Mirror Handle for Mouth Mirror - Helmut Zepf (24.080.01) - Delynov
The Manche pour 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: 24.080.01.
- 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 mouth mirror handle (24.080.01)?
The Helmut Zepf mouth mirror handle, referenced under code 24.080.01 at Delynov, is a manual dental instrument designed to support diagnostic mirrors. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is an essential tool in oral and dental surgery. Its robust structure ensures an optimal grip for the practitioner. This product is delivered non-sterile and requires a rigorous preparation protocol before any use. As a Class I instrument, it meets the regulatory requirements for non-invasive medical devices used in dental practices.
What are the clinical indications for this instrument?
The intended use for this Helmut Zepf mirror handle is that of a classic manual dental instrument. It is indicated for all diagnostic, oral surgery, and implantology procedures requiring the use of a mouth mirror to visualize operating areas that are difficult to access. This device is exclusively reserved for qualified healthcare professionals. Its role is to allow precise manipulation of the mirror to ensure perfect visibility during clinical examinations or surgical interventions. The manufacturer specifies that compatibility with other products, such as mirror heads, must be systematically verified by the practitioner before the procedure.
What are the technical and maintenance characteristics of the 24.080.01 handle?
This Helmut Zepf handle is distinguished by its medical stainless steel composition, guaranteeing resistance to repeated treatment cycles. Although there is no defined maximum limit for the number of achievable treatment cycles due to the quality of the materials, strict maintenance is mandatory. Before the first use and after each subsequent use, the instrument must be fully cleaned, disinfected, and sterilized. The practitioner must visually inspect the product to detect any damage, such as cracks, breaks, or surface defects. It is imperative never to use an instrument showing visible signs of wear.
What are the contraindications for using this mirror handle?
The main contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns hypersensitivity to metals. Contact with this medical stainless steel instrument may cause an intolerance or hypersensitivity reaction in certain sensitive patients. If such a reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to check the patient's history of metal allergies before any manipulation. Furthermore, the use of damaged or worn products is formally prohibited to guarantee patient safety and the effectiveness of the examination.
What are the precautions for use and reprocessing?
The Helmut Zepf mirror handle requires particular vigilance regarding its reprocessing. As it is delivered non-sterile, the cleaning and sterilization steps are crucial before any intraoral placement. The manufacturer insists that each product must be cleaned before use. Due to its design and the materials used, the number of sterilization cycles depends on the physical condition of the instrument. The user must ensure that the device shows no structural failure before each procedure. Compliance with these safety and use instructions is essential to maintain the integrity of the stainless steel and clinical safety.
Who is the manufacturer and what standards are met by this device?
The mouth mirror handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer follows strict manufacturing protocols to ensure the compliance of its manual dental instruments. Although specific CE marking is not detailed in the provided sources, the product is classified as a Class Ir medical device (MDC0483) according to the raw reference MDR text. As a professional instrument, it is exclusively intended for use by experts in the dental and surgical sector, in accordance with the manufacturer's indications.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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