FAQs

Premise: some of the answers may include references to technical specifications (using protocols, time of use and waiting, etc.) and are designated merely illustrative. More specific references, certifications, data sheets and safety, studies, publications, case histories, laws and regulations of reference are available on request.

Q?

Who is Amil Care Italia?

A.

Amil Care Italia produces high-level disinfection systems and operates in the fields of prevention and environmental safety, specializing in development and implementation of new technologies to counter problems related at microbial contamination in critical areas especially in health care, focusing efforts in search for "eco-friendly "(green) solutions to protect the health of workers and environment.

The company has Technicals and Product Specialists with prior extensive experience in the field of disinfection and Medical Devices.

Amil Care Italia is the company that produces and distributes the device Medibios and the disinfectant Evolyse. Also it holds the patent on Medibios device.

Amil Care Italia is certified ISO 9001 and 13485.

Q?

What is Medisystem?

A.

Medisystem is an innovative aerial disinfection system (DSVA), aimed at the prevention and control of hospital and Healthcare-associated infections also available for applications in areas where it is essential to contain the environmental microbiological contamination (areas with high risk of infection/critical areas).

Q?

How is the Medisystem technology composed?

A.

Medisystem is composed of a dispensing apparatus Medibios (Class I Medical Devices) and a disinfectant Evolyse (Class IIa Medical Devices) based on hydrogen peroxide (in two concentrations 6% and 12%) and silver sulfate.

Q?

Are the products certified?

A.

Medibios has EC Declaration of Conformity in accordance with Directive 93/42/EEC and subsequent amendments and is classified as a Class I Medical Device.

In addition, the device complies with Article 14 and Annex I of the Directive 2014/30/EU, reference standard EN 61326-1:2013 (EN 61000-3-2; EN 61000-3-3; CISPR 11; EN 61000-4-3; EN 61000-4-2; EN 61000-4-4; EN 61000-4-5; EN 61000-4-6; EN 61000-4-11) and complies with Article 1 of the Directive 2014/35/EU, reference standard EN 61010-2-040:2005 in conjunction with EN 61010-1:2010

Evolyse has EC Declaration of Conformity in accordance with Directive 93/42/EEC and subsequent amendments and is classified as a Class IIa Medical Device (EC 0426, Notified Body: Italcert).

The technical documentation has been prepared in accordance with the rules: UNI EN ISO 9001; UNI CEI EN ISO 13485; UNI CEI EN ISO 14971

Medibios and Evolyse are also registered with the FDA (Food and Drug Administration) as Class I Medical Devices.

Q?

Is Medibios patented?

A.

Yes it is, it has a patent that makes it unique

Q?

Who certifies the Medibios diffusers as Medical Device?

A.

Amil Care Italia certifies Medibios as CE Medical Device Class I (non-invasive) as it is certified according to ISO 13485 and therefore meets the requirements for a quality management system relating to Medical Devices and may issue the EC Declaration of Conformity.

Q?

Who certifies the Evolyse disinfectants as Medical Device?

A.

Evolyse, being a Medical Device Class IIa, is certified by a Notified Body, specifically Italcert (CE 0426 - Certificate no. 329-00-00-DM) which evaluated the quality system implemented by Amil Care Italia.

Q?

Why is it important the certification as a Medical Device?

A.

Because the checks and strict requirements, testing, periodic inspections that must undergo a medical device guarantee unique quality control and increased security, according to Directive 93/42 EEC.

Q?

How does the Medisystem technology work?

A.

The disinfectant is transformed by micro-nebulization in dry mist (dry fog) that is able to spread to saturation in a uniform way in a closed environment allowing to reach any free surface on the inside.

Q?

There are security risks?

A.

The disinfection process is not toxic or harmful.

The disinfectant decomposes in water and oxygen

decomposes spontaneously into water and oxygen, which are completely non-toxic compounds, does not wet the surfaces and does not leave residue/deposits.

It is recommended to carefully read the procedures/protocols of use, the safety data sheet of the products Evolyse and the user manual of the device Medibios.

Q?

There can be people or animals inside the premises during the treatment?

A.

There can be no people and/or animals during disinfection and decay time (dissolution) of the disinfectant. It can be used the adjacent rooms making sure that there are no leakages from the local subjected to treatment.

Q?

Is the hydrogen peroxide harmful to the materials and equipment?

A.

The use in the micro-nebulization form of the disinfectant makes it compatible with almost all the materials, since it does not wet and does not leave residues.

Q?

How long does it take for the diffusion procedure?

A.

Medibios is among the fastest existing devices. A few examples:
-1 Minute and 12 seconds for a dental operating room (30 cubic meters);
-2 Minutes for a single patient room including bathroom (50 cubic meters);
-5 Minutes for an operating room of medium / large size (125 cubic meters).
Times refer to standard dispensing of 1 ml of disinfectant per cubic meter.

Q?

In how long are the premises re-usable?

A.

Time will vary depending on the protocols used and the characteristics of the environment, in any case, we can say that the waiting time, after the end of diffusion, is from a minimum of 30 minutes to a maximum of 3 hours.

Q?

