Ordering Information - Detax silasoft direct Gebrauchsanweisung

silasoft
Precision impression material, C-silicone based,
light bodied consistency – normal setting, 10:1
Patient Target Group
Persons being treated in the context of a dental procedure.
Catalyst component contains alkyl stannosiloxanes: Do not use for the treatment of pregnant/breastfeeding women and
children.
Intended Users
Dentist
1. Preparation of the impression
Fig. 1
Depending on the impression technique select an appropriate tray. For optimal adhesion of the impression to the tray
apply a thin layer of sili Adhesive Spray or sili Adhesive liquid onto the tray and let dry for 60 sec (Fig. 1). Take preliminary
impression with silaplast FUTUR. To facilitate the flowing out of excessive light body material from the impression
cutting of escape vents and removal of interdental septi in the impression with the use of the special instrument Deta-
Cut is recommended.
2. Mixing and Dosing
Extrusion of the impression material from the cartridges by means of Automix2 gun (Fig. 2). Place cartridge into mixing
gun, remove cartridge plug by rotation. Eject a small amount of material (bleeding) to control that equal amounts
are being extruded from both orifices (Fig. 3). Mount the mixing cannula by using the guides on the cannula and the
Fig. 2
cartridge and lock in place by rotating in the opposite direction (Fig. 4). Feed material applying even pressure. Prior to
use, dispense a small amount of material and visually check that the base and catalyst paste are mixed omogeneously
(Fig. 5). For application into sulcus area use Intra-Oral tips yellow – coloured or a disposable syringe (Fig. 6). After use
remove mixing cannula and close the cartridge by means of the original closure cap.
3. Disinfection
After taking the impression out of the mouth, rinse it under running lukewarm water. Subsequent disinfection can be
carried out with suitable commercially available disinfecting solutions according to the manufacturer's instructions.
4. Model casting
Fig. 3
Not before 30 min. after removal from the mouth, at the latest after 24 hours. Recommended materials: Dental plasters
of class III and IV-also commercially available model acrylics.
5. Galvanisation
Impressions can be electroplated with commercially available copper and silver plating baths.
6. Cleaning of trays
Remove cured material mechanically. Sili Spray or sili liquid film can be easily removed with sili Spray Solvent (free of
FCHC). Work in well ventilated rooms. Clean and disinfect as usual.
Fig. 4
Safety Information
Only for dental use by trained specialists.
In case of stiffness or clogging discard the cartridge; do not use force for application!
Higher temperatures accelerate, lower temperatures delay the curing.
Carefully close cartridge openings immediately after use.
Cured impression materials are chemically resistant – avoid stains on clothing.
Avoid eye contact with catalyst, may cause irritation, rinse eyes immediately with plenty of water if necessary, seek
medical advice immediately.
Do not leave any residues of the impression material in the patient's mouth, and prevent inadvertent pressing of material
Fig. 5
into areas outside the oral cavity through mouth-antrum connections or malformations of the palate.
Wear suitable personal protective equipment during the finishing of the cured material.
Refer to the relevant safety data sheet for hazard and safety information.
Notes
DETAX shall not be held liable for any damage caused by misuse.
Read and understand safety data sheet.
For users and/or patients:
Any serious incidents occurring in connection with this product must be reported immediately to incident@detax.de and
to the competent public authority of the country in which the user and/or patient resides.
Fig. 6
Contraindication
Do not use this material in case of known allergies to any of the ingredients, or contact allergies. Silicone impression materials
are proven a million times over, unwanted effects cannot be expected in proper use. However, immune reactions, e.g. allergies
or irritations cannot be excluded basically. In the case of doubt, we recommend performing an allergy test before application.
Disposal
Disposal of the contents/container must be carried out in accordance with the local/regional/national and international
regulations.
Symbols
Medical Device
1 min. 15 sec.
Working time
4 min. 15 sec.
Setting time
GmbH & Co. KG
Carl-Zeiss-Str. 4 · 76275 Ettlingen/Germany
Telefon: 0 72 43/510-0 · Fax: 0 72 43/510-100
www.detax.de · post@detax.de
direct
®
3 min.
Time in the mouth
Caution: Federal U.S. law restricts this device to
sale by or on the order of a dentist (or trained
specialist personnel).
EN
Instructions for use
Intended use:
Precision impression silicone
material for dental prosthetics
Indication:
Preliminary impressions for the
double impression or double mix
technique (wash)
Reline impressions
Technical Data:
DIN EN ISO 4823 – Type 3
Mixed volume:
50 ml (cartridge)
Mixing ratio:
10:1
Colour code:
base: violet
catalyst: blue
Mixing time:
omitted (Automix2-system)
Working time:
approx. 1 min. 15 sec.*
Setting time:
approx. 4 min. 15 sec.*
Time in mouth:
approx. 3 min.
Strain in compression:
approx. 5 %
Recovery from
deformation:
approx. 98.5 %
Linear dimensional change:
approx. 0.5 %
Application:
At 23 °C ± 2 °C / 73 °F ± 4 °F,
50 ± 5 % rel. humidity
Storage:
25 °C
77 °F
15 °C
59 °F
* from beginning of mixing at 23 °C
± 2 °C / 73 °F ± 4 °F, 50 ± 5 % rel.
humidity. Increased temperatures
accelerate, decreased temperatures
retard a. m. times.
Ordering
information:
silasoft® direct
Automix2
Standard packing
2 x 50 ml cartridges
12 mixing cannulas,
yellow 10:1
12 intra-oral-tips, yellow
Eco packing
8 x 50 ml cartridges
48 mixing cannulas,
yellow 10:1
48 Intra-Oral-Tips, yellow
Mixing cannulas
48 pcs., yellow 10:1
Intra Oral Tips
96 pcs., yellow
Mixing gun
Automix2
1 pc. 10:1
Made in
Germany
09/2019
3
02809
02810
02807
02712
02808