Universal Handle for Dental Surgery. PEEK. - Helmut Zepf (26.193.06) - Delynov
The ZEPF-BIONIK MANCHE UNIVERSEL. PEEK. - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.193.06.
- 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 ZEPF-BIONIK MANCHE UNIVERSEL PEEK?
The ZEPF-BIONIK MANCHE UNIVERSEL (reference 26.193.06) is a manual dental instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This handle is distinguished by the use of PEEK (Polyetheretherketone) and medical stainless steel in its structure. It is a Class I device intended for professional use in dental and oral surgery. This universal handle is delivered non-sterile by Helmut Zepf and requires a complete cleaning, disinfection, and sterilization protocol before its first use, as well as between each subsequent use to ensure the safety of patients and practitioners.
What are the clinical indications for this instrument?
The intended purpose of this manual dental instrument is its use during clinical procedures in dental offices or oral surgical environments. As a Helmut Zepf universal handle, it serves as an ergonomic support for various compatible inserts or tools. It is exclusively reserved for qualified healthcare professionals. Its use requires prior verification of compatibility with other products used during the intervention. The integrity of the instrument must be ensured before each act by checking for the absence of visible damage such as cracks or defects on the contact surfaces.
What are the technical characteristics of handle 26.193.06?
The ZEPF-BIONIK universal handle, bearing technical reference 26.193.06, is manufactured from high-performance materials including PEEK and medical stainless steel. Its design allows for repeated reprocessing in an autoclave. Due to the robustness of the materials used, the manufacturer Helmut Zepf indicates that it is not possible to define a strict maximum limit of achievable treatment cycles, as long as the instrument does not show visible wear. The user must systematically inspect the device for potential breaks or defects before any clinical manipulation, thus ensuring the maintenance of the instrument's technical performance.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer concerns metal intolerance. Although the body of the handle uses PEEK, contact with medical stainless steel parts may trigger undesirable side effects or a hypersensitivity reaction in some patients. If such an allergic reaction or intolerance occurs during the procedure, the practitioner must immediately stop the intervention and take the necessary medical measures. Furthermore, the use of the instrument is strictly prohibited if it shows visible damage, cracks, or marked signs of wear that could compromise the safety of the care.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use and after each use. The cleaning process must be complete to eliminate all residues. It is crucial to check for the absence of visible damage, such as cracks or defects on the cutting edges or attachment points, before proceeding with sterilization. Never use damaged or worn products. The durability of the handle depends directly on compliance with reprocessing protocols and careful handling by healthcare personnel. Compatibility with cleaning solutions and autoclave cycles must comply with the manufacturer's instructions.
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 listed as a Class I medical device (Class Ir according to the mentioned MDC0483 nomenclature). It meets the regulatory requirements for manual dental instruments. The products are delivered non-sterile and must be prepared according to the safety and use instructions provided by Helmut Zepf. Compliance with these standards guarantees the traceability and conformity of the device for safe use within dental and surgical care facilities.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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