Support for basket frame - Helmut Zepf (85.180.01) - Delynov

What is the Helmut Zepf basket frame support (85.180.01)?

The Helmut Zepf basket frame support, referenced under code 85.180.01, is a sterilization accessory designed to hold and organize instrumentation frames or baskets. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is specifically developed to meet equipment management requirements in dental surgery and implantology practices. It allows for an orderly arrangement of instruments, thus facilitating the cleaning, disinfection, and thermal sterilization steps. This support integrates into a rigorous asepsis chain, ensuring that devices remain correctly positioned during treatment in an autoclave or washer-disinfector.

What are the clinical indications for this accessory?

This sterilization basket support is indicated for the logistical organization of manual instruments used during various oral surgery, periodontology, or implantology procedures. Although it is not a cutting or direct insertion instrument, it is essential for the packaging of surgical kits. Its use is reserved for healthcare professionals trained in medical device reprocessing protocols. It allows for the structuring of technical trays before the operative act, thus ensuring immediate and secure availability of the instrumentation required by the practitioner and their assistant during clinical procedures.

What are the technical characteristics of this support?

The Helmut Zepf sterilization frame support is characterized by its robust construction in high-quality medical stainless steel. Its design is engineered to withstand repeated cycles of chemical cleaning and steam sterilization without structural degradation. Due to its nature as a holding accessory, it does not have any sharp or active parts, but its geometry allows for optimal circulation of sterilizing agents around the instruments it supports. The manufacturer specifies that the product design and the materials used do not allow for a maximum limit of treatment cycles to be defined, as long as the physical integrity of the support is preserved.

What are the contraindications for the use of this device?

The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity to metals. An intolerance reaction may occur in the patient if direct contact takes place with the instrument, as it is composed of medical stainless steel. If such a hypersensitivity reaction is triggered, the procedure must be stopped immediately and necessary clinical measures must be taken. Furthermore, it is strictly forbidden to use this support if it shows visible damage such as cracks, breaks, or structural deformations that could compromise the safety of the sterilization process or the handling of instruments.

What are the maintenance and reprocessing precautions?

Like any dental sterilization accessory, this support is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. It must imperatively be cleaned, disinfected, and sterilized before its first use, as well as after each subsequent use. The practitioner must check for the absence of damage and wear before each cycle. The reprocessing process must follow standard hospital or dental practice sterilization protocols. It is crucial to ensure the compatibility of this support with other products and baskets used in the decontamination chain. The use of damaged or worn products is strictly prohibited to guarantee aseptic safety.

Who is the manufacturer and what standards are respected?

This 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 (Class Ir according to the MDC0483 mention for reprocessing). The manufacturer complies with regulatory requirements relating to manual dental instruments. As a Class I device, it meets the safety and performance standards applicable to dental surgery accessories. Following the manufacturer's instructions regarding cleaning and sterilization is mandatory to maintain the compliance of the device throughout its operational life within the practice.

State of the art

Surgical medical consumables play a decisive role in operative safety.