a) DISINFECTANT FOR NEBULIZATION DEVICE:

The disinfectant formulation allows for the disinfection of spaces through the air without corroding surfaces and is compatible with common materials. The product is free from aldehydes and heavy metals and has a broad spectrum of action. It is ready to use and does not leave residues on surfaces. It is recommended for use in critical hospital areas such as ICUs, operating rooms, and emergency units, as well as in mobile healthcare units, ambulances, etc. The disinfectant is suitable for use with a nebulizer and is applied without human presence.

The combination of the disinfectant and the device is an effective process according to the French Standard NFT 72-281 (Disinfection of surfaces through the air – Determination of bactericidal, fungicidal, virucidal, and sporicidal activity) at an application dosage of 7ml/m^³, at 55°C, with an action time of 2 hours. The active ingredients of the product are a stabilized solution of hydrogen peroxide and peracetic acid (+/- 1200 ppm). It is biodegradable according to European legislation.

The disinfectant action, according to the French Standards NFT 72-281, includes bacteria, fungi, viruses, and spores at an application dosage of 7ml/m^³, at 55°C.

Active against	Contact Time
BACTERIA · Pseudomonas aeruginosa · Staphylococcus aureus · Escherichia coli · Enterococcus hirae	30 minutes
· Mycobacterium terrae · Mycobacterium avium	60 minutes
· Klebsiella pneumoniae (BLSE) · Staphylococcus aureus (MRSA)	30 minutes
YEASTS · Candida albicans	15 minutes
FUNGI · Aspergillus niger, Aspergillus brasiliensis	120 minutes
ΙΟΙ · Poliovirus, Adenovirus, Norovirus, Covid sars 1, Covid sars 2	60 minutes
SEEDS · Bacillus subtilis, Bacillus cereus	120 minutes
· Clostridium difficile, Clostridium sporogenes COVID	60 minutes

b) DISINFECTION OPERATIONS FOR SPACES AND EQUIPMENT:

The disinfection process using the automatic nebulization device allows for air-based disinfection of spaces in accordance with the applicable European Standard NFT 72-281. Disinfection data such as consumption, volume of the space, operating time, etc., are recorded in the nebulizer unit and transferred via a USB port to a computer, where they are stored electronically for complete traceability of the disinfection process.

The device used for space disinfection is an electronic, portable, standalone nebulization unit designed for air-based disinfection. The device has been developed and designed to meet the strictest safety and hygiene standards. It is ergonomic, reliable, and easy to maintain. It is subject to a stringent regulatory framework of legislation and has been extensively tested for compliance with the following European Directives (Standards):

• Directive 2006/95/EC: Low Voltage Electrical Equipment
• Directive 2004/108/EC: Electromagnetic Compatibility (EMC)

The combined use as a single disinfection process has been certified for its microbiocidal efficacy. The CE0120 marking on the device certifies its compliance with all relevant legislation.

DESCRIPTION OF THE DISINFECTION PROCESS

Preparation of the space

The client ensures that the area to be disinfected is thoroughly cleaned and ideally pre-disinfected before the nebulization process (equipment surfaces, floors, walls).

During the preparation of the space, the operator checks the layout and size of the area, inspects the cleanliness of the space, verifies the compatibility of the materials, checks for potential leaks, and prepares the area according to the nebulization disinfection protocol.

The air disinfection process is carried out WITHOUT AND AWAY FROM HUMAN PRESENCE and consists of three stages: nebulization (quantity of the product), contact time (minimum time for complete microbiocidal action), and recovery (ventilation of the space).

^1st The nebulization stage consists of the following phases:

The delayed start phase (defined on a case-by-case basis)

This phase allows for the removal of individuals from the area before the spraying phase begins.

The technician leaves the room and closes the doors and windows. They note the time and exit the room.

– The preparation phase (2 minutes 30 seconds)

During this phase, the device operates without heating the product. This phase allows for the filling of the pipes with the disinfectant product before the first use and supplies “fresh” product during the spraying phase.

The preheating phase (maximum 8 minutes)

This phase preheats the product before spraying. Thus, the product is at the correct temperature throughout the spraying phase.

The spraying phase (depending on the volume of the room)

During this phase, the product is sprayed into the room. The online heating of the product maintains a constant temperature throughout the spraying phase at 55°C.

– The nozzle drying phase (1 ½ minutes)

The nozzle is dried after spraying. During this time, only compressed air is supplied to the nozzle. This empties the nozzle of disinfectant residues, preventing splashes or the formation of deposits.

2^nd The contact time stage (minimum time for complete microbiocidal action):

For the process to be effective, the contact time must be observed. The contact time allows the product to act against various strains before the recovery of the room. During this time, the device does not spray. The space remains sealed, and entry into the room is not allowed. For complete disinfection of the area according to the French Standards NFT 72-281 (Bactericidal, fungicidal, virucidal, sporicidal), at an application dosage of 7ml/m^³, at 55°C, the contact time is 120 minutes.

3^rd The recovery stage (ventilation of the space):

After observing the contact time based on the required spectrum of action, the operator enters the room with appropriate Personal Protective Equipment (PPE). To determine when they can re-enter the room, they take into account and calculate the times of all the aforementioned operational phases, from the moment they left the room. Inside the room, they ensure proper ventilation based on the available means. The recovery time for the room is considered complete when the concentration of substances in the air is below the exposure limits set by the relevant Ministry of Labor or Health. An average recovery time of half an hour is recommended. Finally, the operator removes the device cover, checks whether the product level has decreased in the container as confirmation that the device has operated and that there are no traces of the disinfectant on the floor. They also check the device’s screen to ensure that the cycle has been completed successfully. If not, they repeat the process from the beginning.

After the disinfection process is completed, the operator turns on the air conditioning or ventilation system of the room again and allows the public to enter the space.

B) DISINFECTANT FOR NEBULIZATION DEVICE:

The disinfectant formulation allows for the disinfection of spaces through the air without corroding surfaces and is compatible with common materials. The product is free from aldehydes and heavy metals and has a broad spectrum of action. It is ready to use and does not leave residues on surfaces. It is recommended for use in critical hospital areas such as ICUs, operating rooms, and emergency units, as well as in mobile healthcare units, ambulances, etc. The disinfectant is suitable for use with a nebulizer and is applied without human presence.

The combination of the disinfectant and the device is an effective process according to the French Standard NFT 72-281 (Disinfection of surfaces through the air – Determination of bactericidal, fungicidal, virucidal, and sporicidal activity) at an application dosage of 7ml/m^³, at 55°C, with an action time of 2 hours. The active ingredients of the product are a stabilized solution of hydrogen peroxide and peracetic acid (+/- 1200 ppm). It is biodegradable according to European legislation.

The disinfectant action, according to the French Standards NFT 72-281, includes bacteria, fungi, viruses, and spores at an application dosage of 7ml/m^³, at 55°C.