Twisted drills for dental implantology and dental surgery - Helmut Zepf - Delynov
The Manche twister pour embouts d'implantologie et chirurgie dentaire - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf twister handle?
The twister handle for implantology and dental surgery tips from the Helmut Zepf brand is a manual instrument designed to accommodate interchangeable tips. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device belongs to the instrument category (INSTRU). It is specifically structured to offer a stable grip during complex surgical manipulations. This surgery twister handle is delivered non-sterile and requires a complete preparation protocol before any clinical use. Its stainless steel design ensures compatibility with repeated cleaning and sterilization cycles, although no maximum cycle limit is defined by the manufacturer due to the nature of the materials used.
What are the clinical indications?
This surgery tip holder handle is indicated as a manual dental instrument for oral surgery, implantology, and periodontology interventions. Its primary use is to serve as a support for technical tips required during various operative phases. As an implantology twister handle, it facilitates the screwing or manipulation of specific accessories within the oral cavity. It is exclusively reserved for qualified healthcare professionals. The practitioner must verify the compatibility of this handle with other products and tips before proceeding with the intervention. Its use is strictly limited to the purpose intended by the manufacturer Helmut Zepf, thus guaranteeing safety during manual procedures.
What are the technical characteristics?
The Helmut Zepf twister handle is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). It is entirely designed in medical stainless steel, a material chosen for its resistance to the stresses of dental surgery. This dental twister handle does not include an integrated needle, as it is a tool-holding instrument. Its structure allows for thorough cleaning, disinfection, and autoclave sterilization. Before each use, the professional must inspect the instrument for any visible damage such as cracks, breaks, or structural defects. The use of damaged or worn products is formally prohibited to ensure the integrity of care.
What are the contraindications for use?
The main documented medical contraindication for this twister handle is the patient's known hypersensitivity or intolerance to metals, particularly medical stainless steel. A hypersensitivity reaction may be triggered upon contact with the instrument. If such a reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken accordingly. Furthermore, the use of this instrument is contraindicated if it shows visible signs of wear, cracks, or defects on the edges, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the cleaning and reprocessing precautions?
As the product is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, it is imperative to perform complete cleaning, disinfection, and sterilization before the first use, as well as before each subsequent use. The reprocessing process must be rigorous to eliminate any biological residue. Due to the robust design and materials used, the manufacturer does not define a maximum limit for achievable processing cycles, but the instrument must be systematically inspected. Any sign of corrosion or mechanical degradation must lead to the immediate disposal of the device. Compliance with these maintenance instructions is essential to maintain the performance of this implantology tip holder.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This twister handle is a Class I medical device, compliant with the regulatory requirements in force for manual dental instruments. The manufacturer emphasizes that these products are reserved exclusively for healthcare professionals. Each instrument is subject to strict quality controls before being placed on the market. Although specific CE marking is not detailed in the source data, compliance with medical stainless steel manufacturing standards and directives relating to Class I devices ensures a high level of safety for the user and the patient.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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