@memoarchitect/ontology 0.6.2 → 0.6.4
This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.
- package/README.md +25 -3
- package/examples/embedded-infusion-pump/model/catalog/embedded_infusion_pump.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_behavior_actions.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_cybersecurity.sysml +1 -1
- package/examples/gpca-pump/model/catalog/gpca_requirements.sysml +104 -104
- package/examples/gpca-pump/model/catalog/gpca_trace.sysml +4 -4
- package/examples/gpca-pump/model/views/document_architecture_description_view.sysml +6 -0
- package/examples/gpca-pump/model/views/document_cyber_assessment_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_dhf_index_view.sysml +6 -0
- package/examples/gpca-pump/model/views/document_hazard_analysis_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_rmf_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_sdd_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_threat_model_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_usability_view.sysml +2 -0
- package/examples/gpca-pump/model/views/document_vv_view.sysml +2 -0
- package/examples/sysml-diagram-samples/model/samples/requirements_view.sysml +2 -2
- package/examples/sysml-diagram-samples/model/samples/use_case_view.sysml +4 -4
- package/methodologies/default/memo.package.yaml +1 -1
- package/methodologies/gpca/memo.package.yaml +1 -1
- package/ontology/memo.package.yaml +1 -1
- package/package.json +4 -2
- package/profile/memo.package.yaml +1 -1
- package/src/architecture/implementation/software/structure/memo_software_structure.sysml +3 -3
- package/src/architecture/implementation/ui/memo_ui.sysml +1 -1
- package/src/architecture/operational/context/stakeholders/memo_stakeholders.sysml +2 -2
- package/src/architecture/operational/context/use_context/memo_use_context.sysml +26 -1
- package/src/architecture/operational/scenarios/memo_scenarios.sysml +1 -1
- package/src/architecture/operational/use_cases/memo_use_cases.sysml +1 -1
- package/src/architecture/operational/workflows/memo_workflows.sysml +2 -2
- package/src/architecture/realization/deployment/memo_deployment.sysml +2 -2
- package/src/assurance/cybersecurity/memo_cybersecurity.sysml +0 -1
- package/src/assurance/requirements/memo_requirements.sysml +1 -1
- package/src/assurance/requirements/needs/memo_needs.sysml +1 -1
- package/src/compliance/artifacts/memo_artifacts.sysml +0 -1
- package/src/core/common/memo_common.sysml +3 -1
- package/src/core/enumerations/memo_enumerations.sysml +17 -1
- package/src/core/relationships/memo_relationships.sysml +9 -5
- package/src/memo_namespaces.sysml +2 -2
- package/src/methodology/profiles/memo_profiles.sysml +6 -22
- package/src/viewpoints/context/context_viewpoint.sysml +10 -1
- package/src/viewpoints/definitions/memo_viewpoint_definitions.sysml +7 -1
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@@ -24,25 +24,25 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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// ── Stakeholder needs ───────────────────────────────────────
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requirement needSafeTherapy : Need {
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attribute :>> needKind = NeedKind::stakeholder;
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attribute :>> needKind = NeedKind::'stakeholder';
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attribute :>> id = "NEED-001"; attribute :>> name = "SafePatientControlledTherapy";
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attribute :>> statement = "The device shall support safe patient controlled analgesic infusion therapy.";
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attribute :>> priority = "high";
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}
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requirement needEffectiveAnalgesia : Need {
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attribute :>> needKind = NeedKind::stakeholder;
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attribute :>> needKind = NeedKind::'stakeholder';
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attribute :>> id = "NEED-002"; attribute :>> name = "EffectivePainManagement";
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attribute :>> statement = "The device shall deliver the prescribed basal and bolus doses accurately so the patient receives effective analgesia.";
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attribute :>> priority = "high";
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}
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requirement needTimelyAlarms : Need {
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attribute :>> needKind = NeedKind::stakeholder;
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attribute :>> needKind = NeedKind::'stakeholder';
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attribute :>> id = "NEED-003"; attribute :>> name = "TimelyAlarmNotification";
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attribute :>> statement = "Clinicians shall be notified promptly and unambiguously of any condition that interrupts or endangers therapy.";
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attribute :>> priority = "high";
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}
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requirement needAuditableRecord : Need {
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attribute :>> needKind = NeedKind::stakeholder;
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attribute :>> needKind = NeedKind::'stakeholder';
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attribute :>> id = "NEED-004"; attribute :>> name = "AuditableTherapyRecord";
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attribute :>> statement = "All delivered doses, alarms, and prescription changes shall be reviewable after the fact.";
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attribute :>> priority = "medium";
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@@ -401,7 +401,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The system shall always be in only one of the following modes: OFF (default mode), IDLE, PAUSED, BASAL, SQUARE BOLUS or PATIENT BOLUS.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Mode output is always exactly one valid exclusive value.";
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attribute :>> subjectDescription = "GPCA system";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.1 (REQ 1)";
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@@ -412,7 +412,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "If there are mode transitions without change in flow rates between the two modes, the system shall transition within Max_Mode_Change_Duration_const.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::performance;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "transition time <= Max_Mode_Change_Duration_const";
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attribute :>> subjectDescription = "GPCA system";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.1 (REQ 2)";
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@@ -423,7 +423,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "If there are mode transitions with change in flow rates between the two modes, the system shall change from the current mode flow rate to the new mode flow rate at a rate not more than Max_Rateof_Flow_Change_const or within Max_Mode_Change_Duration_const, whichever achieves the new desired flow rate the quickest.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::performance;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "flow ramp rate <= Max_Rateof_Flow_Change_const OR transition time <= Max_Mode_Change_Duration_const (quickest wins)";
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attribute :>> subjectDescription = "GPCA system";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.1 (REQ 3)";
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@@ -434,7 +434,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The system shall transition from OFF mode to ON > IDLE mode when System_start_prog is commanded. At this transition, the variables in App. A.4 shall be set to their default values.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "System_start_prog in OFF => mode = ON > IDLE and A.4 variables at defaults";
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attribute :>> subjectDescription = "GPCA system (OFF -> ON transition)";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.2 (REQ 4)";
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@@ -445,7 +445,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "While in ON mode, when System_stop_prog is commanded, the system shall stop infusion, cancel all notifications and transition to OFF mode.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "System_stop_prog in ON => infusion stopped, active notifications cancelled, mode = OFF";
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attribute :>> subjectDescription = "GPCA system (ON -> OFF transition)";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.1.2 (REQ 5)";
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@@ -458,7 +458,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "While in OFF mode, the system shall not deliver any drug.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "FlowRate_output = 0";
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attribute :>> subjectDescription = "OFF mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.2.1 (REQ 6)";
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@@ -471,7 +471,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "While in ON mode, the system shall allow initiation of infusion only when a saved prescription is available.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Infusion initiation is rejected when no saved prescription exists.";
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attribute :>> subjectDescription = "ON mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 7)";
