Combination Instrument with Onyx Coating - Helmut Zepf (24.748.35OX) - Delynov
The Instrument de Combinaison avec Revêtement en Onyx - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.748.35OX.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf combination instrument with Onyx coating?
The combination instrument (reference 24.748.35OX) is a manual device designed by Helmut Zepf Medizintechnik GmbH for restorative dentistry procedures. Manufactured from medical stainless steel, it benefits from a specific Onyx coating that modifies its surface properties. This onyx composite instrument is structured to provide an optimized interface when working with filling materials. As a Class I instrument, it meets the quality requirements for professional use in dental practices, combining the robustness of surgical steel with an advanced technological finish.
What are the clinical indications for this instrument?
This instrument is indicated as a manual dental instrument for restorative care. Specifically, it is used as a dental modeling spatula for the application, shaping, and smoothing of composite resins or other filling materials. Its design allows for precise manipulation in various access areas, facilitating the reproduction of dental anatomy. It is intended exclusively for healthcare professionals trained in adhesive and restorative dentistry techniques, ensuring optimal integration of materials within the residual tooth structure.
What are the technical characteristics of reference 24.748.35OX?
The Helmut Zepf reference 24.748.35OX is distinguished by its Onyx coating applied over a medical stainless steel base. This surface treatment is particularly sought after for dental modeling spatula type instruments to reduce the adhesion of composite materials during work. Although the maximum number of processing cycles is not fixed due to the design and materials, the instrument is designed to undergo repeated cycles of cleaning, disinfection, and sterilization without immediate alteration of its mechanical functions.
What are the contraindications for the use of this Helmut Zepf instrument?
The main medical contraindication concerns known hypersensitivity or intolerance to metals, particularly the medical stainless steel used in the composition of the instrument. In the event of an allergic reaction or hypersensitivity triggered in the patient upon contact, the manufacturer Helmut Zepf specifies that the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore imperative to check the patient's allergic history before any intervention with this manual instrument.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. It is crucial to visually inspect the device before each intervention to detect any potential damage or visible wear, such as cracks, breaks, or defects on the cutting edges. The use of damaged products is strictly prohibited. The reprocessing process must follow standard hospital or practice sterilization protocols to ensure asepsis and the longevity of the instrument.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with the regulatory requirements for medical devices, classifying this instrument in the Class I category. In accordance with European Medical Device Regulations (MDR), the instrument is subject to rigorous manufacturing protocols. The use of this precision instrument is strictly reserved for qualified healthcare professionals, ensuring compliance with the safety and efficacy standards in force in the European Union.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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