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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-Sensor Device User | Other | This diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-sensor device user | Device | Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2 | For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg. | 4 months |
| Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61 | Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device. | 4 months |
| Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61. | The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2 | 4 months |
| Respiration rate accuracy | Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate | 4 months |
| Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard. | Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias <= 3.0°C and a clinical repeatability <= 3.0°C. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| No serious adverse device effects are reported. | Zero serious adverse device effects are reported. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly A McClary, RN | Contact | +41 (0)797764954 | km@leman-micro.com | |
| Chris J Elliott, PhD | Contact | +41(0)791733306 | cje@leman-micro.com |
| Name | Affiliation | Role |
|---|---|---|
| Chris J Elliott, PhD | Leman Micro-Device | Study Director |
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Each participant tests two equivalent vital sign sensors (devices under test) mounted on two different smartphones, one after another to assess accuracy of the device compared to equivalent reference devices.
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Vital sign results obtained by the device under study are not displayed on phone screen.
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