MINI-LEXER CHISEL-BURIN 10 MM, 18 CM, GRADUATION IN MM (41.550.10) - Hemut ZEPF - Delynov
The MINI-LEXER CISEAU-BURIN 10 MM, 18 CM, GRADUATION EN MM- Hemut ZEPF is a medical device manufactured by le fabricant.
- Compliance: Medical device Class I.
- Manufacturer: le fabricant.
- Reference: 41.550.10.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 10mm mini-lexer chisel-gouge?
The 10mm mini-lexer chisel-gouge from the brand Helmut Zepf is a manual surgical instrument designed specifically for bone work. Manufactured from high-quality medical stainless steel, this device from the brand is distinguished by its robustness and its ability to transmit impact energy axially. Its structure includes a reinforced proximal end to receive hammer blows and a distal end equipped with a 10mm wide cutting edge. This instrument is classified as a Class I medical device, guaranteeing its compliance with basic regulatory requirements for non-invasive or short-term invasive manual instrumentation.
What are the clinical indications for the dental chisel-gouge?
This dental chisel-gouge is indicated for all oral surgery procedures requiring modification of the bone structure. Its main use lies in osteotomy, where it serves to cut or shape the alveolar bone. In clinical practice, this manual dental osteotome is called upon to create access, regularize ridges, or split bone segments. The application of force via a surgical hammer allows for a clean and controlled cut. It is particularly useful in the preparation phases of implant sites or during corrective surgeries where the precision of the 10mm cutting edge is required to respect the surrounding anatomy.
What are the technical characteristics of this instrument?
The device referenced under code 41.550.10 presents rigorous technical specifications. It has a total length of 18cm, offering an optimized lever arm and grip for the surgeon. The working part has a width of 10mm, adapted to the bone volumes encountered in the maxillofacial area. A major feature is the presence of a mm graduation engraved on the blade, allowing the practitioner to measure the depth of penetration into the bone tissue in real time. Designed by the manufacturer Helmut Zepf, this stainless steel instrument is delivered non-sterile and requires a complete protocol of cleaning, disinfection, and sterilization before each use.
What are the contraindications for the use of this manual osteotome?
The main medical contraindication to the use of this instrument is known hypersensitivity or intolerance of the patient to metals, specifically to medical stainless steel. A hypersensitivity reaction can be triggered upon contact between the instrument and the tissues. The manufacturer specifies that if such a reaction occurs during the intervention, the procedure must be immediately stopped and the necessary clinical measures must be taken. Furthermore, the use of this instrument is strictly reserved for qualified health professionals. It must never be used if visible damage, such as cracks, breaks, or defects on the cutting edges, are detected during the preoperative inspection.
What are the maintenance and reprocessing precautions?
As a reusable stainless steel instrument, the chisel-gouge from the brand must undergo a complete reprocessing cycle. Before the first use and after each intervention, it must be cleaned, disinfected, and sterilized. Visual inspection is crucial: any sign of wear or corrosion on the 10mm cutting edge compromises patient safety and the effectiveness of the surgical gesture. Although there is no defined maximum limit of treatment cycles due to the quality of the materials, the longevity of the tool depends on strict compliance with cleaning protocols. It is imperative never to use a blunt or damaged instrument to guarantee the precision of the osteotomy.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik Gmbh, a recognized company located in Seitingen-Oberflacht, Germany. This product belongs to the CONSO category and is registered as a Class I medical device. The manufacturer ensures the traceability and quality of the medical stainless steel used for the manufacture of this 18cm chisel-gouge. Professionals can obtain this material via Delynov, ensuring compliance with the instructions for use provided by the manufacturer. The design meets the safety and performance requirements for manual surgical instruments intended to be struck, guaranteeing efficient energy transmission to the graduated distal end.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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