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DFU START-X

 F19 02 106.X / 01 / 2008  created 10/2008

2 / 50

DENTSPLY MAILLEFER

1338 Ballaigues

Switzerland

For Dental Use Only

DIREctIONS FOR uSE 

(START-X

)

1)  INDIcatIONS FOR uSE

Clinical applications

Tip n°1 

Refinement of access cavity walls 

• 

Tip n°2 

MB2 canal scouting (2nd canal mesio buccal root)

• 

Tip n°3 

Removing obstructions to the canal orifice 

• 

Tip n°4 

Metal post removal 

• 

Tip n°5  

Re-locating the original pulp chamber floor anatomy (calcification, removal of old 

 

• 

 

obturation material)

These instruments are to be used only in a clinical or hospital environment, by qualified users.

2)  cONtRa-INDIcatIONS

None known when used as recommended. It is nevertheless recommended not to use these ultrasonic 

inserts on patients who have a Pacemaker.

3)  WaRNINGS

Please refer to the instructions for use of the manufacturer of the ultrasonic generator. It is important to 

note that the different operating power settings must be adapted to the various clinical applications and 

circumstances.

4)  PREcautIONS

Do not start the generator with damaged ultrasonic inserts.

• 

For improved working comfort and safety, the use of a visual aid is recommended.

• 

Irrigation is recommended when performing procedures (such as dislodging metal posts – tip #4) that 

• 

require high energy to avoid overheating both the insert and the tooth.

The tip must be tightened onto the ultrasonic generator handpiece with the enclosed wrench prior to 

• 

use. The user will pay attention to over tightening as well as under tightening.

5)  aDVERSE REactIONS

To date, no adverse reactions have been reported.

6)  StEP-By-StEP INStRuctIONS

Adjusting the power of the ultrasonic generator

SatELEc / P5 Newtron

EMS miniPiezon

Min

Max

Min

Max

N°1

16

18

8

9

N°2

16

18

8

9

N°3

10

18

4

7

N°4

18

20

9

10

N°5

18 

8

Power settings for other ultrasonic units are available on Dentsply Maillefer website.
Available on Dentsply Maillefer website,

 www.dentsplymaillefer.com

, a video illustrating the use of each 

Start-X™ insert. On request, this video can be mailed.

In general, to maximize clinical performance and safety, and to reduce the potential of instrument breakage, 

start with lower power settings and only increase the power as required to accomplish the clinical task.

All tips should be used with minimal pressure and a light brushing motion.
Irrigation is recommended when performing procedures (such as dislodging metal posts – tip #4) that 

require high energy to avoid overheating both the insert and the tooth.

GB

Summary of Contents for START-X A0660

Page 1: ...I E NL DK FIN S P GR POL Directions for use START X 2 Protocole d utilisation START X 6 GEBRAUCHSANLEITUNG START X 10 MODO DI USO START X 14 MODO OE UTILIZACION START X 18 GEBRUIKSVOORSCHRIFT START X...

Page 2: ...ommended Irrigation is recommended when performing procedures such as dislodging metal posts tip 4 that require high energy to avoid overheating both the insert and the tooth The tip must be tightened...

Page 3: ...nly a disinfecting solution which is approved for its efficacy VAH DGHM listing CE marking FDA approval and in accordance with the DFU of the disinfecting solution manufacturer For all metal instrumen...

Page 4: ...efects broken bent and twisted Follow instructions and observe concentrations and time given by the manufacturer see also general recommendations The disinfecting solution should be aldehyde free and...

Page 5: ...lling material Operation Operating mode Warning 1 Disinfection Immerse the obturation devices in NaOCl 2 5 at least during 5 mn at ambient temperature Do not use disinfecting solutions containing Phen...

Page 6: ...ecommand e L activation de l irrigation est recommand e pour certaines proc dures ex descellement de tenons m talliques pointe 4 qui n cessitent une puissance lev e ceci afin de limiter l chauffement...

Page 7: ...et l utiliser en suivant les instructions d utilisation figurant dans son mode d emploi Pour les instruments m talliques il est recommand d utiliser une solution nettoyante et d sinfectante qui contie...

Page 8: ...ISO 15883 et faire l objet d un entretien et d un talonnage r guliers X X X X OU 4b Nettoyage manuel avec ou sans recours aux ultrasons Placer les instruments dans un kit un conteneur ou sur un suppor...

Page 9: ...couleur des indicateurs de st rlisation int grateurs physico chimiques enregistrements num riques des param tres des diff rents cycles Garantir la tra abilit des protocoles enregistr s X X X X 9 Stock...

Page 10: ...stungseinstellung erfordern z B Entfernung von Metallstiften Spitze Nr 4 sollte zus tzlich gesp lt werden um eine berhitzung der Spitze und des Zahns zu vermeiden Die Spitzen m ssen vor Gebrauch mit d...

Page 11: ...Listung CEKennzeichnung FDA Zulassung und die Gebrauchsanweisung des L sungsherstellers beachten F r metallische Instrumente wird empfohlen eine Reinigungs und desinfektions L sung zu ben tzen die ein...

