Tunneling Decollator Helmut Zepf (46.040.02) - Delynov
The Décolleur de Tunnelisation Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.040.02.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf tunneling elevator?
The Helmut Zepf tunneling elevator, referenced under code 46.040.02, is a manual dental instrument specifically designed for microsurgical interventions. Manufactured from high-quality medical stainless steel, this tool belongs to the Class I instrument category. Its structure is optimized to allow precise manipulation of periodontal soft tissues without compromising their vitality. As a product from the manufacturer Helmut Zepf Medizintechnik GmbH, it meets the rigorous requirements of German manufacturing for surgical instrumentation.
What are the clinical indications?
This instrument is primarily indicated for the tunneling technique in periodontology and implant surgery. It is used by practitioners to prepare the recipient site before a connective tissue graft, allowing the insertion of the graft into a protective envelope. The dental tunneling elevator is essential for lifting the periosteum and creating sufficient space for the graft material while maintaining optimal vascularization. Its use is strictly reserved for qualified healthcare professionals mastering periodontal plastic surgery protocols.
What are the technical characteristics of this device?
Model 46.040.02 is distinguished by its medical stainless steel composition, ensuring the necessary resistance to repeated sterilization cycles. Unlike single-use devices, its robust design allows for prolonged use provided there is adequate maintenance. The manufacturer Helmut Zepf specifies that due to the product design and materials used, there is no defined maximum limit for the number of feasible processing cycles, as long as the instrument shows no visible damage. It is delivered non-sterile and requires complete preparation before each intervention.
What are the contraindications for use?
The main medical contraindication lies in the patient's known hypersensitivity or intolerance to metals, particularly to the components of medical stainless steel. A hypersensitivity reaction may be triggered upon contact with the instrument. If such a reaction occurs during the procedure, the manufacturer Helmut Zepf stipulates that the intervention must be stopped immediately and necessary medical measures must be taken. Furthermore, use is contraindicated if the instrument shows visible damage such as cracks, breaks, or defects on the cutting edges.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to inspect the device for any wear or damage before the surgical act. The use of damaged or worn products is strictly prohibited to ensure patient safety and the effectiveness of the procedure. The reprocessing process must follow standard hospital or dental office sterilization protocols, ensuring compatibility with other products used simultaneously during the decontamination chain.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This elevator is a Class I medical device compliant with current regulations for manual dental instruments. Although specific CE marking is not detailed in the source data, the product respects medical stainless steel manufacturing standards. It is reminded that the use of this instrument is exclusively reserved for healthcare professionals, thus guaranteeing an application in accordance with established scientific data in oral surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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