Universal PEEK Handle for Dental Surgery - Helmut Zepf (26.194.15) - Delynov
The Manche universel en PEEK pour le dentaire - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.194.15.
- 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 (26.194.15)?
The PEEK (polyetheretherketone) universal handle from the Helmut Zepf brand is a manual dental instrument designed to offer optimal ergonomics during surgical procedures. This Class I medical device, referenced under code 26.194.15, is distinguished by the use of high-performance materials adapted to the requirements of the clinical environment. Although the body of the handle is made of PEEK, it is important to note that the associated instrumentation may include medical stainless steel elements. This handle is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and requires a rigorous preparation protocol before any use in a dental practice or operating room.
What are the clinical indications for this instrument?
This universal handle is indicated as a manual dental instrument for various oral surgery and implantology procedures. Its intended purpose is to serve as a support for compatible inserts or tools during manual interventions on dental or periodontal tissues. As a Class I medical device, it is exclusively reserved for use by qualified healthcare professionals. Its design allows for precise handling, essential for dental surgeons and implantologists. Compatibility with other products and instruments should be systematically checked before starting any clinical procedure.
What are the technical and maintenance characteristics?
The Helmut Zepf universal handle (26.194.15) is designed to be reusable. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH specifies that there is no defined maximum limit for the number of feasible processing cycles, as long as the instrument does not show visible damage. Before each use, the practitioner must imperatively inspect the product to detect any cracks, breaks, or defects on the cutting edges. Any instrument showing signs of wear or damage must never be used in order to guarantee patient safety and the effectiveness of the surgical act.
What are the contraindications for the use of this handle?
The main contraindication related to the use of this manual instrument concerns metal intolerance. Although the handle is made of PEEK, contact with medical stainless steel parts can trigger a hypersensitivity reaction in certain sensitive patients. If such an allergic reaction or intolerance occurs during the intervention, the procedure must be stopped immediately. Necessary medical measures must then be taken accordingly. It is therefore recommended to question the patient about their history of metal allergies before any manipulation with this Helmut Zepf instrument.
What are the sterilization and hygiene precautions?
In accordance with the safety instructions of the manufacturer Helmut Zepf Medizintechnik GmbH, all instruments must be cleaned, disinfected, and sterilized before the very first use. This complete reprocessing protocol must be rigorously repeated before each subsequent use. Preliminary cleaning is a critical step to eliminate any residue before the sterilization phase. As the products are delivered non-sterile, strict compliance with the disinfection and sterilization cycles in force in healthcare facilities is imperative to prevent any risk of cross-contamination between patients.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This universal handle is classified as a Class I medical device according to the current regulations. The manufacturer emphasizes that the use of this instrument is strictly reserved for healthcare professionals. Traceability and compliance with safety requirements are ensured by Helmut Zepf's manufacturing protocols, including precise instructions on reprocessing and maintenance to guarantee the longevity and safety of use of the manual dental instrumentation.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |