Surgical Blade Handle Helmut Zepf for (46.005.65) - Delynov
The Changeur de lames de bistouri Helmut Zepf pour is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.005.65.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf scalpel blade changer?
The Helmut Zepf scalpel blade changer, referenced under code 46.005.65, is a manual instrument designed specifically for the secure management of sharp consumables in a surgical environment. Manufactured from medical stainless steel, this robust tool allows for the removal of used blades from their handle without direct manual contact with the sharp edge. This device is part of operating room safety protocols aimed at reducing the risk of blood exposure accidents (BEA) through punctures or cuts. It offers a reliable solution for practitioners requiring controlled handling of invasive devices after oral or implant surgery interventions.
What are the clinical indications for this blade extractor?
The use of this scalpel blade extractor is indicated in all dental, periodontal, and implant surgery procedures requiring the use of a manual scalpel. Its role occurs during the decontamination and disassembly phase of the instrumentation. By facilitating the safety of scalpel blade removal, it protects healthcare personnel during the transition between the surgical act and the cleaning process. The instrument is particularly useful during complex surgeries where fatigue or repetitive movements increase the risk of handling errors with sharp, cutting, or piercing objects (SCP).
What are the technical characteristics of model 46.005.65?
Model 46.005.65 from the Helmut Zepf brand is a reusable instrument designed to fit standard scalpel handles. Its medical stainless steel structure guarantees the corrosion resistance necessary to undergo repeated processing cycles. Although delivered non-sterile, its design allows for complete cleaning and sterilization before each use. As a specialized scalpel blade changer, it ensures a firm grip on the base of the blade for smooth mechanical unlocking, thus avoiding splashes or sudden slips often observed when using pliers not dedicated to this specific use.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. If a patient presents a known allergic reaction to stainless steel during contact with the instrument, the procedure must be immediately interrupted and appropriate clinical measures taken. Outside of this specific metal sensitivity, the instrument must never be used if it shows visible damage such as cracks, breaks, or defects on functional areas. The use of a damaged or worn product is strictly prohibited to ensure operational safety.
What are the maintenance and reprocessing precautions?
The Helmut Zepf blade changer must imperatively be cleaned, disinfected, and sterilized before the first use as well as after each subsequent use. As this is a device delivered non-sterile, rigorous compliance with reprocessing protocols is essential. Before each cycle, the practitioner must inspect the instrument to detect any sign of wear or damage. Due to its high-quality stainless steel composition and simplified mechanical design, there is no defined maximum limit for processing cycles, as long as the physical integrity of the tool is preserved. Its compatibility with other instruments on the technical tray must also be verified beforehand.
Who is the manufacturer and what standards are respected?
This device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device (Class Ir according to the associated technical documentation). The manufacturer guarantees the instrument's compliance with regulatory requirements for manual dental instruments. As a Class I device, it meets the safety and performance standards required for professional use in dental practices and hospital environments. This blade changer is exclusively reserved for healthcare professionals trained in surgical techniques and current hygiene protocols.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |