HL7 Czech Imaging Report IG
0.1.0-ballot - ci-build CZ

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

## Resource Profile: Medical Device: Obligations

Official URL: https://hl7.cz/fhir/img/StructureDefinition/cz-medicalDevice-obl-img | Version: 0.1.0-ballot | Highlight text changes?
Draft as of 2026-05-26 | Computable Name: CZ_MedicalDeviceObligationsImg

This profile defines obligations for a medical device result in FHIR for the purpose of this guide.

Usages:

- This Profile is not used by any profiles in this Specification

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
udiCarrier | O Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
modelNumber | O | 0..1 | string | The model number for the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
type | O | 0..1 | CodeableConcept | The kind or type of device Binding: Medical Device with exceptions (preferred)
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
patient |  | 1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed
reference | Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
note | O | 0..* | Annotation | Device notes and comments
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std.
Device.type | Base | preferred | Medical Device with exceptions | 📦0.3.0 | HL7 Czech Terminology Implementation Guide vnull

#### Constraints

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()`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | CZ_MedicalDevice | Czech medical devices
identifier | O | 0..* | Identifier | Instance identifier
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
udiCarrier | O | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
manufacturer | O | 0..1 | string | Name of device manufacturer
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
deviceName |  |  |  |
name | O | 1..1 | string | The name of the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
modelNumber | O | 0..1 | string | The model number for the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
type | O | 0..1 | CodeableConcept | The kind or type of device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
note | O | 0..* | Annotation | Device notes and comments
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | O Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
partNumber |  | 0..1 | string | The part number of the device
type | O | 0..1 | CodeableConcept | The kind or type of device Binding: Medical Device with exceptions (preferred)
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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 | Σ C | 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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Medical Device (CZ core) | Device: Performer/Observer (CZ core)) | The parent device
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

#### Terminology Bindings

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 Device with exceptions | 📦0.3.0 | HL7 Czech Terminology Implementation Guide vnull
Device.patient.type | Base | extensible | ResourceType | 📍4.0.1 | FHIR Std.

#### Constraints

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()`

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

Summary

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
udiCarrier | O Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
modelNumber | O | 0..1 | string | The model number for the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
type | O | 0..1 | CodeableConcept | The kind or type of device Binding: Medical Device with exceptions (preferred)
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
patient |  | 1..1 | Reference(Patient (CZ core)) | Patient to whom Device is affixed
reference | Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
note | O | 0..* | Annotation | Device notes and comments
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

#### Terminology Bindings

Path | Status | Usage | ValueSet | Version | Source
Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std.
Device.type | Base | preferred | Medical Device with exceptions | 📦0.3.0 | HL7 Czech Terminology Implementation Guide vnull

#### Constraints

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | CZ_MedicalDevice | Czech medical devices
identifier | O | 0..* | Identifier | Instance identifier
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
udiCarrier | O | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
manufacturer | O | 0..1 | string | Name of device manufacturer
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
deviceName |  |  |  |
name | O | 1..1 | string | The name of the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
modelNumber | O | 0..1 | string | The model number for the device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
type | O | 0..1 | CodeableConcept | The kind or type of device
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
note | O | 0..* | Annotation | Device notes and comments
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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.
Additional Bindings | Purpose
AllLanguages | Max Binding
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | O Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
partNumber |  | 0..1 | string | The part number of the device
type | O | 0..1 | CodeableConcept | The kind or type of device Binding: Medical Device with exceptions (preferred)
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
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 | Σ C | 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
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Medical Device (CZ core) | Device: Performer/Observer (CZ core)) | The parent device
Documentation for this format

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

#### Terminology Bindings

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 Device with exceptions | 📦0.3.0 | HL7 Czech Terminology Implementation Guide vnull
Device.patient.type | Base | extensible | ResourceType | 📍4.0.1 | FHIR Std.

#### Constraints

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()`

Name | Creator_L3 | Creator_L2 | Consumer_L2 | Consumer_L3
--- | --- | --- | --- | ---
Device |  |  |  |
identifier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
udiCarrier | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
manufacturer | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
deviceName |  |  |  |
name | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
modelNumber | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
type | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
note | SHALL:able-to-populate | SHOULD:able-to-populate | SHOULD:display | SHALL:display
Documentation for this format

Summary

Other representations of profile: CSV, Excel, Schematron