Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable

The purpose of this study is to assess the performance, usability, and safety of an investigational physiological monitoring technology in neonates, children, adults, and elderly subjects. The study will collect electrocardiogram (ECG) and respiration-related data, including assessment of performance under specific clinical conditions. The data generated will be used to improve measurement technologies, support product development, and provide clinical evidence for safety, performance, and regulatory compliance.

Primary outcomes

• Primary Outcome [Up to 24 hours after time of enrollment]: ECG performance and user-reported usability of the new ECG device

Secondary outcomes

• Secondary Outcome [Up to 24 hours after time of enrollment]: Parameter raw data recorded by the ECG device

Other outcomes

• Safety Outcome [12 months]: Number and type of adverse events, serious adverse events, and device deficiencies

Sex: All

Inclusion Criteria:

1. Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. ECG can be collected

Exclusion Criteria:

1. Are known to be pregnant*
2. Are breastfeeding; OR,
3. Are suffering from infection(s) or immunocompromised patients that require isolation.
4. PI or caring physician decision due to subject health condition