{
  "resourceType": "StructureDefinition",
  "id": "Device",
  "meta": {
    "lastUpdated": "2021-01-01T21:58:31.578+00:00"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
      "valueString": "Base.Entities"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 2
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
      "valueCode": "business"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "oo"
    },
    {
      "url": "http://hl7.org/fhir/build/StructureDefinition/entered-in-error-status",
      "valueCode": ".status = entered-in-error"
    },
    {
      "url": "http://hl7.org/fhir/build/StructureDefinition/proposed-order"
    }
  ],
  "url": "http://hl7.org/fhir/StructureDefinition/Device",
  "version": "4.6.0",
  "name": "Device",
  "status": "draft",
  "date": "2021-01-01T21:58:31+00:00",
  "publisher": "Health Level Seven International (Orders and Observations)",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org/fhir"
        }
      ]
    },
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/orders/index.cfm"
        }
      ]
    }
  ],
  "description": "This resource describes the properties (regulated, has real time clock, etc.), adminstrative (manufacturer name, model number, serial number, firmware, etc), and type (knee replacement, blood pressure cuff, MRI, etc.) of a physical unit (these values do not change much within a given module, for example the serail number, manufacturer name, and model number). An actual unit may consist of several modules in a distinct hierarchy and these are represented by multiple Device resources and bound through the 'parent' element.",
  "purpose": "Allows institutions to track their devices.",
  "fhirVersion": "4.6.0",
  "mapping": [
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    },
    {
      "identity": "interface",
      "uri": "http://hl7.org/fhir/interface",
      "name": "Interface Pattern"
    },
    {
      "identity": "w5",
      "uri": "http://hl7.org/fhir/fivews",
      "name": "FiveWs Pattern Mapping"
    },
    {
      "identity": "udi",
      "uri": "http://fda.gov/UDI",
      "name": "UDI Mapping"
    }
  ],
  "kind": "resource",
  "abstract": false,
  "type": "Device",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/DomainResource",
  "derivation": "specialization",
  "differential": {
    "element": [
      {
        "id": "Device",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "6209."
          },
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "0,0"
          }
        ],
        "path": "Device",
        "short": "Item used in healthcare",
        "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.",
        "min": 0,
        "max": "*",
        "mapping": [
          {
            "identity": "rim",
            "map": "Device"
          },
          {
            "identity": "interface",
            "map": "Participant"
          },
          {
            "identity": "w5",
            "map": "administrative.device"
          }
        ]
      },
      {
        "id": "Device.identifier",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "7662."
          }
        ],
        "path": "Device.identifier",
        "short": "Instance identifier",
        "definition": "Unique instance identifiers assigned to a device by manufacturers other organizations or owners.",
        "comment": "Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. 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. The identifier is typically valued if the serialNumber or lotNumber 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.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.identifier"
          },
          {
            "identity": "rim",
            "map": ".id"
          },
          {
            "identity": "interface",
            "map": "Participant.identifier"
          },
          {
            "identity": "udi",
            "map": "The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI.   The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."
