ZimVie Zfx GenTek TiBasen Gebrauchsanweisung Seite 4

Instruction Manual
GenTek™ Angulated Screw Channel
TiBase, Certain (12 mm Post)
Including fi nal prosthetic screw
*
Placement torque recommendations for GenTek™ Hexalobular
(laboratory Try-in or fi nal prosthetic) Screws:
Only corresponding GenTek™ Hexalobular Screws
Note:
for the Certain connection must be used with the
corresponding GenTek™ Angulated Screw Channel
TiBase. Hex drive screws from other GenTek™ TiBase
systems must not be used with the GenTek™ Angulated
Screw Channel TiBase system.
Angulation Laboratory
Connection
*
Range Try-in Screw
0 – 25
Certain®
degrees
Applicable to single-unit and multi-unit for each connection
*
Minimum of 5 Ncm; Maximum of 15 Ncm
**
Cleaning and Sterilization
The GenTek™ Angulated Screw Channel TiBase is non-sterile. Prior to
placement of the GenTek™ TiBase / restoration and prosthetic screw into
the implant, the GenTek™ TiBase assembly must fi rst be cleaned and
sterilized.
Step 1: Manual Cleaning
1. Rinse the instruments under running cold tap water for 2 minutes.
2. Hand wash instruments in a bath with demineralized water for
5 minutes. Remove debris with a soft brush. Cavities should be rinsed
with a syringe. This step should be repeated until all debris is removed.
3. Clean the instrument in an ultrasonic bath using a mildly alkaline
cleaner (1.5 %) at a frequency of at least 40 kHz for 20 minutes.
4. Rinse thoroughly with demineralized water for 1 min.
Step 2: Sterilization
One of the following sterilization methods is recommended to be used:
× Method 1:
Full cycle pre-vacuum steam sterilization at a temperature of 134 °C
(273.2 °F) for 3 minutes, 4 pulse minimum.
×
Method 2: (alternative to method 1)
Full cycle gravity steam sterilization at 134 °C (273.2 °F) for 3 minutes
minimum.
Step 3: Drying
After sterilization treatment it is recommended to dry the products at a
temperature of maximum 134 °C (273.2 °F) for 10 minutes. The products are
ready for use 5 minutes after completion of the drying process.
Note: Follow the loading instructions issued by the sterilizer
manufacturer.
Zfx GmbH | Kopernikusstraße 15 | 85221 Dachau | Germany
Tel. +49 (0) 8131 / 33 244 - 0 | Fax +49 (0) 8131 / 33 244 - 10
info@zfx-dental.com | www.zfx-dental.com
*
GenTek™
Final Prosthetic
Hexalobular
Screw Torque
DriverScrew
ZFX02HLD21,
Hand-
20 Ncm ZFX02HLD28,
tighten
**
ZFX02HLD36
Version: 3 / 01. 2022
Compiled at: 28. 01. 2022
Eff ective date: 01. 03. 2022
Replaces version: 2 / 05. 2021
Storage and Handling
The GenTek™ TiBase should be stored at room temperature.
Contraindications
The custom abutment and / or restoration that is designed shall not be
angulated more than 20° off the implant axis.
Known Side Eff ects
Allergies to the alloy or contents of the alloy may very rarely occur.
*
Warnings
× The GenTek™ TiBase must only be used and handled by dental professionals
who have approved training in dentistry.
× GenTek™ TiBase may only be used for Zimmer Biomet Dental implant
systems.
×
The black gluing screw is not intended to be used in the patient's mouth.
×
The black gluing screw should not be used when the screw access on the
crown is at an angle.
× The GenTek™ TiBase and prosthetic screw are small and, therefore, they must
be handled with caution to avoid swallowing or inhaling by the patient.
× The use of an incorrect prosthetic screw may result in damage to the GenTek™
TiBase, the prosthetic screw and / or the implant.
×
The use of a prosthetic screw torque higher than the recommended value on
the label may result in damage to the GenTek™ TiBase driver, the prosthetic
screw and / or the implant. The use of torque values lower than those
recommended may result in loosening of the GenTek™ TiBase and / or the
prosthetic screw.
× The screwdriver must be in good condition . A worn screwdriver can lead to
over-rotation of the hex in the screw head which can result in the screw not
being fully tightened and / or not being able to be removed.
×
For any lab work and any try-in of the GenTek™ TiBase, a lab screw (non-Gold-
Tite) must be used. The included prosthetic screw may only be used to
permanently fi x the fi nished restoration.
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