Smart Bear Implementation Guide
0.3.2 - ci-build
Smart Bear Implementation Guide - Local Development build (v0.3.2). See the Directory of published versions
Active as of 2023-11-21 |
Definitions for the HADevice resource profile.
Guidance on how to interpret the contents of this table can be found here.
1. Device | |
2. Device.status | |
Control | 10..1 |
Must Support | true |
3. Device.statusReason | |
Control | 10..1* |
Must Support | true |
4. Device.manufacturer | |
Must Support | true |
5. Device.deviceName | |
Control | 0..1* |
6. Device.type | |
Control | 10..1 |
Binding | The codes SHALL be taken from Hearing Aid device codeFor example codes, see DeviceType |
Must Support | true |
7. Device.property | |
Control | 0..8* |
Must Support | true |
8. Device.property.type | |
Binding | The codes SHALL be taken from HearingAidProperty Value SetFor codes, see (unbound) |
9. Device.patient | |
Control | 10..1 |
Type | Reference(SmartBearPatient|Patient) |
Must Support | true |
Guidance on how to interpret the contents of this table can be found here.
1. Device | |
Definition | A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. |
Control | 0..* |
Summary | false |
Invariants | Defined on this element 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) 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()) |
2. Device.implicitRules | |
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Summary | true |
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
3. Device.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | false |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
4. Device.status | |
Definition | Status of the Device availability. |
Control | 10..1 |
Binding | The codes SHALL be taken from FHIRDeviceStatus The availability status of the device. |
Type | code |
Is Modifier | true |
Must Support | true |
Summary | true |
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
5. Device.statusReason | |
Definition | Reason for the dtatus of the Device availability. |
Control | 10..1* |
Binding | The codes SHALL be taken from FHIRDeviceStatusReason; other codes may be used where these codes are not suitable The availability status reason of the device. |
Type | CodeableConcept |
Must Support | true |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
6. Device.manufacturer | |
Definition | A name of the manufacturer. |
Control | 0..1 |
Type | string |
Must Support | true |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
7. Device.deviceName | |
Definition | This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. |
Control | 0..1* |
Type | BackboneElement |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
8. Device.deviceName.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
9. Device.deviceName.name | |
Definition | The name of the device. |
Control | 1..1 |
Type | string |
Summary | false |
Alternate Names | Σ |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
10. Device.deviceName.type | |
Definition | The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. |
Control | 1..1 |
Binding | The codes SHALL be taken from DeviceNameType The type of name the device is referred by. |
Type | code |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
11. Device.type | |
Definition | The kind or type of device. |
Control | 10..1 |
Binding | The codes SHALL be taken from Hearing Aid device codeFor example codes, see DeviceType |
Type | CodeableConcept |
Must Support | true |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
12. Device.property | |
Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. |
Control | 0..8* |
Type | BackboneElement |
Must Support | true |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
13. Device.property.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | true |
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
Alternate Names | extensions, user content, modifiers |
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
14. Device.property.type | |
Definition | Code that specifies the property DeviceDefinitionPropetyCode (Extensible). |
Control | 1..1 |
Binding | The codes SHALL be taken from HearingAidProperty Value SetFor codes, see (unbound) |
Type | CodeableConcept |
Summary | false |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
15. Device.patient | |
Definition | Patient information, If the device is affixed to a person. |
Control | 10..1 |
Type | Reference(SmartBearPatient|Patient) |
Must Support | true |
Summary | false |
Requirements | If the device is implanted in a patient, then need to associate the device to the patient. |
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here.
1. Device | |||||
Definition | A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. | ||||
Control | 0..* | ||||
Summary | false | ||||
2. Device.id | |||||
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
Control | 0..1 | ||||
Type | id | ||||
Summary | true | ||||
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||||
3. Device.meta | |||||
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Summary | true | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
4. Device.implicitRules | |||||
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true | ||||
Summary | true | ||||
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
5. Device.language | |||||
Definition | The base language in which the resource is written. | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages
A human language
| ||||
Type | code | ||||
Summary | false | ||||
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
6. Device.text | |||||
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Summary | false | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
7. Device.contained | |||||
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Summary | false | ||||
Alternate Names | inline resources, anonymous resources, contained resources | ||||
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. | ||||
8. Device.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
9. Device.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | false | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
10. Device.identifier | |||||
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners. | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Summary | false | ||||
Comments | 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. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
11. Device.definition | |||||
Definition | The reference to the definition for the device. | ||||
Control | 0..1 | ||||
Type | Reference(DeviceDefinition) | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
12. Device.udiCarrier | |||||
Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | true | ||||
Comments | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
13. Device.udiCarrier.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
14. Device.udiCarrier.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
15. Device.udiCarrier.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
16. Device.udiCarrier.deviceIdentifier | |||||
Definition | 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | true | ||||
Alternate Names | DI | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
17. Device.udiCarrier.issuer | |||||
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
| ||||
Control | 0..1 | ||||
Type | uri | ||||
Summary | false | ||||
Alternate Names | Barcode System | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
18. Device.udiCarrier.jurisdiction | |||||
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Summary | false | ||||
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
19. Device.udiCarrier.carrierAIDC | |||||
Definition | 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. | ||||
Control | 0..1 | ||||
Type | base64Binary | ||||
Summary | true | ||||
Alternate Names | Automatic Identification and Data Capture | ||||
Comments | 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. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
20. Device.udiCarrier.carrierHRF | |||||
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | true | ||||
Alternate Names | Human Readable Form | ||||
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
21. Device.udiCarrier.entryType | |||||
Definition | A coded entry to indicate how the data was entered. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from UDIEntryType Codes to identify how UDI data was entered | ||||
Type | code | ||||
Summary | false | ||||
Requirements | Supports a way to distinguish hand entered from machine read data. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