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attribute :>> statement = "While in ON mode, the system shall allow configuring (DataConfig_prog) new or saved prescription data and reservoir initial volume, as described in the Data Configuration Requirements (§4.2).";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::usability;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "DataConfig_prog is accepted in ON mode and enters the §4.2 configuration flow.";
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attribute :>> subjectDescription = "ON mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 8)";
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attribute :>> statement = "While in ON mode, if Infusion_initiate_prog, the system shall display the saved prescription values and allow the clinician to confirm the prescription with another Infusion_initiate_prog.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::usability;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "First Infusion_initiate_prog displays saved values; therapy starts only after a second Infusion_initiate_prog.";
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attribute :>> subjectDescription = "ON mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 9)";
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attribute :>> statement = "While in ON mode, the system shall allow visual and audio notification as described in §4.3.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Notification behaviors of §4.3 are available whenever the system is in ON mode.";
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attribute :>> subjectDescription = "ON mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 10)";
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attribute :>> statement = "While in ON mode, the system shall allow logging as described in §4.4.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::regulatory;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Log behaviors of §4.4 are available whenever the system is in ON mode.";
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attribute :>> subjectDescription = "ON mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.1 (REQ 11)";
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attribute :>> statement = "While in ON mode, when the second Infusion_initiate_prog is commanded as per REQ 9 and Inhibited_Infusion_macro = FALSE, the system shall reset Actual_Infusion_Duration_macro = 0 and Actual_Volume_Infused_macro = 0 and shall transition to ON > THERAPY > ACTIVE > BASAL mode.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Actual_Infusion_Duration_macro = 0 AND Actual_Volume_Infused_macro = 0 AND mode = ON > THERAPY > ACTIVE > BASAL";
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attribute :>> subjectDescription = "ON mode transitions";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.2 (REQ 12)";
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attribute :>> statement = "While in ON mode, when the second Infusion_initiate_prog is commanded as per REQ 9 and Inhibited_Infusion_macro = TRUE, the system shall reset Actual_Infusion_Duration_macro = 0 and Actual_Volume_Infused_macro = 0, shall transition to ON > THERAPY > PAUSED mode and perform actions as described in REQ 59 for 'Infusion Inhibited'.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro = TRUE => mode = ON > THERAPY > PAUSED and 'Infusion Inhibited' actions taken";
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attribute :>> subjectDescription = "ON mode transitions";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.3.2 (REQ 13)";
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attribute :>> statement = "While in IDLE mode, the system shall not deliver any drug.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "FlowRate_output = 0";
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attribute :>> subjectDescription = "ON > IDLE mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.4.1 (REQ 14)";
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attribute :>> statement = "While in IDLE mode for more than Max_IDLE_Duration_const, the system shall take actions as defined in REQ 59 for 'IDLE Time'.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "time in IDLE > Max_IDLE_Duration_const => 'IDLE Time' actions taken";
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attribute :>> subjectDescription = "ON > IDLE mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.4.1 (REQ 15)";
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attribute :>> statement = "While in THERAPY mode, the system shall deliver the drug as per the respective sub-mode's programmed flow rate, FlowRate_Mode_macro, within a tolerance of Tolerance_Max_const.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "FlowRate_output < FlowRate_Mode_macro + Tolerance_Max_const";
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attribute :>> subjectDescription = "ON > THERAPY mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 16)";
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attribute :>> statement = "While in THERAPY mode, the system shall take actions as defined in REQ 59 for 'Under Infusion FlowRate' if the output flow rate falls below the mode flow rate beyond the tolerance windows.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "FlowRate_output < FlowRate_Mode_macro - Tolerance_Min_const for more than Max_Duration_UnderInfusion_const OR FlowRate_output < FlowRate_Mode_macro - Tolerance_Max_const OR FlowRate_output < FlowRate_lo_hd";
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attribute :>> subjectDescription = "ON > THERAPY mode";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 17)";
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attribute :>> statement = "While in THERAPY mode, when the current volume of drug in the reservoir is less than Low_Reservoir_const, the system shall perform the actions defined in REQ 59 for 'Low Reservoir'.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
600
600
|
attribute :>> acceptanceCriteria = "reservoir volume < Low_Reservoir_const => 'Low Reservoir' actions taken";
|
|
601
601
|
attribute :>> subjectDescription = "ON > THERAPY mode";
|
|
602
602
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.1 (REQ 18)";
|
|
@@ -607,7 +607,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
607
607
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform the actions described in REQ 59 for 'Over Infusion FlowRate' if the output flow rate exceeds the mode flow rate beyond the tolerance windows.";
|
|
608
608
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
609
609
|
attribute :>> concernKind = ConcernKind::safety;
|
|
610
|
-
attribute :>>
|
|
610
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
611
611
|
attribute :>> acceptanceCriteria = "FlowRate_output > FlowRate_Mode_macro + Tolerance_Min_const for more than Max_Duration_OverInfusion_const OR FlowRate_output > FlowRate_Mode_macro + Tolerance_Max_const OR FlowRate_output > FlowRate_hi_hd";
|
|
612
612
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
613
613
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 19)";
|
|
@@ -618,7 +618,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
618
618
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and take the actions described in REQ 59 for 'Over Infusion VTBI' if the actual volume infused exceeds the drug-database maximum VTBI.";
|
|
619
619
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
620
620
|
attribute :>> concernKind = ConcernKind::safety;
|
|
621
|
-
attribute :>>
|
|
621
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
622
622
|
attribute :>> acceptanceCriteria = "Actual_Volume_Infused_macro > VTBI_hi_hd";
|
|
623
623
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
624
624
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 20)";
|
|
@@ -629,7 +629,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
629
629
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform the actions defined in REQ 59 for 'Air embolism' if an air bubble of a volume larger than Single_AirBubble_Volume_const flows through the hose, or the sum of volume of all air bubbles flowing through the hose exceeds Cumulative_AirBubble_Volume_const for the same time interval defined for Cumulative_AirBubble_Volume_const.";
|
|
630
630
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
631
631
|
attribute :>> concernKind = ConcernKind::safety;
|
|
632
|
-
attribute :>>
|
|
632
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
633
633
|
attribute :>> acceptanceCriteria = "single bubble volume > Single_AirBubble_Volume_const OR cumulative bubble volume > Cumulative_AirBubble_Volume_const";
|
|
634
634
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
635
635
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 21)";
|
|
@@ -640,7 +640,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
640
640
|
attribute :>> statement = "While in THERAPY mode, the system shall transition to PAUSED mode and perform actions defined in REQ 59 for 'Reverse Delivery' if there is continuous reverse delivery for more than Rev_Delivery_Continuous_Duration_const, or the cumulative time of all reverse delivery episodes exceeds Rev_Delivery_Cumulative_Duration_const.";
|
|
641
641
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
642
642
|
attribute :>> concernKind = ConcernKind::safety;
|
|
643
|
-
attribute :>>
|
|
643
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
644
644
|
attribute :>> acceptanceCriteria = "continuous reverse delivery > Rev_Delivery_Continuous_Duration_const OR cumulative reverse delivery > Rev_Delivery_Cumulative_Duration_const";
|
|
645
645
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
646
646
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 22)";
|
|
@@ -651,7 +651,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
651
651
|
attribute :>> statement = "While in THERAPY mode and if the volume of drug in the reservoir is less than Empty_Reservoir_const, the system shall transition to PAUSED mode and perform actions as listed in REQ 59 for 'Empty Reservoir'.";
|
|
652
652
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
