HL7 Europe Imaging Study Report, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/oijauregui/ehdsimaging/ and changes regularly. See the Directory of published versions

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Resource Profile: Report obligations for EuDevice

Report obligations for EuDevice

Usages:

• This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device	C	0..*	Device	Item used in healthcare Constraints: dev-1
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device.
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	OC	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
type	O	0..*	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value		1..1	string	The version text
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|5.0.0 From the FHIR Standard
Device.name.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|5.0.0 From the FHIR Standard
Device.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dev-1	error	Device	only one Device.name.display SHALL be true when there is more than one Device.name : name.where(display=true).count() <= 1
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	If 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Device	If 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-5	error	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	O	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
type	O	0..*	CodeableConcept	The kind or type of device Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device	C	0..*	Device	Item used in healthcare Constraints: dev-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
displayName		0..1	string	The name used to display by default when the device is referenced
definition		0..1	CodeableReference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	Σ	1..1	string	Mandatory fixed portion of UDI
issuer	Σ	1..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device.
availabilityStatus		0..1	CodeableConcept	lost | damaged | destroyed | available Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device.
biologicalSourceEvent		0..1	Identifier	An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	OC	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
partNumber		0..1	string	The part number or catalog number of the device
category		0..*	CodeableConcept	Indicates a high-level grouping of the device Binding: FHIRDeviceCategory (example): Categories of medical devices.
type	O	0..*	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal Binding: DeviceVersionType (example): The type of version indicated for the device.
component		0..1	Identifier	The hardware or software module of the device to which the version applies
installDate		0..1	dateTime	The date the version was installed on the device
value		1..1	string	The version text
conformsTo		0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: DeviceSpecificationCategory (example): The kind of standards used by the device.
specification		1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to Binding: DeviceSpecificationType (example): The type of version indicated for the device.
version		0..1	string	Specific form or variant of the standard
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: DeviceType (example): Device property type.
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
mode		0..1	CodeableConcept	The designated condition for performing a task Binding: FHIRDeviceOperationMode (example): Operational mode of a device.
cycle		0..1	Count	The series of occurrences that repeats during the operation of the device
duration		0..1	Duration	A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to electronic services provided by the device
gateway		0..*	CodeableReference(Device)	Linked device acting as a communication/data collector, translator or controller
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device Binding: DeviceSafety (example)
parent		0..1	Reference(Device)	The higher level or encompassing device that this device is a logical part of
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|5.0.0 From the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|5.0.0 From the FHIR Standard
Device.availabilityStatus	extensible	FHIRDeviceAvailabilityStatus http://hl7.org/fhir/ValueSet/device-availability-status From the FHIR Standard
Device.name.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|5.0.0 From the FHIR Standard
Device.category	example	FHIRDeviceCategory http://hl7.org/fhir/ValueSet/device-category From the FHIR Standard
Device.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-type From the FHIR Standard
Device.version.type	example	DeviceVersionType http://hl7.org/fhir/ValueSet/device-versiontype From the FHIR Standard
Device.conformsTo.category	example	DeviceSpecificationCategory http://hl7.org/fhir/ValueSet/device-specification-category From the FHIR Standard
Device.conformsTo.specification	example	DeviceSpecificationType http://hl7.org/fhir/ValueSet/device-specification-type From the FHIR Standard
Device.property.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-property-type From the FHIR Standard
Device.mode	example	FHIRDeviceOperationMode http://hl7.org/fhir/ValueSet/device-operation-mode From the FHIR Standard
Device.safety	example	DeviceSafety http://hl7.org/fhir/ValueSet/device-safety From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dev-1	error	Device	only one Device.name.display SHALL be true when there is more than one Device.name : name.where(display=true).count() <= 1
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	If 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Device	If 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-5	error	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Device

