Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard

Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)

The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.

The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.

Inclusion Criteria:

• Adults ≥ 19 years of age (minimum 30% male/female)
• Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.):

Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:

Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-Middle Quarter: ≥ 15.9cm to < 18.3cm Upper-Middle Quarter: ≥ 18.3cm to < 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm

● Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

• Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in)
• Hand or body tremors
• Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation)
• Korotkoff sound K5 not audible
• Pregnant
• A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
• Unwilling to volunteer to participate and to sign the study specific informed consent form