Osteotomy Insert - Helmut Zepf (47.961.38) - Delynov

What is the Helmut Zepf 47.961.38 osteotomy insert?

The osteotomy insert referenced 47.961.38 is a manual instrument developed by Helmut Zepf Medizintechnik GmbH. This Class I medical device is manufactured from medical-grade stainless steel, specifically selected to meet the requirements of surgical environments. As a manual instrument, it is intended to be handled directly by the practitioner during bone preparation phases. This product is delivered non-sterile by the manufacturer and requires complete processing before its first use, including cleaning, disinfection, and sterilization.

What are the clinical indications for this instrument?

This Helmut Zepf osteotomy insert is indicated for dental and oral surgery interventions requiring manual action on hard tissues. Its primary use concerns osteotomy procedures, where the surgeon must section or reshape the alveolar bone. It is particularly relevant in implant or pre-implant surgery protocols. The instrument must be used exclusively by qualified healthcare professionals capable of assessing the compatibility of the device with other products used during the surgical act.

What are the technical characteristics of the 47.961.38 insert?

The Helmut Zepf osteotomy insert is characterized by its manufacture in medical stainless steel, guaranteeing resistance adapted to the mechanical stresses of bone surgery. Identified under technical reference 47.961.38, this device belongs to Class I according to medical device regulations. Its design does not define a maximum limit for processing cycles, as the service life depends on visible wear and potential damage. The practitioner must imperatively check for the absence of cracks, breaks, or defects on the cutting edges before each intervention.

What are the contraindications for the use of this insert?

The main contraindication related to the use of this medical stainless steel insert is known hypersensitivity or intolerance of the patient to metals. A hypersensitivity reaction can be triggered during contact between the instrument and the tissues. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be applied. It is therefore crucial to assess the patient's allergic history before any use of this Helmut Zepf manual instrument.

What are the maintenance and reprocessing precautions?

As the instrument is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, a strict reprocessing protocol is mandatory. Before the first use and after each subsequent use, the insert must be cleaned, disinfected, and sterilized. The manufacturer emphasizes the importance of visually checking the condition of the instrument to detect any signs of wear, such as cracks or dull edges. The use of damaged or worn products is strictly prohibited to ensure patient safety and the effectiveness of the surgical gesture. Due to its design, the number of achievable sterilization cycles is not predetermined.

Who is the manufacturer and what standards are respected?

The osteotomy insert is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I, in accordance with the regulatory requirements in force for manual dental instruments. Compliance with cleaning and sterilization protocols is essential to maintain the product's conformity during its clinical use. The manufacturer specifies that this equipment is strictly reserved for trained healthcare professionals, thus guaranteeing an application consistent with scientific data and the provided safety instructions.

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