Single Point - Helmut Zepf (26.428.04) - Delynov
The Pointe Seule - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.428.04.
- 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 Pointe Seule - Helmut Zepf (26.428.04)?
The Pointe Seule - Helmut Zepf, referenced under code 26.428.04, is a high-precision manual dental instrument designed by Helmut Zepf Medizintechnik GmbH. This medical device belongs to the category of consumables (CONSO) and is manufactured from medical-grade stainless steel. As a Class I device, it meets the regulatory requirements for use in dental practices and oral surgery. This instrument is delivered non-sterile by the manufacturer, requiring a complete preparation protocol before its first clinical use. Its robust stainless steel design ensures durability adapted to the requirements of healthcare professionals, while requiring rigorous inspection before each procedure to guarantee the absence of structural defects.
What are the clinical indications for this Helmut Zepf instrument?
The Pointe Seule (26.428.04) is indicated as a manual dental instrument for various interventions in oral and dental surgery. Its use is strictly reserved for qualified healthcare professionals. It is intended to be handled during procedures requiring the precision of a medical stainless steel tool. The manufacturer Helmut Zepf specifies that the instrument must be systematically checked before use to detect any visible damage such as cracks, breaks, or defects on the cutting edges. The use of a damaged or worn product is formally prohibited to guarantee patient safety and the effectiveness of the surgical act.
What are the technical characteristics of reference 26.428.04?
Technically, reference 26.428.04 is defined by its medical stainless steel composition, a standard material for manual dental instrumentation offering the mechanical resistance necessary for intra-oral care. This device is classified as Class I according to medical device regulations. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH indicates that there is no defined maximum limit for processing cycles (cleaning, disinfection, sterilization) as long as the physical integrity of the instrument is preserved. It is imperative to check compatibility with other products used simultaneously during the intervention.
What are the contraindications and side effects related to this instrument?
The main contraindication for the use of the Pointe Seule Helmut Zepf concerns patients with a known intolerance or hypersensitivity to metals, specifically medical stainless steel. Contact with the instrument may trigger a hypersensitivity reaction in these subjects. If such a reaction occurs during the procedure, the manufacturer stipulates that the intervention must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any handling. Additionally, use is contraindicated if the instrument shows visible signs of wear or defects on the sharp edges.
What are the maintenance and sterilization precautions?
Like any manual dental instrument of the Helmut Zepf brand, the pointe seule must imperatively follow a complete reprocessing cycle before each use. Delivered non-sterile, products must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. Preliminary cleaning is a critical step to remove any residue before sterilization. The professional must meticulously inspect the instrument to identify any cracks or breaks. The absence of a predefined limit for processing cycles imposes increased vigilance on the user regarding the functional wear status of the stainless steel to decide on the maintenance or removal of the device from the instrument pool.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This manufacturer is recognized for its expertise in manual dental instrumentation. The Pointe Seule (26.428.04) product complies with current medical device regulations, classified as Class I. Compliance with the safety and use instructions provided by Helmut Zepf is essential to guarantee the conformity of care. Healthcare professionals must ensure compliance with the cleaning and sterilization protocols recommended by the manufacturer to maintain the level of performance and safety required for this type of surgical instrumentation.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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