Creanova

Airgo™ Wearable

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     Respiratory Wearable Airgo™ - Wearable Medical Device for Respiratory Monitoring

    Wearable Medical Device for Respiratory Monitoring

    Airgo™ is a respiratory device for ventilation and breath dynamics monitoring. This non-invasive wearable marks a step forward in continuous spirometry, sleep disorder screening and ICU respiratory pattern detection, allowing 24/7 real-time minute ventilation monitoring and providing reports useful for caregivers.

    MyAir was engaged in the battle against COVID-19: Airgo™ is being employed in the prediction of respiratory distress in Coronavirus patients both at hospital and at home.The device consists in a holter (worn over the floating ribs) and a recorder unit. The unit collects the signals from the holter and, through proprietary algorithms, produces automated reports and dashboards for doctors.

    Creanova’s team collaborated with MyAir in prototyping, engineering refinement and production of the recorder unit, an essential part of this innovative wearable.

    Prototypes for clinical trials and certification

    Creanova's product engineers took care of Airgo™ prototypes, leveraging our experienced supply chain, which allowed us to refine functional details in very tight spaces by vacuum casting technology.

    Our prototypes of this respiratory device satisfied cytotoxicity requirements for a skin contact lasting for more than 48 hours. The relative test was certified by one of our partner laboratories and was the first step towards a prototype fully suitable for prolonged wearable use.

    The wearable prototypes were used to perform clinical trials and medical device Class IIa certification.

    Industrialization engineering to make a great idea a real product

    Creanova’s product engineers were asked to make the project feasible and manufacturable according to medical regulations and with the goal to realize the product as in the client’s mind. We supported the client through the product development in respecting the medical regulations and requirements.

    The engineering refinement led to the optimization of the recorder units details:

    • Battery compartment cap is reviewed to automatically lift when it is turned and opened
    • An easy-to-deploy solution was found to ensure the electronic contact with the battery, during sleep and each daytime activity
    • The connection mechanism, which links the holter with the recorder unit, is optimized through the resizing of the snaps
    • To meet technical requirements of injection molding, our engineers worked on the directions of removal from the mold, on draft angles, on plastics thickness, all to enhance the project and the device aesthetics

    Engineering refinement resulted in a 3D model with very strict tolerances and small thicknesses, slightly different from the starting project also in design.

    Much attention was paid to the material, as intended to make up a wearable. The recorder unit can stay in contact with the skin for more days and ISO 10993 indications had to be followed to respect the criteria of cytotoxicity, sensitivity and irritation.
     Respiratory Wearable Airgo™ - Industrialization engineering to make a great idea a real product
     Respiratory Wearable Airgo™ - Medical device production and assembly

    Medical device production and assembly

    Creanova supported MyAir up to the end product, smoothly driving the client through mold making, shells and electronic boards production and final assembly.

    The Airgo™ assembly was performed in the Creanova's production site, certified with ISO 13845.

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