RDC Interoperability Guide

Device Model & Device Instance

Overview

These "Device" profile defines the master data of the generic device (model number, version of firmware, manufacturer, etc), other instance-level information like Serial Number and Device settings - as properties.

Structure definition - Devices_DeviceModel :

Canonical url - http://roche.com/fhir/iop/StructureDefinition/Devices_DeviceModel

Devices_DeviceModel (Device)	I		Device	There are no (further) constraints on this element Element id Device Short description Item used in healthcare Definition A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: 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-3: 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().ofType(canonical) \| %resource.descendants().ofType(uri) \| %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dev-1: only one Device.name.display SHALL be true when there is more than one Device.name `name.where(display=true).count() <= 1` Mappings rim: n/a rim: Entity. Role, or Act rim: Entity, Role, or Act w5: administrative.device rim: Device interface: Participant
id	Σ	0..1	id	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. Data type id
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition 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. Comments 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 its narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments 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). Data type code Binding IETF language tag for a human language AllLanguages (required) Additional bindings: CommonLanguages (starter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text	I	0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition 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. Comments Contained resources do not have a 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained	I	0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. Comments 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. Data type Resource Mappings rim: n/a rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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 managable, 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition 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 managable, 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). Requirements 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	I	0..0	Identifier	There are no (further) constraints on this element Element id Device.identifier Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason `value.exists()` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.identifier rim: .id interface: Participant.identifier udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
displayName		0..0	string	There are no (further) constraints on this element Element id Device.displayName Short description The name used to display by default when the device is referenced Definition The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.name, or may be another simple name. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
definition		0..0	CodeableReference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Data type CodeableReference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
udiCarrier	Σ	0..0	BackboneElement	There are no (further) constraints on this element Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string 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. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.identifier rim: .id and .code
status	Σ ?!	0..0	codeBinding	There are no (further) constraints on this element Element id Device.status Short description active \| inactive \| entered-in-error Definition The Device record status. This is not the status of the device like availability. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* code Binding The record status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.status rim: .statusCode interface: Participant.active
availabilityStatus		0..0	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.availabilityStatus Short description lost \| damaged \| destroyed \| available Definition The availability of the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceAvailabilityStatus (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.status
biologicalSourceEvent	I	0..0	Identifier	There are no (further) constraints on this element Element id Device.biologicalSourceEvent Short description An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled Alternate names Distinct Identification Code (DIC) Definition An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled. Comments Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason `value.exists()` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.what[x]
manufacturer		0..0	string	There are no (further) constraints on this element Element id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer or entity legally responsible for the device. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Comments UTC offset is allowed for dates and partial dates Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The date and time beyond which this device is no longer valid or should not be used (if applicable). Comments UTC offset is allowed for dates and partial dates Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..0	string	There are no (further) constraints on this element Element id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..0	string	There are no (further) constraints on this element Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. Comments Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
name	I	0..0	BackboneElement	There are no (further) constraints on this element Element id Device.name Short description The name or names of the device as known to the manufacturer and/or patient Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a interface: Participant.name
modelNumber		0..1	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The manufacturer's model number for the device Definition The manufacturer's model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..0	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number or catalog number of the device Definition The part number or catalog number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
category		0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.category Short description Indicates a high-level grouping of the device Definition Devices may be associated with one or more categories. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Categories of medical devices. FHIRDeviceCategory (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
type		0..*	CodeableConceptBinding	Element id Device.type Short description The kind or type of device Definition The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device. Comments Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor. Data type CodeableConcept Binding Codes to identify medical devices. device-kind (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
conformsTo		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.conformsTo Short description Identifies the standards, specifications, or formal guidances for the capabilities supported by the device Definition Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
property		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. Definition Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes. Comments Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
mode		0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.mode Short description The designated condition for performing a task Definition The designated condition for performing a task with the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Operational mode of a device. FHIRDeviceOperationMode (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
cycle	I	0..0	Count	There are no (further) constraints on this element Element id Device.cycle Short description The series of occurrences that repeats during the operation of the device Definition The series of occurrences that repeats during the operation of the device. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Count Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` cnt-3: There SHALL be a code with a value of "1" if there is a value. If system is present, it SHALL be UCUM. If present, the value SHALL be a whole number. `(code.exists() or value.empty()) and (system.empty() or system = %ucum) and (code.empty() or code = '1') and (value.empty() or value.hasValue().not() or value.toString().contains('.').not())` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
duration	I	0..0	Duration	There are no (further) constraints on this element Element id Device.duration Short description A measurement of time during the device's operation (e.g., days, hours, mins, etc.) Definition A measurement of time during the device's operation (e.g., days, hours, mins, etc.). Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Duration Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` drt-1: There SHALL be a code if there is a value and it SHALL be an expression of time. If system is present, it SHALL be UCUM. `code.exists() implies ((system = %ucum) and value.exists())` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values rim: PQ, IVL<PQ> depending on the values
owner	I	0..0	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact	I	0..0	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location	I	0..0	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..0	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.where[x] rim: .telecom
endpoint	I	0..0	Reference(Endpoint)	There are no (further) constraints on this element Element id Device.endpoint Short description Technical endpoints providing access to electronic services provided by the device Definition Technical endpoints providing access to services provided by the device defined at this resource. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Endpoint) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
gateway		0..0	CodeableReference(Device)	There are no (further) constraints on this element Element id Device.gateway Short description Linked device acting as a communication/data collector, translator or controller Definition The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data). Comments The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead. Data type CodeableReference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
note		0..0	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
safety	Σ	0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding DeviceSafety (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA
parent	I	0..0	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The higher level or encompassing device that this device is a logical part of Definition The higher level or encompassing device that this device is a logical part of. Comments For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Attribute description :

