MICRO NEEDLE HOLDER STRAIGHT - Helmut Zepf (41.010.17TC-M)
Product features
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-M.
- 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 MICRO PORTE AIGUILLE DROIT?
The MICRO PORTE AIGUILLE DROIT from the brand Helmut Zepf, referenced under code 41.010.17TC-M, is a precision surgical instrument designed for handling suture needles. Manufactured from high-quality medical stainless steel, this device belongs to Class I of medical devices. Its structure is specifically designed to offer a firm and stable grip during delicate interventions. As an instrument from the Helmut Zepf Medizintechnik GmbH range, it meets the rigorous requirements of healthcare professionals seeking reliable tools for micro-surgery. This needle holder is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use as well as between each patient to ensure optimal safety within the dental office or clinic.
What are the clinical indications for this needle holder?
The Helmut Zepf MICRO PORTE AIGUILLE DROIT is exclusively reserved for healthcare professionals. Its intended purpose and primary indication lie in the secure holding and manipulation of needles during surgical suture procedures. In oral, implant, or periodontal surgery, this instrument allows the practitioner to guide the needle with precision through soft tissues, thereby facilitating wound closure and flap stabilization. The use of this instrument is indicated for all interventions requiring fine suturing where dexterity and needle control are paramount. The manufacturer Helmut Zepf emphasizes that the instrument must be checked before each use to detect any visible damage such as cracks or defects on the cutting edges to ensure its clinical effectiveness.
What are the technical characteristics of model 41.010.17TC-M?
The MICRO PORTE AIGUILLE DROIT (reference 41.010.17TC-M) is distinguished by its robust medical stainless steel design, a material chosen for its strength and durability over time. Although the manufacturer has not defined a maximum limit for processing cycles due to the quality of the materials used, the longevity of the device depends on compliance with reprocessing protocols. The instrument is designed to be compatible with other surgical products used during interventions, subject to prior verification by the practitioner. Its straight configuration is suitable for direct access in oral surgery. As it is a Class I device, it meets the essential safety standards for non-invasive or invasive instruments for temporary use, guaranteeing ergonomic handling for the dental surgeon.
What are the contraindications for the use of this instrument?
The use of the Helmut Zepf MICRO PORTE AIGUILLE DROIT presents specific contraindications related to the material composition. Metal intolerance in the patient, particularly to medical stainless steel, can lead to hypersensitivity reactions upon contact with the instrument. If such an allergic or adverse reaction occurs during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH recommends immediately stopping the intervention and taking the necessary medical measures. Furthermore, it is strictly contraindicated to use an instrument showing visible signs of wear, cracks, breaks, or structural defects. The use of damaged products compromises the safety of the surgical act and the health of the patient. Finally, the use of this instrument is strictly reserved for qualified medical personnel trained in suturing techniques.
What are the maintenance and sterilization precautions?
As the MICRO PORTE AIGUILLE DROIT is delivered non-sterile, it is imperative to follow a complete reprocessing cycle before the first use. This includes cleaning, disinfection, and sterilization according to current standards. The manufacturer specifies that it is crucial to clean each product before its use to remove any residue. A meticulous inspection must be carried out to identify any trace of wear or damage on the jaws and cutting edges. Due to its design and the materials used, there is no predefined limit on the number of sterilization cycles, but the practitioner must determine the end of life of the tool based on its physical condition. Compliance with these safety instructions not only guarantees the longevity of the Helmut Zepf instrument but also prevents risks of cross-contamination.
Who is the manufacturer and what standards are respected?
The MICRO PORTE AIGUILLE DROIT is manufactured by Helmut Zepf Medizintechnik GmbH, a company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to the regulations in force. The manufacturer ensures the traceability and quality of its instruments through rigorous manufacturing processes. Although the specific CE marking is not detailed in the source data provided, compliance with Class I requirements for medical devices is confirmed. The instrument meets medical stainless steel standards to minimize the risks of intolerance. As the official manufacturer, Helmut Zepf provides precise instructions on the intended purpose, warnings, and reprocessing procedures, thus ensuring that healthcare professionals have a tool that complies with the requirements of modern surgery.
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Specifications
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