Periotome P1 XL with handle - Helmut Zepf - Delynov
Product features
The Periotome P1 XL avec manche - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- 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 Periotome P1 XL with handle by Helmut Zepf?
The Periotome P1 XL with handle is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This medical device is manufactured from medical-grade stainless steel, ensuring robustness suited to the requirements of dental surgery. As a manual instrument, it is specifically developed for precision interventions. This product is delivered non-sterile by Helmut Zepf and requires a complete preparation protocol before any clinical use. Its medical stainless steel design makes it a durable tool, although its service life is not limited by a fixed number of processing cycles but depends on the physical condition of the instrument after each use.
What are the clinical indications for this instrument?
The Periotome P1 XL is indicated as a manual dental instrument for oral surgery procedures. Its use is strictly reserved for qualified healthcare professionals. It is primarily used within the framework of dental care requiring precise manipulation of tissues or dental structures. The manufacturer Helmut Zepf specifies that the instrument must be thoroughly inspected before each intervention to detect any visible damage or wear, such as cracks, breakages, or defects on the cutting edges. The use of this instrument is part of a standard surgical protocol where compatibility with other products used must be verified beforehand by the practitioner.
What are the technical characteristics of this device?
This medical device belongs to Class I according to current regulations. Technically, the Periotome P1 XL is distinguished by its manufacture in medical stainless steel, a material chosen for its resistance and its ability to undergo repeated cleaning and sterilization cycles. Being a manual instrument, it does not contain complex electronic or mechanical components. Its monobloc structure or integrated handle is designed to offer an ergonomic grip during surgical acts. The manufacturer emphasizes that, although the materials used are highly resistant, there is no defined maximum limit for processing cycles, the decision for reprocessing resting with the professional after examining the condition of the tool.
What are the contraindications for the use of the Periotome P1 XL?
The main contraindication related to the use of this medical stainless steel instrument concerns metal intolerance in the patient. Contact with the instrument may trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. Furthermore, it is formally contraindicated to use the product if it shows visible signs of wear, cracks, or defects on the sharp parts. The use of a damaged instrument compromises patient safety and the effectiveness of the surgical act.
What are the maintenance and sterilization precautions?
The Periotome P1 XL from Helmut Zepf is delivered non-sterile. It is imperative to clean, disinfect, and sterilize the instrument before its very first use, as well as before each subsequent use. The cleaning protocol must be complete to guarantee the elimination of all residues. Before each cycle, the professional must check for the absence of visible damage such as breakages or alterations of the cutting edges. Due to the specific design and materials used, the manufacturer does not define a maximum limit of processing cycles but recommends never using worn or defective products. Compliance with these safety instructions is crucial to maintain the integrity of the medical stainless steel.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I, meeting the regulatory requirements for manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used in the design of its tools. As a Class I device, it must be handled exclusively by trained healthcare professionals. Helmut Zepf insists on the practitioner's responsibility regarding the verification of product compatibility and strict compliance with reprocessing procedures (cleaning, disinfection, and sterilization) before any clinical application.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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