Attribute	Description	Terminology reference
modelNumber	Model number referred to a uniquely identified device.
Type	Categorization of a device by its nature.	device-kind

Structure definition - Devices_DeviceInstance :

Canonical url - http://roche.com/fhir/iop/StructureDefinition/Devices_DeviceInstance

Devices_DeviceInstance (Device)	I		Device	There are no (further) constraints on this element Element id Device Short description Item used in healthcare Definition A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: 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-3: 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().ofType(canonical) \| %resource.descendants().ofType(uri) \| %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` dev-1: only one Device.name.display SHALL be true when there is more than one Device.name `name.where(display=true).count() <= 1` Mappings rim: n/a rim: Entity. Role, or Act rim: Entity, Role, or Act w5: administrative.device rim: Device interface: Participant
id	Σ	0..1	id	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. Data type id
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition 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. Comments 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 its narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments 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). Data type code Binding IETF language tag for a human language AllLanguages (required) Additional bindings: CommonLanguages (starter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text	I	0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition 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. Comments Contained resources do not have a 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained	I	0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. Comments 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. Data type Resource Mappings rim: n/a rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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 managable, 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
deviceSettings	I	0..*	Extension(Complex)	Element id Device.extension:deviceSettings Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments 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. Data type Extension(Complex) Extension URL http://roche.com/fhir/iop/StructureDefinition/DeviceSettings Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition 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 managable, 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). Requirements 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	I	0..0	Identifier	There are no (further) constraints on this element Element id Device.identifier Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. Comments Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason `value.exists()` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.identifier rim: .id interface: Participant.identifier udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
displayName		0..0	string	There are no (further) constraints on this element Element id Device.displayName Short description The name used to display by default when the device is referenced Definition The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.name, or may be another simple name. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
definition		0..0	CodeableReference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Data type CodeableReference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
udiCarrier	Σ	0..0	BackboneElement	There are no (further) constraints on this element Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string 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. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.identifier rim: .id and .code
status	Σ ?!	0..0	codeBinding	There are no (further) constraints on this element Element id Device.status Short description active \| inactive \| entered-in-error Definition The Device record status. This is not the status of the device like availability. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* code Binding The record status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.status rim: .statusCode interface: Participant.active
availabilityStatus		0..0	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.availabilityStatus Short description lost \| damaged \| destroyed \| available Definition The availability of the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceAvailabilityStatus (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.status
biologicalSourceEvent	I	0..0	Identifier	There are no (further) constraints on this element Element id Device.biologicalSourceEvent Short description An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled Alternate names Distinct Identification Code (DIC) Definition An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled. Comments Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ident-1: Identifier with no value has limited utility. If communicating that an identifier value has been suppressed or missing, the value element SHOULD be present with an extension indicating the missing semantic - e.g. data-absent-reason `value.exists()` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: FiveWs.what[x]
manufacturer		0..0	string	There are no (further) constraints on this element Element id Device.manufacturer Short description Name of device manufacturer Definition A name of the manufacturer or entity legally responsible for the device. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Comments UTC offset is allowed for dates and partial dates Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The date and time beyond which this device is no longer valid or should not be used (if applicable). Comments UTC offset is allowed for dates and partial dates Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		0..0	string	There are no (further) constraints on this element Element id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		0..1	string	There are no (further) constraints on this element Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition The serial number assigned by the organization when the device was manufactured. Comments Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
name	I	0..0	BackboneElement	There are no (further) constraints on this element Element id Device.name Short description The name or names of the device as known to the manufacturer and/or patient Definition This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a interface: Participant.name
