Spatula for Implantology Helmut Zepf (26.260.00) - Delynov
The spatule pour implantologie Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.260.00.
- 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 implantology spatula (26.260.00)?
The Helmut Zepf implantology spatula, referenced under code 26.260.00 at Delynov, is a manual dental instrument specifically designed for oral surgery procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, this tool is crafted from medical-grade stainless steel, ensuring robustness suited to clinical requirements. This device belongs to the consumables category and is classified as a Class I medical device. It is delivered non-sterile and requires a complete protocol of cleaning, disinfection, and sterilization before its first use, as well as between each patient, to guarantee optimal safety of use within the surgical activity.
What are the clinical indications for this instrument?
This Helmut Zepf spatula is indicated for use as a manual dental instrument during implantology or dental surgery procedures. Its intended purpose is to manipulate materials or assist the practitioner during operative phases requiring fine and rigid instrumentation. As a medical stainless steel instrument, it is intended to be used exclusively by qualified healthcare professionals. The manufacturer specifies that the instrument must be inspected before each use to detect any visible damage, such as cracks, breaks, or defects on the cutting edges, to ensure a damaged or worn product that could compromise the surgical procedure is never used.
What are the technical characteristics of the 26.260.00 spatula?
The Helmut Zepf 26.260.00 spatula is characterized by its medical stainless steel composition, a standard material for precision surgical instrumentation. Due to its design and the materials used, there is no defined maximum limit for the number of processing cycles (cleaning and sterilization) achievable, as long as the instrument does not show signs of wear or degradation. It is designed to be compatible with other products in the manufacturer's range, subject to prior verification by the practitioner. This Class I device meets the durability requirements for repeated use after appropriate reprocessing in an autoclave.
What are the contraindications for the use of this spatula?
The main contraindication related to the use of this instrument is metal intolerance in the patient. Contact with medical stainless steel can, in certain sensitive subjects, trigger a hypersensitivity reaction. If such a reaction occurs during the intervention, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the procedure must be immediately stopped and necessary medical measures must be taken accordingly. Furthermore, the use of the instrument is strictly prohibited if it shows visible damage, signs of wear, cracks, or structural defects that could harm the safety of the patient or healthcare personnel.
What are the maintenance and sterilization precautions?
The reprocessing of the Helmut Zepf spatula is a critical step. All instruments must imperatively be cleaned, disinfected, and sterilized before their very first use. This procedure must be fully repeated before each subsequent use. The manufacturer emphasizes the importance of cleaning each product to remove any residue before the sterilization cycle. It is the responsibility of the healthcare professional to check the condition of the instrument (absence of breaks or defects on the edges) before each act. As the device is delivered non-sterile, strict compliance with current sterilization protocols is essential to prevent any risk of cross-contamination.
Who is the manufacturer and what standards are met?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with the current regulations for manual dental instruments and is listed as Class I (or Class Ir according to the raw MDR text for reusable instruments). The manufacturer guarantees the traceability and quality of the medical stainless steel used. As a Class I medical device, it meets the safety and performance requirements defined by health authorities for non-invasive or invasive surgical instruments for temporary use, intended exclusively for professional use in dental offices or hospital environments.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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