Disposable Scalpel Handle with Safety Shield Ø9.5mm - Helmut Zepf (46.007.18) - Delynov
Product features
The Manche bistouri à contrôle de chute Ø9.5mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.007.18.
- 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 Un composant remplaçable d’un scalpel qui fonctionne comme un manche
et accepte une lame adaptée. 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 drop-control scalpel handle?
The Helmut Zepf scalpel handle (reference 46.007.18) is a replaceable component of a scalpel designed to serve as an ergonomic support for compatible blades. Manufactured from high-quality medical stainless steel, this device features a diameter of 9.5 mm and integrates a drop-control system for secure handling during surgical interventions. This handle is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH and requires a complete processing cycle before its first use. Its robust medical steel design ensures optimal durability for demanding practitioners in oral surgery and implantology.
What are the clinical indications for this scalpel handle?
The intended purpose of this Helmut Zepf device is to function as a scalpel handle accepting a compatible blade for cutting soft tissues. It is specifically indicated for surgical procedures where a precise incision is required. This device is strictly reserved for qualified healthcare professionals. Its use is recommended in sterile clinical environments after undergoing a rigorous cleaning, disinfection, and sterilization protocol. It allows for a firm grip and precise guidance of the blade during incision or dissection phases in dental and maxillofacial surgery.
What are the technical characteristics of this device?
This scalpel handle, bearing technical reference 46.007.18, is distinguished by its 9.5 mm diameter offering a stable grip. Its structure is entirely made of medical stainless steel, a material chosen for its resistance and compatibility with repeated sterilization processes. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH specifies that there is no defined maximum limit for the number of processing cycles achievable, as long as the instrument shows no visible damage. It is the practitioner's responsibility to check for the absence of cracks, breaks, or defects before each use.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this medical stainless steel handle is metal intolerance in the patient. Contact with the instrument can trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken accordingly. Furthermore, it is strictly forbidden to use this product if it shows visible damage or wear, such as cracks or defects on the edges, to ensure patient safety and the effectiveness of the surgical act.
What are the maintenance and safety precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the very first use, as well as before each subsequent use. Preliminary cleaning is a critical step to eliminate any residue. Before each intervention, the healthcare professional must meticulously inspect the handle to detect any signs of wear or breakage. The use of damaged products is strictly prohibited. Compatibility with other products used during surgery, particularly scalpel blades, must also be verified beforehand to ensure a secure and functional assembly.
Who is the manufacturer and what standards are met?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This scalpel handle is a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It meets the regulatory requirements for replaceable scalpel components. As a Class I device, it follows strict compliance protocols for reusable surgical instruments. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to maintain product conformity throughout its life cycle in a dental office or hospital environment.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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