Segment Plate - Helmut Zepf (12.300.17) - Delynov

What is the Helmut Zepf segment plate (12.300.17)?

The Helmut Zepf segment plate, referenced under code 12.300.17, is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. This device belongs to the category of instrumentation consumables for bone surgery. Manufactured from medical stainless steel, it is specifically structured to meet the requirements of oral surgical procedures. As a surgery segment plate, this tool is delivered non-sterile by the manufacturer and requires a complete cycle of cleaning, disinfection, and sterilization before its first use in the office or operating room. Its robust design makes it a reliable bone surgery accessory for demanding practitioners.

What are the clinical indications for this instrument?

This instrument is indicated as a manual dental instrument for various oral and implant surgery procedures. Specifically, this segment plate finds its utility in protocols requiring an osteosynthesis plate to stabilize bone segments or assist the practitioner during critical reconstruction phases. It is used by dental surgeons and implantologists to ensure precision of movement when handling hard tissues. Its use is strictly reserved for qualified healthcare professionals, guaranteeing an application compliant with current clinical standards in bone surgery.

What are the technical characteristics of the 12.300.17 plate?

The Helmut Zepf segment plate is distinguished by its manufacture in high-quality medical stainless steel, guaranteeing compatibility with repeated sterilization processes. Referenced 12.300.17, it is classified as a Class I device according to current regulations. Although specific dimensions are not detailed, its design is optimized for bone surgery instrumentation. The manufacturer specifies that due to the nature of the materials used, there is no defined maximum limit of processing cycles, provided that the visual integrity of the product is maintained. It is imperative to check for the absence of cracks, breaks, or defects on the edges before each use.

What are the contraindications for the use of this device?

The main medical contraindication documented by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Since the instrument is composed of medical stainless steel, contact with the patient can trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Additionally, use is contraindicated if the instrument shows visible damage such as cracks or excessive wear, as this could compromise patient safety and the effectiveness of the surgical gesture.

What are the maintenance and reprocessing precautions?

Like any non-sterile Class I instrument, this segment plate must imperatively follow a rigorous reprocessing protocol. Before the first use and after each intervention, the device must be cleaned, disinfected, and sterilized. The manufacturer Helmut Zepf emphasizes the importance of verifying compatibility with other products used simultaneously. Visual examination is crucial: any sign of corrosion, deformation, or breakage of the cutting edges must lead to the immediate disposal of the product. Although the number of cycles is not limited by a fixed value, the lifespan directly depends on the care taken during cleaning and sterilization.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This product complies with the regulations for Class I medical devices. Manufacturing respects the requirements for manual dental instruments, using medical stainless steel to ensure biological safety and the durability of the instrumentation. As the official manufacturer, Helmut Zepf provides precise instructions on cleaning and sterilization to ensure that the instrument retains its technical properties throughout professional uses. Traceability is ensured by the technical reference 12.300.17.

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Surgical medical consumables play a decisive role in operative safety.