VMD DeviceComponent Profile
Canonical URL
http://devices.fhir.org/StructureDefinition/VmdDeviceComponent
Profile Definition
DeviceComponent | I | DeviceComponent | There are no (further) constraints on this element Element idDeviceComponent An instance of a medical-related component of a medical device DefinitionThe characteristics, operational status and capabilities of a medical-related component of a medical device. For the initial scope, this DeviceComponent resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel. DeviceComponent Constraints
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id | Σ | 0..1 | id | There are no (further) constraints on this element Element idDeviceComponent.id Logical id of this artifact DefinitionThe 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. id Constraints
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meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idDeviceComponent.meta Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource. Meta Constraints
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idDeviceComponent.implicitRules A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. uri Constraints
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idDeviceComponent.language Language of the resource content DefinitionThe 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). code BindingA human language. ?? (extensible)Constraints
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text | I | 0..1 | Narrative | There are no (further) constraints on this element Element idDeviceComponent.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource, and may 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 in formation is added later. Narrative Constraints
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contained | 0..* | Resource | There are no (further) constraints on this element Element idDeviceComponent.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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. Resource Mappings
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extension | I | 0..* | Extension | Element idDeviceComponent.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. In order 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. 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. Extension Sliced:Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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instance | I | 0..1 | Extension(unsignedInt) | Element idDeviceComponent.extension:instance Instance number Alternate namesextensions, user content DefinitionIf multiple instances of the same VMD type exist, the devicecomponent-instance extension allows to define a sequence. 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. Extension(unsignedInt) Extension URLhttp://devices.fhir.org/StructureDefinition/devicecomponent-instance Constraints
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modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idDeviceComponent.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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. Usually modifier elements provide negation or qualification. In order 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. 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. Extension Sliced:Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | Σ | 1..1 | Identifier | There are no (further) constraints on this element Element idDeviceComponent.identifier Instance id assigned by the software stack DefinitionThe locally assigned unique identification by the software. For example: handle ID. Identifier Constraints
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type | Σ | 1..1 | CodeableConceptBinding | Element idDeviceComponent.type Virtual Medical Device (VMD) type DefinitionDeviceComponent.type shall have a coding from the ISO/IEEE 11073 MDC device nomenclature. The Rosetta Terminology Mapping Management System (RTMMS) lists available codes. DeviceComponent.type.coding allows additional coding from other code systems. DeviceComponent.type can be referred to either GDMN (nomenclature system supported by FDA Global UDI Database) or preferable RTMMS coding system. CodeableConcept BindingDescribes the type of the component. ?? (preferred)Constraints
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id | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.type.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size string Constraints
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDeviceComponent.type.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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. 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. Extension Sliced:Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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coding | Σ | 1..* | Coding | Element idDeviceComponent.type.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Coding Sliced:Unordered, Open, by system(Value) Constraints
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11073MDC | Σ | 1..1 | Coding | Element idDeviceComponent.type.coding:11073MDC 11073 MDC code DefinitionCode defined by the ISO/IEEE 11073-10101 Nomenclature Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Coding Constraints
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id | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size string Constraints
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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. 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. Extension Sliced:Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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system | Σ | 1..1 | uriFixed Value | Element idDeviceComponent.type.coding:11073MDC.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously. uri Constraints
urn:iso:std:iso:11073:10101
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version | Σ | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.version Version of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. string Constraints
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code | Σ | 1..1 | code | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.code Symbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Need to refer to a particular code in the system. Note that FHIR strings may not exceed 1MB in size code Constraints
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display | Σ | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Note that FHIR strings may not exceed 1MB in size string Constraints
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userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idDeviceComponent.type.coding:11073MDC.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. boolean Constraints
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text | Σ | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.type.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings. string Constraints
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lastSystemChange | Σ | 0..1 | instant | There are no (further) constraints on this element Element idDeviceComponent.lastSystemChange Recent system change timestamp DefinitionThe timestamp for the most recent system change which includes device configuration or setting change. Note: This is intended for precisely observed times, typically system logs etc., and not human-reported times - for them, see date and dateTime below. Time zone is always required instant Constraints
