Straight Micro Needle Holder - Helmut Zepf (41.010.17TC) - Delynov
The Micro Porte-Aiguille Droit - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.010.17TC.
- 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 Straight Micro Needle Holder (41.010.17TC)?
The Helmut Zepf Straight Micro Needle Holder, referenced under code 41.010.17TC, is a high-precision surgical instrument designed by Helmut Zepf Medizintechnik GmbH. This medical device is manufactured from medical-grade stainless steel, ensuring increased robustness and longevity for delicate interventions. As a micro instrument, it is specifically developed to offer fine manipulation during suturing procedures. This straight model integrates tungsten carbide (TC) inserts, which improves the grip and durability of the jaws. It belongs to the INSTRU category and is classified as a Class I medical device, meeting safety requirements for non-invasive or reusable surgical instrumentation after appropriate processing.
What are the clinical indications for this needle holder?
The Helmut Zepf Straight Micro Needle Holder is exclusively indicated for holding and manipulating needles during surgical suturing. Its use is particularly suited for oral surgery, implantology, and periodontology procedures where precision of movement is crucial. This device allows the practitioner to guide the needle through soft tissues with great stability, thereby facilitating the performance of precise and secure sutures. The use of this instrument is strictly reserved for qualified healthcare professionals. Its ergonomic design and stainless steel structure make it a reliable tool for demanding clinical environments requiring specialized micro instrumentation for flap management and wound closures.
What are the technical characteristics of model 41.010.17TC?
This micro needle holder is distinguished by its straight configuration, ideal for direct access to operative sites. Manufactured by Helmut Zepf, the instrument uses medical stainless steel selected for its corrosion resistance and its ability to undergo repeated sterilization cycles. The TC suffix indicates the presence of reinforced jaws for a firm grip on suture needles, limiting the risk of slipping or undesirable rotation during trans-tissue passage. Although exact dimensions are not specified in the primary technical data, this type of instrument is designed for micro-surgery. It is delivered non-sterile and must imperatively follow a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient.
What are the contraindications for the use of this instrument?
The main contraindication for the use of the Helmut Zepf Straight Micro Needle Holder lies in known intolerance to metals, and more specifically to stainless steel, in the patient. Contact between the instrument and a hypersensitive patient can trigger an allergic reaction or a hypersensitivity reaction. The manufacturer, Helmut Zepf Medizintechnik GmbH, specifies that if such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, it is formally prohibited to use an instrument showing visible damage or wear, such as cracks, breaks, or defects on the edges, as this could compromise patient safety and suturing effectiveness.
What are the maintenance and reprocessing precautions?
As the Straight Micro Needle Holder is a non-sterile device upon delivery, rigorous reprocessing is mandatory. All instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The manufacturer indicates that due to the product design and the materials used, there is no defined maximum limit for the number of processing cycles achievable; the end of the device's life is determined by functional wear or visible damage. It is crucial to verify compatibility with other products used during the cleaning cycle. The use of damaged or worn products is prohibited to ensure tissue integrity during the manipulation of suture needles.
Who is the manufacturer and what standards are respected?
The Straight Micro Needle Holder (41.010.17TC) is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with the current regulations for Class I instruments according to the Medical Device Regulation (MDR). The manufacturer ensures strict monitoring of production protocols to guarantee the quality of its surgical instrumentation. Each instrument is designed to meet the specific needs of dental surgeons and implantologists, respecting European safety standards. Traceability and compliance with the indications for use provided by Helmut Zepf are essential to maintain the clinical performance of the needle holder throughout its use cycle in a dental office or hospital environment.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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