Canadian Baseline
1.1.0 - CI Build Canada flag

Canadian Baseline, published by HL7 Canada - FHIR Implementation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-Canada/ca-baseline/ and changes regularly. See the Directory of published versions

Resource Profile: Device Profile (Medical and Non-medical)

Official URL: http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-device-medical Version: 1.1.0
Draft as of 2020-12-03 Computable Name: DeviceProfileMedical

Proposed constraints on the Device resource for the minimal set of data to query and retrieve a medical or non-medical device.

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.

Usage:

Formal Views of Profile Content

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

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Device Profile
... 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 S 0..* Identifier Instance identifier
Slice: Unordered, Open by value:system
.... 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 .

..... 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
.... identifier:EUI-64 0..1 Identifier IEEE 64-bit Extended Unique Identifier (EUI-64)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... 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
.... identifier:EUI-48 0..1 Identifier MAC Transport address identifier (EUI-48)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string Mandatory fixed portion of UDI
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status 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)
... 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
.... 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.

... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value 1..1 string The version text
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-64.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-48.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 BindingsPurpose
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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-64.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-64.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-48.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-48.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

Slices

This structure defines the following Slices:

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

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Device Profile
... 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 S 0..* Identifier Instance identifier
Slice: Unordered, Open by value:system
.... 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 .

..... 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
.... identifier:EUI-64 0..1 Identifier IEEE 64-bit Extended Unique Identifier (EUI-64)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... 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
.... identifier:EUI-48 0..1 Identifier MAC Transport address identifier (EUI-48)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string Mandatory fixed portion of UDI
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status 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)
... 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
.... 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.

... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value 1..1 string The version text
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-64.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-48.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 BindingsPurpose
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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-64.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-64.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.identifier:EUI-48.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
from the FHIR Standard
Device.identifier:EUI-48.typeextensibleIdentifier Type Codes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf 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-4errorDeviceIf 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-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

Slices

This structure defines the following Slices:

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

 

Other representations of profile: CSV, Excel, Schematron

Notes:

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.