Identification tags for Helmut Zepf (85.312.20) - Delynov
The Plaquettes d'identification pour Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.312.20.
- 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 are the identification plates for Helmut Zepf (85.312.20) - Delynov?
Identification plates for Helmut Zepf, reference 85.312.20, are accessories designed for the organization and marking of dental instrumentation. Manufactured by Helmut Zepf Medizintechnik GmbH, these plates integrate into the logistical management of oral surgery practices. They are designed in medical stainless steel, a standard material ensuring the durability of the device within the clinical environment. This product belongs to the consumables category (CONSO) and is classified as a Class I medical device. Their primary role is to facilitate the rapid identification of instruments during surgical procedures or reprocessing phases, thereby optimizing workflow efficiency for healthcare professionals.
What are the clinical indications for this accessory?
The intended use for these Helmut Zepf identification plates is linked to the use of a manual dental instrument in a professional setting. They are indicated for the organization of technical trays in dental surgery, implantology, and periodontology. By allowing clear segmentation of instrumentation, they help the practitioner and their assistant maintain an orderly working environment. It is imperative that these accessories be used exclusively by qualified healthcare professionals. As they are part of the care cycle, their condition must be systematically checked before each intervention to detect any visible damage such as cracks or breaks that could compromise their function or the hygiene of the tray.
What are the technical characteristics of this device?
Helmut Zepf identification plates (reference 85.312.20) are characterized by their composition of high-quality medical stainless steel. This material is chosen for its resistance to repeated cleaning and sterilization cycles. The manufacturer, Helmut Zepf Medizintechnik GmbH, delivers these products non-sterile, which requires a strict preparation protocol before the first use. Due to their robust design and the materials used, there is no defined maximum limit for the number of processing cycles achievable, although the user must regularly inspect the edges and surface to identify any signs of wear or structural defects before each subsequent use.
What are the contraindications for the use of these plates?
The main contraindication for the use of these medical stainless steel accessories concerns hypersensitivity or intolerance to metals in the patient. Although the plates are identification elements, any direct or indirect contact with a patient having a known allergy to steel components can trigger a hypersensitivity reaction. If such an adverse reaction occurs during the procedure, the manufacturer specifies that the intervention must be immediately stopped and necessary medical measures must be taken. Additionally, the use of products with visible damage, cracks, or defects on the edges is strictly prohibited to ensure aseptic safety.
What are the maintenance and sterilization precautions?
In accordance with the safety instructions from the manufacturer Helmut Zepf Medizintechnik GmbH, all instruments and accessories must imperatively be cleaned, disinfected, and sterilized before their first use. This protocol must be fully repeated before each subsequent use. Thorough cleaning of each product is crucial to remove residues and ensure the effectiveness of the final sterilization. Professionals must also verify the compatibility of these plates with other products and sterilization systems used in the practice. It is reminded that the use of damaged or worn devices is dangerous and that only a validated complete reprocessing ensures the safety of the patient and the healthcare team.
Who is the manufacturer and what standards are met?
These identification plates are manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. The device complies with current regulations for Class I medical devices (Class Ir mentioned for reprocessing). The manufacturer emphasizes that its products are intended exclusively for healthcare professionals. Compliance with cleaning and sterilization protocols is the responsibility of the end user, in accordance with the instructions provided to maintain the compliance and safety of the medical device throughout its life cycle. Traceability is ensured by the technical reference 85.312.20 specific to this model.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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