Nictiz FHIR NL R4 Zib2020 - Local Development build (v0.9.0). See the Directory of published versions

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Resource Profile: zib MedicalDevice.Product ( Abstract )

Medical devices are any internally implanted and external devices and/or aids used by the patient (in the past) to reduce the effects of functional limitations in organ systems or to facilitate the treatment of a disease.

This Device resource represents the Product concept of the Dutch zib (‘Zorginformatiebouwsteen’, i.e. Health and Care Information Model) MedicalDevice v3.3.1 (2020).

Usage:

• Derived from this Resource Profile: nl core MedicalDevice.Product, zib HearingFunction.HearingAid.Product and zib VisualFunction.VisualAid.Product
• Refer to this Resource Profile: zib MedicalDevice

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		0..*	Device	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct Product
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
identifier:hibcProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
Slices for udiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:gs1UdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier		0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
carrierHRF		0..1	string	ProductID
udiCarrier:hibcUdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF		0..1	string	ProductID
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
type		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
note		0..1	Annotation	Device notes and comments
text		1..1	markdown	ProductDescription
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
identifier:hibcProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
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
udiCarrier:gs1UdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
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 Required Pattern: https://www.gs1.org/gtin
carrierHRF	Σ	0..1	string	ProductID
udiCarrier:hibcUdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF	Σ	0..1	string	ProductID
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
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
type		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
note		0..1	Annotation	Device notes and comments
text	Σ	1..1	markdown	ProductDescription
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Device.status	required	FHIRDeviceStatus
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

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	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct 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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
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		0..1	Identifier	ProductID Required Pattern: At least the following
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
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.
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
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 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	Σ	0..1	string	ProductID
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
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 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	Σ	0..1	string	ProductID
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
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..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
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	Σ	1..1	markdown	ProductDescription
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
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType
Device.udiCarrier:gs1UdiCarrier.entryType	required	UDIEntryType
Device.udiCarrier:hibcUdiCarrier.entryType	required	UDIEntryType
Device.status	required	FHIRDeviceStatus
Device.statusReason	extensible	FHIRDeviceStatusReason
Device.deviceName.type	required	DeviceNameType
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

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

Slices

This structure defines the following Slices:

• The element Device.identifier is sliced based on the value of pattern:$this
• The element Device.udiCarrier is sliced based on the value of value:issuer

Differential View

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct Product
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
identifier:hibcProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
Slices for udiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string Slice: Unordered, Open by value:issuer
udiCarrier:gs1UdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier		0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization Required Pattern: https://www.gs1.org/gtin
carrierHRF		0..1	string	ProductID
udiCarrier:hibcUdiCarrier		0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF		0..1	string	ProductID
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
type		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
note		0..1	Annotation	Device notes and comments
text		1..1	markdown	ProductDescription
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct Product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.gs1.org/gtin
identifier:hibcProductID		0..1	Identifier	ProductID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:2.16.840.1.113883.6.40
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
udiCarrier:gs1UdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
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 Required Pattern: https://www.gs1.org/gtin
carrierHRF	Σ	0..1	string	ProductID
udiCarrier:hibcUdiCarrier	Σ	0..1	BackboneElement	Unique Device Identifier (UDI) Barcode string
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
issuer		0..1	uri	UDI Issuing Organization Required Pattern: urn:oid:2.16.840.1.113883.6.40
carrierHRF	Σ	0..1	string	ProductID
status	?!Σ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
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
type		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
note		0..1	Annotation	Device notes and comments
text	Σ	1..1	markdown	ProductDescription
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Device.status	required	FHIRDeviceStatus
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

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	This is an abstract profile. Child profiles: NlcoreMedicalDeviceProduct, ZibHearingFunctionHearingAidProduct, ZibVisualFunctionVisualAidProduct 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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier		0..1	Identifier	Instance identifier Slice: Unordered, Open by pattern:$this
identifier:gs1ProductID		0..1	Identifier	ProductID Required Pattern: At least the following
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		0..1	Identifier	ProductID Required Pattern: At least the following
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
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.
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
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 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	Σ	0..1	string	ProductID
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
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 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	Σ	0..1	string	ProductID
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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		0..1	CodeableConcept	ProductType Binding: http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000 (required)
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..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
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	Σ	1..1	markdown	ProductDescription
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
Device.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Device.udiCarrier.entryType	required	UDIEntryType
Device.udiCarrier:gs1UdiCarrier.entryType	required	UDIEntryType
Device.udiCarrier:hibcUdiCarrier.entryType	required	UDIEntryType
Device.status	required	FHIRDeviceStatus
Device.statusReason	extensible	FHIRDeviceStatusReason
Device.deviceName.type	required	DeviceNameType
Device.type	required	http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1--20200901000000

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

Slices

This structure defines the following Slices:

• The element Device.identifier is sliced based on the value of pattern:$this
• The element Device.udiCarrier is sliced based on the value of value:issuer

Other representations of profile: CSV, Excel, Schematron