HL7® Iniciativa Costa Rica

Guía de Implementación Core de Costa Rica
0.1.0 - ci-build Costa Rica bandera

Guía de Implementación Core de Costa Rica - Versión en desarrollo (v0.1.0): no se debe usar en producción. Es un borrador en discusión en las mesas de trabajo de la Iniciativa HL7® Costa Rica y cambia sin aviso. Vea el ciclo de vida de las guías.

Perfil de los recursos: Dispositivo - Descripciones detalladas

Estado de las normas de la página: Draft Nivel de madurez: 0

Definiciones del cr-device perfil de los recursos.

Las indicaciones para interpretar el contenido de esta tabla estánaquí

0. Device
Definición

Instancia de software o equipo físico usado en salud en Costa Rica. Los perfiles derivados especifican los datos técnicos y usos clínicos de cada clase.


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.

ResumenDispositivo: perfil base nacional para software o equipo físicoItem used in healthcare
Control0..*
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
cr-device-identificacion: La instancia del dispositivo tiene un identificador o número de serie; un UDI que solo identifica el modelo no basta. (identifier.exists() or serialNumber.exists())
2. Device.implicitRules
Definición

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.

ResumenA set of rules under which this content was created
Comentarios

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.

Control0..1
Tipouri
Es modificadortrue porque This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.contained
Definición

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.

ResumenContained, inline Resources
Comentarios

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.

Control0..*
Este elemento está afectado por las siguientes invariantes: dom-2, dom-4, dom-3, dom-5
TipoResource
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosinline resources, anonymous resources, contained resources
6. Device.modifierExtension
Definición

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).

ResumenExtensions that cannot be ignored
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content
Invariantesele-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())
8. Device.identifier
Definición

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

ResumenIdentificador de instancia del dispositivo, cuando aplicaInstance identifier
Comentarios

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.

NotaThis is a business identifier, not a resource identifier (see discusión)
Control0..*
TipoIdentifier
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.displayName
Definición

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.

ResumenNombre visible del dispositivoThe name used to display by default when the device is referenced
Control10..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumenfalse
Max Length:250
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.udiCarrier
Definición

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.

ResumenUDI del dispositivo, cuando aplica; no sustituye el identificador de instanciaUnique Device Identifier (UDI) Barcode string
Comentarios

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.


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.

Control0..*
TipoBackboneElement
Es modificadorfalse
Must Supporttrue
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Device.udiCarrier.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
16. Device.udiCarrier.deviceIdentifier
Definición

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

ResumenMandatory fixed portion of UDI
Control1..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosDI
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Device.udiCarrier.issuer
Definición

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
ResumenUDI Issuing Organization
Control1..1
Tipouri
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosBarcode System
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Device.status
Definición

The Device record status. This is not the status of the device like availability.

ResumenEstado del registro: active | inactive | entered-in-erroractive | inactive | entered-in-error
Control10..1
VinculaciónLos códigos DEBEN tomarse de FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|5.0.0
(required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

The record status of the device.

Tipocode
Es modificadortrue porque This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.serialNumber
Definición

The serial number assigned by the organization when the device was manufactured.

ResumenNúmero de serie de la instancia, cuando aplicaSerial number assigned by the manufacturer
Comentarios

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_.

Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.category
Definición

Devices may be associated with one or more categories.

ResumenCategoría: software u otra categoría de dispositivoIndicates a high-level grouping of the device
Control10..*
VinculaciónPara códigos de ejemplo, vea FHIRDeviceCategoryhttp://hl7.org/fhir/ValueSet/device-category|5.0.0
(example to http://hl7.org/fhir/ValueSet/device-category|5.0.0)

Categories of medical devices.

TipoCodeableConcept
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.type
Definición

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.

ResumenTipo o función principal del dispositivoThe kind or type of device
Comentarios

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.

Control10..1*
VinculaciónPara códigos de ejemplo, vea DeviceTypehttp://hl7.org/fhir/ValueSet/device-type|5.0.0
(example to http://hl7.org/fhir/ValueSet/device-type|5.0.0)

Codes to identify medical devices.

