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XML Format: StructureDefinition-Device-uv-ips

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<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="Device-uv-ips"/>
  <meta>
    <lastUpdated value="2018-02-14T11:49:41.487+01:00"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">This profile represents the constraints applied to the Device resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR R4. A device used by or implanted on the patient is described in the patient summary as an instance of a Device resource constrained by this profile.</div>
  </text>
  <url value="http://hl7.eu/fhir/trillium2/StructureDefinition/Device-uv-ips"/>
  <version value="0.1.0"/>
  <name value="Device_uv_ips"/>
  <title value="Device (Trillium II)"/>
  <status value="draft"/>
  <date value="2018-02-14T00:00:00+01:00"/>
  <publisher value="Trillium II Project"/>
  <description
               value="This profile represents the constraints applied to the Device resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR R4. A device used by or implanted on the patient is described in the patient summary as an instance of a Device resource constrained by this profile."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <purpose
           value="This profile constrains the representation of a medical device used by or impanted on the patient, in the context of the international patient summary as specified by the IPS project of HL7 International."/>
  <fhirVersion value="3.0.1"/>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <mapping>
    <identity value="w5"/>
    <uri value="http://hl7.org/fhir/w5"/>
    <name value="W5 Mapping"/>
  </mapping>
  <mapping>
    <identity value="udi"/>
    <uri
         value="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm"/>
    <name value="UDI Mapping"/>
  </mapping>
  <kind value="resource"/>
  <abstract value="false"/>
  <type value="Device"/>
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Device"/>
  <derivation value="constraint"/>
  <snapshot>
    <element id="Device">
      <path value="Device"/>
      <short value="Item used in healthcare"/>
      <definition
                  value="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."/>
      <comment
               value="This profile applies the rules defined by HL7 International for representing the UDI in the FHIR standard, by the document &quot;Medical Devices and Unique Device Identification (UDI) Pattern, Release 1&quot;"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="dom-2"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
        <expression value="contained.contained.empty()"/>
        <xpath value="not(parent::f:contained and f:contained)"/>
        <source value="DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-1"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL NOT contain any narrative"/>
        <expression value="contained.text.empty()"/>
        <xpath value="not(parent::f:contained and f:text)"/>
        <source value="DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-4"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
        <expression
                    value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
        <xpath
               value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
        <source value="DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-3"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource"/>
        <expression
                    value="contained.where((&#39;#&#39;+id in %resource.descendants().reference).not()).empty()"/>
        <xpath
               value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat(&#39;#&#39;, $id))]))"/>
        <source value="DomainResource"/>
      </constraint>
      <mustSupport value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="Entity. Role, or Act"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Device"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="administrative.device"/>
      </mapping>
    </element>
    <element id="Device.id">
      <path value="Device.id"/>
      <short value="Logical id of this artifact"/>
      <definition
                  value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
      <comment
               value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="id"/>
      </type>
      <mustSupport value="true"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.meta">
      <path value="Device.meta"/>
      <short value="Metadata about the resource"/>
      <definition
                  value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.meta"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Meta"/>
      </type>
      <mustSupport value="true"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.implicitRules">
      <path value="Device.implicitRules"/>
      <short value="A set of rules under which this content was created"/>
      <definition
                  value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content."/>
      <comment
               value="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&#39;s meaning or interpretation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.implicitRules"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <isModifier value="true"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.language">
      <path value="Device.language"/>
      <short value="Language of the resource content"/>
      <definition value="The base language in which the resource is written."/>
      <comment
               value="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)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.language"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
          <valueReference>
            <reference value="http://hl7.org/fhir/ValueSet/all-languages"/>
          </valueReference>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
          <valueBoolean value="true"/>
        </extension>
        <strength value="extensible"/>
        <description value="A human language."/>
        <valueSetReference>
          <reference value="http://hl7.org/fhir/ValueSet/languages"/>
        </valueSetReference>
      </binding>
    </element>
    <element id="Device.text">
      <path value="Device.text"/>
      <short value="Text summary of the resource, for human interpretation"/>
      <definition
                  value="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 &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment
               value="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 &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded in formation is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <condition value="dom-1"/>
