Sterile Gauze with Adhesive Attachment 240x7cm (x50) - Omnia - Delynov

What is the Omnia 240x7cm sterile sheath with adhesive attachment?

The sterile sheath with adhesive attachment 240x7cm (x50) - Omnia - Delynov is a single-use protective device designed by Omnia S.p.A. This device comes in the form of a sterile tubular sleeve intended to cover non-sterile equipment in the surgical environment. Its structure creates an effective physical barrier between motor cords or tubing and the sterile surgical field. The presence of an adhesive attachment facilitates placement and ensures the sheath remains correctly positioned throughout the procedure, preventing any slippage that could compromise asepsis. This product is packaged in boxes of 50 units to meet the needs of practices regularly performing oral surgery.

What are the clinical indications for this sterile sheath?

In oral, implant, and periodontal surgery, maintaining a sterile chain is imperative for the success of interventions. The Omnia sterile cord sheath is indicated for the protection of surgical motor tubing, contra-angle cords, or as a sterile suction sheath. Its use is recommended during any invasive procedure where rotating equipment or irrigation systems are handled in close proximity to the surgical site. By isolating these elements, the practitioner reduces the risks of airborne microbial contamination or direct contact. This device is strictly reserved for healthcare professionals trained in asepsis protocols in a surgical environment, in accordance with the directives of the manufacturer Omnia S.r.l. based in Fidenza.

What are the technical characteristics of this Omnia device?

This sterile sheath with adhesive features specific dimensions of 240x7cm, offering sufficient length to cover the majority of power cords and irrigation tubing used in implantology. The 7cm width allows for easy passage of standard connectors. The device is manufactured by Omnia S.p.A. and meets current safety and performance requirements. It is a product classified as a Class I medical device, bearing the CE25657 marking. The integrated adhesive attachment is a key technical feature that allows the end of the sheath to be securely fixed to the handpiece or cord, ensuring that the surgical tubing protection does not retract during the surgeon's dynamic manipulations.

What are the contraindications for the use of this product?

According to the information provided by the manufacturer Omnia S.r.l., indications and contraindications are detailed in the product's accompanying instructions. The use of this sheath is exclusively reserved for healthcare professionals. It is imperative to read the instructions carefully before use to identify any usage restrictions related to the clinical environment or specific protocols. As with any sterile device, use is contraindicated if the individual packaging is damaged or opened before the intervention, as the sterility of the product would no longer be guaranteed. There are no other specific contraindications mentioned outside of those related to compliance with sterility protocols and standard manufacturer warnings for Class I.

What are the precautions for use and handling?

The handling of the sterile motor sheath must be carried out according to best practices in asepsis. During installation, it is advisable to proceed with the help of a circulating assistant to introduce the non-sterile cord inside the sheath held by the sterile practitioner. Particular attention must be paid to the fixation of the adhesive attachment to avoid any untimely detachment. As this product is for single use, it must under no circumstances be re-sterilized or reused for another intervention, under penalty of major infectious risks. After use, the sheath must be disposed of in accordance with protocols for the disposal of clinical waste (DASRI). Compliance with the CE25657 marking guarantees the device's conformity with safety standards for single use.

Who is the manufacturer and what standards are respected?

The device is manufactured by Omnia S.p.A. (OMNIA S.R.L. IT), a company located in Fidenza, Italy. This manufacturer is recognized for its expertise in designing sterile solutions for surgery. The sterile sheath with adhesive attachment 240x7cm is a Class I medical device, certified with the CE25657 marking. This certification attests that the product meets the essential health and safety requirements defined by the European Medical Device Regulation (MDR). The manufacturer insists that this equipment is exclusively reserved for healthcare professionals. Omnia's traceability and manufacturing quality provide dental surgeons with reliable equipment to secure their operating theaters and protect their patients against healthcare-associated infections.

State of the art

Surgical medical consumables play a decisive role in operative safety.