          }
        ]
      },
      {
        "id": "Device.displayName",
        "path": "Device.displayName",
        "short": "The name used to display by default when the device is referenced",
        "definition": "The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.deviceName, or may be another simple name.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ]
      },
      {
        "id": "Device.definition",
        "path": "Device.definition",
        "short": "The reference to the definition for the device",
        "definition": "The reference to the definition for the device.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableReference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/DeviceDefinition"
            ]
          }
        ]
      },
      {
        "id": "Device.udiCarrier",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "600,0"
          }
        ],
        "path": "Device.udiCarrier",
        "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.",
        "comment": "UDI may identify an unique instance of a device, or it may only identify the type of the device.  See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.identifier"
          },
          {
            "identity": "rim",
            "map": ".id and .code"
          }
        ]
      },
      {
        "id": "Device.udiCarrier.deviceIdentifier",
        "path": "Device.udiCarrier.deviceIdentifier",
        "short": "Mandatory fixed portion of UDI",
        "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.",
        "alias": [
          "DI"
        ],
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": "Role.id.extension"
          },
          {
            "identity": "udi",
            "map": "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
          }
        ]
      },
      {
        "id": "Device.udiCarrier.issuer",
        "path": "Device.udiCarrier.issuer",
        "short": "UDI Issuing Organization",
        "definition": "Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include: \n1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, \n2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI, \n3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, \n4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.",
        "alias": [
          "Barcode System"
        ],
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "uri"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "Role.id.root"
          },
          {
            "identity": "udi",
            "map": "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
          }
        ]
      },
      {
        "id": "Device.udiCarrier.jurisdiction",
        "path": "Device.udiCarrier.jurisdiction",
        "short": "Regional UDI authority",
        "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/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.",
        "requirements": "Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "uri"
          }
        ],
        "mapping": [
          {
            "identity": "rim",
            "map": "Role.scoper"
          }
        ]
      },
      {
        "id": "Device.udiCarrier.carrierAIDC",
        "path": "Device.udiCarrier.carrierAIDC",
        "short": "UDI Machine Readable Barcode String",
        "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.",
        "comment": "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.",
        "alias": [
          "Automatic Identification and Data Capture"
        ],
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "base64Binary"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "Role.id.extension"
          },
          {
            "identity": "udi",
            "map": "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
          }
        ]
      },
      {
        "id": "Device.udiCarrier.carrierHRF",
        "path": "Device.udiCarrier.carrierHRF",
        "short": "UDI Human Readable Barcode String",
        "definition": "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
        "comment": "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
        "alias": [
          "Human Readable Form"
        ],
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "Role.id.extension"
          },
          {
            "identity": "udi",
            "map": "A unique device identifier (UDI) on a device label in plain text"
          }
        ]
      },
      {
        "id": "Device.udiCarrier.entryType",
        "path": "Device.udiCarrier.entryType",
        "short": "barcode | rfid | manual | card | self-reported | electronic-transmission | unknown",
        "definition": "A coded entry to indicate how the data was entered.",
        "requirements": "Supports a way to distinguish hand entered from machine read data.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "code"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "UDIEntryType"
            }
          ],
          "strength": "required",
          "description": "Codes to identify how UDI data was entered.",
          "valueSet": "http://hl7.org/fhir/ValueSet/udi-entry-type"
        },
        "mapping": [
          {
            "identity": "rim",
            "map": "NA"
          }
        ]
      },
      {
        "id": "Device.status",
        "path": "Device.status",
        "short": "active | inactive | entered-in-error | unknown",
        "definition": "Status of the Device record. This is not the status of the device like availability.",
        "comment": "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.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "code"
          }
        ],
        "isModifier": true,
        "isModifierReason": "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",
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "FHIRDeviceStatus"
            }
          ],
          "strength": "required",
          "description": "The availability status of the device.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-status"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.status"
          },
          {
            "identity": "rim",
            "map": ".statusCode"
          },
          {
            "identity": "interface",
            "map": "Participant.active"
          }
        ]
      },
      {
        "id": "Device.statusReason",
        "path": "Device.statusReason",
        "short": "discarded | obsolete | removed",
        "definition": "Reason for the status of the Device record. For example, why is the record not active.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "FHIRDeviceStatusReason"
            }
          ],
          "strength": "extensible",
          "description": "The availability status reason of the device.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-status-reason"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.status"
          }
        ]
      },
      {
        "id": "Device.biologicalSource",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.biologicalSource",
        "short": "An identifier that supports traceability to the biological entity that is the source of biological material in the product",
        "definition": "An identifier that supports traceability to the biological entity that is the source of biological material in the product.",
        "comment": "Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa.  The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*.",
        "alias": [
          "Distinct Identification Code (DIC)"
        ],
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          }
        ]
      },
      {
        "id": "Device.manufacturer",
        "path": "Device.manufacturer",
        "short": "Name of device manufacturer",
        "definition": "A name of the manufacturer or entity legally responsible for the device.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=MANU].scoper.name"
          },
          {
            "identity": "udi",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Device.manufactureDate",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.manufactureDate",
        "short": "Date when the device was made",
        "definition": "The date and time when the device was manufactured.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".existenceTime.low"
          },
          {
            "identity": "udi",
            "map": "The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."
