Detax direct mold Modo De Empleo página 4

direct mold
Permanently elastic silicone for the fabrication of soft-flexible
protectors, long-term durable, cold curing
1. Mixing and Dosing
Extrude material from the cartridge with Automix gun (Fig. 1). Place cartridge into
mixing gun and remove closure cap by rotation. Eject a small amount of material
(bleeding) until equal flow is being extruded from both orifices (Fig. 2). Mount the
mixing cannula by using the guides on the cannula and the cartridge and lock in place
by rotating in the opposite direction (Fig. 3). Feed material applying even pressure.
Prior to use, dispense a small amount of material and visually check that the base and
Fig. 1
catalyst paste are mixed omogeneously (Fig. 4). Only then dosing can be performed
individually. Store cartridge with mixing cannula attached for subsequent use.
2. Application using the direct method
Before taking an impression, the auditory canal and the eardrum have to be examined
(Fig. 5). If distinctive features are found (e.g. inflammations or perforation of the
eardrum, tubes) impression must not be taken. The auditiory canal has to be cleaned
and depilated. In case of insufficient cleaning, remaining cerumen can cause retarded
Fig. 2
setting resp. inhibition of setting process.
Before taking the impression, the eardrum must always be protected with an impression
plug (for ex. blue secure) placed at the end of the external auditory canal in front of
the eardrum (Fig. 6). Now direct mold is injected directly into the prepared ear of the
patient as described under point 1 (Fig. 7). Keep the end of the cannula immersed on
the surface of the material during dispensing. Leave mixing cannula on cartridge after
use, thus sealing the cartridge. After curing remove the impression carefully from the
ear (Fig. 8). Re-examine the ear (Fig. 9). Final trimming and surface elaboration are
Fig. 3 carried out as described at point 4.
3. Indirect application in the laboratory
Prepare the ear impression for the post-processing, apply wax or lacquer. All commercially
available plasters and gel materials can be used for the fabrication of the negative form.
Coat the plaster negative form with a usual alginate based insulation. An insulation
of gel forms is not necessary. The bubble-free injected material vulcanises at room
temperature without pressure application. If a handle is needed, we recommend the
Fig. 4
installation of grip tool or detax handy according to special instructions. A plaster
negative form with counter can be made for the fabrication of otoplastics, in order to
shorten trimming: Fill one part of the brass flask with plaster and embed the insulated
impression. After setting of the plaster deflask the impression. In the negative form
of the impression pre-model the surface of the future earmould in wax. Insulate the
plaster surface with a separating agent (e.g. dish washing liquid), mount the second
part of the flask and fill it with plaster. After setting of the plaster open the flask. Scald
both parts of the flask with boiling water and coat them with a usual alginate based
insulation. Extrude direct mold from the cartridge (described under point 1) into the
Fig. 5
negative form and close flask with counter accurately (Fig. 10). After vulcanisation open
the flask and remove the die. In order to avoid airbubbles curing can also be performed
under pressure.
4. Final trimming and varnishing
For moulding and surface trimming use special grinding sleeves. If a handle is needed,
we recommend the installation of grip tool or detax handy according to their special
Fig. 6 instructions. For smoothing the surface, use aqua coat (solvent-free), dip coat (for
dipping method), express coat (fast-drying), super coat (antibacterial), microporlack
(heat curing) or frosty coat (matt lacquer) according to their special instructions (Fig. 11).
Important working hints
Prior to curing do not combine with condensation curing silicones.
Cured silicone materials are chemically inert – spots on clothing should be avoided.
Latex gloves and latex contaminated surfaces as well as cerumen, cremes and resins
Fig. 7
may affect the setting reaction of direct mold (we recommend standard gloves made
of nitrile rubber or polyethylene).
Where movement is impeded or blocked, discard the cartridge. Do not apply force.
A careful preparation (point 1) as well as a thorough cleaning of the auditory canal is
required before taking an impression.
Careful post-examination of the auditory canal is necessary after every impression
taking.
The cartridges are filled in a vacuum, during quality control thoroughly tested and only
released in air bubble free conditions
Fig. 8
Since under certain environmental conditions (e.g. temperature, air pressure) air bubbles
may be produced afterwards in the cartridge, curing of the material in a pressure-
container is generally recommended.
Please follow the instructions of the safety data sheet!
Safety advice
The application of silicone based materials into the external auditory canal has to be
executed by trained specialist staff only. The working instructions and precautionary
Fig. 9
measures have to be strictly observed. Non-observance might lead to irreparable damage
of the ear or ear drum.
DETAX is not liable for any damage caused by improper application of the impression
material.
Further information:
Silicone based materials are proven a million times. On condition of a proper application,
undesired effects are not to be expected. However, reactions of the immune system like
Fig. 10
allergies, irritations, cannot be absolutely excluded. In case of doubt, we recommend to
make an allergy test before the application of the material.
For use by trained specialists.
Fig. 11
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
Caution: Federal U.S. law
restricts this device to sale by
or on the order of a licensed
healthcare practitioner (or
trained specialist personnel).
Instructions for use
Indications
for use:
Direct or indirect
fabrication of
protective earmoulds
Technical data:
Mixing volume:
50 ml (cartridge)
Mixing ratio: 1:1
Colour code:
rose-transparent
Mixing time:
omitted
(Automix1-system)
Setting time:
direct method:
approx. 4 min.
at body temperature
indirect method:
approx. 15 - 20 min.*
at room temperature
(approx. 23 °C / 73 °F)
Final hardness:
60 shore A
Recovery from
deformation:
approx. 99.7 %
Linear dimensional
change: approx. 0.2 %
Application:
At 23 °C ± 2 °C /
73 °F ± 4 °F,
50 ± 5% rel. humidity
Storage:
15 °C
59 °F
* from beginning of mixing at
23 °C ± 2 °C / 73 °F ± 4 °F, 50 ± 5 %
rel. humidity. Increased tempe-
ratures accelerate, decreased
temperatures retard a. m. times.
Ordering
information:
direct mold
Standard packing
8 x 50 ml cartridge
base + catalyst
Mixing cannulas
6 mm, 50 pcs.
6 mm, 100 pcs.
express coat
aluminium bottle, 100 ml
dip coat
aluminium bottle, 100 ml
super coat
aluminium bottle, 100 ml
micropor lacquer
aluminium bottle, 250 ml
detax handy
5 x blue, 5 x red
grip tool
2 x blue, 2 x red
impression plugs
blue secure
100 pcs., conical
Made in
Germany
01/2019
GB
25 °C
77 °F
02687
02123
02393
03012
03014
02949
02169
02469
03083
03321