Zfx GenTek Manual De Instrucciones página 2

Instruction Manual
GenTek
TM
Hexalobular Screwdriver
Indications for Use
The GenTek™ Hexalobular Screwdriver is used to tighten / loosen GenTek™
Hexalobular (laboratory try-in or fi nal prosthetic) Screws to enable assembly /
disassembly of GenTek™single-unit (engaging) and multi-unit (non-engaging)
restorative systems containing the hexalobular screw to corresponding
Zimmer Biomet Dental Implant Systems.
Hexalobular Drive
Device description
The GenTek™ Hexalobular Screwdriver is used to drive the GenTek™
Hexalobular screw through a restorative screw access channel containing
an angulation of up to 25°.
The screwdriver is designed with an ISO-latch connection allowing for use
with Zimmer Biomet Low Torque Indicating Ratchet Wrench Standard
ISO 1797 Adapter [Item #: C9980]. The Zimmer Biomet Low Torque Indicating
*
Ratchet Wrench Standard ISO 1797 Adapter [Item #: C9980] is intended to
be used with the Zimmer Biomet Low Torque Indicating Ratchet Wrench
(L-TIRW).
The screwdriver is an individually packaged reusable component and is
available in various lengths. The screwdriver is provided non-sterile and
must be cleaned and sterilized prior to use in a patient's mouth.
Materials
GenTek™ Hexalobular Screwdriver are manufactured from medical grade
stainless steel.
Procedure
× Handling
1. Connect the ISO-latch portion of the driver into Low Torque
Indicating Ratchet Wrench Standard ISO 1797 Adapter [Item #: C9980]
2. Engage the screwdriver to the corresponding GenTek™ Hexlobular
Screw to tighten or loosen
Refer to the below table for placement torque recommendations for
GenTek™ Hexalobular (laboratory try-in or fi nal prosthetic) Screws:
Angulation Laboratory
Connection
*
Range Try-in Screw
0 – 25
Certain®
degrees tighten
TSV® /
0 – 25
Trabecular
degrees tighten
Metal™
0 – 25
Eztetic®
degrees tighten
External 0 – 25
Hex degrees tighten
* Applicable to single-unit and multi-unit for each connection
** Minimum of 5 Ncm; Maximum of 15 Ncm
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
Final GenTek™
Prosthetic Hexalobular
Screw Torque Driver
ZFX02HLD21,
Hand-
20 Ncm ZFX02HLD28,
**
ZFX02HLD36
ZFX02HLD21,
Hand-
30 Ncm ZFX02HLD28,
**
ZFX02HLD36
ZFX02HLD21,
Hand-
30 Ncm ZFX02HLD28,
**
ZFX02HLD36
ZFX02HLD21,
Hand-
32 Ncm ZFX02HLD28,
**
ZFX02HLD36
Version: 2 / 05. 2021
Compiled at: 19.05. 2021
Eff ective date: 19.05. 2021
Replaces version: 1 / 04. 2021
21
6
×
Cleaning and Sterilization
The GenTek™ Hexalobular Screwdriver is non-sterile. Prior to use, the driver
must fi rst be cleaned and sterilized. The driver can be used up to 15 cleaning /
sterilization cycles.
Cleaning
1. Rinse the driver 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.
Sterilization
The recommended sterilization procedure is full cycle pre-vacuum steam
sterilization at a temperature of 134 °C (273.2 °F) for 3 minutes, 4 pulse mini-
mum or full cycle gravity steam sterilization at 134 °C (273.2 °F) for 3 minutes
minimum. The products are ready for use 5 minutes after completion of the
autoclaving process.
Note: Follow the loading instructions issued by the sterilizer
*
manufacturer.
Storage and Handling
The GenTek™ Hexalobular Screwdriver should be stored at room temperature.
Contraindications
None
Known Side Eff ects
None
36
28
21
13
2