653
653
|
attribute :>> concernKind = ConcernKind::safety;
|
|
654
|
-
attribute :>>
|
|
654
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
655
655
|
attribute :>> acceptanceCriteria = "reservoir volume < Empty_Reservoir_const => mode = PAUSED and 'Empty Reservoir' actions taken";
|
|
656
656
|
attribute :>> subjectDescription = "ON > THERAPY mode transitions";
|
|
657
657
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.5.2 (REQ 23)";
|
|
@@ -664,7 +664,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
664
664
|
attribute :>> statement = "While in ACTIVE mode, the system shall schedule to start a SQUARE BOLUS every Interval_sbolus_prog and end after Duration_sbolus_prog during the Duration_total_prog.";
|
|
665
665
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
666
666
|
attribute :>> concernKind = ConcernKind::safety;
|
|
667
|
-
attribute :>>
|
|
667
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
668
668
|
attribute :>> acceptanceCriteria = "Square boluses are auto-scheduled by the system every Interval_sbolus_prog for Duration_sbolus_prog; no external trigger is required.";
|
|
669
669
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
670
670
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 24)";
|
|
@@ -675,7 +675,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
675
675
|
attribute :>> statement = "While in ACTIVE mode, when BolusRequest_prog, the system shall ignore the patient bolus request (BolusRequest_prog = FALSE) if: (1) Inhibited_Infusion_macro = TRUE, OR (2) Inhibited_PatientBolus_macro = TRUE, OR (3) the interval between the most recent PATIENT BOLUS mode end time and the current BolusRequest_prog time violates LockOutPeriod_pbolus_prog, OR (4) the total number of delivered patient boluses for the current prescription violates the programmed maximum number of patient boluses, OR (5) the system is currently in PATIENT BOLUS mode.";
|
|
676
676
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
677
677
|
attribute :>> concernKind = ConcernKind::safety;
|
|
678
|
-
attribute :>>
|
|
678
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
679
679
|
attribute :>> acceptanceCriteria = "Source formal conditions: (3) (BolusRequest_prog time - most recent PATIENT BOLUS end time) > LockOutPeriod_pbolus_prog; (4) sum of occurrences of all PATIENT BOLUS modes > NumberMax_pbolus_prog (source prose and formal expressions are inconsistent; transcribed as written).";
|
|
680
680
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
681
681
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 25)";
|
|
@@ -686,7 +686,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
686
686
|
attribute :>> statement = "While in ACTIVE mode, the system shall perform the actions described in REQ 59 for 'Frequent Bolus Requests' if the condition described in REQ 25.3 or REQ 25.5 occurs.";
|
|
687
687
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
688
688
|
attribute :>> concernKind = ConcernKind::safety;
|
|
689
|
-
attribute :>>
|
|
689
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
690
690
|
attribute :>> acceptanceCriteria = "REQ 25 condition 3 or 5 => 'Frequent Bolus Requests' actions taken";
|
|
691
691
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
692
692
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 26)";
|
|
@@ -697,7 +697,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
697
697
|
attribute :>> statement = "While in ACTIVE mode, the system shall perform the actions described in REQ 59 for 'Bolus Exceeded' if the condition described in REQ 25.4 occurs.";
|
|
698
698
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
699
699
|
attribute :>> concernKind = ConcernKind::safety;
|
|
700
|
-
attribute :>>
|
|
700
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
701
701
|
attribute :>> acceptanceCriteria = "REQ 25 condition 4 => 'Bolus Exceeded' actions taken";
|
|
702
702
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode";
|
|
703
703
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.1 (REQ 27)";
|
|
@@ -708,7 +708,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
708
708
|
attribute :>> statement = "While in ACTIVE mode, the system shall transition to IDLE and perform actions described in REQ 59 for 'Infusion Complete' if the actual duration of infusion is greater than or equal to the programmed prescription total duration, or the total volume infused is greater than or equal to the programmed prescription maximum VTBI.";
|
|
709
709
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
710
710
|
attribute :>> concernKind = ConcernKind::safety;
|
|
711
|
-
attribute :>>
|
|
711
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
712
712
|
attribute :>> acceptanceCriteria = "Actual_Infusion_Duration_macro >= Duration_total_prog OR Actual_Volume_Infused_macro >= VTBI_total_prog";
|
|
713
713
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
714
714
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 28)";
|
|
@@ -719,7 +719,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
719
719
|
attribute :>> statement = "While in ACTIVE mode, when Infusion_inhibit_prog, the system shall transition to PAUSED mode and perform actions described in REQ 59 for 'Infusion Manually Inhibited'.";
|
|
720
720
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
721
721
|
attribute :>> concernKind = ConcernKind::safety;
|
|
722
|
-
attribute :>>
|
|
722
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
723
723
|
attribute :>> acceptanceCriteria = "Infusion_inhibit_prog => mode = PAUSED and 'Infusion Manually Inhibited' actions taken";
|
|
724
724
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
725
725
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 29)";
|
|
@@ -730,7 +730,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
730
730
|
attribute :>> statement = "While in ACTIVE mode, when Inhibited_Infusion_macro = TRUE, Inhibited_Bolus_macro = TRUE and Inhibited_PatientBolus_macro = TRUE, the system shall transition to PAUSED mode.";
|
|
731
731
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
732
732
|
attribute :>> concernKind = ConcernKind::safety;
|
|
733
|
-
attribute :>>
|
|
733
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
734
734
|
attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro AND Inhibited_Bolus_macro AND Inhibited_PatientBolus_macro => mode = PAUSED";
|
|
735
735
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
736
736
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 30)";
|
|
@@ -741,7 +741,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
741
741
|
attribute :>> statement = "While in BASAL mode, when SQUARE BOLUS is initiated as described in REQ 24, the system shall transition to SQUARE BOLUS mode if (1) Inhibited_Bolus_macro = FALSE, AND (2) Inhibited_Infusion_macro = FALSE, AND (3) either there is no BolusRequest_prog, or there is a BolusRequest_prog and at least one of the conditions listed in REQ 25 is true.";
|
|
742
742
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
743
743
|
attribute :>> concernKind = ConcernKind::safety;
|
|
744
|
-
attribute :>>
|
|
744
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
745
745
|
attribute :>> acceptanceCriteria = "NOT Inhibited_Bolus_macro AND NOT Inhibited_Infusion_macro AND (no BolusRequest_prog OR a REQ 25 ignore condition holds)";
|
|
746
746
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
747
747
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 31)";
|
|
@@ -752,7 +752,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
752
752
|
attribute :>> statement = "While in BASAL mode, the system shall transition to PATIENT BOLUS mode when BolusRequest_prog and none of the conditions listed in REQ 25 are true.";
|
|
753
753
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
754
754
|
attribute :>> concernKind = ConcernKind::safety;
|
|
755
|
-
attribute :>>
|
|
755
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
756
756
|
attribute :>> acceptanceCriteria = "BolusRequest_prog AND no REQ 25 ignore condition holds => mode = PATIENT BOLUS";
|
|
757
757
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
758
758
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 32)";
|
|
@@ -763,7 +763,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
763
763
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall transition to PATIENT BOLUS mode if BolusRequest_prog and none of the conditions listed in REQ 25 are true.";
|
|
764
764
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
765
765
|
attribute :>> concernKind = ConcernKind::safety;
|
|
766
|
-
attribute :>>
|
|
766
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
767
767
|
attribute :>> acceptanceCriteria = "BolusRequest_prog AND no REQ 25 ignore condition holds => mode = PATIENT BOLUS";
|
|
768
768
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
769
769
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 33)";
|
|
@@ -774,7 +774,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
774
774
|
attribute :>> statement = "While in SQUARE BOLUS mode, if Inhibited_Bolus_macro = TRUE or the SQUARE BOLUS is scheduled to end (as described in REQ 24), the system shall transition to BASAL mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) there is no BolusRequest_prog, or BolusRequest_prog and at least one of the conditions listed in REQ 25 is true.";
|
|
775
775
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
776
776
|
attribute :>> concernKind = ConcernKind::safety;
|
|
777
|
-
attribute :>>
|
|
777
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
778
778
|
attribute :>> acceptanceCriteria = "(Inhibited_Bolus_macro OR scheduled end) AND NOT Inhibited_Infusion_macro AND (no BolusRequest_prog OR a REQ 25 ignore condition holds) => mode = BASAL";
|
|
779
779
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
780
780
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 34)";
|
|
@@ -785,7 +785,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
785
785
|