TipoCodeableConcept
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Device.owner
Definición

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

ResumenOrganización responsable de operar el dispositivo, cuando se conoceOrganization responsible for device
Control0..1
TipoReference(Organización, Organization)
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Las indicaciones para interpretar el contenido de esta tabla estánaquí

0. Device
Definición

Instancia de software o equipo físico usado en salud en Costa Rica. Los perfiles derivados especifican los datos técnicos y usos clínicos de cada clase.

ResumenDispositivo: perfil base nacional para software o equipo físico
Invariantescr-device-identificacion: La instancia del dispositivo tiene un identificador o número de serie; un UDI que solo identifica el modelo no basta. (identifier.exists() or serialNumber.exists())
2. Device.identifier
ResumenIdentificador de instancia del dispositivo, cuando aplica
NotaThis is a business identifier, not a resource identifier (see discusión)
Must Supporttrue
4. Device.displayName
ResumenNombre visible del dispositivo
Control1..?
Must Supporttrue
Max Length:250
6. Device.udiCarrier
ResumenUDI del dispositivo, cuando aplica; no sustituye el identificador de instancia
Must Supporttrue
8. Device.status
ResumenEstado del registro: active | inactive | entered-in-error
Control1..?
Must Supporttrue
10. Device.serialNumber
ResumenNúmero de serie de la instancia, cuando aplica
Must Supporttrue
12. Device.category
ResumenCategoría: software u otra categoría de dispositivo
Control1..?
Must Supporttrue
14. Device.type
ResumenTipo o función principal del dispositivo
Control1..1
Must Supporttrue
16. Device.owner
ResumenOrganización responsable de operar el dispositivo, cuando se conoce
TipoReference(Organización)
Must Supporttrue

Las indicaciones para interpretar el contenido de esta tabla estánaquí

0. Device
Definición

Instancia de software o equipo físico usado en salud en Costa Rica. Los perfiles derivados especifican los datos técnicos y usos clínicos de cada clase.

ResumenDispositivo: perfil base nacional para software o equipo físico
Control0..*
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesdev-1: only one Device.name.display SHALL be true when there is more than one Device.name (name.where(display=true).count() <= 1)
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
cr-device-identificacion: La instancia del dispositivo tiene un identificador o número de serie; un UDI que solo identifica el modelo no basta. (identifier.exists() or serialNumber.exists())
2. Device.id
Definición

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ResumenLogical id of this artifact
Comentarios

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.

Control0..1
Tipoid
Es modificadorfalse
Must Supportfalse
Resumentrue
4. Device.meta
Definición

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.

ResumenMetadata about the resource
Control0..1
TipoMeta
Es modificadorfalse
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Device.implicitRules
Definición

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.

ResumenA set of rules under which this content was created
Comentarios

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.

Control0..1
Tipouri
Es modificadortrue porque This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Device.language
Definición

The base language in which the resource is written.

ResumenLanguage of the resource content
Comentarios

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).

Control0..1
VinculaciónLos códigos DEBEN tomarse de AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

IETF language tag for a human language

Tipocode
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.text
Definición

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.

ResumenText summary of the resource, for human interpretation
Comentarios

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.

Control0..1
Este elemento está afectado por las siguientes invariantes: dom-6
TipoNarrative
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosnarrative, html, xhtml, display
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.contained
Definición

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.

ResumenContained, inline Resources
Comentarios

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.

Control0..*
Este elemento está afectado por las siguientes invariantes: dom-2, dom-4, dom-3, dom-5
TipoResource
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosinline resources, anonymous resources, contained resources
14. Device.extension
Definición

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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
16. Device.modifierExtension
Definición

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).

ResumenExtensions that cannot be ignored
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content
Invariantesele-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())
18. Device.identifier
Definición

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

ResumenIdentificador de instancia del dispositivo, cuando aplica
Comentarios

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.

NotaThis is a business identifier, not a resource identifier (see discusión)
Control0..*
TipoIdentifier
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Device.displayName
Definición

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.

ResumenNombre visible del dispositivo
Control1..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumenfalse
Max Length:250
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.definition
Definición

The reference to the definition for the device.

ResumenThe reference to the definition for the device
Control0..1
TipoCodeableReference(DeviceDefinition)
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.udiCarrier
Definición

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.

ResumenUDI del dispositivo, cuando aplica; no sustituye el identificador de instancia
Comentarios

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.

