Fragment Decorticator - Helmut Zepf (17.055.02) - Delynov
The Decortiqueur 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: 17.055.02.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf fragment scraper?
The Helmut Zepf fragment scraper, referenced under code 17.055.02, is a manual instrument specific to oral surgery. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is designed for harvesting hard tissue. Its structure is optimized to allow the practitioner to recover fine bone fragments directly from the patient. As a bone harvesting instrument, it meets the durability and resistance requirements necessary for bone surgery interventions. This product is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient.
What are the clinical indications for the dental bone scraper?
The use of this dental scraper is indicated in all procedures requiring the collection of autogenous bone for grafts. In implantology and periodontal surgery, it is used to collect bone chips from the mandible or maxilla. These fragments are then repositioned to fill bone defects, increase the volume of an alveolar ridge, or stabilize an implantation site. This dental surgery instrument is particularly useful during the preparation phases of the recipient site, offering a controlled manual method for managing hard tissue without systematically resorting to more invasive rotary devices.
What are the technical characteristics of model 17.055.02?
The Helmut Zepf 17.055.02 fragment scraper is characterized by its construction from high-quality medical stainless steel. Its ergonomic design allows for a firm grip to apply the necessary force during decortication of the cortical bone. The manufacturer specifies that the instrument must undergo a rigorous visual inspection before each use to detect potential damage such as cracks, breaks, or wear of the cutting edges. Compatibility with other products in the Helmut Zepf range must be verified beforehand. There is no defined maximum limit for processing cycles, as this depends on maintenance and the visible state of wear of the instrument.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals. Since the scraper is composed of medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, it is strictly forbidden to use an instrument presenting visible defects, cracks, or dull edges, as this could compromise patient safety and the effectiveness of the surgical procedure.
What are the maintenance and reprocessing precautions?
As the scraper is a non-sterile device, it must imperatively follow a complete reprocessing cycle including cleaning, disinfection, and sterilization before any use. It is crucial to carefully clean the instrument to remove all biological residues before autoclaving. The manufacturer does not define a maximum number of cycles but emphasizes that wear, mechanical damage, or corrosion constitute criteria for disposal. The use of damaged or worn products is prohibited. This device is exclusively reserved for healthcare professionals trained in dental surgery techniques and the reprocessing of reusable medical devices.
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 fragment scraper belongs to Class I (Class Ir according to certain reprocessing nomenclatures). It complies with regulatory requirements relating to manual dental instruments made of medical stainless steel. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the conformity of the device throughout its useful life. The instrument must be used in accordance with its intended purpose and under the responsibility of a qualified practitioner, respecting the sterilization protocols in force in dental offices and hospitals.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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