Osteotomy Instrument - Helmut Zepf (47.942.33) - Delynov

What is the Helmut Zepf (47.942.33) osteotomy instrument?

The osteotomy instrument referenced under code 47.942.33 is a manual dental instrument developed by Helmut Zepf Medizintechnik GmbH. It is manufactured from medical-grade stainless steel, a standard material for surgical instrumentation ensuring the necessary resistance to mechanical stress. This device belongs to the INSTRU category and is specifically designed for bone manipulation during oral surgery procedures. As a manual instrument, it offers the practitioner direct control during use on hard tissues.

What are the clinical indications for this instrument?

The intended use for this Helmut Zepf device is that of a manual dental instrument. It is indicated for osteotomy procedures, meaning the surgical sectioning or modification of bone tissues in the oral cavity. Dental surgeons and implantologists use this tool during procedures requiring precise preparation of the bone site, whether for complex extractions, alveolar ridge regularizations, or specific steps in implant surgery. Its use is strictly reserved for qualified healthcare professionals.

What are the technical characteristics of this instrument?

This osteotomy instrument, bearing reference 47.942.33, is designed by the manufacturer Helmut Zepf Medizintechnik GmbH. Its structure is entirely made of medical stainless steel. It is a non-sterile device upon delivery, requiring a complete reprocessing protocol before each use. Due to its design and the materials used, the manufacturer states that there is no defined maximum limit for the number of treatment cycles, although the instrument must be inspected for any visible damage or wear before use.

What are the contraindications for the use of this device?

The main contraindication mentioned by the manufacturer concerns metal intolerance or hypersensitivity. Contact with the medical stainless steel of the instrument can trigger a reaction in sensitive patients. If such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible damage such as cracks, breaks, or defects on the cutting edges.

What are the maintenance and sterilization precautions?

All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. The reprocessing process must be complete to ensure the safety of the patient and the practitioner. Before each use, it is crucial to check the condition of the instrument to identify any signs of wear or corrosion. The use of damaged or worn products is prohibited. Compatibility with other instruments used during the procedure must also be verified beforehand.

Who is the manufacturer and what standards are met?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This product is classified as a Class I medical device according to current regulations. It meets the safety and performance requirements for manual dental instruments. The manufacturer emphasizes the importance of following the provided instructions for use and safety to maintain the integrity of the medical stainless steel and ensure the proper functioning of the instrument during repeated treatment cycles.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.