Control0..*
TipoBackboneElement
Es modificadorfalse
Must Supporttrue
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.udiCarrier.id
Definición

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ResumenUnique id for inter-element referencing
Control0..1
Este elemento está afectado por las siguientes invariantes: ele-1
Tipostring
Es modificadorfalse
Formato XMLEn el formato XML, esta propiedad se representa como un atributo.
Resumenfalse
28. Device.udiCarrier.extension
Definición

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
30. Device.udiCarrier.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
32. Device.udiCarrier.deviceIdentifier
Definición

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

ResumenMandatory fixed portion of UDI
Control1..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosDI
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Device.udiCarrier.issuer
Definición

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
ResumenUDI Issuing Organization
Control1..1
Tipouri
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosBarcode System
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Device.udiCarrier.jurisdiction
Definición

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

ResumenRegional UDI authority
Control0..1
Tipouri
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Requisitos

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Device.udiCarrier.carrierAIDC
Definición

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

ResumenUDI Machine Readable Barcode String
Comentarios

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Control0..1
Tipobase64Binary
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosAutomatic Identification and Data Capture
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Device.udiCarrier.carrierHRF
Definición

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

ResumenUDI Human Readable Barcode String
Comentarios

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosHuman Readable Form
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Device.udiCarrier.entryType
Definición

A coded entry to indicate how the data was entered.

Resumenbarcode | rfid | manual | card | self-reported | electronic-transmission | unknown
Control0..1
VinculaciónLos códigos DEBEN tomarse de UDIEntryType
(required to http://hl7.org/fhir/ValueSet/udi-entry-type|5.0.0)

Codes to identify how UDI data was entered.

Tipocode
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Requisitos

Supports a way to distinguish hand entered from machine read data.

Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Device.status
Definición

The Device record status. This is not the status of the device like availability.

ResumenEstado del registro: active | inactive | entered-in-error
Control1..1
VinculaciónLos códigos DEBEN tomarse de FHIRDeviceStatus
(required to http://hl7.org/fhir/ValueSet/device-status|5.0.0)

The record status of the device.

Tipocode
Es modificadortrue porque This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Device.availabilityStatus
Definición

The availability of the device.

Resumenlost | damaged | destroyed | available
Control0..1
VinculaciónSalvo que no sean adecuados, estos códigos DEBEN tomarse de FHIRDeviceAvailabilityStatus
(extensible to http://hl7.org/fhir/ValueSet/device-availability-status|5.0.0)

The availability status reason of the device.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Device.biologicalSourceEvent
Definición

An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

ResumenAn identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
Comentarios

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.

Control0..1
TipoIdentifier
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosDistinct Identification Code (DIC)
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Device.manufacturer
Definición

A name of the manufacturer or entity legally responsible for the device.

ResumenName of device manufacturer
Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Device.manufactureDate
Definición

The date and time when the device was manufactured.

ResumenDate when the device was made
Control0..1
TipodateTime
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Device.expirationDate
Definición

The date and time beyond which this device is no longer valid or should not be used (if applicable).

ResumenDate and time of expiry of this device (if applicable)
Control0..1
TipodateTime
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Device.lotNumber
Definición

Lot number assigned by the manufacturer.

ResumenLot number of manufacture
Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Device.serialNumber
Definición

The serial number assigned by the organization when the device was manufactured.

ResumenNúmero de serie de la instancia, cuando aplica
Comentarios

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_.

Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Device.name
Definición

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.

ResumenThe name or names of the device as known to the manufacturer and/or patient
Control0..*
Este elemento está afectado por las siguientes invariantes: dev-1
TipoBackboneElement
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Device.name.id
Definición

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ResumenUnique id for inter-element referencing
Control0..1
Este elemento está afectado por las siguientes invariantes: ele-1
Tipostring
Es modificadorfalse
Formato XMLEn el formato XML, esta propiedad se representa como un atributo.
Resumenfalse
64. Device.name.extension
Definición

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
66. Device.name.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
68. Device.name.value
Definición

The actual name that identifies the device.

ResumenThe term that names the device
Control1..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Nombres alternativosΣ
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Device.name.type
Definición

Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

Resumenregistered-name | user-friendly-name | patient-reported-name
Control1..1
VinculaciónLos códigos DEBEN tomarse de DeviceNameType
(required to http://hl7.org/fhir/ValueSet/device-nametype|5.0.0)

The type of name the device is referred by.

