RDC EMR Implementation Guide

Overview

This is the tree for the Device resource in the RDC EMR Implementation project. You can find the resource on https://simplifier.net/rdcemrintegrations/phg-device. Notice that the path in the URL is exactly the same as the placeholder.

phg-device (Device)	I		Device	There are no (further) constraints on this element Element id Device Short description Item used in healthcare Definition This resource identifies an instance or 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. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc. Data type Device Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative `contained.text.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource `contained.where(('#'+id in %resource.descendants().reference).not()).empty()` Mappings rim: Entity. Role, or Act rim: Device w5: administrative.device
id	Σ	0..1	id	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. Common Languages (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
text	I	0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. 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 in formation is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. 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. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier		0..0	Identifier	There are no (further) constraints on this element Element id Device.identifier Short description Instance identifier Alternate names Serial Number Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. 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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty. rim: .id w5: id
udi	Σ	0..1	BackboneElement	There are no (further) constraints on this element Element id Device.udi Short description Unique Device Identifier (UDI) Barcode string Definition Unique device identifier (UDI) assigned to device label or package. Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: .id and .code w5: id
id		0..1	string	There are no (further) constraints on this element Element id Device.udi.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.udi.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.udi.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content, modifiers 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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
deviceIdentifier	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udi.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI 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. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. rim: Role.id.extension w5: what
name	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udi.name Short description Device Name as appears on UDI label Alternate names Brand Name Definition Name of device as used in labeling or catalog. Comments Use the `Device.type` for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: Propietary/Trade Name of the medical Device as used in the labeling or catalog rim: .displayName w5: what
jurisdiction		0..1	uri	There are no (further) constraints on this element Element id Device.udi.jurisdiction Short description Regional UDI authority 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. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: Role.scoper
carrierHRF	Σ	0..1	string	There are no (further) constraints on this element Element id Device.udi.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: A unique device identifier (UDI) on a device label in plain text rim: Role.id.extension
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Device.udi.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture 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. 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. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology. rim: Role.id.extension
issuer		0..1	uri	There are no (further) constraints on this element Element id Device.udi.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other rim: Role.id.root
entryType		0..1	codeBinding	There are no (further) constraints on this element Element id Device.udi.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Comments Note that FHIR strings may not exceed 1MB in size Data type code Binding Codes to identify how UDI data was entered UDIEntryType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: NA
status	Σ ?!	1..1	codeBindingFixed Value	Element id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition Status of the Device availability. 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. Data type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value active Mappings rim: n/a rim: .statusCode w5: status ACSPIX2FHIR: active GREENDOT: active CDF2FHIR: active
type		1..1	CodeableConceptBinding	Element id Device.type Short description What kind of device this is Definition Code or identifier to identify a kind of device. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes to identify medical devices ?? (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD udi: Type description using GMDN or other code system rim: .code w5: what GLUCI-CHEK: Software
id		0..1	string	There are no (further) constraints on this element Element id Device.type.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.type.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	1..1	Coding	There are no (further) constraints on this element Element id Device.type.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Device.type.coding.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.type.coding.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	Σ	0..1	uri	Element id Device.type.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem ACSPIX2FHIR: http://roche.com/fhir/rdc/cdf GREENDOT: http://roche.com/fhir/rdc/cdf CDF2FHIR: http://roche.com/fhir/rdc/cdf
version	Σ	0..1	string	There are no (further) constraints on this element Element id Device.type.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	Element id Device.type.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings may not exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code ACSPIX2FHIR: cdf.dev.im GREENDOT: cdf.dev.im CDF2FHIR: cdf.dev.im
display	Σ	0..1	string	Element id Device.type.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName ACSPIX2FHIR: Manual interface GREENDOT: Manual interface CDF2FHIR: Manual interface
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Device.type.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Device.type.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
lotNumber		0..0	string	There are no (further) constraints on this element Element id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. rim: .lotNumberText w5: what
manufacturer		1..1	string	Element id Device.manufacturer Short description Actual options: "Roche" and "mySugr" Definition Actual options: "Roche" and "mySugr" Comments Actual options: "Roche" and "mySugr" Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: N/A rim: .playedRole[typeCode=MANU].scoper.name w5: what ACSPIX2FHIR: Roche GREENDOT: Roche CDF2FHIR: Roche
manufactureDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. rim: .existenceTime.low w5: what
expirationDate		0..0	dateTime	There are no (further) constraints on this element Element id Device.expirationDate Short description Date and time of expiry of this device (if applicable) Definition The date and time beyond which this device is no longer valid or should not be used (if applicable). Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”. rim: .expirationTime w5: what
model		1..1	string	Element id Device.model Short description Model id assigned by the manufacturer Definition The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: .playedRole[typeCode=MANU].code w5: what ACSPIX2FHIR: source GREENDOT: GreenDot GLUCI-CHEK: ACSPIX.SN CDF2FHIR: source
version		1..1	string	Element id Device.version Short description Version number (i.e. software) Definition The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: .softwareName (included as part) w5: what ACSPIX2FHIR: version GREENDOT: software version GLUCI-CHEK: ACSPIX.Ver CDF2FHIR: version
patient	I	0..0	Reference(Patient)	There are no (further) constraints on this element Element id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5: who.focus
owner	I	0..0	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .playedRole[typeCode=OWN].scoper w5: who.source
contact	I	0..0	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` cpt-2: A system is required if a value is provided. `value.empty() or system.exists()` Mappings rim: n/a v2: XTN rim: TEL servd: ContactPoint rim: .scopedRole[typeCode=CON].player w5: who.source
location	I	0..0	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the resource is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) rim: .playedRole[typeCode=LOCE].scoper w5: where
url		0..0	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. Comments If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: .telecom w5: where
note		0..*	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Comments For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Act rim: .text
safety	Σ	0..0	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes used to identify medical devices safety characterics. These codes are derived in part from the [United States Food and Drug Administration recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. DeviceSafety (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD rim: NA