Sterile Gauze with Elastic Bandage 120x7cm (x50) - Omnia - Delynov
The Gaine stérile avec élastique de fixation 120x7cm (x50) - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE2565.
- Compliance: Medical device Class I, CE marking CE2565.
- Manufacturer: Omnia S.p.A..
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Omnia 120x7cm sterile sheath with fixation elastic?
The sterile sheath with fixation elastic developed by Omnia is a single-use protective device designed for the surgical environment. Presented in the form of a sterile cord sheath, it measures 120x7cm, offering a length adapted to cover the majority of rotary equipment and tubings. Its structure allows for the creation of a physical barrier between the equipment and the sterile field, thus guaranteeing compliance with rigorous hygiene protocols. This product is delivered in boxes of 50 units, each individually packaged to maintain its sterility until the moment of use in the operating room or oral surgery office.
What are the clinical indications for this protective sheath?
The use of this dental sterile sheath is indicated during any invasive procedure requiring a controlled environment. In implant surgery, periodontal surgery, or during complex extractions, the dental motor protection sheath allows for wrapping the cords of contra-angles and surgical motors. This clinical application is crucial for preventing cross-contamination between the equipment and the surgical site. It is particularly recommended when the practitioner handles devices connected to central units that cannot be autoclaved, thus ensuring continuity of the sterile chain throughout the surgical act.
What are the technical characteristics of this Omnia device?
This Omnia device is distinguished by its specific dimensions of 120x7cm, optimized for surgery cord protection. The 7cm width allows for easy passage of connectors and technical plugs, while the 120cm length ensures extended coverage of the cable up to the control unit. A major technical element is the inclusion of a fixation elastic, which keeps the sheath firmly in place on the cord, thus avoiding any slipping or accidental exposure of the non-sterile part during the practitioner's movements. The product is designed to be intuitive and quick to set up by the pre-operative assistant.
What are the contraindications for the use of this product?
According to information provided by the manufacturer Omnia S.p.A., there are no specific medical contraindications listed for the use of this protective sheath. However, as with any sterile device, its use is strictly reserved for qualified healthcare professionals. It is imperative not to use the product if the individual packaging is damaged or open, as sterility would no longer be guaranteed. This device is for single use; any attempt at reprocessing or re-sterilization is prohibited to avoid risks of mechanical failure or residual microbiological contamination.
What are the precautions for use and handling?
The use of the cord protection sheath requires aseptic handling during the opening of the pouch. The practitioner or assistant must ensure the cord is inserted inside the sheath without touching the sterile exterior with non-decontaminated elements. The fixation elastic must be positioned to secure the end without excessively compressing the internal components of the cord. After the procedure, the sheath must be disposed of in accordance with protocols for the management of infectious clinical waste. It is advised to carefully read the instruction manual before the first handling to guarantee setup in accordance with the manufacturer's recommendations.
Who is the manufacturer and what standards are respected?
This device is manufactured by Omnia S.p.A. (Omnia S.r.l.), a recognized company located in Fidenza, Italy. The product complies with current European regulatory requirements for medical devices. It is classified as a Class I device and bears the CE2565 marking. Compliance with these standards guarantees that the sheath meets the safety and performance criteria defined by legislation. As an Omnia product, it benefits from the expertise of a manufacturer specialized in sterile consumables for dental surgery, ensuring practitioners a high level of reliability for their daily procedures.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
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