Blade Handle for Scalpels - Helmut Zepf (46.007.00) - Delynov
Product features
The Manche pour bistouris - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Intended use: Surgical instrument intended for oral, dental, periodontal, and implant surgery, used by trained practitioners in sterile environments.
- Reference: 46.007.00.
- 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 scalpel handle (46.007.00)?
The Helmut Zepf scalpel handle, referenced under code 46.007.00, is a surgical instrument designed to serve as a replaceable component of a scalpel. Manufactured from high-quality medical stainless steel, this device functions as a robust handle intended to receive a suitable blade. Its structure is specifically designed to provide a precise grip during surgical procedures. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH and requires a complete preparation protocol before any clinical use. As a reusable stainless steel instrument, it combines durability and compatibility with standard reprocessing procedures in the medical environment, meeting the requirements of practitioners for oral surgery procedures.
What are the clinical indications for this scalpel handle?
The intended use of this scalpel handle is to serve as a support for an interchangeable scalpel blade for performing surgical incisions. Its primary indication concerns procedures where precise cutting of soft tissue is required. This Helmut Zepf device is exclusively reserved for qualified healthcare professionals. It is indicated for use in dental, oral, and implant surgery, allowing the surgeon to adapt the specific blade to the planned surgical act. Before each use, the practitioner must imperatively check for the absence of visible damage or wear, such as cracks or defects on the attachment areas, in order to guarantee the safety of the procedure and the precision of the incision.
What are the technical characteristics of the 46.007.00 instrument?
The Helmut Zepf scalpel handle (46.007.00) is characterized by its medical stainless steel manufacture, ensuring increased mechanical resistance and longevity. This material allows the device to be repeatedly cleaned, disinfected, and sterilized. Due to its design and the materials used, there is no defined maximum limit for the number of processing cycles, as long as the physical integrity of the instrument is preserved. It is essential to check the condition of the handle before each intervention to detect any potential breaks or alterations of the edges. Compatibility with other products and blades must also be verified beforehand to ensure a secure assembly of the complete scalpel.
What are the contraindications for the use of this device?
The main contraindication related to the use of this medical stainless steel scalpel handle is metal intolerance in the patient. Contact with the instrument may cause a hypersensitivity reaction in sensitive subjects. If such a reaction occurs during the procedure, the intervention must be stopped immediately and necessary medical measures must be taken. Furthermore, the use of products showing visible damage, cracks, or signs of wear is strictly prohibited. The use of this instrument is strictly reserved for trained healthcare professionals, and its use by unqualified personnel constitutes a major contraindication according to the Helmut Zepf manufacturer safety instructions.
What are the maintenance and reprocessing precautions?
As it is a non-absorbable stainless steel instrument, strict cleaning and sterilization precautions apply. All instruments must be cleaned, disinfected, and sterilized before the first use, as well as before each subsequent use. It is crucial to perform a complete cleaning to remove all residues before the sterilization cycle. The practitioner must carefully inspect the handle to identify any wear, cracks, or structural failure. A damaged instrument must never be used. The reprocessing procedure is determined by the physical state of the object, as the material does not have a predefined cycle limit, subject to compliance with the maintenance protocols recommended by Helmut Zepf Medizintechnik GmbH.
Who is the manufacturer and what standards are respected?
This scalpel handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer imposes rigorous safety instructions, including the obligation of reprocessing (cleaning, disinfection, and sterilization) before any use, in accordance with medical standards. Although specific CE marking is not detailed in the provided sources, the product meets the requirements for Class I devices intended for healthcare professionals. The traceability and quality of the stainless steel used highlight the commitment of the Helmut Zepf brand to providing surgical instruments that meet the needs of the dental and implant sector.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs that minimize tissue trauma. Precision and reliability are top priorities.
Specifications
| Manufacturer | Helmut Zepf |
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