Bactilemon 2000 Nebulizer

Extended compatibility and practicality of application: the aqueous matrix allows to apply the disinfectant product on the surface of any material, even the most delicate one such as Plexiglas and polycarbonate; sometimes the nebulizer allows to deliver the disinfectant solution directly onto the aesthetic-medical-surgical instruments, increasing the contact surface and therefore the speed of action.

The product is classified as dangerous according to the provisions of Regulation (EC) 1272/2008 (CLP) (and subsequent amendments and adjustments). The product therefore requires a safety data sheet in compliance with the provisions of Regulation (EC) 1907/2006 and subsequent amendments.

PHYSICAL CHEMICAL CHARACTERISTICS

Benzalkonium chloride solution, Didecyldimethylammonium chloride (4th generation quaternary ammonium salt) and Chlorhexidine digluconate.

Neutral pH and lemon fragrance. This pH value enhances the germicidal properties of the active ingredients which decrease significantly at acid pH.

Field and method of use

1. Disinfection by spraying the surfaces of medical devices: typical examples are surfaces of medical equipment, in dental offices, beauty and tattoo and dermopigmentation centers, hospitals, rest homes and private institutions. BACTILEMON 2000 is particularly suitable for the disinfection of plastic, plexiglas and polycarbonate surfaces.
2. Decontamination and simultaneous cleansing, by immersion, of surgical instruments and medical devices: as per Decree 28 September 1990: Rules for protection from professional infection from HIV in public and private health and care facilities; “The reusable devices must, after use, be immediately immersed in a chemical disinfectant of recognized efficacy on HIV before disassembly or cleaning, to be carried out as preparation for sterilization”. It is also useful for the disinfection of dental impressions.
   Sterile-temporary storage of surgical instruments: when you have to remove the instruments from the solution, take them aseptically and rinse them carefully with sterile water.

The solution is ready for use.

USE BY MISTING

Direct steaming

• With the aid of a special nebulizer to be applied to the multidose pack, spray onto several points on the surface.
• Distribute the vaporized solution using an appropriate clean and dry non-woven cloth.
• Wait at least 5 minutes before reuse.

Indirect vaporization

• With the aid of a special nebulizer to be applied to the multidose pack, spray onto a suitable clean and dry non-woven cloth.
• Apply on the surface.
• Leave to dry for at least 5 minutes and do not rinse unless the surface is intended for direct contact with mucous membranes or food.

USE BY IMMERSION

For invasive and non-invasive multipurpose medical devices, such as surgical tools and instruments, immerse them in the solution as it is and wait at least 10 minutes. The product is also suitable for washing or decontaminating contaminated surgical instruments in ultrasound tanks. To remove the instruments from the solution, they must be removed aseptically. The excess of disinfectant solution can be removed from medical devices, rinsing with sterile water or drying with cloths or sterile paper. One of the peculiar characteristics of this formulation is the synergistic action of the different active ingredients with different action mechanism and target. This allows with a single product to meet several of the ideal requirements of a disinfectant for medical surgical instruments, namely:

• ability to act even in the presence of organic material: it is a peculiar characteristic of both quaternary ammonium salts and chlorhexidine digluconate, not affected by their biocidal action, the presence of organic material; remember also that quaternary ammonium salts are cationic surfactants and as such reducing the surface tension allow the solution to enter the different interstices in which microorganisms generally nest to protect themselves from chemical or physical aggression;
• persistent and cumulative effect: both chlorhexidine and both quaternary ammonium salts are positively charged and therefore after evaporation of the aqueous matrix, without rinsing, remain absorbed on the treated surface, generally negatively charged, allowing to maintain the “aseptic” state initially obtained. It is evident that for repeated applications this adsorption turns into a cumulative effect with overlapping of different microlayers of active principles;
• extended compatibility and practicality of application: the aqueous matrix allows to apply the disinfectant product on the surface of any material, even the most delicate one such as Plexiglas and polycarbonate; sometimes the nebulizer allows to deliver directly the disinfectant solution on the medical-surgical instruments increasing the contact surface and therefore the speed of action.

Compatibility with materials

The solution, thanks to the presence of sodium nitrite, has no oxidizing power. Its use in its pure state does not cause corrosive effects on metal, plastic and rubber materials; does not damage sharp tools. For the pH close to neutral, it does not damage the materials with which it comes into contact. The active ingredients are not absorbed by any type of plastic or elastomeric material (natural and synthetic rubbers).

Storage and stability

Store the product at room temperature, in a dry place and away from light and any heat source. The solution, in the original sealed packaging, is valid for 36 months. If the package is opened and closed correctly at the end of each disinfection operation, the preparation maintains its chemical-physical and microbiological characteristics unaltered for 12 months.

Quality checks

The components (raw materials, containers, labels, etc.) and the intermediate processing phases of each individual production batch are punctually and carefully checked following the procedures laid down by the UNI EN ISO 9001 and 13485 certification standards.

Authorizations and Certifications

Notified Body Certificate n ° 0546 – CERTIQUALITY

Medical Device Class: llb

CND classification: D020199

Type: CE certificate n. 16494

Competent authority: Certiquality s.r.l. – Notified body No. 0546