Universal PEEK Handpiece - Helmut Zepf (26.194.03) - 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: 26.194.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf PEEK universal handle?
The Helmut Zepf universal handle, bearing reference 26.194.03, is a manual dental instrument designed by Helmut Zepf Medizintechnik GmbH. This device is distinguished by the use of PEEK (Polyetheretherketone), a high-performance polymer used in the medical field. This handle serves as an ergonomic base for various inserts or instruments, allowing the practitioner to perform precise movements in oral surgery or periodontology. Unlike fully metallic handles, PEEK offers specific properties of lightness and chemical resistance, while maintaining compatibility with the rigorous sterilization protocols necessary in dental practices.
What are the clinical indications for this instrument?
The manufacturer Helmut Zepf indicates that this product is a manual dental instrument intended for professional use. In clinical practice, it is used during dental surgery, implantology, or conservative care procedures requiring the use of interchangeable instruments. Its primary role is to provide a stable and secure grip for the operator when applying controlled manual forces. It is suitable for interventions on the soft and hard tissues of the oral cavity, subject to prior verification of compatibility with other products and instruments used during the procedure.
What are the technical characteristics of this handle?
The Helmut Zepf handle (ref. 26.194.03) is a Class I device. Although the main body is made of PEEK, the manufacturer mentions the presence of medical stainless steel in the composition of its instruments, which guarantees indispensable mechanical robustness. The product is delivered non-sterile and requires a complete preparation cycle before its first use and between each patient. The handle design allows for repeated reprocessing, although no maximum cycle limit is defined by the manufacturer due to the variability of cleaning and sterilization methods. It is imperative to check for the absence of visible damage such as cracks or breaks before each use.
What are the contraindications for the use of this device?
The main contraindication mentioned by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Although the handle uses PEEK, contact with medical stainless steel parts can trigger an allergic reaction in certain sensitive patients. If a hypersensitivity reaction is observed during the procedure, the intervention must be immediately stopped and necessary medical measures must be taken. Furthermore, use is strictly reserved for qualified healthcare professionals. The use of an instrument showing signs of wear, defective cutting edges, or cracks is formally prohibited to guarantee patient safety.
What are the maintenance and sterilization precautions?
Like all Helmut Zepf products, this handle must undergo a strict cleaning, disinfection, and sterilization protocol before the first use and after each clinical act. The reprocessing process must be complete to eliminate any risk of cross-contamination. It is crucial to visually inspect the instrument to detect any structural defects or premature wear. The manufacturer emphasizes that compatibility with other products in the range or third-party systems must be verified beforehand by the practitioner. Compliance with the manufacturer's safety and usage instructions is essential to maintain the integrity of the PEEK material and metallic components.
Who is the manufacturer and what standards are respected?
This handle is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer follows strict quality protocols for the production of its manual instruments, using materials such as medical stainless steel and technical polymers like PEEK. The products comply with safety requirements for manual dental instruments, guaranteeing traceability and reliability adapted to the requirements of dental operating blocks. Each reference, such as 26.194.03, is subjected to rigorous controls before being placed on the market.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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