Tunneling Knife for Surgery - Helmut Zepf (24.751.523M) - Delynov
The Couteau à tunnelisation pour chirurgie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.751.523M.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf tunneling knife?
The surgery tunneling knife, referenced under code 24.751.523M by Helmut Zepf, is a high-tech dental micro-surgery instrument. Manufactured from medical stainless steel, this manual tool is specifically designed for delicate interventions on soft tissues in periodontology and implantology. It belongs to the category of Class I surgical consumables. Its structure is optimized to allow rigorous handling during the creation of sub-mucosal tunnels, thus avoiding external vertical incisions and promoting a minimally invasive approach for the patient.
What are the clinical indications for this instrument?
This instrument is indicated for all periodontal plastic surgery procedures requiring a tunneling technique. It is primarily used for the treatment of gingival recessions, allowing the preparation of the recipient site for a connective tissue graft without compromising the vascularization of the overlying tissues. Its use also extends to pre-implant surgery for the management of soft tissue thickness. As a dental tunneling knife, it allows the practitioner to detach the flap in a selective and controlled manner, ensuring adequate preparation of the graft bed while respecting the integrity of the interdental papillae.
What are the technical characteristics of reference 24.751.523M?
The Helmut Zepf tunneling knife is distinguished by its medical stainless steel design, guaranteeing the necessary resistance to cleaning and sterilization cycles. Although delivered non-sterile by Helmut Zepf Medizintechnik GmbH, the instrument is designed to withstand complete reprocessing (cleaning, disinfection, and sterilization) before each use. Its specific geometry is adapted to periodontal anatomy, allowing access to narrow areas with great ease. Due to its manufacture in medical steel, it is imperative to check for the absence of visible damage, such as cracks or defects on the cutting edges, before any surgical intervention.
What are the contraindications for the use of this knife?
The main medical contraindication identified for the use of this medical stainless steel instrument is hypersensitivity or intolerance to metals in the patient. An allergic reaction may occur during direct contact between the instrument and oral tissues. If such a hypersensitivity reaction is triggered during the operative act, the procedure must be immediately stopped and the necessary clinical measures must be taken. It is therefore recommended to validate the absence of known metal allergies during the preoperative anamnesis. Additionally, the use of the instrument is strictly reserved for qualified healthcare professionals.
What are the maintenance and reprocessing precautions?
Like any non-sterile dental micro-surgery instrument, this knife must imperatively be cleaned, disinfected, and sterilized before its first use and after each subsequent use. The manufacturer Helmut Zepf specifies that there is no defined maximum limit for treatment cycles due to the robustness of the materials used, but the user must systematically inspect the tool to detect any wear or corrosion. The use of a damaged instrument, presenting breaks or blunt edges, is prohibited. Compatibility with other cleaning and disinfection products must also be verified by the professional to maintain the integrity of the stainless steel.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The product is classified as a Class I manual instrument according to current regulations. It meets the strict quality requirements imposed by the manufacturer for stainless steel medical devices. Traceability is ensured by the technical reference 24.751.523M. As a Class Ir instrument (according to the raw MDR text), it is subject to rigorous cleaning and sterilization protocols, guaranteeing the safety of the patient and the practitioner during oral surgical interventions.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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