Universal PEEK Handle - Helmut Zepf (26.193.13) - 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: 26.193.13.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf universal PEEK handle?
The Helmut Zepf universal handle (reference 26.193.13) is an ergonomic support designed to accommodate various manual dental instruments. Its main structure uses PEEK (polyetheretherketone), a high-performance technical polymer recognized in the medical field for its mechanical strength and stability during sterilization cycles. This device, manufactured by Helmut Zepf Medizintechnik GmbH, allows practitioners to modulate their oral surgery tools according to clinical needs while maintaining a consistent and lightweight grip.
What are the clinical indications for this handle?
This device is indicated as a manual dental instrument for use during various procedures in dental, periodontal, or implant surgery. It serves as a handling base for compatible active ends. Its use is strictly reserved for qualified healthcare professionals. It allows for precise clinical movements in the mouth, depending on the insert attached to it, thus facilitating diagnostic or surgical treatment interventions.
What are the technical characteristics of this device?
The Helmut Zepf handle reference 26.193.13 is distinguished by its composition integrating PEEK, offering a lightweight alternative to traditional handles while guaranteeing the robustness required for the constraints of surgery. Although the body is made of polymer, contact with the metal parts of the instrument (medical stainless steel) must be taken into account. It is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before the first use and between each patient.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Although the handle uses PEEK, the complete instrument contains medical stainless steel. If a hypersensitivity reaction is triggered in the patient upon contact, the procedure must be immediately interrupted and appropriate medical measures taken. It is also prohibited to use the product if it shows visible damage such as cracks, breaks, or defects on the fixation areas.
What are the maintenance and reprocessing precautions?
As the handle is a reusable device, it requires a rigorous reprocessing protocol. Before any use, the practitioner must check for the absence of wear or damage. Due to its design and the materials used, there is no defined maximum limit for treatment cycles, but compatibility with other cleaning and sterilization products must be verified beforehand. Any damaged or worn product must never be used to ensure patient safety and the effectiveness of the surgical procedure.
Who is the manufacturer and what standards are respected?
This universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I medical device (Class Ir according to certain reprocessing specifications). In accordance with regulations, the manufacturer requires cleaning and sterilization before any commissioning. Compliance with the safety and use instructions provided by Helmut Zepf is essential to maintain the device's conformity during professional dental surgery interventions.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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