Universal PEEK Handle - Helmut Zepf (26.194.20) - Delynov
The Manche universel en PEEK - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.20.
- 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 Instrument dentaire manuel 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 Helmut Zepf PEEK universal handle (26.194.20)?
The Helmut Zepf PEEK universal handle is a manual dental instrument designed to offer optimal ergonomics during surgical procedures. Referenced under code 26.194.20 at Delynov, this device is distinguished by its design integrating PEEK and medical stainless steel. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH. It belongs to the category of instruments (INSTRU) and is classified as a Class I device according to current regulations. Its structure is specifically designed to meet the requirements of healthcare professionals practicing oral surgery and implantology, ensuring precise and durable handling.
What are the clinical indications for this instrument?
This universal handle is indicated as a manual dental instrument for various oral surgery procedures. Its intended purpose is to serve as an ergonomic support for practitioners when using compatible inserts or tools. As a Class I medical device manufactured by Helmut Zepf, it is exclusively reserved for use by qualified healthcare professionals. Its use occurs within the framework of dental care requiring reliable grip and mechanical resistance adapted to the constraints of the oral cavity. It is imperative to check compatibility with other products used before any clinical intervention.
What are the technical and maintenance characteristics of handle 26.194.20?
The Helmut Zepf universal handle features technical characteristics related to its hybrid composition including medical stainless steel. Due to its design and the materials used, the manufacturer specifies that there is no defined maximum limit for the number of processing cycles achievable, although these depend on visible wear. Before each use, the instrument must imperatively be cleaned, disinfected, and sterilized. Rigorous visual inspection is necessary to detect any damage such as cracks, breaks, or defects on the edges. Any product showing visible wear or structural damage must never be used.
What are the contraindications for the use of this Helmut Zepf device?
The main contraindication related to the use of this Helmut Zepf instrument concerns hypersensitivity to the material components. Contact with medical stainless steel can cause undesirable side effects, including metal intolerance or a hypersensitivity reaction in some patients. If such a reaction is triggered during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be stopped immediately and necessary medical measures must be taken. It is the practitioner's responsibility to evaluate the patient's allergic history before using this manual instrument.
What are the precautions for use and sterilization protocols?
All instruments delivered by Helmut Zepf Medizintechnik GmbH are supplied non-sterile. The strict protocol requires that each product be cleaned, disinfected, and sterilized before the very first use, as well as between each patient for subsequent uses. Thorough cleaning is a crucial step before sterilization. Professionals must ensure the absence of debris or visible damage on the handle before proceeding with thermal or chemical treatment. Compliance with these safety instructions is essential to guarantee asepsis and the longevity of the manual dental instrument in a demanding surgical environment.
Who is the manufacturer and what standards are met by this product?
The official manufacturer of this universal handle is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with regulations relating to manual dental instruments and is registered under Class I (Class Ir according to certain reprocessing nomenclatures). Although the specific CE marking is not detailed in the source data, the product meets the safety and performance requirements defined by the manufacturer for the medical sector. As a Class I device, it follows rigorous quality control protocols specific to Helmut Zepf standards, ensuring traceability and reliability for dental surgeons.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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