Micro-Scissors - Helmut Zepf (46.319.17) - Delynov
The Micro-Ciseaux - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.319.17.
- Reserved for healthcare professionals. Read instructions carefully before use.
What are the Helmut Zepf micro-scissors (46.319.17)?
The micro-scissors referenced under code 46.319.17 by Helmut Zepf are specialized microsurgery instruments. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, these instruments are specifically designed to offer great precision during tissue handling. They belong to the Class I instrument category according to medical device regulations. Their structure is optimized to meet the requirements of dental surgeons and periodontists requiring fine instrumentation for cutting and separating soft tissues or auxiliary materials such as sutures in demanding clinical environments.
What are the clinical indications?
These microsurgery scissors are indicated for use in oral and periodontal surgery. The intended purpose by the manufacturer Helmut Zepf is the separation and cutting of biological tissues. Beyond tissue excision, they are also intended to section surgical aids, notably sutures and drainage tubes. They find their primary application during procedures requiring high precision, where the use of standard scissors would be too bulky. The instrument is exclusively reserved for qualified healthcare professionals, ensuring use in accordance with current surgical protocols.
What are the technical characteristics?
The Helmut Zepf micro-scissors (46.319.17) are characterized by their medical stainless steel composition, a material chosen for its resistance and its capacity to be reprocessed. Delivered non-sterile, these instruments must imperatively undergo a full cycle of cleaning, disinfection, and sterilization before their first use and between each patient. The manufacturer specifies that due to the design and materials used, there is no defined maximum limit for the number of processing cycles, as long as the instrument shows no visible damage. It is crucial to inspect the cutting edges for any cracks or wear before any intervention.
What are the contraindications for use?
The main contraindication for the use of this Helmut Zepf instrument concerns the patient's known hypersensitivity to metals. Contact with medical stainless steel can trigger an allergic reaction or intolerance in certain individuals. If such a hypersensitivity reaction occurs during the intervention, the manufacturer stipulates that the procedure must be immediately stopped and necessary medical measures must be taken. Additionally, it is strictly forbidden to use the instrument if it shows visible damage, such as cracks, breaks, or defects on the cutting edges, in order to guarantee patient safety and the effectiveness of the surgical procedure.
What are the maintenance and reprocessing precautions?
As a non-resorbable and reusable instrument, maintenance precautions are strict. Before each use, the practitioner must check for the absence of wear and defects on the blades. The reprocessing process includes complete cleaning, disinfection, and systematic sterilization. Helmut Zepf Medizintechnik GmbH emphasizes the importance of cleaning each product before using it for the first time. Compatibility with other products used during surgery must also be verified beforehand. The absence of a defined limit for processing cycles allows for long-term use, subject to rigorous maintenance and compliance with the manufacturer's safety instructions.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with regulatory requirements for medical devices, classifying these micro-scissors as Class I. As a precision medical instrument, it meets the quality standards for medical stainless steel. Helmut Zepf products are designed for strict professional use in dental offices or hospital environments. Rigorous monitoring of the instructions for use and safety provided by Helmut Zepf Medizintechnik GmbH ensures the compliance of the device throughout its operational life cycle.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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