Terumo CDI OneView - Intended Patient Population

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System Overview
Intended Patient PopulationIntended Patient Population
The CDI OneView System is used during cardiopulmonary bypass procedures with
patient populations ranging from neonates to adults.
Frequently Used FunctionsFrequently Used Functions
• Module components connection
• Connecting probes and components
• Setting probes conguration
• Setting display conguration
• Exporting case data
• Monitoring parameters
• Performing in-vivo recalibration
• Adjusting patient blood parameters values
• Marking key clinical events during monitoring
• Changing O
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consumption
• Switching temperature measurement method between alpha-stat and pH-stat
• Adjusting arterial blood temperature to the desired range
• Adjusting system display angle
• Monitoring alarm signals
• Adjusting alarm volume
• Alarm limits setting
• Alarm inactivation
User ProfileUser Profile
This system is operated by a perfusionist in possession of all licenses, certications
and/or training as required by the region(s) in which they practice, and it should never
be left unattended.
Minimum Physical Requirements: The user must have the physical ability to stand for
long periods of time and to stoop, bend, reach, grasp and sense as needed. They must
be capable of lifting approximately 22 pounds (10 kilograms) from the oor location to
countertop height and must possess normal visual and audible acuity (with correction
if needed).
Clinical BenefitsClinical Benefits
Continuous in-line monitoring of blood gas parameters enables continuous patient
monitoring to support perfusionist decisions during the cardiopulmonary bypass
procedure and may indirectly improve patient outcomes.
Potential Undesirable Side EffectsPotential Undesirable Side Effects
• Delay to procedure • Adverse bodily reaction
• Infection • Hemolysis
• Embolism • Blood loss
• Unable to meet performance claims