Universal PEEK handle - Helmut Zepf (26.194.10) - Delynov
Product features
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: 26.194.10.
- 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 Les poignées sont conçues de manière ergonomique pour bien tenir dans la main et pour être utilisées comme extensions de diverses extrémités de travail dentaire. 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 (26.194.10) universal PEEK handle?
The universal PEEK handle, referenced under code 26.194.10 by Helmut Zepf, is an ergonomic dental instrument designed to serve as an extension for various working ends. Manufactured from PEEK, a high-performance polymer material, this bionic handle is specifically developed to offer an optimal grip during surgical or dental interventions. Its ergonomic design allows practitioners to manipulate inserts with precision while reducing manual fatigue. This medical device from Helmut Zepf Medizintechnik GmbH combines lightness and robustness, meeting the requirements of modern clinical environments. It is delivered non-sterile and requires a rigorous preparation protocol before any use in the mouth.
What are the clinical indications for the Helmut Zepf universal handle?
The Helmut Zepf universal handle is indicated for use as a support or extension for various working ends in the dental field. Its intended purpose is to facilitate the manipulation of instruments during oral care or surgery procedures. Thanks to its bionic ergonomics, it ensures a firm and secure hold in the practitioner's hand, which is essential for the precision of technical gestures. This device is exclusively reserved for qualified healthcare professionals. It allows for the adaptation of different interchangeable inserts, thus offering increased versatility during diagnostic, treatment, or implantation phases, while guaranteeing prolonged user comfort during complex interventions.
What are the technical characteristics of this device?
This universal handle, bearing technical reference 26.194.10, is distinguished by its PEEK composition and its bionic ergonomic structure. Unlike entirely metallic instruments, the use of PEEK offers specific properties of lightness and thermal resistance. However, it should be noted that contact with the medical stainless steel parts of the instrument may occur. The manufacturer Helmut Zepf specifies that the product design and the materials used do not allow for the definition of a maximum limit of processing cycles (cleaning, disinfection, sterilization). The durability of the handle depends on the absence of visible damage such as cracks or breakages. It is the professional's responsibility to check the condition of the instrument and its compatibility with other products before each use.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity to the components of the instrument. Although the handle is made of PEEK, contact with medical stainless steel can cause undesirable side effects, including metal intolerance reactions in certain patients. If a hypersensitivity reaction is triggered during the intervention, the procedure must be stopped immediately and the necessary medical measures must be taken. Furthermore, the use of this handle is strictly prohibited if the device shows visible damage or wear, such as cracks or defects on the fastening structures. Use is exclusively reserved for trained healthcare professionals, prohibiting any manipulation by unqualified personnel.
What are the maintenance and sterilization precautions?
As the Helmut Zepf universal handle is delivered non-sterile, it is imperative to follow a strict reprocessing protocol. All instruments must be fully cleaned, disinfected, and sterilized before the first use, as well as before each subsequent use. The manufacturer emphasizes the crucial importance of cleaning the product before proceeding with sterilization. A meticulous visual inspection is required to detect any signs of wear, breakages, or cracks; never use a damaged product. Although no maximum limit of processing cycles is defined by Helmut Zepf Medizintechnik GmbH due to the quality of the materials, the practitioner must validate the compatibility of the handle with other devices and ensure the functional integrity of the assembly before any clinical intervention.
Who is the manufacturer and what standards are respected?
The universal PEEK handle is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer guarantees the conformity of its products to safety and performance requirements for professional use in a dental environment. As a Class I device, it meets the strict quality standards imposed by the manufacturer for reusable instruments. Safety instructions stipulate that compliance with cleaning and sterilization protocols is mandatory to maintain the device's conformity throughout its life cycle. Helmut Zepf thus ensures the traceability and manufacturing quality of its instruments intended for dental surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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