X-TOOL ELEV. SEPARATOR. - Helmut Zepf

What is the Helmut Zepf 17.008.90 elevation instrument?

The Helmut Zepf separator elevation instrument, referenced under code 17.008.90, is a manual device specifically developed for oral surgery. Manufactured from high-quality medical stainless steel, this instrument is designed to withstand mechanical stress during clinical interventions. It belongs to the category of manual dynamic instruments used by dental surgeons for the manipulation of tissues and dental structures. As a Helmut Zepf Medizintechnik GmbH product, it benefits from the expertise of a manufacturer recognized in the field of precision instrumentation. This device is delivered non-sterile and requires a complete preparation protocol before any use in the office or operating room.

What are the clinical indications for this elevator?

This instrument is indicated as a manual dental instrument for various oral surgery procedures. Its primary use lies in the elevation and separation of tissues or roots during the preparatory phases of an extraction or during implant surgeries. As a dental surgery elevator, it allows the practitioner to apply controlled force to release periodontal attachments or mobilize a root fragment. The use of this root elevator is exclusively reserved for qualified healthcare professionals, ensuring application in accordance with current clinical protocols. It is essential to check the condition of the instrument, particularly for the absence of cracks or defects on the cutting edges, before each intervention to ensure patient safety.

What are the technical characteristics of this instrument?

The Helmut Zepf 17.008.90 instrument is characterized by its manufacture in medical stainless steel, a standard material for surgical instrumentation ensuring compatibility with sterilization cycles. It is a Class I device according to medical device regulations. The technical reference 17.008.90 corresponds to a specific separator configuration, optimized for elevation. The manufacturer specifies that due to the product design and the materials used, there is no defined maximum limit for the number of reprocessing cycles, as long as the instrument does not show visible damage. Each product must be inspected for any wear, breakage, or defects on the active parts before use.

What are the contraindications for the use of this device?

The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity to metallic components. Metal intolerance in the patient can result from direct contact with the medical stainless steel instrument, potentially triggering a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, it is formally contraindicated to use the instrument if it shows visible damage such as cracks, breaks, or defects on the cutting edges, as this could compromise the safety of the surgical gesture and the integrity of the patient's tissues.

What are the maintenance and sterilization precautions?

All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use, as well as after each subsequent use. The reprocessing process must be complete to guarantee asepsis. Since the products are delivered non-sterile, it is the responsibility of the healthcare professional to validate compatibility with other products and to follow the manufacturer's safety instructions. Visual inspection is a crucial step: any instrument showing signs of wear or structural damage must never be reused. Although the number of achievable processing cycles is not limited by a fixed value, durability depends directly on compliance with cleaning protocols and careful handling of the stainless steel.

Who is the manufacturer and what standards are respected?

The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I, in accordance with regulatory requirements for manual dental instruments. The manufacturer ensures the traceability and quality of the medical stainless steel used for production. As a Class I device, it meets the safety and performance standards imposed for this category of non-invasive or temporary-use invasive surgical instruments. Compliance with cleaning, disinfection, and sterilization protocols is essential to maintain product compliance throughout its useful life in a clinical environment.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.