Zimmer Biomet Zfx EIGER Manual De Instrucciones página 2

Instruction Manual
Zfx Hex / Hexalobular
TM
Screwdriver
Indications for Use
The Hex / Hexalobular Screwdriver is used to tighten / loosen Hex / Hexalobular
(laboratory try-in or fi nal prosthetic) Screws to enable assembly /
disassembly of single-unit (engaging) and multi-unit (non-engaging)
restorative systems containing the Hex / Hexalobular screw to corresponding
Zimmer Biomet Dental Implant Systems.
HLD –Hexalobular Drive
Device description
The Zfx™ Hex / Hexalobular Screwdriver is used to drive the Hex /Hexalobular
screw in a straight or angulated position. The limitation of angulation for
Hexalobular is 25° and Hexagonal 20°. The Screwdriver are available in diff er-
ent overall length per size, refer to table 1.
The screwdriver is designed with an ISO-latch connection allowing for use
with Torque Wrench or appropriate other fabricates adapters according the
ISO 1797 Standard.
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
The Zfx™ Hex / Hexalobular Screwdriver are manufactured from medical
grade stainless steel.
Procedure
× Handling
1. Connect the ISO-latch portion of the driver into the Torque Wrench or
the Hand Piece.
2. Engage the correct screwdriver to the corresponding Hexagonal /
Hexlobular Screw to tighten or loosen.
Refer to the table on page 3 for maximum torque recommendations for the
use of Zfx™ Hex / Hexalobular Screwdrivers.
Please note: For the recommended fi nal Prosthetic Screw torque values
please refer to the label on the screw package or to product catalog information!
28
21
13
6
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
HD –Hex Drive
36
21
Version: 1 / 06. 2021
Compiled at: 08.06. 2021
Eff ective date: 08.06. 2021
Replaces version: -
× Cleaning and Sterilization
The Hex / 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 where possible. Cavities should be rinsed
with a syringe. This 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 134º 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.
Follow the loading instructions issued by the sterilizer
Note:
manufacturer.
Storage and Handling
The Hex / Hexalobular Screwdriver should be stored at room temperature.
Contraindications
None
Known Side Eff ects
None
2