Dental Surgery Support - Helmut Zepf (12.300.80)
The Support - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 12.300.80.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf support (12.300.80)?
The support referenced 12.300.80 is a device designed by Helmut Zepf Medizintechnik GmbH for the organization of manual instruments. Manufactured from medical stainless steel, this component is intended to hold instruments during reprocessing steps. This product is part of a rigorous technical tray management logic in oral and implant surgery. Its metallic structure allows it to withstand the thermal and chemical stresses associated with repeated cleaning and disinfection cycles in the dental office. It is delivered non-sterile and requires complete processing before its first use, in accordance with hospital hygiene and sterilization protocols.
What are the clinical indications?
The intended use for this Helmut Zepf device is that of a manual dental instrument. It is indicated for the support and positioning of surgical instruments during decontamination and sterilization phases. Its use facilitates the organization of examination or surgery kits, thus allowing safe handling of sharp or delicate instruments by healthcare personnel. Although the support itself is not a cutting or direct gripping tool on the patient, it is an essential link in the sterilization chain, ensuring that instruments remain correctly arranged for optimal exposure to sterilizing agents.
What are the technical characteristics?
The Helmut Zepf support (code 12.300.80) is manufactured from high-quality medical stainless steel. This composition ensures resistance to steam sterilization cycles. As a Class I device, it meets the design requirements for reusable instruments. Its design allows for the fluid circulation of cleaning liquids and steam, avoiding contaminant retention areas. It is important to check for the absence of visible damage, such as cracks or deformations, before each cycle. Compatibility with other products in the Helmut Zepf range and the dimensions of the sterilization cassettes must be verified beforehand by the professional.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. If a patient presents an allergic reaction or hypersensitivity upon contact with the medical stainless steel instrument, the procedure must be immediately interrupted and necessary clinical measures must be taken. Furthermore, the use of this support is strictly reserved for qualified healthcare professionals. The use of damaged products, showing signs of wear, breakage, or structural defects is formally prohibited to guarantee the safety of the patient and the practitioner.
What are the maintenance and sterilization precautions?
Helmut Zepf products are delivered non-sterile. It is imperative to perform complete cleaning, disinfection, and sterilization before the first use and after each subsequent use. Reprocessing does not have a defined maximum limit of cycles, as this depends on the design, materials, and intended use. However, a rigorous visual examination is required to detect any corrosion or metal fatigue. Failure to comply with cleaning protocols can compromise final sterility. It is recommended to follow the validated cycle parameters for medical stainless steel to preserve the structural integrity of the support over the long term.
Who is the manufacturer and what standards are respected?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I medical device (Class Ir according to MDC0483). The manufacturer complies with regulatory requirements for manual dental instruments. As a recognized manufacturer, Helmut Zepf ensures the traceability and quality of the materials used, particularly medical stainless steel. Professionals must ensure that the product is used in accordance with the manufacturer's instructions and that associated devices, such as autoclaves or disinfection solutions, are compatible with the technical specifications of the 12.300.80 support.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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