Axial Instrument for Fillings - Helmut Zepf (26.200.00) - Delynov
The Instrument axial pour plombages - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.200.00.
- 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 axial filling instrument (26.200.00)?
The axial filling instrument, referenced under code 26.200.00 at Delynov, is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This device is manufactured from medical-grade stainless steel, ensuring robustness suited to the demands of daily dental practice. As a manual instrument, it is specifically developed to assist practitioners during dental restoration procedures. This product belongs to the instrument category (INSTRU) and is classified as a Class I medical device. It is delivered non-sterile, which requires a rigorous preparation protocol before any clinical use to ensure patient and practitioner safety.
What are the clinical indications for this dental instrument?
The Helmut Zepf axial instrument is indicated for use as a manual dental instrument during conservative and restorative care. Its intended purpose is to assist the dental surgeon or healthcare professional in the steps of placing and handling filling materials. Its use is strictly reserved for qualified healthcare professionals. The main indication is based on the need for a precise stainless steel tool for operative dentistry interventions. It is essential for the practitioner to verify the compatibility of this instrument with other products and materials used during the clinical procedure to ensure optimal efficiency.
What are the technical characteristics of reference 26.200.00?
Technical reference 26.200.00 designates an axial filling instrument manufactured by Helmut Zepf Medizintechnik GmbH. Its main characteristic lies in its medical stainless steel composition, a standard material for manual dental instrumentation. This Class I device is designed to be reusable, although there is no defined maximum limit for the number of processing cycles. The lifespan of the instrument depends on its physical condition: the manufacturer recommends systematically checking for the absence of visible damage, such as cracks, breaks, or defects on the cutting edges, before each use. Any marked sign of wear must lead to the immediate removal of the instrument from the clinical circuit.
What are the contraindications for using this stainless steel instrument?
The main contraindication related to the use of this Helmut Zepf instrument concerns metal intolerance. Contact with the instrument may cause a hypersensitivity reaction in patients with a known allergy or intolerance to medical stainless steel components. If such a reaction occurs during the intervention, the manufacturer specifies that the procedure must be stopped immediately and necessary medical measures must be taken accordingly. It is the practitioner's responsibility to question the patient about their allergic history before any manipulation. Furthermore, the use of the instrument is prohibited if it shows visible damage or structural defects compromising the safety of care.
What are the maintenance and sterilization precautions?
Helmut Zepf brand instruments are delivered non-sterile and must imperatively follow a complete reprocessing cycle before the first use, as well as after each subsequent use. The mandatory protocol includes cleaning, disinfection, and complete sterilization. It is crucial to clean each product before use to remove any residue. Before each cycle, a visual inspection is required to detect any cracks or wear of the edges. Due to the design of the instrument and the materials used, the manufacturer does not define a maximum limit of cycles, but emphasizes that the use of damaged or worn products is strictly prohibited to guarantee the integrity of the care provided.
Who is the manufacturer and what standards are met by this device?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with the regulations in force for Class I (Class Ir according to the raw MDR text). The manufacturer applies rigorous standards for the production of its medical stainless steel manual instruments. As a Class I device, it meets the safety and performance requirements defined for this category of dental instruments. Compliance with the instructions for use, safety, and reprocessing issued by Helmut Zepf is essential to maintain product compliance throughout its use in dental offices or hospital environments.
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Specifications
| Manufacturer | Helmut Zepf |
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