Heidbrink. Fragment Decorticator - Helmut Zepf (17.052.01) - Delynov
The Heidbrink. Décortiqueur à Fragments - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 17.052.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Heidbrink Helmut Zepf?
The Heidbrink, referenced under code 17.052.01, is a specialized manual instrument called a fragment decorticator. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is designed in high-quality medical stainless steel. It belongs to the category of consumables and reusable instruments for oral surgery and implantology. Its structure is specifically designed to offer optimal grip during delicate interventions requiring the removal of small solid elements within the oral cavity. As a non-sterile instrument upon delivery, it requires a rigorous processing protocol before its first use.
What are the clinical indications?
The Heidbrink fragment decorticator from Helmut Zepf is primarily indicated for dental extraction procedures and alveolar surgery. Its clinical role consists of grasping and removing fractured root fragments, bone splinters, or residual debris after an avulsion. It is used by dental surgeons and implantologists to ensure the cleanliness of the surgical site before closure or implant placement. This manual instrument is essential during complex extractions where roots may break, requiring precise intervention to avoid post-operative complications related to fragment retention.
What are the technical characteristics?
The Heidbrink model (reference 17.052.01) is distinguished by its medical stainless steel construction, guaranteeing corrosion resistance and durability in compliance with Class I device requirements. This decorticator is designed by Helmut Zepf Medizintechnik GmbH according to rigorous precision standards. The instrument is delivered in a non-sterile state, which requires the practitioner to carry out a complete cycle of cleaning, disinfection, and sterilization before any use. Its ergonomic design allows for efficient transmission of manual force while maintaining the finesse necessary to access narrow areas of the dental socket.
What are the contraindications for use?
The main contraindication for the use of this Helmut Zepf instrument is known patient hypersensitivity or intolerance to metals, particularly medical stainless steel. An allergic reaction may occur during direct contact with the instrument. If such a hypersensitivity reaction manifests during the procedure, the manufacturer specifies that the intervention must be stopped immediately and necessary medical measures must be taken. Furthermore, the use of the instrument is strictly prohibited if it shows visible damage, such as cracks, breaks, or defects on the active parts, to guarantee patient safety.
What are the maintenance and reprocessing precautions?
Given that Helmut Zepf products are delivered non-sterile, complete reprocessing is mandatory before the first use and after each subsequent use. This includes thorough cleaning, disinfection, and sterilization. The practitioner must inspect the instrument before each intervention to detect any signs of wear or damage. Due to the robust design and materials used, there is no defined maximum limit of processing cycles, as long as the physical integrity of the instrument is preserved. The use of damaged or worn instruments is formally prohibited to avoid any clinical risk.
Who is the manufacturer and what standards are respected?
The Heidbrink fragment decorticator is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (Class Ir according to certain reprocessing nomenclatures). It complies with regulatory requirements regarding manual dental instruments. The manufacturer emphasizes that the use of this instrument is strictly reserved for qualified healthcare professionals. Compliance with safety and quality standards is ensured by Helmut Zepf's rigorous manufacturing processes, including verification of compatibility with other medical products used during surgery.
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