Dental Direkt DD Ti-Base 2CUT Mode D'emploi page 5

ENGLISH
Cleaning, disinfecting and sterilizing:
The DD Ti-Base 2CUT and accompanying implant screws are cle-
aned at Dental Direkt, but are not sterilized before being packa-
ged. After processing and before being used on the patient, the
implant components must be cleaned, disinfected and sterilized
following the procedure described by Dental Direkt.
Cleaning / disinfecting:
Automatic cleaning in a washer-disinfector suitable for this appli-
cation with an appropriate cleaning program for medical instru-
ments (e.g. "Vario TD Program", Miele).
OR
The following manual cleaning procedure:
• Rinse with cold tap water for 1 minute
• Rinse the screw channel using a disposable syringe
(min. capacity 10 ml)
• Clean at 60°C (140° F), e.g. using Dr. Weigert neodisher® LM 2
for 10 minutes at a concentration of 5% in the ultrasonic cleaner
• Neutralize with cold distilled water for 2 minutes
• Rinse in the ultrasonic cleaner using distilled water at 60°C
(140° F) for 10 minutes
Sterilizing:
Double-seal products in sterilization film conforming to EN ISO
11607-1. Steam sterilize in a suitable sterilizer with 3x fractio-
nated prevacuum: 134°C (273°F) for 5 minutes, drying time: 20
minutes. Then store in sterile packaging.
Restrictions on use:
• Components from the set must not be resold individually.
• DD Solid Connect® Implant Components must only be used
by dental professionals and in compliance with the current
instructions for use.
• Damaged implant components must not be used.
• The Lab Screw must not be used for placement of the abutment
in the patient's mouth.
• All elements of the DD Ti-Base 2CUT Set are exclusively
intended for single use, on a specific implant, at a specific
location, for a single patient.
• DD Ti-Base 2CUT Abutments from the respective series can
only be combined with the corresponding compatible implant
system. This also applies to the corresponding platform
diameters.
• When DD Solid Connect® Implant Components are used for
restorations on reduced-diameter implants, limited indications
apply. These can be found in the relevant instructions for use
from the implant manufacturer.
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190
Gebrauchsanweisung-Instructions for use_DD Ti-Base 2CUT_Rev.03_2021/02
Instructions for use
DD Ti-Base 2CUT
Warnings and safety instructions:
Always use an extraction system when processing and sandblas-
ting. Metal dusts are harmful to health. Therefore always wear
respiratory protection and safety goggles. The titanium bonding
base must not display any sign of damage. An undamaged and
correct implant interface is essential for correct placement of the
abutment.
Possible side effects and interactions:
Allergic reactions or skin irritations are possible in very rare cases.
Different alloys in the oral cavity can lead to galvanic reactions
when in direct contact.
Warranty:
Our products are subject to strict quality control and correspond
to the current technical standards. Please refer to our current
warranty terms and conditions for further details.
Our products are subject to continual development, so we reserve
the right to make changes. You will find the latest version of the
instructions for use on our homepage at:
www.dentaldirekt.de/en.
This version replaces all previous version.
Explanation of symbols:
Manufacturer
Date of manufacture
LOT
Batch code
REF
Article number
Keep dry
Non-sterile
Do not use if package is damaged
Torque
Consult instructions for use
Caution: U.S. Federal law restricts this device to sale by or
on the order of a dentist
Do not re-use
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