Point-of-Care Device Implementation Guide
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Point-of-Care Device Implementation Guide, published by HL7 International - Devices Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/uv-pocd/ and changes regularly. See the Directory of published versions

Resource Profile: VmdDevice - Detailed Descriptions

Draft as of 2022-01-16

Definitions for the VmdDevice resource profile.

Guidance on how to interpret the contents of this table can be found here.

1. Device
2. Device.extension
SlicingThis element introduces a set of slices on Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
3. Device.extension:instance
SliceNameinstance
Definition

Instance number or label for multiple components of the same type.

Control0..1
TypeExtension(DeviceInstance) (Complex Extension)
Must Supporttrue
4. Device.extension:instance.extension:number
SliceNamenumber
Control0..?
5. Device.extension:instance.extension:number.valueUnsignedInt
Control0..?
6. Device.extension:instance.extension:label
SliceNamelabel
Control0..?
7. Device.extension:instance.extension:label.valueString
Control0..?
8. Device.extension:approvedJurisdictions
SliceNameapprovedJurisdictions
Definition

List of regions in which a device is approved to be operated.

Control0..?
TypeExtension(ApprovedJurisdictions) (Extension Type: CodeableConcept)
Must Supporttrue
9. Device.extension:approvedJurisdictions.valueCodeableConcept
Control0..?
10. Device.extension:approvedJurisdictions.valueCodeableConcept.coding
Control0..?
11. Device.extension:approvedJurisdictions.valueCodeableConcept.coding.system
Control0..?
12. Device.extension:approvedJurisdictions.valueCodeableConcept.coding.code
Control0..?
13. Device.extension:operatingHours
SliceNameoperatingHours
Definition

Optional amount of operating hours (e.g., an OR light).

Control0..1
TypeExtension(OperatingHours) (Extension Type: unsignedInt)
Must Supporttrue
14. Device.extension:operatingHours.valueUnsignedInt
Control0..?
15. Device.extension:operatingCycles
SliceNameoperatingCycles
Definition

Optional amount of operating cycles, e.g., the number of measurements taken within the component.

Control0..1
TypeExtension(OperatingCycles) (Extension Type: unsignedInt)
Must Supporttrue
16. Device.extension:operatingCycles.valueUnsignedInt
Control0..?
17. Device.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Must Supporttrue
18. Device.identifier.system
Control0..?
19. Device.identifier.value
Control0..?
20. Device.udiCarrier
Must Supporttrue
21. Device.udiCarrier.deviceIdentifier
22. Device.udiCarrier.issuer
23. Device.udiCarrier.jurisdiction
24. Device.udiCarrier.carrierHRF
25. Device.status
Must Supporttrue
26. Device.statusReason
Must Supporttrue
27. Device.manufacturer
Must Supporttrue
28. Device.manufactureDate
29. Device.expirationDate
30. Device.lotNumber
31. Device.serialNumber
Must Supporttrue
32. Device.deviceName
Must Supporttrue
33. Device.modelNumber
Must Supporttrue
34. Device.partNumber
Must Supporttrue
35. Device.type
Control10..1
BindingThe codes SHALL be taken from MDC Object infrastructure and Device nomenclature; other codes may be used where these codes are not suitableFor example codes, see DeviceType
Must Supporttrue
36. Device.type.coding
Control0..?
37. Device.type.coding.system
Control0..?
38. Device.type.coding.version
NoteThis is a business versionId, not a resource version id (see discussion)
Control0..?
39. Device.type.coding.code
Control0..?
40. Device.type.text
Control0..?
41. Device.version
NoteThis is a business versionId, not a resource version id (see discussion)
Must Supporttrue
42. Device.version.type
43. Device.version.type.coding
Control0..?
44. Device.version.type.coding.system
Control0..?
45. Device.version.type.coding.version
NoteThis is a business versionId, not a resource version id (see discussion)
Control0..?
46. Device.version.type.coding.code
Control0..?
47. Device.version.component
48. Device.version.value
49. Device.patient
Control0..01
50. Device.location
Control0..01
51. Device.safety
Must Supporttrue
52. Device.safety.coding
Control0..?
53. Device.safety.coding.system
Definition

http://hl7.org/fhir/uv/pocd/ValueSet/safety

Control0..?
54. Device.safety.coding.code
Control0..?
BindingThe codes SHALL be taken from Safety Safety classificatio
55. Device.parent
Control10..1
TypeReference(MdsDevice|Device)
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here.