attribute :>> statement = "While in PATIENT BOLUS mode, when Inhibited_PatientBolus_macro = TRUE or the total duration in the current PATIENT BOLUS mode is greater than or equal to Duration_pbolus_prog, the system shall stop the PATIENT BOLUS delivery and transition to BASAL mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) no SQUARE BOLUS is scheduled to be in progress at the time of transition, OR (3) a SQUARE BOLUS is scheduled to be in progress at the time of transition and Inhibited_Bolus_macro = TRUE.";
|
|
786
786
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
787
787
|
attribute :>> concernKind = ConcernKind::safety;
|
|
788
|
-
attribute :>>
|
|
788
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
789
789
|
attribute :>> acceptanceCriteria = "(Inhibited_PatientBolus_macro OR patient-bolus duration >= Duration_pbolus_prog) AND NOT Inhibited_Infusion_macro AND (no square bolus scheduled OR (square bolus scheduled AND Inhibited_Bolus_macro)) => mode = BASAL";
|
|
790
790
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
791
791
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 35)";
|
|
@@ -796,7 +796,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
796
796
|
attribute :>> statement = "While in PATIENT BOLUS mode, when Inhibited_PatientBolus_macro = TRUE or the total duration in the current PATIENT BOLUS mode is greater than or equal to Duration_pbolus_prog, the system shall stop the PATIENT BOLUS delivery and transition to SQUARE BOLUS mode if (1) Inhibited_Infusion_macro = FALSE, AND (2) a SQUARE BOLUS is scheduled to be in progress at the time of transition, AND (3) Inhibited_Bolus_macro = FALSE.";
|
|
797
797
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
798
798
|
attribute :>> concernKind = ConcernKind::safety;
|
|
799
|
-
attribute :>>
|
|
799
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
800
800
|
attribute :>> acceptanceCriteria = "(Inhibited_PatientBolus_macro OR patient-bolus duration >= Duration_pbolus_prog) AND NOT Inhibited_Infusion_macro AND square bolus scheduled AND NOT Inhibited_Bolus_macro => mode = SQUARE BOLUS";
|
|
801
801
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
802
802
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 36)";
|
|
@@ -807,7 +807,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
807
807
|
attribute :>> statement = "While in BASAL mode, if Inhibited_Infusion_macro = TRUE, the system shall transition to PAUSE mode.";
|
|
808
808
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
809
809
|
attribute :>> concernKind = ConcernKind::safety;
|
|
810
|
-
attribute :>>
|
|
810
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
811
811
|
attribute :>> acceptanceCriteria = "Inhibited_Infusion_macro => mode = PAUSED";
|
|
812
812
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
813
813
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 37)";
|
|
@@ -818,7 +818,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
818
818
|
attribute :>> statement = "While in PATIENT BOLUS mode, the system shall transition to PAUSE mode if Inhibited_PatientBolus_macro = TRUE and Inhibited_Infusion_macro = TRUE.";
|
|
819
819
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
820
820
|
attribute :>> concernKind = ConcernKind::safety;
|
|
821
|
-
attribute :>>
|
|
821
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
822
822
|
attribute :>> acceptanceCriteria = "Inhibited_PatientBolus_macro AND Inhibited_Infusion_macro => mode = PAUSED";
|
|
823
823
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
824
824
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 38)";
|
|
@@ -829,7 +829,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
829
829
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall transition to PAUSE mode if Inhibited_Bolus_macro = TRUE and Inhibited_Infusion_macro = TRUE.";
|
|
830
830
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
831
831
|
attribute :>> concernKind = ConcernKind::safety;
|
|
832
|
-
attribute :>>
|
|
832
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
833
833
|
attribute :>> acceptanceCriteria = "Inhibited_Bolus_macro AND Inhibited_Infusion_macro => mode = PAUSED";
|
|
834
834
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE mode transitions";
|
|
835
835
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.6.2 (REQ 39)";
|
|
@@ -842,7 +842,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
842
842
|
attribute :>> statement = "While in BASAL mode, the system shall deliver the drug at a flow rate FlowRate_basal_prog with a variation up to Tolerance_Max_const.";
|
|
843
843
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
844
844
|
attribute :>> concernKind = ConcernKind::safety;
|
|
845
|
-
attribute :>>
|
|
845
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
846
846
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_basal_prog";
|
|
847
847
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > BASAL mode";
|
|
848
848
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.7.1 (REQ 40)";
|
|
@@ -853,7 +853,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
853
853
|
attribute :>> statement = "While in SQUARE BOLUS mode, the system shall deliver the drug at a flow rate FlowRate_sbolus_prog with a variation up to Tolerance_Max_const.";
|
|
854
854
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
855
855
|
attribute :>> concernKind = ConcernKind::safety;
|
|
856
|
-
attribute :>>
|
|
856
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
857
857
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_sbolus_prog";
|
|
858
858
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > SQUARE BOLUS mode";
|
|
859
859
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.8.1 (REQ 41)";
|
|
@@ -864,7 +864,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
864
864
|
attribute :>> statement = "While in PATIENT BOLUS mode, the system shall deliver the drug at a flow rate FlowRate_pbolus_prog with a variation up to Tolerance_Max_const.";
|
|
865
865
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
866
866
|
attribute :>> concernKind = ConcernKind::safety;
|
|
867
|
-
attribute :>>
|
|
867
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
868
868
|
attribute :>> acceptanceCriteria = "FlowRate_output within Tolerance_Max_const of FlowRate_pbolus_prog";
|
|
869
869
|
attribute :>> subjectDescription = "ON > THERAPY > ACTIVE > PATIENT BOLUS mode";
|
|
870
870
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.9.1 (REQ 42)";
|
|
@@ -877,7 +877,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
877
877
|
attribute :>> statement = "While in PAUSED mode, the system shall allow drug infusion at a flow rate FlowRate_kvo_hd with a variation up to Tolerance_Max_const, to keep the vein open when infusion is paused.";
|
|
878
878
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
879
879
|
attribute :>> concernKind = ConcernKind::safety;
|
|
880
|
-
attribute :>>
|
|
880
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
881
881
|
attribute :>> acceptanceCriteria = "FlowRate_Mode_macro = FlowRate_kvo_hd; FlowRate_output within Tolerance_Max_const of FlowRate_kvo_hd (KVO flow, not zero)";
|
|
882
882
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
883
883
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 43)";
|
|
@@ -888,7 +888,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
888
888
|
attribute :>> statement = "While in PAUSED mode for more than Max_PAUSED_Duration_const, the system shall perform actions as described in REQ 59 for 'PAUSED Time'.";
|
|
889
889
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
890
890
|
attribute :>> concernKind = ConcernKind::safety;
|
|
891
|
-
attribute :>>
|
|
891
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
892
892
|
attribute :>> acceptanceCriteria = "time in PAUSED > Max_PAUSED_Duration_const => 'PAUSED Time' actions taken";
|
|
893
893
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
894
894
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 44)";
|
|
@@ -899,7 +899,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
899
899
|
attribute :>> statement = "While in PAUSED mode, when Infusion_initiate_prog and Inhibited_Infusion_macro = TRUE, the system shall not perform any transition.";
|
|
900
900
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
901
901
|
attribute :>> concernKind = ConcernKind::safety;
|
|
902
|
-
attribute :>>
|
|
902
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
903
903
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog AND Inhibited_Infusion_macro => mode unchanged";
|
|
904
904
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode";
|
|
905
905
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.1 (REQ 45)";
|
|
@@ -910,7 +910,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
910
910
|
attribute :>> statement = "While in PAUSED mode, when Infusion_initiate_prog and Inhibited_Infusion_macro = FALSE, the system shall transition to ON > THERAPY > ACTIVE > BASAL mode.";
|
|
911
911
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
912
912
|
attribute :>> concernKind = ConcernKind::safety;
|
|
913
|
-
attribute :>>
|
|
913
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
914
914
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog AND NOT Inhibited_Infusion_macro => mode = ON > THERAPY > ACTIVE > BASAL";
|
|
915
915
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode transitions";
|
|
916
916
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.2 (REQ 46)";
|
|
@@ -921,7 +921,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
921
921
|
attribute :>> statement = "While in PAUSED mode, when Infusion_inhibit_prog, the system shall transition to ON > IDLE mode and perform actions as described in REQ 59 for 'Infusion Stopped Manually'.";
|
|
922
922
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
923
923
|
attribute :>> concernKind = ConcernKind::safety;
|
|
924
|
-
attribute :>>
|
|
924
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
925
925
|
attribute :>> acceptanceCriteria = "Infusion_inhibit_prog => mode = ON > IDLE and 'Infusion Stopped Manually' actions taken";
|
|
926
926
|
attribute :>> subjectDescription = "ON > THERAPY > PAUSED mode transitions";
|
|
927
927
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.1.10.2 (REQ 47)";
|
|
@@ -934,7 +934,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
