75x50 cm Draped with Adhesive Opening 6x9 - Omnia - Delynov
The x75 drapé cm 50x75 avec ouverture adhésive cm 6x9 - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE25657.
- Compliance: Medical device Class I, CE marking CE25657.
- Manufacturer: Omnia S.p.A..
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Omnia 50x75 drape with adhesive aperture?
The sterile surgical drape designed by Omnia is an essential protective device for maintaining asepsis during invasive interventions. This specific model features dimensions of 50x75cm, offering sufficient coverage for the patient's torso or head. Its structure integrates a central 6x9cm aperture equipped with an adhesive border. This configuration allows for the creation of a perfectly maintained sterile field with aperture, preventing the drape from slipping during the surgical act. Manufactured by Omnia S.p.A., this device meets the sterility requirements necessary to prevent post-operative infections in a clinical environment.
What are the clinical indications?
This surgical drape with aperture is primarily indicated in oral surgery, implantology, and periodontology. It is used to isolate the oral cavity or a specific skin area from the rest of the patient's body and the non-sterile environment. The use of an adhesive sterile drape is recommended during implant placement, bone grafting, or apical resection surgeries. By fixing the 6x9cm adhesive around the mouth or the incision area, the practitioner ensures that the fenestrated surgical drape remains immobile, thus guaranteeing an effective microbial barrier throughout the intervention.
What are the technical characteristics?
The Omnia device is distinguished by its precise dimensional specifications: a total format of 50x75cm and a 6x9cm working window. The major technical characteristic lies in the quality of its adhesive surrounding the aperture, designed to adhere securely without irritating the tissues. This sterile field with aperture is packaged for single use, guaranteeing a total absence of contaminants at the time of unpacking. As a Class I product, it complies with safety standards for non-invasive or transiently invasive medical devices used by healthcare professionals.
What are the contraindications for use?
According to information from the manufacturer Omnia S.R.L., the use of this product is strictly reserved for qualified healthcare professionals. Although the raw MDR text does not list specific medical contraindications related to the composition, it is imperative to check the integrity of the sterile packaging before use. Damaged packaging renders the product unfit for surgical use. Application protocols on clean, dry skin must also be followed to ensure optimal adhesion of the 6x9cm aperture and to avoid any risk of accidental detachment during the procedure.
What are the precautions for use and storage?
This sterile surgical drape is a single-use device; it must under no circumstances be resterilized or reused, or it will lose its barrier properties and adhesion. Professionals must read the instructions carefully before use. Storage must be in a dry place, away from direct light and heat to preserve the integrity of the adhesive zone. When placing the surgical drape with aperture, the practitioner must ensure not to contaminate the patient side during deployment, respecting standardized surgical draping techniques.
Who is the manufacturer and what standards are met?
This device is manufactured by Omnia S.p.A. (Omnia S.R.L.), located in Fidenza, Italy. It is a Class I medical device, compliant with current European regulations. The product bears the CE25657 marking, attesting to its compliance with safety and performance requirements. The manufacturer Omnia is recognized in the dental sector for the quality of its draping and asepsis management solutions. Each production step is controlled to guarantee that the sterile field with aperture meets the critical needs of oral surgery and implantology operating rooms.
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Surgical medical consumables play a decisive role in operative safety.