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The MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application is an application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.

The MY01 Continuous Compartmental Pressure Monitor (the MY01 device) allows for continuous measurement and real-time display of muscle compartment pressure that is intended to be used as an aid in the diagnosis of Compartment Syndrome (Acute and Chronic).

The MY01 device is a single-use, sterile, prescription medical device. It consists of two major components: the Introducer (with a plastic housing and 17-gauge stainless-steel needle that allows for placement of a pressure sensor into muscle compartments) and the Pressure Monitor. The Pressure Monitor is a battery-powered component controlled by integrated software and firmware. It utilizes a capacitive Micro-Electro-Mechanical System (MEMS) sensor embedded on a flexible printed circuit board (FPCB), which extends and connects via a lead-wire to a rigid PCB located within the device body that houses a liquid crystal display (LCD) and push-button to control device function. The sensor continuously outputs pressure values when inserted into the patient's muscle compartment. Muscle compartment pressure is measured relative to atmospheric pressure, which is captured by a secondary MEMS sensor embedded within the device body. The embedded software/firmware system in the Pressure Monitor handles all processing functions of the MY01 device. Pressure measurements, user notifications, and device status information are displayed on the LCD screen of the Pressure Monitor and stored in non-volatile memory.

The MY01 device communicates securely via Bluetooth with the MY01 Mobile Application (the MY01 App) to transmit and display continuously in real time the measured muscle compartment pressure, user notifications and device status information. The muscle compartment pressure is displayed on the MY01 App along with the estimated muscle perfusion pressure that is derived using a manually entered diastolic pressure. The perfusion pressure is calculated using a simple subtraction: Muscle Perfusion Pressure = Diastolic Pressure - Muscle Compartment Pressure. The muscle compartment pressure is displayed as real-time numerical values and a continuously updated graph to visualize pressure trends over time. The muscle perfusion pressure is also displayed continuously with a dashed black line, indicating the estimated perfusion pressure based on the latest diastolic pressure entry.

The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device. The MY01 App is not intended for active patient monitoring.

Optionally, the MY01 App may connect via an encrypted Wi-Fi/Cellular network to the MY01 Application Server (a cloud-based server managed by MY01 Inc.) to transmit the recorded session and pressure data for off-line review, reporting and archival purposes. Registered clinicians using a MY01 device may review previously recorded session data on the MY01 App and may download this data from the cloud server as a comma separated value (.csv) file. The MY01 Application Server is a Non-Device Medical Device Data Systems (MDDS); it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data.

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