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Zimmer Biomet ZFX Manual De Instrucciones página 2

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Instruction Manual
Zfx
Intraoral Scanbody
TM
Intended Use
The Zfx™ Intraoral Scanbody is intended to capture the location, angulation
and connection orientation of the dental implant in the patient's mouth
during the scanning period. For specifi c dental implant compatibility, please
refer to the information on the individual product label. Zfx™ Intraoral Scan-
body are compatible with the related tooling as outlined in the Zfx™
Construction Components Catalog.
Device description
The Zfx™ Intraoral Scanbody is a two-piece post with a titanium alloy grade
5 ELI (TiAl6V4 ELI) base and a PolyEtherEtherKetone (PEEK) coronal section.
The Scanbody engages the connection of the implant and is secured with
an integrated screw. The Zfx™ Intraoral Scan Bodies are available in two
diff erent heights, 4 mm and 7 mm. The 7 mm height Scanbody has an
additional step on the occlusal surface for identifi cation.
Product life time
The scan bodies are multiple use with a product life time of 25 autoclave
cycles. Product accuracy cannot be guaranteed when exceeding this
number of autoclave cycles.
Cleaning and Sterilization
The Zfx™ Intraoral Scanbody is non-sterile. Prior to placement of the Zfx™
Intraoral Scanbody into the patient and prior to each use, the Scanbody
must be cleaned and sterilized. Do not disassemble the Scanbody prior to
cleaning and sterilization.
Cleaning
1.
Rinse the Intraoral Scanbody 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 minute.
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 minimum 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
auto claving 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
Version: 4 / 05. 2021
Compiled at: 21. 05. 2021
Eff ective date: 21. 05. 2021
Replaces version: 3 / 11. 2019
Intra Oral Scanning
×
Remove any provisional abutment, cover screw, healing abutment
or similar from the implant upon which the Scanbody is intended to
be placed.
×
Confi rm that the selected Scanbody is the same size as the implant.
×
Ensure that the seating surface of the implant is clean, free of residue,
bone, or soft tissue and is dry when mounting.
×
Affi x the Zfx™ Intraoral Scanbody into the implant hand tight using
suitable Hex Driver. For constructions over more than one implant (bridge or
multi unit restorations) it is recommended to assemble two or more Zfx™
Intraoral Scan Bodies contemporarily to the relative implants. This avoids
possible inaccuracies in the scan output.
×
Proceed with scanning.
Warnings
×
Do not over-tighten the Scanbody as it can cause damage and lead to
inaccurate scanning. It is recommended to affi x the Zfx™ Intraoral Scanbody
hand tight.
×
DO NOT acquire the bite scan with the Scanbody still in place. The Scanbody
is not designed to withstand biting forces and should be discarded if a patient
bites down on it.
×
As the Scanbody is a high precision tool, it may not be used while still warm
from the autoclave, as the thermal expansion may lead to inaccurate
scanning data.
×
Refer to the instruction for use of the scanner for details on the recommended
protocol of the respective scanner.
×
The Intraoral Scanbody may only be used with a compatible digital
library fi le installed in the design software.
×
The Zfx™ Intraoral Scanbody must only be used and handled by dental
sprofessionals who have approved training in dentistry.
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