          }
        ]
      },
      {
        "id": "Device.expirationDate",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.expirationDate",
        "short": "Date and time of expiry of this device (if applicable)",
        "definition": "The date and time beyond which this device is no longer valid or should not be used (if applicable).",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".expirationTime"
          },
          {
            "identity": "udi",
            "map": "the expiration date of a specific device -  which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."
          }
        ]
      },
      {
        "id": "Device.lotNumber",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.lotNumber",
        "short": "Lot number of manufacture",
        "definition": "Lot number assigned by the manufacturer.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".lotNumberText"
          },
          {
            "identity": "udi",
            "map": "The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."
          }
        ]
      },
      {
        "id": "Device.serialNumber",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.serialNumber",
        "short": "Serial number assigned by the manufacturer",
        "definition": "The serial number assigned by the organization when the device was manufactured.",
        "comment": "Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier.  When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type.  Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=MANU].id"
          }
        ]
      },
      {
        "id": "Device.deviceName",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "400,0"
          }
        ],
        "path": "Device.deviceName",
        "short": "The name or names of the device as known to the manufacturer and/or patient",
        "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.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ],
        "mapping": [
          {
            "identity": "interface",
            "map": "Participant.name"
          }
        ]
      },
      {
        "id": "Device.deviceName.name",
        "path": "Device.deviceName.name",
        "short": "The name that identifies the device",
        "definition": "The name that identifies the device.",
        "alias": [
          "Σ"
        ],
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ]
      },
      {
        "id": "Device.deviceName.type",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.deviceName.type",
        "short": "registered-name | user-friendly-name | patient-reported-name",
        "definition": "The type of deviceName. Note that ManufactureDeviceName means that the name is the name as given by the manufacturer, not the name of the manufacturer.\nRegisteredName | UserFriendlyName | PatientReportedName.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "code"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "DeviceNameType"
            }
          ],
          "strength": "required",
          "description": "The type of name the device is referred by.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-nametype"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=MANU].code"
          }
        ]
      },
      {
        "id": "Device.modelNumber",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.modelNumber",
        "short": "The manufacturer's model number for the device",
        "definition": "The manufacturer's model number for the device.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".softwareName (included as part)"
          }
        ]
      },
      {
        "id": "Device.partNumber",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "W5 note what = what.productidentification."
          }
        ],
        "path": "Device.partNumber",
        "short": "The part number or catalog number of the device",
        "definition": "The part number or catalog number of the device.",
        "comment": "Alphanumeric Maximum 20.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=MANU].id"
          }
        ]
      },
      {
        "id": "Device.type",
        "path": "Device.type",
        "short": "The kind or type of device",
        "definition": "The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.",
        "comment": "Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "DeviceType"
            },
            {
              "url": "http://hl7.org/fhir/build/StructureDefinition/copyright",
              "valueString": "‘GMDN’ is a registered trade mark owned by GMDN Agency Ltd."
