At-Home In-Vitro Test Report
1.1.0 - STU 1.1

At-Home In-Vitro Test Report, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/home-lab-report/ and changes regularly. See the Directory of published versions

## Resource Profile: Device - At-Home In-Vitro Test

Official URL: http://hl7.org/fhir/us/home-lab-report/StructureDefinition/Device-at-home-in-vitro-test | Version: 1.1.0
Active as of 2024-08-08 | Computable Name: DeviceAtHomeInVitroTest
Other Identifiers: OID:2.16.840.1.113883.4.642.40.32.42.2

This profile constrains the Device resource for At-Home In-Vitro Tests.

The data elements in this profile contain narrative guidance (mappings) to specific columns in the "LOINC Mapping" tab contained in the LIVD Spreadsheet.

Although most at home test kits will have a single udiCarrier.deviceIdentifier for the "test kit" (all in one package of reagents, test card/device, etc.) it is possible for at home kits to have a resuable "reader device" which would need a distinct "equipment id". In this case, the reader device would have an "equipment UID" that may be the same for multiple tests performed. For these cases use multiple Devices - one to represent the test kit (which would have the Test Kit Name ID recorded in Device.udiCarrier.deviceIdentifier) and one to represent the reader device (which would have the Equipment ID recorded in Device.udiCarrier.deviceIdentifier).

Usage:

- Refer to this Resource Profile: Observation - At-Home In-Vitro Test Result
- Examples for this Resource Profile: Device/device-fast-sars-antigen-test and Device/device-hometest1-s-trevor

### Formal Views of Profile Content

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

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  |  | Device |
udiCarrier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
manufacturer | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
name | S | 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 Fixed Value: model-name
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiCarrier | S Σ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
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 | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices |  |  |  | Content/Rules for all slices
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.
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 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. Fixed Value: model-name
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` from the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.deviceName:modelName.type | required | Fixed Value: model-name `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
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 |  | 0..* | Identifier | Instance identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | S Σ | 0..1 | 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 | S Σ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
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 | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices |  |  |  | Content/Rules for all slices
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.
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
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 | S | 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. Fixed Value: model-name
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type |  | 0..1 | CodeableConcept | The kind or type of device 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 |  | 0..1 | Reference(Patient) | 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 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(Device) | The parent device
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Device.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` from the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` from the FHIR Standard
Device.statusReason | extensible | FHIRDeviceStatusReason `http://hl7.org/fhir/ValueSet/device-status-reason` from the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.deviceName:modelName.type | required | Fixed Value: model-name `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.type | example | DeviceType `http://hl7.org/fhir/ValueSet/device-type` from the FHIR Standard

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 9 elements
Fixed: 1 element

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Device.deviceName

Differential View

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  |  | Device |
udiCarrier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
manufacturer | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
name | S | 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 Fixed Value: model-name
Documentation for this format

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiCarrier | S Σ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
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 | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices |  |  |  | Content/Rules for all slices
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.
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name | S | 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. Fixed Value: model-name
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` from the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.deviceName:modelName.type | required | Fixed Value: model-name `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
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 |  | 0..* | Identifier | Instance identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | S Σ | 0..1 | 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 | S Σ | 1..1 | string | LIVD Spreadsheet | LOINC Mapping.Testkit Name ID or LIVD Spreadsheet | LOINC Mapping.Testkit Equipment UID V2: OBX-17.1
issuer | S | 0..1 | uri | Organization that issues the UDI for this test. Not included in V2 IG.
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 | S | 0..1 | string | LIVD Spreadsheet | LOINC Mapping.Manufacturer
manufactureDate | S | 0..1 | dateTime | Date when the device was made
expirationDate | S | 0..1 | dateTime | Expiration date of the test kit. Not included in V2 IG.
lotNumber | S | 0..1 | string | Lot number of the test kit. Not included in V2 IG.
serialNumber | S | 0..1 | string | Serial number of the test kit. Not included in V2 IG.
Slices for deviceName |  | 1..* | BackboneElement | The name of the device as given by the manufacturer Slice: Unordered, Open by value:type
deviceName:All Slices |  |  |  | Content/Rules for all slices
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.
deviceName:modelName |  | 1..1 | BackboneElement | LIVD Spreadsheet | LOINC Mapping.Model
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 | S | 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. Fixed Value: model-name
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type |  | 0..1 | CodeableConcept | The kind or type of device 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 |  | 0..1 | Reference(Patient) | 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 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(Device) | The parent device
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Device.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` from the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` from the FHIR Standard
Device.statusReason | extensible | FHIRDeviceStatusReason `http://hl7.org/fhir/ValueSet/device-status-reason` from the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.deviceName:modelName.type | required | Fixed Value: model-name `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` from the FHIR Standard
Device.type | example | DeviceType `http://hl7.org/fhir/ValueSet/device-type` from the FHIR Standard

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 9 elements
Fixed: 1 element

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of Device.deviceName

Other representations of profile: CSV, Excel, Schematron