Adapter for KaVo Vacuum Cleaners Ø 6/11/16 mm - Omnia - Delynov
The X1 Embout pour aspirateurs KaVo Ø 6/11/16 mm - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE12774.
- Compliance: Medical device Class I, CE marking CE12774.
- Manufacturer: Omnia S.p.A..
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant :OMNIA S.R.L. IT - 43036 FIDENZA (PR) - VIA FRANCESCO DELNEVO 190 réservé aux professionnels de santé.Lire attentivement la notice avant utilisation.
What is the X1 Tip for KaVo aspirators Ø 6/11/16 mm from the brand Omnia?
The X1 Tip for KaVo aspirators is a medical device designed by Omnia S.p.A. to specifically adapt to KaVo suction systems. This component is essential for maintaining a clear surgical field during surgical procedures. It features diameters of 6 mm, 11 mm, and 16 mm, allowing for precise compatibility with standard equipment. This product belongs to the CONSO category and is part of the high-quality range of consumables developed by Omnia. This device is strictly reserved for use by qualified healthcare professionals, ensuring secure integration into the clinical workflow.
What are the clinical indications for this aspirator tip?
The intended use of this Omnia tip is related to oral and dental surgery procedures requiring effective fluid aspiration. According to the indications from the manufacturer Omnia S.r.l., this device is exclusively reserved for healthcare professionals. It is used to facilitate the practitioner's visibility by evacuating biological fluids during the operative phases. Its application must be carried out in strict compliance with current clinical protocols. Practitioners must systematically refer to the instructions for use before any manipulation to ensure the device is appropriately suited for the planned surgical act.
What are the technical characteristics of this X1 tip?
This technical tip is distinguished by its compatibility with KaVo systems and its specific dimensions of Ø 6/11/16 mm. Manufactured by Omnia S.p.A., it meets the requirements of Class I for medical devices. The design is optimized to guarantee a reliable connection and constant performance during aspiration. Although the exact material composition is not specified in the raw technical data, the product is identified under the CE12774 marking, certifying its compliance with applicable European standards. Its structure is designed to meet the ergonomic needs of dental practices and implant surgery units.
What are the contraindications for the use of this device?
The contraindications and warnings provided by the manufacturer Omnia S.r.l. specify that this device is reserved for healthcare professionals. It must not be used by unqualified persons. Any use outside the scope provided by the technical instructions is prohibited. It is imperative to check the integrity of the device before use. Although specific data on material-related contraindications are not detailed, compliance with the indications and warnings appearing on the labeling and in the accompanying instructions is mandatory to prevent any clinical risk or technical malfunction during aspiration.
What are the precautions for use for the Omnia tip?
To ensure optimal use of the X1 tip for KaVo aspirators, healthcare professionals must follow the recommendations of Omnia S.p.A. It is crucial to read the instructions carefully before any use. As with any Class I device used in a surgical environment, handling must be performed with care to maintain hygiene and safety standards. The device must be correctly connected to the corresponding diameters (6, 11, or 16 mm) to avoid any loss of suction power. Compliance with the manufacturer's warnings located in Fidenza, Italy, is a sine qua non condition for the safety of the patient and the practitioner.
Who is the manufacturer and what standards are respected?
The X1 tip is manufactured by Omnia S.r.l. (Omnia S.p.A.), whose head office is located at Via Francesco Delnevo 190, 43036 Fidenza (PR), Italy. This medical device is certified under the CE12774 marking, guaranteeing compliance with European regulatory requirements. It is classified as a Class I device. The manufacturer emphasizes that this equipment is exclusively reserved for healthcare professionals. Compliance with current standards ensures clinicians a reliable product for their daily dental surgery interventions. Any use must be preceded by a rigorous reading of the instructions for use provided by Omnia.
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Surgical medical consumables play a decisive role in operative safety.