PLAQUETTE D'IDENTIFICATION - Helmut Zepf
The Plaquette d'identification - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.312.01.
- 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 identification plate (85.312.01)?
The Helmut Zepf identification plate, referenced under code 85.312.01 at Delynov, is an accessory for manual dental instruments designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This device is manufactured from high-quality medical stainless steel, ensuring durability adapted to the requirements of the surgical environment. As part of the CONSO category, this instrument is delivered non-sterile and requires a complete preparation protocol before any clinical use. Its design allows for clear identification of instruments within the dental practice, thus facilitating the organization of technical trays during oral surgery or implantology procedures.
What are the clinical indications for this Helmut Zepf device?
This device is indicated as an accessory for manual dental instruments within the framework of oral care procedures. Its intended purpose is to serve as an identification interface for tools used by healthcare professionals. The use of this medical stainless steel instrument is strictly reserved for qualified practitioners in dental and oral surgery. It integrates into the daily workflow to optimize instrument management while respecting the rigorous hygiene protocols necessary in a surgical environment. The manufacturer specifies that the product must be checked for any signs of visible damage or wear, such as cracks or defects, before each procedure.
What are the technical characteristics of the 85.312.01 plate?
The Helmut Zepf identification plate (85.312.01) is distinguished by its medical stainless steel composition, a material chosen for its resistance to repeated reprocessing cycles. This device belongs to Class I according to medical device regulations. Due to its specific design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH indicates that there is no defined maximum limit for the number of processing cycles achievable, subject to a prior visual inspection. It is imperative to check the compatibility of this accessory with other products and instruments used during the surgical procedure.
What are the contraindications and possible side effects?
The main contraindication for the use of this instrument is metal intolerance in the patient. Contact with this medical stainless steel accessory may trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately stopped and the necessary medical measures must be taken accordingly. Furthermore, it is formally prohibited to use the product if it shows visible damage, such as breaks or defects on the edges. The use of worn or damaged products compromises patient safety and the effectiveness of the surgical act.
What are the maintenance and sterilization precautions?
Helmut Zepf products are delivered non-sterile. It is mandatory to perform cleaning, disinfection, and complete sterilization before the first use, as well as before each subsequent use. Strict compliance with these safety instructions is crucial to prevent the risks of cross-contamination. The practitioner must ensure that each product is perfectly clean and free of debris before being subjected to the sterilization cycle. As it is a non-resorbable device intended for instrumental organization, its regular maintenance guarantees the permanence of its physical and mechanical properties within the operating room.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It meets the strict regulatory requirements for manual dental instruments. The manufacturer emphasizes that the use of this equipment is exclusively reserved for trained healthcare professionals. Traceability and compliance with German manufacturing standards ensure oral surgeons a high level of reliability for their surgical equipment, in accordance with the indications provided by Helmut Zepf.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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