092903 #30309.1 South Jordan, Utah 84095 USA
should not be To prevent cross-contamination, a used syringe
505 West 10200 South
syringe. express contents of unit dose syringe back into IndiSpense
on plunger of unit dose syringe to facilitate loading. Do not
© Copyright 2003 Ultradent Products, Inc. All Rights Reserved.
at the plunger with the nondominant hand. Slightly pull out
fill unit dose syringe to desired level.
hand, depress plunger of IndiSpense and syringe is depressed while the unit dose syringe is stabilized
unit dose syringe with the non-dominant or visit www.ultradent.com.
syringe. While supporting plunger of Outside U.S. call (801) 572-4200
2. With palm grasp (Fig. 2) the plunger of the IndiSpense
is twisted firmly onto the IndiSpense
refer to Ultradent’s catalog or call Toll Free 1-800-552-5512.
Figs. 1&2 A 1.2ml unit dose syringe thread of the IndiSpense as show in Fig. 1. For immediate reorder and/or complete descriptions of Ultradent’s product line,
Keep out of reach of children.
luer lock of the unit dose syringe snugly onto the male
U.S. federal law restricts the sale of this device by or on the order of a dentist.
end of the large, no-waste IndiSpense syringe by turning the
1. An empty 1.2ml or 5ml syringe is attached to the
A. IndiSpense® System delivery:
Preliminary Steps:
The first two numbers are the month, and the third number is the last number of the year.
Procedure: The letter is a lot number used for manufacturing purposes and the three numbers are the expiration date.
one letter and three numbers.
Ultradent syringes have an expiration date stamped on the side of the syringe consisting of
free water, plain EDTA or local anesthetic.
regimen used we recommend a final rinse with clean bacteria
agent, is an alternative for this purpose. Regardless of
Solution
for smear layer removal. Ultradent’s EDTA 18%, a chelating
Shelf Life: 24 months. Store at room temperature.
canal walls. It can also be used as a mild etchant/conditioner 10%
removal of calcium hydroxide materials (i.e. UltraCal®) from
MSDS Included
provided in a 30ml IndiSpense® Syringe. Citric Acid facilitates
Minimal = 0
Citric Acid
It is slightly orange tinted for easy identification and is
Slight = 1
Moderate = 2 0
0
Reactivity Health
Citric Acid 10% is a slightly thickened, water-soluble solution.
Serious = 3 0
Severe = 4
Description & Indications:
Flammability
HazaRd Rating Citric Acid
reattached to the IndiSpense syringe.
Tegnforklaring:
Controlled Product Yes No Key:
3
MATERIAL SAFETY DATA SHEET
SECTION I - IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Merkkien
Legenda:
Legende:
3. Remove luer lock cap from syringe. Twist a NaviFX? Tip or NaviTip? Material Manufactured by Ultradent Products, Inc.
Ultradent 10% Citric Acid
Name
505 West 10200 South Clave:
Explication: selitykset:
Material South Jordan, Utah 84095 USA
For neutralization and removal of Calcium Hydroxide
Use
firmly onto syringe. Gauge NaviFX Tip with Emergency Legenda:
Erklärung der
from root canals. Kλειδί:
1-800-552-5512
or 1-801-572-4200 (Outside USA)
Contact
Date EC Representative
08/27/03 Teckenförklaring:
Packungssymbole:
Prepared by:
the rubber stop at least 2mm short of the root terminus Peter Allred Use by Date Use antes de la fecha Käytettävä ennen
SECTION II - COMPOSITION/INFORMATION ON INGREDIENTS Να ρησιµπιηθε? µέρ?
Verwendbar bis de vencimiento.
Approximate LD50/LC50
Active Ingredients C.A.S. N.A. or U.N. Numbers
as show in Fig. 3. A utiliser avant Usar até à data
Concentration % Specify Species and Route
Fig. 3 Measure NaviFX tip 2mm Houdbaarheidsdatum Användes före
Citric Acid 10% 6730 mg/kg/oral (rat) 5949-29-1
short of root apex and loosely Usare entro la data indicata Bruges inden
Procedure: fitted in canal.
Non riutilizzare Genbruges ikke
Do not reuse
1. Make sure NaviFX Tip is loose in canal and at least 2mm short of No re-use Älä käytä uudelleen
Nur zum Einmalgebrauch
SECTION III - HAZARDS IDENTIFICATION
Adverse Human Chronic Health Effects: Not Known. Irritant in case of eye or skin exposure. Não reutilizar Να µην επαναρησιµπιηθε?
