Root Elevator 4 mm - Helmut Zepf (17.001.12) - Delynov
The Élévateur à racines 4 mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 17.001.12.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 4 mm root elevator - Helmut Zepf?
The 4 mm root elevator, reference 17.001.12, is a manual instrument designed by Helmut Zepf Medizintechnik GmbH. It is manufactured from medical stainless steel, a standard material for surgical instrumentation ensuring compatibility with cleaning and sterilization processes. This tool is specifically structured for root luxation during simple or complex extraction procedures. As a Class I device, it meets the regulatory requirements for non-invasive or invasive instruments for temporary use, intended for use by qualified healthcare professionals in a clinical setting.
What are the clinical indications?
This instrument is indicated for exodontia surgery. Its primary role is the mobilization of dental roots through the application of controlled leverage forces. It is used to separate the root from its alveolar attachment by severing the periodontal ligaments. The use of this Helmut Zepf elevator is particularly relevant during preparation for an extraction or to remove fractured root fragments. It is integrated into the standard operative protocol for oral surgery and implantology where preserving the integrity of the alveolar bone plate is required before potential implant placement.
What are the technical characteristics?
The Helmut Zepf elevator (reference 17.001.12) features a working part with a width of 4 mm. This dimension is calibrated to allow effective insertion into the socket. The instrument is delivered non-sterile and must undergo a complete cycle of cleaning, disinfection, and sterilization before its first use, as well as between each patient. Its medical stainless steel design ensures the necessary resistance to the mechanical stresses of torsion and leverage exerted during the surgical act. The manufacturer specifies that the service life of the instrument depends on the absence of visible damage such as cracks or defects on the edges.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known patient hypersensitivity or intolerance to metals, specifically medical stainless steel. If a hypersensitivity reaction is triggered upon contact with the instrument, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, the use of the instrument is contraindicated if it shows visible signs of wear, cracks, breaks, or defects on the cutting edges, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the maintenance and reprocessing precautions?
Like any non-absorbable and reusable oral surgery instrument, this elevator requires a rigorous reprocessing protocol. Before each use, the practitioner must check the condition of the instrument to detect any trace of corrosion or deformation. Cleaning must be complete before sterilization. Helmut Zepf specifies that due to the product design and materials used, it is not possible to define a maximum limit of treatment cycles. Compatibility with other cleaning and disinfection products must be verified beforehand. It is imperative never to use a damaged instrument to guarantee operative safety.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer in the field of dental instrumentation ensures the compliance of this device with current regulations. The 4 mm root elevator is classified as a Class I medical device (Class Ir according to certain reprocessing nomenclatures). Compliance with cleaning, disinfection, and sterilization protocols is the responsibility of the healthcare professional, in accordance with the instructions provided by Helmut Zepf to ensure safe and prolonged use of the instrument within the dental office or surgical clinic.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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