Invasive/Non-Invasive Ventilator


Project: Invasive/Non-Invasive Ventilator

Client Need:

  • Provide the software and algorithms for different breathing patterns (different sicknesses need different therapy profiles)
  • Adapt to abnormal breathing events (mask leaks, coughing)
  • Add a cost-efficient internal handpiece (by making it autoclavable)

How RBC Added Value:
By adding new electronics, mechanisms and software to the predicate ventilator, RBC created a new and improved combination invasive/non-invasive ventilation product.

RBC designed and developed the mechanical, electrical, and software for this improved ventilation product.

 We created the embedded grey nozzle, a complex electro-mechanical, autoclavable module.

With the “sidecar” enhancement, the invasive/non-invasive ventilator now includes these benefits:

  • Patient adaptation: The invasive/non-invasive enhancement allows for quick patient adaptation to from invasive to non-invasive care.
  • Cost containment: The invasive/non-invasive ventilator electro-mechanical control module is autoclavable for repeated use and cost containment.
  • Single unit: Hospitals now have a single ventilator (since the functionality of two units were combined) to meet the changing therapeutic needs of adult and pediatric patients.
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Before RBC
After RBC
RBC Medical is a great way to expand your organization’s development capacity and accomplish your strategic initiatives!
Design improvements
  • Addressed leaks: When the hospital switches a patient to a non-invasive ventilation approach by using a face mask, the invasive/non-invasive ventilator can quickly adapt to the dynamics of possible mask leaks and active exhalation (coughing or patients fighting the ventilator).
  • Added alarms: RBC also designed into the invasive/non-invasive ventilator an emergency ventilation mode (and alarms) to provide the same oxygen settings for a single limb until help can arrive.
  • Ensured easy training: RBC designed the invasive/non-invasive ventilator GUI (Graphical User Interface) with the same look and feel as the previous ventilator to minimize training for the staff.
Technical & Design Challenges

Creating a functional autoclavable module presented several challenges:

  • Finding materials that could be autoclaved without cracking or warping.
  • Designing the autoclavable electro-mechanical control module for easy user connection to the added control module and base unit.
  • Developing effective software algorithms for the patient’s breathing response to adapt to mask leaks by the patients, coughs due to their illness, or the patient fighting the ventilator.
  • Adhering to the appropriate FDA mandated alarms, RBC designed a ‘synchrony’ flow dynamics algorithm which adapts for the best respiratory care of critically ill patients.

By choosing RBC, the client’s engineering team was able to work on a different strategic initiative while we addressed this one.

510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.