Solid Mallet - Helmut Zepf (41.500.17M) - Delynov
The Maillet Massif - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.500.17M.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf massive surgical mallet?
The massive surgical mallet, referenced under code 41.500.17M, is a striking instrument designed by Helmut Zepf Medizintechnik GmbH. This medical equipment is manufactured from medical grade stainless steel, ensuring robustness adapted to the requirements of bone surgery. As a massive implantology mallet, it features a dense structure allowing for the delivery of precise impact energy without excessive rebound. This device belongs to Class I of medical devices, meeting the rigorous manufacturing standards of the German manufacturer for use in a sterile environment after appropriate processing.
What are the clinical indications in dental surgery?
This dental surgery mallet is indicated for all procedures requiring the application of indirect mechanical force. In clinical practice, it is used by the surgeon to strike cutting or separating instruments, such as bone chisels or osteotomes. Its use is frequent in implantology during ridge expansion or crestal sinus lifts. It is also used during complex extractions requiring the use of elevators or for the insertion of certain prosthetic components requiring a controlled impulse for their final placement.
What are the technical characteristics of this instrument?
The Helmut Zepf mallet (reference 41.500.17M) is characterized by its massive design in medical stainless steel. Unlike models with interchangeable faces, this massive surgical mallet offers a homogeneous and durable striking surface. It is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and between each patient. Its monobloc design facilitates reprocessing by eliminating complex retention zones, although a visual inspection to detect potential cracks or breakages is required before each surgical act.
What are the contraindications for the use of this mallet?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity or intolerance to metals. As the instrument is composed of medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, the use of the instrument is strictly contraindicated if it shows visible damage, such as cracks or defects on the striking surfaces, in order to guarantee the safety of the patient and the practitioner.
What are the maintenance and reprocessing precautions?
The massive implantology mallet must follow a strict reprocessing protocol. Before any use, the medical equipment must be cleaned, disinfected, and sterilized. Helmut Zepf specifies that due to the robust design and materials used, there is no defined maximum limit of treatment cycles, as long as the instrument does not show signs of wear or functional degradation. It is crucial to check compatibility with other products used simultaneously. The use of damaged or worn products is prohibited to avoid any risk of intraoperative complication. Cleaning must be complete to ensure the effectiveness of subsequent sterilization.
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 mallet is classified as a Class I medical device according to the current regulations (MDC0483). Compliance with German manufacturing standards guarantees a reliable instrument for healthcare professionals. In accordance with the manufacturer's guidelines, this product is exclusively reserved for use by qualified healthcare professionals. Helmut Zepf ensures the traceability and quality of its instruments through rigorous manufacturing protocols, although the products are delivered non-sterile and require prior preparation by the end user.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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