Osteotomy instrument - Helmut Zepf (47.945.28) - Delynov
The Ostéotome convexe, angulé, Ø 2.3 / 2,8 mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.945.28.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf angled convex osteotome?
The angled convex osteotome (reference 47.945.28) is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. Manufactured from medical stainless steel, this tool features a convex working end with diameters of 2.3 mm and 2.8 mm. Its angled structure is specifically designed to allow the practitioner to access posterior areas of the oral cavity with improved ergonomics. As a Class I instrument, it meets the quality requirements for reusable surgical devices, requiring a full cleaning and sterilization cycle before each procedure.
What are the clinical indications for this instrument?
This osteotome is primarily indicated for implantology material procedures requiring meticulous bone preparation. Its convex tip is suitable for condensing cancellous bone and controlled expansion of the alveolar ridge. In pre-implant surgery, it is frequently used for crestal approach sinus lift techniques (Summers technique), where the convex shape helps push back the sinus membrane without risk of direct perforation. The angulation of the handle facilitates the positioning of the instrument in the posterior maxillary sectors, thus optimizing force transmission during manual impaction.
What are the technical characteristics of the 47.945.28 osteotome?
The Helmut Zepf instrument is distinguished by a dual diameter graduation, moving from 2.3 mm to 2.8 mm, allowing for sequential progression during osteotomy. Manufactured from medical stainless steel, it offers high resistance to corrosion and repeated sterilization cycles. Its angled geometry is a major asset for clinical visibility and access. It is delivered non-sterile and must undergo a complete reprocessing protocol (cleaning, disinfection, and sterilization) before the first use and after each subsequent use to ensure the safety of the patient and healthcare staff.
What are the contraindications for the use of this osteotome?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity to metals. As the instrument is composed of medical stainless steel, an allergic reaction or intolerance in the patient may occur upon contact. If a hypersensitivity reaction is triggered during the procedure, the intervention must be stopped immediately and necessary medical measures must be taken. Furthermore, 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 clinical safety.
What are the maintenance and sterilization precautions?
Like any Class I surgical instrument, this osteotome requires rigorous maintenance. Before the first use, and after each intervention, it must be cleaned, disinfected, and sterilized. The manufacturer emphasizes the crucial importance of checking the condition of the instrument before use: any sign of wear, cracks, or deformation must lead to its immediate disposal. Although there is no defined maximum limit for the number of processing cycles due to the robustness of the materials used, the user must evaluate the functionality of the instrument after each sterilization cycle to ensure it retains its cutting and condensation properties.
Who is the manufacturer and what standards are met?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer guarantees the use of materials complying with medical standards, notably high-quality stainless steel. Helmut Zepf products are delivered non-sterile and their use is strictly reserved for healthcare professionals qualified in dental and implant surgery. Compliance with reprocessing protocols and verification of compatibility with other instruments used are essential to maintain the conformity and performance of the device.
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Specifications
| Manufacturer | Helmut Zepf |
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