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Resource Profile: Implantable Device: Prosthesis

This StructureDefinition contains the maps for VistA file PROSTHESIS INSTALLED (130.01) to us-core-implantable-device.

Usage:

• CapabilityStatements using this Resource Profile: Lighthouse Patient Health API
• This Resource Profile is not used by any profiles in this Implementation Guide

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
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0) dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier		0..*	Identifier	Instance identifier ele-1: All FHIR elements must have a @value or children
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
system	SΣ	0..1	uri	The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	SΣ	0..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
udiCarrier	SΣ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
deviceIdentifier	SΣ	1..1	string	Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children
carrierHRF	SΣ	0..1	string	UDI Human Readable Barcode String ele-1: All FHIR elements must have a @value or children
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children
distinctIdentifier	S	0..1	string	The distinct identification string ele-1: All FHIR elements must have a @value or children
manufacturer	S	0..1	string	Name of device manufacturer ele-1: All FHIR elements must have a @value or children
manufactureDate	S	0..1	dateTime	Date when the device was made ele-1: All FHIR elements must have a @value or children
expirationDate	S	0..1	dateTime	Date and time of expiry of this device (if applicable) ele-1: All FHIR elements must have a @value or children
lotNumber	S	0..1	string	Lot number of manufacture ele-1: All FHIR elements must have a @value or children
serialNumber	S	0..1	string	Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children
deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
name	S	1..1	string	The name of the device ele-1: All FHIR elements must have a @value or children
type	S	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. ele-1: All FHIR elements must have a @value or children Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device ele-1: All FHIR elements must have a @value or children
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
patient	S	1..1	Reference(Patient)	Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children
owner	S	0..1	Reference(Organization)	Organization responsible for device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Device.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|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.deviceName.type	required	Pattern: model-name http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	Pattern: SNOMED-CT Code 63653004("Biomedical device") http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

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 USCoreImplantableDeviceProfile

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0)
identifier
system	S	0..1	uri	The namespace for the identifier value Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	S	0..1	string	The value that is unique
udiCarrier
deviceIdentifier		1..1	string	Mandatory fixed portion of UDI
carrierHRF		0..1	string	UDI Human Readable Barcode String
status		0..1	code	active | inactive | entered-in-error | unknown
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	S	0..1	string	Name of device manufacturer
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
name	S	1..1	string	The name of the device
type	S	1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device
type		1..1	CodeableConcept	The kind or type of device Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
patient		1..1	Reference(Patient)	Patient to whom Device is affixed
owner	S	0..1	Reference(Organization)	Organization responsible for device
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0)
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		0..*	Identifier	Instance identifier
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	0..1	uri	The namespace for the identifier value Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	SΣ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	SΣ	0..1	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	SΣ	1..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	SΣ	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	S	0..1	string	The distinct identification string
manufacturer	S	0..1	string	Name of device manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber	S	0..1	string	Lot number of manufacture
serialNumber	S	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	S	1..1	string	The name of the device
type	S	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. Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
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	S	1..1	Reference(Patient)	Patient to whom Device is affixed
owner	S	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 / Code	URI
Device.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Device.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type 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	Pattern: model-name http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	Pattern: SNOMED-CT Code 63653004("Biomedical device") http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

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 USCoreImplantableDeviceProfile

Summary

Must-Support: 7 elements

Structures

This structure refers to these other structures:

• Patient (http://va.gov/fhir/StructureDefinition/Patient)
• Organization (http://va.gov/fhir/StructureDefinition/Organization)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0) dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier		0..*	Identifier	Instance identifier ele-1: All FHIR elements must have a @value or children
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
system	SΣ	0..1	uri	The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	SΣ	0..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
udiCarrier	SΣ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
deviceIdentifier	SΣ	1..1	string	Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children
carrierHRF	SΣ	0..1	string	UDI Human Readable Barcode String ele-1: All FHIR elements must have a @value or children
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children
distinctIdentifier	S	0..1	string	The distinct identification string ele-1: All FHIR elements must have a @value or children
manufacturer	S	0..1	string	Name of device manufacturer ele-1: All FHIR elements must have a @value or children
manufactureDate	S	0..1	dateTime	Date when the device was made ele-1: All FHIR elements must have a @value or children
expirationDate	S	0..1	dateTime	Date and time of expiry of this device (if applicable) ele-1: All FHIR elements must have a @value or children
lotNumber	S	0..1	string	Lot number of manufacture ele-1: All FHIR elements must have a @value or children
serialNumber	S	0..1	string	Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children
deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
name	S	1..1	string	The name of the device ele-1: All FHIR elements must have a @value or children
type	S	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. ele-1: All FHIR elements must have a @value or children Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device ele-1: All FHIR elements must have a @value or children
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
patient	S	1..1	Reference(Patient)	Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children
owner	S	0..1	Reference(Organization)	Organization responsible for device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Device.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|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.deviceName.type	required	Pattern: model-name http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	Pattern: SNOMED-CT Code 63653004("Biomedical device") http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

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()

Differential View

This structure is derived from USCoreImplantableDeviceProfile

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0)
identifier
system	S	0..1	uri	The namespace for the identifier value Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	S	0..1	string	The value that is unique
udiCarrier
deviceIdentifier		1..1	string	Mandatory fixed portion of UDI
carrierHRF		0..1	string	UDI Human Readable Barcode String
status		0..1	code	active | inactive | entered-in-error | unknown
distinctIdentifier		0..1	string	The distinct identification string
manufacturer	S	0..1	string	Name of device manufacturer
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
name	S	1..1	string	The name of the device
type	S	1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device
type		1..1	CodeableConcept	The kind or type of device Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
patient		1..1	Reference(Patient)	Patient to whom Device is affixed
owner	S	0..1	Reference(Organization)	Organization responsible for device
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	USCoreImplantableDeviceProfile(5.0.1)	Item used in healthcare This profile also complies with the profiles US Core Implantable Device Profile (6.1.0) and US Core Implantable Device Profile (7.0.0)
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		0..*	Identifier	Instance identifier
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	0..1	uri	The namespace for the identifier value Required Pattern: http://va.gov/identifiers/$Sta3n/131.01
value	SΣ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
udiCarrier	SΣ	0..1	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	SΣ	1..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	SΣ	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	S	0..1	string	The distinct identification string
manufacturer	S	0..1	string	Name of device manufacturer
manufactureDate	S	0..1	dateTime	Date when the device was made
expirationDate	S	0..1	dateTime	Date and time of expiry of this device (if applicable)
lotNumber	S	0..1	string	Lot number of manufacture
serialNumber	S	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	S	1..1	string	The name of the device
type	S	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. Required Pattern: model-name
modelNumber	S	0..1	string	The model number for the device
partNumber		0..1	string	The part number of the device
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 63653004
display		1..1	string	Representation defined by the system Fixed Value: Biomedical device
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
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	S	1..1	Reference(Patient)	Patient to whom Device is affixed
owner	S	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 / Code	URI
Device.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Device.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type 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	Pattern: model-name http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	Pattern: SNOMED-CT Code 63653004("Biomedical device") http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

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 USCoreImplantableDeviceProfile

Summary

Must-Support: 7 elements

Structures

This structure refers to these other structures:

• Patient (http://va.gov/fhir/StructureDefinition/Patient)
• Organization (http://va.gov/fhir/StructureDefinition/Organization)

Other representations of profile: CSV, Excel, Schematron