Tipocode
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Device.name.display
Definición

Indicates the default or preferred name to be displayed.

ResumenThe preferred device name
Control0..1
Este elemento está afectado por las siguientes invariantes: dev-1
Tipoboolean
Es modificadortrue porque This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Device.modelNumber
Definición

The manufacturer's model number for the device.

ResumenThe manufacturer's model number for the device
Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Device.partNumber
Definición

The part number or catalog number of the device.

ResumenThe part number or catalog number of the device
Comentarios

Alphanumeric Maximum 20.

Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Device.category
Definición

Devices may be associated with one or more categories.

ResumenCategoría: software u otra categoría de dispositivo
Control1..*
VinculaciónPara códigos de ejemplo, vea FHIRDeviceCategory
(example to http://hl7.org/fhir/ValueSet/device-category|5.0.0)

Categories of medical devices.

TipoCodeableConcept
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Device.type
Definición

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.

ResumenTipo o función principal del dispositivo
Comentarios

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.

Control1..1
VinculaciónPara códigos de ejemplo, vea DeviceType
(example to http://hl7.org/fhir/ValueSet/device-type|5.0.0)

Codes to identify medical devices.

TipoCodeableConcept
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. Device.version
Definición

The actual design of the device or software version running on the device.

ResumenThe actual design of the device or software version running on the device
NotaEs un identificador de versión de negocio, no de versión del recurso (vea discusión)
Control0..*
TipoBackboneElement
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. Device.version.id
Definición

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ResumenUnique id for inter-element referencing
Control0..1
Este elemento está afectado por las siguientes invariantes: ele-1
Tipostring
Es modificadorfalse
Formato XMLEn el formato XML, esta propiedad se representa como un atributo.
Resumenfalse
86. Device.version.extension
Definición

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
88. Device.version.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
90. Device.version.type
Definición

The type of the device version, e.g. manufacturer, approved, internal.

ResumenThe type of the device version, e.g. manufacturer, approved, internal
Control0..1
VinculaciónPara códigos de ejemplo, vea DeviceVersionType
(example to http://hl7.org/fhir/ValueSet/device-versiontype|5.0.0)

The type of version indicated for the device.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Nombres alternativosΣ
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Device.version.component
Definición

The hardware or software module of the device to which the version applies.

ResumenThe hardware or software module of the device to which the version applies
Comentarios

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

Control0..1
TipoIdentifier
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Device.version.installDate
Definición

The date the version was installed on the device.

ResumenThe date the version was installed on the device
Control0..1
TipodateTime
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Device.version.value
Definición

The version text.

ResumenThe version text
Control1..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Device.conformsTo
Definición

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.

ResumenIdentifies the standards, specifications, or formal guidances for the capabilities supported by the device
Control0..*
TipoBackboneElement
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. Device.conformsTo.id
Definición

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ResumenUnique id for inter-element referencing
Control0..1
Este elemento está afectado por las siguientes invariantes: ele-1
Tipostring
Es modificadorfalse
Formato XMLEn el formato XML, esta propiedad se representa como un atributo.
Resumenfalse
102. Device.conformsTo.extension
Definición

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
104. Device.conformsTo.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
106. Device.conformsTo.category
Definición

Describes the type of the standard, specification, or formal guidance.

ResumenDescribes the common type of the standard, specification, or formal guidance. communication | performance | measurement
Control0..1
VinculaciónPara códigos de ejemplo, vea DeviceSpecificationCategory
(example to http://hl7.org/fhir/ValueSet/device-specification-category|5.0.0)

The kind of standards used by the device.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. Device.conformsTo.specification
Definición

Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

ResumenIdentifies the standard, specification, or formal guidance that the device adheres to
Control1..1
VinculaciónPara códigos de ejemplo, vea DeviceSpecificationType
(example to http://hl7.org/fhir/ValueSet/device-specification-type|5.0.0)

The type of version indicated for the device.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. Device.conformsTo.version
Definición

Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

ResumenSpecific form or variant of the standard
NotaEs un identificador de versión de negocio, no de versión del recurso (vea discusión)
Control0..1
Tipostring
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. Device.property
Definición

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.

ResumenInherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Comentarios

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.

