Healthy
Conditions
Brief 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
Interventions
DEVICEMasimo SET® and Masimo W1®
Pulse oximeter and wrist wearable device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion. * Skin condition which would preclude proper ECG placement. * Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them. * Subject is allergic to any supplies used in the study (e.g., ECG gel, adhesives). * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity of Masimo SET® | 1-2 hours |
Countries
United States
Outcome results
None listed