Sponge-brush Tecnoscrub Omnia - Delynov x24
The 24 Éponges brosses à usage unique stérile pour les ongles et les mains Tecnoscrub, 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: 32.Z0500.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Omnia Tecnoscrub brush sponge?
The Tecnoscrub brush sponge, developed by the manufacturer Omnia S.p.A., is a sterile single-use medical device designed specifically for preoperative hygiene. This product comes in the form of a combination brush and sponge, allowing for effective mechanical cleaning of the hands and forearms. Intended for healthcare professionals, this sterile nail brush is individually packaged to guarantee total asepsis until the moment of use in the operating theater or dental surgery office. Its structure is designed to offer a cleansing action without compromising the integrity of the practitioner's skin barrier.
What are the clinical indications for this device?
The use of the Tecnoscrub surgical hand brush is indicated before any invasive procedure requiring a level of surgical asepsis. In oral, implant, or periodontal surgery, scrubbing the hands and nails is a critical step in the hygiene protocol. This device allows for the elimination of impurities and the reduction of transient flora as well as resident flora on the skin. The use of a sterile hand wash brush is recommended to prepare the personal surgical field of the surgeon and their assistants, thus minimizing the risks of cross-contamination during the manipulation of implants, grafts, or surgical instruments.
What are the technical characteristics of reference 32.Z0500.00?
Technical reference 32.Z0500.00 corresponds to a pack of 24 units of Tecnoscrub brush sponges produced by Omnia. Each unit is sterile and ready to use. The design incorporates a brush side for cleaning difficult areas such as subungual spaces and a sponge side for gentle soaping of larger skin surfaces. This device is classified as a Class I equipment according to current regulations. Its manufacture by Omnia S.p.A. meets safety and performance requirements for operating room accessories, guaranteeing reliable use for surgical nail scrubbing in a sterile environment.
What are the contraindications for using these brushes?
Although the raw MDR text does not specify direct medical contraindications for this Class I device, standard precautions for use apply. The use of the surgical hand wash brush should be avoided on skin presenting open lesions, severe inflammatory dermatoses, or burns, to avoid worsening the skin condition. It is imperative not to reuse the device, as its single-use nature is essential to prevent healthcare-associated infections. Practitioners must consult the instructions before use to ensure compatibility with the specific disinfection protocols of their facility.
What are the precautions for use and storage?
To guarantee the effectiveness of the Tecnoscrub sterile nail brush, it is necessary to check the integrity of the individual packaging before opening. Any punctured or damaged pouch makes the product unfit for surgical use. After use, the brush sponge must be disposed of in accordance with the waste management protocols for infectious clinical waste (DASRI). Storage must be in a dry place, away from direct light and heat to preserve the properties of the materials. Compliance with these instructions by qualified personnel ensures the maintenance of the hygiene level required for complex oral surgery interventions.
Who is the manufacturer and what standards are respected?
This device is manufactured by Omnia S.p.A. (Omnia S.R.L.), a company located in Fidenza, Italy, recognized for its expertise in sterile solutions for surgery. Tecnoscrub brush sponges benefit from the CE2565 marking, certifying their compliance with European requirements for Class I medical devices. Compliance with these standards guarantees that the product meets the safety and performance criteria for surgical scrubbing. As an Omnia product, it is part of a rigorous quality chain intended exclusively for healthcare professionals, ensuring traceability and reliability essential in a clinical environment.
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