Periotome P1 XL with handle - Helmut Zepf - Delynov
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.
What is the P1 XL periotome with handle?
The P1 XL periotome with handle is a precision manual instrument developed by Helmut Zepf Medizintechnik GmbH. It belongs to the category of dental surgery instruments and consists of a handle integrated with a thin working part. Its structure is entirely made of medical stainless steel, a standard material for surgical instrumentation ensuring the necessary rigidity during syndesmotomy maneuvers. This device is specifically designed for the purchase of periotomes by healthcare professionals demanding robust tools for initial luxation. As a Class I instrument, it meets the manufacturing requirements for non-invasive or invasive medical devices for temporary use.
What are the clinical indications for the P1 XL periotome?
The P1 XL periotome is indicated for performing syndesmotomy during oral and implant surgeries. Its primary role is to section the fibers of the periodontal ligament (desmodontium) within the alveolar space. This step is crucial before an extraction to minimize mechanical resistance and preserve the integrity of the alveolar bone walls, particularly within the framework of immediate implantation protocols. This manual periotome is used by dental surgeons to separate the marginal gingiva and deepen the passage along the root. Its XL version allows for reaching deeper areas or intervening on long roots with optimized visibility.
What are the technical characteristics of this instrument?
The P1 XL Helmut Zepf periotome is distinguished by its monobloc or assembled design with an ergonomic handle favoring the transmission of axial force. Manufactured by Helmut Zepf Medizintechnik GmbH in Germany, it is designed in high-quality medical stainless steel. The tip is sharpened to allow atraumatic insertion into the narrow ligament space. Unlike classic elevators, the periotome has a thinner blade that is not intended for prying with excessive force, but for cutting attachments. The instrument is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use in the office or operating room.
What are the contraindications for the use of this device?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns patients with known hypersensitivity or intolerance to metals, specifically to the components of medical stainless steel. In the event of an allergic reaction or hypersensitivity triggered during contact with the instrument, the surgical procedure must be immediately interrupted and necessary clinical measures must be taken. Additionally, the use of the instrument is contraindicated if it shows visible damage such as cracks, breaks, or defects on the cutting edges, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the maintenance and reprocessing precautions?
Like any reusable Class I instrument, the P1 XL periotome requires a rigorous reprocessing protocol. Before each use, the practitioner must check for the absence of wear or deformation. Cleaning, disinfection, and sterilization must be carried out in accordance with the manufacturer's safety instructions. Helmut Zepf specifies that due to the design and materials used, there is no defined maximum limit of treatment cycles, as long as the instrument does not show signs of degradation. It is imperative to clean each product before exposing it to the heat of the autoclave to avoid the fixation of organic residues on the stainless steel.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This manufacturer is recognized for its expertise in high-tech dental instrumentation. The P1 XL periotome is a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It complies with the regulatory requirements applicable to manual dental instruments. The manufacturer emphasizes that the use of these products is strictly reserved for qualified healthcare professionals. Traceability and compliance with safety standards are ensured by the rigorous manufacturing processes of Helmut Zepf, guaranteeing a reliable tool for the daily practice of dental surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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