Page 12: ...en Kontakt zwischen den Instrumenten bzw Stiften w hrend der Behandlung im Reinigungs und Desinfektionsger t vermeiden Kits St nder oder Beh lter verwenden Anleitung und Konzentrationsangaben des Hers...

Page 13: ...60 EN 285 Gem ISO 17665 validiertes Sterilisationsverfahren verwenden Angaben des Herstellers zur Wartung des Autoklavs beachten Ausschlie lich das empfohlene Sterilisationsverfahren anwenden Wirksamk...

Page 14: ...otenza elevata come la rimozione di perni in metallo punta n 4 si raccomanda l utilizzo di irrigazione al fine di evitare il surriscaldamento sia dell inserto che del dente Prima dell utilizzo serrare...

Page 15: ...solo soluzioni disinfettanti la cui efficacia sia stata approvata elenco VAH DGHM marcatura CE approvazione FDA e in accordo con le Istruzioni d uso del produttore della soluzione disinfettante Per g...

Page 16: ...vaschetta a ultrasuoni Sugli strumenti non devono essere visibili impurit Eliminare gli strumenti con evidenti difetti rotti piegati o deformati Seguire le istruzioni e rispettare i tempi e le concent...

Page 17: ...anneggiata o umida Controllare la busta e I dispositivi prima di utilizzarli integrit della busta no umidit e periodo di validit X X X X B Materiale d otturazione Operazione Modalit operativa Avverten...

Page 18: ...g n tipo de ayuda visual Ante situaciones que requieran altas potencias como eliminaci n de postes met licos punta 4 se recomienda usar irrigaci n para evitar sobrecalentamiento de la punta as como de...

Page 19: ...es desinfectantes aprobadas por su eficacia Incluidas en la lista VAH DGHM con la marca CE o aprobadas por la FDA y en concordancia con las instrucciones de uso del fabricante de la soluci n desinfect...

Page 20: ...ciones generales Usar s lo termodesinfectadoras que cumplan la normativa EN ISO 15883 realizando su mantenimiento y calibrado regularmente X X X X O 4b Limpieza ymanual o combinada con cubas de ultras...

Page 21: ...ricos de los indicadores integradores f sico qu micos documentaci n digital de los par metros de cada ciclo Trazabilidad de las documentaciones de los procedimientos X X X X 9 Almacenamiento Mantener...

Page 22: ...rigatie wordt aanbevolen bij het uitvoeren van bepaalde procedures waarbij veel vermogen is vereist zoals het lostrillen van metalen stiften tip 4 om oververhitting van zowel de tand als de tip te voo...

Page 23: ...antia die om hun doeltreffendheid zijn goedgekeurd VAD DGHM lijst CEmarkering FDA goedkeuring en op de wijze als aangegeven in de gebruiksaanwijzing van de fabrikant Voor alle metalen instrumenten wor...

Page 24: ...desinfector elk contact tussen instrumenten en stiften Gebruik hiervoor de sets houders of overeenstemmende containers Volg de instructies en let op de concentraties zoals door de fabrikant aangegeven...

Page 25: ...een sterilisatieprocedure conform de ISO 17665 Houd u aan de onderhoudsprocedure van de autoclaaf zoals aangegeven door de fabrikant Pas uitsluitend de opgegeven sterilisatieprocedure toe Controleer...

Page 26: ...or at undg overophedning af b de tand og spids anbefales det j vnligt at skylle under udf relsen af procedurer som kr ver h j energi som fx fjernelse af metalstifter spids nr 4 Spidsen skal v re sp nd...

Page 27: ...er der er godkendt for effektivitet VAH DGHM listede CEm rkede FDA godkendte iht producentens brugsanvisningen for desinfektionsopl sningen Det anbefales at anvende desinfektions og reng ringsmidler d...

Page 28: ...nbefalinger Anvend en godkendt dental opvaskemaskine iht EN ISO 15883 vedligehold og kalibrer regelm ssigt X X X X Ao 4b Manuel reng ring evt med anvendelse af ultralydsrensekar Placer tingene i et s...

Page 29: ...overskredet holdbarhedsdatoen farveindikatorer skal have underg et den rigtige farve ndring og fysio kemiske integratorer og digitale registreringer af cyclus skal udvise korrekt X X X X 9 Opbevaring...

Page 30: ...ineiden k ytt jolloin ty skentely on mukavampaa ja turvallisempaa Jatkuvaa huuhtelua suositellaan toimenpiteisiin jotka vaativat suurta energiaa kuten poistettaessa metallinastoja k rki 4 N in v ltet...

Page 31: ...l Yleiset suositukset K yt ainoastaan teholtaan hyv ksyttyj desinfiointiliuoksia VAH DGHM listaus CE merkint FDA n hyv ksynt ja desinfektioliuoksen valmistajan antaman k ytt ohjeen mukaisesti Kaikille...

Page 32: ...aan EN ISO 15883 n mukaista pesudesinfektoria ja huolehdi sen s nn llisest huollosta ja kalibroinnista X X X X Ao 4b K sin teht v tai ultra nilaitteella tehostettu puhdistus Aseta instrumentit telinee...

