Koppelmij Implementation Guide
0.1.0 - ci-build

Koppelmij Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: KT2_Device - Detailed Descriptions

Draft as of 2023-02-07

Definitions for the KT2Device resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. 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.

ShortItem used in healthcare
Control0..*
Is Modifierfalse
Summaryfalse
Invariantsdom-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())
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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.extension:resource-origin
Slice Nameresource-origin
Definition

Defines the author of the resource.

ShortExtension
Comments

Part of the authorisation model. Upon creation of the resource this extension is set to the device that created it.

Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(KT2_ResourceOrigin) (Extension Type: Reference(KT2_Device))
Is Modifierfalse
Summaryfalse
Invariantsele-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())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. 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).

ShortExtensions that cannot be ignored
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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
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
Invariantsele-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())
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Device.identifier
    Definition

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

    ShortInstance identifier
    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.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..*
    This element is affected by the following invariants: ele-1
    TypeIdentifier
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Device.identifier.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

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

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
    (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    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.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Device.identifier.system
    Definition

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

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    Control0..1
    Typeuri
    Is Modifierfalse
    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.

    Fixed Valuehttp://vzvz.nl/fhir/NamingSystem/koppeltaal-client-id
    ExampleGeneral: http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Device.status
    Definition

    Status of the Device availability.

    Shortactive | inactive | entered-in-error | unknown
    Comments

    The default value should be set to 'active'.


    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.

    Control10..1
    BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
    (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

    The availability status of the device.

    Typecode
    Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. Device.statusReason
    Definition

    Reason for the status of the Device availability.


    Reason for the dtatus of the Device availability.

    Shortonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control0..0*
    This element is affected by the following invariants: ele-1
    BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reason
    (extensible to http://hl7.org/fhir/ValueSet/device-status-reason)

    The availability status reason of the device.

    TypeCodeableConcept
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. 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.

    ShortThe name of the device as given by the manufacturer
    Control10..*
    This element is affected by the following invariants: ele-1
    TypeBackboneElement
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. 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).

    ShortExtensions that cannot be ignored even if unrecognized
    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.

    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    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
    Invariantsele-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())
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    22. Device.deviceName.name
    Definition

    The name of the device.

    ShortThe name of the device
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

    Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
    Control1..1
    BindingThe codes SHALL be taken from DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1
    (required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

    The type of name the device is referred by.

    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Fixed Valueuser-friendly-name
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Device.owner
    Definition

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

    ShortOrganization responsible for device
    Comments

    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeReference(nl core HealthcareProvider Organization, Organization)
    Is Modifierfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))

    Guidance on how to interpret the contents of this table can be foundhere

    0. Device
    2. Device.extension:resource-origin
    Slice Nameresource-origin
    Control0..*
    TypeExtension(KT2_ResourceOrigin) (Extension Type: Reference(KT2_Device))
    4. Device.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..?
    6. Device.identifier.system
    Fixed Valuehttp://vzvz.nl/fhir/NamingSystem/koppeltaal-client-id
    8. Device.status
    Comments

    The default value should be set to 'active'.

    Control1..?
    10. Device.statusReason
    Definition

    Reason for the status of the Device availability.

    Control0..0
    12. Device.deviceName
    Control1..?
    14. Device.deviceName.type
    Fixed Valueuser-friendly-name
    16. Device.owner
    TypeReference(nl core HealthcareProvider Organization)

    Guidance on how to interpret the contents of this table can be foundhere

    0. 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.

    ShortItem used in healthcare
    Control0..*
    Is Modifierfalse
    Summaryfalse
    Invariantsdom-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.id
    Definition

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

    ShortLogical id of this artifact
    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.

    Control0..1
    Typeid
    Is Modifierfalse
    Summarytrue
    4. 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.

    ShortMetadata about the resource
    Control0..1
    TypeMeta
    Is Modifierfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. 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.

    ShortA set of rules under which this content was created
    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.

    Control0..1
    Typeuri
    Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. Device.language
    Definition

    The base language in which the resource is written.

    ShortLanguage of the resource content
    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).

    Control0..1
    BindingThe codes SHOULD be taken from CommonLanguages
    (preferred to http://hl7.org/fhir/ValueSet/languages)

    A human language.

    Additional BindingsPurpose
    AllLanguagesMax Binding
    Typecode
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. 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.

    ShortText summary of the resource, for human interpretation
    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.

    Control0..1
    TypeNarrative
    Is Modifierfalse
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. 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.

    ShortContained, inline 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.

    Control0..*
    TypeResource
    Is Modifierfalse
    Summaryfalse
    Alternate Namesinline resources, anonymous resources, contained resources
    14. Device.extension
    Definition

    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.

    ShortAdditional content defined by implementations
    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.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-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 areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 16. Device.extension:resource-origin
      Slice Nameresource-origin
      Definition

      Defines the author of the resource.