modelNumber		0..0	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The manufacturer's model number for the device Definition The manufacturer's model number for the device. Comments Note that FHIR strings SHALL NOT exceed 1,048,576 (10241024) characters in size Data type* string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..0	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number or catalog number of the device Definition The part number or catalog number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
category		0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.category Short description Indicates a high-level grouping of the device Definition Devices may be associated with one or more categories. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Categories of medical devices. FHIRDeviceCategory (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
type		0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.type Short description The kind or type of device Definition The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device. Comments Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor. Data type CodeableConcept Binding Codes to identify medical devices. DeviceType (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
version		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
conformsTo		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.conformsTo Short description Identifies the standards, specifications, or formal guidances for the capabilities supported by the device Definition Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
property		0..0	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. Definition Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes. Comments Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
mode		0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.mode Short description The designated condition for performing a task Definition The designated condition for performing a task with the device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Operational mode of a device. FHIRDeviceOperationMode (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
cycle	I	0..0	Count	There are no (further) constraints on this element Element id Device.cycle Short description The series of occurrences that repeats during the operation of the device Definition The series of occurrences that repeats during the operation of the device. Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Count Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` cnt-3: There SHALL be a code with a value of "1" if there is a value. If system is present, it SHALL be UCUM. If present, the value SHALL be a whole number. `(code.exists() or value.empty()) and (system.empty() or system = %ucum) and (code.empty() or code = '1') and (value.empty() or value.hasValue().not() or value.toString().contains('.').not())` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values
duration	I	0..0	Duration	There are no (further) constraints on this element Element id Device.duration Short description A measurement of time during the device's operation (e.g., days, hours, mins, etc.) Definition A measurement of time during the device's operation (e.g., days, hours, mins, etc.). Comments The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. Data type Duration Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` qty-3: If a code for the unit is present, the system SHALL also be present `code.empty() or system.exists()` drt-1: There SHALL be a code if there is a value and it SHALL be an expression of time. If system is present, it SHALL be UCUM. `code.exists() implies ((system = %ucum) and value.exists())` Mappings rim: n/a v2: SN (see also Range) or CQ rim: PQ, IVL<PQ>, MO, CO, depending on the values rim: PQ, IVL<PQ> depending on the values
owner	I	0..0	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact	I	0..0	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location	I	0..0	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..0	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.where[x] rim: .telecom
endpoint	I	0..0	Reference(Endpoint)	There are no (further) constraints on this element Element id Device.endpoint Short description Technical endpoints providing access to electronic services provided by the device Definition Technical endpoints providing access to services provided by the device defined at this resource. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Endpoint) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
gateway		0..0	CodeableReference(Device)	There are no (further) constraints on this element Element id Device.gateway Short description Linked device acting as a communication/data collector, translator or controller Definition The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data). Comments The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead. Data type CodeableReference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
note		0..0	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
safety	Σ	0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding DeviceSafety (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA
parent	I	0..1	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The higher level or encompassing device that this device is a logical part of Definition The higher level or encompassing device that this device is a logical part of. Comments For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))` ref-2: At least one of reference, identifier and display SHALL be present (unless an extension is provided). `reference.exists() or identifier.exists() or display.exists() or extension.exists()` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Attribute description :

Attribute	Description	Terminology reference
serial number	Unique Device Business Identifier.
Parent	Hierarchical relationship to other Device that controls this instance.
extension : settings	Properties defined as settings for the device's functioning.	device-settings-codes

Data Flow for Device(s) profiles :

Could not find subject. Project was not found for Devices-diagram.

Data Flow for write action :

Could not find subject. Project was not found for devices-dataflow.

1. 'Devices_DeviceModel' needs to be send as first resource (if not available prior)
2. 'Devices_DeviceInstance' should be send next with reference to parent resource 'Devices_DeviceModel' (if not available prior)

Device Model & Device Instance

Extensions

DeviceSettings

Examples