Osteotomy Instrument for Implantology and Oral Surgery - Helmut Zepf (47.943.43) - Delynov
The Instrument d'ostéotomie pour l'implantologie et la chirurgie orale - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.943.43.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 47.943.43 osteotomy instrument?
The osteotomy instrument referenced 47.943.43, manufactured by Helmut Zepf Medizintechnik GmbH, is a manual dental instrument specifically designed for oral surgery and implantology procedures. Made of high-quality medical stainless steel, this tool is intended for the manipulation of bone structures. It belongs to the Class I category according to current regulations. Its robust structure allows for efficient force transmission during osteotomy procedures, ensuring a controlled intervention for the practitioner. Like any instrument from the Helmut Zepf brand, it is delivered non-sterile and requires a complete processing cycle before its first use in a dental office or hospital environment.
What are the clinical indications for this osteotome?
This Helmut Zepf osteotome is indicated for all oral surgery procedures requiring the sectioning or modification of the bone structure. In implantology, it is used to prepare the implant site, particularly during ridge expansion techniques or specific bone preparation. Its use is strictly reserved for qualified healthcare professionals. The instrument allows for precise bone-cutting gestures, thus facilitating the insertion of implants or the correction of bone defects. It is essential to check the condition of the instrument, especially the absence of cracks or defects on the cutting edges, before each intervention to guarantee patient safety and the effectiveness of the surgical act.
What are the technical characteristics of this instrument?
The Helmut Zepf osteotomy instrument (reference 47.943.43) is characterized by its manufacture in medical stainless steel, a material chosen for its resistance and compatibility with repeated sterilization protocols. Although the manufacturer does not define a maximum limit for processing cycles due to the durable design and materials used, the instrument must undergo a rigorous visual inspection. The practitioner must look for any visible damage, such as wear, breakage, or alterations of the sharp edges. The ergonomics of the instrument are adapted to the requirements of oral surgery, ensuring a stable grip for complex osteotomy maneuvers in implantology.
What are the contraindications for using this instrument?
The main contraindication for using this Helmut Zepf instrument is the patient's known hypersensitivity or intolerance to metals. As the instrument is composed of medical stainless steel, contact can trigger an allergic or hypersensitivity reaction. If such a reaction occurs during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any surgical intervention. Furthermore, the use of an instrument showing visible damage, cracks, or excessive wear is formally prohibited.
What are the maintenance and sterilization precautions?
As this is a non-absorbable and reusable instrument, strict cleaning and sterilization precautions apply. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the very first use, as well after each subsequent use. The reprocessing process must be complete to ensure asepsis. It is crucial to clean each product individually and check compatibility with other products used simultaneously. Due to its stainless steel composition, there is no predefined limit on sterilization cycles, but the lifespan depends on maintenance and the absence of mechanical damage. Never use a blunt or damaged instrument.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to the Medical Device Regulation (MDR). The manufacturer ensures the traceability and quality of its products through rigorous manufacturing processes compliant with European requirements for manual dental instruments. Healthcare professionals can refer to the manufacturer's instructions for specific safety guidelines. Helmut Zepf's commitment to the production of medical stainless steel instruments guarantees reliable equipment for the daily requirements of oral surgery and implantology.
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Specifications
| Manufacturer | Helmut Zepf |
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