      ShortExtension
      Comments

      Part of the authorisation model. Upon creation of the resource this extension is set to the device that created it.

      Control0..1
      TypeExtension(KT2_ResourceOrigin) (Extension Type: Reference(KT2_Device))
      Is Modifierfalse
      Summaryfalse
      Invariantsele-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())
      18. 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).

      ShortExtensions that cannot be ignored
      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.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      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
      Invariantsele-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.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 20. Device.identifier
        Definition

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

        ShortInstance identifier
        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.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control1..*
        This element is affected by the following invariants: ele-1
        TypeIdentifier
        Is Modifierfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. 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.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        24. 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.

        ShortAdditional content defined by implementations
        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.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-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 areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 26. Device.identifier.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary | old (If known)
          Comments

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

          Control0..1
          BindingThe codes SHALL be taken from IdentifierUse
          (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
          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.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. Device.identifier.type
          Definition

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

          ShortDescription of identifier
          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

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

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

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

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Device.identifier.system
          Definition

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

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          Control0..1
          Typeuri
          Is Modifierfalse
          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.

          Fixed Valuehttp://vzvz.nl/fhir/NamingSystem/koppeltaal-client-id
          ExampleGeneral: http://www.acme.com/identifiers/patient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Device.identifier.value
          Definition

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

          ShortThe value that is unique
          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.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          ExampleGeneral: 123456
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Device.identifier.period
          Definition

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

          ShortTime period when id is/was valid for use
          Comments

          A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").

          Period is not used for a duration (a measure of elapsed time). See Duration.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
          36. Device.identifier.assigner
          Definition

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeReference(Organization)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
          38. Device.definition
          Definition

          The reference to the definition for the device.

          ShortThe reference to the definition for the device
          Comments

          References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeReference(DeviceDefinition)
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
          40. 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.

          ShortUnique Device Identifier (UDI) Barcode string
          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.

          Control0..*
          This element is affected by the following invariants: ele-1
          TypeBackboneElement
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. 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.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          44. 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.

          ShortAdditional content defined by implementations
          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.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-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.udiCarrier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 46. 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).

            ShortExtensions that cannot be ignored even if unrecognized
            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.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            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
            Invariantsele-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())
            48. 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.

            ShortMandatory fixed portion of UDI
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Alternate NamesDI
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. 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.
            ShortUDI Issuing Organization
            Comments

            see http://en.wikipedia.org/wiki/Uniform_resource_identifier

            Control0..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Alternate NamesBarcode System
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            52. 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.

            ShortRegional UDI authority
            Comments

            see http://en.wikipedia.org/wiki/Uniform_resource_identifier

            Control0..1
            Typeuri
            Is Modifierfalse
            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.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            54. 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.

            ShortUDI Machine Readable Barcode String
            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.

            Control0..1
            This element is affected by the following invariants: ele-1
            Typebase64Binary
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Alternate NamesAutomatic Identification and Data Capture
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. 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.

            ShortUDI Human Readable Barcode String
            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.

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Alternate NamesHuman Readable Form
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. Device.udiCarrier.entryType
            Definition

            A coded entry to indicate how the data was entered.

            Shortbarcode | rfid | manual +
            Control0..1
            BindingThe codes SHALL be taken from UDIEntryType
            (required to http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1)

            Codes to identify how UDI data was entered.

            Typecode
            Is Modifierfalse
            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.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. Device.status
            Definition

            Status of the Device availability.

            Shortactive | inactive | entered-in-error | unknown
            Comments

            The default value should be set to 'active'.

            Control1..1
            BindingThe codes SHALL be taken from FHIRDeviceStatus
            (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

            The availability status of the device.

            Typecode
            Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. Device.statusReason
            Definition

            Reason for the status of the Device availability.

            Shortonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
            Comments

            Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

            Control0..0
            This element is affected by the following invariants: ele-1
            BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason
            (extensible to http://hl7.org/fhir/ValueSet/device-status-reason)

            The availability status reason of the device.

            TypeCodeableConcept
            Is Modifierfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            64. Device.distinctIdentifier
            Definition

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

            ShortThe distinct identification string
            Comments

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

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Alternate NamesDistinct Identification Code (DIC)
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. Device.manufacturer
            Definition

            A name of the manufacturer.

            ShortName of device manufacturer
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. Device.manufactureDate
            Definition

            The date and time when the device was manufactured.

            ShortDate when the device was made
            Control0..1
            TypedateTime
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. Device.expirationDate
            Definition

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

            ShortDate and time of expiry of this device (if applicable)
            Control0..1
            TypedateTime
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            72. Device.lotNumber
            Definition

            Lot number assigned by the manufacturer.

            ShortLot number of manufacture
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

            ShortSerial number assigned by the manufacturer
            Comments

            Alphanumeric Maximum 20.

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. 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.

