Prosthetic Kit with Inserts - Helmut Zepf (47.830.00) - Delynov
The Kit prothétique avec inserts - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.830.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Helmut Zepf prosthetic kit with inserts?
Le kit prothétique Helmut Zepf avec inserts, référence 47.830.00, est un ensemble d'instruments chirurgicaux conçu spécifiquement pour les procédures de pose et de fixation de vis dans l'os maxillaire ou mandibulaire. Fabriqué en acier inoxydable médical de haute qualité, cet instrument assure la robustesse requise pour les contraintes mécaniques durant les phases prothétiques. Ce kit de prothèse est un dispositif de Classe I, livré non stérile, nécessitant un protocole de préparation rigoureux avant toute utilisation clinique. Il regroupe les instruments et inserts nécessaires pour sécuriser les composants prothétiques sur des implants préalablement intégrés.
What are the clinical indications?
The primary indication for this implant prosthetic kit is use as a surgical instrument to fix screws in the jaw or bone. It is particularly required during implant prosthesis stages, where the precision of screwing abutments or crowns is crucial for the durability of the restoration. This implant prosthesis kit is intended exclusively for healthcare professionals trained in oral surgery and implantology techniques. Its use generally occurs after the osseointegration phase of the implants, allowing for the finalization of the prosthetic structure through stable and controlled mechanical fixation of the various screwed components.
What are the technical characteristics?
This Helmut Zepf kit is distinguished by its medical stainless steel design, a material chosen for its corrosion resistance and its ability to withstand repeated sterilization cycles. Technical reference 47.830.00 includes specific inserts adapted for handling fixation screws. Although the manufacturer does not define a strict maximum limit for the number of processing cycles, the product's longevity depends directly on compliance with cleaning and disinfection protocols. It is imperative to check for the absence of visible damage, such as cracks, breaks, or defects on the edges before each intervention, to guarantee operative safety.
What are the contraindications for use?
La principale contre-indication médicale concerne l'intolérance aux métaux. Le contact avec l'instrument en acier inoxydable médical peut provoquer une réaction d'hypersensibilité chez certains patients sensibles. Si une telle réaction survient pendant l'intervention, celle-ci doit être immédiatement interrompue et les mesures médicales nécessaires doivent être prises. De plus, l'utilisation du kit est strictement interdite si les instruments présentent des signes visibles d'usure, des fissures ou des défauts de coupe, car cela pourrait compromettre l'intégrité de l'acte chirurgical ou la sécurité du patient.
What are the precautions for use and reprocessing?
Helmut Zepf products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use, as well as between each patient. The complete cleaning process is a critical step before sterilization. Due to the product design and materials used, there is no defined maximum limit for reprocessing cycles, but the user must assess functional wear. It is also essential to check compatibility with other products used simultaneously during surgery. The use of damaged or worn instruments is strictly prohibited to prevent any risk of complication during screw fixation.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This prosthetic kit is classified as a Class I medical device according to current regulations. The manufacturer insists that the use of these instruments is strictly reserved for qualified healthcare professionals. Compliance with the safety and maintenance instructions detailed by Helmut Zepf is indispensable to ensure the conformity of the device throughout its useful life. Each product must be inspected meticulously before use to detect any structural anomaly that could affect its clinical performance.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
