Kulzer Flexitime Xtreme 2 Instrucciones De Uso

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Description of applicational / packaging icons
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Manufacturer: Distributed in USA / Canada exclusively by:
Kulzer GmbH
Kulzer, LLC
Leipziger Straße 2
4315 South Lafayette Blvd.
63450 Hanau (Germany)
South Bend, IN 46614-2517
1-800-431-1785
Made in Romania
Caution: Federal law restricts this device
to sale by or on the order of a dentist.
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Cartridge System, 50 ml
➀ Intra Oral Tip
➁ Mixing Tip
➂ Dispensing Gun 2
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C
F
H
G
Medical device
Dispositif médical
Producto sanitario
Instructions for use
Vinyl Polysiloxane impression material system
Side effects:
This product or one of its components may in particular cases cause hypersensitive reactions.
If suspected, information on the ingredients can be obtained from the manufacturer.
Contraindications:
The use of this product is contraindicated in case of known or suspected allergies against components of this product.
Notes on use:
Not to be used in conjunction with other silicone materials.
Dispense a small amount of material from a 50 ml cartridge before attaching a mixing tip. After use, leave the mixing tip on the
cartridge to keep it closed. Immediately before the next use remove the mixing tip and attach a new one. Mixing tips and intraoral
tips are single use products. To prevent cross – contamination between patients mixing tips and intraoral tips must be discarded
after each use.
In all addition-curing silicone impression materials, the setting process may be affected by contact with products containing active Sulfur or Nitrogen,
as well as by fresh composite fillings or core build-ups. These products include latex gloves, Polysulfide impression materials, retraction solutions,
etc. Therefore, please ensure that patient's mouth (ie. preparation and gingival margin) is thoroughly washed and dried before impression taking
commences. Flexitime Xtreme 2 contains surfactants for hydroxylation, which in some patients may cause a superficial anesthetic effect. Surplus
material on the impression tray or in the patient's mouth should be avoided as this may result in gagging, swallowing or aspiration. To further
reduce these risks during impression taking, the patient should be positioned as upright as possible.
Flexitime Xtreme 2 impression materials should be at room temperature 23°C (73°F) for processing. Visually inspect for damage before first use.
Damaged products must not be used.
Flexitime Consistency
Xtreme 2
ISO 4823
Base
Type 1
Heavy Tray
violet
heavy bodied
Type 3
Correct Flow light green
light bodied
* at room temperature of 23°C (73°F), 50 % rel. humidity. Higher temperatures shorten, lower temperatures prolong these times.
If there are substantial undercuts or highly divergent teeth in the impression area, appropriate blocking out must be performed if
using Flexitime Xtreme 2 Heavy Tray.
Model fabrication:
Pouring can take place 15 min. after impression is removed from the mouth. No other limitations apply.
The set impression has guaranteed long term dimensional stability.
Recommended Model Material:
Compatible with all commercially available modelling materials.
We recommend: Type III – Modern Materials
Type IV – Modern Materials
Disinfection:
Impressions should generally be treated by immersion for 10 minutes* in 5.25% Sodium Hypochlorite solution. Other silicon specific disinfectant
solutions should be used as directed by the products manufacturer.
* Gelson Luís Adabo, DDS, PhD, Elaine Zanarotti, Renata Garcia Fonseca, and Carlos Alberto dos Santos Cruz, DDS, PhD – Effect of
D
disinfectant agents on dimensional stability of elastomeric impression materials. J Prosthet Dent, 81, 621–4,1999
Tray Adhesive:
We always recommend the use of Kulzer Silicone Universal Adhesive.
Warnings and safety instructions:
K
Avoid contact with skin and eyes. May be irritating to eyes and skin. If product comes into contact with the skin, thoroughly wash with soap and
water immediately. If material comes into contact with the eyes, rinse it out with water for several minutes. If symptoms persist, consult an eye
specialist. Do not leave any residual material in sulcus or oral cavity, as this may lead to abscess formation.
Do not swallow and ingest. If health problems arise after swallowing impression material, seek medical attention immediately. Intestinal
blockage may arise in rare cases. Wear protective gloves (EN 374, category III, e.g. Dermatril from KCL, Germany). Polyvinyl siloxanes are
chemically resistant. Material which has not set can soil clothing.
Please quote batch number and article number in all correspondence about the product. According to the EU Medical Devices Regulation, users /
patients are obliged to report serious events with a medical device to the manufacturer and to the competent authority of the country in which
they occurred.
Storage conditions:
Do not store above temperature 25°C (77°F). Do not use after the expiration date (see information on the package). For disposal please follow
the instructions on the material safety data sheet and national regulations.
Only to be used by dentists and for its intended use.
Dated: 2019-03
Product Colour Mixing time Extraoral Intraoral working
Working time* time (35°C
(23°C (73°F)) (95°F))
Catalyst s min:s min:s
light grey auto 1:30 –
white auto 1:30 0:30
® Labstone ® ,
Die-Stone .
® ®
Description of applicational / packaging icons
A = Only use pastes with same LOT No
B = Icon "Use of the special program at the
Dynamix ® speed Mixing Unit possible"
C = Mixing ratio
D = Mixing time
Minimum Appropriate Accessories
time in mouth
min:s Mixing Tips Intraoral Tips
green
1:30 na
66001989
yellow yellow
1:30
66001988 66000782
E = Extraoral working time
F = Intraoral working time
G = Time in mouth
H = Static mixing tip
K = Intraoral tip