Muqueux Trepan - Helmut Zepf (08.920.04) - Delynov - Mucous Trephine
The TREPAN MUQUEUX - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.920.04.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 08.920.04 mucosal trephine?
The Helmut Zepf mucosal trephine, referenced under code 08.920.04 at Delynov, is a precision manual instrument intended for oral surgery. Designed by the manufacturer Helmut Zepf Medizintechnik GmbH, this tool is manufactured from medical-grade stainless steel to ensure compatibility with clinical requirements. It comes in the form of a circular sharp instrument, often called a mucosal punch, allowing for a clean and calibrated cut of soft tissues. This device belongs to Class I of medical devices, ensuring compliance with safety standards for non-invasive manual surgical instruments or those reusable after processing.
What are the clinical indications for this mucosal punch?
This surgical mucosal trephine is specifically indicated for procedures requiring the extraction of a punch biopsy or the harvesting of mucosal and skin grafts. In daily practice, dental surgeons and implantologists use it to obtain soft tissue grafts with precise geometry, thus facilitating root coverage surgeries or the augmentation of keratinized gingiva around implants. The instrument allows for a clean circular excision, limiting irregularities in the wound edges, which is crucial for post-operative healing in periodontal and implant surgery.
What are the technical characteristics of instrument 08.920.04?
The Helmut Zepf mucosal trephine is characterized by a sharpened circular working part, designed to penetrate the mucosa with minimal resistance. Manufactured from medical stainless steel, it offers the necessary rigidity for controlled manipulation during the surgical procedure. As a Class I device, it meets the design requirements for manual instruments. It is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which implies rigorous preparation before the first use and between each patient. Its design allows for complete reprocessing, including cleaning, disinfection, and steam sterilization.
What are the contraindications for the use of this trephine?
The main medical contraindication documented by the manufacturer Helmut Zepf concerns known hypersensitivity or metal intolerance. As the instrument is composed of medical stainless steel, contact with the patient can trigger an allergic reaction in sensitive individuals. If a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and appropriate clinical measures must be taken. It is therefore recommended to avoid the use of this instrument in patients with a history of allergies to metallic components, particularly nickel or chromium, often present in surgical steel alloys.
What are the maintenance and sterilization precautions?
Like any surgical instrument of the Helmut Zepf brand, this trephine must imperatively be cleaned, disinfected, and sterilized before its first use and after each subsequent use. Before each intervention, the practitioner must visually inspect the product to detect any potential damage or signs of wear, such as cracks, breaks, or defects on the cutting edges. The use of a damaged or blunt instrument is strictly prohibited as it could compromise the precision of the harvest and patient safety. Due to the materials used, there is no defined maximum limit for processing cycles, as long as functional integrity is preserved.
Who is the manufacturer and what standards are respected?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device according to current regulations. Compliance with cleaning and sterilization protocols is essential to maintain the instrument's compliance and performance. The use of this mucosal trephine is strictly reserved for qualified healthcare professionals, such as dental surgeons and stomatologists, trained in tissue harvesting and biopsy techniques. Compatibility with other instruments must also be verified by the practitioner before any complex intervention.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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