Universal PEEK Handle - Helmut Zepf (26.193.14) - 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: 26.193.14.
- 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?
The PEEK universal handle, referenced under code 26.193.14 at Delynov, is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This ergonomic device is manufactured from PEEK (Polyetheretherketone), a high-performance material recognized for its strength and lightness. It is specifically developed to serve as a support for dental instruments during surgical interventions. This handle is part of the category of reusable instruments, requiring a strict cleaning and sterilization protocol before each use. Its universal design allows for fluid integration into dental and implant surgery protocols, offering precise manipulation for practitioners.
What are the clinical indications for this instrument?
This universal handle from the Helmut Zepf brand is indicated as a manual dental instrument for various procedures in oral and implant surgery. Its intended purpose is to serve as a support during clinical manipulations by qualified healthcare professionals. It is intended to be used in a sterile environment after undergoing a full reprocessing cycle. The use of this instrument is reserved exclusively for trained healthcare professionals, thus ensuring safe application compliant with the specific needs of each patient during dental care.
What are the technical characteristics of handle 26.193.14?
The Helmut Zepf universal handle (26.193.14) is distinguished by its PEEK composition, a technical polymer offering excellent durability against repeated sterilization cycles. Although the main body is made of PEEK, the instrument may include medical stainless steel elements. It is classified as a Class I medical device. This product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH and must imperatively be cleaned, disinfected, and sterilized before its first use, as well as between each patient. Due to its robust design, there is no defined maximum limit for treatment cycles, subject to rigorous visual inspection.
What are the contraindications and side effects?
The main contraindication concerns metal intolerance in the patient. Although the handle is primarily made of PEEK, contact with medical stainless steel parts may trigger a hypersensitivity or intolerance reaction. If such an allergic reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any use. Additionally, the use of the instrument is contraindicated if it shows visible damage such as cracks, breaks, or structural defects.
What are the maintenance and safety precautions?
To ensure patient safety and device longevity, all Helmut Zepf instruments must be fully cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is imperative to check the condition of each product before use to detect any damage or signs of wear. Never use damaged products or those with defective cutting edges. Compatibility with other instruments must also be checked beforehand. The reprocessing process must follow the health facility's standard protocols, taking into account that the number of achievable cycles depends on the maintenance and physical condition of the instrument.
Who is the manufacturer and what standards are respected?
The PEEK universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device complies with Class I according to current regulations. As a precision instrument, it meets the strict quality requirements imposed by the manufacturer for manual dental devices. Healthcare professionals can refer to the manufacturer's instructions for cleaning and sterilization to maintain product compliance and safety. This device is strictly reserved for professional use within the framework of dental and surgical care.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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