Data Model Libraries
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    Class DeviceDefinition

    DeviceDefinition Class

    This is a specialized resource that defines the characteristics and capabilities of a device.

    FHIR Specification

    • Short: An instance of a medical-related component of a medical device
    • Definition: The characteristics, operational status and capabilities of a medical-related component of a medical device.
    • Comment: For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
    • FHIR Version: 5.0.0

    FHIR DeviceDefinition

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    constructor

    Properties

    description? identifier? udiDeviceIdentifier? regulatoryIdentifier? partNumber? manufacturer? deviceName? modelNumber? classification? conformsTo? hasPart? packaging? version? safety? shelfLifeStorage? languageCode? property? owner? contact? link? note? material? deviceProductidentifierinudiEnum productionIdentifierInUDI? guideline? correctiveAction? chargeItem?

    Methods

    parse getDescriptionElement setDescriptionElement hasDescriptionElement getDescription setDescription hasDescription getIdentifier setIdentifier addIdentifier hasIdentifier getUdiDeviceIdentifier setUdiDeviceIdentifier addUdiDeviceIdentifier hasUdiDeviceIdentifier getRegulatoryIdentifier setRegulatoryIdentifier addRegulatoryIdentifier hasRegulatoryIdentifier getPartNumberElement setPartNumberElement hasPartNumberElement getPartNumber setPartNumber hasPartNumber getManufacturer setManufacturer hasManufacturer getDeviceName setDeviceName addDeviceName hasDeviceName getModelNumberElement setModelNumberElement hasModelNumberElement getModelNumber setModelNumber hasModelNumber getClassification setClassification addClassification hasClassification getConformsTo setConformsTo addConformsTo hasConformsTo getHasPart setHasPart addHasPart hasHasPart getPackaging setPackaging addPackaging hasPackaging getVersion setVersion addVersion hasVersion getSafety setSafety addSafety hasSafety getShelfLifeStorage setShelfLifeStorage addShelfLifeStorage hasShelfLifeStorage getLanguageCode setLanguageCode addLanguageCode hasLanguageCode getProperty setProperty addProperty hasProperty getOwner setOwner hasOwner getContact setContact addContact hasContact getLink setLink addLink hasLink getNote setNote addNote hasNote getMaterial setMaterial addMaterial hasMaterial getProductionIdentifierInUDIEnumType setProductionIdentifierInUDIEnumType addProductionIdentifierInUDIEnumType hasProductionIdentifierInUDIEnumType getProductionIdentifierInUDIElement setProductionIdentifierInUDIElement addProductionIdentifierInUDIElement hasProductionIdentifierInUDIElement getProductionIdentifierInUDI setProductionIdentifierInUDI addProductionIdentifierInUDI hasProductionIdentifierInUDI getGuideline setGuideline hasGuideline getCorrectiveAction setCorrectiveAction hasCorrectiveAction getChargeItem setChargeItem addChargeItem hasChargeItem fhirType isEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isRequiredFieldsEmpty isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initUdiDeviceIdentifier initRegulatoryIdentifier initDeviceName initClassification initConformsTo initHasPart initPackaging initVersion initSafety initShelfLifeStorage initLanguageCode initProperty initContact initLink initNote initMaterial initProductionIdentifierInUDI initChargeItem

    Constructors

    Properties

    description?: MarkdownType

    DeviceDefinition.description Element

    FHIR Specification

    • Short: Additional information to describe the device
    • Definition: Additional information to describe the device.
    • FHIR Type: markdown
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    identifier?: Identifier[]

    DeviceDefinition.identifier Element

    FHIR Specification

    • Short: Instance identifier
    • Definition: Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    udiDeviceIdentifier?: DeviceDefinitionUdiDeviceIdentifierComponent[]

    DeviceDefinition.udiDeviceIdentifier Element

    FHIR Specification

    • Short: Unique Device Identifier (UDI) Barcode string
    • 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.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    regulatoryIdentifier?: DeviceDefinitionRegulatoryIdentifierComponent[]

    DeviceDefinition.regulatoryIdentifier Element

    FHIR Specification

    • Short: Regulatory identifier(s) associated with this device
    • Definition: Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.
    • Comment: This should not be used for regulatory authorization numbers which are to be captured elsewhere.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    partNumber?: StringType

    DeviceDefinition.partNumber Element

    FHIR Specification

    • Short: The part number or catalog number of the device
    • Definition: The part number or catalog number of the device.
    • Comment: Alphanumeric Maximum 20.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    manufacturer?: Reference

    DeviceDefinition.manufacturer Element

    FHIR Specification

    • Short: Name of device manufacturer
    • Definition: A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    deviceName?: DeviceDefinitionDeviceNameComponent[]

    DeviceDefinition.deviceName Element

    FHIR Specification

    • Short: The name or names of the device as given by the manufacturer
    • Definition: The name or names of the device as given by the manufacturer.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    modelNumber?: StringType

    DeviceDefinition.modelNumber Element

    FHIR Specification

    • Short: The catalog or model number for the device for example as defined by the manufacturer
    • Definition: The model number for the device for example as defined by the manufacturer or labeler, or other agency.
    • FHIR Type: string
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    classification?: DeviceDefinitionClassificationComponent[]

