Interchangeable Scalpel Handle - Helmut Zepf (24.751.179) - Delynov
The Pointe de bistouri interchangeable - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.751.179.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf interchangeable scalpel tip (24.751.179)?
The Helmut Zepf interchangeable scalpel tip, referenced under code 24.751.179, is a removable cutting component designed for oral surgery. Manufactured by Helmut Zepf Medizintechnik GmbH, this tip is designed in medical stainless steel, ensuring compatibility with rigorous sterilization protocols in dental practices. Unlike monoblock models, this system allows for the replacement of only the sharp end, thus ensuring optimal cutting acuity for each intervention without changing the entire handle. This device is delivered non-sterile and requires a complete cycle of cleaning, disinfection, and sterilization before its first use and after each clinical cycle.
What are the clinical indications for this surgical scalpel tip?
This surgical scalpel tip is indicated as a manual dental instrument for cutting and incising soft tissues during various oral interventions. Its use is particularly relevant in implantology, periodontology, and general oral surgery for the creation of flaps or the excision of gingival tissues. As a manual instrument, it allows the practitioner direct manipulation for high-precision movements. The manufacturer specifies that use is strictly reserved for qualified healthcare professionals. The interchangeable design facilitates the maintenance of a perfect cutting edge, essential for limiting tissue trauma during primary or secondary incision phases.
What are the technical characteristics of tip 24.751.179?
The Helmut Zepf interchangeable scalpel tip is characterized by its construction in medical-grade stainless steel, a standard material for reusable surgical instrumentation. Although the maximum number of treatment cycles cannot be defined due to its design, the instrument must undergo systematic visual inspection. Before each use, the practitioner must check for the absence of visible damage such as cracks, breaks, or defects on the cutting edges. Any product showing signs of wear or damage must be immediately discarded. Reference 24.751.179 ensures specific compatibility with handles from the corresponding Helmut Zepf range.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Being composed of medical stainless steel, the tip may cause an allergic reaction in certain patients sensitive to its components. If such a hypersensitivity reaction manifests during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any use. Furthermore, the use of damaged, cracked instruments or those with defective cutting edges is formally prohibited to guarantee patient safety and the effectiveness of the surgical act.
What are the maintenance and reprocessing precautions?
Helmut Zepf products are delivered non-sterile. A strict reprocessing protocol is mandatory before the first use and after each subsequent use. This process includes cleaning, disinfection, and sterilization. It is imperative to clean each product before proceeding to sterilization to remove any biological residue. The manufacturer emphasizes that there is no defined maximum limit for treatment cycles, as this depends on the intended use and observed mechanical wear. Verification of compatibility with other instruments used during the procedure is also required beforehand to ensure secure assembly of the interchangeable tip.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I (Class Ir according to the mentioned MDC0483 nomenclature). As a Class I product, it meets the regulatory safety and performance requirements in force for manual dental instrumentation. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to maintain the device's conformity throughout its useful life. The instrument is exclusively intended for use by healthcare professionals trained in dental and oral surgery techniques.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |