Release 5 Preview #2
Orders and Observations Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the DeviceDefinition resource.

DeviceDefinition
Element IdDeviceDefinition
Definition

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

Cardinality0..*
TypeDomainResource
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 IdDeviceDefinition.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 identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
DeviceDefinition.udiDeviceIdentifier
Element IdDeviceDefinition.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.

Cardinality0..*
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Element IdDeviceDefinition.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.

Cardinality1..1
Typestring
DeviceDefinition.udiDeviceIdentifier.issuer
Element IdDeviceDefinition.udiDeviceIdentifier.issuer
Definition

The organization that assigns the identifier algorithm.

Cardinality1..1
Typeuri
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Element IdDeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality1..1
Typeuri
DeviceDefinition.manufacturer[x]
Element IdDeviceDefinition.manufacturer[x]
Definition

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

Cardinality0..1
Typestring|Reference(Organization)
[x] NoteSee Choice of Data Types for further information about how to use [x]
DeviceDefinition.deviceName
Element IdDeviceDefinition.deviceName
Definition

The name or names of the device as given by the manufacturer.

Cardinality0..*
DeviceDefinition.deviceName.name
Element IdDeviceDefinition.deviceName.name
Definition

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

Cardinality1..1
Typestring
Alternate NamesΣ
DeviceDefinition.deviceName.type
Element IdDeviceDefinition.deviceName.type
Definition

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

Cardinality1..1
Terminology BindingDeviceNameType (Required)
Typecode
DeviceDefinition.modelNumber
Element IdDeviceDefinition.modelNumber
Definition

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

Cardinality0..1
Typestring
DeviceDefinition.type
Element IdDeviceDefinition.type
Definition

What kind of device or device system this is.

Cardinality0..1
Terminology BindingFHIR Device Types (Example)
TypeCodeableConcept
DeviceDefinition.specialization
Element IdDeviceDefinition.specialization
Definition

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

Cardinality0..*
DeviceDefinition.specialization.systemType
Element IdDeviceDefinition.specialization.systemType
Definition

The standard that is used to operate and communicate.

Cardinality1..1
Typestring
Alternate NamesΣ
DeviceDefinition.specialization.version
Element IdDeviceDefinition.specialization.version
Definition

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

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
DeviceDefinition.version
Element IdDeviceDefinition.version
Definition

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

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..*
Typestring
DeviceDefinition.safety
Element IdDeviceDefinition.safety
Definition

Safety characteristics of the device.

Cardinality0..*
Terminology BindingDevice safety (Example)
TypeCodeableConcept
Summarytrue
DeviceDefinition.shelfLifeStorage
Element IdDeviceDefinition.shelfLifeStorage
Definition

Shelf Life and storage information.

Cardinality0..*
TypeProductShelfLife
DeviceDefinition.physicalCharacteristics
Element IdDeviceDefinition.physicalCharacteristics
Definition

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.

Cardinality0..1
TypeProdCharacteristic
DeviceDefinition.languageCode
Element IdDeviceDefinition.languageCode
Definition

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

Cardinality0..*
TypeCodeableConcept
DeviceDefinition.capability
Element IdDeviceDefinition.capability
Definition

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

Cardinality0..*
DeviceDefinition.capability.type
Element IdDeviceDefinition.capability.type
Definition

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

Cardinality1..1
TypeCodeableConcept
DeviceDefinition.capability.description
Element IdDeviceDefinition.capability.description
Definition

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

Cardinality0..*
TypeCodeableConcept
DeviceDefinition.property
Element IdDeviceDefinition.property
Definition

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

Cardinality0..*
DeviceDefinition.property.type
Element IdDeviceDefinition.property.type
Definition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Cardinality1..1
TypeCodeableConcept
DeviceDefinition.property.valueQuantity
Element IdDeviceDefinition.property.valueQuantity
Definition

Property value as a quantity.

Cardinality0..*
TypeQuantity
DeviceDefinition.property.valueCode
Element IdDeviceDefinition.property.valueCode
Definition

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

Cardinality0..*
TypeCodeableConcept
DeviceDefinition.owner
Element IdDeviceDefinition.owner
Definition

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

Cardinality0..1
TypeReference(Organization)
DeviceDefinition.contact
Element IdDeviceDefinition.contact
Definition

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

Cardinality0..*
TypeContactPoint
Comments

used for troubleshooting etc.

DeviceDefinition.onlineInformation
Element IdDeviceDefinition.onlineInformation
Definition

Access to on-line information about the device.

Cardinality0..1
Typeuri
DeviceDefinition.note
Element IdDeviceDefinition.note
Definition

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

Cardinality0..*
TypeAnnotation
DeviceDefinition.quantity
Element IdDeviceDefinition.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).

Cardinality0..1
TypeQuantity
DeviceDefinition.parentDevice
Element IdDeviceDefinition.parentDevice
Definition

The parent device it can be part of.

Cardinality0..1
TypeReference(DeviceDefinition)
Summarytrue
DeviceDefinition.material
Element IdDeviceDefinition.material
Definition

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

Cardinality0..*
DeviceDefinition.material.substance
Element IdDeviceDefinition.material.substance
Definition

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.

Cardinality1..1
TypeCodeableConcept
DeviceDefinition.material.alternate
Element IdDeviceDefinition.material.alternate
Definition

Indicates an alternative material of the device.

Cardinality0..1
Typeboolean
DeviceDefinition.material.allergenicIndicator
Element IdDeviceDefinition.material.allergenicIndicator
Definition

Whether the substance is a known or suspected allergen.

Cardinality0..1
Typeboolean