CA Baseline Device (Medical and Non-medical) Profile

This profile sets minimum expectations for the Device resource to record and search for medical and non-medical devices, wearable devices personal health devices, virtual devices such as computer programs and systems, etc., except patient's implantable device(s). It identifies which core elements SHALL be present in the resource when using this profile.

This profile defines core localization concepts for use in the Canadian context.

Mandatory Data Elements

All elements or attributes within the FHIR specification have cardinality as part of their definition - a minimum number of required appearances and a maximum number of allowable appearances.

Most elements in the FHIR specification have a minimum cardinality of 0, so most elements are not required and subsequently they may be missing from a resource when it is exchanged between systems.

Required elements in the Device (Implantable) profile:

• The type of the device (Device.type)

Must Support Data Elements

Some elements are marked as Must Support. This means that implementations generating, receiving, or otherwise using resources with Must Support elements SHALL provide support for those elements in some meaningful way (see Must Support definition).

The following elements are marked as Must Support in the Device (Medical and Non-medical) profile:

Must Support elements:

• Device resource identifier
• Unique Device Identifier (UDI) Barcode string
• distinct identification string
• device manufacturer
• date/time when the device was made
• expiration date/time of the device
• serial number assigned by the manufacturer
• name of the device
• type of the device
• version of the device
• patient

Usage Note

The following are example usage scenarios for the Medical and Non-medical Device profile:

• To record and query information about Personal Health Devices (PHDs) to be used in remote patient monitoring programs.
• To record and query information about the Virtual Medical Device installed as software on the computer system.

• 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	Device Profile
Slices for identifier	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
type	S	0..1	CodeableConcept	Description of identifier
system	S	0..1	uri	The namespace for the identifier value
value	S	0..1	string	The value that is unique within the system.
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64)
system		1..1	uri	EUI-64 system identifier Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value		1..1	string	The value that is unique
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48)
system		1..1	uri	EUI-48 system identifier Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value		1..1	string	The value that is unique
udiCarrier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	S	0..1	string	Mandatory fixed portion of UDI
carrierAIDC	S	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	S	0..1	string	UDI Human Readable Barcode String
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)
serialNumber	S	0..1	string	Serial number assigned by the manufacturer
deviceName	S	0..*	BackboneElement	The name of the device as given by the manufacturer
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
version	S	0..*	BackboneElement	The actual design of the device or software version running on the device
patient	S	0..1	Reference(Patient Profile)	Patient to whom Device is affixed
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	extensible	FHIRDeviceTypes http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Device Profile 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
Slices for identifier	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
identifier:All Slices				Content/Rules for all slices
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
type	SΣ	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. 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 Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique within the system. ele-1: All FHIR elements must have a @value or children Example General: 123456
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64) 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	Σ	1..1	uri	EUI-64 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value	Σ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48) 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	Σ	1..1	uri	EUI-48 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value	Σ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
udiCarrier	SΣ	0..*	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	0..1	string	Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children
carrierAIDC	SΣ	0..1	base64Binary	UDI Machine Readable Barcode String 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
serialNumber	S	0..1	string	Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children
deviceName	S	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		1..1	string	The name of the device ele-1: All FHIR elements must have a @value or children
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. 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
version	S	0..*	BackboneElement	The actual design of the device or software version running on the device 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
value		1..1	string	The version text ele-1: All FHIR elements must have a @value or children
patient	S	0..1	Reference(Patient Profile)	Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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.identifier:EUI-64.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-48.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	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	FHIRDeviceTypes 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()

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Device Profile
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	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system
identifier: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 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	SΣ	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 Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique within the system. 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)
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64)
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	Σ	1..1	uri	EUI-64 system identifier Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value	Σ	1..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)
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48)
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	Σ	1..1	uri	EUI-48 system identifier Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value	Σ	1..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..*	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	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	SΣ	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		0..1	string	Lot number of manufacture
serialNumber	S	0..1	string	Serial number assigned by the manufacturer
deviceName	S	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	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
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	S	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	0..1	Reference(Patient Profile)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	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.identifier:EUI-64.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-64.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Device.identifier:EUI-48.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-48.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	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	FHIRDeviceTypes 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 Device

