Clinical Accuracy of Vital Sign Pressure Sensor Clinical Trial
Official title:
An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user
tests two devices mounted on two smartphones.
- Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her
temperature interfaced with a temperature specific 'app'. Before and after the the
temperature is obtained using the V-Sensor, the temperature will be obtained using an
equivalent thermometer.
- Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted
on the two phones interfaced with a blood pressure specific 'app'. Before and after each
measurement, a reference measurement using a mercury sphygmomanometer will be taken.
- Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using
2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration,
and SpO2 'app'. Before and after each measurement, a reference measurement using
equivalent reference devices will be taken.
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