Bone Scraper II - Helmut Zepf (47.957.20) - Delynov
The Grattoir à os Bone Scraper II - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.957.20.
- 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 Bone Scraper II Helmut Zepf (47.957.20)?
The Bone Scraper II, referenced under code 47.957.20 at Delynov, is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This bone scraper is manufactured from medical-grade stainless steel, a material chosen for its robustness and compatibility with the requirements of oral surgery. As a Class I device, this instrument is specifically developed to meet the needs of healthcare professionals during autogenous bone harvesting procedures. Its design allows for precise handling, essential for collecting bone chips needed for grafts. The product is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use and after each clinical cycle.
What are the clinical indications for the Bone Scraper II bone scraper?
The Bone Scraper II from Helmut Zepf is indicated for use as a manual dental instrument during surgical procedures requiring bone recovery. Its intended purpose is to facilitate the manual harvesting of bone tissue. It is primarily used by dental surgeons, implantologists, and oral surgery specialists for bone regeneration procedures. Using this medical stainless steel instrument allows for high-quality autogenous bone chips to be obtained directly from the patient's donor site. This device is exclusively reserved for qualified healthcare professionals, ensuring a safe application in compliance with modern dental practice standards.
What are the technical characteristics of this Helmut Zepf instrument?
The Helmut Zepf instrument (reference 47.957.20) is characterized by its high-performance medical stainless steel manufacturing. Its structure is designed to withstand repeated processing cycles, although there is no defined maximum limit for the number of reprocessing cycles achievable due to the nature of the materials used. Before each intervention, the practitioner must imperatively inspect the instrument to detect any potential damage or visible wear, such as cracks, breaks, or defects on the cutting edges. The use of a damaged or worn product is strictly prohibited to ensure cutting efficiency and patient safety. Its ergonomic design is optimized for precise manual harvesting in a surgical environment.
What are the contraindications for using the Bone Scraper II?
The main contraindication related to the use of the Bone Scraper II bone scraper lies in metal intolerance. Contact with this medical stainless steel instrument may cause adverse side effects in patients with a known sensitivity to this material. A hypersensitivity reaction may be triggered during use. If such a reaction occurs during the procedure, the manufacturer Helmut Zepf specifies that the intervention must be stopped immediately and necessary medical measures must be taken accordingly. It is therefore crucial to assess the patient's allergic history before any surgical manipulation with this manual instrument.
What are the maintenance and sterilization precautions for this device?
As the Bone Scraper II is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, it is imperative to follow a rigorous protocol before the first use and for each subsequent use. The instrument must be fully cleaned, disinfected, and sterilized. The manufacturer emphasizes that it is very important to clean each product before use to remove any residue. Due to its design and the materials used, the reprocessing process must be carried out with care to maintain the integrity of the cutting edges. Any instrument showing signs of wear, such as cracks or cutting defects, must be removed from service. Compatibility with other products used during the intervention must also be verified beforehand by the healthcare professional.
Who is the manufacturer and what standards are met by this instrument?
The Bone Scraper II is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to the mentioned MDC0483 reference). The manufacturer complies with strict regulatory requirements for manual stainless steel dental instruments. As a Class I product, it meets the safety and performance standards required for non-invasive or surgically invasive medical devices for transient use. Traceability is ensured by the technical reference 47.957.20. This equipment is strictly reserved for healthcare professionals, ensuring that its application and maintenance are performed according to professional standards and instructions provided by Helmut Zepf.
State of the art
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Specifications
| Manufacturer | Helmut Zepf |
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