10-piece irrigation ensemble 1/2Y W&H Elcomed 200/100. Astratech Elcomed 100 - Omnia - Delynov
The x10 ensemble d'irrigation 1/2Y W&H Elcomed 200/100. Astratech Elcomed 100 - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE14590.
- Compliance: Medical device Class I, CE marking CE14590.
- Manufacturer: Omnia S.p.A..
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the 1/2Y W&H Elcomed 200/100 irrigation set?
The x10 1/2Y W&H Elcomed 200/100 irrigation set, designed by the manufacturer Omnia, is a single-use medical device. It comes in the form of a complete surgical irrigation set, specifically configured to fit oral surgery motor systems. This device ensures the circulation of cooling fluids essential for preventing thermal heating of bone tissues during critical drilling phases. The structure of this irrigation tubing is optimized to guarantee perfect compatibility with the peristaltic pumps of compatible motors, thus ensuring a constant and secure flow throughout the surgical procedure.
What are the clinical indications for this irrigation set?
This Omnia device is indicated for all oral surgery, periodontology, and implantology procedures requiring the use of a surgical motor. As an implantology motor irrigation line, its primary role is to cool the burs and alveolar bone to avoid any thermal necrosis during implant site preparation. The use of this sterile irrigation tubing is crucial for maintaining the asepsis of the surgical field while allowing effective rinsing of the intervention area. It is exclusively reserved for use by qualified healthcare professionals, in accordance with the directives of the manufacturer Omnia S.p.A.
What are the technical characteristics of this device?
The Omnia irrigation set is distinguished by its 1/2Y technical configuration, specifically studied for the W&H Elcomed 200/100 and Astratech Elcomed 100 models. As a surgical motor irrigation line, it is designed to withstand the pressures exerted by peristaltic pumps without collapsing, guaranteeing an uninterrupted flow of saline solution. This product belongs to Class I of medical devices and bears the CE14590 marking, certifying its compliance with current European standards. The sterility of the component is a central aspect, allowing its immediate integration into a strict surgical protocol without risk of cross-contamination.
What are the contraindications for the use of this tubing?
Specific contraindications are related to the warnings provided by the manufacturer Omnia S.R.L. located in Fidenza, Italy. This device is strictly reserved for healthcare professionals trained in oral surgery and implantology techniques. It must not be used if the sterile packaging is damaged, as the integrity of the microbial barrier would no longer be guaranteed. Although materials are not specified in the short technical data, it is advisable to refer to the instructions before use to check for any known incompatibility with standard irrigation solutions or specific patient sensitivities to medical polymers.
What are the precautions for use and handling?
As a non-resorbable Class I device, precautions for use are based on maintaining the sterile chain and respecting the installation protocols on the surgery motor. It is imperative to read the instructions carefully before any use. The installation of the irrigation tubing must be done with care to avoid any kinks or pinching that could hinder the passage of the cooling liquid. After the intervention, this irrigation set must be disposed of according to the protocols for managing infectious clinical waste, as it is a single-use product that must under no circumstances be resterilized or reused.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Omnia S.p.A. (OMNIA S.R.L.), with headquarters located in Fidenza (PR), Italy. This product benefits from the CE14590 marking, guaranteeing compliance with the essential safety and performance requirements defined by European medical device regulations. Classified as a Class I device, this irrigation set meets the quality standards required for safe use in hospital settings or dental offices. Omnia is a recognized player in the supply of sterile consumables for surgery, ensuring rigorous traceability and compliance for demanding practitioners.
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Surgical medical consumables play a decisive role in operative safety.