臺灣核心實作指引(TW Core IG)
0.3.0 - Trial Use
臺灣核心實作指引(TW Core IG)
0.3.0 - Trial Use
This page is part of the 臺灣核心實作指引(TW Core IG) (v0.3.0: Releases) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Official URL: https://twcore.mohw.gov.tw/ig/twcore/StructureDefinition/Device-twcore | Version: 0.3.0 | |||
| Active as of 2024-10-15 | Computable Name: TWCoreImplantableDevice | |||
此臺灣核心-植入式裝置（TW Core Implantable Device） Profile說明本IG如何進一步定義FHIR的Device Resource以呈現植入式裝置資料。
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Device
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Device |
0..* | Device | 植入式醫療器材 | |
  identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
 udiCarrier |
S | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
 deviceIdentifier |
S | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
 carrierHRF |
S | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
| manufacturer |
S | 0..1 | string | 製造商 |
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 |
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 |
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 |
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 |
 patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device |
0..* | Device | 植入式醫療器材 | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
| udiCarrier |
SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier |
SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
| carrierHRF |
SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
| manufacturer |
S | 0..1 | string | 製造商 |
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 |
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 |
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 |
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. |
| patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | |
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Device |
0..* | Device | 植入式醫療器材 | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) | ||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
| udiCarrier |
SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| deviceIdentifier |
SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 | ||||
| issuer |
0..1 | uri | UDI Issuing Organization | |||||
| jurisdiction |
0..1 | uri | Regional UDI authority | |||||
| carrierAIDC |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
| carrierHRF |
SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 | ||||
| entryType |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
| statusReason |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
| distinctIdentifier |
0..1 | string | The distinct identification string | |||||
| manufacturer |
S | 0..1 | string | 製造商 | ||||
| manufactureDate |
0..1 | dateTime | Date when the device was made | |||||
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 | ||||
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 | ||||
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 | ||||
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | The name of the device | |||||
| type |
1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. | |||||
| modelNumber |
0..1 | string | The model number for the device | |||||
| partNumber |
0..1 | string | The part number of the device | |||||
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. | ||||
| specialization |
0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| systemType |
1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
| version |
0..1 | string | The version of the standard that is used to operate and communicate | |||||
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
0..1 | CodeableConcept | The type of the device version | |||||
| component |
0..1 | Identifier | A single component of the device version | |||||
| value |
1..1 | string | The version text | |||||
| property |
0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity |
0..* | Quantity | Property value as a quantity | |||||
| valueCode |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 | ||||
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |||||
| contact |
0..* | ContactPoint | Details for human/organization for support | |||||
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |||||
| url |
0..1 | uri | Network address to contact device | |||||
| note |
0..* | Annotation | Device notes and comments | |||||
| safety |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Device
Summary
Mandatory: 1 element(1 nested mandatory element)
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Differential View
This structure is derived from Device
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device |
0..* | Device | 植入式醫療器材 | |
| identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
| udiCarrier |
S | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
| deviceIdentifier |
S | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
| carrierHRF |
S | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
| manufacturer |
S | 0..1 | string | 製造商 |
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 |
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 |
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 |
