Surgical product Title: Roller Blinds. Octagonal Handle. Figure 17 - Helmut Zepf (24.101.17) - Delynov
The Sonnette. Manche octogonal. Figure 17 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.101.17.
- 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 Instrument dentaire manuel 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 octagonal handle Sonnette?
The Helmut Zepf Sonnette (reference 24.101.17) is a high-precision manual dental instrument designed for oral surgery procedures. It is distinguished by its ergonomic octagonal handle offering a stable and secure grip during clinical acts. Manufactured from medical-grade stainless steel by Helmut Zepf Medizintechnik GmbH, this device belongs to the category of instruments (INSTRU) of Class I. This equipment is delivered non-sterile by the manufacturer, requiring rigorous preparation before any use in the dental office. Its robust medical steel design ensures optimal longevity, although no maximum limit for processing cycles is defined due to the nature of the materials used and its specific design.
What are the clinical indications for this dental instrument?
The intended use of this Helmut Zepf instrument is strictly limited to manual dental procedures performed by qualified healthcare professionals. It is indicated for interventions requiring the use of a sonnette (Figure 17) in the context of oral surgery or implantology. The practitioner must ensure the compatibility of this tool with other products used during the intervention. As a manual instrument, it is essential to check for the absence of visible damage, such as cracks or breaks on the cutting edges, before each surgical act to guarantee patient safety and the efficiency of the technical gesture.
What are the technical characteristics of reference 24.101.17?
The Helmut Zepf Sonnette, listed under code 24.101.17, is characterized by its Figure 17 configuration and its octagonal-shaped handle. This specific design allows for increased tactile control during delicate manipulations in the mouth. The instrument is entirely composed of medical stainless steel, a material chosen for its resistance and its capacity to undergo repeated sterilization cycles. Being a Class I device, it meets the regulatory requirements for non-invasive or minimally invasive manual dental instruments. The manufacturer specifies that due to the quality of the steel and the structure of the instrument, the number of achievable reprocessing cycles depends on the actual wear observed by the healthcare professional rather than a predefined limit.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this medical stainless steel instrument concerns metal intolerance. Contact with the instrument may cause a hypersensitivity reaction in certain patients sensitive to the components of the alloy. If such an adverse reaction or intolerance is detected during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the intervention must be immediately stopped. Necessary medical measures must then be taken accordingly. It is therefore recommended to question the patient about their history of metal allergies before any use of this manual instrument.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use, as well as after each subsequent use. The reprocessing process must be complete to guarantee asepsis. It is crucial to meticulously inspect each product before use to detect potential defects, visible wear, cracks, or alterations of the sharp edges. A damaged or worn instrument must never be used, as this compromises clinical safety. As the products are delivered non-sterile, compliance with the cleaning and sterilization protocols in force in healthcare facilities is a strict obligation for authorized personnel.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the traceability and quality of its products through rigorous manufacturing processes. The use of this instrument is strictly reserved for trained healthcare professionals. The manufacturer emphasizes the importance of verifying compatibility with other devices before the act and reminds that the medical stainless steel used is subject to standard cleaning and sterilization protocols to maintain its functional properties over the long term.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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