Unit of Assurance

ContextOfUse

Cou1 cpb

https://uofa.net/morrison-v09/cou/cou1-cpb

Described in packs/vv40/examples/morrison-v09/cou1/uofa-morrison-v09-cou1.jsonld

Fields

@type ContextOfUse
schema:name COU1: Cardiopulmonary bypass use (Class II)
schema:description A CFD model is used to evaluate the sensitivity of pump-induced hemolysis to variations in component dimensions for a centrifugal blood pump used during cardiopulmonary bypass surgery. Model influence is MEDIUM (testing confirms results); decision consequence is HIGH (incorrect tolerance decision could impact clinical hemolysis levels). Model Risk Level 2.
uofa:intendedUse Use CFD to identify worst-case operating conditions for hemolysis across 5 flow-speed combinations for a Class II CPB device. Results compared against predicate device hemolysis using relative hemolysis index (RH < 1 acceptance criterion).
uofa:deviceClass Class II
uofa:modelInfluence Medium
uofa:decisionConsequence High

Referenced by

Which records point at this identifier, and through which property. This relationship is not written down anywhere in the packages themselves; it is derived by indexing the whole corpus.

RecordPropertySource
https://uofa.net/morrison-v09/cou1 uofa:hasContextOfUse uofa-morrison-v09-cou1.jsonld