This page is part of the Loinc/IVD Mapping FHIR IG (v0.1.0: STU 1 Draft) based on FHIR v3.5.0. . For a full list of available versions, see the Directory of published versions

This is a pre-release version (Draft for Comment) of Loinc/IVD Mapping (LIVD) R1 (STU). There is no current official version.
For a full list of available versions, see the Directory of published versions .

StructureDefinition: LIVD Device Definition

The official URL for this profile is:

http://hl7.org/fhir/uv/livd/StructureDefinition/devicedefinition-uv-livd

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from DeviceDefinition

Summary

Mandatory: 3 elements (3 nested mandatory elements)
Must-Support: 1 element
Prohibited: 8 elements

Extensions

This structure refers to these extensions:

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*LIVD Device Definition
... extension ExtensionSlice: Unordered, Open by value:value
... ext-capability S1..*Reference(LIVD ObservationDefinition)Extension
URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-capability
... identifier 0..0
... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringMandatory fixed portion of UDI
.... issuer 1..1uriUDI Issuing Organization
.... jurisdiction 1..1uriRegional UDI authority
... modelNumber 1..1stringModel id assigned by the manufacturer
... type 0..0
... version 0..0
... safety 0..0
... owner 0..0
... contact 0..0
... url 0..0
... note 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*LIVD Device Definition
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension ExtensionExtension
Slice: Unordered, Open by value:value
... ext-capability SI1..*Reference(LIVD ObservationDefinition)Extension
URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-capability
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... udiDeviceIdentifier I0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... deviceIdentifier 1..1stringMandatory fixed portion of UDI
.... issuer 1..1uriUDI Issuing Organization
.... jurisdiction 1..1uriRegional UDI authority
... manufacturer[x] 0..1string, Reference(Organization)Name of device manufacturer
... deviceName I0..*BackboneElementA name given to the device to identify it
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber 1..1stringModel id assigned by the manufacturer
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... onlineInformation 0..1uriAccess to on-line information
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

This structure is derived from DeviceDefinition

Summary

Mandatory: 3 elements (3 nested mandatory elements)
Must-Support: 1 element
Prohibited: 8 elements

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*LIVD Device Definition
... extension ExtensionSlice: Unordered, Open by value:value
... ext-capability S1..*Reference(LIVD ObservationDefinition)Extension
URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-capability
... identifier 0..0
... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringMandatory fixed portion of UDI
.... issuer 1..1uriUDI Issuing Organization
.... jurisdiction 1..1uriRegional UDI authority
... modelNumber 1..1stringModel id assigned by the manufacturer
... type 0..0
... version 0..0
... safety 0..0
... owner 0..0
... contact 0..0
... url 0..0
... note 0..0

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*LIVD Device Definition
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension ExtensionExtension
Slice: Unordered, Open by value:value
... ext-capability SI1..*Reference(LIVD ObservationDefinition)Extension
URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-capability
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... udiDeviceIdentifier I0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... deviceIdentifier 1..1stringMandatory fixed portion of UDI
.... issuer 1..1uriUDI Issuing Organization
.... jurisdiction 1..1uriRegional UDI authority
... manufacturer[x] 0..1string, Reference(Organization)Name of device manufacturer
... deviceName I0..*BackboneElementA name given to the device to identify it
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber 1..1stringModel id assigned by the manufacturer
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... onlineInformation 0..1uriAccess to on-line information
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

 

Other representations of profile: Schematron

Terminology Bindings

PathNameConformanceValueSet
DeviceDefinition.languageLanguagepreferredCommon Languages
DeviceDefinition.deviceName.typeDeviceNameTyperequiredDeviceNameType

Constraints

IdPathDetailsRequirements
dom-2DeviceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-4DeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-3DeviceDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-6DeviceDefinitionA resource should have narrative for robust management
: text.div.exists()
dom-5DeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
ele-1DeviceDefinition.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1DeviceDefinition.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1DeviceDefinition.extensionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1DeviceDefinition.extensionMust have either extensions or value[x], not both
: extension.exists() != value.exists()
ele-1DeviceDefinition.udiDeviceIdentifierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1DeviceDefinition.deviceNameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1DeviceDefinition.specializationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1DeviceDefinition.capabilityAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1DeviceDefinition.propertyAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1DeviceDefinition.materialAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())