Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057

Korábbi kezelés

• Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.

Más betegség

• Subjects with an implantable defibrillator or cardiac pacing device.
• Subjects with a skin condition which would preclude proper ECG electrode placement..
• Subjects with known allergic reactions to adhesive tapes or ECG gel.

Egyéb

• Subjects who are physically unable to wear a wristwatch
• Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
• Subjects not suitable for the investigation at the discretion of the investigator or the clinical team

• Subject is 22 years of age or older
• Subject is comfortable to read and communicate in English*
• Subject belongs to one of two groups:
• Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
• Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) *This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.