1 pack of 10 Protective sleeves 120X7 cm, with guide OMNISLEEVE (pack of 10)(22.U0005.00) Omnia - Delynov
The 1 paquet de 10 Gaines de protection 120X7 cm, avec guide OMNISLEEVE (lot de 10)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..
- Reference: 22.U0005.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Omnisleeve protective sheath?
The Omnisleeve protective sheath, developed by Omnia, is a single-use sterile protective device designed specifically for the surgical environment. This pack of 10 units features dimensions of 120X7cm, providing an effective physical barrier for equipment. Each sheath is equipped with a practical insertion guide that allows healthcare personnel to easily slide the cords inside without breaking the sterility chain. This Omnia S.p.A. product meets the protection requirements for surfaces and medical devices that cannot be sterilized in an autoclave, thus ensuring a secure working environment during invasive procedures.
What are the clinical indications for this sheath?
The use of this dental surgery protection sheath is indicated for all procedures requiring strict asepsis, such as implantology, surgical periodontology, or maxillofacial surgery. It acts as a sterile dental cord cover to cover surgical motor cables, optical fibers, or suction tubing. By isolating these elements, the practitioner drastically reduces the risks of contamination of the operating field. Its 120X7cm format design allows for extended coverage, protecting a large part of the connectivity linked to the central unit, which is essential for maintaining the integrity of the sterile zone throughout the surgical act.
What are the technical characteristics of reference 22.U0005.00?
Technical reference 22.U0005.00 corresponds to a lot of 10 Omnisleeve sterile sheaths. Each sheath has a width of 7cm and a total length of 120cm, dimensions optimized to fit the majority of motor cords on the market. The presence of an integrated insertion guide is a major technical feature, simplifying handling during the preparation of the operating room. This device is classified as sterile, ensuring reliable protection against pathogens. Manufactured by Omnia S.p.A., this dental motor cord sheath combines flexibility and resistance so as not to hinder the surgeon's movements while guaranteeing a continuous protective barrier.
What are the contraindications for the use of this device?
According to the 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. Furthermore, this device is for single use; any reuse is prohibited to avoid the risks of cross-contamination and material degradation. Practitioners must read the instructions carefully before any handling.
What are the precautions for use and handling?
When using the Omnisleeve sterile protective sheath, it is crucial to respect asepsis protocols when opening the pouch. The insertion guide must be used to slide the cord inside the sheath without direct contact with non-sterile surfaces. Although the material is designed to be resistant, contact with sharp or pointed instruments that could puncture the 7cm wide wall should be avoided. Once the intervention is completed, the sheath must be removed and disposed of in accordance with waste management protocols for infectious risk healthcare activities (DASRI). Compliance with these steps guarantees maximum protection effectiveness.
Who is the manufacturer and what standards are respected?
The Omnisleeve device is manufactured by Omnia S.p.A., a recognized Italian company located in Fidenza. This product benefits from the CE2565 marking, certifying its compliance with current European regulatory requirements. It is categorized as a Class I medical device. Manufacturing by Omnia S.p.A. guarantees a high level of quality and traceability for dental and oral surgery professionals. As a sterile Class I device, it meets the safety standards necessary to be integrated into the surgical arsenal of clinics and dental offices specialized in implantology.
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