Universal PEEK Handpiece - Helmut Zepf (26.193.19) - 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: 26.193.19.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf PEEK universal handle?
The PEEK universal handle, referenced under code 26.193.19 by the manufacturer Helmut Zepf Medizintechnik GmbH, is a manual instrument designed for dental and oral surgery practice. This device is distinguished by the use of PEEK (Polyetheretherketone), a high-performance polymer recognized for its mechanical properties and chemical resistance. This handle serves as an ergonomic base to receive different interchangeable tips or inserts, thus allowing increased versatility during clinical interventions. It belongs to the manual instrumentation category (INSTRU) and benefits from the German manufacturing rigor associated with the Helmut Zepf brand.
What are the clinical indications for this instrument?
This universal handle is indicated as a manual dental instrument for use during various oral, periodontal, or implant surgery procedures. As a support for active ends, it facilitates the practitioner's technical gestures, whether for probing, debridement, or tissue manipulation. Its use is strictly reserved for qualified healthcare professionals. The manufacturer Helmut Zepf specifies that the instrument must be used in accordance with its intended purpose as a manual device for the oral cavity. Its universal design allows it to adapt to several types of interventions depending on the inserts attached to it, thus optimizing the organization of the technical tray during complex surgeries.
What are the technical characteristics of the 26.193.19 handle?
The Helmut Zepf 26.193.19 handle is manufactured from PEEK, an advanced thermoplastic material. Although the main body is made of polymer, the device integrates medical stainless steel components to ensure the connection with the inserts. It is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use, as well as after each subsequent use. Due to its design and the materials used, there is no defined maximum limit of reprocessing cycles, although the user must check for the absence of visible damage such as cracks or defects before each intervention.
What are the contraindications for the use of this device?
The major contraindications mainly concern hypersensitivity reactions. Although the body is made of PEEK, contact with medical stainless steel parts can cause metal intolerance in certain sensitive patients. If an allergic reaction or hypersensitivity is triggered during the surgical act, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use the instrument if it shows visible signs of wear, breaks, or defective cutting edges, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the maintenance and reprocessing precautions?
The reprocessing of this Helmut Zepf instrument follows a strict protocol: cleaning, disinfection, and sterilization. Before any use, compatibility with other products and inserts must be verified. It is crucial to visually inspect the handle to detect any trace of corrosion, crack, or deformation. The products are delivered non-sterile by Helmut Zepf Medizintechnik GmbH and require rigorous preparation beforehand. The manufacturer emphasizes that no maximum number of cycles is predetermined, the end of the product's life being dictated by the appearance of damage or wear. Thorough cleaning before each sterilization is essential to guarantee asepsis and the longevity of the device.
Who is the manufacturer and what standards are respected?
The PEEK universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (Class Ir according to reprocessing mentions). The manufacturer complies with regulatory requirements for manual dental instruments. As a Class I device, it meets the safety and performance standards applicable to reusable instruments. Helmut Zepf's expertise in the field of dental instrumentation guarantees a product that meets the expectations of dental surgeons and implantologists in terms of manufacturing quality and clinical safety, subject to strict compliance with the instructions for use and sterilization.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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