Universal PEEK Handpiece - Helmut Zepf (26.194.03) - 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: 26.194.03.
- 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 PEEK universal handle - Helmut Zepf (26.194.03)?
The PEEK universal handle, referenced under code 26.194.03 by Helmut Zepf, is a manual dental instrument designed to offer optimal ergonomics during surgical interventions. Manufactured from PEEK, a high-performance polymer, it also integrates medical stainless steel components to guarantee robustness and durability. This Class I medical device is specifically developed for healthcare professionals demanding increased precision. Marketed by Delynov, this Helmut Zepf handle combines lightness and resistance, meeting the rigorous standards of instruments used in modern oral and dental surgery.
What are the clinical indications for this instrument?
The Helmut Zepf universal handle is indicated as a manual dental instrument for various procedures within the dental office or oral surgery clinic. Its intended purpose is to serve as an ergonomic support for practitioners when performing precise clinical movements. As a Class I medical device, it is exclusively reserved for use by qualified healthcare professionals. Its use is part of a surgical or routine dental care framework, where the manipulation of manual instruments is required for patient treatment.
What are the technical characteristics of this handle?
This universal handle is distinguished by its hybrid design using PEEK and medical stainless steel. Reference 26.194.03 from Helmut Zepf Medizintechnik GmbH is delivered non-sterile, requiring a rigorous preparation protocol before any use. Due to its design and the materials used, the manufacturer specifies that there is no defined maximum limit for the number of processing cycles, although the service life depends on visible wear. It is imperative to check for the absence of cracks, breaks, or defects on the product before each intervention to guarantee operative safety.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this instrument lies in metal intolerance. Although the body is made of PEEK, contact with the medical stainless steel parts can trigger hypersensitivity reactions in some sensitive patients. If such an allergic reaction or intolerance occurs during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH recommends immediately stopping the intervention and taking the necessary medical measures. Furthermore, use is strictly contraindicated if the instrument shows visible damage such as cracks or marked wear of the edges.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use, as well as before each subsequent use. This complete reprocessing process is essential to maintain asepsis. The professional must meticulously inspect the handle to detect any signs of wear, corrosion, or structural damage (cracks, breaks) before use. It is formally forbidden to use a damaged product. Compatibility with other products must also be verified beforehand to ensure the proper functioning of the instrumental assembly during surgery.
Who is the manufacturer and what standards are respected?
The universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer guarantees the quality of its products through rigorous manufacturing processes, although the products are delivered non-sterile. Compliance with cleaning and sterilization instructions by the end user is a sine qua non condition for compliance with safety requirements. This device is exclusively reserved for healthcare professionals trained in dental and surgical techniques.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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