            }
          ],
          "strength": "example",
          "description": "Codes to identify medical devices.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-type"
        }
      },
      {
        "id": "Device.version",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "800,100"
          }
        ],
        "path": "Device.version",
        "short": "The actual design of the device or software version running on the device",
        "definition": "The actual design of the device or software version running on the device.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "Device.version.type",
        "path": "Device.version.type",
        "short": "The type of the device version, e.g. manufacturer, approved, internal",
        "definition": "The type of the device version, e.g. manufacturer, approved, internal.",
        "alias": [
          "Σ"
        ],
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ]
      },
      {
        "id": "Device.version.component",
        "path": "Device.version.component",
        "short": "The hardware or software module of the device to which the version applies",
        "definition": "The hardware or software module of the device to which the version applies.",
        "comment": "Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Identifier"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          }
        ]
      },
      {
        "id": "Device.version.installDate",
        "path": "Device.version.installDate",
        "short": "The date the version was installed on the device",
        "definition": "The date the version was installed on the device.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "dateTime"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          }
        ]
      },
      {
        "id": "Device.version.value",
        "path": "Device.version.value",
        "short": "The version text",
        "definition": "The version text.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ]
      },
      {
        "id": "Device.property",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/svg",
            "valueCode": "400,180"
          }
        ],
        "path": "Device.property",
        "short": "The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties",
        "definition": "The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "Device.property.type",
        "path": "Device.property.type",
        "short": "Code that specifies the property being represented",
        "definition": "Code that specifies the property being represented. No codes are specified but the MDC codes are an example: https://build.fhir.org/mdc.html.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ]
      },
      {
        "id": "Device.property.value[x]",
        "path": "Device.property.value[x]",
        "short": "Property value - as a code, quantity, boolean, string or attachmment",
        "definition": "Property value - can be a code, quantity, boolean, string or attachment.",
        "comment": "The string is used for properties that are intrinsically text, such as warning text, or assemlby instructions. CodeableConcept.text also supports unencoded text but should be used where the characteristic is a concept that might be coded but there is no assigned code for the present value. For example, a security class can be a code like 'Class 1' but in some cases may contain a string like 'Depending on the settings' - in this case the property is normally coded but this is an exception",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Quantity"
          },
          {
            "code": "CodeableConcept"
          },
          {
            "code": "string"
          },
          {
            "code": "boolean"
          },
          {
            "code": "integer"
          },
          {
            "code": "Range"
          },
          {
            "code": "Attachment"
          }
        ]
      },
      {
        "id": "Device.subject",
        "path": "Device.subject",
        "short": "Patient to whom Device is affixed",
        "definition": "Patient information, if the device is affixed to, or associated to a patient for their specific use, irrespective of the procedure, use, observation, or other activity that the device is involved in. The use of Patient is also appropriate for the use of devices outside a healthcare setting, such as a fitness tracker.",
        "requirements": "If the device is implanted, or otherwise in use by the patient (e.g., wheelchair, oxygen tank), without further describing its specific use, then the device needs to be associated to the patient.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Patient",
              "http://hl7.org/fhir/StructureDefinition/Practitioner"
            ]
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.subject[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"
          },
          {
            "identity": "w5",
            "map": "FiveWs.subject"
          }
        ]
      },
      {
        "id": "Device.operationalStatus",
        "path": "Device.operationalStatus",
        "short": "The status of the device itself - whether it is switched on, or activated, etc",
        "definition": "The status of the device itself - whether it is switched on, or activated, etc.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "Device.operationalStatus.value",
        "path": "Device.operationalStatus.value",
        "short": "on |off | standby",
        "definition": "on |off | standby.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "DeviceOperationalStatus"
            }
          ],
          "strength": "example",
          "description": "OperationalStatus of a device.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-operationalstatus"
        }
      },
      {
        "id": "Device.operationalStatus.reason",
        "path": "Device.operationalStatus.reason",
        "short": "The reasons given for the current operational status",
        "definition": "The reasons given for the current operational status - i.e. why is the device switched on etc.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ]
      },
      {
        "id": "Device.associationStatus",
        "path": "Device.associationStatus",
        "short": "The state of the usage or application of the device",
        "definition": "The state of the usage or application of the device - whether the device is implanted, or explanted, or attached to the patient.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "Device.associationStatus.value",
        "path": "Device.associationStatus.value",
        "short": "implanted|explanted|attached",
        "definition": "implanted|explanted|attached.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "DeviceAssociationStatus"
            }
          ],
          "strength": "example",
          "description": "Association Status of a device.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-associationstatus"
        }
      },
      {
        "id": "Device.associationStatus.reason",
        "path": "Device.associationStatus.reason",
        "short": "The reasons given for the current association status",
        "definition": "The reasons given for the current association status - i.e. why is the device explanted, or attached to the patient, etc.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ]
      },
      {
        "id": "Device.owner",
        "path": "Device.owner",
        "short": "Organization responsible for device",
        "definition": "An organization that is responsible for the provision and ongoing maintenance of the device.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Organization"
            ]
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.source"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=OWN].scoper"
          }
        ]
      },
      {
        "id": "Device.contact",
        "path": "Device.contact",
        "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.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "ContactPoint"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.source"
          },
          {
            "identity": "rim",
            "map": ".scopedRole[typeCode=CON].player"
          }
        ]
      },
      {
        "id": "Device.distributor",
        "path": "The distributor of the model of device",
        "definition": "The distributor of the model of device, other than the manufacturer.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "BackboneElement"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=DIST].scoper.name"
          }
        ]
      },
      {
        "id": "Device.distributor.name",
        "path": "Device.distributor.name",
        "short": "The name of the distributor",
        "definition": "The human-readble name of the device distributor.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "string"
          }
        ]
      },
      {
        "id": "Device.distributor.organizationReference",
        "path": "Device.distributor.organizationReference",
        "short": "The organization of the device distributor",
        "definition": "The organization that the distributor of the device belongs to.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Organization"
            ]
          }
        ]
      },
      {
        "id": "Device.location",
        "extension": [
          {
            "url": "http://hl7.org/fhir/build/StructureDefinition/committee-notes",
            "valueString": "#7418."
