ZF 19 02 123X / 01 / 2012 updated 11/2012 1/4

Directions for use Endodontic Files Ref. A 0800

Portugus 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)..

Nederlands 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).

Suomi 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).

Svenska 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).

Dansk 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).

Polski 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).

Lietuvi k. 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) .

Latvieu 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.

Eesti 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).

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ZF 19 02 123X / 01 / 2012 updated 11/2012 2/4

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.

ZF 19 02 123X / 01 / 2012 updated 11/2012 3/4

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.

ZF 19 02 123X / 01 / 2012 updated 11/2012 4/4

GB F D E I

Symbols Symboles Symbole Simbolos Simboli

Handle Right angle RA

Manche angle droit 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 Umdrehungsgeschwindigkeit

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

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

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