10 x IRRIGATION LINES - Bienair (1500984-010P) - Delynov
The 10 x LIGNES D'IRRIGATION - Bienair is a medical device manufactured by le fabricant — Class IIa, CE marking CE0459.
- Compliance: Medical device Class IIa, CE marking CE0459.
- Manufacturer: le fabricant.
- Reference: 1500984-010P.
- Reserved for healthcare professionals. Read instructions carefully before use.
What are the Bienair irrigation lines (1500984-010P)?
The irrigation lines offered by the brand Bien-Air Medical Technologies, under technical reference 1500984-010P, are essential consumable medical devices for oral surgery interventions. This implantology motor tubing is designed to ensure a secure and sterile transfer of irrigation fluids from the saline bag to the handpiece or contra-angle. This product, manufactured by PROMEPLA SAM, meets the strict requirements of surgical practice in clinics or hospitals. Its role is crucial for maintaining optimal visibility of the surgical field and preventing thermal overheating of bone tissues during drilling or cutting phases.
What are the clinical indications for this device?
This device from the brand Bien-Air Medical Technologies is intended for versatile use in the field of oral health. According to the manufacturer's specifications, it is indicated for general dentistry, including restorative dentistry and prophylaxis care. More specifically, its use is recommended during complex procedures in oral surgery, maxillofacial surgery, as well as in periodontology. The use of this implantology motor tubing supports surgical movements requiring constant irrigation, thus guaranteeing compliance with current clinical protocols for the preservation of tissue vitality and the success of implant treatments.
What are the technical characteristics of these irrigation lines?
Bienair irrigation lines, identified by code 1500984-010P, are developed to integrate perfectly with surgical motor systems. Although the exact composition is not specified, the design is optimized for single use to guarantee total asepsis during the intervention. These tubings are packaged in sets of 10 units, allowing efficient stock management for clinics regularly practicing implantology and periodontal surgery. The brand Bien-Air Medical Technologies ensures rigorous technical compatibility with the specified equipment, avoiding any leakage or loss of pressure during active irrigation of the surgical site.
What are the contraindications for the use of this product?
Regarding specific contraindications, the manufacturer PROMEPLA SAM does not list any particular medical restrictions related to materials in the provided documentation. However, as with any medical device in this category, use is strictly reserved for qualified healthcare professionals. It is imperative not to use the product if the sterile packaging is damaged or if the expiration date has passed. The practitioner must carefully read the enclosed instructions before any handling to ensure that the patient's clinical status and the planned procedure are in alignment with the intended use of the device.
What are the precautions for use and handling?
As a Class IIa device, this implantology motor tubing must be handled according to rigorous aseptic protocols. It is a single-use product; any attempt at resterilization or reuse could compromise patient safety and the mechanical integrity of the conduit. Bien-Air Medical Technologies recommends checking the perfect connection between the irrigation line and the motor before starting the intervention. Particular attention must be paid to the path of the tubing to avoid any pinching that could interrupt the fluid flow, which would risk causing thermal necrosis of the bone during implant drilling.
Who is the manufacturer and what standards are respected?
These irrigation lines are manufactured by the company PROMEPLA SAM, located at 9 avenue Albert II, 98000 Monaco. This medical device belongs to Class IIa, which attests to its compliance with safety and performance requirements for short-term invasive devices. The product bears the CE0459 marking, guaranteeing that the manufacturing process and quality control meet current European standards. Traceability is ensured by reference 1500984-010P from the brand Bien-Air Medical Technologies, allowing dental surgeons and implantologists to use this equipment with full confidence in their daily therapeutic arsenal.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
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