Design Continuous Compartmental Pressure Monitor The MY01 Continuous Compartmental Pressure Monitor is a sterile, single-use device. MY01’s Continuous Compartment Pressure Monitor uses a patented intuitive insertion mechanism to deliver reliable MicroElectroMechanical Systems (MEMS) technology35 directly within the muscle-enabling reliable, continuous pressure measurements. The Continuous Compartment Pressure Monitor is specifically designed to minimize common use errors36 in order to provide quick, reliable continuous pressure readings over time Key Characteristics Quickly delivering proven MEMS technology in situ providing reliable continuous pressure measurements, relative to current methods. Enables single point measurements for survey and placing sensor in most at-risk muscle compartment. Specifically designed for continuous pressure monitoring while minimizing use errors by design. Wireless capabilities enable visualization of data over time enabling physicians to augment clinical findings. Product Composition The MY01 monitor comes equipped with an intuitively designed introducing mechanism that provides up to 5 single point measurements for determining the most at-risk compartment. After which, the introducer can be removed to allow the MY01 to continuously measure the most at-risk compartment for up to 18 hours. The MY01 device measures one compartment at a time. Indications The MY01 Monitor continuously measures compartmental pressures in real-time to aid in diagnosing compartment syndrome. The MY01 Mobile App optionally stores and displays identical pressure values from the monitor for informational purposes only, not for diagnosis or active patient monitoring. Approach Peel the Tyvek lid, lift the cover, and remove the device. Hold the Introducer, remove the Needle Cap, then turn on the device. Press and hold the Push-Button firmly until the MY01 logo appears, followed by a pressure value of 0. Gently insert the Needle into the muscle compartment in a controlled motion, using its markings to estimate depth. Avoid excessive force on the Display. Once the Sensor is positioned and readings stabilize, gently press the Introducer's back opening to eject the Pressure Monitor, exposing the adhesive strip. Hold the Introducer and use the adhesive strip to secure the Device Body face-up near the insertion point. Ensure slack in the Lead-Wire, extending straight to show the Sensor's insertion angle. Rotate the Introducer 180° to disengage the Sensor, then slowly remove and dispose of it in a biohazard-sharps receptacle per facility guidelines. Monitor pressure readings for up to 18 hours, ensuring the device remains secured and the Lead-Wire does not displace the Sensor. Remove the dressing, gently pull the Lead-Wire to remove the Sensor, and dispose of the Pressure Monitor in a biohazard container per facility guidelines. References