Validation of the Dozee System

The most common parameters supervised by healthcare professionals tomonitor patients’ health are heart rate (HR), heart rate variability (HRV),respiration rate (RR), oxygen saturation (SpO2), temperature, blood pressure(BP), and heart rhythm [1]. Existing gold standard methods for measuring HR,HRV and RR necessitate the use of multi-lead ECG sensors [2] and nasalthermistor/nasal cannulas [3], which are both cumbersome and require a highlevel of patient compliance. These methods, too, necessitate some clinicalexpertise for proper application. Many advances have been made in the use ofwearables to achieve long-term monitoring of vitals [4,5]. However wearablesalso require a high level of patient compliance. Monitoring of these vitalswith less cumbersome techniques would be ideal in long term monitoring ofpatients and healthy people to detect any sudden abnormalities and long-termhealth deterioration.

The Dozee device developed by Turtle Shell Technologies Pvt. Ltd., is anon-contact continuous vital parameters monitoring system. It is designed forcontinuous and contactless measurement of HR HR, RR, and SpO2 (when connectedwith an accessory). The device uses the concept of ballistocardiography anddeploys piezoelectric sensors to capture the micro-vibrations originating fromcardiac contractions, upper respiratory tract activity and body movements. Thisdata is then analyzed by a proprietary algorithm and the values of the vitalparameters are generated. The sensor sheet is placed below the mattress andcaptures data while the user is resting or sleeping and does not require asensor to be fixed to the body making it ideal when compared to currentmethods. Monitoring people’s vital signs outside an ICU often relies on nursingstaff conducting checks at set intervals. The device can reduce the workloadfor nursing staff in non-ICU wards. This device is intended to be used tomonitor individuals/patients greater than eighteen years of age (between40kg-150kgs) and can measure their vital signs during sleep and resting state.The data can be viewed on the dashboard, exported, and even be directlytransferred to the in-house hospital management software. This protocol aims atvalidating the effectiveness of the investigational device in a general-careclinical environment.

1. Dias D, Paulo Silva Cunha J. Wearable Health Devices-Vital SignMonitoring, Systems and Technologies. Sensors (Basel). 2018 Jul25;18(8):2414. doi: 10.3390/s18082414. PMID:30044415; PMCID: PMC6111409.

2. Sandau KE, et.al., American Heart Association Council onCardiovascular and Stroke Nursing;Council on Clinical Cardiology; and Councilon Cardiovascular Disease in the Young. Update to Practice Standards forElectrocardiographic Monitoring in Hospital Settings: A ScientificStatement From the American Heart Association. Circulation. Nov7;136(19):e273-e344.(2017)

3. Subbe, Christian Peter & Kinsella, Sean. (2018). ContinuousMonitoring of Respiratory Rate in Emergency Admissions: Evaluation of theRespiraSenseTM Sensor in Acute Care Compared to the Industry Standard andGold Standard. Sensors. 18. 2700. 10.3390/s18082700.

4. Etiwy M, Akhrass Z, Gillinov L, et al. Accuracy of wearable heartrate monitors in cardiac rehabilitation [published correction appears inCardiovasc Diagn Ther. 2020 Jun;10(3):644-645]. Cardiovasc Diagn Ther.2019;9(3):262-271. doi:10.21037/cdt.2019.04.08

5. Charlton PH, Bonnici T, Tarassenko L, Clifton DA, Beale R, WatkinsonPJ. An assessment of algorithms to estimate respiratory rate from theelectrocardiogram and photoplethysmogram. Physiol Meas.2016;37(4):610-626. doi:10.1088/0967-3334/37/4/610