1. Device
Definition

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

Control0..*
Summaryfalse
InvariantsDefined on this element
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
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 (: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (: text.`div`.exists())
2. Device.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. Device.extension
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
4. Device.extension:instance
SliceNameinstance
Definition

Instance number or label for multiple components of the same type.

May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..1* This element is affected by the following invariants: ele-1
TypeExtension(DeviceInstance) (Complex Extension)
Must Supporttrue
InvariantsDefined on this element
ele-1: (: )
ext-1: (: )
5. Device.extension:instance.extension:number
SliceNamenumber
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..1*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
6. Device.extension:instance.extension:number.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuenumber
7. Device.extension:instance.extension:number.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
8. Device.extension:instance.extension:number.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
9. Device.extension:instance.extension:label
SliceNamelabel
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..1*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. Device.extension:instance.extension:label.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuelabel
11. Device.extension:instance.extension:label.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
12. Device.extension:instance.extension:label.value[x]:valueString
SliceNamevalueString
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: string, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. Device.extension:instance.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/device-instance
14. Device.extension:instance.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control0..01
TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. Device.extension:approvedJurisdictions
SliceNameapprovedJurisdictions
Definition

List of regions in which a device is approved to be operated.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension(ApprovedJurisdictions) (Extension Type: CodeableConcept)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
16. Device.extension:approvedJurisdictions.extension
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
17. Device.extension:approvedJurisdictions.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
18. Device.extension:approvedJurisdictions.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
19. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept
SliceNamevalueCodeableConcept
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
BindingThe codes SHALL be taken from Jurisdiction ValueSet; other codes may be used where these codes are not suitableFor codes, see (unbound) Codes for country, country subdivision and regio
TypeChoice of: CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. Device.extension:operatingHours
SliceNameoperatingHours
Definition

Optional amount of operating hours (e.g., an OR light).

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(OperatingHours) (Extension Type: unsignedInt)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
21. Device.extension:operatingHours.extension
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
22. Device.extension:operatingHours.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours
23. Device.extension:operatingHours.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
24. Device.extension:operatingHours.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. Device.extension:operatingCycles
SliceNameoperatingCycles
Definition

Optional amount of operating cycles, e.g., the number of measurements taken within the component.

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(OperatingCycles) (Extension Type: unsignedInt)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
26. Device.extension:operatingCycles.extension
Definition

An Extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..0*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
27. Device.extension:operatingCycles.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
28. Device.extension:operatingCycles.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
29. Device.extension:operatingCycles.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control10..1
TypeChoice of: unsignedInt, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
30. Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
31. Device.identifier
Definition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Must Supporttrue
Summaryfalse
Comments

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. Device.identifier.use
Definition

The purpose of this identifier.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse

Identifies the purpose for this identifier, if known .

Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. Device.identifier.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. Device.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. Device.udiCarrier
Definition

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Control0..*
TypeBackboneElement
Must Supporttrue
Summarytrue
Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
36. Device.udiCarrier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
37. Device.udiCarrier.deviceIdentifier
Definition

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate NamesDI
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. Device.udiCarrier.issuer
Definition

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Alternate NamesBarcode System
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. Device.udiCarrier.jurisdiction
Definition

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. Device.udiCarrier.carrierHRF
Definition

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate NamesHuman Readable Form
Comments

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. Device.status
Definition

Status of the Device availability.

Control0..1
BindingThe codes SHALL be taken from FHIRDeviceStatus

The availability status of the device.

Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Comments

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. Device.statusReason
Definition

Reason for the dtatus of the Device availability.

Control0..*
BindingThe codes SHALL be taken from FHIRDeviceStatusReason; other codes may be used where these codes are not suitable

The availability status reason of the device.

TypeCodeableConcept
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. Device.manufacturer
Definition

A name of the manufacturer.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
44. Device.manufactureDate
Definition

The date and time when the device was manufactured.

