Universal PEEK Handle - Helmut Zepf (26.194.68) - Delynov
The Manche universel en PEEK - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.68.
- 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 PEEK universal handle (26.194.68)?
The PEEK universal handle, referenced under code 26.194.68 by Helmut Zepf, is a manual dental instrument designed to provide optimal ergonomics during surgical interventions. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is distinguished by the use of PEEK, a high-performance polymer, combined with medical stainless steel components. This handle is specifically developed for healthcare professionals demanding lightweight and resistant instruments. It integrates perfectly into the arsenal of oral surgery and implantology practitioners, guaranteeing precise handling. This product is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use in the dental office.
What are the clinical indications for this Helmut Zepf instrument?
The Helmut Zepf universal handle is indicated as a manual dental instrument for various oral surgery procedures. Its intended purpose is to serve as an ergonomic support for practitioners during operative phases. As a Class I device, it meets the standard needs of clinicians for general and specialized dentistry procedures. The manufacturer specifies that the use of this instrument is strictly reserved for qualified healthcare professionals. It is essential to verify the compatibility of the handle with other products and accessories used before any intervention to ensure patient safety and the effectiveness of the surgical gesture.
What are the technical characteristics of this device?
This universal handle (reference 26.194.68) is designed using PEEK and medical stainless steel, materials recognized for their durability in the surgical field. Due to its robust design and the materials used, Helmut Zepf Medizintechnik GmbH indicates that there is no defined maximum limit for the number of processing cycles achievable, as long as the instrument does not show signs of wear. Before each use, the practitioner must imperatively inspect the handle to detect any visible damage, such as cracks, breaks, or structural defects. Any product showing marked wear or degradation must be immediately discarded to guarantee the integrity of care.
What are the contraindications and possible side effects?
The main contraindication concerns patients presenting an intolerance or hypersensitivity to metals, notably the medical stainless steel used in the composition of the instrument. Contact with the instrument may trigger a hypersensitivity reaction in these patients. If such a reaction occurs during the procedure, the manufacturer Helmut Zepf stipulates that the intervention must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any use. Furthermore, the use of damaged products or those presenting defects on the cutting edges is formally prohibited.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must follow a strict reprocessing protocol. They must be cleaned, disinfected, and sterilized before the very first use, as well as after each subsequent use. The manufacturer emphasizes that it is of the utmost importance to clean each product before proceeding to final sterilization. Professionals must ensure that the cleaning process is complete to eliminate all residue. As the device is delivered non-sterile, compliance with hygiene instructions is a sine qua non condition to prevent the risks of cross-infection. A meticulous inspection for damage and wear must be carried out systematically after reprocessing.
Who is the manufacturer and what standards are respected?
The universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to the current regulations. The manufacturer guarantees the quality of its products through rigorous manufacturing processes compliant with the requirements for manual dental instruments. Although specific CE marking is not detailed in the source data, the product is explicitly classified as Class Ir (MDC0483) in the associated technical documentation, confirming its status as a regulated medical device. Its use is strictly reserved for trained healthcare professionals, thus guaranteeing application in accordance with clinical safety standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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