This page is part of the MyHealth@Eu Laboratory Report (v0.0.1: QA Preview) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

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Resource Profile: Device: specimen subject

This profile defines how to represent a device in HL7 FHIR, when used as specimen subject, for the purpose of this guide.

Usage:

• Use this Resource Profile: Bundle: Laboratory
• Refer to this Resource Profile: Specimen: Laboratory

Formal Views of Profile Content

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

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

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device			Device
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
udiCarrier	O	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
deviceName
name	O	1..1	string	The name of the device Obligations Actor handle LabReportHandler
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
udiCarrier	OΣ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	OΣ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
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	0..1	string	Mandatory fixed portion of UDI
issuer		0..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 + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber		0..1	string	Lot number of manufacture
serialNumber		0..1	string	Serial number assigned by the manufacturer
deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer
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
name	O	1..1	string	The name of the device Obligations Actor handle LabReportHandler
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber		0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
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
systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version		0..*	BackboneElement	The actual design of the device or software version running on 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
type		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version
value		1..1	string	The version text
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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 DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
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
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.statusReason	extensible	FHIRDeviceStatusReason http://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard
Device.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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

Differential View

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device			Device
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
udiCarrier	O	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
deviceName
name	O	1..1	string	The name of the device Obligations Actor handle LabReportHandler
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
udiCarrier	OΣ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Item used in healthcare
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	O	0..*	Identifier	Instance identifier Obligations Actor handle LabReportHandler
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	OΣ	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string Obligations Actor handle LabReportHandler
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	0..1	string	Mandatory fixed portion of UDI
issuer		0..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 + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	O	0..1	string	Name of device manufacturer Obligations Actor handle LabReportHandler handle LabReportHandler
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber		0..1	string	Lot number of manufacture
serialNumber		0..1	string	Serial number assigned by the manufacturer
deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer
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
name	O	1..1	string	The name of the device Obligations Actor handle LabReportHandler
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber		0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type	O	0..1	CodeableConcept	The type of device Binding: eHDSI Medical Device with exceptions (required) Obligations Actor handle LabReportHandler
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
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
systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version		0..*	BackboneElement	The actual design of the device or software version running on 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
type		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version
value		1..1	string	The version text
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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 DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
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
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Device.udiCarrier.entryType	required	UDIEntryType http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1 from the FHIR Standard
Device.status	required	FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 from the FHIR Standard
Device.statusReason	extensible	FHIRDeviceStatusReason http://hl7.org/fhir/ValueSet/device-status-reason from the FHIR Standard
Device.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	required	EHDSIMedicalDeviceWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIMedicalDeviceWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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