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. Device.expirationDate
Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
47. Device.serialNumber
Definition

The serial number assigned by the organization when the device was manufactured.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Comments

Alphanumeric Maximum 20.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. Device.deviceName
Definition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

Control0..*
TypeBackboneElement
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. Device.deviceName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
50. Device.deviceName.name
Definition

The name of the device.

Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Alternate NamesΣ
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. Device.deviceName.type
Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Control1..1
BindingThe codes SHALL be taken from DeviceNameType

The type of name the device is referred by.

Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. Device.modelNumber
Definition

The model number for the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
53. Device.partNumber
Definition

The part number of the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Comments

Alphanumeric Maximum 20.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
54. Device.type
Definition

The kind or type of device.

Control10..1
BindingThe codes SHALL be taken from MDC Object infrastructure and Device nomenclature; other codes may be used where these codes are not suitableFor example codes, see DeviceType
TypeCodeableConcept
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
55. Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
56. Device.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. Device.type.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
58. Device.type.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
59. Device.type.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
60. Device.version
Definition

The actual design of the device or software version running on the device.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..*
TypeBackboneElement
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. Device.version.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
62. Device.version.type
Definition

The type of the device version.

Control0..1
TypeCodeableConcept
Summaryfalse
Alternate NamesΣ
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
63. Device.version.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
64. Device.version.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
65. Device.version.type.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
66. Device.version.type.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
67. Device.version.component
Definition

A single component of the device version.

Control0..1
TypeIdentifier
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
68. Device.version.value
Definition

The version text.

Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
69. Device.patient
Definition

Patient information, If the device is affixed to a person.

Control0..01
TypeReference(Patient)
Summaryfalse
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
70. Device.location
Definition

The place where the device can be found.

Control0..01
TypeReference(Location)
Summaryfalse
Requirements

Device.location can be used to track device location.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
71. Device.safety
Definition

Provides additional safety characteristics about a medical device. For example devices containing latex.

Control0..*
TypeCodeableConcept
Must Supporttrue
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
72. Device.safety.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
73. Device.safety.coding.system
Definition

http://hl7.org/fhir/uv/pocd/ValueSet/safety

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
74. Device.safety.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
BindingThe codes SHALL be taken from SafetyFor codes, see (unbound) Safety classificatio
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
75. Device.parent
Definition

The parent device.

Control10..1
TypeReference(MdsDevice|Device)
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here.

1. Device
Definition

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

Control0..*
Summaryfalse
2. Device.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Summarytrue
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

3. Device.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Control0..1
TypeMeta
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. Device.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. Device.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages A human language
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. Device.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Control0..1
TypeNarrative
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. Device.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

8. Device.extension
Definition

An Extension

Control0..*
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
9. Device.extension:instance
SliceNameinstance
Definition

Instance number or label for multiple components of the same type.

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(DeviceInstance) (Complex Extension)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
10. Device.extension:instance.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
11. Device.extension:instance.extension
Definition

An Extension

Control0..*
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
12. Device.extension:instance.extension:number
SliceNamenumber
Definition

An Extension

Control0..1
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
13. Device.extension:instance.extension:number.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
14. Device.extension:instance.extension:number.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
15. Device.extension:instance.extension:number.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuenumber
16. Device.extension:instance.extension:number.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
17. Device.extension:instance.extension:number.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. Device.extension:instance.extension:label
SliceNamelabel
Definition

An Extension

Control0..1
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
19. Device.extension:instance.extension:label.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
20. Device.extension:instance.extension:label.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
21. Device.extension:instance.extension:label.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuelabel
22. Device.extension:instance.extension:label.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
Typestring
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
23. Device.extension:instance.extension:label.value[x]:valueString
SliceNamevalueString
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
Typestring
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. Device.extension:instance.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/device-instance
25. Device.extension:instance.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control0..0
TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. Device.extension:approvedJurisdictions
SliceNameapprovedJurisdictions
Definition

List of regions in which a device is approved to be operated.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension(ApprovedJurisdictions) (Extension Type: CodeableConcept)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
27. Device.extension:approvedJurisdictions.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
28. Device.extension:approvedJurisdictions.extension
Definition

An Extension

Control0..0
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
29. Device.extension:approvedJurisdictions.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
30. Device.extension:approvedJurisdictions.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
31. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept
SliceNamevalueCodeableConcept
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
BindingThe codes SHALL be taken from Jurisdiction ValueSet; other codes may be used where these codes are not suitable Codes for country, country subdivision and regio
TypeCodeableConcept
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
33. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.value[x].extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
34. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
35. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
36. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.value[x].coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
37. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
38. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
42. Device.extension:approvedJurisdictions.value[x]:valueCodeableConcept.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
43. Device.extension:operatingHours
SliceNameoperatingHours
Definition

Optional amount of operating hours (e.g., an OR light).