934
934
|
attribute :>> statement = "When in ON mode, if DataConfig_prog as described in REQ 8, the system shall display the saved prescription and reservoir initial volume values or their default values (if there are no saved prescription and reservoir initial volume values) in the order listed in §3.1.1 and §3.1.3.";
|
|
935
935
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
936
936
|
attribute :>> concernKind = ConcernKind::usability;
|
|
937
|
-
attribute :>>
|
|
937
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
938
938
|
attribute :>> acceptanceCriteria = "Displayed values equal saved values (or defaults) in the interface-specified order.";
|
|
939
939
|
attribute :>> subjectDescription = "Data configuration";
|
|
940
940
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 48)";
|
|
@@ -945,7 +945,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
945
945
|
attribute :>> statement = "When the prescription and reservoir initial volume data are displayed as described in REQ 48, the system shall allow editing the values one at a time in the order they are displayed.";
|
|
946
946
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
947
947
|
attribute :>> concernKind = ConcernKind::usability;
|
|
948
|
-
attribute :>>
|
|
948
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
949
949
|
attribute :>> acceptanceCriteria = "Exactly one value is editable at a time, in display order.";
|
|
950
950
|
attribute :>> subjectDescription = "Data configuration";
|
|
951
951
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 49)";
|
|
@@ -956,7 +956,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
956
956
|
attribute :>> statement = "When the values are modified as described in REQ 49, the system shall allow infusion initiation with the new set of values (Infusion_initiate_prog).";
|
|
957
957
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
958
958
|
attribute :>> concernKind = ConcernKind::usability;
|
|
959
|
-
attribute :>>
|
|
959
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
960
960
|
attribute :>> acceptanceCriteria = "Infusion_initiate_prog is accepted with the modified value set.";
|
|
961
961
|
attribute :>> subjectDescription = "Data configuration";
|
|
962
962
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 50)";
|
|
@@ -967,7 +967,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
967
967
|
attribute :>> statement = "When Infusion_initiate_prog as described in REQ 50, the system shall validate if all the values are consistent with the conditions specified in their respective Type Condition fields in §3.1.1 and §3.1.3.";
|
|
968
968
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
969
969
|
attribute :>> concernKind = ConcernKind::safety;
|
|
970
|
-
attribute :>>
|
|
970
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
971
971
|
attribute :>> acceptanceCriteria = "Every entered value satisfies its Type Condition constraints before saving.";
|
|
972
972
|
attribute :>> subjectDescription = "Data configuration";
|
|
973
973
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 51)";
|
|
@@ -978,7 +978,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
978
978
|
attribute :>> statement = "When the system is validating data as described in REQ 51, if the system is unable to access the drug database safe values, the system shall not save the values and perform actions as described in REQ 59 for 'Drug database not reachable'.";
|
|
979
979
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
980
980
|
attribute :>> concernKind = ConcernKind::safety;
|
|
981
|
-
attribute :>>
|
|
981
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
982
982
|
attribute :>> acceptanceCriteria = "Database unreachable => values not saved and 'Drug database not reachable' actions taken";
|
|
983
983
|
attribute :>> subjectDescription = "Data configuration";
|
|
984
984
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 52)";
|
|
@@ -989,7 +989,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
989
989
|
attribute :>> statement = "When the system is validating data as described in REQ 51, if any of the drug database safe values listed in §3.5 is not present, the system shall not perform the validation with respect to that missing field, perform actions as described in REQ 59 for 'Drug safe value not present' and continue validation.";
|
|
990
990
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
991
991
|
attribute :>> concernKind = ConcernKind::safety;
|
|
992
|
-
attribute :>>
|
|
992
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
993
993
|
attribute :>> acceptanceCriteria = "Missing safe value => that field's validation skipped, 'Drug safe value not present' actions taken, validation continues";
|
|
994
994
|
attribute :>> subjectDescription = "Data configuration";
|
|
995
995
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 53)";
|
|
@@ -1000,7 +1000,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1000
1000
|
attribute :>> statement = "If there are no notifications from REQ 51 and REQ 52, the system shall save the prescription values, clear all the notifications previously generated by REQ 51, REQ 52 and REQ 53 if any, and allow initiate infusion with the new values as described in REQ 9.";
|
|
1001
1001
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1002
1002
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1003
|
-
attribute :>>
|
|
1003
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1004
1004
|
attribute :>> acceptanceCriteria = "Validation clean => values saved, prior validation notifications cleared, initiation enabled per REQ 9.";
|
|
1005
1005
|
attribute :>> subjectDescription = "Data configuration";
|
|
1006
1006
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 54)";
|
|
@@ -1011,7 +1011,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1011
1011
|
attribute :>> statement = "If REQ 51 or REQ 52 had generated a notification, the system shall not save the prescription values, allow the clinician to edit the values of the fields as described in REQ 49 and then repeat steps from REQ 50 until all validations are passed as described in REQ 54.";
|
|
1012
1012
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1013
1013
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1014
|
-
attribute :>>
|
|
1014
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1015
1015
|
attribute :>> acceptanceCriteria = "Validation notification present => values not saved; edit-and-revalidate loop until clean.";
|
|
1016
1016
|
attribute :>> subjectDescription = "Data configuration";
|
|
1017
1017
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 55)";
|
|
@@ -1022,7 +1022,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1022
1022
|
attribute :>> statement = "While data configuration is in progress, the system shall remain in its current mode with the currently active prescription values, until infusion is initiated with the new prescription values as described in REQ 54.";
|
|
1023
1023
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1024
1024
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1025
|
-
attribute :>>
|
|
1025
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1026
1026
|
attribute :>> acceptanceCriteria = "Mode and active prescription are unchanged during configuration.";
|
|
1027
1027
|
attribute :>> subjectDescription = "Data configuration";
|
|
1028
1028
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 56)";
|
|
@@ -1033,7 +1033,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1033
1033
|
attribute :>> statement = "When the clinician has attempted to configure the data for more than Config_Warning_Duration_const continuously, the system shall perform actions as described in REQ 59 for 'Config Time'.";
|
|
1034
1034
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1035
1035
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1036
|
-
attribute :>>
|
|
1036
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1037
1037
|
attribute :>> acceptanceCriteria = "continuous configuration time > Config_Warning_Duration_const => 'Config Time' actions taken";
|
|
1038
1038
|
attribute :>> subjectDescription = "Data configuration";
|
|
1039
1039
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 57)";
|
|
@@ -1044,7 +1044,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1044
1044
|
attribute :>> statement = "When the clinician has attempted to configure the data for more than Max_Config_Duration_const continuously, the system shall clear all unsaved prescription values and shall perform actions as described in REQ 59 for 'Unsaved Configuration Cleared'.";
|
|
1045
1045
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1046
1046
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1047
|
-
attribute :>>
|
|
1047
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1048
1048
|
attribute :>> acceptanceCriteria = "continuous configuration time > Max_Config_Duration_const => unsaved values cleared ('Unsaved Configuration Cleared' is referenced by the source but absent from the REQ 59 table — a documented source inconsistency).";
|
|
1049
1049
|
attribute :>> subjectDescription = "Data configuration";
|
|
1050
1050
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.2 (REQ 58)";
|
|
@@ -1057,7 +1057,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1057
1057
|
attribute :>> statement = "The system shall perform all the actions listed in the notification action table for the respective notification. The table defines, for each of the 20 notifications, its priority (High/Med/Low) and the actions Visual, Audio, Inhibit Infusion, Inhibit Square Bolus, Inhibit Patient Bolus, and Stop Bolus. Notification requirements have higher precedence over all other requirements in the system.";
|
|
1058
1058
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1059
1059
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1060
|
-
attribute :>>
|
|
1060
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1061
1061
|
attribute :>> acceptanceCriteria = "For every raised notification, the actions equal the NOTIF-01..NOTIF-20 table row: Inhibit Infusion => Inhibited_Infusion_macro = TRUE; Inhibit Square Bolus => Inhibited_Bolus_macro = TRUE; Inhibit Patient Bolus => Inhibited_PatientBolus_macro = TRUE; Stop Bolus => stop all boluses in progress.";