Ne pas réutiliser
Effects and Symptoms
Skall ej återanvändas
Niet opnieuw gebruiken
SECTION IV - FIRST AID MEASURES
terminus. Gently deliver the Citric Acid with NaviFX Tip. Move brush Eye
Inhalation N/A Immediately flush eyes with water for at least 15 min.
Contact Do not use eye ointment. Seek medical attention. Numero di catalogo (codice d'ordine) Katalognr.
Catalog Number
Skin Neutralize affected area with Sodium Bicarbonate (baking soda). Ingestion Give water or milk to dilute and induce vomiting.
Número de catálogo Luettelonumero
Bestell-Nr.
tip up and down to agitate and brush solution, cleaning walls with Contact Rinse wll with water. If irritation persists, seek medicl attention.
REF Número do catálogo Αριθµ? καταλγυ
Référence du catalogue
SECTION V - FIRE-FIGHTING MEASURES
Flammability If Yes, Under Ingestion Katalog nummer
Catalogusnummer
Citric Acid as shown in Fig. 4. Do not express Citric Acid when 3
Yes No Which Conditions:
Means of Protective Equipment N/A
N/A for Firefighters
Extinction
See Instructions For Use Siga las instrucciones
SECTION VI - ACCIDENTAL RELEASE MEASURES SECTION VII - HANDLING AND STORAGE
canula tip is at full length or if it fits tight against the canal walls. Siehe Gebrauchsinfo Ver instruções para uso
Handling
Personal & Environmental Avoid contact with
skin or eyes.
Precautions Use latex gloves.
Precautions Voir le Mode d’Emploi Se bruksanvisning före användning
Fig. 4 Express Citric Acid into Storage
Methods for Wipe up with a paper towel. Room temperature.
Cleaning Requirements Lees de gebruiksvoorschriften
canal. Scrub tip up and down. Se brugsanvisning
2. Flush out canal with copious sodium hypochlorite (we recommend
Rinse canal thoroughly wiht plain Leggere attentamente le Katso käyttöohjeita
SECTION VIII - EXPOSURE CONTROLS/PERSONAL PROTECTION
Respiratory Eye Protective eyewear.
EDTA, N/A istruzioni d'uso ∆είτ? τις δηγίε? ρήσεω?
Protection Protection
Hand
ChlorCid). Perform a final rinse with clean bacteria free water, plain EDTA or or local clean bacteria free water
anesthetic. Skin Lab coat.
Use latex gloves.
Protection Protection Batch Code Codice di Lotto Batch nr.
SECTION IX - PHYSICAL & CHEMICAL PROPERTIES Chargen-Nummer Código de grupo Eränumero
Melting
local anesthetic. Quick and effective removal of most of the Solubility in
Appearance
Orange low viscosity gel. Soluble N/A
Point/Range
Water Numéro de lot Código de lote Κωδικ? παρτίδας
Other Data
pH
Odor N/A N/A
~3 Batch nummer
Seriecode
Citric Acid solution or other irrigants is facilitated by using a Luer Vacuum Adapter SECTION X - STABILITY AND REACTIVITY
Chemical Stability Conditions and Hazardous Decomposition
N/A
Yes 3 No Materials to Avoid Products
Keep out of reach of children. Manter fora do alcance das crianças.
with a Capillary Tip or 10mm Micro Capillary. SECTION XI - TOXICOLOGICAL INFORMATION Außerhalb der Reichweite von Kindern aufbewahren. Förvaras utom räckhåll för barn.
3
Route of Entry Skin Contact Skin Absorption Eye Contact Inhalation Acute Inhalation Chronic Ingestion Tenir hors de portée des enfants. Opbevares utilgængelig for børn.
Effects and Symptoms May cause irritation in case of skin or eye contact. Buiten bereik van kinderen houden. Pidettävä poissa lasten ulottuvilta.
of Short-Term Exposure
3. One or two paper points are usually all that are required for final drying of canals if Chronic Effects and Symptoms Tenere fuori dalla portata dei bambini. Φυλάτ? µακριά τα παιδιά.
Product is non toxic.
of Long-Term Exposure Manténgase fuera del alcance de los niños.
Irritancy
Sensitization N/A N/A
canals are first vacuumed out as per step 2 above. of Product °F °C Recommended storage temperature. Temperatura de armazenagem aconselhada.
SECTION XII - ECOLOGICAL INFORMATION SECTION XIII - DISPOSAL CONSIDERATIONS
Method of Empfohlene Lager-Temperatur. Rekommenderad Förvarings Temperatur.
