Universal PEEK Handle - Helmut Zepf (26.194.01) - Delynov
The Manche universel en PEEK - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf universal PEEK handle?
The universal PEEK (polyetheretherketone) handle, referenced under code 26.194.01 by Helmut Zepf Medizintechnik GmbH, is a manual instrument designed for dental surgery. This device is distinguished by the use of PEEK, a high-performance polymer used for its mechanical properties and compatibility with sterilization processes. It serves as an ergonomic base for the use of interchangeable inserts, allowing practitioners to modulate their instrumentation according to the specific needs of each oral or implant surgery intervention.
What are the clinical indications?
This universal handle is indicated as a manual dental instrument for various clinical procedures. Its use is primarily intended for the manipulation and guiding of surgical inserts during periodontology, implantology, or general oral surgery care. As a manual instrument, it allows the surgeon to exercise direct tactile control during diagnostic or treatment phases. The manufacturer Helmut Zepf specifies that this device is exclusively reserved for use by qualified healthcare professionals in a controlled clinical environment.
What are the technical characteristics?
The Helmut Zepf handle (ref. 26.194.01) is designed to be compatible with a range of dental instruments. Although the main body is made of PEEK, the instrument contains medical stainless steel, ensuring the robustness necessary for mechanical stresses. It is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use, as well as between each patient. Its design allows it to withstand several thermal treatment cycles without immediate alteration of its functions, although the user must check for the absence of cracks or defects before each use.
What are the contraindications for use?
The main contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Although the handle uses PEEK, the presence of medical stainless steel can trigger allergic reactions in some patients. In case of a hypersensitivity reaction during the intervention, the procedure must be immediately interrupted and appropriate medical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible damage such as breaks, cracks, or defects on the junction areas.
What are the maintenance and reprocessing precautions?
Like any reusable Class I instrument, this handle requires a rigorous reprocessing protocol. Before any use, it must be cleaned, disinfected, and sterilized according to current standards. The manufacturer emphasizes the importance of checking compatibility with other products and instruments used simultaneously. Due to its design and the materials used, there is no defined maximum limit of sterilization cycles, but the product's lifespan depends on the absence of visible wear. Any worn or damaged instrument must be immediately discarded to guarantee patient safety and the effectiveness of the surgical gesture.
Who is the manufacturer and what standards are met?
The universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to certain reprocessing nomenclatures). It meets the regulatory requirements relating to manual dental instruments. Compliance with cleaning and sterilization protocols is essential to maintain product conformity during its clinical use. Professionals must refer to the manufacturer's instructions to ensure use in accordance with health safety standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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