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The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The device does not actively monitor or diagnose the patient and does not issue any alarms.

Wesper Lab ("the device") is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. The device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are multi-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are the same and differ only in their anatomical designation, which is determined by the order in which the user applies them at test setup time. The flexible fabric allows the patch to contract and expand as the patient breathes and moves during sleep. The mobile application ("the app") resides on the patient's personal mobile device, relaying sleep data wirelessly to a secure remote storage location ("the cloud") for subsequent analysis by a healthcare professional. The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient. The device's BLE ports connect to the following: - 1. Abdominal patch - 2. Thoracic patch - 3. Pulse oximeter The patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and airflow / air pressure. The patches leverage accelerometry and optical sensing to provide these measurements. Data from the patches is transmitted via BLE throughout the night to the app, which uploads the data to the cloud. A third BLE port on the app connects to an FDA cleared pulse oximeter, which provides heart rate and blood oxygen saturation measurements. The data recorded by the patches is relayed to a remote secure storage, where it will be downloaded to a local PC. Then, Wesper staff will execute the Study Output Module (SOM) and save the data locally on the desktop computer. The data is then ready for interpretation by a healthcare provider.

WesperO2 is a finger-worn pulse oximeter in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs and home use.

WesperO2 ("the device") is a pulse oximeter, meant to be worn on the finger of an adult patient over the age of 21. The device is intended for spot checking or continuous collection of functional oxygen saturation of arterial hemoglobin by way of sensing peripheral capillary perfusion ("SpO2") and Pulse Rate. It is intended to be used in the patient's home or in a sleep lab. The device's core technology is based on collecting reflected light from the intact skin of the patient's finger to form Photoplethysmography ("PPG") waveforms. These waveforms can then be used to extract a measurement of SpO2 and Pulse Rate. The sensing component is carried by an electronics assembly, which is comprised of a battery-powered Printed Circuit Board ("PCB"). The electronics assembly is housed inside of a soft, flexible casing, which encapsulates the entirety of the assembly, except for the actual optical front-end of the sensing component, which exposes an array, consisting of two LEDs and a photodiode. The entire assembly is referred to as "the WesperO2 probe." The silicone housing has a "thimble-style" form factor, such that the patient can wear it on their fingertip, with the optical sensor pointed at the pad of their finger. The probe is then meant to create a snug, yet comfortable fit to ensure consistent positioning of the optical sensor throughout the usage period. The probe has a Bluetooth interface through which it sends SpO2 and Pulse Rate measurements to a companion mobile application ("WesperO2 app"), which resides on the patient's mobile device. The application can both record the data and display it in real-time to the patient. Recordings are saved on the mobile device and can be shared later through the application with a healthcare provider over the internet.

The Wesper Lab is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep apnea by trained personnel. Wesper Lab is intended to be used for adult sleep studies at home or clinical environment. The body-worn component of the system is single-use, to be discarded nightly application. The device does not monitor or diagnose the patient and does not issue any alarms.

Wesper Lab ("the device") is indicated as a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. Wesper Lab records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The device consists of an abdominal patch, a thoracic patch and a mobile application. The patches are single-use wearable, flexible, thin, and wireless, and are designed to record sleep data in adult patients. Both patches are identical and differ only in their anatomical designation at test setup time. The flexible fabric allows the patch to retract and expand as the patient breathes and moves during sleep. The mobile application ("the app") resides on the patient's personal mobile device, relaying sleep data wirelessly to a secure remote storage location ("the cloud") for subsequent analysis by a healthcare professional. The patches collect multiple physiological parameters related to sleep to be used by a healthcare professional. Specifically, the patches measure sleep position, respiratory effort, and Wesper-Sum- Flow / Wesper-Sum-Pressure. Data from the patches is transmitted via Bluetooth low energy (BLE) throughout the night to the app, which uploads the data to the cloud. A third BLE port on the app connects to an FDA cleared pulse oximeter, which provides pulse rate and blood oxygen saturation measurements. The data recorded by the patches is relayed to a remote secure storage, where it will be downloaded to a local PC. Then, Wesper staff will execute the Study Output Module (SOM) and save the data locally on the desktop computer. The data is then ready for interpretation by a healthcare provider.