completed

Cloud-DX Vitaliti (TM) is a groundbreaking new low-profile automated vital sign monitor which includes:

  • A continuous non-invasive blood pressure measurement system
  • 2-Lead ECG (sampled at 500 Hz)
  • Heart rate and heart rate variability
  • Respiration rate
  • Temperature (infrared sensor in ear sampled at 20 Hz)
  • Blood oxygen saturation (Red, IR, and Green channels sampled at 200 Hz)
  • Pulse wave velocity.

Cloud-DX Vitaliti (TM) has undergone clinical verification testing to achieve compliance with the Institute of Electrical and Electronics Engineers (IEEE) and the American Safety in Medical Technology (AAMI- ISO) standards of medical grade device.

This testing required two nurse observers and engineer observer to complete necessary measurement and calibration steps as per protocol.

Study Type

Interventional - Device

Study Design

Multi-centre, blinded RCT

NO. of Countries

1

NO. of Sites

1

NO. of Participants

78

Study Period

2018-2019

Sponsor

PHRI

FedDev Ontario

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