Biodegradability Yes In accoradance with governmental regulations.
Waste Disposal
4. Fit master cone then obturate. We recommend the ADO? Method using EndoREZ? Further Details Temperature de Stockage Recommandée. Anbefalet Opbevaringstemperatur.
None
8°
SECTION XIV - TRANSPORT INFORMATION SECTION XV - REGULATORY INFORMATION 46° Aanbevolen bewaartemperatuur. Suositeltu säilytyslämpötila.
Hydrophilic Sealer and gutta percha. No limitations. None 2°
36° Temperatura di stoccaggio consigliata. Συνιστώµενη θερµκρασί? απθήκευση?
SECTION XVI - OTHER INFORMATION Temperatura Recomendada Para
FOR DENTAL USE ONLY. Use as directed.
Precautions: Almacenamiento.
The information and recommendations are taken from sources (raw material MSDS(s) and manufacturer’s knowledge) believed to be accurate;
however, Ultradent Products, Inc., makes no warranty with respect to the accuracy of the information or the suitability of the recommendation
and assumes no liability to any user thereof. Each user should review these recommendations in the specific context of the intended use and
determine whether they are appropriate.
1. Always us a rubber dame for endodontic therapy. Prevent ingestion of Citric Acid solution.
Filing and Chelating Agent Upplösande, Smörjande Dentin Behandlare
EDTA-Gel zur Wurzelkanalaufbereitung Smøre- og chelateringsmiddel
Agent Chélatant Pehmentävä ja Voiteleva Dentiinin
Citric Acid 10% Chelaterende gel Käsittelyaine
Agente Chelante Endodontico Παράγντα? ήλιση? για τη ρίνιση
Gel Quelante
Preparação do Canal com Ouelante EDTA
Solution
°F °C
1. For Professional use only.
2. Review instructions, precautions, and MSdS before beginning treatment. Use only as directed.
3. Keep products out of heat/sunlight.
4. avoid skin exposure to resins.
85° 30°
naviFX tip 5. isolate strong chemicals to area of treatment.
65° 18°
6. Confirm that patient has no known allergies to treatment materials.
7. test flow of materials from syringe and tip before using intraorally.
8. never force syringe plungers.
Allgemeine Vorsichtsmaßnahmen:
Store at room 1. nur für professionellen zahnmedizinischen gebrauch.
temperature 2. Lesen Sie die gebrauchsinformationen und Warnhinweise sorgfältig, bevor Sie die Behandlung beginnen.
Verwenden Sie die Materialien nur gemäß Vorschrift.
3. Schützen Sie die Produkte vor Hitze und direktem Sonnenlicht.
4. Vermeiden Sie Hautkontakt mit Kunststoff-Materialien.
5. Beschränken Sie den Einfluß stark wirkender agenzien auf das Behandlungsgebiet.
6. Fragen Sie den Patient nach bekannten allergien auf die zur Behandlung verwendeten Materialien.
7. Prüfen Sie den Fluß des Materials aus der Spritze und durch den Spritzenansatz, bevor Sie intraoral applizieren.
8. drücken Sie einen Spritzenstempel nie mit gewalt ein.
Précautions générales:
1. Exclusivement réservé à l’usage professionnel.
2. Voir les instructions, les précautions et la notice de sécurité avant le traitement. Utiliser uniquement selon les instructions.
3. tenir les produits àl’abri de la lumière du soleil et de la chaleur.
4. Eviter le contact des résines avec la peau.
5. Limiter l’application des produits aux seules zones de traitement.
Express Citric acid into canal. Scrub tip up
Measure naviFX tip 2mm short of root 6. S’assurer que le patient ne présente aucune allergie aux produits utilisés lors du traitement.
and down. Rinse canal thoroughly with plain 7. tester le débit des matériaux à travers les seringues et les embouts d’application avant toute utilisation intra-buccale.
apex and loosely fitted in canal. 8. ne jamais forcer sur le piston des seringues.
Edta, clean bacteria free water or local
Algemene voorzorgsmaatregelen:
anesthetic. 1. Uitsluitend bestemd voor aflevering aan en toepassing door tandartsen.
2. Raadpleeg gebruiksaanwijzingen en houd rekening met de daarin genoemde aanbevelingen. gebruik alleen zoals is
Beschreven.
3. Bewaar de producten koel en donker.
4. Vermijd huidcontact met harsen.
5. appliceer alleen daar waar nodig.
