Terumo CDI OneView - System Overview; Indications for Use

1-1
System Overview
The Terumo Cardiovascular CDI OneView
TM
System (CDI OneView) is a blood monitoring
system to be used on a single patient during cardiopulmonary bypass procedures. The
CDI OneView System continuously monitors the blood in the extracorporeal circuit and
provides ongoing information about the blood parameters, which is displayed on its
easy-to-read screen.
The CDI OneView System is a modular and user-congurable design comprised of a
central Core, a Display, a Calibrator unit, probes for different parameters measurements,
cables to external module devices, mounting accessories and disposables.
The CDI OneView System can display potential of Hydrogen (pH), partial pressure of
Oxygen (pO
2
) and partial pressure of Carbon Dioxide (pCO
2
) parameters either at actual
temperature or adjusted to 37°C.
The CDI OneView System and all related accessories are latex-free.
Indications for Use
The CDI OneView Monitoring System is a patient parameter monitoring system to be
used on a single patient during cardiopulmonary bypass procedures. By measurement
or acquisition from other devices, it displays and outputs information to provide
continuous, in-line monitoring of various patient parameters contained within the
extracorporeal perfusion circuit and patient. The following parameters are available,
based on conguration:
• Potential of Hydrogen (pH)
• Partial Pressure of Carbon Dioxide (pCO
2
)
• Partial Pressure of Oxygen (pO
2
)
• Potassium Ion (K
+
)
• Oxygen Saturation (SO
2
)
• Hematocrit (HCT)
• Hemoglobin (Hgb)
• Blood Flow Rate (Q

)
• Cardiac Index (CI)
• Base Excess (BE)
• Bicarbonate (HCO
3
−
)
• Oxygen Consumption (VO
2
)
• Indexed Oxygen Consumption (VO
2
i)
• Oxygen Delivery (DO
2
)
• Indexed Oxygen Delivery (DO
2
i)
• Cerebral Regional Oxygen Saturation (rSO
2
)
• Oxygen Extraction Ratio (O
2
ER)
• Body Surface Area (BSA)
• Shunt Sensor Temperature
ContraindicationsContraindications
None.