| POCP_MT070100UV A_DeviceActDefinitionInVitroDiagnostic |
Derived from RMIM: POCP_RM070100UV and HMD: POCP_HD070100UV |
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| Observation |
Design Comments: A description of an observation which the device performs. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
Design Comments: Fixed to OBS (observation). |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
Design Comments: Fixed to DEF (definition). |
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| id [0..*] Observation (DSET<II>) |
Design Comments: A unique identifier for this observation definition for later specific reference. |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
Design Comments: The code for this observation. This is used to specify the standard code by which observation results produced with this device would be referred to. E.g., a LOINC code. This code will help any users of the device to report observation results in an interoperable manner. |
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| title [0..1] Observation (ED) |
Design Comments: A text name for the observation. |
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| text [0..1] Observation (ED) |
Design Comments: A text description of the observation. |
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| effectiveTime [0..1] Observation (QSET<TS>) |
Design Comments: Any timing characteristics which would apply for this observation including an outer bound absolute interval which can declare the timeframe in which this description is valid. |
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| confidentialityCode [0..1] Observation (CD) {CWE:D:Confidentiality} |
Design Comments: A code that may declare the detail of this observation description as a trade secret. It would block the information from being shared until such time at which the product is being marketed. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: The value range delivered for this observed property by this device. |
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| analyte [0..*] (Participant) |
Design Comments: Links the observation to a substance which it analyzes (the analyte). |
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| consumable [0..*] (Consumable) | |||||||||
| generalization [0..*] (Generalization) | |||||||||
| derivedFrom [0..*] (DerivedFrom) |
Design Comments: Links an observation to other observation definitions from which it is derived. This also allows specifying specifically how the observation is calculated. |
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| referenceRange [0..*] (ReferenceRange) |
Design Comments: Links an interpretation range to the observation definition. |
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| component [0..*] (Component) |
Design Comments: Links child observations to a common parent. Can be used to specify observations which are produced together or specifies in detail in what sequence they are performed. |
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| Participant |
Design Comments: Links the observation to a substance which it analyzes (the analyte). |
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| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAnalyte, root= "ALY"} |
Design Comments: Fixed to ALY (analyte). |
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| presentSubstance [1..1] (R_PresentSubstanceUniversal) | |||||||||
| Consumable | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationConsumable, root= "CSM"} |
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| presentSubstance [1..1] (R_PresentSubstanceUniversal) | |||||||||
| Generalization | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasGeneralization, root= "GEN"} |
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| observation [1..1] (Observation) | |||||||||
| DerivedFrom |
Design Comments: Links an observation to other observation definitions from which it is derived. This also allows specifying specifically how the observation is calculated. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipIsDerivedFrom, root= "DRIV"} |
Design Comments: 0 |
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| localVariableName [0..1] ActRelationship (ST.SIMPLE) |
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| subsetCode [0..1] ActRelationship (CS) {CNE:V:ActRelationshipSubset} |
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| observation [1..1] (Observation) | |||||||||
| ReferenceRange |
Design Comments: Links an interpretation range to the observation definition. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasReferenceValues, root= "REFV"} |
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| observationCriterion [1..1] (ObservationCriterion) |
Design Comments: Specifies an observation result criterion. |
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| ObservationCriterion |
Design Comments: Specifies an observation result criterion. |
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| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventCriterion, root= "EVN.CRT"} |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
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| isCriterionInd [0..1] Observation (BL){fixed value= "true"} |
Design Comments: Fixed value (true) indicating that this is a criterion and not an event that actually took place. |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
Design Comments: Specifies the observation value range. |
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| interpretationCode [0..1] Observation (CD) {CWE:D:ObservationInterpretation} |
Design Comments: Specifies the kind of range provided if reference range is for Normal, Abnormal, Low, High, etc. If an interpretation range is provided with a manifestation relationship, no interpretation code may need to be specified. |
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| manifestationOf [0..*] (ManifestationOf) | |||||||||
| ManifestationOf | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipIsManifestationOf, root= "MFST"} |
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| observationCriterion [1..1] (ObservationCriterion) | |||||||||
| Component |
Design Comments: Links child observations to a common parent. Can be used to specify observations which are produced together or specifies in detail in what sequence they are performed. |
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| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
Design Comments: The value, COMP, indicates the source act is a component of the target act. |
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| sequenceNumber [0..1] ActRelationship (INT.NONNEG) |
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| priorityNumber [0..1] ActRelationship (REAL) |
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| pauseQuantity [0..1] ActRelationship (PQ.TIME) |
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| checkpointCode [0..1] ActRelationship (CS) {CNE:V:ActRelationshipCheckpoint} |
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| splitCode [0..1] ActRelationship (CS) {CNE:V:ActRelationshipSplit} |
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| joinCode [0..1] ActRelationship (CS) {CNE:V:ActRelationshipJoin} |
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| localVariableName [0..1] ActRelationship (ST.SIMPLE) |
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| observation [1..1] (Observation) | |||||||||