Osteotomy Set - Helmut Zepf (47.962.20) - Delynov
The Insert d'ostéotomie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.962.20.
- 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 is the Helmut Zepf osteotomy insert (47.962.20)?
The Helmut Zepf osteotomy insert, referenced under code 47.962.20, is a manual dental instrument designed for precision surgical interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is crafted from high-quality medical stainless steel to ensure optimal performance during osteotomy procedures. This device belongs to the consumables category (CONSO) and is classified as a Class I medical device. Its robust stainless steel structure is specifically adapted to the requirements of oral surgery, providing practitioners with a reliable instrument for bone tissue manipulation. It is delivered non-sterile and requires a complete preparation protocol before any clinical use.
What are the clinical indications for this osteotomy insert?
This osteotomy insert is indicated as a manual dental instrument for surgical procedures requiring intervention on bone structures. Its use is strictly reserved for healthcare professionals qualified in dental, oral, or implant surgery. The manufacturer Helmut Zepf specifies that the instrument is intended for use in a rigorous clinical setting. Before each intervention, the practitioner must imperatively check for the absence of visible damage, such as cracks, breaks, or defects on the cutting edges, in order to guarantee patient safety and the effectiveness of the surgical act. The use of a damaged or worn product is formally prohibited to maintain standards of care.
What are the technical characteristics of this instrument?
The Helmut Zepf osteotomy insert (47.962.20) is characterized by its medical stainless steel composition, a material chosen for its strength and compatibility with reprocessing cycles. As a Class I device, it meets the regulatory requirements for non-invasive or minimally invasive manual instruments. A major technical feature lies in its durable design: the manufacturer indicates that due to the materials used, there is no defined maximum limit of achievable treatment cycles, as long as the physical integrity of the instrument is preserved. Professionals must, however, inspect the cutting edges before each use. Compatibility with other products used during the intervention must also be verified beforehand by the surgeon.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this medical stainless steel insert concerns metal intolerance in the patient. Contact with the instrument may trigger a hypersensitivity reaction or undesirable side effects in sensitive subjects. If such an allergic reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to validate the absence of known metal allergies before the procedure. Furthermore, the use of this instrument is contraindicated if it shows visible signs of wear, cracks, or alterations of the cutting edges that could compromise the precision of the movement or patient safety.
What are the maintenance and sterilization precautions?
Helmut Zepf Medizintechnik GmbH products are delivered non-sterile, which necessitates a strict reprocessing protocol. All instruments must be cleaned, disinfected, and sterilized before their first use, as well as before each subsequent use. The complete cleaning of each product is a critical step to eliminate any residue. The manufacturer emphasizes the importance of checking the general condition of the insert (absence of breaks or defects) after each sterilization cycle. Although no fixed limit of cycles is imposed by the stainless steel design, natural wear of the cutting edges must lead to the replacement of the tool as soon as its performance is no longer optimal. Compliance with these safety instructions is essential for the longevity of the device.
Who is the manufacturer and what standards are respected?
The osteotomy insert is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This manufacturer is recognized for its expertise in high-precision dental instrumentation. This medical device complies with Class I regulations (Class Ir according to reprocessing mentions). Compliance with the instructions for use and safety issued by Helmut Zepf guarantees use in accordance with medical requirements. As an instrument intended exclusively for healthcare professionals, it follows rigorous manufacturing processes in medical stainless steel. Users must refer to the manufacturer's instructions for cleaning and sterilization to maintain device compliance throughout its useful life in the practice or hospital environment.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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