Cement spatula with octagonal handle - Helmut Zepf (26.130.01) - Delynov
The Spatule à ciment avec manche octogonal - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.130.01.
- 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 cement spatula with octagonal handle?
The cement spatula with octagonal handle (reference 26.130.01) is a manual dental instrument designed by Helmut Zepf Medizintechnik GmbH. This medical device is manufactured from high-quality medical stainless steel, ensuring robustness suited to the requirements of dental surgery. Its structure is distinguished by an ergonomic octagonal handle offering a precise grip for the practitioner. As a Class I instrument, it is specifically developed for the handling and mixing of sealing materials in the dental office. This product is delivered non-sterile by Delynov and requires a complete preparation protocol before any clinical use.
What are the clinical indications for this Helmut Zepf instrument?
This manual dental instrument is indicated for dentistry procedures requiring the preparation and application of cements. Its intended use by the manufacturer Helmut Zepf Medizintechnik GmbH concerns exclusively qualified healthcare professionals. It is used during restoration or prosthetic sealing phases to handle dental materials. Thanks to its medical stainless steel design, it allows for a homogeneous mixing of components. It is imperative to check the integrity of the instrument before each intervention to detect any visible damage, such as cracks or defects on the edges, in order to guarantee patient safety and the effectiveness of the surgical act.
What are the technical characteristics of the 26.130.01 spatula?
The Helmut Zepf cement spatula is characterized by its technical reference 26.130.01 and its medical stainless steel manufacturing. Its particularity lies in its octagonal handle, which ensures optimal control when applying mixing forces. This device belongs to the INSTRU category and is classified as a Class I instrument according to medical device regulations. Due to its design and the materials used, there is no defined maximum limit for achievable processing cycles, provided that the instrument shows no visible wear. Its compatibility with other dental products must be verified by the professional before the procedure.
What are the contraindications for the use of this cement spatula?
The main contraindication related to the use of this instrument is metal intolerance in the patient. Contact with medical stainless steel can lead to undesirable side effects or a hypersensitivity reaction. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. Furthermore, the use of the instrument is strictly contraindicated if it shows visible damage, breaks, or pronounced wear. Using damaged products compromises clinical safety and compliance with care protocols.
What are the maintenance and sterilization precautions?
Helmut Zepf instruments are delivered non-sterile and must imperatively follow a complete reprocessing cycle before the first use and after each subsequent use. The mandatory protocol includes cleaning, disinfection, and sterilization. It is crucial to carefully clean each product to remove any residue before autoclaving. The practitioner must inspect the instrument to identify any trace of corrosion, crack, or deformation. Due to the quality of the stainless steel used, the number of sterilization cycles is not arbitrarily limited, but depends on the actual physical condition of the spatula. Never use an instrument whose integrity is compromised.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with current regulations and is classified as Class I (Class Ir according to certain reprocessing nomenclatures). The manufacturer imposes strict instructions for use and safety, reserving the use of this manual instrument to healthcare professionals only. Compliance with cleaning and sterilization protocols is a sine qua non condition for maintaining the device's conformity. Traceability is ensured by the product code 26.130.01, guaranteeing the origin and quality of the materials used by Helmut Zepf.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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