Kit de chirurgie Immediate Dentoalveolar Restoration (IDR) du Dr José Carlos Martins Da Rosa - Helmut Zepf (41.550.00) - Delynov
Product features
The Kit de chirurgie Immediate Dentoalveolar Restorationdu Dr José Carlos Martins Da Rosa - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Intended use: Single-use sterile surgical kit for oral, implant, and periodontal procedures; ensures regulatory traceability (UDI).
- Reference: 41.550.00.
- 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 Un instrument chirurgical manuel sur lequel une force est appliquée à l'extrémité
proximale via un marteau pour couper et/ou façonner l'os en
frappant avec l'extrémité distale (bord coupant ou tranchant). 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 Dr. José Carlos Martins Da Rosa Immediate Dentoalveolar Restoration (IDR) Surgery Kit - Helmut Zepf?
The Immediate Dentoalveolar Restoration (IDR) Surgery Kit, developed by Helmut Zepf in collaboration with Dr. José Carlos Martins Da Rosa, is a set of specialized manual surgical instruments. Designed for immediate dentoalveolar restoration procedures, this kit (reference 41.550.00) consists of tools manufactured from high-quality medical stainless steel. These instruments are designed to receive force applied to the proximal end via a hammer, thereby allowing the bone to be cut or shaped with precision thanks to their sharp distal end. This equipment is specifically intended for healthcare professionals practicing oral surgery and implantology, offering a robust solution for bone reconstruction protocols.
What are the clinical indications for the Helmut Zepf IDR kit?
The intended purpose and primary indication of this Helmut Zepf surgical kit lie in the manipulation of bone structures during dentoalveolar surgeries. It is specifically indicated for cutting and shaping bone using a controlled manual striking technique. The distal instrument, equipped with a cutting or sharp edge, allows for precise action on the surgical site when the practitioner applies force to the proximal end using a hammer. This device is essential for IDR protocols where management of the extraction site and bone preparation require specialized instrumentation to ensure an effective intervention adapted to alveolar reconstruction needs.
What are the technical characteristics of this medical device?
The Helmut Zepf 41.550.00 kit is characterized by rigorous manufacturing in medical stainless steel, guaranteeing the durability necessary for bone surgery interventions. Technically, each instrument is designed to transmit impact energy from a hammer from the proximal end to the distal cutting edge. Due to the design and materials used, there is no defined maximum limit for the number of processing cycles achievable, although longevity depends on maintenance. The products are delivered non-sterile and must imperatively undergo a complete process of cleaning, disinfection, and sterilization before the first use and after each subsequent use.
What are the contraindications for the use of these instruments?
The main contraindication related to the use of these medical stainless steel instruments is metal intolerance. In a patient with a known hypersensitivity to these components, contact with the instrument may trigger an adverse reaction. The manufacturer specifies that if such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken accordingly. It is therefore crucial to check the patient's allergic history before any manipulation. Furthermore, use is strictly reserved for qualified healthcare professionals mastering manual bone surgery techniques.
What are the precautions for use and maintenance for the IDR kit?
Patient and practitioner safety relies on a strict maintenance protocol. Before each use, it is imperative to visually inspect the instruments to detect any visible damage or wear, such as cracks, breaks, or defects on the cutting edges. Damaged or worn products must never be used. As Helmut Zepf devices are delivered non-sterile, they must be cleaned, disinfected, and sterilized before initial commissioning. Compatibility with other products used during the intervention must also be verified beforehand. Complete cleaning before each sterilization cycle is essential to maintain the integrity of the medical stainless steel.
Who is the manufacturer and what standards are met by this kit?
This kit is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. In accordance with medical device regulations, this equipment is classified as Class I (Class Ir according to reprocessing mentions). The manufacturer ensures the traceability and quality of its instruments through rigorous manufacturing processes in medical stainless steel. As a Class I device, it meets the safety and performance requirements applicable to reusable manual surgical instruments. Compliance with the cleaning and sterilization instructions recommended by Helmut Zepf is indispensable to guarantee product conformity throughout its clinical life.
State of the art
Single-use sterile surgical kits significantly reduce the risk of intraoperative contamination. Regulatory traceability (UDI) remains a key concern.
Specifications
| Manufacturer | Helmut Zepf |
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