0.3.0 - Second STU ballot

This page is part of a downloaded copy of this specification. This page is part of the Da Vinci Coverage Requirements Discovery (CRD) FHIR IG (v0.3.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

## StructureDefinition: DeviceSTU3

The official URL for this profile is:

    http://hl7.org/fhir/us/davinci-crd/STU3/StructureDefinition/profile-device-stu3

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Text Summary
- Differential Table
- Snapshot Table
- All

This structure is derived from US Core Implanted Device Profile

Summary

Must-Support: 1 element

This structure is derived from US Core Implanted Device Profile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device | I | 0..* |  | US Core Implanted Device Profile
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: Common Languages (extensible) Max Binding: All Languages
text | I | 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 |  | 0..* | Identifier | Instance identifier
udi | S Σ I | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | xml:id (or equivalent in JSON)
extension |  | 0..* | Extension | Additional Content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
name | Σ | 0..1 | string | Device Name as appears on UDI label
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierHRF | Σ | 0..1 | string | UDI Human Readable Barcode String
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
issuer |  | 0..1 | uri | UDI Issuing Organization
entryType |  | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required)
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required)
type | S | 1..1 | CodeableConcept | What kind of device this is Binding: FHIR Device Types (extensible)
lotNumber |  | 0..1 | string | Lot number of manufacture
manufacturer |  | 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)
model |  | 0..1 | string | Model id assigned by the manufacturer
version |  | 0..1 | string | Version number (i.e. software)
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
owner |  | 0..1 | Reference(Organization) | Organization responsible for device
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the resource 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 Binding: DeviceSafety (example)
Documentation for this format

This structure is derived from US Core Implanted Device Profile

Summary

Must-Support: 1 element

Differential View

This structure is derived from US Core Implanted Device Profile

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device | I | 0..* |  | US Core Implanted Device Profile
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: Common Languages (extensible) Max Binding: All Languages
text | I | 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 |  | 0..* | Identifier | Instance identifier
udi | S Σ I | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | xml:id (or equivalent in JSON)
extension |  | 0..* | Extension | Additional Content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
name | Σ | 0..1 | string | Device Name as appears on UDI label
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierHRF | Σ | 0..1 | string | UDI Human Readable Barcode String
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
issuer |  | 0..1 | uri | UDI Issuing Organization
entryType |  | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required)
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required)
type | S | 1..1 | CodeableConcept | What kind of device this is Binding: FHIR Device Types (extensible)
lotNumber |  | 0..1 | string | Lot number of manufacture
manufacturer |  | 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)
model |  | 0..1 | string | Model id assigned by the manufacturer
version |  | 0..1 | string | Version number (i.e. software)
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
owner |  | 0..1 | Reference(Organization) | Organization responsible for device
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the resource 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 Binding: DeviceSafety (example)
Documentation for this format

Other representations of profile: Schematron

### Terminology Bindings

Path | Conformance | ValueSet
Device.type | extensible | FHIR Device Types

### Constraints

Id | Path | Details | Requirements
dom-2 | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-1 | Device | If the resource is contained in another resource, it SHALL NOT contain any narrative : contained.text.empty() |
dom-4 | 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-3 | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource : contained.where(('#'+id in %resource.descendants().reference).not()).empty() |
ele-1 | Device.udi | All FHIR elements must have a @value or children : hasValue() | (children().count() > id.count()) |