Bands for Matrix for Dental Surgery and Implantology - Helmut Zepf (19.061.02) - Delynov
The Rubans pour matrices pour chirurgie dentaire et implantologie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 19.061.02.
- 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 are Helmut Zepf matrix bands (19.061.02)?
Helmut Zepf matrix bands, referenced under code 19.061.02, are essential manual dental instruments for dental surgery and implantology. Designed by Helmut Zepf Medizintechnik GmbH, these devices are manufactured from high-quality medical stainless steel to ensure optimal performance during restorative procedures. They belong to the consumables category (CONSO) and are classified as Class I medical devices. These bands are delivered non-sterile and require a full cycle of cleaning, disinfection, and sterilization before their first use in the dental office or operating room, as well as before each subsequent reuse.
What are the clinical indications for these matrix bands?
The intended purpose and primary indication for these Helmut Zepf matrix bands lie in their function as a manual dental instrument. They are specifically used by healthcare professionals during dental care requiring the delimitation or maintenance of restorative materials. Their medical stainless steel design makes them suitable for the demanding clinical environments of oral surgery and implantology. The use of these instruments is strictly reserved for qualified practitioners, thereby ensuring handling in accordance with current care protocols.
What are the technical characteristics of model 19.061.02?
Model 19.061.02 is distinguished by its robust manufacture in medical stainless steel, a material chosen by Helmut Zepf for its durability and resistance to reprocessing cycles. Due to the specific design of the product and the materials used, the manufacturer indicates that there is no defined maximum limit for the number of processing cycles achievable, although the user must systematically inspect the instrument. Before each use, it is imperative to check for the absence of visible damage, such as cracks, breaks, or defects on the cutting edges, to ensure patient safety.
What are the contraindications for the use of this instrument?
The main contraindication and adverse side effect mentioned by Helmut Medizintechnik GmbH concerns metal intolerance. Contact with the medical stainless steel instrument can trigger a hypersensitivity reaction in certain sensitive patients. If such an allergic reaction or intolerance occurs during the intervention, the procedure must be stopped immediately. Necessary medical measures must then be taken accordingly to ensure patient safety. It is therefore recommended to evaluate the patient's allergic history before any use of this metallic instrument.
What maintenance and safety precautions must be followed?
The safety of use for Helmut Zepf matrix bands relies on a strict reprocessing protocol. All instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The manufacturer emphasizes that it is crucial to clean each product before use. The use of damaged or worn products is formally prohibited. Practitioners must also check compatibility with other products used during the procedure. Since these bands are delivered non-sterile, rigorous compliance with cleaning and sterilization instructions is mandatory to prevent any risk of cross-contamination.
Who is the manufacturer and what standards are respected?
These matrix bands are manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with the current regulations for Class I (Class Ir according to the reference MDR text). The manufacturer ensures the traceability and quality of its manual instruments intended exclusively for healthcare professionals. As a Class I device, it meets the safety and performance requirements defined by the competent authorities for reusable manual dental instruments, subject to maintenance in accordance with the instructions provided by Helmut Zepf.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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