Generated Narrative: StructureDefinition devicedefinition-uv-livd Name Flags Card. Type Description & Constraints DeviceDefinition 0..* DeviceDefinition LIVDDeviceDefinition #xD; identifier 0..0 Instance identifier #xD; udiDeviceIdentifier S 0..1 BackboneElement Unique Device Identifier (UDI) Barcode string #xD; deviceIdentifier S 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier #xD; <a href="StructureDefinition-devicedefinition-uv-livd-definitions.html#DeviceDefinition.udiDeviceIdentifier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :#xA;1) GS1: #xA;http://hl7.org/fhir/NamingSystem/gs1-di, #xA;2) HIBCC:#xA;http://hl7.org/fhir/NamingSystem/hibcc-dI, #xA;3) ICCBBA for blood containers:#xA;http://hl7.org/fhir/NamingSystem/iccbba-blood-di, #xA;4) ICCBA for other devices:#xA;http://hl7.org/fhir/NamingSystem/iccbba-other-di.">issuer S 1..1 uri UDI Issuing Organization #xD; <a href="StructureDefinition-devicedefinition-uv-livd-definitions.html#DeviceDefinition.udiDeviceIdentifier.jurisdiction" title="The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.">jurisdiction S 1..1 uri Regional UDI authority #xD; manufacturer[x] S 1..1 string Name of device manufacturer #xD; deviceName 0..0 A name given to the device to identify it #xD; <a href="StructureDefinition-devicedefinition-uv-livd-definitions.html#DeviceDefinition.modelNumber" title="The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by all the devices sold as the same type. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.">modelNumber S 1..1 string Model id assigned by the manufacturer #xD; type S 0..1 CodeableConcept What kind of device or device system this is Binding: IVD device types for LIVD device definitions VS (extensible): IVD device types for LIVD device definitions (extensible). #xD; specialization 0..0 The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication #xD; version 0..0 Available versions #xD; safety 0..0 Safety characteristics of the device #xD; shelfLifeStorage 0..0 Shelf Life and storage information #xD; physicalCharacteristics 0..0 Dimensions, color etc. #xD; languageCode 0..0 Language code for the human-readable text strings produced by the device (all supported) #xD; capability S 1..* BackboneElement Device capabilities #xD; Slices for extension 1..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:DeviceDefinitionExtensionAnalyte S 1..* Reference(LIVDObservationDefinition) LIVD Test Analyte URL: http://hl7.org/fhir/uv/livd/StructureDefinition/ext-analyte #xD; type S 1..1 CodeableConcept Type of capability #xD; description 0..0 Description of capability #xD; property 0..0 The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties #xD; owner 0..0 Organization responsible for device #xD; contact 0..0 Details for human/organization for support #xD; url 0..0 Network address to contact device #xD; onlineInformation 0..0 Access to on-line information #xD; note 0..0 Device notes and comments #xD; quantity 0..0 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) #xD; Documentation for this format
HL7 International / Orders and Observations
Profile on the DeviceDefinition resource for representing the devices included in the LIVD catalog for which mappings are defined.
The characteristics, operational status and capabilities of a medical-related component of a medical device.
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.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.
Unique Device Identifier (UDI) Barcode string
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.
In this profile only a type of device can be represented where the UDI only identifies the type of the device.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
While the device identifier is a mandatory part of the UDI definition, for this profile the deviceidentifier does not need to be communicated. If it is communicated, it is communicated here. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
OBX-18 (pre-V2.7) or PRT 10 or PRT-16 (V2.7 onward)
The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
This field is required when Device.udi.deviceIdentifier is valued.
All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
A name given to the device to identify it
A name given to the device to identify it.
udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
The type of name the device is referred by.
The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by all the devices sold as the same type. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
The Device.model field is used to map the Device to the correct Concept Map (using ConceptMap.group.source) and IVD Test Code System (using CodeSystem.identifier).
What kind of device or device system this is
What kind of device or device system this is.
IVD device types for LIVD device definitions (extensible).
The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
The standard that is used to operate and communicate
The standard that is used to operate and communicate.
The version of the standard that is used to operate and communicate
The version of the standard that is used to operate and communicate.
The available versions of the device, e.g., software versions.
Language code for the human-readable text strings produced by the device (all supported)
Language code for the human-readable text strings produced by the device (all supported).
Add a reference from DeviceDefinition.capability to one or more ObservationDefinition resources representing test analytes that may be measured.
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
removed "DeviceCapabilityType (ObservationDefinition)" from Value column.
The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Code that specifies the property DeviceDefinitionPropetyCode (Extensible).
Property value as a code, e.g., NTP4 (synced to NTP)
Property value as a code, e.g., NTP4 (synced to NTP).
An organization that is responsible for the provision and ongoing maintenance of the device.
Details for human/organization for support
Contact details for an organization or a particular human that is responsible for the device.
A network address on which the device may be contacted directly.
If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
Access to on-line information about the device.
Descriptive information, usage information or implantation information that is not captured in an existing element.
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)
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).
A substance used to create the material(s) of which the device is made
A substance used to create the material(s) of which the device is made.
Indicates an alternative material of the device
Indicates an alternative material of the device.
Whether the substance is a known or suspected allergen
Whether the substance is a known or suspected allergen.