            ShortThe name of the device as given by the manufacturer
            Control1..*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            Is Modifierfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. 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.

            ShortUnique id for inter-element referencing
            Control0..1
            Typestring
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            80. 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.

            ShortAdditional content defined by implementations
            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.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-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.deviceName.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 82. 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).

              ShortExtensions that cannot be ignored even if unrecognized
              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.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              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
              Invariantsele-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())
              84. Device.deviceName.name
              Definition

              The name of the device.

              ShortThe name of the device
              Comments

              Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

              Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
              Control1..1
              BindingThe codes SHALL be taken from DeviceNameType
              (required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

              The type of name the device is referred by.

              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Fixed Valueuser-friendly-name
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              88. Device.modelNumber
              Definition

              The model number for the device.

              ShortThe model number for the device
              Comments

              Note that FHIR strings SHALL NOT exceed 1MB in size

              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              90. Device.partNumber
              Definition

              The part number of the device.

              ShortThe part number of the device
              Comments

              Alphanumeric Maximum 20.

              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-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.

              ShortThe kind or type of device
              Comments

              Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

              Control0..1
              This element is affected by the following invariants: ele-1
              BindingFor example codes, see DeviceType
              (example to http://hl7.org/fhir/ValueSet/device-type)

              Codes to identify medical devices.

              TypeCodeableConcept
              Is Modifierfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              94. 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.

              ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
              Control0..*
              This element is affected by the following invariants: ele-1
              TypeBackboneElement
              Is Modifierfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              96. 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.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              98. 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.

              ShortAdditional content defined by implementations
              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.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-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.specialization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 100. 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).

                ShortExtensions that cannot be ignored even if unrecognized
                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.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                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
                Invariantsele-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())
                102. Device.specialization.systemType
                Definition

                The standard that is used to operate and communicate.

                ShortThe standard that is used to operate and communicate
                Comments

                Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                Control1..1
                This element is affected by the following invariants: ele-1
                TypeCodeableConcept
                Is Modifierfalse
                Alternate NamesΣ
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                104. Device.specialization.version
                Definition

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

                ShortThe version of the standard that is used to operate and communicate
                Comments

                Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

                ShortThe actual design of the device or software version running on the device
                NoteThis is a business version Id, not a resource version Id (see discussion)
                Control0..*
                This element is affected by the following invariants: ele-1
                TypeBackboneElement
                Is Modifierfalse
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                108. 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.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                110. 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.

                ShortAdditional content defined by implementations
                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.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-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.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 112. 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).

                  ShortExtensions that cannot be ignored even if unrecognized
                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  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
                  Invariantsele-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.

                  ShortThe type of the device version
                  Comments

                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeCodeableConcept
                  Is Modifierfalse
                  Alternate NamesΣ
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  116. Device.version.component
                  Definition

                  A single component of the device version.

                  ShortA single component of the device version
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeIdentifier
                  Is Modifierfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  118. Device.version.value
                  Definition

                  The version text.

                  ShortThe version text
                  Comments

                  Note that FHIR strings SHALL NOT exceed 1MB in size

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

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

                  ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeBackboneElement
                  Is Modifierfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  122. 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.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  124. 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.

                  ShortAdditional content defined by implementations
                  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.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-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.property.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 126. 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).

                    ShortExtensions that cannot be ignored even if unrecognized
                    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.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    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
                    Invariantsele-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())
                    128. Device.property.type
                    Definition

                    Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

                    ShortCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    130. Device.property.valueQuantity
                    Definition

                    Property value as a quantity.

                    ShortProperty value as a quantity
                    Comments

                    The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeQuantity
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                    132. Device.property.valueCode
                    Definition

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

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

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    134. Device.patient
                    Definition

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

                    ShortPatient to whom Device is affixed
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Patient)
                    Is Modifierfalse
                    Requirements

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

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    136. Device.owner
                    Definition

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

                    ShortOrganization responsible for device
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(nl core HealthcareProvider Organization)
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    138. Device.contact
                    Definition

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

                    ShortDetails for human/organization for support
                    Comments

                    used for troubleshooting etc.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeContactPoint
                    Is Modifierfalse
                    Invariantscpt-2: A system is required if a value is provided. (value.empty() or system.exists())
                    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    140. Device.location
                    Definition

                    The place where the device can be found.

                    ShortWhere the device is found
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Location)
                    Is Modifierfalse
                    Requirements

                    Device.location can be used to track device location.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    142. Device.url
                    Definition

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

                    ShortNetwork address to contact device
                    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.

                    Control0..1
                    Typeuri
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summaryfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    144. Device.note
                    Definition

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

                    ShortDevice notes and comments
                    Comments

                    For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeAnnotation
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    146. Device.safety
                    Definition

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

                    ShortSafety Characteristics of Device
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    148. Device.parent
                    Definition

                    The parent device.

                    ShortThe parent device
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Device)
                    Is Modifierfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))