|
|
1062
1062
|
attribute :>> subjectDescription = "Notification handling (see NOTIF-01..NOTIF-20)";
|
|
1063
1063
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 59)";
|
|
@@ -1068,7 +1068,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1068
1068
|
attribute :>> statement = "When more than one notification having different priorities occurs at the same time, the system shall take actions listed for the highest priority notification.";
|
|
1069
1069
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1070
1070
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1071
|
-
attribute :>>
|
|
1071
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1072
1072
|
attribute :>> acceptanceCriteria = "Simultaneous notifications with different priorities => actions of the highest priority notification are taken.";
|
|
1073
1073
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1074
1074
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 60)";
|
|
@@ -1079,7 +1079,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1079
1079
|
attribute :>> statement = "When more than one notification having same priorities and different set of actions occurs at the same time, the system shall take actions listed for the most restrictive notification.";
|
|
1080
1080
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1081
1081
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1082
|
-
attribute :>>
|
|
1082
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1083
1083
|
attribute :>> acceptanceCriteria = "Order of restriction: Inhibit All Infusion > Inhibit Square Bolus > Inhibit Patient Bolus.";
|
|
1084
1084
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1085
1085
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 61)";
|
|
@@ -1090,7 +1090,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1090
1090
|
attribute :>> statement = "When more than one notification having same priorities and same set of actions occurs at the same time, the system will take actions for the notification that has the most restrictive actions as listed in REQ 59.";
|
|
1091
1091
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1092
1092
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1093
|
-
attribute :>>
|
|
1093
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1094
1094
|
attribute :>> acceptanceCriteria = "Tie on priority and actions => REQ 59 restriction ordering breaks the tie.";
|
|
1095
1095
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1096
1096
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 62)";
|
|
@@ -1101,7 +1101,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1101
1101
|
attribute :>> statement = "While a low priority or less restrictive notification is in effect and a higher priority or more restrictive same-priority notification occurs, the system shall take actions for the high priority or more restrictive notification as listed in REQ 59.";
|
|
1102
1102
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1103
1103
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1104
|
-
attribute :>>
|
|
1104
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1105
1105
|
attribute :>> acceptanceCriteria = "In-effect notification is superseded by a higher-priority or more restrictive notification.";
|
|
1106
1106
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1107
1107
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 63)";
|
|
@@ -1112,7 +1112,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1112
1112
|
attribute :>> statement = "While a high priority notification is in effect and a low priority notification occurs, the system shall only add the notification to the active notification list and shall not take any other actions for the low priority notification.";
|
|
1113
1113
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1114
1114
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1115
|
-
attribute :>>
|
|
1115
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1116
1116
|
attribute :>> acceptanceCriteria = "Lower-priority notification is listed but its actions are not taken while a higher-priority notification is in effect.";
|
|
1117
1117
|
attribute :>> subjectDescription = "Notification precedence";
|
|
1118
1118
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 64)";
|
|
@@ -1123,7 +1123,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1123
1123
|
attribute :>> statement = "The system shall allow the clinician to cancel the active notifications, starting from the first in the list, one at a time (Notification_cancel_prog).";
|
|
1124
1124
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1125
1125
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1126
|
-
attribute :>>
|
|
1126
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1127
1127
|
attribute :>> acceptanceCriteria = "Cancellation proceeds one notification at a time from the head of the list.";
|
|
1128
1128
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1129
1129
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 65)";
|
|
@@ -1134,7 +1134,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1134
1134
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system shall cancel and clear the restrictions for that notification: Inhibited_Infusion_macro = FALSE, Inhibited_Bolus_macro = FALSE, Inhibited_PatientBolus_macro = FALSE, and cancel and clear the corresponding audio notification.";
|
|
1135
1135
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1136
1136
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1137
|
-
attribute :>>
|
|
1137
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1138
1138
|
attribute :>> acceptanceCriteria = "After cancel: Inhibited_Infusion_macro = FALSE AND Inhibited_Bolus_macro = FALSE AND Inhibited_PatientBolus_macro = FALSE AND audio cleared for that notification.";
|
|
1139
1139
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1140
1140
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 66)";
|
|
@@ -1145,7 +1145,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1145
1145
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system takes actions for the next active notification in order of priority and descending order of occurrence.";
|
|
1146
1146
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1147
1147
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1148
|
-
attribute :>>
|
|
1148
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1149
1149
|
attribute :>> acceptanceCriteria = "After cancel, the next active notification (by priority, then recency) becomes the notification in effect.";
|
|
1150
1150
|
attribute :>> subjectDescription = "Notification cancellation";
|
|
1151
1151
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3 (REQ 67)";
|
|
@@ -1158,7 +1158,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1158
1158
|
attribute :>> statement = "The system shall display all active notifications in order of priority and descending order of occurrence (Notification_Visual_output).";
|
|
1159
1159
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1160
1160
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1161
|
-
attribute :>>
|
|
1161
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1162
1162
|
attribute :>> acceptanceCriteria = "Notification_Visual_output lists active notifications ordered by priority, then most recent first.";
|
|
1163
1163
|
attribute :>> subjectDescription = "Visual notification";
|
|
1164
1164
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 68)";
|
|
@@ -1169,7 +1169,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1169
1169
|
attribute :>> statement = "The system shall display the name of all the active notifications and the time of the occurrence.";
|
|
1170
1170
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1171
1171
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1172
|
-
attribute :>>
|
|
1172
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1173
1173
|
attribute :>> acceptanceCriteria = "Every active notification is shown with name and occurrence time.";
|
|
1174
1174
|
attribute :>> subjectDescription = "Visual notification";
|
|
1175
1175
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 69)";
|
|
@@ -1180,7 +1180,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1180
1180
|
attribute :>> statement = "When more than one notification occurs at the same time, the system shall display all the notifications as per REQ 68.";
|
|
1181
1181
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1182
1182
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1183
|
-
attribute :>>
|
|
1183
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1184
1184
|
attribute :>> acceptanceCriteria = "Simultaneous notifications are all displayed in REQ 68 order.";
|
|
1185
1185
|
attribute :>> subjectDescription = "Visual notification";
|
|
1186
1186
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 70)";
|
|
@@ -1191,7 +1191,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1191
1191
|
attribute :>> statement = "When Notification_cancel_prog for a notification, the system shall remove the notification from the list and shall display the list of remaining notifications.";
|
|
1192
1192
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1193
1193
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1194
|
-
attribute :>>
|
|
1194
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1195
1195
|
attribute :>> acceptanceCriteria = "Cancelled notification disappears from the displayed list; remaining list stays displayed.";
|
|
1196
1196
|
attribute :>> subjectDescription = "Visual notification";
|
|
1197
1197
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.1 (REQ 71)";
|
|
@@ -1204,7 +1204,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1204
1204
|
attribute :>> statement = "When each notification occurs that requires an audio alarm as listed in REQ 59, the system shall produce a single audible sound of Audio_level_const, unless the audio is disabled or silenced.";
|
|
1205
1205
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1206