6. Overtuig u ervan dat de patiënt niet allergisch is voor de toegepaste materialen.
drücken Sie Citric acid in den Kanal. Reiben
Messen Sie die naviFX Spitze 2mm 7. test het functioneren van spuitjes alvorens intra-oraal te gebruiken.
DE Sie die Spitze auf und ab. Spüllen Sie den 8. Oefen nooit overmatige kracht uit bij de spuitjes.
kürzer als die zahnwurzelspitze und Precauzioni Generali:
Kanal gründlich mit reinem Edta, sauberem,
1. Prodotto riservato all ‘uso professionale.
legen Sie sie lose in den Kanal. kiemfreiem Wasser oder einem lokalen 2. Prima di iniziare il trattamento vanno esaminate le istruzioni, le precauzioni d’uso ed i moduli per la sicurezza dei
prodotti (MSdS). Utilizzare esclusivamente nei modi indicati.
anästhetikum aus.
3. Conservare i prodotti al riparo dal calore e dall’esposizione diretta alla luce del sole.
4. Evitare l’esposizione della pelle alle resine.
5. La presenza di prodotti chimici forti deve essere isolata all’area di trattamento.
6. Verificare che il paziente non sia allergico ai prodotti scelti per il trattamento.
appliquer Citric acid dans le canal. Frotter 7. Prima dell’uso intraorale deve essere verificato il flusso del materiale dalla siringa e dalla punta
Mesurez le bout de naviFX jusqu’? 8. non forzare mai gli stantuffi delle siringhe.
FR de bas en haut à l’aide de l’embout. Rincer
2mm de l’apex de la racine et ajustez-le Precauciones Generales:
minutieusement le canal avec de l’Edta 1. Para Uso Exclusivo de Profesionales.
sans serrer dans le canal. 2. antes de empezar el tratamiento, revise las instrucciones, precauciones y el MSdS. Siga las instrucciones.
simple, de l’eau propre dépourvue de
3. Mantenga siempre los productos alejados del calor y de la luz solar.
bactéries ou avec un anesthésique local. 4. Evite el contacto de las resinas con la piel.
5. aisle los químicos fuertes del área de tratamiento.
6. asegúrese de que el paciente no es alérgico a los materiales.
7. antes de usar en la boca, verifique que los materiales fluyan de la jeringa y la punta.
8. nunca empuje con fuerzá el émbolo.
druk Citric acid in het kanaal. Beweeg de
Meet de naviFX-top 2mm korter dan Precauções gerais:
NL top op en neer. Spoel het kanaal grondig met 1. Somente para uso profissional.
het wortelpunt, waarbij deze los in het 2. Ler instruções, precauções e MSdS antes de começar o tratamento. Utilizar só como indicado.
normaal Edta, schoon bacterievrij water of
3. Manter os produtos longe do calor e da luz solar directa.
kanaal is geplaatst. een lokaal anaestheticum. 4. Evitar contacto com a pele.
5. aplicar substâncias químicas fortes só na área de tratamento.
6. Confirmar se os pacientes não tem alergías aos materiais utilizados.
7. testar o escoamento dos materiais através da seringa e ponta antes da aplicação intraoral.
8. nunca forçar os êmbolos da seringa.
Generella försiktighetsåtgärder:
Spremere Citric acid nel canale. Sfregare 1. Enbart för professionellt bruk.
IT Misurare la punta di naviFX in modo 2. Läs bruksanvisningar, försiktighetsåtgärder, och varuinformationsblad innan behandling påbörjas. använd endast enligt
la punta muovendola verso l’alto e verso il
anvisning.
che sia 2mm più corta dell’apice della basso. Sciacquare bene il canale con Edta 3. Håll produkten borta från värme och solljus.
4. Undvik hudkontakt med resiner.
radice ed entri senza difficoltà nel non diluito, acqua non contaminata da batteri 5. Håll behandlingsområdet isolerat från starka kemikalier.
canale. 6. Kontrollera att patienten inte är allergisk för behandlingsmaterialet.
o anestetico locale.
7. testa att materialet flyter fritt ur sprutans spets innan användning intraoralt.
8. tvinga ej med “våld? hårt tryck pistongen i sprutan.
Generelle forholdsregler:
1. Kun til professionelt brug.
Vierta Citric acid en el canal. Frote la
Mida la punta de naviFX a 2 mm 2. Læs vejledningen, forholdsreglerne og sikkerhedsdatabladet før behandlingens start. Bør kun anvendes som foreskrevet.