Control0..*
TipoBackboneElement
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Device.property.id
Definición

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ResumenUnique id for inter-element referencing
Control0..1
Este elemento está afectado por las siguientes invariantes: ele-1
Tipostring
Es modificadorfalse
Formato XMLEn el formato XML, esta propiedad se representa como un atributo.
Resumenfalse
116. Device.property.extension
Definición

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

ResumenAdditional content defined by implementations
Comentarios

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.

Control0..*
TipoExtension
Es modificadorfalse
Resumenfalse
Nombres alternativosextensions, user content
Invariantesele-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())
118. Device.property.modifierExtension
Definición

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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. 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).

ResumenExtensions that cannot be ignored even if unrecognized
Comentarios

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.

Control0..*
TipoExtension
Es modificadortrue porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Resumentrue
Requisitos

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.

Nombres alternativosextensions, user content, modifiers
Invariantesele-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())
120. Device.property.type
Definición

Code that specifies the property, such as resolution, color, size, being represented.

ResumenCode that specifies the property being represented
Control1..1
VinculaciónPara códigos de ejemplo, vea DeviceType
(example to http://hl7.org/fhir/ValueSet/device-property-type|5.0.0)

Device property type.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Device.property.value[x]
Definición

The value of the property specified by the associated property.type code.

ResumenValue of the property
Comentarios

The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

Control1..1
TipoElección de: Quantity, CodeableConcept, string, boolean, integer, Range, Attachment
Nota sobre [x]VeaElección de tipos de datospara más información sobre cómo usar [x]
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. Device.mode
Definición

The designated condition for performing a task with the device.

ResumenThe designated condition for performing a task
Control0..1
VinculaciónPara códigos de ejemplo, vea FHIRDeviceOperationMode
(example to http://hl7.org/fhir/ValueSet/device-operation-mode|5.0.0)

Operational mode of a device.

TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. Device.cycle
Definición

The series of occurrences that repeats during the operation of the device.

ResumenThe series of occurrences that repeats during the operation of the device
Control0..1
TipoCount
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. Device.duration
Definición

A measurement of time during the device's operation (e.g., days, hours, mins, etc.).

ResumenA measurement of time during the device's operation (e.g., days, hours, mins, etc.)
Control0..1
TipoDuration
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Device.owner
Definición

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

ResumenOrganización responsable de operar el dispositivo, cuando se conoce
Control0..1
TipoReference(Organización)
Es modificadorfalse
Must Supporttrue
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. Device.contact
Definición

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

ResumenDetails for human/organization for support
Comentarios

used for troubleshooting etc.

Control0..*
TipoContactPoint
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. Device.location
Definición

The place where the device can be found.

ResumenWhere the device is found
Control0..1
TipoReference(Location)
Es modificadorfalse
Must Supportfalse
Resumenfalse
Requisitos

Device.location can be used to track device location.

Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. Device.url
Definición

A network address on which the device may be contacted directly.

ResumenNetwork address to contact device
Comentarios

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Control0..1
Tipouri
Es modificadorfalse
Valor primitivoEste elemento primitivo puede estar presente, ausente o reemplazado por una extensión
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
138. Device.endpoint
Definición

Technical endpoints providing access to services provided by the device defined at this resource.

ResumenTechnical endpoints providing access to electronic services provided by the device
Control0..*
TipoReference(Endpoint)
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. Device.gateway
Definición

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).

ResumenLinked device acting as a communication/data collector, translator or controller
Comentarios

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.

Control0..*
TipoCodeableReference(Device)
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
142. Device.note
Definición

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

ResumenDevice notes and comments
Control0..*
TipoAnnotation
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. Device.safety
Definición

Provides additional safety characteristics about a medical device. For example devices containing latex.

ResumenSafety Characteristics of Device
Control0..*
VinculaciónPara códigos de ejemplo, vea DeviceSafety
(example to http://hl7.org/fhir/ValueSet/device-safety|5.0.0)
TipoCodeableConcept
Es modificadorfalse
Must Supportfalse
Resumentrue
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. Device.parent
Definición

The higher level or encompassing device that this device is a logical part of.

ResumenThe higher level or encompassing device that this device is a logical part of
Comentarios

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.

Control0..1
TipoReference(Device)
Es modificadorfalse
Must Supportfalse
Resumenfalse
Invariantesele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))