Universal PEEK Handle - Helmut Zepf (26.193.13) - 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: 26.193.13.
- 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 (26.193.13)?
The PEEK universal handle, referenced under code 26.193.13, is a manual dental instrument designed by Helmut Zepf Medizintechnik GmbH. This device is distinguished by its ergonomic design using PEEK, a high-performance polymer material, combined with medical stainless steel components. This instrument is specifically developed to provide an optimal grip during oral and dental surgery procedures. As a Class I device, it meets the regulatory requirements for non-invasive or invasive instruments for temporary use. This universal handle is delivered non-sterile by Delynov and requires a complete preparation protocol before its first use in the office or operating room.
What are the clinical indications for this Helmut Zepf instrument?
This universal handle is indicated as a manual dental instrument for various oral surgery procedures. Its intended use by the manufacturer Helmut Zepf Medizintechnik GmbH is strictly reserved for qualified healthcare professionals. It serves as an ergonomic support for compatible inserts, facilitating technical movements in implantology, periodontology, or general dental surgery. Its design allows for precise manipulation, essential for practitioners demanding constant reliability. It is imperative to verify compatibility with other products and instruments before any intervention to ensure patient safety and the effectiveness of the clinical procedure.
What are the technical and maintenance characteristics of the 26.193.13 handle?
The Helmut Zepf universal handle (26.193.13) is manufactured from medical stainless steel and PEEK. Due to its robust design and the materials used, the manufacturer specifies 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, complete cleaning, disinfection, and sterilization are mandatory. The practitioner must imperatively inspect the device to detect any visible damage, such as cracks, breaks, or structural defects. Any damaged or worn instrument must never be used in order to maintain the integrity of care.
What are the contraindications for the use of this device?
The main contraindication related to the use of this Helmut Zepf instrument concerns hypersensitivity to materials. Contact with the instrument, which contains medical stainless steel, can cause undesirable side effects in patients with metal intolerance. If a hypersensitivity reaction is triggered during the surgical act, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. It is the responsibility of the healthcare professional to evaluate the patient's allergic history before any manipulation with this Class I instrument to prevent any risk of inflammatory or allergic reaction.
What are the precautions for use and safety instructions?
The use of the Helmut Zepf PEEK universal handle requires strict compliance with the manufacturer's safety instructions. All instruments must be cleaned before the first use and after each subsequent use. The process must systematically include cleaning, disinfection, and sterilization. It is crucial to check for the absence of visible damage such as cracks or defects on the edges before each intervention. This equipment is exclusively reserved for healthcare professionals. As the products are delivered non-sterile, the responsibility for implementing the reprocessing protocol lies with the practitioner, ensuring compatibility with other devices used simultaneously.
Who is the manufacturer and what standards are respected by this product?
The universal handle is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I according to current regulations. The manufacturer ensures the compliance of its production processes to meet the demanding quality standards of the dental sector. Although the specific CE marking is not detailed in the source data, the product follows the directives relating to manual dental instruments. Compliance with the cleaning and sterilization cycles recommended by Helmut Zepf guarantees the longevity of the device and the safety of patients during care provided by dental surgeons.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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