Universal PEEK Handpiece - Helmut Zepf (26.193.18) - 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: 26.193.18.
- 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 (26.193.18)?
The PEEK universal handle, referenced under code 26.193.18 by Helmut Zepf, is a manual dental instrument designed to offer optimal ergonomics during surgical interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is distinguished by the use of PEEK, a high-performance polymer, combined with medical stainless steel components. This handle is specifically developed for dental healthcare professionals seeking a reliable and durable tool. As a Class I instrument, it meets the basic regulatory requirements for non-invasive or transient medical devices. Its design allows for precise handling, essential for oral surgery and implantology procedures, while ensuring compatibility with the rigorous cleaning and sterilization standards of the medical sector.
What are the clinical indications for this instrument?
The Helmut Zepf universal handle is indicated as a manual dental instrument for various procedures in dental offices and hospital settings. Its intended purpose is to serve as a support or manipulation vector during oral care. It is exclusively reserved for use by qualified healthcare professionals. This device is particularly suitable for interventions requiring a stable grip and controlled force transmission. The manufacturer specifies that the instrument must be checked before each use to detect any visible damage, such as cracks or defects on the edges, to ensure patient safety and the effectiveness of the clinical act. Its use falls within the framework of standard dental surgery protocols.
What are the technical characteristics of this handle?
The Helmut Zepf universal handle (reference 26.193.18) combines the lightness and chemical resistance of PEEK with the robustness of medical stainless steel. This blend of materials ensures increased longevity against repeated processing cycles. Although the manufacturer does not define a strict maximum limit for the number of achievable processing cycles, this depends directly on the product design and the materials used. The device is delivered non-sterile and mandatorily requires complete preparation before its first use. The technical characteristics of this manual instrument are optimized to meet the needs of modern implantology and oral surgery, offering an interface compatible with other products in the Helmut Zepf range, subject to prior verification.
What are the contraindications for the use of this device?
The main contraindication related to the use of this Helmut Zepf instrument concerns metal intolerance. Indeed, contact with the instrument, which contains medical stainless steel, can cause hypersensitivity reactions in certain sensitive patients. If such an allergic reaction or intolerance manifests during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken accordingly. Furthermore, it is formally prohibited to use the instrument if it shows visible signs of wear, breakages, or structural defects. The use of damaged products compromises clinical safety and constitutes a major contraindication to maintaining the operative protocol.
What are the maintenance and sterilization precautions?
Like any Class I instrument provided by Helmut Zepf Medizintechnik GmbH, this handle must follow a strict reprocessing protocol. The products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. It is crucial to clean each product individually to remove any residue before the sterilization cycle. The professional must inspect the instrument to identify any trace of corrosion, crack, or surface degradation. The manufacturer emphasizes that due to the high quality of the materials, there is no predefined limit of sterilization cycles, but the service life depends on careful handling and compliance with cleaning instructions. Rigorous maintenance is the guarantee of the instrument's continuous performance.
Who is the manufacturer and what standards are respected?
The PEEK universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to the regulations in force. The manufacturer ensures the compliance of its products with safety and performance requirements for manual dental instruments. Although specific details of the CE marking are not explicitly detailed in the simplified technical documentation, compliance with MDR standards is implicit for the European market placement of Class I devices. Each instrument is subject to rigorous quality controls to ensure it meets the needs of dental surgeons. Traceability is ensured by product reference 26.193.18, guaranteeing the origin and compliance of the Helmut Zepf equipment.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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