Bernard Right Angle Syndesmotome - Hu-Friedy - Delynov
The Syndesmotome Bernard droit - 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.
| Manufacturer: Hu-Friedy |
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What is the Hu-Friedy straight Bernard syndesmotome?
The straight Bernard syndesmotome is a precision surgical instrument manufactured by Hu-Friedy Mfg. Co., LLC. It belongs to the category of consumables and manual instruments intended for oral surgery. This instrument consists of a rigid handle and a straight, tapered working part. Unlike standard elevators, the Bernard syndesmotome is specifically developed to be inserted into the desmodontal space. Its structure allows for fine manipulation to break ligament attachments without damaging the surrounding alveolar bone walls, thus ensuring optimal site preparation before avulsion.
What are the clinical indications for the Bernard syndesmotome?
Le syndesmotome de Bernard est principalement indiqué lors des extractions chirurgicales simples ou complexes, notamment en implantologie où la préservation de la table osseuse est critique. En tant qu'instrument Hu-Friedy, il est utilisé pour sectionner le ligament parodontal (syndesmotomie) sur toute la circonférence de l'organe à extraire. Son utilisation clinique s'étend à la luxation primaire des racines, permettant de mobiliser l'organe avant d'appliquer une force de traction. Il est particulièrement efficace pour les secteurs antérieurs et prémolaires grâce à son axe droit, facilitant le passage dans le sulcus pour une séparation nette des tissus mous et durs.
What are the technical characteristics of this instrument?
Ce dispositif médical de Classe I se distingue par sa conception robuste et sa finition méticuleuse, caractéristiques de Hu-Friedy. Le modèle droit est doté d'une lame fine et tranchante qui permet une pénétration précise dans l'espace ligamentaire. Sa géométrie est conçue pour offrir un levier suffisant lors de la luxation tout en maintenant une sensibilité tactile élevée pour le praticien. L'instrument est conçu pour répondre aux exigences de stérilisation répétée en chirurgie orale. En tant que produit Hu-Friedy, il bénéficie de l'expertise industrielle de la marque basée à Chicago, garantissant la conformité aux normes de santé professionnelles.
What are the contraindications for the use of this device?
According to information provided by Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for qualified healthcare professionals. Contraindications include use on non-targeted anatomical structures or by personnel not trained in oral surgery techniques. Although specific medical contraindications are not exhaustively listed in the short technical documentation, the instrument should not be used in cases of extreme bone fragility where leverage force could cause an unwanted mandibular or maxillary fracture. It is imperative to read the instructions carefully before use.
What are the maintenance and handling precautions?
The Bernard syndesmotome, being a Class I reusable instrument, requires a rigorous decontamination and sterilization protocol after each intervention. The practitioner must visually inspect the integrity of the straight tip before use to ensure the absence of deformation or dullness that could compromise the precision of the syndesmotomy. Handling must be performed with care to avoid any trauma to the adjacent gingival tissues. Hu-Friedy recommends following the specific cleaning instructions to maintain the mechanical properties of the instrument over the long term and guarantee patient safety.
Who is the manufacturer and what standards are met?
The official manufacturer of this Bernard syndesmotome is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, IL 60618 in the USA. This medical device is classified as Class I according to current regulations. As a product intended exclusively for healthcare professionals, it meets the quality and safety requirements imposed for manual surgical instruments. Although specific CE marking is not mentioned in the source data, manufacturing by Hu-Friedy ensures compliance with rigorous manufacturing protocols. Practitioners are invited to consult the full instructions for use for additional regulatory details.
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