Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits
Turtle Shell Technologies Pvt. Ltd.
Summary
The Dozee VS system (K221555) is a contactless device that tracks heart rate and breathing rate using a sensor sheet placed under the mattress. It captures body vibrations and converts them into vital signs, which can be monitored remotely in real time. The system also supports add-ons like a blood pressure cuff, pulse oximeter, and thermometer, offering a complete monitoring solution. This study aims to validate the updated AI-powered heart rate and improved breathing rate algorithms across different sensor sheet types to confirm clinical accuracy
Description
The Dozee VS system (K221555), developed by Turtle Shell Technologies, is a non-invasive, contactless device that continuously monitors heart rate (HR) and breathing rate (RR). A thin sensor sheet placed under the mattress detects tiny body vibrations from the heart and lungs, which are processed by smart algorithms and displayed on a secure online dashboard for real-time monitoring. Unlike traditional methods such as ECGs, nasal tubes, or thermistors-which are invasive, require skilled placement, and are uncomfortable for long-term use-Dozee is simple, comfortable, and doesn't rely on patien…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Subjects will be included if they meet the following inclusion criteria: 1. Adults Male or female. (Above 18 years of age) 2. Provide written informed consent. 3. Weight between 40kg/88.18lbs and 120kg/264.55lbs 4. Agree to not eat during the testing period 5. Able to move and exit the bed independently and safely. Exclusion Criteria: Subjects will be excluded if they have any of the following inclusion criteria: 1. Are connected to a device that may interfere with the device monitoring in this study. 2. Are receiving any bedside care which may be incompatible with the…
Interventions
- DeviceDevice: Telemetry monitoring
All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).
Location
- ERA Health ResearchMidland, Texas