Release 4 5 Preview #2
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Detailed Descriptions for the elements in the DeviceDefinition resource.

DeviceDefinition
Element Id DeviceDefinition
Definition

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

Cardinality 0..*
Type DomainResource
Comments

For the initial scope, this DeviceDefinition 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.

DeviceDefinition.identifier
Element Id DeviceDefinition.identifier
Definition

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

Note This is a business identifier, not a resource identifier (see discussion )
Cardinality 0..*
Type Identifier
DeviceDefinition.udiDeviceIdentifier
Element Id DeviceDefinition.udiDeviceIdentifier
Definition

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Cardinality 0..*
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Element Id DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition

The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.

Cardinality 1..1
Type string
DeviceDefinition.udiDeviceIdentifier.issuer
Element Id DeviceDefinition.udiDeviceIdentifier.issuer
Definition

The organization that assigns the identifier algorithm.

Cardinality 1..1
Type uri
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Element Id DeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality 1..1
Type uri
DeviceDefinition.manufacturer[x]
Element Id DeviceDefinition.manufacturer[x]
Definition

A name of the manufacturer. manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.

Cardinality 0..1
Type string | Reference ( Organization )
[x] Note See Choice of Data Types for further information about how to use [x]
DeviceDefinition.deviceName
Element Id DeviceDefinition.deviceName
Definition

A The name given to or names of the device to identify it. as given by the manufacturer.

Cardinality 0..*
DeviceDefinition.deviceName.name
Element Id DeviceDefinition.deviceName.name
Definition

The A human-friendly name of that is used to refer to the device. device - depending on the type, it can be the brand name, the common name or alias, or other.

Cardinality 1..1
Type string
Alternate Names Σ
DeviceDefinition.deviceName.type
Element Id DeviceDefinition.deviceName.type
Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Cardinality 1..1
Terminology Binding DeviceNameType ( Required )
Type code
DeviceDefinition.modelNumber
Element Id DeviceDefinition.modelNumber
Definition

The model number for the device. device for example as defined by the manufacturer or labeler, or other agency.

Cardinality 0..1
Type string
DeviceDefinition.type
Element Id DeviceDefinition.type
Definition

What kind of device or device system this is.

Cardinality 0..1
Terminology Binding FHIR Device Types ( Example )
Type CodeableConcept
DeviceDefinition.specialization
Element Id DeviceDefinition.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Cardinality 0..*
DeviceDefinition.specialization.systemType
Element Id DeviceDefinition.specialization.systemType
Definition

The standard that is used to operate and communicate.

Cardinality 1..1
Type string
Alternate Names Σ
DeviceDefinition.specialization.version
Element Id DeviceDefinition.specialization.version
Definition

The version of the standard that is used to operate and communicate.

Note This is a business versionId, not a resource version id (see discussion )
Cardinality 0..1
Type string
DeviceDefinition.version
Element Id DeviceDefinition.version
Definition

The available versions of the device, e.g., software versions.

Note This is a business versionId, not a resource version id (see discussion )
Cardinality 0..*
Type string
DeviceDefinition.safety
Element Id DeviceDefinition.safety
Definition

Safety characteristics of the device.

Cardinality 0..*
Terminology Binding Device safety ( Example )
Type CodeableConcept
Summary true
DeviceDefinition.shelfLifeStorage
Element Id DeviceDefinition.shelfLifeStorage
Definition

Shelf Life and storage information.

Cardinality 0..*
Type ProductShelfLife
DeviceDefinition.physicalCharacteristics
Element Id DeviceDefinition.physicalCharacteristics
Definition

Dimensions, Physical characteristics to define or specify the product - for example dimensions, color etc. These can be defined by the manufacturer or labeler, or can be used to specify characteristics when ordering.

Cardinality 0..1
Type ProdCharacteristic
DeviceDefinition.languageCode
Element Id DeviceDefinition.languageCode
Definition

Language code for the human-readable text strings produced by the device (all supported).

Cardinality 0..*
Type CodeableConcept
DeviceDefinition.capability
Element Id DeviceDefinition.capability
Definition

Device capabilities. Additional capabilities that the device is defined or required to have e.g. "water resistant", "long life".

Cardinality 0..*
DeviceDefinition.capability.type
Element Id DeviceDefinition.capability.type
Definition

Type The type of capability. capability - whether it is a physical attribute, a customization needed. For exampl e "water ingress protection".

Cardinality 1..1
Type CodeableConcept
DeviceDefinition.capability.description
Element Id DeviceDefinition.capability.description
Definition

Description The actual capability of capability. the device e.g. IP67.

Cardinality 0..*
Type CodeableConcept
DeviceDefinition.property
Element Id DeviceDefinition.property
Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Cardinality 0..*
DeviceDefinition.property.type
Element Id DeviceDefinition.property.type
Definition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Cardinality 1..1
Type CodeableConcept
DeviceDefinition.property.valueQuantity
Element Id DeviceDefinition.property.valueQuantity
Definition

Property value as a quantity.

Cardinality 0..*
Type Quantity
DeviceDefinition.property.valueCode
Element Id DeviceDefinition.property.valueCode
Definition

Property value as a code, e.g., NTP4 (synced to NTP).

Cardinality 0..*
Type CodeableConcept
DeviceDefinition.owner
Element Id DeviceDefinition.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Cardinality 0..1
Type Reference ( Organization )
DeviceDefinition.contact
Element Id DeviceDefinition.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Cardinality 0..*
Type ContactPoint
Comments

used for troubleshooting etc.

DeviceDefinition.url Element Id DeviceDefinition.url Definition A network address on which the device may be contacted directly. Cardinality 0..1 Type uri Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. DeviceDefinition.onlineInformation
Element Id DeviceDefinition.onlineInformation
Definition

Access to on-line information about the device.

Cardinality 0..1
Type uri
DeviceDefinition.note
Element Id DeviceDefinition.note
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Cardinality 0..*
Type Annotation
DeviceDefinition.quantity
Element Id DeviceDefinition.quantity
Definition

The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).

Cardinality 0..1
Type Quantity
DeviceDefinition.parentDevice
Element Id DeviceDefinition.parentDevice
Definition

The parent device it can be part of.

Cardinality 0..1
Type Reference ( DeviceDefinition )
Summary true
DeviceDefinition.material
Element Id DeviceDefinition.material
Definition

A substance used to create the material(s) of which the device is made.

Cardinality 0..*
DeviceDefinition.material.substance
Element Id DeviceDefinition.material.substance
Definition

The substance. A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.

Cardinality 1..1
Type CodeableConcept
DeviceDefinition.material.alternate
Element Id DeviceDefinition.material.alternate
Definition

Indicates an alternative material of the device.

Cardinality 0..1
Type boolean
DeviceDefinition.material.allergenicIndicator
Element Id DeviceDefinition.material.allergenicIndicator
Definition

Whether the substance is a known or suspected allergen.

Cardinality 0..1
Type boolean