A multicenter, prospective and retrospective, observational, post market study.
This observational study is to collect real-world data on the safety and performance of the Tempus Pro device, its accessories and the IntelliSpace Corsium telemedicine software device when used according to its intended purpose and the instructions for use, when used for patient monitoring.
Study Type
OBSERVATIONAL
Enrollment
103
Standard of care for emergency events per local guidelines.
Philips
Pittsburgh, Pennsylvania, United States
Clinician assessment of 12-lead ECG reports
The proportion of 12-lead ECG pairs that are identical, after a cardiologist's review of printouts from Corsium IntelliSpace (transmitted) ECG and the original ECG from the Tempus Pro device.
Time frame: through study completion, an average of 1 year
Diagnostic quality of 12-lead
The printed patient record ECG will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality.
Time frame: through study completion, an average of 1 year
Consistency of transmitted vital signs by Tempus Pro via IntelliSpace Corsium
The number and proportion of patient vital sign data points, comparing direct data with identical units of measure from printouts from IntelliSpace Corsium (transmitted) vital signs and the original vital signs from the Tempus Pro device.
Time frame: through study completion, an average of 1 year
Number of all activated alarms
The 'Summary Record of Care' indicates all alarms - for all alarm-settable parameters - were activated at the thresholds set by the user, as indicated in the 'Technical Log'
Time frame: through study completion, an average of 1 year
IntelliSpace Corsium transmission
The Summary Record of Care (SRoC) data transmission from Tempus Pro to IntelliSpace Corsium will be independently reviewed for abnormalities and distortion by a clinician. The clinician will note any abnormalities altering diagnostic quality of the transmission.
Time frame: through study completion, an average of 1 year
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