Advance Care Planning (PZP), published by IKNL. This guide is not an authorized publication; it is the continuous build for version 1.0.0-rc1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IKNL/PZP-FHIR-R4/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: MedicalDevice Product ICD

The medical device (internally or externally). In the context of ACP, this profile is used to capture information on a patient's implantable cardioverter defibrillator (ICD). Based on nl-core-MedicalDeviceProduct and HCIM MedicalDevice.

Usages:

• Refer to this Profile: MedicalDevice
• Examples for this Profile: Device/F1-ACP-MedicalDevice.Product-ICD and Device/P2-ACP-MedicalDevice.Product-ICD

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		0..*	NlcoreMedicalDeviceProduct	Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:hibcProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
Slices for udiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
udiCarrier:gs1UdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
udiCarrier:hibcUdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
type	O	0..1	CodeableConcept	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
note		0..1	Annotation	Device notes and comments
text	OΣ	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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	Device.implicitRules, Device.modifierExtension, Device.identifier, Device.identifier:gs1ProductID, Device.identifier:hibcProductID, Device.udiCarrier, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.issuer, Device.udiCarrier:gs1UdiCarrier.carrierHRF, Device.udiCarrier:hibcUdiCarrier, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.issuer, Device.udiCarrier:hibcUdiCarrier.carrierHRF, Device.status, Device.type, Device.note, Device.note.text	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	Device.modifierExtension, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from NlcoreMedicalDeviceProduct

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	NlcoreMedicalDeviceProduct	Product
Slices for identifier				Content/Rules for all slices
identifier:gs1ProductID	O	0..1	Identifier	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
identifier:hibcProductID	O	0..1	Identifier	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Slices for udiCarrier				Content/Rules for all slices
udiCarrier:gs1UdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
carrierHRF	O	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
udiCarrier:hibcUdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
carrierHRF	O	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
type	O	0..1	CodeableConcept	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
note
text	O	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	NlcoreMedicalDeviceProduct	Product
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 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 Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:hibcProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		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
Slices for udiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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.
udiCarrier:gs1UdiCarrier	Σ	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
deviceIdentifier	Σ	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
udiCarrier:hibcUdiCarrier	Σ	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
deviceIdentifier	Σ	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
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		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		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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
name		1..1	string	The name of the device
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	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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..1	Annotation	Device notes and comments
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
author[x]	Σ	0..1		Individual responsible for the annotation
authorReference			Reference(Practitioner | Patient | RelatedPerson | Organization)
authorString			string
time	Σ	0..1	dateTime	When the annotation was made
text	OΣ	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Device.udiCarrier.entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.udiCarrier:gs1UdiCarrier.​entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.udiCarrier:hibcUdiCarrier.​entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.statusReason	Base	extensible	FHIRDeviceStatusReason	📍4.0.1	FHIR Std.
Device.deviceName.type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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	Device.meta, Device.implicitRules, Device.language, Device.text, Device.extension, Device.modifierExtension, Device.identifier, Device.identifier:gs1ProductID, Device.identifier:hibcProductID, Device.definition, Device.udiCarrier, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.issuer, Device.udiCarrier.jurisdiction, Device.udiCarrier.carrierAIDC, Device.udiCarrier.carrierHRF, Device.udiCarrier.entryType, Device.udiCarrier:gs1UdiCarrier, Device.udiCarrier:gs1UdiCarrier.extension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.deviceIdentifier, Device.udiCarrier:gs1UdiCarrier.issuer, Device.udiCarrier:gs1UdiCarrier.jurisdiction, Device.udiCarrier:gs1UdiCarrier.carrierAIDC, Device.udiCarrier:gs1UdiCarrier.carrierHRF, Device.udiCarrier:gs1UdiCarrier.entryType, Device.udiCarrier:hibcUdiCarrier, Device.udiCarrier:hibcUdiCarrier.extension, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.deviceIdentifier, Device.udiCarrier:hibcUdiCarrier.issuer, Device.udiCarrier:hibcUdiCarrier.jurisdiction, Device.udiCarrier:hibcUdiCarrier.carrierAIDC, Device.udiCarrier:hibcUdiCarrier.carrierHRF, Device.udiCarrier:hibcUdiCarrier.entryType, Device.status, Device.statusReason, Device.distinctIdentifier, Device.manufacturer, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.modelNumber, Device.partNumber, Device.type, Device.specialization, Device.specialization.extension, Device.specialization.modifierExtension, Device.specialization.systemType, Device.specialization.version, Device.version, Device.version.extension, Device.version.modifierExtension, Device.version.type, Device.version.component, Device.version.value, Device.property, Device.property.extension, Device.property.modifierExtension, Device.property.type, Device.property.valueQuantity, Device.property.valueCode, Device.patient, Device.owner, Device.contact, Device.location, Device.url, Device.note, Device.note.extension, Device.note.author[x], Device.note.time, Device.note.text, Device.safety, Device.parent	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	Device.extension, Device.modifierExtension, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.extension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.extension, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.specialization.extension, Device.specialization.modifierExtension, Device.version.extension, Device.version.modifierExtension, Device.property.extension, Device.property.modifierExtension, Device.note.extension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from NlcoreMedicalDeviceProduct

