Axial instrument for plastic fillings - Helmut Zepf (26.200.18) - Delynov
The Instrument axial pour plombages plastiques - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.200.18.
- 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 Instrument dentaire manuel 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 axial instrument for plastic fillings (26.200.18)?
The Helmut Zepf axial instrument, referenced under code 26.200.18, is a manual dental instrument specifically designed for the manipulation and shaping of plastic filling materials. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this tool is intended for professional use in dental practices. Its axial structure allows for increased precision during restorative interventions. As a Class I medical device, it meets the safety requirements for reusable instruments. It is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use, as well as between each patient, to ensure perfect asepsis.
What are the clinical indications for this dental instrument?
This instrument is indicated for restorative dentistry procedures involving the application and modeling of plastic materials. It is a versatile manual dental instrument used by healthcare professionals for cavity filling. Its use is strictly reserved for qualified practitioners in dental and oral surgery. The primary indication is based on the fine manipulation of filling materials, where the Helmut Zepf brand axial design facilitates access and precise placement of the material in the treatment area. It is essential to check the integrity of the instrument, particularly the absence of cracks or defects on the working parts, before any clinical intervention.
What are the technical characteristics of the 26.200.18 instrument?
The Helmut Zepf 26.200.18 instrument is distinguished by its manufacture in medical stainless steel, a material chosen for its resistance and durability against repeated sterilization cycles. Its ergonomic axial design is optimized for plastic fillings. Although there is no maximum limit defined for the number of treatment cycles due to the robustness of the materials used, the service life of the instrument depends on its maintenance. Technical characteristics include mechanical resistance adapted to the constraints of restorative dentistry. Professionals must visually inspect the tool for any visible damage or wear, such as breaks or defects on the edges, before each use.
What are the contraindications for the use of this stainless steel instrument?
The main contraindication to the use of this Helmut Zepf instrument lies in hypersensitivity or intolerance to metals in the patient. Since the instrument is composed of medical stainless steel, contact may trigger an allergic reaction in sensitive subjects. If a hypersensitivity reaction is observed during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be immediately stopped and necessary medical measures taken. Furthermore, the use of the instrument is formally contraindicated if it shows visible signs of wear, cracks, or damaged cutting edges, in order to prevent any risk of injury or clinical complication.
What are the maintenance and sterilization precautions?
Being delivered non-sterile, this Class I instrument must imperatively follow a complete cleaning, disinfection, and sterilization cycle before its first commissioning. This procedure must be rigorously repeated before each subsequent use. The manufacturer specifies that it is crucial to clean each product individually and to check its compatibility with other products used during reprocessing. Due to the specific design and high-quality materials, it is not possible to define a maximum limit of sterilization cycles, but the practitioner's vigilance is required. The use of damaged or worn products is strictly prohibited to maintain patient safety and the effectiveness of the surgical procedure.
Who is the manufacturer and what standards are respected by this device?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the traceability and quality of its products through rigorous manufacturing protocols in medical stainless steel. Although the specific CE marking is not detailed in the sources provided, compliance with European standards for manual dental instruments is inherent to its marketing by a recognized European manufacturer. The product is exclusively reserved for healthcare professionals, guaranteeing use in accordance with modern dental practice standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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