General Information - DENTAURUM tomas-pin SD Mode D'emploi

re-sterilized. A tomas -pin that has been removed from the packaging but has
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not been inserted, may also no longer be used or re-sterilized.
5.2 Non-sterile pins (tomas
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The non-sterile tomas -pin versions should be cleaned, disinfected and
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sterilized before clinical application. The steps that are described below have
been validated (Medical Devices Services – Dr. Rossberger GmbH, Germany).
Throughout the entire procedure, from removing the pin from the packaging
to insertion, the tomas -pin thread should not be touched or contaminated
®
in any way. Wear sterile gloves and only grip the head of the tomas
with sterile tweezers. If several tomas
not come into contact with each other during cleaning, disinfection and
sterilization.
5.2.1 Manual cleaning of tomas
The tomas ® -pin should be cleaned in an ultrasonic cleaner. We recommend
using a 5 % n-propanol solution (consisting of 70 % n-propanol and de-
ionized water) as the cleaning agent. Degas the solution for 5 min (time
setting on the ultrasonic cleaner) before beginning the actual cleaning
procedure.
Remove the tomas -pin from the packaging and place it in the basket of the
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ultrasonic cleaner. Clean it in the ultrasonic unit for 8 min at 25° C / 77° F.
Then remove the cleaning basket. Allow the cleaning liquid to drain from the
tomas -pin and the basket. Then rinse thoroughly with sterile water or water
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with a low germ and endotoxin content.
The cleaning agent should be renewed regularly according to the
manufacturer's instructions.
5.2.2 Manual disinfection of the tomas
The pin is disinfected with 70% n-propanol. Immerse the cleaning basket for
20 min in the disinfectant (room temperature). Then remove the tomas
allow to drip dry and rinse thoroughly at least three times using sterile water
or water with a low germ and endotoxin content. Allow the tomas
for 15 min at room temperature and then pack for sterilization.
The disinfectant should be renewed regularly according to the manufacturer's
instructions.
5.2.3 Mechanical cleaning and disinfection of the tomas
The tomas -pin can be cleaned and disinfected in a thermodisinfector, which
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is DGHM (German Society for Hygiene and Microbiology) or FDA approved
or has a CE mark (DIN EN ISO 15883). The cleaning agent and disinfectant
used should have a proven efficacy and be compatible with the material of
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-pin SD N and tomas -pin EP N)
®
-pin are to be prepared, they should
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-pin
®
-pin
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the tomas -pin. Adhere to the concentrations prescribed by the manufacturer.
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Place the tomas
program (DES-VAR-MEDIZYM). The thermal disinfection program must consist
of the following sub-steps:
• Pre-rinse (rinse temperature: 10 ± 2 °C / 50 ± 36 °F; rinse time: 1 min)
• Clean (cleaning temperature: 45 ± 2 °C / 113 ± 36 °F; cleaning time: 5
min, cleaning agent: neodisher MediZym, concentration 0.2 % [2 ml / l])
• Rinse (sterile water or water with a low germ and endotoxin content;
-pin
®
rinse temperature: 10 ± 2 °C / 50 ± 36 °F; rinse time: 2 min)
• Thermal disinfection (disinfection temperature: 93 ± 2 °C / 199 ± 36 °F;
disinfection time: 10 min)
• Drying
When the program has finished, remove the tomas
check and pack immediately for sterilization.
5.2.4 Sterilization of the tomas
The dry tomas
components in the tomas
inserts in the tray for sterilization.
Shrink-wrap each tomas
sterilization. Sterilize the pins in an autoclave. Adhere strictly to the autoclave
manufacturer's instructions for use. Complete steam sterilization at a
temperature of 134 °C / 273 °F with a minimum hold time of 25 min.
6. Insertion of the tomas

6.1 General information

Adhere to all essential hygienic measures for invasive surgery such as sterile
surgical area, sterile gloves, facemask etc. during insertion of the tomas
-pin,
®
To ensure that the tomas
anchorage in the bone (primary stability) and that the head is placed in the
-pin to dry
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region of the attached gingiva (gingiva alveolaris). When using the tomas
pin as an anchorage unit, ensure that the head and surrounding soft tissue
are not subjected to detrimental mechanical influences (e. g. movement of the
mucosa, interference from bands and/or the tongue or manipulation).
-pin
®
In the maxilla, the tomas
alveolar ridge. The tomas
anterior palatal region. In the mandible the pin shall always be inserted
buccally and on the centre of the alveolar ridge. In accordance with the latest
findings, insertion of the tomas
-pin in a suitable tray in the thermodisinfector and start the
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-pin
®
® -pin can be sterilized separately or together with other tomas
-tool tray. Place the tomas
®
-pin in a suitably-sized foil bag for separate
®
-pin SD and tomas
®
-pin functions safely it is essential that it has stable
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-pin can be placed buccally, palatally or on the
®
® -pin EP is primarily intended for insertion in the
-pin in the region of the mobile mucosa, on
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EN
-pin from the disinfector,
®
®
-pin in one of the empty
®
-pin EP
®
-pin.
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