1206
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1207
|
-
attribute :>>
|
|
1207
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1208
1208
|
attribute :>> acceptanceCriteria = "Audio-flagged notification => one audible sound at Audio_level_const (50 db for 2 seconds per I 8) unless Disable_audio_prog is set.";
|
|
1209
1209
|
attribute :>> subjectDescription = "Audio notification";
|
|
1210
1210
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 72)";
|
|
@@ -1215,7 +1215,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1215
1215
|
attribute :>> statement = "The system shall allow the clinician to disable audible alarm, silence the alarm temporarily and enable a disabled or silenced alarm.";
|
|
1216
1216
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1217
1217
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1218
|
-
attribute :>>
|
|
1218
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1219
1219
|
attribute :>> acceptanceCriteria = "Notification_Audio_output = FALSE if Disable_audio_prog = 'PERM' (disabled) or 'TEMP' (silenced); Notification_Audio_output = TRUE if Disable_audio_prog = FALSE.";
|
|
1220
1220
|
attribute :>> subjectDescription = "Audio notification";
|
|
1221
1221
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 73)";
|
|
@@ -1226,7 +1226,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1226
1226
|
attribute :>> statement = "If Disable_audio_prog = 'PERM' or 'TEMP', the system shall not produce audible alarm until it is enabled (Disable_audio_prog = FALSE).";
|
|
1227
1227
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1228
1228
|
attribute :>> concernKind = ConcernKind::usability;
|
|
1229
|
-
attribute :>>
|
|
1229
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1230
1230
|
attribute :>> acceptanceCriteria = "No audible alarm while Disable_audio_prog is 'PERM' or 'TEMP'.";
|
|
1231
1231
|
attribute :>> subjectDescription = "Audio notification";
|
|
1232
1232
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 74)";
|
|
@@ -1237,7 +1237,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1237
1237
|
attribute :>> statement = "If Disable_audio_prog = 'TEMP', the system shall automatically enable it (Disable_audio_prog = FALSE) after Audio_Enable_Duration_const minutes.";
|
|
1238
1238
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1239
1239
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1240
|
-
attribute :>>
|
|
1240
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1241
1241
|
attribute :>> acceptanceCriteria = "Temporary silence expires after Audio_Enable_Duration_const (30) minutes.";
|
|
1242
1242
|
attribute :>> subjectDescription = "Audio notification";
|
|
1243
1243
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 75)";
|
|
@@ -1248,7 +1248,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1248
1248
|
attribute :>> statement = "For every notification with audio alarm that is active for more than Audio_Enable_Duration_const minutes, the system shall produce audible sound as described in REQ 72.";
|
|
1249
1249
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1250
1250
|
attribute :>> concernKind = ConcernKind::safety;
|
|
1251
|
-
attribute :>>
|
|
1251
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1252
1252
|
attribute :>> acceptanceCriteria = "Audio-flagged notification active > Audio_Enable_Duration_const minutes => REQ 72 sound re-produced.";
|
|
1253
1253
|
attribute :>> subjectDescription = "Audio notification";
|
|
1254
1254
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.3.2 (REQ 76)";
|
|
@@ -1261,7 +1261,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1261
1261
|
attribute :>> statement = "The system shall log all the operational and error data when the system is in ON mode.";
|
|
1262
1262
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1263
1263
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1264
|
-
attribute :>>
|
|
1264
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1265
1265
|
attribute :>> acceptanceCriteria = "Operational log and error log are recorded whenever the system is in ON mode.";
|
|
1266
1266
|
attribute :>> subjectDescription = "Logging";
|
|
1267
1267
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 77)";
|
|
@@ -1272,7 +1272,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1272
1272
|
attribute :>> statement = "While in ON mode, every Log_Interval_const minutes or when a mode transition occurs, the system shall record the following information in an 'Operational log': (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) Patient ID, (4) prescription information, (5) current mode of the system, (6) current flow rate of the system.";
|
|
1273
1273
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1274
1274
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1275
|
-
attribute :>>
|
|
1275
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1276
1276
|
attribute :>> acceptanceCriteria = "Operational log entries appear every Log_Interval_const (5) minutes and on every mode transition, with all six fields.";
|
|
1277
1277
|
attribute :>> subjectDescription = "Logging";
|
|
1278
1278
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 78)";
|
|
@@ -1283,7 +1283,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1283
1283
|
attribute :>> statement = "When infusion is completed as per REQ 28, the system shall record the following information in addition to the information listed in REQ 78 in the 'Operational log': (1) total volume infused for that prescription, (2) total duration of infusion for that prescription (total duration in ACTIVE mode).";
|
|
1284
1284
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1285
1285
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1286
|
-
attribute :>>
|
|
1286
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1287
1287
|
attribute :>> acceptanceCriteria = "Infusion-complete log entry includes total volume infused and total ACTIVE-mode duration.";
|
|
1288
1288
|
attribute :>> subjectDescription = "Logging";
|
|
1289
1289
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 79)";
|
|
@@ -1294,7 +1294,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1294
1294
|
attribute :>> statement = "When any notification condition listed in REQ 59 occurs, the system shall record the following information in an error log: (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) notification description, (4) current mode of the system, (5) remaining drug volume.";
|
|
1295
1295
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1296
1296
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1297
|
-
attribute :>>
|
|
1297
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1298
1298
|
attribute :>> acceptanceCriteria = "Every REQ 59 notification produces an error log entry with all five fields.";
|
|
1299
1299
|
attribute :>> subjectDescription = "Logging";
|
|
1300
1300
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 80)";
|
|
@@ -1305,7 +1305,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1305
1305
|
attribute :>> statement = "When a notification is cancelled as described in REQ 66, the system shall record the following information in the 'Operational log': (1) date in dd/MM/yy format, (2) time in HH:MM:SS GMT, (3) description of the notification cancelled.";
|
|
1306
1306
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1307
1307
|
attribute :>> concernKind = ConcernKind::regulatory;
|
|
1308
|
-
attribute :>>
|
|
1308
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1309
1309
|
attribute :>> acceptanceCriteria = "Every notification cancellation produces an operational log entry with all three fields.";
|
|
1310
1310
|
attribute :>> subjectDescription = "Logging";
|
|
1311
1311
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.4 (REQ 81)";
|
|
@@ -1318,7 +1318,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1318
1318
|
attribute :>> statement = "The system shall allow only authorized clinicians to configure the system.";
|
|
1319
1319
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1320
1320
|
attribute :>> concernKind = ConcernKind::cybersecurity;
|
|
1321
|
-
attribute :>>
|
|
1321
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1322
1322
|
attribute :>> acceptanceCriteria = "Configuration is rejected for unauthorized users.";
|
|
1323
1323
|
attribute :>> subjectDescription = "System configuration access";
|
|
1324
1324
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §4.5 (REQ 82)";
|
|
@@ -1331,7 +1331,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1331
1331
|
attribute :>> statement = "The system shall be unbreakable if it is dropped on a laminate floor from y m of height with no additional force than gravity.";
|
|
1332
1332
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1333
1333
|
attribute :>> concernKind = ConcernKind::reliability;
|
|
1334
|
-
attribute :>>
|
|
1334
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1335
1335
|
attribute :>> acceptanceCriteria = "Drop from height y m (value left open by the source) onto laminate floor causes no breakage.";
|
|
1336
1336
|
attribute :>> subjectDescription = "GPCA enclosure";
|
|
1337
1337
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 83)";
|
|
@@ -1342,7 +1342,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
|
|
|
1342
1342
|
attribute :>> statement = "The system shall be waterproof to non-acidic liquid of less than x ml on any side of the pump for a maximum of 2 hours.";
|
|
1343
1343
|
attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
|
|
1344
1344
|
attribute :>> concernKind = ConcernKind::reliability;
|
|
1345
|
-
attribute :>>
|
|
1345
|
+
attribute :>> requirementStatus = RequirementStatusKind::approved;
|
|
1346
1346
|
attribute :>> acceptanceCriteria = "Exposure to < x ml (value left open by the source) non-acidic liquid for up to 2 hours causes no ingress failure.";
|
|
1347
1347
|
attribute :>> subjectDescription = "GPCA enclosure";
|
|
1348
1348
|
attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 84)";