Page 33: ...kkauksen kunto ei kosteutta indikaattorin v rin muutos fysikaalis kemialliset integraattorit syklien parametrien digitaaliset tallenteet Tapahtuman tallenteiden oltava l ydett viss X X X X 9 S ilytys...

Page 34: ...mmenderas visuell kontroll Vattenkylning vid arbetsmoment som kr ver h g ultraljuds frekvens som avl gsnande av metall stift stift 4 rekommenderas f r att undvika verhettning av b de spetsen och tande...

Page 35: ...visningen MTA Glyde och Topseal Allm nna rekommendationer Anv nd enbart desinficerande v tskor som r godk nda f r sin effektivitet VAH DGHM listade CE m rkta FDA godk nda och i enlighet med respektive...

Page 36: ...tor i enlighet med EN ISO 15883 underh ll och kalibrera den regelbundet X X X X Ao 4b Manuell reng ring eller med ultraljudsbad Placera instrumenten i ett set st ll eller beh llare f r att undvika all...

Page 37: ...autoklav indikatorerna fysiskt kemiska integratorer digitala minnen f r autoklavcyklarnas parameter Lagringsm jlighet och m jlighet att ta fram tidigare k rda autoklaverings program f r kontroll X X X...

Page 38: ...iga o recomendada ao executar os procedimentos tais como a remo o de pinos met licos ponta 4 que requerem grande energia para evitar o sobreaquecimento das pontas e dos dentes Antes da utiliza o a pon...

Page 39: ...TA Glyde Topseal Recomenda es gerais Utilize somente solu o desinfetante que esteja comprovada a sua efic cia Listagem VAH DGHM marcas CE aprova o FDA e de acordo com as Instru es de Utiliza o da solu...

Page 40: ...e qualquer contato entre instrumentos ou pinos quando colocados na lavadora termodesinfectadora Use estojos suportes ou recipientes Siga as instru es e observe as concentra es indicadas pelo fabricant...

Page 41: ...285 Use procedimento de esteriliza o validado de acordo com a ISO 17665 1 2006 Respeite o procedimento de manuten o do aparelho de autoclave dado pelo fabricante Use unicamente procedimentos de ester...

Page 42: ...LLEFER 1338 Ballaigues Switzerland START X 1 1 2 2 2 3 4 5 2 3 4 4 5 6 SATELEC P5 Newtron EMS miniPiezon Min Max Min Max N 1 16 18 8 9 N 2 16 18 8 9 N 3 10 18 4 7 N 4 18 20 9 10 N 5 7 18 3 8 Dentsply...

Page 43: ...X F19 02 106 X 01 2008 created 10 2008 43 50 DENTSPLY MAILLEFER 1338 Ballaigues Switzerland 7 A1 carbide A2 A3 B Thermafil MTA Glyde TopSeal VAH DGHM CE FDA NiTi H2O2 NiTi 5 NaOCl 5 pH 6 pH 8 tungste...

Page 44: ...DFU START X F19 02 106 X 01 2008 created 10 2008 44 50 DENTSPLY MAILLEFER 1338 Ballaigues Switzerland A A3 A2 A1 X 1 X 2 X 3 1 X 4a Ao 3000 5 90 C ISO 15883 X X X X 4b X X X 5 1 X X X...

Page 45: ...X F19 02 106 X 01 2008 created 10 2008 45 50 DENTSPLY MAILLEFER 1338 Ballaigues Switzerland 6 X X X X 7 141 C 286 F ISO 11607 X X X X 8 134 C 273 F 18 EN 13060 EN 285 ISO 17665 X X X X 9 X X X X B 1 N...

Page 46: ...widoczno Aby unikn przegrzewania ko c wki oraz z ba podczas zabieg w wymagaj cych zastosowania wysokiej mocy zaleca si stosowanie irygacji na przyk ad podczas usuwania wk ad w metalowych ko c wka nr...

Page 47: ...k tnice endometry i inne urz dzenia z procedurami om wionymi indywidualnie w instrukcji obs ugi MTA Glyde I uszczelniacz TopSeal Og lne zalecenia Stosuj tylko p yny dezynfekuj ce zalecane ze wzgl du...

Page 48: ...tylko akceptowane myjki dezynfekuj ce zgodnie z EN ISO 15883 konserwuj i kalibruj urz dzenia regularnie X X X X LUB 4b Mycie r czne lub wspomagane urz dzeniem ultradwi kowym Umie narz dzia w zestawach...

Page 49: ...ak wilgoci zmian koloru wska nika sterylizacji wska niki fizyko chemiczne cyfrowy zapis parametr w cykli Stosuj zapisy jako ci cykli sterylizacji mo liwe do skontrolowania X X X X 9 Przechowywanie Trz...

Page 50: ...sostituibili Los embalajes abiertos no se cambian Geopende verpakkingen worden niet vervangen Assortment Assortiment Sortiment Assortimento Surtido Assortiment Green dot Point vert Der Gr ne Punkt Pu...

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