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(OperatingHours) (Extension Type: unsignedInt)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
44. Device.extension:operatingHours.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
45. Device.extension:operatingHours.extension
Definition

An Extension

Control0..0
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
46. Device.extension:operatingHours.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours
47. Device.extension:operatingHours.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
48. Device.extension:operatingHours.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. Device.extension:operatingCycles
SliceNameoperatingCycles
Definition

Optional amount of operating cycles, e.g., the number of measurements taken within the component.

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(OperatingCycles) (Extension Type: unsignedInt)
Must Supporttrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
50. Device.extension:operatingCycles.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
51. Device.extension:operatingCycles.extension
Definition

An Extension

Control0..0
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
52. Device.extension:operatingCycles.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Control1..1
Typeuri
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Fixed Valuehttp://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
53. Device.extension:operatingCycles.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Device.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
54. Device.extension:operatingCycles.value[x]:valueUnsignedInt
SliceNamevalueUnsignedInt
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Control1..1
TypeunsignedInt
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
55. Device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
56. Device.identifier
Definition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Must Supporttrue
Summaryfalse
Comments

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. Device.identifier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
58. Device.identifier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
59. Device.identifier.use
Definition

The purpose of this identifier.

Control0..1
BindingThe codes SHALL be taken from IdentifierUse Identifies the purpose for this identifier, if known
Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
60. Device.identifier.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Control0..1
BindingThe codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable A coded type for an identifier that can be used to determine which identifier to use for a specific purpose
TypeCodeableConcept
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
61. Device.identifier.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

Identifier.system is always case sensitive.

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
62. Device.identifier.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
63. Device.identifier.period
Definition

Time period during which identifier is/was valid for use.

Control0..1
TypePeriod
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
64. Device.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..1
TypeReference(Organization)
Summarytrue
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
65. Device.definition
Definition

The reference to the definition for the device.

Control0..1
TypeReference(DeviceDefinition)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
66. Device.udiCarrier
Definition

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Control0..*
TypeBackboneElement
Must Supporttrue
Summarytrue
Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
67. Device.udiCarrier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
68. Device.udiCarrier.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
69. Device.udiCarrier.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
70. Device.udiCarrier.deviceIdentifier
Definition

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate NamesDI
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
71. Device.udiCarrier.issuer
Definition

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Alternate NamesBarcode System
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
72. Device.udiCarrier.jurisdiction
Definition

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
73. Device.udiCarrier.carrierAIDC
Definition

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

Control0..1
Typebase64Binary
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate NamesAutomatic Identification and Data Capture
Comments

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
74. Device.udiCarrier.carrierHRF
Definition

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Alternate NamesHuman Readable Form
Comments

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
75. Device.udiCarrier.entryType
Definition

A coded entry to indicate how the data was entered.

Control0..1
BindingThe codes SHALL be taken from UDIEntryType Codes to identify how UDI data was entered
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Requirements

Supports a way to distinguish hand entered from machine read data.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
76. Device.status
Definition

Status of the Device availability.

Control0..1
BindingThe codes SHALL be taken from FHIRDeviceStatus The availability status of the device
Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Comments

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
77. Device.statusReason
Definition

Reason for the dtatus of the Device availability.

Control0..*
BindingThe codes SHALL be taken from FHIRDeviceStatusReason; other codes may be used where these codes are not suitable The availability status reason of the device
TypeCodeableConcept
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
78. Device.distinctIdentifier
Definition

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Alternate NamesDistinct Identification Code (DIC)
Comments

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
79. Device.manufacturer
Definition

A name of the manufacturer.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
80. Device.manufactureDate
Definition

The date and time when the device was manufactured.

