Long Screwdriver
The Tournevis long - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.833.05.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf long screwdriver?
The Helmut Zepf long screwdriver, referenced under code 47.833.05, is a manual instrument specifically designed for oral and implant surgery interventions. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this tool is intended for the precise handling of fixation components or abutments. Its elongated structure offers increased reach, essential for deep or difficult-to-access surgical sites. As a Class I device, it meets quality requirements for repeated use after a full sterilization cycle. This screwdriver is integrated into guided bone regeneration (GBR) protocols where component stability is paramount for treatment success.
What are the clinical indications?
The clinical indications for this Helmut Zepf long screwdriver primarily concern pre-implant and implant surgery procedures. It is indicated for the manual tightening or loosening of cover screws, healing abutments, or fixation screws for membranes and bone blocks within the framework of GBR procedures. Its length is a major asset during surgeries on patients with limited mouth opening or for intervening in posterior sectors. The use of this instrument is strictly reserved for qualified healthcare professionals, such as dental surgeons, implantologists, and stomatologists, guaranteeing handling in accordance with current clinical protocols.
What are the technical characteristics?
The Helmut Zepf screwdriver (47.833.05) is characterized by a robust medical stainless steel construction, guaranteeing corrosion resistance and durability during cleaning cycles. Its ergonomic design allows for a firm grip for optimal tactile control when applying tightening torque. Reference 47.833.05 corresponds to a long model, optimizing visibility and access to the operative field. This device is delivered non-sterile and must imperatively undergo a decontamination, cleaning, and sterilization protocol before its first use and after each subsequent use. Compatibility with other devices must be systematically verified by the practitioner before any intervention.
What are the contraindications for use?
The main medical contraindication for the use of this instrument is known hypersensitivity or intolerance of the patient to metals, and more particularly to the components of medical stainless steel. In the event of a hypersensitivity reaction triggered during contact with the instrument, the procedure must be immediately interrupted and necessary medical measures must be taken. Additionally, the use of the instrument is contraindicated if it shows visible damage such as cracks, breaks, or defects on the active parts. The use of worn or damaged products can compromise patient safety and the effectiveness of the surgical act, which is why a rigorous visual inspection is required before each intervention.
What are the maintenance and reprocessing precautions?
As a non-resorbable and reusable instrument, the Helmut Zepf screwdriver requires rigorous reprocessing. All instruments must be cleaned, disinfected, and sterilized before the first use and after each clinical cycle. The manufacturer specifies that due to the product design and the materials used, it is not possible to define a maximum limit of treatment cycles. However, the lifespan of the instrument depends on the absence of visible damage and wear. It is imperative never to use a screwdriver showing signs of structural fatigue. Strict compliance with cleaning and sterilization instructions guarantees not only septic safety but also the maintenance of the technical performance of the medical stainless steel over the long term.
Who is the manufacturer and what standards are respected?
The long screwdriver (47.833.05) is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer ensures the compliance of its products with safety and performance requirements, notably via the appropriate regulatory marking. Quality management by Helmut Zepf Medizintechnik GmbH guarantees that each instrument is produced according to high standards to meet the needs of dental surgeons. Professionals must refer to the manufacturer's instructions for reprocessing and verify the compatibility of instruments with each other, in accordance with MDC0483 directives to ensure safe and effective clinical practice.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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