Repair and production of artificial ventilation apparatus

The urgent need for maintenance, repair and production of artificial lung ventilation devices in Ukraine is linked to the need to ensure effective treatment and rehabilitation of Ukrainian citizens during the COVID-19 epidemic in the absence of time. It should also be noted that since 2009 there is no operating enterprise in Ukraine for the production of strategically important devices of artificial ventilation.
Body-Forming Group currently has specialized specialists needed to get started with the premises and equipment and contacts with related and contracting organizations in Ukraine and abroad. In the process of IVL repair, communication with manufacturers of IVL equipment and manufacturers of related radioelectronic, compressor, gas distribution equipment, Body Forming specialists have gained understanding of the design, technological, technical mechanisms and processes of production organization, certification procedures and operation of US IVL manufacturers in Europe.
The cost of acquiring mechanical ventilation directly from manufacturers at present and in the future is not the optimal solution to the question for the following reasons:
– under the current conditions of the COVID-19 pandemic, the manufacturers of artificial ventilation apparatus are overloaded with their countries’ orders and cannot deliver in the required quantities and nomenclature;
– the cost of modern IVL with the optimal set of functions is from 20 to 40 thousand euros;
in Ukraine there are no enterprises that produce mechanical ventilation or have the necessary equipment and experience. Burevisnik has been manufacturing mechanical ventilation by 2009. The “Breeze” model, to which part of the documentation does not meet the modern requirements for mechanical ventilation equipment, for it the adjacent enterprises do not produce expendable parts, the software is incompatible with the existing control and operation systems;
the situation in Ukraine in the context of the COVID-19 pandemic gives grounds to claim that the availability of own production of mechanical ventilation equipment is necessary for ensuring the safety of citizens and strategically important for the state.

Solution. The specialists of Body-Forming GC have agreed to receive design, technological documentation and specifications on special terms for Ukraine (without royalties, without royalties, lump sums and other contributions to owners). Organization of production under the above conditions:
– significantly shorten the period from the beginning of production to the production of the prototype -3-4 months, to the production of certification series (30 sets) – 5-6 months.
– since Ukraine has been certified by EU standards for medical devices since 2016, and partners have such certificates – ISO13485 (medical device) certification can be held immediately before the series release date.
the cost of mechanical ventilation equipment manufactured by Ukraine will be substantially lower than that of foreign counterparts: devices of Ukrainian production from $8,000 to $12,000, similar devices from foreign production from $18,000 to $40,000.

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