Osteotome straight conical Helmut Zepf (47.949.04) - Delynov
The Osteotome droit conique Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.949.04.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf straight conical osteotome (47.949.04)?
The Helmut Zepf straight conical osteotome, referenced under code 47.949.04, is a high-precision manual dental instrument. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device belongs to the category of Class I surgical consumables. Its straight structure and conical tip are specifically designed to meet the requirements of oral surgery professionals. As an instrument delivered non-sterile, it requires a strict reprocessing protocol before each use. Its robust stainless steel design ensures compatibility with repeated sterilization cycles, although a visual inspection is imperative to detect any wear or damage before the surgical act.
What are the clinical indications for this instrument?
This manual instrument is indicated for dental surgery procedures requiring manipulation or modification of the bone structure. The Helmut Zepf straight conical osteotome is primarily used by implantologists and oral surgeons for the preparation of implant sites, particularly for the condensation of cancellous bone or the expansion of the alveolar ridge. Its use allows for the preparation of the implant housing while optimizing the surrounding bone density. It is exclusively reserved for qualified healthcare professionals who must verify the compatibility of the instrument with other devices used during the intervention.
What are the technical characteristics of the 47.949.04 osteotome?
The Helmut Zepf 47.949.04 osteotome is characterized by a straight shaft and a conical active tip. It is entirely designed in medical stainless steel, a material chosen for its resistance and its ability to undergo cleaning and sterilization processes. This device is classified as a Class I instrument according to current regulations. It does not have a defined maximum limit of treatment cycles, as this depends on maintenance and the potential appearance of signs of wear such as cracks or defects on the edges. Each product must be scrupulously cleaned, disinfected, and sterilized before its first use and between each patient.
What are the contraindications for the use of this osteotome?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Contact of medical stainless steel with an allergic patient can trigger a hypersensitivity reaction. If such a reaction occurs during the procedure, the practitioner must immediately stop the intervention and take the necessary corrective measures. Furthermore, the use of the instrument is strictly prohibited if visible damage is identified, such as cracks, breaks, or defects on the active parts, in order to guarantee patient safety and the effectiveness of the surgical gesture.
What are the maintenance and reprocessing precautions?
Helmut Zepf instruments are delivered non-sterile and must imperatively follow a complete cycle of cleaning, disinfection, and sterilization before any use. It is crucial to clean each product to remove any residue before autoclaving. The manufacturer emphasizes that due to the design and materials used, there is no fixed limit on the number of reprocessing cycles. The lifespan of the instrument is determined by its physical condition: the practitioner must systematically check for the absence of wear, corrosion, or deformation. Any instrument showing defective cutting edges or signs of structural fatigue must be removed from service.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This manufacturer complies with the regulatory requirements relating to medical devices, classifying this osteotome as Class I. As the official manufacturer, Helmut Zepf provides precise safety instructions regarding the use of medical stainless steel and mandatory reprocessing protocols. The use of this instrument is strictly reserved for healthcare professionals, ensuring that oral surgery procedures are performed with equipment that complies with the quality and safety standards in force in the European Union.
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Specifications
| Manufacturer | Helmut Zepf |
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