R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R3 R2

Health Care Devices Work GroupMaturity Level: 1 Trial Use Compartments: Device

Detailed Descriptions for the elements in the DeviceComponent resource.

DeviceComponent
Element IdDeviceComponent
Definition

The characteristics, operational status and capabilities of a medical-related component of a medical device.

Control1..1
Summarytrue
Comments

For the initial scope, this DeviceComponent resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

DeviceComponent.identifier
Element IdDeviceComponent.identifier
Definition

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
DeviceComponent.type
Element IdDeviceComponent.type
Definition

The component type as defined in the object-oriented or metric nomenclature partition.

Control1..1
Terminology BindingFHIR Device Types (Preferred)
TypeCodeableConcept
Summarytrue
Comments

DeviceComponent.type can be referred to either GDMN (nomenclature system supported by FDA Global UDI Database) or preferable RTMMS coding system.

DeviceComponent.lastSystemChange
Element IdDeviceComponent.lastSystemChange
Definition

The timestamp for the most recent system change which includes device configuration or setting change.

Control0..1
Typeinstant
Summarytrue
DeviceComponent.source
Element IdDeviceComponent.source
Definition

The link to the source Device that contains administrative device information such as manufacture, serial number, etc.

Control0..1
TypeReference(Device)
Summarytrue
DeviceComponent.parent
Element IdDeviceComponent.parent
Definition

The link to the parent resource. For example: Channel is linked to its VMD parent.

Control0..1
TypeReference(DeviceComponent)
Summarytrue
DeviceComponent.operationalStatus
Element IdDeviceComponent.operationalStatus
Definition

The current operational status of the device. For example: On, Off, Standby, etc.

Control0..*
Terminology BindingDeviceComponentOperationalStatus (Extensible)
TypeCodeableConcept
Summarytrue
Comments

OperationalStatus for the MDS, VMD, or Channel will be bound to a specific ValueSet that is defined in its profile.

DeviceComponent.parameterGroup
Element IdDeviceComponent.parameterGroup
Definition

The parameter group supported by the current device component that is based on some nomenclature, e.g. cardiovascular.

Control0..1
Terminology BindingDeviceComponentParameterGroup (Extensible)
TypeCodeableConcept
Summarytrue
DeviceComponent.measurementPrinciple
Element IdDeviceComponent.measurementPrinciple
Definition

The physical principle of the measurement. For example: thermal, chemical, acoustical, etc.

Control0..1
Terminology BindingMeasmntPrinciple (Required)
Typecode
Summarytrue
DeviceComponent.productionSpecification
Element IdDeviceComponent.productionSpecification
Definition

The production specification such as component revision, serial number, etc.

Control0..*
Summarytrue
DeviceComponent.productionSpecification.specType
Element IdDeviceComponent.productionSpecification.specType
Definition

The specification type, such as, serial number, part number, hardware revision, software revision, etc.

Control0..1
Terminology BindingDeviceSpecificationSpecType (Extensible)
TypeCodeableConcept
Summarytrue
DeviceComponent.productionSpecification.componentId
Element IdDeviceComponent.productionSpecification.componentId
Definition

The internal component unique identification. This is a provision for manufacture specific standard components using a private OID. 11073-10101 has a partition for private OID semantic that the manufacturer can make use of.

Control0..1
TypeIdentifier
Summarytrue
DeviceComponent.productionSpecification.productionSpec
Element IdDeviceComponent.productionSpecification.productionSpec
Definition

The printable string defining the component.

Control0..1
Typestring
Summarytrue
DeviceComponent.languageCode
Element IdDeviceComponent.languageCode
Definition

The language code for the human-readable text string produced by the device. This language code will follow the IETF language tag. Example: en-US.

Control0..1
Terminology BindingCommon Languages (Extensible but limited to ??)
TypeCodeableConcept
Summarytrue
DeviceComponent.property
Element IdDeviceComponent.property
Definition

Other device properties expressed as a type which identifies the property and a value(s) either as a quantity or a code.

Control0..*
Summarytrue
DeviceComponent.property.type
Element IdDeviceComponent.property.type
Definition

The code for the device property identifying the property being reported such as 'time capability'.

Control1..1
Terminology BindingDeviceComponentPropertyCode (Extensible)
TypeCodeableConcept
Summarytrue
DeviceComponent.property.valueQuantity
Element IdDeviceComponent.property.valueQuantity
Definition

The property value when the property being reported is a quantity such as the resolution of a real time clock.

Control0..*
TypeQuantity
Summarytrue
DeviceComponent.property.valueCode
Element IdDeviceComponent.property.valueCode
Definition

The property value when the property being reported is a code, such as the code indicating that the device supports a real time clock using absolute time.

Control0..*
Terminology BindingDeviceComponentPropertyValue:
TypeCodeableConcept
Summarytrue
Comments

An example of a case with mulitple coded values would be the set of specializations for which the device has been certified.