Summary

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device	C	0..*	Device	Item used in healthcare Constraints: dev-1
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device.
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	OC	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
type	O	0..*	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value		1..1	string	The version text
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|5.0.0 From the FHIR Standard
Device.name.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|5.0.0 From the FHIR Standard
Device.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dev-1	error	Device	only one Device.name.display SHALL be true when there is more than one Device.name : name.where(display=true).count() <= 1
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	If 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Device	If 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-5	error	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	O	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
type	O	0..*	CodeableConcept	The kind or type of device Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device	C	0..*	Device	Item used in healthcare Constraints: dev-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor SHALL:populate-if-known Imaging study report provider
displayName		0..1	string	The name used to display by default when the device is referenced
definition		0..1	CodeableReference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	Σ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	Σ	1..1	string	Mandatory fixed portion of UDI
issuer	Σ	1..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	Σ	0..1	string	UDI Human Readable Barcode String
entryType		0..1	code	barcode | rfid | manual | card | self-reported | electronic-transmission | unknown Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error Binding: FHIRDeviceStatus (required): The record status of the device.
availabilityStatus		0..1	CodeableConcept	lost | damaged | destroyed | available Binding: FHIRDeviceAvailabilityStatus (extensible): The availability status reason of the device.
biologicalSourceEvent		0..1	Identifier	An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
manufactureDate	O	0..1	dateTime	Date when the device was made Obligations Actor SHALL:populate-if-known Imaging study report provider
expirationDate	O	0..1	dateTime	Date and time of expiry of this device (if applicable) Obligations Actor SHALL:populate-if-known Imaging study report provider
lotNumber	O	0..1	string	Lot number of manufacture Obligations Actor SHALL:populate-if-known Imaging study report provider
serialNumber	O	0..1	string	Serial number assigned by the manufacturer Obligations Actor SHALL:populate-if-known Imaging study report provider
name	OC	0..*	BackboneElement	The name or names of the device as known to the manufacturer and/or patient Obligations Actor SHALL:populate-if-known Imaging study report provider
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
value	Σ	1..1	string	The term that names the device
type	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by.
display	?!ΣC	0..1	boolean	The preferred device name
modelNumber	O	0..1	string	The manufacturer's model number for the device Obligations Actor SHALL:populate-if-known Imaging study report provider
partNumber		0..1	string	The part number or catalog number of the device
category		0..*	CodeableConcept	Indicates a high-level grouping of the device Binding: FHIRDeviceCategory (example): Categories of medical devices.
type	O	0..*	CodeableConcept	The kind or type of device Binding: DeviceType (example): Codes to identify medical devices. Obligations Actor SHALL:populate-if-known Imaging study report provider
version	O	0..*	BackboneElement	The actual design of the device or software version running on the device Obligations Actor SHALL:populate-if-known Imaging study report provider
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal Binding: DeviceVersionType (example): The type of version indicated for the device.
component		0..1	Identifier	The hardware or software module of the device to which the version applies
installDate		0..1	dateTime	The date the version was installed on the device
value		1..1	string	The version text
conformsTo		0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category		0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement Binding: DeviceSpecificationCategory (example): The kind of standards used by the device.
specification		1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to Binding: DeviceSpecificationType (example): The type of version indicated for the device.
version		0..1	string	Specific form or variant of the standard
property		0..*	BackboneElement	Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property being represented Binding: DeviceType (example): Device property type.
value[x]		1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
mode		0..1	CodeableConcept	The designated condition for performing a task Binding: FHIRDeviceOperationMode (example): Operational mode of a device.
cycle		0..1	Count	The series of occurrences that repeats during the operation of the device
duration		0..1	Duration	A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
endpoint		0..*	Reference(Endpoint)	Technical endpoints providing access to electronic services provided by the device
gateway		0..*	CodeableReference(Device)	Linked device acting as a communication/data collector, translator or controller
note	O	0..*	Annotation	Device notes and comments Obligations Actor SHALL:populate-if-known Imaging study report provider
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device Binding: DeviceSafety (example)
parent		0..1	Reference(Device)	The higher level or encompassing device that this device is a logical part of
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|5.0.0 From the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|5.0.0 From the FHIR Standard
Device.availabilityStatus	extensible	FHIRDeviceAvailabilityStatus http://hl7.org/fhir/ValueSet/device-availability-status From the FHIR Standard
Device.name.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|5.0.0 From the FHIR Standard
Device.category	example	FHIRDeviceCategory http://hl7.org/fhir/ValueSet/device-category From the FHIR Standard
Device.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-type From the FHIR Standard
Device.version.type	example	DeviceVersionType http://hl7.org/fhir/ValueSet/device-versiontype From the FHIR Standard
Device.conformsTo.category	example	DeviceSpecificationCategory http://hl7.org/fhir/ValueSet/device-specification-category From the FHIR Standard
Device.conformsTo.specification	example	DeviceSpecificationType http://hl7.org/fhir/ValueSet/device-specification-type From the FHIR Standard
Device.property.type	example	DeviceType http://hl7.org/fhir/ValueSet/device-property-type From the FHIR Standard
Device.mode	example	FHIRDeviceOperationMode http://hl7.org/fhir/ValueSet/device-operation-mode From the FHIR Standard
Device.safety	example	DeviceSafety http://hl7.org/fhir/ValueSet/device-safety From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dev-1	error	Device	only one Device.name.display SHALL be true when there is more than one Device.name : name.where(display=true).count() <= 1
dom-2	error	Device	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Device	If 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Device	If 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-5	error	Device	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Device	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Device

Summary

Other representations of profile: CSV, Excel, Schematron