How much is the disinfectant consumption?

A.

Using the same examples above, the consumption is 1 milliliter of product per cubic meter treated. For 100 cubic meters are consumed 100 ml. 1 liter of product is used for 1000 cubic meters.
There are also shock protocols and consumption is proportional to the dose (3ml, 5ml per cubic meter, etc.).

Q?

How can I do if I had to access to the room during the dispensing or before the expected time required?

A.

Wearing the appropriate personal protective equipment (PPE) specified in safety data sheets and in procedures/protocols

Q?

Is it necessary to prepare the premises before use Medisystem?

A.

The premises must be clean and dry. The environment must be closed and must be denied access of people and/or animals for as long as necessary.

Q?

Should I turn off the air extraction?

A.

Yes, make sure that there are no air extraction systems turned on during the treatment.

 

 

 

In case it is not possible to turn off the ventilation plant will be evaluated correction factors on the basis of plant features

Q?

Is it necessary to ventilate the premises after the treatment?

A.

Do not need ventilate the premises after the recommended waiting time.

Q?

Is it necessary clean or remove residue or dry off surfaces after Medisystem use?

A.

The system doesn’t leave residues and doesn’t wet. Doesn’t need any operation after the treatment.

Q?

How many cubic meters can be treated?

A.

With a single Medibios device you can treat up to 1000 cubic meters. It is also possible to disinfect larger environments by operating multiple devices simultaneously.

Q?

How can we be sure of reaching the furthest corners even in very large, full of furnishings and equipment environments, or with a very complex structure?

A.

Thanks to the innovative patent, we get the complete saturation of the premises even in the most adverse conditions using chemical indicators sensitive to hydrogen peroxide, placed in the furthest and hidden corners reaching always every exposed surface.

Q?

Can it be operated in presence of other electrical or electronic equipment?

A.

Medibios device complies with Article 14 and Annex I of the Directive 2014/30/EU, reference standard EN 61326-1:2013 (EN 61000-3-2; EN 61000-3-3; CISPR 11; EN 61000-4-3; EN 61000-4-2; EN 61000-4-4; EN 61000-4-5; EN 61000-4-6; EN 61000-4-11) for the electromagnetic compatibility and complies with Article 1 of the Directive 2014/35/EU, reference standard EN 61010-2-040:2005 in conjunction with EN 61010-1:2010 for electrical safety.

Q?

Is the device portable? How much does it weigh?

A.

It weighs 9,2 Kg and is easily transportable by hand or on a trolley. Medibios is also arranged to be positioned in a room with programmed automatically start.

Q?

Is the use complicated?

A.

The system is extremely simple to use. It can be used easily by following the procedures/protocols.

Q?

Is there a training course for the use of the system?

A.

There are training and starter use of the system courses

Q?

Is it possible to program the starting automatically, without operator?

A.

Medibios has the option to program starts automatically in the date and hour selected.

Q?

Is there a warning when the liquid end?

A.

Medibios provides an alarm signal in case the bottle finish the liquid.

Q?

Is the disinfectant effective on bacteria only or on spores too?

A.

Evolyse is bactericidal, sporicidal, virucidal and fungicidal. The active ingredient, hydrogen peroxide, is universally known as effective on bacteria, viruses, spores, fungi, biofilm, tuberculosis.

Q?

What about the resistant and multidrug-resistant micro organisms?

A.

The system is tested on the majority of the most dangerous micro organisms about the resistance both in health and in general. The research and experimentation are increased and are updated continuously.

Q?

Which levels of decontamination can be reached?

A.

It can easily reach level of microbial reduction from 1.000 to 10.000 times (minus 3-4 log.), but we have developed protocols that can ensure decontamination levels from less than 100.000 to 1.000.000 times where necessary.

Q?

How can I be sure to have reached the desired result of decontamination?

A.

Can be used of chemical indicators to verify the saturation of hydrogen peroxide into the room and perform some microbiological controls of the microbial that exists on air and surfaces before and after Medisystem treatment.

Q?

How can I know if the diffusion has been successful?

A.

Medibios has a system of control and monitoring of the performed treatment.

Q?

Is it possible to reach the sterilization?

A.

Yes, with the protocols that we have developed, it is possible to reach decontamination levels of 1.000.000 times where needed (minus 6 log. equal to sterilization).

Q?

How can I be sure to reach a sterilization?

A.

To validate the method are used appropriate biological indicators for sterilization (we suggest preformed strips with Geobacillus stearothermophilus spores on steel disks).

Q?

Is the system evaluated as an expensive method?

A.

It can be define a economical system because it allows the disinfection of an operating room with superior guarantees to any manual intervention.

Q?

What is the difference between traditional systems and Medisystem?

A.

The Medisystem system allows a high standard of disinfection which is always repeatable (standardized), a complete protection of the worker to exposure to chemical and biological risk, the possibility of control, by the Infection Control Committee or whoever is in charge down, of the disinfection cycle and eliminates the factors of failure of disinfection as:

- Dilution
- Contact time
- Ratio disinfection/m3
- Pollution of the product (atmospheric and accidental agents)
- Use of unsuitable materials