Cover for Mixing Bowl - Helmut Zepf (85.251.10) - Delynov
The Couvercle pour cupule de mélange - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 85.251.10.
- 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 mixing cup lid?
The lid for the mixing cup, referenced under code 85.251.10, is an accessory designed by Helmut Zepf Medizintechnik GmbH. This manual dental instrument is manufactured from high-quality medical stainless steel, ensuring durability suited to the requirements of oral surgery practices. This device is specifically intended to cover cups used during the preparation and mixing of dental materials. As a product in the CONSO category, it integrates perfectly into the workflow of practitioners seeking reliable instruments. It is delivered non-sterile and requires a complete reprocessing protocol before its first use and between each patient to ensure optimal safety of use.
What are the clinical indications for this accessory?
The Helmut Zepf lid is indicated as a manual dental instrument for use during oral surgery, implantology, or general dentistry procedures. Its intended purpose is to serve as a protective interface or closure for mixing cups. It helps maintain the integrity of preparations made by the healthcare professional prior to their clinical application. This device is strictly reserved for qualified healthcare professionals. Its use is part of a care setting where the handling of materials requires containers and accessories resistant to repeated cleaning and sterilization cycles, inherent to the rigorous hygiene protocols of dental operating theaters.
What are the technical specifications of reference 85.251.10?
The Helmut Zepf mixing cup lid (ref. 85.251.10) is distinguished by its robust medical stainless steel design. This material is chosen for its corrosion resistance and its ability to withstand cleaning, disinfection, and sterilization cycles. This device belongs to Class I according to medical device regulations. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH states that there is no defined maximum limit for the number of processing cycles achievable, although the user must systematically check for the absence of visible damage, such as cracks or surface defects, before each use.
What are the contraindications for the use of this device?
The main contraindication for the use of this medical stainless steel lid concerns metal intolerance in the patient. Contact with the instrument may trigger a hypersensitivity reaction or an allergic reaction. If such a reaction occurs during the procedure, the manufacturer Helmut Zepf recommends immediately stopping the intervention and taking the necessary medical measures. Furthermore, it is formally contraindicated to use the product if it shows visible damage or wear, such as breaks or defects on the edges. The use of damaged products compromises patient safety and the effectiveness of the surgical procedure.
What are the maintenance and reprocessing precautions?
The Helmut Zepf cup lid is delivered non-sterile. It is imperative to perform complete cleaning, disinfection, and sterilization before the very first use, as well as after each subsequent use. The professional must carefully inspect the instrument for any cracks or deformations before each cycle. Compatibility with other products used during mixing must also be verified beforehand. As this is a non-resorbable instrument intended for external or preparatory use, its maintenance follows standard protocols for dynamic and static instrumentation in dental surgery, thus ensuring the longevity of the equipment and the aseptic protection of the surgical field.
Who is the manufacturer and what standards are met?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device. The manufacturer complies with the regulatory requirements in force for manual dental instruments, ensuring that the stainless steel used meets medical standards. Each product is identified by a precise technical reference (85.251.10) allowing for rigorous traceability. As a Class I device, it meets the safety and performance criteria defined for non-invasive dental surgical consumables and instruments, subject to strict compliance with the cleaning and sterilization instructions issued by Helmut Zepf.
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Specifications
| Manufacturer | Helmut Zepf |
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