Osteotomy Instrument - Helmut Zepf (47.940.60) - Delynov

What is the Helmut Zepf osteotomy instrument (47.940.60)?

The osteotomy instrument referenced 47.940.60 is a high-quality manual device manufactured by Helmut Zepf Medizintechnik GmbH. Designed specifically for oral surgery, this instrument is crafted from medical-grade stainless steel, ensuring compatibility with the rigorous sterilization protocols of dental practices. It belongs to the category of manual instruments (INSTRU) and is distinguished by its robust design adapted to the mechanical constraints of interventions on hard tissues. As a Class I device, it meets the basic regulatory requirements for non-invasive or reusable surgical instruments after reprocessing.

What are the clinical indications for this instrument?

This Helmut Zepf instrument is indicated for osteotomy and bone remodeling procedures within the framework of dental and implant surgery. Its intended use is as a manual dental instrument designed to assist the practitioner in cutting, modifying, or removing bone segments. It is particularly used during alveolar preparation phases or during corrective surgeries where precise manual manipulation is required. The use of this instrument is strictly reserved for qualified healthcare professionals mastering oral surgical techniques.

What are the technical characteristics of instrument 47.940.60?

The Helmut Zepf osteotomy instrument is characterized by its manufacture in medical stainless steel, a material chosen for its corrosion resistance and durability. Identified by the reference code 47.940.60, this device is delivered non-sterile and requires a complete reprocessing cycle before its first use. Its design allows for repeated cleaning, disinfection, and sterilization, although there is no defined maximum limit for treatment cycles. The manufacturer emphasizes the importance of checking for visible damage, such as cracks, breaks, or defects on the cutting edges, before each intervention.

What are the contraindications for the use of this device?

The main medical contraindication concerns patients with a known intolerance or hypersensitivity to metals. Contact with the medical stainless steel of the instrument can trigger a hypersensitivity reaction in these subjects. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary clinical measures must be taken. Furthermore, the use of the instrument is prohibited if it shows visible signs of wear, cracks, or defects in the sharp edges, in order to guarantee patient safety and the effectiveness of the surgical gesture.

What are the maintenance and reprocessing precautions?

Like any reusable surgical instrument from the Helmut Zepf brand, this device must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The reprocessing process is conditioned by the design of the instrument and the materials used. It is crucial to follow the manufacturer's safety instructions: never use damaged or worn products. Verification of compatibility with other products used simultaneously is also required. Although no cycle limit is set, functional wear must be systematically evaluated by the practitioner before each act.

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 is classified as a Class I medical device according to current regulations. The manufacturer ensures the instrument's compliance with quality standards for manual medical stainless steel devices. Healthcare professionals must refer to the instructions provided by Helmut Zepf to ensure usage in accordance with the requirements of the Medical Device Regulation (MDR), particularly regarding the cleaning and technical maintenance of surgical instrumentation.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.