10 x IRRIGATION LINES - Bienair (1500984-010P) - Delynov
Product features
The 10 x LIGNES D'IRRIGATION - Bienair is a medical device manufactured by Bien-Air Dental SA — Class IIa, CE marking CE0459.
- Compliance: Medical device Class IIa, CE marking CE0459.
- Manufacturer: Bien-Air Dental SA.
- Intended use: Surgical consumable designed for oral, dental, and implant surgery procedures by qualified healthcare professionals.
- Reference: 1500984-010P.
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant : PROMEPLA SAM, 9 avenue Albert II, 98000 Monaco,. but prévu / indication Dispositif destiné à être utilisé en dentisterie générale pour la dentisterie restauratrice et la prophylaxie. Dispositif destiné à être utilisé en chirurgie buccale, chirurgie maxillo-faciale et parodontologie.lire attentivement la notice.
. réservé aux professionnels de santé.
What is the pack of 10 Bienair irrigation lines (1500984-010P) - Delynov?
The pack of 10 irrigation lines for Bienair systems, referenced under code 1500984-010P by the Marque, is an essential medical device for dental and oral surgery procedures. This technical consumable ensures the fluid and secure transport of irrigation solutions to the surgical site. Designed to meet the precision requirements of practitioners, these Marque irrigation lines guarantee optimal compatibility with Bienair equipment. They are part of a rigorous patient safety approach, allowing for effective cooling of tissues and rotary instruments during critical phases of drilling or implant placement. This Marque product is an indispensable element for maintaining a clean surgical field and preventing thermal overheating of bone tissues.
What are the clinical indications for these irrigation lines?
According to the manufacturer's data, this device is specifically intended for use in general dentistry for restorative dentistry and prophylaxis procedures. Its indications also extend to more specialized fields such as oral surgery, maxillofacial surgery, and periodontology. The use of these irrigation lines is crucial during surgical protocols requiring a constant supply of sterile liquid for irrigation of the surgical site. Whether for complex extractions, periodontal surgeries, or maxillofacial reconstruction procedures, this device maintains optimal visibility and preserves the biological integrity of surrounding tissues through adequate thermal control during the surgical act.
What are the technical characteristics of reference 1500984-010P?
Reference 1500984-010P corresponds to a set of 10 irrigation lines designed for perfect integration with systems in the Bienair range. Although the specific material composition is not detailed in the provided technical documentation, the device is developed to meet the performance standards required in a surgical environment. These lines ensure a constant flow and a perfect seal when connected to irrigation pumps and contra-angles or handpieces. The technical design aims to minimize contamination risks while offering smooth handling for the dental assistant or surgeon. It is a high-precision accessory whose structure is adapted to the mechanical constraints of prolonged oral surgery interventions.
What are the contraindications for the use of this device?
The use of these irrigation lines must be in strict compliance with established clinical protocols. It is imperative to read the instructions provided by the manufacturer carefully before any use. Although specific contraindications are not exhaustively listed in the source data, the device is exclusively reserved for qualified healthcare professionals. Use by untrained personnel or in a non-surgical setting constitutes a major contraindication. Furthermore, any use outside the intended indications (general dentistry, restorative, prophylaxis, oral surgery, maxillofacial, and periodontology) is prohibited. The practitioner must ensure the compatibility of the device with the irrigation solutions used and the motor equipment in place.
What are the precautions for use for these irrigation lines?
Like any medical device used in dental surgery, irrigation lines require rigorous precautions for use to guarantee aseptic safety. It is essential to check the integrity of the packaging before opening to maintain the sterility of the product. As the device is intended for professional use, the practitioner must follow assembly recommendations to avoid any liquid leakage or flow interruption during the procedure. Particular attention must be paid during connection to rotary instruments so as not to hinder their movement. After the intervention, waste processing must comply with current standards for medical consumables. The manufacturer's instructions from PROMEPLA SAM must be consulted for any clarification on the safe handling of the device.
Who is the manufacturer and what standards are met?
The official manufacturer of these irrigation lines is PROMEPLA SAM, located at 9 avenue Albert II, 98000 Monaco. This medical device is classified as Class IIa, which attests to its level of safety and performance for surgical interventions. It benefits from CE0459 marking, confirming its compliance with current European regulatory requirements. As a Class IIa product, it is subject to strict controls guaranteeing its reliability in a clinical environment. This equipment is exclusively reserved for healthcare professionals. Compliance with these standards by the manufacturer ensures that dental surgeons and implantologists have a reliable product meeting the quality standards required for restorative dentistry and maxillofacial surgery.
State of the art
Surgical medical consumables play a decisive role in operative safety and tissue regeneration quality.
Specifications
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