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 |
| patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device |
0..* | Device | 植入式醫療器材 | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) |
| udiCarrier |
SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier |
SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 |
| carrierHRF |
SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 |
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
| manufacturer |
S | 0..1 | string | 製造商 |
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 |
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 |
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 |
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. |
| patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 |
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | |
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Device |
0..* | Device | 植入式醫療器材 | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
S | 0..* | Identifier | 植入式醫療器材識別代碼，可為機構內器材代碼或為醫療器材單一識別碼之產品識別碼(UDI-DI) | ||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
| udiCarrier |
SΣ | 0..1 | BackboneElement | 醫療器材單一識別標示，詳細規定可參考「醫療器材標籤應刊載單一識別碼規定」。 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| deviceIdentifier |
SΣ | 1..1 | string | 醫療器材單一識別碼之產品識別碼(UDI-DI)。可於食品藥物管理署「醫療器材單一識別系統資訊管理平台(udid.fda.gov.tw)」查詢相關資訊。 Example General: 08436569590324 | ||||
| issuer |
0..1 | uri | UDI Issuing Organization | |||||
| jurisdiction |
0..1 | uri | Regional UDI authority | |||||
| carrierAIDC |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
| carrierHRF |
SΣ | 0..1 | string | 醫療器材單一識別標示之人眼可識別資訊(HRI) Example General: (01)08436569590324(17)250101(10)PT13254 | ||||
| entryType |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
| statusReason |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
| distinctIdentifier |
0..1 | string | The distinct identification string | |||||
| manufacturer |
S | 0..1 | string | 製造商 | ||||
| manufactureDate |
0..1 | dateTime | Date when the device was made | |||||
| expirationDate |
S | 0..1 | dateTime | 有效期限。格式：YYYY-MM-DD Example General: 2025-01-01 | ||||
| lotNumber |
S | 0..1 | string | 批號 Example General: 250101 | ||||
| serialNumber |
S | 0..1 | string | 序號 Example S1538501: S1538501 | ||||
| deviceName |
0..* | BackboneElement | The name of the device as given by the manufacturer | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | The name of the device | |||||
| type |
1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by. | |||||
| modelNumber |
0..1 | string | The model number for the device | |||||
| partNumber |
0..1 | string | The part number of the device | |||||
| type |
S | 0..1 | CodeableConcept | 醫療器材產品類別 Binding: DeviceType (example): Codes to identify medical devices. | ||||
| specialization |
0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| systemType |
1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
| version |
0..1 | string | The version of the standard that is used to operate and communicate | |||||
| version |
0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
0..1 | CodeableConcept | The type of the device version | |||||
| component |
0..1 | Identifier | A single component of the device version | |||||
| value |
1..1 | string | The version text | |||||
| property |
0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
| valueQuantity |
0..* | Quantity | Property value as a quantity | |||||
| valueCode |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
| patient |
S | 1..1 | Reference(TW Core Patient) | 病人資訊 | ||||
| owner |
0..1 | Reference(TW Core Organization) | Organization responsible for device | |||||
| contact |
0..* | ContactPoint | Details for human/organization for support | |||||
| location |
0..1 | Reference(TW Core Location) | Where the device is found | |||||
| url |
0..1 | uri | Network address to contact device | |||||
| note |
0..* | Annotation | Device notes and comments | |||||
| safety |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
| parent |
0..1 | Reference(TW Core Implantable Device) | The parent device | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | example | DeviceTypehttp://hl7.org/fhir/ValueSet/device-typefrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Device
Summary
Mandatory: 1 element(1 nested mandatory element)
Must-Support: 10 elements
Structures
This structure refers to these other structures:
Other representations of profile: CSV, Excel, Schematron
以下概述了此Profile所需的RESTful FHIR互動功能。有關TW Core IG支援的RESTful互動功能的完整清單，請參閱TW Core Server能力聲明。
必須（SHALL） 支援透過查詢參數 patient 查詢所有Device：
(如何透過reference查詢)
GET [base]/Device?patient={Type/}[id]
例子：
(1) GET [base]/Device?patient=Patient/pat-example
建議應該（SHOULD） 支援透過查詢參數 patient 及 type 查詢所有Device：
(如何透過reference查詢)
(如何透過token查詢)
GET [base]/Device?patient={Type/}[id]&type={system|}[code]
例子：
(1) GET [base]/Device?patient=Patient/pat-example&type=http://snomed.info/sct|468063009
建議應該（SHOULD） 支援透過查詢參數 patient 及 status 查詢所有Device：
(如何透過reference查詢)
(如何透過token查詢)
GET [base]/Device?patient={Type/}[id]&status=[code]
例子：
(1) GET [base]/Device?patient=Patient/pat-example&status=active