Instrument handle made of titanium - Helmut Zepf (26.181.03) - Delynov
The Manche d'instrument en titane - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.181.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf titanium instrument handle?
The Helmut Zepf titanium instrument handle, referenced under code 26.181.03 at Delynov, is a manual support designed to receive various working ends. Manufactured by Helmut Zepf Medizintechnik GmbH, this device utilizes titanium for its lightweight and strength properties, offering a stable grip for high-precision interventions. This titanium instrument handle is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use and after each clinical cycle, in accordance with the manufacturer's guidelines.
What are the clinical indications for this device?
This device is indicated as a manual instrument for oral surgery and implantology procedures. It is primarily used as a periotome handle to facilitate the sectioning of ligament fibers during atraumatic extractions or for the manipulation of micro-surgery instruments. Its role is to provide an ergonomic interface between the practitioner's hand and the active end of the instrument. The intended use, as defined by Helmut Zepf, is that of a manual dental instrument intended exclusively for qualified healthcare professionals.
What are the technical characteristics of handle 26.181.03?
The Helmut Zepf instrument handle (ref. 26.181.03) is distinguished by its titanium composition, a material of choice for surgical instrumentation. Its design allows compatibility with interchangeable tips from the Helmut Zepf Medizintechnik GmbH range. Before any use, the practitioner must check for the absence of visible damage such as cracks, breaks, or defects on the attachment areas. Due to its robust structure, there is no defined maximum limit of processing cycles, although compatibility with other products must be verified beforehand.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Although the handle is primarily titanium, the manufacturer's text mentions medical stainless steel as a potential component that could trigger an allergic reaction in certain patients. In the event of an immediate hypersensitivity reaction during the intervention, the procedure must be interrupted without delay and appropriate medical measures must be taken. It is imperative to validate the patient's allergic history before any contact with the instrument.
What are the maintenance and reprocessing precautions?
The Helmut Zepf handle is a reusable device that must undergo a complete reprocessing cycle. All instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to perform a visual inspection to detect any wear or damage before each intervention; the use of damaged or worn products is strictly prohibited. As the products are delivered non-sterile, the responsibility for sterilization lies with the healthcare professional. The product design does not allow for a maximum number of cycles to be defined, as the lifespan depends on compliance with maintenance protocols.
Who is the manufacturer and what standards are met?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It belongs to Class I according to medical device regulations. As a Class I product, it meets the safety and performance requirements applicable to manual dental instruments. The manufacturer emphasizes that the use of this instrument is strictly reserved for trained healthcare professionals. Traceability and compliance are ensured by the technical reference 26.181.03, guaranteeing the origin and German manufacturing quality of the instrument.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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