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This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers.
The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Experimental | 1 arm. Healthy volunteers assigned to different interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Happy Flow / Baseline | Device | Baseline (without make-up or mask) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | To compare the Pulse Rate (Beats per Minute) measured by the VitalSigns Camera with the Pulse Rate measured by the reference device. | Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week. |
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Inclusion Criteria:
Exclusion Criteria:
Individuals who are not able to read and understand the English language
Known allergic reaction to facial make-up
COVID-19 exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips Research North America | Cambridge | Massachusetts | 02141 | United States |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| Make-up |
| Device |
To test device on participant who is wearing facial make-up |
|
| Sunglasses | Device | To test device on participant who is wearing sunglasses |
|
| Face mask | Device | To test device on participant who is wearing a facial mask |
|
| Minimum requirements camera | Device | To test the minimum requirements of the camera |
|
| Worst case hardware | Device | To test if software still works with an older smartphone |
|
| Damaged lens | Device | To test if software is still working when the lens of the smartphone is damaged |
|
| Face or chest outside test frame | Device | To test software if the participants face or chest is outside the test frame |
|
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |