Universal PEEK Handle - Helmut Zepf (26.193.15) - 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: 26.193.15.
- 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 PEEK universal handle?
The PEEK universal handle (reference 26.193.15) from the Helmut Zepf brand is an ergonomic dental instrument designed to serve as an extension for various working ends. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is developed to offer optimal grip during surgical interventions. Its PEEK (Polyetheretherketone) structure is combined with medical stainless steel components, ensuring robustness adapted to the requirements of daily dental practice. This handle is delivered non-sterile and requires a rigorous preparation protocol before any clinical use.
What are the clinical indications for the Helmut Zepf 26.193.15 handle?
This universal handle is specifically indicated as an ergonomic support for dental working instruments. Its intended purpose is to facilitate the manipulation of active ends during oral surgery, implantology, or general dental care procedures. As an ergonomic extension, it allows the practitioner to maintain high precision while reducing manual fatigue. It is exclusively reserved for use by qualified healthcare professionals. The manufacturer specifies that the product must be inspected before each use to detect any visible damage such as cracks or breaks.
What are the technical characteristics of this instrument?
The Helmut Zepf universal handle is distinguished by its ergonomic design which ensures a stable hold in the hand. Although the main body is made of PEEK, the instrument integrates medical stainless steel to ensure the connection with the working ends. It belongs to Class I of medical devices according to current regulations. An important characteristic lies in its durability: due to the quality of the materials used, there is no defined maximum limit for processing cycles, provided that the instrument shows no wear or defects on the cutting edges.
What are the contraindications for the use of this PEEK handle?
The main contraindication concerns hypersensitivity or intolerance to metals. Although the handle uses PEEK, contact with medical stainless steel parts can trigger allergic reactions in some patients. In the event of a hypersensitivity reaction during the intervention, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the procedure must be stopped immediately and necessary medical measures must be taken. Furthermore, the use of an instrument presenting visible damage, cracks, or surface defects is strictly prohibited to guarantee patient safety.
What are the maintenance and sterilization precautions?
The Helmut Zepf universal handle is delivered non-sterile. It is imperative to clean, disinfect, and sterilize the instrument before its very first use, as well as after each subsequent use. The reprocessing process must be complete to ensure asepsis. The practitioner must verify compatibility with other products used simultaneously. Before each cycle, a meticulous visual inspection is required to identify any trace of wear, corrosion, or breakage. The use of damaged products is dangerous and can compromise the outcome of the surgical act.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is classified as a Class I medical device. The manufacturer complies with regulatory requirements relating to dental instruments, particularly regarding the choice of materials such as medical stainless steel. Compliance with the safety and use instructions provided by Helmut Zepf is essential to guarantee the conformity of the device during its life cycle. Any use diverted from its intended purpose as an extension of dental working ends is the responsibility of the healthcare professional.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |