MICROSURGICAL SCALPEL HANDLE - Helmut Zepf (46.013.00Z) - Delynov
Product features
The MANCHE BISTOURI MICROCHIRURGICAL - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.013.00Z.
- 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 46.013.00Z microsurgical scalpel handle?
The Helmut Zepf microsurgical scalpel handle (reference 46.013.00Z) is a replaceable component of a scalpel designed to serve as an ergonomic and stable support during microsurgery interventions. This medical device is manufactured from medical-grade stainless steel, ensuring durability suited to operating room requirements. It functions as a reusable handle accepting a suitable blade to allow for precise incisions. As a Class I device, it meets the manufacturing standards of Helmut Zepf Medizintechnik GmbH. Its design is specifically studied to offer optimal maneuverability to healthcare professionals during delicate surgical procedures requiring high precision.
What are the clinical indications for this scalpel handle?
The intended purpose for this Helmut Zepf scalpel handle is to serve as a support for an interchangeable scalpel blade during surgical acts. It is indicated for procedures where a controlled incision is necessary. This device is exclusively reserved for use by qualified healthcare professionals. Its use is central in oral surgery and implantology protocols for flap preparation or precision incisions. The manufacturer specifies that the instrument must be systematically checked before each intervention to detect any visible damage, such as cracks or defects on the attachment areas, in order to guarantee patient safety and the effectiveness of the surgical act.
What are the technical characteristics of the 46.013.00Z handle?
This microsurgical scalpel handle is distinguished by its medical stainless steel composition, a material chosen for its resistance and its ability to undergo repeated cleaning cycles. Referenced under code 46.013.00Z, this device is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. Due to its robust design and the materials used, the manufacturer indicates that there is no defined maximum limit for the number of processing cycles achievable, as long as the instrument does not show signs of wear or structural damage. Its compatibility with other products and scalpel blades must be verified by the practitioner before any use to ensure secure assembly.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer concerns metal intolerance. Contact with this medical stainless steel instrument may cause a hypersensitivity reaction in certain sensitive patients. If such an allergic reaction or intolerance manifests during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. Furthermore, it is formally contraindicated to use the product if it shows visible damage, breaks, or defects on the edges, as this could compromise the safety of the surgical act and the patient's health.
What are the maintenance and sterilization precautions?
Like all instruments from the Helmut Zepf brand, this scalpel handle must imperatively be cleaned, disinfected, and sterilized before its very first use, as well as after each subsequent use. The reprocessing process must be complete to guarantee asepsis. It is crucial to clean each product before proceeding to sterilization. The practitioner must inspect the instrument to identify any trace of wear, crack, or deformation before use. Damaged or worn products must never be reused. Given that the device is delivered non-sterile, rigorous compliance with cleaning and sterilization protocols in the office or hospital environment is a sine qua non condition for its use.
Who is the manufacturer and what standards are respected?
This scalpel handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The device is classified as a Class I instrument according to medical device regulations. The manufacturer ensures the traceability and quality of its instruments through rigorous production processes. As a Class I medical device, it is intended exclusively for healthcare professionals. Compliance with the safety and use instructions provided by Helmut Zepf is essential to maintain the conformity of the device throughout its useful life. Practitioners must refer to the manufacturer's instructions for the reprocessing and maintenance of this surgical instrument.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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