Summary

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	NlcoreMedicalDeviceProduct	Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:hibcProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
Slices for udiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
udiCarrier:gs1UdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
udiCarrier:hibcUdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
type	O	0..1	CodeableConcept	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
note		0..1	Annotation	Device notes and comments
text	OΣ	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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	Device.implicitRules, Device.modifierExtension, Device.identifier, Device.identifier:gs1ProductID, Device.identifier:hibcProductID, Device.udiCarrier, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.issuer, Device.udiCarrier:gs1UdiCarrier.carrierHRF, Device.udiCarrier:hibcUdiCarrier, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.issuer, Device.udiCarrier:hibcUdiCarrier.carrierHRF, Device.status, Device.type, Device.note, Device.note.text	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	Device.modifierExtension, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential View

This structure is derived from NlcoreMedicalDeviceProduct

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	NlcoreMedicalDeviceProduct	Product
Slices for identifier				Content/Rules for all slices
identifier:gs1ProductID	O	0..1	Identifier	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
identifier:hibcProductID	O	0..1	Identifier	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Slices for udiCarrier				Content/Rules for all slices
udiCarrier:gs1UdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
carrierHRF	O	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
udiCarrier:hibcUdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
carrierHRF	O	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
type	O	0..1	CodeableConcept	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
note
text	O	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	NlcoreMedicalDeviceProduct	Product
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 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 Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:hibcProductID	O	0..1	Identifier	ProductID Required Pattern: At least the following Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		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
Slices for udiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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.
udiCarrier:gs1UdiCarrier	Σ	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
deviceIdentifier	Σ	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
udiCarrier:hibcUdiCarrier	Σ	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
deviceIdentifier	Σ	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	OΣ	0..1	string	ProductID Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
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		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		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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
name		1..1	string	The name of the device
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	ProductType Binding: ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required) Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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..1	Annotation	Device notes and comments
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
author[x]	Σ	0..1		Individual responsible for the annotation
authorReference			Reference(Practitioner | Patient | RelatedPerson | Organization)
authorString			string
time	Σ	0..1	dateTime	When the annotation was made
text	OΣ	1..1	markdown	ProductDescription Obligations Actor SHALL:populate-if-known ACP Actor Provider SHALL:no-error ACP Actor Consulter
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Device.udiCarrier.entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.udiCarrier:gs1UdiCarrier.​entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.udiCarrier:hibcUdiCarrier.​entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.statusReason	Base	extensible	FHIRDeviceStatusReason	📍4.0.1	FHIR Std.
Device.deviceName.type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
Device.type	Base	required	MedicalDevice ProductType ICD	📍1.0.0-rc1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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	Device.meta, Device.implicitRules, Device.language, Device.text, Device.extension, Device.modifierExtension, Device.identifier, Device.identifier:gs1ProductID, Device.identifier:hibcProductID, Device.definition, Device.udiCarrier, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.issuer, Device.udiCarrier.jurisdiction, Device.udiCarrier.carrierAIDC, Device.udiCarrier.carrierHRF, Device.udiCarrier.entryType, Device.udiCarrier:gs1UdiCarrier, Device.udiCarrier:gs1UdiCarrier.extension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.deviceIdentifier, Device.udiCarrier:gs1UdiCarrier.issuer, Device.udiCarrier:gs1UdiCarrier.jurisdiction, Device.udiCarrier:gs1UdiCarrier.carrierAIDC, Device.udiCarrier:gs1UdiCarrier.carrierHRF, Device.udiCarrier:gs1UdiCarrier.entryType, Device.udiCarrier:hibcUdiCarrier, Device.udiCarrier:hibcUdiCarrier.extension, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.deviceIdentifier, Device.udiCarrier:hibcUdiCarrier.issuer, Device.udiCarrier:hibcUdiCarrier.jurisdiction, Device.udiCarrier:hibcUdiCarrier.carrierAIDC, Device.udiCarrier:hibcUdiCarrier.carrierHRF, Device.udiCarrier:hibcUdiCarrier.entryType, Device.status, Device.statusReason, Device.distinctIdentifier, Device.manufacturer, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.modelNumber, Device.partNumber, Device.type, Device.specialization, Device.specialization.extension, Device.specialization.modifierExtension, Device.specialization.systemType, Device.specialization.version, Device.version, Device.version.extension, Device.version.modifierExtension, Device.version.type, Device.version.component, Device.version.value, Device.property, Device.property.extension, Device.property.modifierExtension, Device.property.type, Device.property.valueQuantity, Device.property.valueCode, Device.patient, Device.owner, Device.contact, Device.location, Device.url, Device.note, Device.note.extension, Device.note.author[x], Device.note.time, Device.note.text, Device.safety, Device.parent	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	Device.extension, Device.modifierExtension, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier:gs1UdiCarrier.extension, Device.udiCarrier:gs1UdiCarrier.modifierExtension, Device.udiCarrier:hibcUdiCarrier.extension, Device.udiCarrier:hibcUdiCarrier.modifierExtension, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.specialization.extension, Device.specialization.modifierExtension, Device.version.extension, Device.version.modifierExtension, Device.property.extension, Device.property.modifierExtension, Device.note.extension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from NlcoreMedicalDeviceProduct

Summary

Other representations of profile: CSV, Excel, Schematron