Screwdriver long - Helmut Zepf (47.833.03)
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: 47.833.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf long screwdriver?
The long screwdriver referenced 47.833.03 is a manual precision instrument manufactured by Helmut Zepf Medizintechnik GmbH. Specifically designed for oral surgery, this tool is crafted from medical stainless steel, a standard material for surgical instrumentation ensuring resistance to sterilization processes. This device belongs to the category of guided bone regeneration (GBR) instruments and is distinguished by its length, allowing the practitioner to reach clinical areas that are sometimes difficult to access with standard instruments. It is delivered non-sterile and must undergo a cleaning and sterilization protocol before its first use as well as between each patient.
What are the clinical indications?
This Helmut Zepf long screwdriver is indicated for all dental and implant surgery procedures requiring the use of an elongated manual instrument. Its primary use concerns the manipulation of screws or prosthetic and implant components in complex surgical environments. It is particularly useful during guided bone regeneration (GBR) procedures or implant placement where the workspace is restricted or located deep within. As a manual instrument, it offers the surgeon direct tactile control during tightening or loosening, complementing the arsenal of rotary or dynamic instruments. Its use is strictly reserved for qualified healthcare professionals mastering the associated surgical techniques.
What are the technical characteristics?
The Helmut Zepf screwdriver (code 47.833.03) is a Class I medical device. Its major technical characteristic lies in its elongated shaft, optimized for visibility and access to surgical sites. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, it meets the durability requirements necessary for repeated reprocessing. The instrument is designed to be compatible with other devices in the range, although this compatibility must be verified by the practitioner before the procedure. Due to its metallic structure, it does not have a defined maximum limit of processing cycles, subject to a rigorous visual inspection before each use to detect possible structural defects or signs of wear.
What are the contraindications for use?
The main medical contraindication to the use of this Helmut Zepf instrument is the patient's known hypersensitivity or intolerance to metals, and specifically to medical stainless steel. A hypersensitivity reaction can be triggered during contact between the instrument and the tissues. If such a reaction occurs during the procedure, the manufacturer specifies that the procedure must be immediately stopped and necessary medical measures must be taken. Apart from this material-related contraindication, the use of the instrument is contraindicated if it shows visible damage such as cracks, breaks, or defects on the active parts, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the maintenance and reprocessing precautions?
The Helmut Zepf long screwdriver is delivered non-sterile. It is imperative to carry out complete cleaning, disinfection, and sterilization before the first use, as well as after each subsequent use. The manufacturer emphasizes the importance of cleaning each product before checking for the absence of visible damage and wear. It is formally discouraged to use a damaged or worn product (cracks, breaks). Being a non-resorbable and reusable instrument, its integrity depends on compliance with the recommended thermal or chemical reprocessing protocols for medical stainless steel. The practitioner must also verify the compatibility of the instrument with other devices used simultaneously during the surgical intervention.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This long screwdriver is classified as a Class I medical device according to current regulations. It complies with manufacturing standards for manual dental instruments made of stainless steel. In accordance with the manufacturer's guidelines, the product must be used exclusively by trained healthcare professionals. Although specific CE marking or full MDR details are not detailed beyond Class Ir (MDC0483), the instrument is designed to meet safety and performance requirements for its intended purpose in dental surgery, including traceability via its reference code 47.833.03.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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