Silicone Support for Dental Surgery and Implantology - Helmut Zepf (85.180.05) - Delynov
The Support en silicone pour chirurgie dentaire et implantologie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.180.05.
- 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 silicone holder (85.180.05)?
The Helmut Zepf silicone holder, referenced under code 85.180.05, is a manual dental instrument specifically designed for the organization and holding of tools during dental surgery and implantology procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is classified as a Class I instrument according to current regulations. It is delivered non-sterile and requires a complete reprocessing protocol before its first use and between each patient. Its design is based on materials allowing for repeated treatment cycles without a maximum limit defined by the manufacturer, subject to a prior visual inspection to ensure the absence of damage or wear.
What are the clinical indications for this silicone holder?
This holder is indicated as an auxiliary manual dental instrument within the framework of oral surgical procedures and implantology. Its intended purpose is to facilitate the handling and organization of instruments within the operating block. The use of this product is strictly reserved for qualified healthcare professionals. It must be integrated into a workflow that respects the instructions for use and safety guidelines from the manufacturer Helmut Zepf. Before any intervention, the practitioner must verify the compatibility of this holder with other products and instruments used to ensure optimal safety during the surgical act.
What are the technical characteristics of this device?
The Helmut Zepf holder (85.180.05) is distinguished by its composition adapted to the requirements of the surgical environment. Although the main instrument is made of silicone, the manufacturer mentions the use of medical stainless steel in its range, emphasizing the importance of biocompatibility. This device is designed to withstand cleaning, disinfection, and sterilization processes. Due to its robust design and selected materials, there is no defined maximum limit of treatment cycles, provided that the physical integrity of the object is preserved. Each product must be inspected to detect any potential cracks or defects before use.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns patient hypersensitivity to the materials used. Metal intolerance may result from contact with the instrument if it contains medical stainless steel. If a hypersensitivity reaction is triggered during the procedure, it must be immediately stopped and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use products showing visible damage or wear, such as cracks, breaks, or defects on the edges, as this could compromise patient safety and the effectiveness of the procedure.
What are the maintenance and sterilization precautions?
All instruments supplied by Helmut Zepf Medizintechnik GmbH must follow a rigorous protocol before use. Being delivered non-sterile, they must imperatively be cleaned, disinfected, and sterilized before the first commissioning, and then after each subsequent use. Cleaning is a critical step that must be completed before sterilization. The professional must ensure that the product shows no signs of visible wear. The use of damaged products is prohibited. Reprocessing is possible over many cycles, but the decision to discard the instrument rests on the clinical evaluation of its physical condition by the practitioner.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This silicone holder is a Class I medical device, compliant with regulatory requirements for manual dental instruments. The manufacturer insists that the use of this equipment is strictly reserved for healthcare professionals. Compliance with safety instructions, notably systematic cleaning and sterilization, is mandatory to guarantee conformity with care standards. The traceability and manufacturing quality of Helmut Zepf ensure a reliable tool for the requirements of modern implant surgery.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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