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
81. Device.expirationDate
Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
82. Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
83. Device.serialNumber
Definition

The serial number assigned by the organization when the device was manufactured.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Comments

Alphanumeric Maximum 20.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
84. Device.deviceName
Definition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

Control0..*
TypeBackboneElement
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
85. Device.deviceName.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
86. Device.deviceName.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
87. Device.deviceName.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
88. Device.deviceName.name
Definition

The name of the device.

Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Alternate NamesΣ
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
89. Device.deviceName.type
Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Control1..1
BindingThe codes SHALL be taken from DeviceNameType The type of name the device is referred by
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
90. Device.modelNumber
Definition

The model number for the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
91. Device.partNumber
Definition

The part number of the device.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Comments

Alphanumeric Maximum 20.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
92. Device.type
Definition

The kind or type of device.

Control1..1
BindingThe codes SHALL be taken from MDC Object infrastructure and Device nomenclature; other codes may be used where these codes are not suitable
TypeCodeableConcept
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
93. Device.type.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
94. Device.type.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
95. Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
96. Device.type.coding.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
97. Device.type.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.type.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
98. Device.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
99. Device.type.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
100. Device.type.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
101. Device.type.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
102. Device.type.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
103. Device.type.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
104. Device.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Control0..*
TypeBackboneElement
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
105. Device.specialization.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
106. Device.specialization.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
107. Device.specialization.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
108. Device.specialization.systemType
Definition

The standard that is used to operate and communicate.

Control1..1
TypeCodeableConcept
Summaryfalse
Alternate NamesΣ
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
109. Device.specialization.version
Definition

The version of the standard that is used to operate and communicate.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
110. Device.version
Definition

The actual design of the device or software version running on the device.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..*
TypeBackboneElement
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
111. Device.version.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
112. Device.version.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
113. Device.version.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
114. Device.version.type
Definition

The type of the device version.

Control0..1
TypeCodeableConcept
Summaryfalse
Alternate NamesΣ
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
115. Device.version.type.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
116. Device.version.type.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.version.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
117. Device.version.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
118. Device.version.type.coding.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
119. Device.version.type.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.version.type.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
120. Device.version.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
121. Device.version.type.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
122. Device.version.type.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
123. Device.version.type.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
124. Device.version.type.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
125. Device.version.type.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
126. Device.version.component
Definition

A single component of the device version.

Control0..1
TypeIdentifier
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
127. Device.version.value
Definition

The version text.

Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
128. Device.property
Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Control0..*
TypeBackboneElement
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
129. Device.property.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
130. Device.property.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
131. Device.property.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
132. Device.property.type
Definition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Control1..1
TypeCodeableConcept
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
133. Device.property.valueQuantity
Definition

Property value as a quantity.

Control0..*
TypeQuantity
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
134. Device.property.valueCode
Definition

Property value as a code, e.g., NTP4 (synced to NTP).

Control0..*
TypeCodeableConcept
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
135. Device.patient
Definition

Patient information, If the device is affixed to a person.

Control0..0
TypeReference(Patient)
Summaryfalse
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
136. Device.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Control0..1
TypeReference(Organization)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
137. Device.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Control0..*
TypeContactPoint
Summaryfalse
Comments

used for troubleshooting etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
138. Device.location
Definition

The place where the device can be found.

Control0..0
TypeReference(Location)
Summaryfalse
Requirements

Device.location can be used to track device location.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
139. Device.url
Definition

A network address on which the device may be contacted directly.

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
140. Device.note
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Control0..*
TypeAnnotation
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
141. Device.safety
Definition

Provides additional safety characteristics about a medical device. For example devices containing latex.

Control0..*
TypeCodeableConcept
Must Supporttrue
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
142. Device.safety.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
143. Device.safety.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.safety.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
144. Device.safety.coding
Definition

A reference to a code defined by a terminology system.

Control0..*
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
145. Device.safety.coding.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
146. Device.safety.coding.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.safety.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
147. Device.safety.coding.system
Definition

http://hl7.org/fhir/uv/pocd/ValueSet/safety

Control0..1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
148. Device.safety.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
149. Device.safety.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control0..1
BindingThe codes SHALL be taken from Safety Safety classificatio
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
150. Device.safety.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
151. Device.safety.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Control0..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
152. Device.safety.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
153. Device.parent
Definition

The parent device.

Control1..1
TypeReference(MdsDevice)
Must Supporttrue
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))