Universal Root - Helmut Zepf (14.700.01Z) - Delynov
The Racines Universel - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 14.700.01Z.
- 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 Pince à racines : instrument de type pince dentaire pour extraire les racines dentaires / les restes de racines. Pince à explantation : instrument de type pince dentaire pour extraire les racines dentaires artificielles (implants dentaires). 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 Racines Universel - Helmut Zepf (14.700.01Z)?
The Racines Universel by the brand Helmut Zepf is a high-precision surgical instrument designed for specialized dental procedures. Manufactured from medical stainless steel, this instrument is a robust dental forceps intended for the manipulation of residual or artificial dental structures. This device belongs to the consumables (CONSO) category and is classified as a Class I medical device according to current regulations. Developed by Helmut Zepf Medizintechnik GmbH, this model (reference 14.700.01Z) is delivered non-sterile and requires a complete protocol of cleaning, disinfection, and sterilization before its first use as well as after each procedure to ensure patient safety and tool longevity.
What are the clinical indications for this instrument?
The Racines Universel Helmut Zepf has two main clinical indications in oral surgery and implantology. As root forceps, it is specifically indicated for the extraction of natural dental roots or persistent root remains following a crown fracture. As explantation forceps, its use is intended for the extraction of artificial dental roots, commonly known as dental implants. Its universal design allows healthcare professionals to have a versatile instrument for complex avulsion procedures. The use of this instrument is strictly reserved for qualified healthcare professionals mastering dental surgical techniques.
What are the technical characteristics of model 14.700.01Z?
The technical characteristics of the Racines Universel (code_ref: 14.700.01Z) are based on the use of high-quality medical stainless steel, chosen for its mechanical resistance and its ability to undergo repeated reprocessing cycles. Due to the specific design of the product and the materials used by Helmut Zepf Medizintechnik GmbH, there is no defined maximum limit for treatment cycles; the lifespan depends on visible wear and the integrity of the cutting edges. Before each use, the practitioner must imperatively inspect the instrument to detect any potential damage such as cracks, breaks, or structural defects. The use of damaged or worn products is formally prohibited to maintain operative safety.
What are the contraindications for using these forceps?
The main contraindication for the use of the Racines Universel Helmut Zepf is patient metal intolerance. Contact of medical stainless steel with a patient presenting a known hypersensitivity can trigger allergic reactions or undesirable side effects. If such a hypersensitivity reaction occurs during the procedure, the manufacturer Helmut Zepf Medizintechnik GmbH stipulates that the procedure must be immediately stopped and that necessary medical measures must be taken accordingly. It is therefore recommended to evaluate the patient's allergic history before any surgical manipulation with this metallic instrument.
What are the maintenance and sterilization precautions?
As the Racines Universel is delivered non-sterile, it is imperative to follow a strict protocol before the first use and for each subsequent cycle. All instruments must be completely cleaned, disinfected, and sterilized. The reprocessing process must include a verification of compatibility with other products used simultaneously. It is crucial to clean each product before exposing it to sterilization to eliminate all organic residue. The manufacturer specifies that the number of achievable treatment cycles cannot be fixed, but depends on the physical condition of the instrument. Any sign of wear on the cutting edges or structural failure must lead to the immediate disposal of the device.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device is listed as Class I, meeting the regulatory requirements for non-invasive or surgically invasive dental instruments for temporary use. Compliance with Helmut Zepf manufacturing protocols guarantees an instrument that conforms to medical stainless steel standards. As a Class I device, it follows the safety and performance directives defined by the manufacturer for the extraction of natural and artificial roots. Traceability is ensured by the technical reference 14.700.01Z, allowing dental practices to maintain precise tracking of their surgical instrument inventory.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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