Mirror handle with mouth - Helmut Zepf (24.089.02) - Delynov
The Manche de miroir à bouche - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.089.02.
- 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 is the Helmut Zepf mouth mirror handle (24.089.02)?
The Helmut Zepf mouth mirror handle, referenced under code 24.089.02, is a manual dental instrument designed for healthcare professionals. Manufactured from high-quality medical stainless steel, this accessory is essential for securely holding mirrors during examinations and oral surgery procedures. This device belongs to the INSTRU category and benefits from the expertise of Helmut Zepf Medizintechnik GmbH. Delivered non-sterile, it requires a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient to guarantee irreproachable hygiene in the dental practice.
What are the clinical indications for this instrument?
This mirror handle is indicated as a manual dental instrument to facilitate visual exploration and clinical procedures in dentistry and oral surgery. Its use is strictly reserved for qualified healthcare professionals. It allows for precise manipulation of the mouth mirror for the observation of soft and hard tissues. The manufacturer Helmut Zepf specifies that the instrument must be inspected before each use to detect any visible damage or wear, such as cracks or defects, in order to never use a damaged product that could compromise the safety of care.
What are the technical characteristics of the 24.089.02 handle?
The Helmut Zepf mirror handle (ref. 24.089.02) is distinguished by its medical stainless steel design, a material chosen for its durability and resistance to repeated reprocessing cycles. As a Class I device, it meets the safety requirements for non-invasive manual instruments. Its structure is designed to offer an ergonomic grip for the practitioner. Due to its metallic composition and robust design, the manufacturer indicates that there is no defined maximum limit of treatment cycles, as long as the instrument does not show signs of wear or structural degradation.
What are the contraindications for the use of this device?
The main contraindication related to the use of this medical stainless steel mirror handle concerns metal intolerance. A hypersensitivity reaction in the patient can be triggered upon contact with the instrument. If such an allergic reaction or intolerance occurs during the procedure, the manufacturer Helmut Zepf stipulates that the intervention must be immediately stopped and that the necessary medical measures must be taken accordingly. It is therefore recommended to check the patient's history of metal allergies before any clinical manipulation.
What are the maintenance and sterilization precautions?
The reprocessing of this instrument is a critical step. All Helmut Zepf products are delivered non-sterile and must imperatively be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. The process must be complete and rigorous. Before sterilization, the practitioner must check compatibility with other products used and visually inspect the handle to identify any potential breaks or defects on the edges. The use of worn or damaged products is strictly prohibited to guarantee patient safety and the effectiveness of the surgical act.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I instrument compliant with current regulations for medical devices (MDR). The manufacturer ensures the traceability and quality of the medical stainless steel used. As a manual dental instrument intended exclusively for professionals, it respects the rigorous manufacturing standards of Helmut Zepf. The safety and use instructions provided by the manufacturer must be scrupulously followed to maintain the compliance of the device throughout its useful life within the clinic.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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