English - Instruction For Use - Elos Prosthetic Screw Mode D'emploi

English – Instruction for use
1. Indications for Use: The Elos Prosthetic Screw is intended for fixation of prosthetic restorations to endosseous dental
implants
2. Device Description: The Elos Prosthetic Screw is manufactured from biocompatible titanium alloy grade 4/5 ELI
(TiAl6V4 ELI). Depending on the specific variant, the Elos Prosthetic screw includes biocompatible coatings.
3. Contraindications: Allergies to the alloy, or contents of the alloy may very rarely occur.
4. Operating procedure: Ensure that the prosthetic restoration is positioned correctly on the implant. Tighten the Elos
prosthetic screw to the recommended torque using an appropriate tool. Recommended torque value is stated on label.
5. Warnings:

The use of torque values higher than the recommended may result in damage to the prosthetic restoration, the
screw and/or the implant. The use of torque values lower than those recommended may result in loosening of the
prosthetic restoration.

When mounting the Elos Prosthetic Screw, it is important to use a manual screwdriver before using any kind of
torque wrench.

The Elos Prosthetic Screw is for single use only. Reuse can result in loss of functionality and/ or infections.

Since the Elos Prosthetic Screw is small it must be handled with caution to avoid the patient swallowing or
inhaling them.
6. Precautions: The Elos Prosthetic Screw must only be used and handled by dental professionals who have approved
training in dentistry.
For any lab work and any try-in of the prosthetic restoration, a lab screw must be used. The Elos Prosthetic Screw may
only be used to permanently fix the finished restoration.
7. Cleaning and Sterilization: Prior to installing, the Elos Prosthetic Screw must be cleaned with water and brush followed
by disinfection and sterilization. The recommended sterilisation procedure is a full cycle pre-vacuum steam sterilization at
a temperature of 134 ºC (273˚F) for 3 minutes minimum or 121°C (250°F) for 15 minutes minimum.
8. Compatibility: For compatibility of the Elos Prosthetic Screw please refer to information on individual product label.
9. MRI Statement: The Elos Prosthetic Screw has not been evaluated for safety, heating, migration or compatibility in the
Magnetic Resonance Imaging (MRI) environment.
10. Storage and Handling: The Elos Prosthetic Screw should be stored at room temperature protected from direct sunlight.
11. Disposal: Must be disposed as biological waste.
12. Symbols:
Catalogue number
Batch code
Manufacturer
Consult instructions for use
Do not re-use
Non-sterile
Elos Medtech Pinol A/S
Engvej 33
DK - 3330 Gørløse
www.elosmedtech.com
Electronic IFU with additional languages can be accessed at
Document ID: DEV-00680 version 10.0
www.elosmedtech.com/IFU
Do not use if package is damaged
Prescription only
Date of manufacture
Medical Device
Recommended torque
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