Universal PEEK Handle - Helmut Zepf (26.194.06) - 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: 26.194.06.
- 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 (26.194.06)?
The PEEK universal handle, referenced under code 26.194.06 by Helmut Zepf, is a high-end manual dental instrument distributed by Delynov. Designed by the manufacturer 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 to offer optimal ergonomics and increased durability during surgical interventions. As a Class I instrument, it meets strict regulatory requirements for non-invasive or short-term invasive medical devices. Its design allows for precise handling, essential for demanding practitioners in dental and implant surgery.
What are the clinical indications for this Helmut Zepf instrument?
The Helmut Zepf universal handle is indicated as a manual dental instrument for various procedures in oral surgery and implantology. Its intended purpose is to serve as an ergonomic support for practitioners during dental care. This device is exclusively reserved for qualified healthcare professionals. It must be used in a controlled clinical environment to ensure patient safety. Before any intervention, the practitioner must ensure the compatibility of the handle with the other instruments or inserts used. Its versatility makes it a tool of choice for dental practices seeking to standardize their instrumentation with modern and resistant materials like PEEK.
What are the technical and maintenance characteristics of this handle?
This universal handle (ref 26.194.06) is manufactured from PEEK and medical stainless steel. A major technical characteristic is that it is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. It is imperative to clean, disinfect, and sterilize the instrument before its first use, as well as before each subsequent use. The manufacturer emphasizes that due to the robust design and materials used, there is no defined maximum limit for reprocessing cycles, as long as the instrument does not show visible damage. The practitioner must regularly inspect the product for any cracks, breakage, or defects before use, and systematically discard any worn instrument.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this instrument lies in hypersensitivity to the component materials. Although the body is made of PEEK, contact with the medical stainless steel parts may cause metal intolerance reactions in some patients. If a hypersensitivity reaction is triggered during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. It is also contraindicated to use the product if it shows visible signs of wear, such as cracks or defects on the edges, as this could compromise patient safety and the effectiveness of care.
What are the precautions for use and reprocessing?
The use of the Helmut Zepf universal handle requires strict compliance with the manufacturer's safety instructions. All instruments must undergo a complete cycle of cleaning, disinfection, and sterilization before each use. It is crucial to check for the absence of visible damage before any handling. The use of damaged or worn products is strictly prohibited. Regarding reprocessing, the durability of the instrument depends on its maintenance and the nature of the treatment cycles applied. As it is a Class I device, compliance with hygiene protocols is decisive for maintaining the integrity of the PEEK material and stainless steel over the long term.
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 is classified as Class I according to current regulations. The manufacturer guarantees traceability and manufacturing quality in accordance with European standards for manual dental instruments. Helmut Zepf products are recognized for their technical precision and reliability. As a Class I device, it meets the essential requirements for safety and performance. Healthcare professionals can refer to the instructions provided by Helmut Zepf Medizintechnik GmbH to ensure use in accordance with the manufacturer's indications.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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