20 irrigation tubes for W&H ImplaMed - Omnia - Delynov machines
The x20 tuyaux d'irrigation pour machines W&H ImplaMed - Omnia is a medical device manufactured by Omnia S.p.A. — Class I, CE marking CE25657.
- Compliance: Medical device Class I, CE marking CE25657.
- 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 set of x20 Omnia irrigation lines for W&H ImplaMed machines?
The set of x20 Omnia irrigation lines is a medical device specifically designed for use with W&H ImplaMed machines. This CONSO category equipment is essential for ensuring optimal cooling and effective cleaning of the surgical site during surgical procedures. Manufactured by Omnia S.p.A., this product guarantees rigorous technical compatibility for implantology professionals. This irrigation set is a reliable solution for maintaining a sterile and secure working environment, meeting the requirements of modern dental operating rooms.
What are the clinical indications for these irrigation lines?
Clinical indications for the use of this Omnia irrigation set include all oral surgery, periodontology, and implantology procedures requiring a physiological liquid cooling system. This device is strictly reserved for healthcare professionals. Its use is recommended during implant placement or complex bone surgeries where tissue temperature control is crucial for the success of the intervention. The use of this equipment helps prevent thermal heating of the alveolar bone, thus ensuring better integration of implantable devices.
What are the technical characteristics of this irrigation set?
This irrigation set features technical characteristics adapted to W&H ImplaMed surgical motors. Although the exact material composition is not specified, the product is designed to meet the performance standards of essential 1/2 Y or F1204 type irrigation sets used in the dental field. This Class I device is packaged in boxes of 20 units to meet the logistical needs of surgical practices. Each component is developed to ensure a constant and precise flow of the irrigation solution, minimizing the risk of interruption during the surgical act.
What are the contraindications for the use of this medical device?
Contraindications for the use of these Omnia irrigation lines primarily concern any use outside the intended surgical framework or by unqualified personnel. This product is exclusively reserved for healthcare professionals trained in oral surgery techniques. It must not be used if the packaging is damaged, compromising the sterility of the device. The instructions for use provided by the manufacturer Omnia S.R.L. should always be consulted before any implementation to ensure the absence of specific contraindications related to the patient or the planned procedure.
What are the precautions for use and handling?
Precautions for use for this Omnia irrigation set include careful reading of the instructions before use. As a Class I medical device, rigorous handling is necessary to maintain the integrity of the tubing system. The practitioner must verify the perfect connection with the W&H ImplaMed machine before starting irrigation. As with any dental irrigation set type equipment, it is imperative to respect current asepsis protocols. Particular attention must be paid to the installation of the line to avoid any kinking that could obstruct the passage of the cooling liquid.
Who is the manufacturer and what standards are respected by this product?
This device is manufactured by the Italian company Omnia S.p.A., located in Fidenza. The irrigation line set benefits from the CE25657 marking, certifying its compliance with current European regulatory requirements for Class I medical devices. The manufacturer, OMNIA S.R.L., guarantees that this equipment meets the safety and performance standards necessary for professional use in a surgical environment. Compliance with these standards provides dental surgeons and implantologists with a reliable, traceable product perfectly adapted to the constraints of contemporary oral surgery.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
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