ZEPF-BIONIK. UNIVERSAL HANDLE. PEEK. - Helmut Zepf (26.194.02)
Product features
The ZEPF-BIONIK. MANCHE UNIVERSEL. PEEK. - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.02.
- 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 ZEPF-BIONIK universal handle in PEEK?
The ZEPF-BIONIK universal handle, referenced under code 26.194.02, is a high-end dental instrument designed by Helmut Zepf. This device is manufactured in PEEK, a high-performance polymer recognized for its durability and lightness. Its ergonomic structure has been specifically studied to offer optimal grip during surgical interventions. This handle serves as an extension for various dental working ends, allowing practitioners to modulate their instrumentation according to the needs of the operative procedure. As a Class I device, it meets quality requirements for repeated use in dental practices or hospital environments, combining ease of use and technical precision for the surgeon.
What are the clinical indications for this Helmut Zepf handle?
The intended purpose and primary indication of this Helmut Zepf universal handle lie in its role as an ergonomic extension for various dental working instruments. It is designed to adapt to different active ends, thereby facilitating oral surgery, implantology, or general dentistry procedures. Its bionic design allows for precise manipulation and reduces manual fatigue during prolonged sessions. This device is exclusively reserved for qualified healthcare professionals. It is imperative to verify the compatibility of the handle with other products and working ends before any intervention. The use of this instrument must be part of a strict clinical protocol aimed at ensuring the effectiveness of the surgical gesture while guaranteeing patient comfort.
What are the technical characteristics of handle 26.194.02?
The ZEPF-BIONIK handle (reference 26.194.02) is distinguished by its bionic ergonomic design which ensures an excellent grip. Manufactured from PEEK and medical stainless steel for the functional parts, it offers high mechanical resistance. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH. Before each use, the instrument must undergo a complete cycle of cleaning, disinfection, and sterilization. Due to the quality of the materials used, there is no defined maximum limit for the number of processing cycles achievable, although the user must visually inspect the product for any signs of wear, cracks, or defects on the edges before each use.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this instrument concerns hypersensitivity to the materials. Although the handle is primarily made of PEEK, contact with the medical stainless steel parts may cause metal intolerance reactions in certain sensitive 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, it is formally contraindicated to use an instrument presenting visible damage such as cracks, breaks, or structural defects. The use of damaged or worn products compromises patient safety and the effectiveness of the surgical treatment.
What are the maintenance and sterilization precautions?
As a non-resorbable and reusable device, the ZEPF-BIONIK handle requires a rigorous maintenance protocol. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. It is crucial to perform a complete cleaning to eliminate all residues before sterilization. The practitioner must carefully inspect the instrument to identify any potential damage or signs of wear before each cycle. As the device is composed of robust materials, the manufacturer does not establish a strict limit on the number of reprocessing cycles, leaving it to the responsibility of the healthcare professional to determine if the condition of the instrument still allows for its safe use.
Who is the manufacturer and what standards are met?
This universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device, in accordance with the regulations in force for manual dental instrumentation. The manufacturer guarantees that its products are designed to meet the safety and clinical performance requirements of healthcare professionals. Each unit is identified by a precise technical reference (26.194.02) ensuring the traceability of the device. Compliance with the cleaning and sterilization protocols recommended by Helmut Zepf is essential to maintain the conformity of the instrument throughout its operational life within the dental practice.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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