Universal CMF Box - Helmut Zepf (47.501.03) - Delynov

What is the Helmut Zepf universal CMF box (47.501.03)?

The universal CMF box, referenced under code 47.501.03 by the manufacturer Helmut Zepf Medizintechnik GmbH, is a Class I device intended for the organization of manual instrumentation. Designed in medical stainless steel, this cmf sterilization box allows for the grouping of tools necessary for cranio-maxillofacial surgery interventions. Its structure is designed to withstand repeated cleaning, disinfection, and sterilization cycles in hospital environments or specialized practices. As an instrument storage box, it ensures the protection of medical devices while facilitating their handling by healthcare personnel before and after the surgical act.

What are the clinical indications for this maxillofacial instrumentation box?

The intended use for this Helmut Zepf device is as a support for manual dental instruments. In clinical practice, this surgery sterilization cassette is indicated for organizing instruments used during oral, implant, or reconstructive surgery procedures. It serves as a secure receptacle during the pretreatment and sterilization phases. The manufacturer specifies that the use of these products is strictly reserved for qualified healthcare professionals. The box maintains the integrity of CMF surgery instruments, avoiding shocks between active parts and guaranteeing immediate availability of the complete set during complex surgical interventions.

What are the technical characteristics of this device?

This cmf instrumentation box is characterized by its manufacture in high-quality medical stainless steel, selected by Helmut Zepf for its resistance to cleaning agents and high autoclave temperatures. Reference code 47.501.03 corresponds to a universal format adapted to standard technical trays. Due to the robust design of the product and the materials used, there is no defined maximum limit for the number of processing cycles, provided that the physical integrity of the device is preserved. Users must imperatively check for the absence of visible damage, such as cracks or breaks, before each commissioning.

What are the contraindications for the use of this equipment?

The main contraindication mentioned by the manufacturer Helmut Zepf concerns patients with an intolerance or hypersensitivity to metals. Although the instrument is manufactured in medical stainless steel, contact can trigger an allergic reaction. If such a hypersensitivity reaction occurs during the procedure, the intervention must be immediately interrupted and the necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any use. Furthermore, it is strictly forbidden to use the product if it shows visible signs of wear, defects on the edges, or structural damage compromising its function or safety.

What are the sterilization and maintenance precautions?

All instruments contained in the cmf instrumentation cassette must be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. Helmut Zepf products are delivered non-sterile. The reprocessing process must be complete and rigorous to guarantee patient safety. It is imperative to clean each product before use to remove any residue. The manufacturer emphasizes the importance of checking compatibility with other products before processing. The absence of a fixed limit on sterilization cycles requires systematic visual inspection: any device showing cracks, breaks, or defects on the active parts must be removed from service.

Who is the manufacturer and what standards are respected?

The universal CMF box is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. Compliance with rigorous manufacturing protocols guarantees a product adapted to the requirements of maxillofacial surgery. As a Class I device, it meets the essential safety and performance requirements defined for manual dental instruments and their storage accessories. Traceability is ensured by technical reference 47.501.03, allowing precise monitoring within sterilization units and operating rooms.

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Surgical medical consumables play a decisive role in operative safety.