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source | Σ I | 1..1 | Reference(PoC Device Profile) | Element idDeviceComponent.source Top-level device resource link DefinitionDeviceComponent.source shall be present and refer to a Device resource according to the PoC Device profile. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (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. Reference(PoC Device Profile) Constraints
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parent | Σ I | 1..1 | Reference(MDS DeviceComponent Profile) | Element idDeviceComponent.parent Parent resource link DefinitionDeviceComponent.parent is a reference to the next upper level DeviceComponent resource. For VMD DeviceComponent, it shall be present and refer to a MDS DeviceComponent. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (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. Reference(MDS DeviceComponent Profile) Constraints
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operationalStatus | Σ | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idDeviceComponent.operationalStatus Current operational status of the component, for example On, Off or Standby DefinitionThe current operational status of the device. For example: On, Off, Standby, etc. OperationalStatus for the MDS, VMD, or Channel will be bound to a specific ValueSet that is defined in its profile. CodeableConcept BindingCodes representing the current status of the device - on, off, suspended, etc. ?? (extensible)Constraints
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parameterGroup | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idDeviceComponent.parameterGroup Current supported parameter group DefinitionThe parameter group supported by the current device component that is based on some nomenclature, e.g. cardiovascular. 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. CodeableConcept BindingCodes identifying groupings of parameters; e.g. Cardiovascular. ?? (extensible)Constraints
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measurementPrinciple | Σ | 0..1 | codeBinding | There are no (further) constraints on this element Element idDeviceComponent.measurementPrinciple other | chemical | electrical | impedance | nuclear | optical | thermal | biological | mechanical | acoustical | manual+ DefinitionThe physical principle of the measurement. For example: thermal, chemical, acoustical, etc. Note that FHIR strings may not exceed 1MB in size code BindingDifferent measurement principle supported by the device. ?? (required)Constraints
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productionSpecification | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification Specification details such as Component Revisions, or Serial Numbers DefinitionThe production specification such as component revision, serial number, etc. BackboneElement Constraints
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id | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size string Constraints
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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. 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. Extension Sliced:Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content, modifiers DefinitionMay 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 that contains it. Usually modifier elements provide negation or qualification. In order 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. 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. Extension Constraints
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specType | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.specType Type or kind of production specification, for example serial number or software revision DefinitionThe specification type, such as, serial number, part number, hardware revision, software revision, etc. 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. CodeableConcept BindingCodes for device specification types such as serial number, part number, hardware revision, software revision, etc. ?? (extensible)Constraints
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componentId | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.componentId Internal component unique identification DefinitionThe internal component unique identification. This is a provision for manufacture specific standard components using a private OID. 11073-10101 has a partition for private OID semantic that the manufacturer can make use of. Identifier Constraints
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productionSpec | Σ | 0..1 | string | There are no (further) constraints on this element Element idDeviceComponent.productionSpecification.productionSpec A printable string defining the component DefinitionThe printable string defining the component. Note that FHIR strings may not exceed 1MB in size string Constraints
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languageCode | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idDeviceComponent.languageCode Language code for the human-readable text strings produced by the device DefinitionThe language code for the human-readable text string produced by the device. This language code will follow the IETF language tag. Example: en-US. 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. CodeableConcept BindingA human language. ?? (extensible)Constraints
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Example (XML view)
Example of an ECG VMD DeviceComponent
<DeviceComponent xmlns="http://hl7.org/fhir"> <id value="428" /> <meta> <profile value="http://devices.fhir.org/StructureDefinition/VmdDeviceComponent" /> </meta> <identifier> <use value="temp" /> <system value="urn:ietf:rfc:3986" /> <value value="urn:uuid:64b1772b-e383-4aa7-b2f8-3610124a4e07" /> </identifier> <type> <coding> <system value="urn:iso:std:iso:11073:10101" /> <code value="69798" /> <display value="MDC_DEV_ECG_VMD" /> </coding> </type> <source> <reference value="Device/72" /> </source> <parent> <reference value="DeviceComponent/427" /> </parent> <operationalStatus> <coding> <system value="http://hl7.org/fhir/operational-status" /> <code value="on" /> <display value="On" /> </coding> </operationalStatus> <parameterGroup> <coding> <system value="http://hl7.org/fhir/parameter-group" /> <code value="ecg" /> <display value="ECG Parameter Group" /> </coding> </parameterGroup> </DeviceComponent>
Example (JSON view)
Example of an ECG VMD DeviceComponent
{ "resourceType": "DeviceComponent", "id": "428", "meta": { "profile": [ "http://devices.fhir.org/StructureDefinition/VmdDeviceComponent" ] }, "identifier": { "use": "temp", "system": "urn:ietf:rfc:3986", "value": "urn:uuid:64b1772b-e383-4aa7-b2f8-3610124a4e07" }, "type": { "coding": [ { "system": "urn:iso:std:iso:11073:10101", "code": "69798", "display": "MDC_DEV_ECG_VMD" } ] }, "source": { "reference": "Device/72" }, "parent": { "reference": "DeviceComponent/427" }, "operationalStatus": [ { "coding": [ { "system": "http://hl7.org/fhir/operational-status", "code": "on", "display": "On" } ] } ], "parameterGroup": { "coding": [ { "system": "http://hl7.org/fhir/parameter-group", "code": "ecg", "display": "ECG Parameter Group" } ] } }