Single Point - Helmut Zepf (26.428.04) - Delynov

What is the Replacement Tip - Helmut Zepf (26.428.04)?

The Helmut Zepf replacement tip, referenced under code 26.428.04, is a manual instrumentation component designed by Helmut Zepf Medizintechnik GmbH. Manufactured from medical stainless steel, this terminal part is intended to be mounted on a compatible handle to perform ligament sectioning maneuvers. This Class I device belongs to the category of consumables for surgical instrumentation. Its structure is specifically designed to meet the requirements of oral surgery, offering mechanical resistance adapted to the stresses exerted during the separation of soft tissues from the root structure.

What are the clinical indications for this instrument?

This instrument is indicated for oral surgery interventions requiring precise separation of periodontal tissues. As a syndesmotome blade, its primary use lies in syndesmotomy, an essential preliminary step to tooth extraction. It allows for the sectioning of the periodontal ligament and the release of the gingival attachment, thereby reducing the risk of alveolar ridge fracture. Its use is particularly relevant during the avulsion of ankylosed teeth or to prepare the site before implant placement, ensuring respectful handling of the surrounding tissues.

What are the technical characteristics of the 26.428.04 tip?

The Helmut Zepf replacement tip (26.428.04) is characterized by its high-quality medical stainless steel composition, ensuring biocompatibility during mucosal contact. As a manual instrument, it features sharpened cutting edges for a clean incision of periodontal fibers. This product is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use. Its design allows for precise integration onto the brand's tip-holder handles, ensuring optimal force transmission during the surgical procedure.

What are the contraindications for the use of this device?

La principale contre-indication médicale documentée concerne l'hypersensibilité connue du patient aux métaux. L'instrument étant fabriqué en acier inoxydable de qualité médicale, le contact peut déclencher une réaction allergique ou une intolérance chez les sujets sensibles. Si une telle réaction survient pendant l'acte opératoire, la procédure doit être immédiatement interrompue et les mesures cliniques nécessaires doivent être appliquées. De plus, l'utilisation est strictement réservée aux professionnels de santé qualifiés maîtrisant les techniques de chirurgie orale, d'implantologie et de parodontologie.

What are the maintenance and reprocessing precautions?

Like any reusable instrument, this tip requires rigorous reprocessing. Before each use, the practitioner must visually inspect the device to detect possible damage such as cracks, breaks, or wear of the cutting edges. The use of damaged products is prohibited. The protocol includes thorough cleaning followed by sterilization. Although no maximum limit of cycles is defined due to the materials used, the longevity of the blade depends on the intended use and compliance with maintenance instructions. Compatibility with other products of the Helmut Zepf system must be verified beforehand.

Who is the manufacturer and what standards are met?

Ce dispositif médical est fabriqué par Helmut Zepf Medizintechnik GmbH, à Seitingen-Oberflacht, Allemagne. C'est un instrument de Classe I, conforme aux exigences réglementaires pour les dispositifs médicaux manuels. L'acier inoxydable médical est utilisé pour la sécurité du patient. En tant que dispositif de Classe Ir (réutilisable), il répond aux normes de fabrication rigoureuses de Helmut Zepf, assurant une fiabilité constante pour les praticiens en chirurgie orale. Le respect des protocoles de nettoyage et de stérilisation décrits dans la notice d'utilisation est essentiel pour maintenir la conformité du produit lors de son usage clinique.

State of the art

Surgical medical consumables play a decisive role in operative safety.