          }
        ],
        "path": "Device.location",
        "short": "Where the device is found",
        "definition": "The place where the device can be found.",
        "requirements": "Device.location can be used to track device location.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Location"
            ]
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.where[x]"
          },
          {
            "identity": "rim",
            "map": ".playedRole[typeCode=LOCE].scoper"
          }
        ]
      },
      {
        "id": "Device.url",
        "path": "Device.url",
        "short": "Network address to contact device",
        "definition": "A network address on which the device may be contacted directly.",
        "comment": "If the device is running a FHIR server, the network address should  be the Base URL from which a conformance statement may be retrieved.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "uri"
          }
        ],
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.where[x]"
          },
          {
            "identity": "rim",
            "map": ".telecom"
          }
        ]
      },
      {
        "id": "Device.endpoint",
        "path": "Device.endpoint",
        "short": "Technical endpoints providing access to electronic services provided by the device",
        "definition": "Technical endpoints providing access to services provided by the device defined at this resource.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Endpoint"
            ]
          }
        ],
        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
          }
        ]
      },
      {
        "id": "Device.link",
        "path": "Device.link",
        "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.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "BackboneElement"
          }
        ]
      },
      {
        "id": "Device.link.relation",
        "path": "Device.link.relation",
        "short": "The type indicates the relationship of the related device to the device instance",
        "definition": "The type indicates the relationship of the related device to the device instance.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "Coding"
          }
        ],
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "DeviceRelationType"
            }
          ],
          "strength": "extensible",
          "description": "The type of relation between this and the linked device.",
          "valueSet": "http://hl7.org/fhir/ValueSet/device-relationtype"
        }
      },
      {
        "id": "Device.link.relatedDevice",
        "path": "Device.link.relatedDevice",
        "short": "A reference to the linked device",
        "definition": "A reference to the linked device.",
        "min": 1,
        "max": "1",
        "type": [
          {
            "code": "CodeableReference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Device"
            ]
          }
        ]
      },
      {
        "id": "Device.note",
        "path": "Device.note",
        "short": "Device notes and comments",
        "definition": "Descriptive information, usage information or implantation information that is not captured in an existing element.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "Annotation"
          }
        ],
        "mapping": [
          {
            "identity": "rim",
            "map": ".text"
          }
        ]
      },
      {
        "id": "Device.safety",
        "path": "Device.safety",
        "short": "Safety Characteristics of Device",
        "definition": "Provides additional safety characteristics about a medical device.  For example devices containing latex.",
        "min": 0,
        "max": "*",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "NA"
          }
        ]
      },
      {
        "id": "Device.parent",
        "path": "Device.parent",
        "short": "The device that this device is attached to or is part of",
        "definition": "The higher level or encompassing device that this device is a logical part of.",
        "comment": "For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules.  These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Device"
            ]
          }
        ]
      }
    ]
  }
}