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The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization under the direction of a licensed medical professional to record, display, and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; e) Systolic and Diastolic Blood Pressure and f) other validated data sources. The SimpleSense Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSense Platform is intended to be used by patients at rest with a stationary torso. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSense Platform does not produce alarms and is not intended for active patient monitoring. The SimpleSense Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSense Platform is not intended for use in the presence of a pacemaker. The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

The SimpleSense-BP Software Application accesses the physiological parameters like ECG, heart sounds, and thoracic impedance captured by the SimpleSense Device for processing into the vital sign outputs of the product which includes estimation of Systolic and Diastolic blood pressure. The software uses recorded data from the SimpleSense electronics module as inputs into a validated computational model for estimating blood pressure over the period of wear. The system samples blood pressure while the user is at rest. In addition, SimpleSense-BP Software utilizes inputs such as demographic information (age, weight, height, and gender) and a blood pressure measurement for clinical stratification to the algorithm. The blood pressure outputs are returned to the SimpleSense Mobile Application and/or SimpleSense webserver for display, review and interpretation by a physician. The Nanowear SimpleSense system is a non-invasive, wearable, and portable medical device for the evaluation and monitoring of patients. It utilizes physiologic and biometric sensors embedded in a garment and an electronics module to gather the heart health data. The specific physiological parameters recorded by the device include: two vectors of Electrocardiogram (ECG), respiratory rate though thoracic impedance, heart sounds, and activity including posture. The signals are recorded by the electronics module on a removable data storage card and are periodically transferred to a smartphone mobile application that connects to the electronics module over a wireless Bluetooth connection. The mobile application provides the functionality of transferring the data collected by the electronics module then relaying the data to the Nanowear web server for display of the data by a physician.

The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not produce alarms and is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.

The Nanowear SimpleSENSE Platform is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture and movement with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, which is then forwarded to a medical professional for review. The garment is designed to be unobtrusive to everyday activity and provide an easier and more efficient means of capturing ECG data from patients. The device consists of a combination of: The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance. A MEMS microphone for measuring heart sounds. The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to a phone running iOS or Android. An accelerometer to measure activity. The SimpleSENSE Mobile Application: mobile application to start/stop a recording, logging symptoms, and data transmission. SimpleSENSE Web Server: allows initiation of a test, storage, and review of prescribed test data by a medical professional.

The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

The Nanowear SimpleSENSE device is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients. The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components: - The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds. - The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity. - The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.

The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the nead ly assess their cardiac rhythm disturbance. ECC data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation.

The Nanowear SimplECG (“SimplECG”) device is a wearable garment (either a shirt or brassiere) that is magnetically attached to a communication module which is secured in place by an elastic pouch. The SimplECG is designed for reliability, patient comfort and ease of use in clinical-quality electrocardiogram (“ECG”) applications. The SimplECG device does not perform any automatic beat or rhythm classification on the acquired ECG data. The intended duration of use of the SimplECG device is up to 24 hours. The SimplECG Communication Module can collect continuous ECG data from the garment, securely stores it and transfers to a compatible mobile device (iOS), which then uploads the recorded ECG data to a secure Nanowear Inc. (“Nanowear”) server for review by a medical professional (inclusive of a physician, nurse or technician). The device consists of four (4) components: • The SimplECG Garment: a shirt or brassiere, consisting of a network of nanosensors integrated directly into the garment, that collects ECG signals directly from the skin which are then captured by the communication module. • The SimplECG Communication Module*: collects, stores and wirelessly transmits ECG signals from the garment to the patient mobile device. • The SimplECG Mobile Application: allows for patient logging of symptoms and transmission of ECG recordings to a secure, remote server through a patient-supplied mobile device operating on Apple iOS. • The Nanowear Web Application: allows initiation of a test, and storage and review of patient ECG data sent from the Mobile Application to the server. *The electronic enclosure for the SimplECG Communication Module is made of Nylon/PA2200.