Swedish Model Needle Holder - Helmut Zepf (41.246.15TC) - Delynov
Product features
The Porte-aiguille modèle suédois - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.246.15TC.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant : HELMUT ZEPF Medizintechnik Gmbh , Obere Hauptstraße 16-22, D- 78606 Seitingen-Oberflacht BUT PRÉVU / INDICATION Les porte-aiguilles sont utilisés pour maintenir et manipuler les aiguilles lors de la suture chirurgicale.. Les effets secondaires indésirables l'intolérance aux métaux chez le patient peut résulter d'un contact avec l'instrument, qui est en acier inoxydable médical une réaction d'hypersensibilité était toujours déclenchée devenir. la procédure doit être arrêtée si une telle réaction se produit et les mesures nécessaires sont prises en conséquence. consignes d'utilisation et de sécurité tous les instruments doivent être nettoyés avant d'être utilisés pour la première fois et compléter avant toute utilisation ultérieure nettoyé, désinfecté et stérilisé ! il est très important de nettoyer chaque produit avant utilisation dommages et usures visibles, par ex. b. fissures, cassures ou des défauts sur les arêtes de coupe. n'utilisez jamais de produits endommagés ou usés. les produits de helmut zepf medizintechnik gmbh sont livrés non stériles. les produits doivent être à l'avance nettoyé et stérilisé. la compatibilité aussi les autres produits doivent être vérifiés au préalable. retraitement en raison de la conception du produit, des matériaux utilisés et il ne peut y avoir de limite maximale définie pour l'utilisation prévue des cycles de traitement réalisables peuvent être déterminés.réservé aux professionnels de santé.
What is the Helmut Zepf Swedish model needle holder?
The Swedish model needle holder, referenced under code 41.246.15TC at Delynov, is a precision surgical instrument designed by Helmut Zepf Medizintechnik GmbH. Manufactured from high-quality medical stainless steel, this device is specifically developed to offer a stable and secure grip during interventions. Its robust structure allows for fluid manipulation of suture needles. As a Class I instrument, it meets the safety requirements for non-invasive or temporary invasive devices. This model incorporates reinforced jaws, as indicated by the TC suffix, ensuring increased durability and optimal wear resistance during repeated demands in the operating room or dental office.
What are the clinical indications for this device?
Helmut Zepf needle holders are exclusively intended for holding and manipulating needles during surgical suturing. They are useful in various oral surgery, implantology, and periodontology procedures where precision of movement is crucial for tissue closure. The primary indication is the controlled guidance of the needle through soft tissues, allowing the practitioner to perform precise and consistent stitches. The use of this instrument is strictly reserved for qualified healthcare professionals, thus ensuring an application consistent with current clinical protocols for surgical wound management.
What are the technical characteristics of model 41.246.15TC?
This Helmut Zepf needle holder is distinguished by its ergonomic design adapted to the requirements of micro-surgery and dental surgery. Although exact dimensions are not specified beyond its technical reference 41.246.15TC, its manufacture from medical stainless steel ensures standard biocompatibility. The instrument is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH, which requires a strict preparation protocol before any use. The product design and materials used do not allow for a maximum limit of processing cycles to be defined, which means that the instrument's lifespan depends directly on maintenance and the absence of visible damage during prior inspections.
What are the contraindications for using this instrument?
The main contraindication related to the use of this medical stainless steel needle holder concerns metal intolerance in the patient. Contact with the instrument may trigger a hypersensitivity reaction or an allergic skin or mucosal reaction. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, it is formally prohibited to use the instrument if it shows visible damage or wear, such as cracks, breaks, or defects on the active parts. Using a damaged product compromises the safety of the surgical act and the integrity of the manipulated tissues.
What maintenance and safety precautions must be followed?
To ensure patient safety and instrument longevity, all Helmut Zepf products must be cleaned, disinfected, and sterilized before the first use, as well as after each subsequent use. It is imperative to perform a complete cleaning to remove all biological residue. Before each intervention, the practitioner must check the compatibility of the instrument with other devices used, particularly suture needles. A thorough inspection is required to detect any signs of wear. Since reprocessing depends on the design and materials, the number of achievable cycles is not limited by a fixed value, but by the actual physical state of the instrument as assessed by the healthcare professional.
Who is the manufacturer and what standards are met?
The Swedish model needle holder is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to the regulations in force. The manufacturer ensures that each instrument is designed to meet the specific needs of dental surgeons and implantologists. As a Class I device, it follows the conformity assessment procedures applicable to this category of reusable surgical instruments. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to maintain product conformity and ensure optimal performance during complex surgical sutures.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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