Red Mark Osteotome - Helmut Zepf (47.945.38) - Delynov
The Ostéotome marque rouge, convexe, angulé, Ø 3,4 / 3,8 mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.945.38.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf red mark osteotome?
The red mark osteotome, referenced under code 47.945.38 by Helmut Zepf, is a precision manual instrument used in oral surgery. Manufactured from high-quality medical stainless steel, this device is distinguished by its convex tip and angled shaft. It features a double diameter of 3.4 mm and 3.8 mm, allowing for progressive adaptation during surgical maneuvers. As a Class I instrument, it meets safety requirements for non-invasive or short-term invasive devices, guaranteeing the robustness necessary for bone compaction procedures.
What are the clinical indications for this instrument?
This instrument is primarily indicated for implantology interventions requiring manipulation of bone density. The angled convex osteotome is used for implant site preparation, specifically for ridge expansion or crestal sinus lifting (Summers technique). Its convex tip is specifically designed to push and condense cancellous bone toward the apex and lateral walls, thereby improving the primary stability of the implant. The angulation of the shaft is a major asset for reaching posterior maxillary areas where access is limited by the mouth opening.
What are the technical characteristics of the 47.945.38 osteotome?
The Helmut Zepf osteotome presents rigorous technical specifications to meet the needs of implantologists. Its working part is of the convex type, which promotes compression rather than bone cutting. The diameter is calibrated at 3.4 / 3.8 mm, offering a precise transition during the osteogenic drilling sequence. The angled structure of the instrument allows for optimal axial force transmission even in difficult-to-access sectors. Designed in medical stainless steel, it is delivered non-sterile and must undergo a complete reprocessing protocol before each use in the practice.
What are the contraindications for the use of this osteotome?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity to metals. As the instrument is composed of medical stainless steel, contact with a patient presenting an intolerance can trigger an allergic reaction. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and necessary clinical measures must be taken. Additionally, use is strictly contraindicated with instruments showing visible damage, such as cracks, breaks, or defects on the edges, to avoid any risk of intraoperative complications.
What are the maintenance and sterilization precautions?
Like any reusable surgical instrument, this osteotome requires a strict maintenance protocol. Before the first use and after each intervention, the instrument must be cleaned, disinfected, and sterilized. The manufacturer emphasizes the importance of checking the surface condition to detect any wear or corrosion before use. Although there is no defined maximum limit for processing cycles due to the quality of the materials used, the longevity of the device depends on compliance with cleaning instructions. Helmut Zepf products must be inspected to ensure the absence of defects on the active parts before being introduced into the mouth.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This product belongs to the category of Class I surgical consumables according to medical device regulations. It is exclusively reserved for use by qualified healthcare professionals in dental surgery. Compliance with cleaning and sterilization protocols is imperative to maintain the instrument's conformity. Traceability is ensured by the technical reference 47.945.38, guaranteeing the German manufacturing origin and quality specific to the Helmut Zepf brand.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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