Universal PEEK Handpiece - Helmut Zepf (26.194.17) - 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: 26.194.17.
- 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 (26.194.17)?
The Helmut Zepf PEEK universal handle is a manual dental instrument designed to offer optimal ergonomics during surgical procedures. Manufactured from PEEK, a high-performance polymer, this handle is identified under reference 26.194.17 at Delynov. It is intended for use by qualified healthcare professionals. This Class I medical device is distinguished by its lightness and robustness, meeting the requirements of practitioners in oral surgery and implantology. As an instrument of the Helmut Zepf brand, it benefits from the expertise of Helmut Zepf Medizintechnik GmbH in the design of precision tooling.
What are the clinical indications for this instrument?
This Helmut Zepf universal handle is indicated as a manual dental instrument for various procedures in dental offices or hospital settings. Its intended purpose is to serve as an ergonomic support for practitioners during intra-oral manipulations. It is exclusively reserved for professional use by trained practitioners. The use of this instrument must be preceded by a careful check of the product's condition. Indications include any intervention requiring a reliable manual instrument, provided that the patient does not present hypersensitivity to the constituent materials, notably the medical stainless steel present in certain components of the associated instrumentation.
What are the technical characteristics of the 26.194.17 handle?
The Helmut Zepf universal handle (reference 26.194.17) is designed to be both durable and reusable. Although a maximum limit of processing cycles cannot be precisely defined due to the design and materials used, its longevity depends on compliance with maintenance protocols. It is imperative to visually inspect the product before each use to detect potential damage such as cracks, breaks, or defects on the edges. Any instrument showing visible signs of wear must never be used. This device is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use.
What are the contraindications for the use of this device?
The main contraindication related to the use of this Helmut Zepf manual instrument concerns metal intolerance. Contact with the instrument, which contains medical stainless steel, may cause a hypersensitivity reaction in certain sensitive patients. If such an allergic reaction or intolerance occurs during the intervention, the procedure must be immediately interrupted and the necessary medical measures must be taken. Furthermore, use is contraindicated if the instrument shows visible damage, as this could compromise patient safety and the effectiveness of the surgical act.
What are the maintenance and sterilization precautions?
All instruments supplied by Helmut Zepf Medizintechnik GmbH must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. Pre-cleaning is a critical step to ensure the effectiveness of sterilization. It is essential to check compatibility with other products used simultaneously. Due to its technical composition, reprocessing must follow rigorous protocols. Professionals must ensure that the product shows no premature wear. The absence of a defined maximum limit for processing cycles requires constant vigilance from the practitioner regarding the physical integrity of the PEEK handle.
Who is the manufacturer and what standards are met?
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 emphasizes that its products are intended exclusively for healthcare professionals. Each instrument is designed to meet the safety and performance requirements expected in dental surgery. The manufacturer's safety instructions specify that strict compliance with cleaning and sterilization steps is mandatory to maintain the device's conformity and safety during its clinical use.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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