Osteotomy Instrument - Helmut Zepf (47.942.38) - Delynov
The Instrument d'ostéotomie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.942.38.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf osteotomy instrument (47.942.38)?
The Helmut Zepf osteotomy instrument, referenced under code 47.942.38, is a manual device specifically designed for oral surgery. Manufactured from high-quality medical stainless steel, this instrument belongs to the implant surgery instrumentation category. Its structure is optimized to meet the requirements of practitioners performing precise actions on hard tissues. As a device from the brand Helmut Zepf Medizintechnik GmbH, it benefits from the expertise of a manufacturer recognized in the field of dental instrumentation. This product is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use, as well as after each clinical intervention.
What are the clinical indications for this instrument?
The intended use for this manual instrument is strictly limited to dental procedures. Its primary indication concerns osteotomy acts, where the practitioner must intervene on the patient's bone structure. Within the framework of implant surgery instrumentation, it is used to prepare the recipient site or to modify the alveolar bone architecture. Its role is decisive during the bone cutting or rectification phases necessary for the success of implant and periodontal treatments. The use of this instrument is exclusively reserved for qualified healthcare professionals, thus guaranteeing an application compliant with current surgical protocols and optimal safety for the patient during the operative act.
What are the technical characteristics of the 47.942.38 instrument?
This osteotomy instrument is characterized by its manufacture in medical stainless steel, a material chosen for its resistance and compatibility with thermal reprocessing cycles. Technical code 47.942.38 precisely identifies this model within the Helmut Zepf range. On a technical level, the instrument must undergo a rigorous inspection before each use to detect possible visible damage such as cracks, breaks, or defects on the cutting edges. Due to its design and the materials used, the manufacturer Helmut Zepf specifies that there is no defined maximum limit for the number of achievable treatment cycles, the service life depending directly on maintenance and the absence of critical wear noted by the professional.
What are the contraindications for the use of this instrument?
The main medical contraindication related to the use of this osteotomy instrument is intolerance or hypersensitivity to metals. Contact of the medical stainless steel with the patient's tissues can trigger a hypersensitivity reaction in sensitive subjects. If such a reaction occurs during the surgical procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be immediately stopped and that necessary medical measures must be taken accordingly. Furthermore, it is formally prohibited to use an instrument showing visible signs of wear, cracks, or damaged cutting edges, as this could compromise patient safety and the effectiveness of the surgical gesture.
What are the maintenance and sterilization precautions?
Like any non-sterile Class I instrument, this osteotomy device must imperatively follow a complete cycle of cleaning, disinfection, and sterilization before its first use and after each subsequent use. Cleaning must be meticulous to remove all biological residue before the sterilization phase. It is crucial to check the compatibility of the instrument with other products and reprocessing equipment used in the practice. The manufacturer emphasizes the importance of visually checking the condition of the medical stainless steel before each intervention. Any damaged or worn product must be removed from the clinical circuit. Compliance with these safety instructions guarantees the longevity of the implant surgery instrumentation and prevents risks of cross-contamination.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the compliance of its products with safety and performance requirements for manual dental instruments. Traceability is ensured by reference 47.942.38. As a Class I device, it meets the strict manufacturing standards imposed by the European Union for reusable surgical instruments. Healthcare professionals can refer to the manufacturer's instructions for reprocessing, knowing that the medical stainless steel design allows for secure integration into the standard sterilization protocol of dental clinics and oral surgery departments.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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