Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Masimo Corporation
Summary
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Subject is 18 to 80 years of age. * Comfortable to read and communicate in English.\* * Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures * This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in English only). Exclusion Criteria: * Subject currently has a known cardiac disease condition. * Subject is pregnant or breastfeeding. * Subjects with a skin condition affecting t…
Interventions
- DeviceMasimo SET® and Masimo W1®
Pulse oximeter and wrist wearable device
Location
- Masimo CorporationIrvine, California