1 pack of 10 Protective sleeves 120X7 cm, with guide OMNISLEEVE (pack of 10)(22.U0005.00) Omnia - Delynov

What is the OMNISLEEVE protective sleeve from Omnia?

The OMNISLEEVE protective sleeve, offered by the brand Omnia, is a medical device designed to provide an effective protective barrier during surgical procedures. This specific model comes in a pack of 10 sleeves, each with precise dimensions of 120X7cm. Designed to meet sterility requirements in clinical environments, this sleeve is equipped with a guide facilitating its placement on equipment. This device is essential for maintaining the asepsis of the operating field by covering cords or non-sterilizable instruments. The 120cm length and 7cm width format allows for extended protection, adapted to the needs of practitioners in oral surgery and implantology.

What are the clinical indications for this device?

The use of the OMNISLEEVE sleeve from Omnia is exclusively reserved for healthcare professionals, in accordance with the directives of the manufacturer Omnia S.p.A. It is indicated for the protection of surfaces and cables of medical equipment during dental surgery, periodontology, or implantology procedures. By acting as a sterile protective sleeve, it prevents the risks of cross-contamination between the equipment and the patient. Its design with a guide allows for rapid and precise application, ensuring compliance with the rigorous hygiene protocols necessary during invasive procedures in the dental office or operating block.

What are the technical characteristics of the OMNISLEEVE sleeve (22.U0005.00)?

This product, referenced under code 22.U0005.00, is distinguished by its rigorous technical specifications. Each sleeve measures 120X7cm, offering optimal coverage for the majority of motor or turbine cords. The lot of 10 units allows for simplified stock management for the practice. The presence of an insertion guide is a key feature that optimizes surgical preparation time. Although the specific material is not detailed in the raw MDR technical documentation, this Omnia device is designed to meet the sterile protection standards required for Class I devices, thus ensuring a reliable physical barrier throughout the duration of the surgical procedure.

What are the contraindications for the use of these sleeves?

According to the information provided by the manufacturer OMNIA S.R.L. located in Fidenza, Italy, the use of these sleeves is strictly reserved for qualified healthcare professionals. There are no specific contraindications listed other than use not in accordance with the indications provided by the manufacturer. It is imperative not to use the product if the sterile packaging is damaged, so as not to compromise asepsis. Practitioners must read the instructions carefully before use to ensure that the device is suitable for the specific instrumentation used. As with any sterile single-use device, reuse is prohibited to avoid any infectious risk.

What are the precautions for use and storage conditions?

To guarantee the effectiveness of the OMNISLEEVE protective sleeve, it is crucial to respect the warnings of the manufacturer Omnia S.p.A. The device must be handled with sterile gloves to maintain the integrity of the aseptic chain during its installation on the equipment. Although this product is not a suture and therefore does not involve resorption by hydrolysis, its nature as a single-use device requires immediate disposal after the intervention according to the protocols for treating infectious clinical waste (DASRI). Storage must be in a dry place, away from direct light, to preserve the physical properties of the sleeve until use.

Who is the manufacturer and what standards are met by this product?

OMNISLEEVE sleeves are manufactured by OMNIA S.R.L. (Omnia S.p.A.), whose headquarters are located in Fidenza, Italy. This medical device belongs to Class I and complies with the regulatory requirements in force, as evidenced by its CE25657 marking. Compliance with these standards guarantees that the product meets the safety and performance criteria defined by European legislation on medical devices (MDR). As a specialized supplier, Delynov ensures that these Omnia products intended for dental surgeons and implantologists scrupulously respect the official indications and warnings for safe clinical practice.

State of the art

Surgical medical consumables play a decisive role in operative safety.