22. Device.status | |||||
Definition | Status of the Device availability. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from FHIRDeviceStatus The availability status of the device | ||||
Type | code | ||||
Is Modifier | true | ||||
Must Support | true | ||||
Summary | true | ||||
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
23. Device.statusReason | |||||
Definition | Reason for the dtatus of the Device availability. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from FHIRDeviceStatusReason; other codes may be used where these codes are not suitable The availability status reason of the device | ||||
Type | CodeableConcept | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
24. Device.distinctIdentifier | |||||
Definition | The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Alternate Names | Distinct Identification Code (DIC) | ||||
Comments | For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
25. Device.manufacturer | |||||
Definition | A name of the manufacturer. | ||||
Control | 0..1 | ||||
Type | string | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
26. Device.manufactureDate | |||||
Definition | The date and time when the device was manufactured. | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
27. Device.expirationDate | |||||
Definition | The date and time beyond which this device is no longer valid or should not be used (if applicable). | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
28. Device.lotNumber | |||||
Definition | Lot number assigned by the manufacturer. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
29. Device.serialNumber | |||||
Definition | The serial number assigned by the organization when the device was manufactured. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Comments | Alphanumeric Maximum 20. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
30. Device.deviceName | |||||
Definition | This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. | ||||
Control | 0..1 | ||||
Type | BackboneElement | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
31. Device.deviceName.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
32. Device.deviceName.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
33. Device.deviceName.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
34. Device.deviceName.name | |||||
Definition | The name of the device. | ||||
Control | 1..1 | ||||
Type | string | ||||
Summary | false | ||||
Alternate Names | Σ | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
35. Device.deviceName.type | |||||
Definition | The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from DeviceNameType The type of name the device is referred by | ||||
Type | code | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
36. Device.modelNumber | |||||
Definition | The model number for the device. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
37. Device.partNumber | |||||
Definition | The part number of the device. | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Comments | Alphanumeric Maximum 20. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
38. Device.type | |||||
Definition | The kind or type of device. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from Hearing Aid device code | ||||
Type | CodeableConcept | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
39. Device.specialization | |||||
Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
40. Device.specialization.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
41. Device.specialization.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
42. Device.specialization.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
43. Device.specialization.systemType | |||||
Definition | The standard that is used to operate and communicate. | ||||
Control | 1..1 | ||||
Type | CodeableConcept | ||||
Summary | false | ||||
Alternate Names | Σ | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
44. Device.specialization.version | |||||
Definition | The version of the standard that is used to operate and communicate. | ||||
Note | This is a business versionId, not a resource version id (see discussion) | ||||
Control | 0..1 | ||||
Type | string | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
45. Device.version | |||||
Definition | The actual design of the device or software version running on the device. | ||||
Note | This is a business versionId, not a resource version id (see discussion) | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
46. Device.version.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
47. Device.version.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
48. Device.version.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
49. Device.version.type | |||||
Definition | The type of the device version. | ||||
Control | 0..1 | ||||
Type | CodeableConcept | ||||
Summary | false | ||||
Alternate Names | Σ | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
50. Device.version.component | |||||
Definition | A single component of the device version. | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
51. Device.version.value | |||||
Definition | The version text. | ||||
Control | 1..1 | ||||
Type | string | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
52. Device.property | |||||
Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. | ||||
Control | 0..8 | ||||
Type | BackboneElement | ||||
Must Support | true | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
53. Device.property.id | |||||
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
54. Device.property.extension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
55. Device.property.modifierExtension | |||||
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
Alternate Names | extensions, user content, modifiers | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
56. Device.property.type | |||||
Definition | Code that specifies the property DeviceDefinitionPropetyCode (Extensible). | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from HearingAidProperty Value Set | ||||
Type | CodeableConcept | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
57. Device.property.valueQuantity | |||||
Definition | Property value as a quantity. | ||||
Control | 0..* | ||||
Type | Quantity | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
58. Device.property.valueCode | |||||
Definition | Property value as a code, e.g., NTP4 (synced to NTP). | ||||
Control | 0..* | ||||
Type | CodeableConcept | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
59. Device.patient | |||||
Definition | Patient information, If the device is affixed to a person. | ||||
Control | 1..1 | ||||
Type | Reference(SmartBearPatient) | ||||
Must Support | true | ||||
Summary | false | ||||
Requirements | If the device is implanted in a patient, then need to associate the device to the patient. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
60. Device.owner | |||||
Definition | An organization that is responsible for the provision and ongoing maintenance of the device. | ||||
Control | 0..1 | ||||
Type | Reference(Organization) | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
61. Device.contact | |||||
Definition | Contact details for an organization or a particular human that is responsible for the device. | ||||
Control | 0..* | ||||
Type | ContactPoint | ||||
Summary | false | ||||
Comments | used for troubleshooting etc. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
62. Device.location | |||||
Definition | The place where the device can be found. | ||||
Control | 0..1 | ||||
Type | Reference(Location) | ||||
Summary | false | ||||
Requirements | Device.location can be used to track device location. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
63. Device.url | |||||
Definition | A network address on which the device may be contacted directly. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Summary | false | ||||
Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
64. Device.note | |||||
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element. | ||||
Control | 0..* | ||||
Type | Annotation | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
65. Device.safety | |||||
Definition | Provides additional safety characteristics about a medical device. For example devices containing latex. | ||||
Control | 0..* | ||||
Type | CodeableConcept | ||||
Summary | true | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
66. Device.parent | |||||
Definition | The parent device. | ||||
Control | 0..1 | ||||
Type | Reference(Device) | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |