CMFSystem screwdriver shaft - Helmut Zepf (47.524.12) - Delynov
The Arbre de tournevis CMFSystem- Helmut ZEPF is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.524.12.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the CMFSystem Helmut Zepf screwdriver shaft?
The CMFSystem screwdriver shaft, bearing reference 47.524.12, is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This device is manufactured from high-quality medical stainless steel, ensuring resistance adapted to the stresses of oral surgery. As part of the CMF system, this implantology screwdriver shaft serves as an interface between the practitioner's hand and the fixation screws or prosthetic components. Its monobloc design ensures precise and direct force transmission. This equipment is delivered non-sterile and requires a complete reprocessing protocol before each clinical use to guarantee patient safety.
What are the clinical indications for this instrument?
This implantology screwdriver tip is indicated for dental and maxillofacial surgery procedures requiring the manipulation of fixation devices. Its primary use concerns work on teeth or dental appliances during complex surgical treatments, such as guided bone regeneration (GBR) or the placement of retention systems. It allows the healthcare professional to act with precision on CMFSystem components. The instrument is strictly reserved for professional use by qualified practitioners in implantology or oral surgery, trained in the specific protocols of the manufacturer Helmut Zepf.
What are the technical characteristics of model 47.524.12?
The screwdriver shaft referenced 47.524.12 is distinguished by its medical stainless steel construction, a material chosen for its biocompatibility and durability through sterilization cycles. It belongs to Class I according to the classification of medical devices. The implantology screwdriver rod features an optimized geometry to fit perfectly with CMFSystem screw heads, thus preventing slipping or premature wear of the components. Although the manufacturer has not defined a maximum limit for treatment cycles, the instrument must undergo rigorous inspection before each use to detect possible visible damage such as cracks or defects on the coupling areas.
What are the contraindications for the use of this screwdriver shaft?
The main medical contraindication lies in the patient's known hypersensitivity or intolerance to metals, specifically medical stainless steel. A hypersensitivity reaction may be triggered upon contact with the instrument during the surgical procedure. If such a reaction occurs, the manufacturer Helmut Zepf stipulates that the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore imperative to check the patient's allergic history before any intervention. Furthermore, use of the instrument is contraindicated if it shows signs of wear, corrosion, or structural deformation.
What are the maintenance and sterilization precautions?
Like any non-sterile instrument from the Helmut Zepf brand, this implant screwdriver tip must imperatively be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. Cleaning must be complete to remove all biological residue. The practitioner must check for the absence of visible damage such as breaks or defects on the edges before proceeding with sterilization. Due to its design and the materials used, the number of reprocessing cycles is not fixedly limited but depends on the physical condition of the object. The use of damaged or worn products is formally prohibited to maintain the integrity of the surgical act.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with the regulatory requirements for Class I medical devices. The product is designed to meet the specific needs of dental surgeons regarding reliability and safety. Manufacturing protocols follow medical stainless steel standards to ensure optimal biological compatibility, subject to the absence of specific allergies in the patient. Each instrument is identified by a precise technical reference (47.524.12) allowing traceability within the dental office or hospital structure.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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