Universal PEEK handle - Helmut Zepf (26.194.16) - 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: 26.194.16.
- 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 (26.194.16)?
The PEEK universal handle, referenced under code 26.194.16 by Helmut Zepf, is a manual dental instrument designed to provide optimal ergonomics during surgical procedures. Manufactured from PEEK, a high-performance polymer, this device is combined with medical stainless steel for its functional components. This handle is distinguished by its lightness and resistance, meeting the requirements of healthcare professionals in oral surgery. As an instrument from the brand Helmut Zepf Medizintechnik GmbH, it benefits from the expertise of a manufacturer recognized for the precision of its devices. This product is delivered non-sterile and requires a complete preparation protocol before any clinical use.
What are the clinical indications for this universal handle?
This universal handle is indicated as a manual dental instrument for various procedures within the dental practice or operating room. Its intended purpose is to serve as an ergonomic support for practitioners during treatment or surgical phases. The use of this Helmut Zepf device is strictly reserved for qualified healthcare professionals. It is particularly suitable for interventions requiring precise and repeated manipulation, where the durability of the PEEK material and medical stainless steel is an asset. The manufacturer specifies that compatibility with other products must be verified beforehand to ensure the safety and efficacy of the planned surgical procedure.
What are the technical characteristics of this instrument?
The Helmut Zepf 26.194.16 handle is classified as a Class I device according to current regulations. Its design is based on the use of PEEK and medical stainless steel, materials chosen for their robustness and compatibility with reprocessing cycles. A major technical point concerns the absence of a defined maximum limit for achievable processing cycles; the number of cycles depends on the design, materials, and intended use, as long as the instrument does not show visible damage. Before each use, a meticulous inspection is imperative to detect any cracks, breaks, or defects on the edges, thus ensuring the technical integrity of the device during the surgical act.
What are the contraindications for the use of this device?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns metal intolerance. Although the handle is made of PEEK, it contains medical stainless steel which can cause hypersensitivity reactions in some patients. If such a reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken. Furthermore, the use of the instrument is formally prohibited if it shows visible damage or wear, such as cracks or ruptures. Finally, this device must not be used by persons other than trained healthcare professionals, in accordance with the manufacturer's instructions.
What are the maintenance and sterilization precautions?
The universal handle is delivered non-sterile. It is imperative to follow a strict protocol of cleaning, disinfection, and sterilization before the very first use, as well as before each subsequent use. Complete cleaning of each product is a critical step for patient safety. The manufacturer emphasizes that it is essential to check for the absence of visible damage before reusing the instrument. The use of damaged or worn products is strictly prohibited. Due to the high quality of the materials used by Helmut Zepf, reprocessing is possible over many cycles, provided that the physical integrity of the instrument is preserved and systematically verified by the practitioner.
Who is the manufacturer and what standards are respected?
The PEEK universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, whose headquarters are located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I, respecting the regulatory requirements relating to manual dental instruments. The manufacturer ensures the traceability and quality of its products through rigorous manufacturing processes. Although the specific CE marking is not detailed in the source data, compliance with European standards for Class I devices is inherent to its marketing. Helmut Zepf imposes strict safety instructions, particularly on reprocessing and exclusive use by professionals, to guarantee an optimal level of safety.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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