KIRSCH. SINUS 8 - Helmut Zepf
The Implant Kirsch Sinus 8 - Instrument chirurgical pour sinus - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.868.08.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Kirsch Sinus 8 Implant?
The Kirsch Sinus 8 Implant, referenced under code 41.868.08 by Helmut Zepf, is a manual surgical instrument specifically developed for sinus surgery interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is designed in high-quality medical stainless steel to guarantee its functionality during dental procedures. As an instrument in the INSTRU category, it is presented as a robust device intended to be handled by qualified healthcare professionals. Its structure is adapted to the requirements of the oral environment, allowing precise management during critical stages of sinus elevation or the placement of bone substitutes.
What are the clinical indications?
This instrument is indicated as a manual dental instrument for use in oral and implant surgery. More specifically, the Kirsch Sinus 8 Implant is used during sinus surgery protocols. It allows the practitioner to intervene with precision in the maxillary sinus area, whether for site preparation or the manipulation of components necessary for bone reconstruction. Its use is strictly reserved for healthcare professionals trained in dental surgical techniques. The official indication from the manufacturer Helmut Zepf specifies its role as a manual tool for invasive dental procedures requiring reliable and sterilizable instrumentation.
What are the technical characteristics?
The Kirsch Sinus 8 instrument is characterized by its manufacture in medical stainless steel, a material chosen for its resistance and its ability to undergo repeated reprocessing cycles. Registered under technical reference 41.868.08, this device belongs to Class I according to the regulatory classification of medical devices. It is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which imposes a strict protocol of cleaning, disinfection, and sterilization before the first use and after each subsequent use. The manufacturer emphasizes the importance of checking for the absence of visible damage, such as cracks or defects on the edges, before any intervention.
What are the contraindications for use?
The main medical contraindication related to the use of this instrument is intolerance or allergy to metals. Since the instrument is composed of medical stainless steel, contact with the patient can trigger a hypersensitivity reaction in sensitive individuals. If such a reaction occurs during the surgical act, the manufacturer Helmut Zepf stipulates that the procedure must be immediately stopped and that the necessary medical measures must be taken accordingly. It is therefore crucial to evaluate the patient's allergic history before any intervention involving this manual instrument.
What are the maintenance and safety precautions?
Like any reusable surgical instrument from the Helmut Zepf brand, the Kirsch Sinus 8 Implant must imperatively be cleaned, disinfected, and sterilized before its first use and between each patient. The manufacturer includes a warning concerning wear: it is forbidden to use damaged products presenting breaks or visible defects. Although reprocessing is possible, the maximum number of cycles is not fixedly defined; it depends on the product design and the materials used. Compatibility with other products used during sinus surgery must also be verified beforehand by the practitioner.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I, in accordance with the regulations in force for manual dental instruments. Compliance with rigorous manufacturing protocols ensures that the medical stainless steel used meets safety standards for temporary contact with human tissue. As a Helmut Zepf product, it benefits from the expertise of a manufacturer specialized in precision instrumentation for dental surgery, thus guaranteeing a tool compliant with safety and performance requirements for healthcare professionals.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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