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@@ -1353,7 +1353,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The system shall persist the most recent 30 days of error log data and 15 days of operational log data.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::regulatory;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "error log retention >= Error_Log_Retention (30 days); operational log retention >= Operational_Log_Retention (15 days)";
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attribute :>> subjectDescription = "Logging";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 85)";
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@@ -1364,7 +1364,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The system shall persist the last saved prescription data for 15 days.";
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attribute :>> sourceKind = RequirementSourceKind::sourceDocument;
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attribute :>> concernKind = ConcernKind::regulatory;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "saved prescription retention >= Prescription_Persist_Duration (15 days)";
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attribute :>> subjectDescription = "Prescription storage";
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attribute :>> sourceReference = "CITE-001: CriSys GPCA System Requirements (2013), §5.1 (REQ 86)";
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@@ -1381,7 +1381,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "When a prescription parameter is entered, the system shall reject values outside drug-library hard limits and shall require explicit confirmation for values outside soft limits.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Hard-limit violations cannot be saved; soft-limit violations require a distinct confirmation step; both are logged.";
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attribute :>> subjectDescription = "Config";
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attribute :>> actorDescription = "clinician";
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@@ -1400,7 +1400,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "On power-up, the system shall complete a self test of CPU, memory, watchdog, and safety sensors before permitting therapy, and shall remain locked out of therapy if any check fails.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Failed POST inhibits all infusion modes and raises a High-priority notification.";
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attribute :>> subjectDescription = "System_Monitor and Top_Level_Mode";
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attribute :>> actorDescription = "clinician";
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@@ -1419,7 +1419,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "If all power is lost, the system shall retain the confirmed prescription and event log, and on power restoration shall resume therapy only after clinician confirmation.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Stored prescription checksum verifies after power cycle; therapy does not auto-resume. Retention durations remain governed by REQ-CS-85/86.";
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attribute :>> subjectDescription = "Config and Top_Level_Mode";
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attribute :>> actorDescription = "clinician";
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@@ -1439,7 +1439,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Occlusion above threshold pauses infusion within one execution step and annunciates. Complements REQ-CS-17 under-infusion detection with a direct pressure measurement.";
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attribute :>> subjectDescription = "Alarm and Infusion_Manager";
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attribute :>> actorDescription = "patient";
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@@ -1454,7 +1454,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Flow command forced to zero whenever door state is open; notification raised on transition during ACTIVE.";
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attribute :>> subjectDescription = "Infusion_Manager";
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attribute :>> actorDescription = "clinician";
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@@ -1474,7 +1474,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Cumulative delivered volume in every one-hour window is at or below the prescribed maximum. Complements the CriSys total-VTBI ceiling (REQ-CS-20, REQ-CS-28).";
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attribute :>> subjectDescription = "Infusion_Manager";
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attribute :>> actorDescription = "patient";
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@@ -1489,7 +1489,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::regulatory;
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attribute :>> safetyClass = SafetyClassKind::B;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Modification of a stored log entry is detectable. Log content and cadence are governed by REQ-CS-77..81; retention by REQ-CS-85.";
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attribute :>> subjectDescription = "Logging";
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attribute :>> actorDescription = "clinician and auditor";
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@@ -1504,7 +1504,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Induced CPU hang results in zero flow and alarm within the watchdog timeout.";
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attribute :>> subjectDescription = "System_Monitor and watchdog hardware";
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attribute :>> actorDescription = "clinician";
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@@ -1524,7 +1524,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Continuous assertion beyond 60 s produces no bolus and raises a notification. Complements REQ-CS-25/26 request-level filtering with an input-failure check.";
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attribute :>> subjectDescription = "Infusion_Manager";
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attribute :>> actorDescription = "patient";
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@@ -1539,7 +1539,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>> safetyClass = SafetyClassKind::C;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Injected flow deviation beyond Tolerance_Min_const (5 %) sustained past Max_Duration_OverInfusion_const pauses therapy and annunciates; detection is independent of motor control.";
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attribute :>> subjectDescription = "Alarm and Infusion_Manager";
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attribute :>> actorDescription = "patient";
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@@ -1553,7 +1553,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The pump mechanism shall deliver programmed volumes with an accuracy of plus or minus Tolerance_Min_const (5 percent) over the full rate range, so that the system-level flow tolerances of REQ-CS-16 are achievable.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::performance;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Gravimetric bench test across min/nominal/max rates within ±5% (Tolerance_Min_const).";
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attribute :>> subjectDescription = "PumpMotorAssembly";
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attribute :>> actorDescription = "patient";
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@@ -1568,7 +1568,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The audible annunciator shall produce notification tones at the sound level defined by Audio_level_const (50 db for 2 seconds per interface spec I 8), distinguishable by priority.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::usability;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Calibrated SPL measurement meets Audio_level_const for each priority tone.";
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attribute :>> subjectDescription = "AudibleAlarmAnnunciator";
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attribute :>> actorDescription = "clinician";
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@@ -1583,7 +1583,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The battery shall sustain nominal therapy and alarm annunciation for at least 4 hours after loss of mains power.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::reliability;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "Discharge test at nominal rate exceeds 4 h with low-battery warning at 30 min remaining.";
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attribute :>> subjectDescription = "BatteryPack";
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attribute :>> actorDescription = "clinician";
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@@ -1598,7 +1598,7 @@ package memo_examples_gpca_pump_model_catalog_gpca_requirements {
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attribute :>> statement = "The fluid path shall include a mechanical anti-free-flow valve that blocks gravity flow whenever the administration set is disengaged from the pumping mechanism.";
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attribute :>> sourceKind = RequirementSourceKind::extension;
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attribute :>> concernKind = ConcernKind::safety;
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attribute :>>
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attribute :>> requirementStatus = RequirementStatusKind::approved;
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attribute :>> acceptanceCriteria = "No measurable flow under gravity head with set disengaged and door open.";
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attribute :>> subjectDescription = "AntiFreeFlowValve";
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attribute :>> actorDescription = "patient";
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