Instrument A Main - Helmut Zepf (26.123.01) - Delynov would translate to Main Instrument A - Helmut Zepf (26.123.01) - Delynov for a dental surgery product on the Delynov website.
The Instrument A Main - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.123.01.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf hand instrument (26.123.01)?
The Helmut Zepf hand instrument, bearing reference 26.123.01, is a manual medical device specifically designed for the dental sector. Manufactured from medical stainless steel by Helmut Zepf Medizintechnik GmbH, this tool is intended for repeated use after a rigorous cleaning and sterilization protocol. As a Class I device, it meets basic safety requirements for non-invasive or short-term invasive instruments. Its robust steel structure guarantees stability during clinical interventions, although it is delivered non-sterile by the manufacturer. Each professional must ensure the absence of visible damage, such as cracks or defects on the edges, before any implementation at the chairside.
What are the clinical indications for this instrument?
This Helmut Zepf manual instrument is indicated for various procedures in oral surgery and implantology. Its intended use is that of a versatile manual dental instrument, used by practitioners for precise technical movements on dental tissues or structures. Although the manufacturer does not detail a single procedure, its design makes it suitable for integration into the standard technical platform of dental surgeons. It is imperative to check the compatibility of this accessory with other products used during the intervention. Its application is strictly reserved for qualified healthcare professionals, thus guaranteeing handling in accordance with current medical protocols.
What are the technical characteristics of this device?
The Helmut Zepf instrument (reference 26.123.01) is characterized by its manufacture from high-quality medical stainless steel, a standard material for surgical instrumentation guaranteeing resistance to sterilization cycles. It belongs to Class Ir (Class I). The manufacturer, Helmut Zepf Medizintechnik GmbH, specifies that due to the design and materials used, there is no defined maximum limit for the number of reprocessing cycles, as long as the instrument does not show signs of wear, corrosion, or deformation. Before each use, a meticulous inspection of the cutting edges and structural integrity is required to maintain operational safety.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this Helmut Zepf instrument is the patient's known hypersensitivity or intolerance to metals, and more particularly to the components of medical stainless steel. Contact with the instrument can trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the surgical act, the manufacturer stipulates that the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any intervention using this type of manual metallic instrumentation.
What are the maintenance and reprocessing precautions?
Helmut Zepf products are delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before the first use, as well as after each subsequent use. Reprocessing must follow standard hospital or practice protocols for stainless steel. It is crucial never to use damaged or worn products, presenting for example cracks or breaks. As it is a non-resorbable and reusable instrument, the practitioner's vigilance regarding the surface condition is paramount. The design of the instrument does not allow for the definition of a maximum number of cycles, the end of life being determined by functional wear or physical damage observed during pre-operative quality control.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. The device is classified as Class I according to the current regulations on medical devices. The manufacturer ensures the compliance of its products with safety and performance requirements, although specific details of the CE marking are not explicitly mentioned in the provided source documentation. Compliance with the cleaning and sterilization instructions issued by Helmut Zepf is essential to guarantee the longevity of the device and patient safety. This equipment is strictly reserved for professional use by practitioners trained in dental surgery techniques.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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