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Device Profile
Slices for identifier	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
type	S	0..1	CodeableConcept	Description of identifier
system	S	0..1	uri	The namespace for the identifier value
value	S	0..1	string	The value that is unique within the system.
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64)
system		1..1	uri	EUI-64 system identifier Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value		1..1	string	The value that is unique
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48)
system		1..1	uri	EUI-48 system identifier Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value		1..1	string	The value that is unique
udiCarrier	S	0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
deviceIdentifier	S	0..1	string	Mandatory fixed portion of UDI
carrierAIDC	S	0..1	base64Binary	UDI Machine Readable Barcode String
carrierHRF	S	0..1	string	UDI Human Readable Barcode String
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)
serialNumber	S	0..1	string	Serial number assigned by the manufacturer
deviceName	S	0..*	BackboneElement	The name of the device as given by the manufacturer
type	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
version	S	0..*	BackboneElement	The actual design of the device or software version running on the device
patient	S	0..1	Reference(Patient Profile)	Patient to whom Device is affixed
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Device.type	extensible	FHIRDeviceTypes http://hl7.org/fhir/ValueSet/device-kind from the FHIR Standard

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Device Profile 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
Slices for identifier	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
identifier:All Slices				Content/Rules for all slices
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
type	SΣ	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. 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 Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique within the system. ele-1: All FHIR elements must have a @value or children Example General: 123456
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64) 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	Σ	1..1	uri	EUI-64 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value	Σ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48) 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	Σ	1..1	uri	EUI-48 system identifier ele-1: All FHIR elements must have a @value or children Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value	Σ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
udiCarrier	SΣ	0..*	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	0..1	string	Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children
carrierAIDC	SΣ	0..1	base64Binary	UDI Machine Readable Barcode String 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
serialNumber	S	0..1	string	Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children
deviceName	S	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		1..1	string	The name of the device ele-1: All FHIR elements must have a @value or children
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. 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
version	S	0..*	BackboneElement	The actual design of the device or software version running on the device 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
value		1..1	string	The version text ele-1: All FHIR elements must have a @value or children
patient	S	0..1	Reference(Patient Profile)	Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
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.identifier:EUI-64.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-48.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	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	FHIRDeviceTypes 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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Device		0..*	Device	Device Profile
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	S	0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system
identifier: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 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	SΣ	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 Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique within the system. 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)
identifier:EUI-64		0..1	Identifier	IEEE 64-bit Extended Unique Identifier (EUI-64)
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	Σ	1..1	uri	EUI-64 system identifier Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
value	Σ	1..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)
identifier:EUI-48		0..1	Identifier	MAC Transport address identifier (EUI-48)
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	Σ	1..1	uri	EUI-48 system identifier Fixed Value: http://terminology.hl7.org/fhir/sid/eui-48
value	Σ	1..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..*	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	0..1	string	Mandatory fixed portion of UDI
issuer		0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority
carrierAIDC	SΣ	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		0..1	string	Lot number of manufacture
serialNumber	S	0..1	string	Serial number assigned by the manufacturer
deviceName	S	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	S	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
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	S	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	0..1	Reference(Patient Profile)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
safety	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device Profile (Medical and Non-medical))	The parent device
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	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.identifier:EUI-64.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-64.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Device.identifier:EUI-48.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Device.identifier:EUI-48.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	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
Device.type	extensible	FHIRDeviceTypes 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 Device

Summary

Mandatory: 1 element(4 nested mandatory elements)
Must-Support: 17 elements
Fixed: 2 elements

Structures

This structure refers to these other structures:

• Patient Profile (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-patient)
• Device Profile (Medical and Non-medical) (http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-device-medical)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Device.identifier

Identifier

The Device.identifier specifies a unique instance identifiers assigned to a device by manufacturer. This Device profile constrains the use of the Extended Unique Identifier (EUI) such as 64-bit Extended Unique Identifier (EUI-64) or 48-bit Extended Unique Identifier (EUI-48) by fixing the Identifier.system namespace for the identifier value.