    DeviceDefinition.classification Element

    FHIR Specification

    • Short: What kind of device or device system this is
    • Definition: What kind of device or device system this is.
    • Comment: In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    conformsTo?: DeviceDefinitionConformsToComponent[]

    DeviceDefinition.conformsTo Element

    FHIR Specification

    • Short: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    • Definition: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    hasPart?: DeviceDefinitionHasPartComponent[]

    DeviceDefinition.hasPart Element

    FHIR Specification

    • Short: A device, part of the current one
    • Definition: A device that is part (for example a component) of the present device.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    packaging?: DeviceDefinitionPackagingComponent[]

    DeviceDefinition.packaging Element

    FHIR Specification

    • Short: Information about the packaging of the device, i.e. how the device is packaged
    • Definition: Information about the packaging of the device, i.e. how the device is packaged.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    version?: DeviceDefinitionVersionComponent[]

    DeviceDefinition.version Element

    FHIR Specification

    • Short: The version of the device or software
    • Definition: The version of the device or software.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    safety?: CodeableConcept[]

    DeviceDefinition.safety Element

    FHIR Specification

    • Short: Safety characteristics of the device
    • Definition: Safety characteristics of the device.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    shelfLifeStorage?: ProductShelfLife[]

    DeviceDefinition.shelfLifeStorage Element

    FHIR Specification

    • Short: Shelf Life and storage information
    • Definition: Shelf Life and storage information.
    • FHIR Type: ProductShelfLife
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    languageCode?: CodeableConcept[]

    DeviceDefinition.languageCode Element

    FHIR Specification

    • Short: Language code for the human-readable text strings produced by the device (all supported)
    • Definition: Language code for the human-readable text strings produced by the device (all supported).
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    property?: DeviceDefinitionPropertyComponent[]

    DeviceDefinition.property Element

    FHIR Specification

    • Short: Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    • Definition: Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.
    • Comment: Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    owner?: Reference

    DeviceDefinition.owner Element

    FHIR Specification

    • Short: Organization responsible for device
    • Definition: An organization that is responsible for the provision and ongoing maintenance of the device.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    contact?: ContactPoint[]

    DeviceDefinition.contact Element

    FHIR Specification

    • Short: Details for human/organization for support
    • Definition: Contact details for an organization or a particular human that is responsible for the device.
    • Comment: used for troubleshooting etc.
    • FHIR Type: ContactPoint
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    link?: DeviceDefinitionLinkComponent[]

    DeviceDefinition.link Element

    FHIR Specification

    • Short: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    • Definition: An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    note?: Annotation[]

    DeviceDefinition.note Element

    FHIR Specification

    • Short: Device notes and comments
    • Definition: Descriptive information, usage information or implantation information that is not captured in an existing element.
    • FHIR Type: Annotation
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    material?: DeviceDefinitionMaterialComponent[]

    DeviceDefinition.material Element

    FHIR Specification

    • Short: A substance used to create the material(s) of which the device is made
    • Definition: A substance used to create the material(s) of which the device is made.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false
    deviceProductidentifierinudiEnum: DeviceProductidentifierinudiEnum

    FHIR CodeSystem: DeviceProductidentifierinudi

    DeviceProductidentifierinudiEnum

    productionIdentifierInUDI?: EnumCodeType[]

    DeviceDefinition.productionIdentifierInUDI Element

    FHIR Specification

    • Short: lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
    • Definition: Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.
    • FHIR Type: code
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    CodeSystem Enumeration: DeviceProductidentifierinudiEnum

    guideline?: DeviceDefinitionGuidelineComponent

    DeviceDefinition.guideline Element

    FHIR Specification

    • Short: Information aimed at providing directions for the usage of this model of device
    • Definition: Information aimed at providing directions for the usage of this model of device.
    • Comment: For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.
    • FHIR Type: BackboneElement
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    correctiveAction?: DeviceDefinitionCorrectiveActionComponent

    DeviceDefinition.correctiveAction Element

    FHIR Specification

    • Short: Tracking of latest field safety corrective action
    • Definition: Tracking of latest field safety corrective action.
    • FHIR Type: BackboneElement
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    chargeItem?: DeviceDefinitionChargeItemComponent[]

    DeviceDefinition.chargeItem Element

    FHIR Specification

    • Short: Billing code or reference associated with the device
    • Definition: Billing code or reference associated with the device.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: false

    Methods

    • Parse the provided DeviceDefinition JSON to instantiate the DeviceDefinition data model.

      Parameters

      • sourceJson: Value

        JSON representing FHIR DeviceDefinition

      • OptionaloptSourceField: string

        Optional data source field (e.g. <complexTypeName>.<complexTypeFieldName>); defaults to DeviceDefinition

      Returns undefined | DeviceDefinition

      DeviceDefinition data model or undefined for DeviceDefinition

      JsonError if the provided JSON is not a valid JSON object

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if and only if the data model has required fields (min cardinality > 0) and at least one of those required fields in the instance is empty; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise

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