Universal PEEK Handpiece - Helmut Zepf (26.193.11) - 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: 26.193.11.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf universal PEEK handle?
The Helmut Zepf universal handle, referenced under code 26.193.11, is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. It is manufactured from PEEK (Polyetheretherketone), a high-performance technical polymer recognized for its lightness and chemical resistance. This device serves as an ergonomic support for various examination accessories. Unlike all-metal models, its PEEK structure offers a specific grip while maintaining the properties necessary for repeated use in demanding clinical environments. This product is part of the specialized instrumentation range for oral health professionals.
What are the clinical indications for this device?
The intended use for this Helmut Zepf device is that of a manual dental instrument. In clinical practice, it is primarily used as an autoclavable mirror handle to facilitate visual examination during oral surgery, periodontology, or implantology procedures. It allows the practitioner to attach mirror heads or other compatible instruments to access hard-to-reach areas of the oral cavity. Its role is central during pre-operative diagnostic and post-operative follow-up phases, ensuring precise handling of visual exploration tools.
What are the technical characteristics of this handle?
This universal handle is distinguished by the use of PEEK, a material that withstands frequent cleaning and sterilization cycles. Technical reference 26.193.11 corresponds to a universal attachment standard allowing interoperability with various accessories. Although the body of the instrument uses advanced polymers, it may include medical stainless steel elements to ensure the mechanical connection with the tips. It is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH and must imperatively undergo a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient.
What are the contraindications for use?
According to information from the manufacturer Helmut Zepf Medizintechnik GmbH, the main contraindication concerns hypersensitivity or metal intolerance. Although the body is made of PEEK, contact with medical stainless steel parts can trigger a hypersensitivity reaction in certain sensitive patients. If such a reaction occurs during the intervention, 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 damage such as cracks, breaks, or structural defects compromising its safety.
What are the maintenance and reprocessing precautions?
The Helmut Zepf universal handle is a reusable device that requires rigorous reprocessing. Before any use, the instrument must be cleaned, disinfected, and sterilized in accordance with the manufacturer's safety instructions. Due to its design and the materials used, there is no defined maximum limit for the number of treatment cycles, provided that the physical integrity of the product is preserved. The practitioner must check for the absence of wear or damage before each use. The use of damaged products is prohibited to guarantee patient safety and the effectiveness of the surgical act.
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 the specified nomenclature), meeting the regulatory requirements for non-invasive or invasive manual instruments for temporary use. The manufacturer emphasizes that these products are exclusively reserved for qualified healthcare professionals. Compliance with cleaning and sterilization protocols is essential to maintain the device's conformity during its use in the dental office or operating room.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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