ES punta arriba y abajo. Enjuague el canal 3. Udsæt ikke produktet for varme og sollys.
del inicio de la raíz y encajada 4. Undgå hudkontakt med resiner.
completamente sólo con Edta, agua libre de
5. isoler stærke kemikalier til behandlingsområdet.
holgadamente en el canal. bacterias o anestesia local. 6. Få bekræftet at patienten ikke har kendte allergier mod de produkter, der anvendes ved behandlingen.
7. Check at materialet flyder frit fra sprøjte og spids før brug intraoralt.
8. Undlad at bruge voldsom kraft til at tvinge et stempel i funktion. Hvis stemplet ikke glider uhindret bør årsagen udredes
først.
Yleiset ohjeet:
1. Vain ammattikäyttöön.
Esprema Citric acid para dentro do canal. 2. tutustu käyttöohjeisiin, suojaustoimenpiteisiin ja käyttöturvallisuustiedotteeseen ennen toimenpiteen aloittamista.
a ponta naviFX deve ser 2mm mais Käytä ainoastaan ohjeiden mukaisesti.
PT Esfregue a ponta para cima e para baixo. 3. Säilytä tuote lämmöltä ja auringonvalolta suojattuna.
curta que o ápice radicular e ajustado 4. Vältä ihokosketusta resiinin kanssa.
Enxagúe abundantemente o canal com Edta
5. Eristä käsiteltävä alue.
de forma solta no canal. simples, água bacteriologicamente pura ou 6. Varmista että potilaalla ei ole todettuja allergioita hoitoimenpiteessä käytettäville aineille.
7. testaa materiaalin juoksevuus ruiskusta ja kärjestä ennen materiaalin käyttöä intraoraalisesti.
um anestésico local.
8. Älä käytä liikaa voimaa painaessasi ruiskun mäntää.
ΓENIKEΣ ΠPOΦYΛΑEIΣ:
1. Για επαγγελµατική xρήση µvo.
2. ∆ιαάστε τις δηγίε?. πρoυλάεις και MSDS πριν εκινήσετ? τη θεραπεία. Nα τo xρησιµoπoιείτε πάvτoτε σύµωvα µε τις
För ned Citric acid i rotkanalen. gnid fram
SV Mät in naviFX-änden 2mm före oδηγίες.
och tillbaka med spetsen. Spola kanalen 3. Φυλάτ? τα πρoίvτα απ? την έκθεση τoυς στo ηλιακ? ω? ή σε θερµτητ?.
rotspetsen sittande löst i kanalen. 4. Aπoύγετ? την επα? της ρητίvης µε τo δέρµα.
ordentligt med vanlig Edta, rent bakteriefritt
5. Περιoρίστε την επα? των ισυρώv ηµικώ? µvo στηv περιoxή της θεραπείας.
vatten eller lokalbedövningsmedel. 6. Nα επιεαιώσετε τ? ? ασθενής δεν έxει καµiα γνωστή αλλεργική αντiδραση στα υλικά της θεραπεiας.
7. Nα δκιµάσετ? τη ρ? των υλικών απ? τη σύριγγα και τ? ρύγς πριν‑τ? ρησιµπιήσετ? ενδστµατικά.
8. Mην πιέετ? πτ? µε δύναµη τ? έµλ? της σύριγγας.
tryk noget Citric acid ned i kanalen. Børst
Mål naviFX spidsen 2mm inden apex
DA op og ned med spidsen. Skyl kanalen grundigt
og let tilpasset kanalen. med almindeligt Edta, rent og bakteriefrit
vand eller en lokal anæstesiopløsning.
Purista Citric acid juurikanavaan. Harjaa
FI Suorita mittaus siten, että naviFX:n
kärkeä ylös-alas-suuntaan. Huuhtele
kärki jää 2 mm päähän juuren kärjestä ja juurikanava perusteellisesti pelkällä Edta:
istuu väljästi juurikanavassa. lla, puhtaalla bakteerittomalla vedellä tai
paikallispuudutteella.
Εγύστ? Citric Acid εντ? τ?
EL Ρυθµίστε τ? άκρ? τ? NaviFX 2mm σωλήνα. Τρίψτε επάνω‑κάτ? τ?
απ? την επάνω απληψ? της ρία? άκρ?. Εκπλύντε σλαστικά τ?
και πρσαρµστε τ? αλαρ? στ? σωλήνα µε απλ? EDTA, µε καθαρ?
ριικ σωλήνα. νερ? απαλλαγµέν? απ? ακτηρίδι?
ή µε τ?ικ? αναισθητικ?.
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