HL7 Czech Imaging Report IG
0.1.0-ballot - ci-build
HL7 Czech Imaging Report IG
0.1.0-ballot - ci-build
HL7 Czech Imaging Report IG, published by HL7 Czech Republic. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-cz/img/ and changes regularly. See the Directory of published versions
| Official URL: https://hl7.cz/fhir/img/StructureDefinition/cz-medicalDevice-obl-img | Version: 0.1.0-ballot | |||
| Standards status: Informative | Maturity Level: 0 | Computable Name: CZ_MedicalDeviceObligationsImg | ||
This profile defines obligations for a medical device result in FHIR for the purpose of this guide.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
  Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||||||||
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||||||||||||
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||||||||||||||
 identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||||||||
 udiCarrier |
OΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||||||||
  modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||||||||||||
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||||||||||||||
| manufacturer |
O | 0..1 | string | Name of device manufacturer
| ||||||||||||||||
| modelNumber |
O | 0..1 | string | The model number for the device
| ||||||||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set. Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device
| ||||||||||||||||
 patient |
1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed | |||||||||||||||||
| reference |
ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||||||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||||||||
| Documentation for this format | ||||||||||||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.type | Base | preferred | Medical Devices - SNOMED CT + Absent/Unknown - IPS | 📦1.1.0 | International Patient Summary Implementation Guide v1.1 |
| Id | Grade | Path(s) | Description | Expression |
| 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 CZ_MedicalDevice
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||
 identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||
| udiCarrier |
O | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||
| manufacturer |
O | 0..1 | string | Name of device manufacturer
| ||||||||||
| deviceName |
||||||||||||||
| name |
O | 1..1 | string | The name of the device
| ||||||||||
| modelNumber |
O | 0..1 | string | The model number for the device
| ||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
| ||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||
| Documentation for this format | ||||||||||||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||||||||
| 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||||||||
| contained |
0..* | Resource | Contained, inline Resources | |||||||||||||||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||||||||||||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||||||||||||||
| identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||||||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||||||||||||||
| udiCarrier |
OΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||||||||
| 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 |
Σ | 0..1 | string | Mandatory fixed portion of UDI | ||||||||||||||||
| 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 |
Σ | 0..1 | string | UDI Human Readable Barcode String | ||||||||||||||||
| 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 |
O | 0..1 | string | Name of device manufacturer
| ||||||||||||||||
| manufactureDate |
0..1 | dateTime | Date when the device was made | |||||||||||||||||
| expirationDate |
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||||||||||||||
| lotNumber |
0..1 | string | Lot number of manufacture | |||||||||||||||||
| serialNumber |
0..1 | string | Serial number assigned by the manufacturer | |||||||||||||||||
| 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 |
O | 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 |
O | 0..1 | string | The model number for the device
| ||||||||||||||||
| partNumber |
0..1 | string | The part number of the device | |||||||||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set. Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device
| ||||||||||||||||
| 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 |
1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed | |||||||||||||||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||||||||||||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||||||||
| reference |
ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||||||||||||||
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||||||||||||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||||||||||||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||||||||||||||
| owner |
0..1 | Reference(Organization (CZ core)) | Organization responsible for device | |||||||||||||||||
| contact |
0..* | ContactPoint | Details for human/organization for support | |||||||||||||||||
| location |
0..1 | Reference(Location (CZ core)) | Where the device is found | |||||||||||||||||
| url |
0..1 | uri | Network address to contact device | |||||||||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||||||||
| safety |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||||||||||||||
| parent |
0..1 | Reference(Medical Device (CZ) | Device: Performer/Observer (CZ)) | The parent device | |||||||||||||||||
| Documentation for this format | ||||||||||||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | preferred | Medical Devices - SNOMED CT + Absent/Unknown - IPS | 📦1.1.0 | International Patient Summary Implementation Guide v1.1 |
