Broach Applicator - Helmut Zepf (47.950.02) - Delynov

What is the Helmut Zepf pin applicator?

The Helmut Zepf pin applicator, bearing reference 47.950.02, is a manual instrument specifically designed for oral surgery and osteosynthesis. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is made of medical stainless steel, a standard material for surgical instrumentation ensuring compatibility with cleaning and sterilization processes. As a Class I instrument, it is intended for strict professional use. Its structure is optimized for gripping and manipulating fixation pins, allowing the practitioner to perform technical movements with a control adapted to the requirements of the oral environment.

What are the clinical indications?

The intended use for this instrument is that of a manual dental instrument. In a clinical setting, this pin placement instrument is indicated for oral, maxillofacial, and implant surgery procedures where osteosynthesis is required. It is primarily used for the application of pins to stabilize bone fragments or maintain guided bone regeneration devices. Its use is reserved for qualified healthcare professionals trained in specific surgical techniques. The manufacturer specifies that the instrument must be checked before each use for any visible damage such as cracks or breaks to ensure operative safety.

What are the technical characteristics?

The Helmut Zepf pin applicator (ref. 47.950.02) is characterized by its high-quality medical stainless steel construction. Classified as a Class I medical device, it is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use and after each clinical cycle. The design of the instrument does not define a maximum limit for processing cycles, as the service life depends on actual wear and the absence of defects on the edges or structure. It is imperative to verify the compatibility of this applicator with other products and components of the osteosynthesis system used simultaneously during the surgical act.

What are the contraindications for use?

The main contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns the patient's known hypersensitivity or intolerance to metals, specifically medical stainless steel. An allergic reaction may be triggered upon contact with the instrument. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, the use of the instrument is formally contraindicated if visible damage, such as cracks, breaks, or defects on the active parts, is noted during the mandatory preoperative inspection.

What are the maintenance and reprocessing precautions?

As a non-absorbable and reusable instrument, the surgical pin applicator must follow a rigorous reprocessing cycle. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use. The manufacturer emphasizes the importance of cleaning each product before proceeding to final sterilization. Due to the materials used, there is no predetermined number of cycles, but the instrument must be discarded as soon as signs of wear or corrosion appear. Compliance with these safety and maintenance instructions is essential to maintain the integrity of the osteosynthesis instrument and ensure patient safety during contact phases.

Who is the manufacturer and what standards are respected?

The official manufacturer of this instrument is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to the MDC0483 mention associated with the MDR text). As a recognized manufacturer in the dental instrumentation sector, Helmut Zepf guarantees that its products meet the regulatory requirements for manual medical devices. The instrument is delivered non-sterile, in accordance with standards for reusable stainless steel instrumentation. Traceability and compliance are ensured by technical reference 47.950.02, allowing precise identification within the surgical arsenal of the office or clinic.

State of the art

Surgical medical consumables play a decisive role in operative safety.