Está basado en un ciclador automático de resucitadores manuales para la emergencia y en el contexto de pandemia, para su uso exclusivo frente a una situación de catástrofe. La documentación técnica se presenta en formato Open Source para la comunidad, libre de cargos y restricciones.
El Instituto Tecnológico de Buenos Aires (ITBA), Mirgor y Toyota Argentina se unieron para colaborar en la lucha por la pandemia del Covid19, a través del diseño y desarrollo de un prototipo de soporte respiratorio mecánico de emergencia construido con partes y componentes disponibles en el mercado.
El dispositivo está basado en un ciclador automático de resucitadores manuales tipo AMBU y su desarrollo se ha realizado siguiendo los estándares establecidos por la Sociedad Argentina de Terapia Intensiva (SATI).
El dispositivo, que posee el modo ventilación controlada por presión (VCP) mandatorio con monitoreo del volumen tidal, se distingue por contar con sensores de control de presión en la inspiración todo el ciclo respiratorio y de flujo para el cálculo del volumen tidal suministrado al paciente.
Fue creado para ser utilizado exclusivamente en situaciones de emergencia y en el contexto de pandemia frente a una situación de catástrofe tal como define SATI. Los destinatarios son pacientes adultos con un peso mayor a 40kg y el usuario previsto es personal sanitario debidamente capacitado. Tiene como objetivo brindar soporte hasta que el paciente pueda ser trasladado a una unidad de terapia intensiva y recibir asistencia mediante un respirador.
Su automatización y sistema de alarmas de monitoreo apunta a ser un complemento al personal médico y paramédico, evitando que el mismo deba dar asistencia respiratoria accionando de forma manual un resucitador AMBU y permitiendo su supervisión sobre más de un paciente a la vez.
El prototipo ha sido sometido a diversas pruebas internas, aunque no ha sido aún certificado bajo ensayos de laboratorios y, para su fabricación, deberá procederse a su homologación y seguir las reglamentaciones locales para productos médicos.
De obtenerse su homologación, Mirgor y Toyota Argentina se comprometen a donar las partes y componentes para la fabricación de 250 dispositivos, siempre y cuando la misma sea realizada sin fines de lucro.
Las tres instituciones que participaron del proyecto decidieron poner a disposición de la comunidad científica tecnológica del país y del mundo, así como de las autoridades, libre de cargos y restricciones, los planos, protocolos y demás especificaciones técnicas del prototipo, que se encuentran disponibles para su descarga en el sitio https://ciclador.itba.edu.ar/ .
De esta forma, aquellos fabricantes de equipamiento médico, ya sean de carácter público o privado, interesados en su manufactura, podrán emprender sin restricción alguna, los pasos necesarios para su homologación ante las autoridades de aplicación de su respectiva jurisdicción.
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