DK EER Endpoint Register (EER), published by . This guide is not an authorized publication; it is the continuous build for version 0.8.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/medcomdk/dk-ehmi-eer/ and changes regularly. See the Directory of published versions

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Resource Profile: EER EndpointDeviceDefinition - EUA

An EerEndpointDeviceDefinition-EUA profile of the EerEndpointDeviceDefinition resource.

Usage:

• Examples for this Resource Profile: DeviceDefinition/EerEndpointDeviceDefinition4EUA

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 EerEndpointDeviceDefinition

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device
type		1..1	CodeableConcept	What kind of device or device system this is Fixed Value: As shown
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	S	0..1	Identifier	Instance identifier ele-1: All FHIR elements must have a @value or children
type	S	1..1	CodeableConcept	What kind of device or device system this is Binding: EER SOR Organization Identier Type Valueset (required) ele-1: All FHIR elements must have a @value or children Fixed Value: As shown
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
version		0..0	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
userSelected		0..0	boolean	If this coding was chosen directly by the user
text		0..0	string	Plain text representation of the concept
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DeviceDefinition.type	required	Fixed Value: EUA("End User Application") http://medcomehmi.dk/ig/dk-ehmi-eer/ValueSet/eer-device-type-valueset from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	DeviceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DeviceDefinition	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	DeviceDefinition	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	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DeviceDefinition	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
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	S	0..1	Identifier	Instance identifier
manufacturer[x]		0..1		Name of device manufacturer
manufacturerString			string
manufacturerReference			Reference(Organization)
deviceName		0..*	BackboneElement	A name given to the device to identify it
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
type	S	1..1	CodeableConcept	What kind of device or device system this is Binding: EER SOR Organization Identier Type Valueset (required) Fixed Value: As shown
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
version		0..0	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
userSelected		0..0	boolean	If this coding was chosen directly by the user
text		0..0	string	Plain text representation of the concept
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
systemType		1..1	string	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..*	string	Available versions
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
capability		0..*	BackboneElement	Device capabilities
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	Type of capability
description		0..*	CodeableConcept	Description of capability
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)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
onlineInformation		0..1	uri	Access to on-line information
note		0..*	Annotation	Device notes and comments
quantity		0..1	Quantity	The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
parentDevice	Σ	0..1	Reference(DeviceDefinition)	The parent device it can be part of
material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
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
substance		1..1	CodeableConcept	The substance
alternate		0..1	boolean	Indicates an alternative material of the device
allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DeviceDefinition.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
DeviceDefinition.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
DeviceDefinition.type	required	Fixed Value: EUA("End User Application") http://medcomehmi.dk/ig/dk-ehmi-eer/ValueSet/eer-device-type-valueset from this IG
DeviceDefinition.safety	example	DeviceSafety http://hl7.org/fhir/ValueSet/device-safety from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	DeviceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DeviceDefinition	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	DeviceDefinition	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	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DeviceDefinition	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 EerEndpointDeviceDefinition

Summary

Fixed: 1 element

Differential View

This structure is derived from EerEndpointDeviceDefinition

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device
type		1..1	CodeableConcept	What kind of device or device system this is Fixed Value: As shown
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
identifier	S	0..1	Identifier	Instance identifier ele-1: All FHIR elements must have a @value or children
type	S	1..1	CodeableConcept	What kind of device or device system this is Binding: EER SOR Organization Identier Type Valueset (required) ele-1: All FHIR elements must have a @value or children Fixed Value: As shown
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
version		0..0	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
userSelected		0..0	boolean	If this coding was chosen directly by the user
text		0..0	string	Plain text representation of the concept
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DeviceDefinition.type	required	Fixed Value: EUA("End User Application") http://medcomehmi.dk/ig/dk-ehmi-eer/ValueSet/eer-device-type-valueset from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	DeviceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DeviceDefinition	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	DeviceDefinition	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	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DeviceDefinition	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
DeviceDefinition		0..*	EerEndpointDeviceDefinition	An instance of a medical-related component of a medical device
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	S	0..1	Identifier	Instance identifier
manufacturer[x]		0..1		Name of device manufacturer
manufacturerString			string
manufacturerReference			Reference(Organization)
deviceName		0..*	BackboneElement	A name given to the device to identify it
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
type	S	1..1	CodeableConcept	What kind of device or device system this is Binding: EER SOR Organization Identier Type Valueset (required) Fixed Value: As shown
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
coding		1..1	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..0	string	Unique id for inter-element referencing
extension		0..0	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://medcomehmi.dk/ig/dk-ehmi-eer/CodeSystem/eer-device-type
version		0..0	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: EUA
display		1..1	string	Representation defined by the system Fixed Value: End User Application
userSelected		0..0	boolean	If this coding was chosen directly by the user
text		0..0	string	Plain text representation of the concept
specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
systemType		1..1	string	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..*	string	Available versions
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
capability		0..*	BackboneElement	Device capabilities
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	Type of capability
description		0..*	CodeableConcept	Description of capability
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)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
onlineInformation		0..1	uri	Access to on-line information
note		0..*	Annotation	Device notes and comments
quantity		0..1	Quantity	The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
parentDevice	Σ	0..1	Reference(DeviceDefinition)	The parent device it can be part of
material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
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
substance		1..1	CodeableConcept	The substance
alternate		0..1	boolean	Indicates an alternative material of the device
allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
DeviceDefinition.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
DeviceDefinition.deviceName.type	required	DeviceNameType http://hl7.org/fhir/ValueSet/device-nametype|4.0.1 from the FHIR Standard
DeviceDefinition.type	required	Fixed Value: EUA("End User Application") http://medcomehmi.dk/ig/dk-ehmi-eer/ValueSet/eer-device-type-valueset from this IG
DeviceDefinition.safety	example	DeviceSafety http://hl7.org/fhir/ValueSet/device-safety from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	DeviceDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	DeviceDefinition	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	DeviceDefinition	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	DeviceDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	DeviceDefinition	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 EerEndpointDeviceDefinition

Summary

Fixed: 1 element

Other representations of profile: CSV, Excel, Schematron