltes: Portugali (POR),
Hollandi (NL), Taani (DK), Rootsi (S), Soome (FIN), Kreeka (GR), Poola (POL), Lti
(LV) ja Eesti (EE) ja Leedu (LT).

Visit our website : www.dentsplymaillefer.com

ZF 19 02 123X / 01 / 2012 updated 11/2012

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FOR DENTAL USE ONLY

GB

Directions for Use for the PROTAPER NEXTTM instruments

Endodontic Files - Ref A 0800
PROTAPER NEXTTM Files for endodontic treatment:
PROTAPER NEXTTM X1 / 017/04 VARIABLE TAPERED INSTRUMENT
PROTAPER NEXTTM X2 / 025/06 VARIABLE TAPERED INSTRUMENT
PROTAPER NEXTTM X3 / 030/07 VARIABLE TAPERED INSTRUMENT
PROTAPER NEXTTM X4 / 040/06 VARIABLE TAPERED INSTRUMENT
PROTAPER NEXTTM X5 / 050/06 VARIABLE TAPERED INSTRUMENT
COMPOSITION

The cutting part of these instruments is made of a nickel-titanium alloy named M-Wire .
1. INDICATIONS FOR USE
The PROTAPER NEXTTM instruments are used in endodontic treatment for shaping &
cleaning the root canal system.
These instruments are to be used only in a clinical environment by qualified users.
2. CONTRA-INDICATIONS
In common with all mechanically driven root canal instruments, the PROTAPER NEXTTM
instruments should not be used in cases of very severe and sudden apical curvatures.
3. WARNINGS
This product contains Nickel and should not be used for individuals with known allergic
sensitivity to this metal.
In order to prevent infectious agent transfer it is highly recommended to use a rubber
dam system during the endodontic procedure.
PROTAPER NEXTTM is provided sterile and reuse can increase the risk of cross
contamination or breakage
4. PRECAUTIONS
PROTAPER NEXTTM files are single use devices. They can become less efficient after
multiple uses causing undue stress to the file. This can lead to file separation.
Exercise caution in the apical area and around significant curvatures.
For your own safety, wear personal protective equipment (gloves, glasses, mask).
These instruments should not be immersed in a sodium hypochlorite solution.
Irrigate the root canal copiously and frequently during the shaping procedure.
Lubricants such as NaOCl, EDTA, ProLube, GlydeTM are recommended.
Establish a reproducible glide path using small-sized manual and/or dedicated
mechanical glide path files.
Use in a constant rotation at a speed of 300 rpm with light apical pressure.
For optimal usage, torque control devices are recommended at 2Ncm (adjustable up
to 5.2 Ncm according to practitioner experience)
Clean flutes frequently and check for signs of distortion or wear.
The PROTAPER NEXTTM instruments are recommended to be used mechanically
(manually in very severe curvatures) in a clockwise continuous motion.
The PROTAPER NEXTTM instruments are recommended to be used with a brushing
motion, away from external root concavities, to facilitate flute unloading and apical file
progression.
Use the PROTAPER NEXTTM files to passively follow the canal until the working
length is achieved.
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5. ADVERSE REACTIONS
In common with all mechanically driven root canal instruments, the PROTAPER NEXTTM
instruments should not be used in cases of very severe and sudden apical curvatures.
6. STEP BY STEP INSTRUCTIONS FOR THE PROTAPER NEXTTM FILES
Protocol of use:
1.

Prepare straightline access to canal orifice.

2.

Explore the canal using small-sized hand files, determine working length, verify
patency and confirm a smooth, reproducible glide path.

3.

Always irrigate and if necessary, expand the glide path using small-sized hand files or
dedicated mechanical glide path files.

4.

In the presence of NaOCl, brush and follow, along the glide path, with the PROTAPER
NEXTTM X1 (017/04) file, in one or more passes, alternatively with small-sized hand files
if necessary, until the working length is reached.

5.

Use PROTAPER NEXTTM X2 (025/06), exactly as described for PROTAPER NEXTTM

X1 file, until the working length is passively reached.

6.

Inspect the apical flutes of the PROTAPER NEXTTM X2 file; if they are loaded with
dentin, then the shape is finished, the correspondingly sized gutta percha master cone
or size verifier may be fitted, and the canal is ready for disinfection.

7.

Alternatively, gauge the foramen with a size 025 hand file and, if this file is snug at
length, the canal is shaped and ready for disinfection.

8.

If the size 025 hand file is loose at length, then continue shaping with the PROTAPER
NEXTTM X3 (30/07) and, when necessary, the PROTAPER NEXTTM X4 (040/06) or
PROTAPER NEXTTM X5 (050/06), gauging after each instrument with the 030, 040 or
050 hand files, respectively.

During protocol of use, irrigate, recapitulate with a small-sized hand file after each
sequential PROTAPER NEXTTM instrument, then re-irrigate.

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GB

Symbols

Symboles

Symbole

Simbolos

Simboli

Handle Right angle Manche angle droit

RA
AD

Winkelstck (WS)

Contra-ngulo

contrangolo

Expiry date

Date de premption

Verfallsdatum

Fecha de caducidad

Data di scadenza

Manufacturer

Fabricant

Hersteller

Fabricante

Fabbricante

Reference number

Numro de rfrence Referenz-Nummer

Nmero de referencia

Numero di referenza

Sterilized product,
electromagnetic or
ionic radiation
sterilization
process

Produit strile,
processus de
strilisation avec un
rayonnement
lectromagntique
ou ionique

Steriles Produkt,
Sterilisationsanwendung
mit elektromagnetischer
oder ionischer
Bestrahlung

Producto estril.
Proceso de
esterilizacin con la
radiacin
electromagntica o ion

Prodotto sterilizzato,
processo di
sterilizzazione con
radiazioni
elettromagnetiche o
ioniche

One use only

Usage unique

Einmalverwendung

Un slo uso

Monouso

Recommended
rotation speed

Vitesse de rotation
recommande

Empfohlene
Umdrehungsgeschwindi
gkeit

Velocidad de rotacin
recomendada

Velocit di rotazione
raccomandata

Batch number

N de lot

Lot - Nummer

Nmero de lote

Numero di lotto

Assortment

Assortiment

Sortiment

Surtido

Assortimento

Nickel titanium

NiTi

Nickel-Titan

Niquel Titanio

Nickel-titanio

silicone

silicone

silikon

silicona

silicone

m-Wire
nickel Titanium

m-Wire
nickel Titanium

m-Wire
Nickel-Titan

m-Wire
nquel titanio

m-Wire
nichel titanio

Do not use if seal

broken

Ne pas utiliser si le
sceau est bris

nicht, wenn Siegel

gebrochen verwenden

No lo use si el sello
roto

non usare se il sigillo

rotto

Chemin du Verger 3
CH 1338 Ballaigues
Switzerland
www.dentsplymaillefer.com

FISDR / F 19 02 123X / 01 / 2012 updated 11/2012

ZF 19 02 123X / 01 / 2012 updated 11/2012

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