| Device.patient.type | Base | extensible | ResourceType | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 CZ_MedicalDevice
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||||||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||||||||||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||||||||||||||
| identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||||||||
| udiCarrier |
OΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||||||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||||||||||||
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||||||||||||||
| manufacturer |
O | 0..1 | string | Name of device manufacturer
| ||||||||||||||||
| modelNumber |
O | 0..1 | string | The model number for the device
| ||||||||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set. Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device
| ||||||||||||||||
| patient |
1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed | |||||||||||||||||
| reference |
ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||||||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||||||||
| Documentation for this format | ||||||||||||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.type | Base | preferred | Medical Devices - SNOMED CT + Absent/Unknown - IPS | 📦1.1.0 | International Patient Summary Implementation Guide v1.1 |
| Id | Grade | Path(s) | Description | Expression |
| 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()
|
Differential View
This structure is derived from CZ_MedicalDevice
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||
| identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||
| udiCarrier |
O | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||
| manufacturer |
O | 0..1 | string | Name of device manufacturer
| ||||||||||
| deviceName |
||||||||||||||
| name |
O | 1..1 | string | The name of the device
| ||||||||||
| modelNumber |
O | 0..1 | string | The model number for the device
| ||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
| ||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||
| Documentation for this format | ||||||||||||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device |
0..* | CZ_MedicalDevice | Czech medical devices | |||||||||||||||||
| 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||||||||
| contained |
0..* | Resource | Contained, inline Resources | |||||||||||||||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||||||||||||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||||||||||||||
| identifier |
O | 0..* | Identifier | Instance identifier
| ||||||||||||||||
| definition |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||||||||||||||
| udiCarrier |
OΣ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
| ||||||||||||||||
| 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 |
Σ | 0..1 | string | Mandatory fixed portion of UDI | ||||||||||||||||
| 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 |
Σ | 0..1 | string | UDI Human Readable Barcode String | ||||||||||||||||
| 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 |
O | 0..1 | string | Name of device manufacturer
| ||||||||||||||||
| manufactureDate |
0..1 | dateTime | Date when the device was made | |||||||||||||||||
| expirationDate |
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |||||||||||||||||
| lotNumber |
0..1 | string | Lot number of manufacture | |||||||||||||||||
| serialNumber |
0..1 | string | Serial number assigned by the manufacturer | |||||||||||||||||
| 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 |
O | 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 |
O | 0..1 | string | The model number for the device
| ||||||||||||||||
| partNumber |
0..1 | string | The part number of the device | |||||||||||||||||
| type |
O | 0..1 | CodeableConcept | Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or absence of devices, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set. Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device
| ||||||||||||||||
| 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 |
1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed | |||||||||||||||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||||||||||||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||||||||
| reference |
ΣC | 1..1 | string | Literal reference, Relative, internal or absolute URL | ||||||||||||||||
| type |
Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | ||||||||||||||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||||||||||||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||||||||||||||
| owner |
0..1 | Reference(Organization (CZ core)) | Organization responsible for device | |||||||||||||||||
| contact |
0..* | ContactPoint | Details for human/organization for support | |||||||||||||||||
| location |
0..1 | Reference(Location (CZ core)) | Where the device is found | |||||||||||||||||
| url |
0..1 | uri | Network address to contact device | |||||||||||||||||
| note |
O | 0..* | Annotation | Device notes and comments
| ||||||||||||||||
| safety |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||||||||||||||
| parent |
0..1 | Reference(Medical Device (CZ) | Device: Performer/Observer (CZ)) | The parent device | |||||||||||||||||
| Documentation for this format | ||||||||||||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | preferred | Medical Devices - SNOMED CT + Absent/Unknown - IPS | 📦1.1.0 | International Patient Summary Implementation Guide v1.1 |
| Device.patient.type | Base | extensible | ResourceType | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 CZ_MedicalDevice
Other representations of profile: CSV, Excel, Schematron