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Challenge: Frustrated with current capnography techniques, anesthesiologist JW Beard, MD knew there had to be a better way to monitor CO2 output while oxygenating a patient. He approached Gilero with the idea to design an oxygen mask with a port to monitor CO2.
Approach: The initial mask we designed was exactly what the customer asked for: an oxygen mask with PVC Luers molded into it. Before settling on a mask made up of one large molded PVC piece, Gilero engineers brainstormed other solutions and decided to try adding a Luer to a standard O2 mask. Our engineers prototyped a mask that looked and functioned like a standard O2 mask with the addition of two ports on either side. This idea evolved into the final multipiece design with two twist lock Luers bonded into an oxygen mask that could be hooked up to monitors for capnography. Luers on both sides of the mask provided two points of access so that monitor tubing could be connected on whichever side was more comfortable for the patient. Aside from designing and developing the product, our team had to complete a great deal of testing in order to demonstrate the efficacy of this device to monitor CO2 levels. We built a breathing simulator that simulated human breath by CO2 expiration, supplying us with a normal CO2 profile that we control and test. We were able to prove through our testing that the device’s ability to measure CO2 and deliver O2 was equivalent to current methods on the market while being easier to use. We also executed ISO 594-2 Luer testing, force testing, clip retention testing, accelerated aging and real time aging.
Outcome: The CapnoVue M1, a capnography face mask that incorporates CO2 sampling ports into an oxygen delivery mask and can be used on adult, pediatric and infant patients. Dr. Beard’s company, Monitor Mask, was ultimately acquired by Salter Labs.