Apical Elevator West No.1 with Handle No.1 - Hu-Friedy - Delynov
The Elévateur Apical West #1 manche #1 - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the West #1 apical elevator handle #1 - Hu-Friedy?
The West #1 apical elevator is a precision instrument manufactured by Hu-Friedy Mfg. Co., LLC, intended for oral surgery. This device consists of a specific working part, the West #1 model, mounted on a #1 type handle. It belongs to the category of manual luxation instruments. Its structure is designed to meet the requirements of practitioners during dental extractions. As a product from a recognized manufacturer, this instrument meets the quality standards necessary for clinical interventions in dental offices or hospital settings. It is exclusively reserved for professional use by qualified oral surgery practitioners.
What are the clinical indications?
The use of the Hu-Friedy brand West #1 apical elevator is primarily indicated for the extraction of roots, root fragments, or apices. In oral and implant surgery, this instrument is used to break the periodontal ligament fibers and luxate the dental structure before using forceps. It is particularly useful in situations where access to roots is restricted or when roots are fractured below the level of the alveolar crest. Its application allows for careful preparation of the alveolar site, a crucial step for the preservation of surrounding tissues during immediate extraction-implantation protocols.
What are the technical characteristics?
The West #1 apical elevator is characterized by a refined working part, optimized to fit into the periodontal space. The #1 handle offers a grip adapted to the rotation and leverage maneuvers necessary for root mobilization. Manufactured by Hu-Friedy Mfg. Co., LLC, this Class I instrument benefits from the production expertise of the manufacturer located in Chicago. Although specific material details are not listed in the source data, the overall design of the instrument aims to ensure efficient force transmission during luxation while allowing precise manipulation in dense anatomical areas.
What are the contraindications for use?
According to information from the manufacturer Hu-Friedy, the use of this instrument is strictly reserved for duly trained healthcare professionals. Although no specific medical contraindication related to a pathology or material is explicitly mentioned in the raw MDR documentation provided, the practitioner must assess the relevance of using the elevator based on the patient's clinical condition. The instrument should not be used for functions other than those intended by the manufacturer, such as the manipulation of non-dental or non-indicated bone structures, to avoid any risk of instrument breakage or iatrogenic injury.
What are the precautions for use and maintenance?
Like any Class I instrument intended for surgery, the Hu-Friedy West #1 apical elevator requires rigorous handling. It is imperative to read the instructions carefully before any use. Before the first use and after each intervention, the device must follow a cleaning, disinfection, and sterilization protocol in accordance with the manufacturer's guidelines and current hygiene standards. The practitioner must inspect the instrument before use to detect any signs of wear or deformation of the active tip. Inappropriate use, such as applying excessive leverage on an inadequate fulcrum, can compromise the integrity of the instrument or damage periodontal tissues.
Who is the manufacturer and what standards are met?
The official manufacturer of this instrument is Hu-Friedy Mfg. Co., LLC, headquartered at 3232 N. Rockwell St. Chicago, IL 60618, USA. This medical device is classified as Class I according to current regulations. Compliance with Hu-Friedy's manufacturing protocols ensures that the instrument meets the safety and performance requirements for oral surgery interventions. As a Class I device, it is subject to the conformity assessment procedures applicable to this category, thus providing healthcare professionals with a reliable tool for their daily practice in clinics or specialized surgery centers.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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