Axial Instrument - Helmut Zepf (26.200.13)
The Instrument axial - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.200.13.
- 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 instrument (26.200.13)?
The Helmut Zepf axial instrument (reference 26.200.13) is a manual dental instrument designed for oral surgery interventions. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this tool is specifically developed to meet the requirements of healthcare professionals. This device belongs to Class I of medical devices. It is delivered non-sterile and requires a complete preparation protocol before any clinical use. Its robust stainless steel design ensures durability suitable for intensive professional use, while requiring rigorous inspection to detect any visible damage or wear, such as cracks or defects on the cutting edges, before each intervention.
What are the clinical indications for this dental instrument?
This Helmut Zepf manual instrument is indicated for use during dental and surgical procedures in private practices or hospital settings. Its intended purpose is to assist the practitioner as a manual dental instrument during various clinical manipulations. Due to its metallic nature, it is exclusively reserved for use by qualified healthcare professionals. The primary indication is based on the need for a precision tool made of medical stainless steel for dental surgery procedures. It is imperative to verify the compatibility of this axial instrument with other products used during the procedure to ensure optimal safety for the patient and the practitioner during the operation.
What are the technical characteristics of instrument 26.200.13?
The Helmut Zepf axial instrument is distinguished by its medical stainless steel composition, a standard material for surgical instrumentation guaranteeing appropriate mechanical resistance. Listed under technical reference 26.200.13, this device is classified as Class I according to current regulations. A major characteristic of this instrument is the absence of a defined maximum limit for achievable processing cycles. This durability directly depends on compliance with reprocessing protocols and the physical condition of the tool. The manufacturer specifies that the product must be systematically cleaned, disinfected, and sterilized before the first use and after each subsequent use. The absence of visible damage, breakage, or defects on the active parts is an indispensable technical prerequisite before any manipulation.
What are the contraindications for the use of this instrument?
The main contraindication for the use of this Helmut Zepf axial instrument concerns patients with a known intolerance to metals. Contact with medical stainless steel can, in certain cases, trigger a hypersensitivity reaction or undesirable side effects in sensitive subjects. If such an allergic reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. Furthermore, the use of the instrument is formally contraindicated if it shows signs of wear, cracks, breakage, or defects on the cutting edges, as this could compromise the safety of the care and the integrity of the patient's tissues.
What are the maintenance and sterilization precautions?
As the instrument is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, a complete reprocessing cycle is mandatory before the first commissioning. This includes thorough cleaning, disinfection, and sterilization. These steps must be repeated before each subsequent use to prevent any risk of cross-contamination. It is crucial to visually inspect the instrument to identify any premature wear. The manufacturer emphasizes that due to the design and materials used, there is no predefined maximum number of sterilization cycles, but the practitioner must judge the suitability of the instrument based on its surface condition and structural integrity. The use of damaged or worn products is strictly prohibited.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with the applicable regulations for Class I products. The manufacturer ensures the traceability and quality of the medical stainless steel used in the design of its instruments. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the conformity of the device during its clinical use. This product is exclusively reserved for healthcare professionals, ensuring that its handling and reprocessing are carried out according to current medical standards. Compliance relies on a strict cleaning and sterilization protocol under the responsibility of the end user.
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Specifications
| Manufacturer | Helmut Zepf |
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