ZEPF-BIONIK Universal Handle, PEEK - Helmut Zepf (26.194.12)
The ZEPF-BIONIK. MANCHE UNIVERSEL. PEEK. - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.12.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant : HELMUT ZEPF Medizintechnik Gmbh , Obere Hauptstraße 16-22, D- 78606 Seitingen-Oberflacht BUT PRÉVU / INDICATION Les poignées sont conçues de manière ergonomique pour bien tenir dans la main et pour être utilisées comme extensions de diverses extrémités de travail dentaire. Les effets secondaires indésirables l'intolérance aux métaux chez le patient peut résulter d'un contact avec l'instrument, qui est en acier inoxydable médical une réaction d'hypersensibilité était toujours déclenchée devenir. la procédure doit être arrêtée si une telle réaction se produit et les mesures nécessaires sont prises en conséquence. consignes d'utilisation et de sécurité tous les instruments doivent être nettoyés avant d'être utilisés pour la première fois et compléter avant toute utilisation ultérieure nettoyé, désinfecté et stérilisé ! il est très important de nettoyer chaque produit avant utilisation dommages et usures visibles, par ex. b. fissures, cassures ou des défauts sur les arêtes de coupe. n'utilisez jamais de produits endommagés ou usés. les produits de helmut zepf medizintechnik gmbh sont livrés non stériles. les produits doivent être à l'avance nettoyé et stérilisé. la compatibilité aussi les autres produits doivent être vérifiés au préalable. retraitement en raison de la conception du produit, des matériaux utilisés et il ne peut y avoir de limite maximale définie pour l'utilisation prévue des cycles de traitement réalisables peuvent être déterminés.réservé aux professionnels de santé.
What is the ZEPF-BIONIK PEEK universal handle?
The ZEPF-BIONIK (reference 26.194.12) is a universal handle designed by Helmut Zepf, specifically developed to serve as an ergonomic extension for various working ends used in dental surgery. This device is distinguished by its PEEK design, offering an optimal grip for the practitioner. As a Class I instrument, it meets the quality and safety requirements for dental office interventions. This handle is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and requires a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient to ensure perfect asepsis.
What are the clinical indications for this instrument?
The intended purpose and primary indication of this Helmut Zepf universal handle lie in its role as an ergonomic extension for dental instruments. It is designed to adapt to various working ends, thereby facilitating manipulation during oral surgery or implantology procedures. Its ergonomic shape is specifically studied to ensure a firm and precise hold in the healthcare professional's hand. The use of this device is strictly reserved for qualified healthcare professionals, ensuring application in accordance with current clinical standards within the framework of specialized dental care.
What are the technical characteristics of the ZEPF-BIONIK handle?
The ZEPF-BIONIK universal handle, bearing technical reference 26.194.12, is manufactured from high-quality materials including medical stainless steel for certain functional parts. Its ergonomic design aims to reduce practitioner fatigue while maximizing the precision of the surgical gesture. Helmut Zepf specifies that, due to the robust design of the product and the materials used, there is no defined maximum limit for the achievable processing cycles, although the user must systematically check for the absence of visible damage, such as cracks or defects, before each intervention.
What are the contraindications and possible side effects?
The main contraindication related to the use of this instrument concerns hypersensitivity to metals. Indeed, the instrument contains medical stainless steel, which can cause an allergic reaction or intolerance in certain sensitive patients. If such a hypersensitivity reaction is triggered during contact with the patient, the manufacturer Helmut Zepf stipulates that the procedure must be immediately stopped and that necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any intervention using this device.
What are the maintenance and sterilization precautions?
All instruments supplied by Helmut Zepf Medizintechnik GmbH must imperatively follow a complete reprocessing cycle before each use. This includes thorough cleaning, disinfection, and sterilization. It is crucial to check the condition of the instrument before use to detect any visible wear, cracks, or breakage. The use of damaged or worn products is strictly prohibited. Compatibility with other products must also be verified beforehand. Compliance with these safety instructions ensures the longevity of the universal handle and patient safety during the surgical procedure.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I instrument, compliant with current regulations for dental medical devices. The manufacturer emphasizes that its products are intended exclusively for professional use. As a Class I device, it meets the rigorous manufacturing standards imposed by the medical sector. The traceability and manufacturing quality of Helmut Zepf guarantee a reliable instrument for demanding dental surgeons and implantologists.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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