Blood Pressure Clinical Trial
Official title:
Verification Protocol for The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component for Clinical Use and Self Measurement According to the American Safety in Medical Technology and the IEEE
The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.
Several automated vital sign measurement systems have been developed recently; however,
non-invasive continuous blood pressure monitoring continues to be a major limitation. To
circumvent the limitations of current systems of interval hemodynamic measurement and
increasing demands on health care providers, a non-invasive automated continuous vital sign
monitor that can integrate into hospital early warning systems and warn health care providers
of deteriorating vital sign parameters would be of significant value and a major advance for
current hospital monitoring systems.
Cloud-DX Vitaliti™ is a new low profile automated vital sign monitor, which includes a
continuous non-invasive blood pressure measurement system. Additional parameters are also
measured. Paired with companion software from cloud based computing, Vitaliti™ features a
user friendly interface, onboard radios for communication with smartphones/tablets/personal
computers, and several sensors.
Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for verification to
achieve compliance with AAMI/ISO and IEEE standards of medical grade device. At the Hamilton
General Hospital (HGH), Cardiac Surgical Intensive Care Unit (CICU) and Vascular Surgical
Step Down Units, arterial catheters are standard of care and performed on most patients for
variable periods of post-operative recovery. Within this setting, the IEEE Std 1708 and
AAMI-ISO 81060-2 would be fully met. Furthermore, the cardiovascular surgical caseloads at
HGH would provide sufficient test subjects to validate VitalitiTM in a timely fashion.
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