Langenbeck Retractor - Helmut Zepf (38.430.04)
Product features
The LANGENBECK Écarteur - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Intended use: Surgical instrument intended for oral, dental, periodontal, and implant surgery, used by trained practitioners in sterile environments.
- Reference: 38.430.04.
- 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 Un instrument pour maintenir la zone chirurgicale ouverte. 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 LANGENBECK retractor?
The LANGENBECK retractor, bearing reference 38.430.04, is a high-precision surgical instrument designed by Helmut Zepf Medizintechnik GmbH. This tool is manufactured from high-quality medical stainless steel, ensuring the robustness required for the demands of oral and maxillofacial surgery. Its structure is specifically designed to offer ergonomic handling while ensuring optimal durability. This device is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use in the office or operating room. As a reusable instrument, its design allows for multiple processing cycles, although a rigorous inspection before each use is imperative to detect any potential damage or visible signs of wear.
What are the clinical indications for this instrument?
The Helmut Zepf LANGENBECK retractor is intended for the primary indication of maintaining the surgical field open during interventions. In dental, implant, or oral surgery, it allows for the retraction of soft tissues, such as mucoperiosteal flaps or cheeks, to provide the practitioner with optimal visibility and secure access to the operative site. This instrument facilitates the exposure of essential anatomical structures, thereby allowing for increased precision during complex surgical procedures. Its use is strictly reserved for qualified healthcare professionals trained in surgical techniques requiring stable and controlled tissue retraction.
What are the technical characteristics of the 38.430.04 retractor?
The LANGENBECK retractor (reference 38.430.04) is distinguished by its medical stainless steel construction, a material chosen for its corrosion resistance and compatibility with repeated sterilization processes. According to data from the manufacturer Helmut Zepf Medizintechnik GmbH, the instrument's design does not define a maximum limit for processing cycles, as this depends on the intended use and compliance with cleaning protocols. Before each intervention, the practitioner must check for the absence of cracks, breaks, or defects on the edges. Compatibility with other products used during surgery must also be verified beforehand to ensure patient safety and surgical efficiency.
What are the contraindications for the use of this retractor?
The main contraindication for the use of this instrument is metal intolerance in the patient. Contact with medical stainless steel can, in some cases, cause a hypersensitivity reaction or intolerance. If such a reaction occurs during the intervention, the procedure must be stopped immediately and necessary medical measures must be taken accordingly. Furthermore, the use of the instrument is strictly prohibited if it shows visible damage, such as cracks or structural defects, as this could compromise patient safety or the integrity of the manipulated tissues. Insufficient cleaning also constitutes a major contraindication to its implementation.
What are the precautions for use and maintenance?
As the LANGENBECK retractor is a non-sterile device upon delivery, it is crucial to follow a strict protocol: every instrument must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. The manufacturer emphasizes the vital importance of cleaning to remove all residues before sterilization. Professionals must inspect the instrument for any wear, cracks, or breaks, particularly on the active parts. Never use damaged products. Due to the materials used, there is no fixed limit for reprocessing cycles, but the practitioner's vigilance during preoperative inspection is decisive in ensuring the continued performance of the Helmut Zepf brand instrument.
Who is the manufacturer and what standards are respected?
The LANGENBECK retractor is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer adheres to rigorous production standards to guarantee the quality of its medical stainless steel instruments. Although specific CE marking is not detailed in the provided sources, the product complies with the requirements of its regulatory class for use by healthcare professionals. Each instrument is designed to meet the specific needs of dental and oral surgery, while respecting safety instructions and indications related to the intended purpose of the device.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs that minimize tissue trauma. Precision and reliability are top priorities.
Specifications
| Manufacturer | Helmut Zepf |
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