Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation

Korábbi kezelés

• Participants with known clotting disorders or currently taking a prescription blood thinner.

Más betegség

• Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
• Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
• Participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
• Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.

Laborértékek

• Participants suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula.

Egyéb

• Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential.
• A wrist circumference below 14 cm or above 23 cm.
• An upper arm circumference < 22cm or > 42cm.
• Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.

• Participants must be able to provide an informed consent to participate.
• Participant must be willing and able to comply with all of the study procedures and return for a day 2 visit.
• Participants must be 22 to 59 years of age.
• Participant or witness must be able to read or write in English.