      <mapping>
        <identity value="rim"/>
        <map value="Act.text?"/>
      </mapping>
    </element>
    <element id="Device.contained">
      <path value="Device.contained"/>
      <short value="Contained, inline Resources"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="inline resources"/>
      <alias value="anonymous resources"/>
      <alias value="contained resources"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.contained"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Resource"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.extension">
      <path value="Device.extension"/>
      <short value="Additional Content defined by implementations"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.modifierExtension">
      <path value="Device.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <isModifier value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.identifier">
      <path value="Device.identifier"/>
      <short value="Instance identifier"/>
      <definition
                  value="Unique instance identifiers assigned to a device by manufacturers other organizations or owners."/>
      <comment
               value="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](http://hl7.org/fhir/STU3/device.html#5.11.3.2.2),  this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See [UDI mappings](http://hl7.org/fhir/STU3/device-mappings.html#udi) for a complete mapping of UDI parts to Device."/>
      <alias value="Serial Number"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <mustSupport value="true"/>
      <mapping>
        <identity value="udi"/>
        <map
             value="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."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".id"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="id"/>
      </mapping>
    </element>
    <element id="Device.udi">
      <path value="Device.udi"/>
      <short value="Unique Device Identifier (UDI) Barcode string"/>
      <definition
                  value="[Unique device identifier (UDI)](http://hl7.org/fhir/STU3/device.html#5.11.3.2.2) assigned to device label or package."/>
      <comment
               value="UDI may identify an unique instance of a device, or it may only identify the type of the device.  See [UDI mappings](http://hl7.org/fhir/STU3/device-mappings.html#udi) for a complete mapping of UDI parts to Device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() | (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="Element"/>
      </constraint>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value=".id and .code"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="id"/>
      </mapping>
    </element>
    <element id="Device.udi.id">
      <path value="Device.udi.id"/>
      <representation value="xmlAttr"/>
      <short value="xml:id (or equivalent in JSON)"/>
      <definition
                  value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.udi.extension">
      <path value="Device.udi.extension"/>
      <short value="Additional Content defined by implementations"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.udi.modifierExtension">
      <path value="Device.udi.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <isModifier value="true"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.udi.deviceIdentifier">
      <path value="Device.udi.deviceIdentifier"/>
      <short value="Mandatory fixed portion of UDI"/>
      <definition
                  value="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."/>
      <alias value="DI"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.deviceIdentifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="udi"/>
        <map
             value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.udi.name">
      <path value="Device.udi.name"/>
      <short value="Device Name as appears on UDI label"/>
      <definition value="Name of device as used in labeling or catalog."/>
      <comment
               value="Use the `Device.type`  for a generic type or kind of device name.  Note the [GUDID](http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/globaludidatabasegudid/default.htm) lists the name as the &#39;Brand Name&#39;."/>
      <alias value="Brand Name"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.name"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="udi"/>
        <map
             value="Propietary/Trade Name of the medical Device as used in the labeling or catalog"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".displayName"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.udi.jurisdiction">
      <path value="Device.udi.jurisdiction"/>
      <short value="Regional UDI authority"/>
      <definition
                  value="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
                    value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.jurisdiction"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="Role.scoper"/>
      </mapping>
    </element>
    <element id="Device.udi.carrierHRF">
      <path value="Device.udi.carrierHRF"/>
      <short value="UDI Human Readable Barcode String"/>
      <definition
                  value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device."/>
      <comment
               value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label."/>
      <alias value="Human Readable Form"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.carrierHRF"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="udi"/>
        <map
             value="A unique device identifier (UDI) on a device label in plain text"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
    </element>
    <element id="Device.udi.carrierAIDC">
      <path value="Device.udi.carrierAIDC"/>
      <short value="UDI Machine Readable Barcode String"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="Automatic Identification and Data Capture"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.carrierAIDC"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="udi"/>
        <map
             value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
    </element>
    <element id="Device.udi.issuer">
      <path value="Device.udi.issuer"/>
      <short value="UDI Issuing Organization"/>
      <definition
                  value="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :
1) GS1: 
http://hl7.org/fhir/NamingSystem/gs1-di, 
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI, 
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di."/>
      <alias value="Barcode System"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.issuer"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <mapping>
        <identity value="udi"/>
        <map
             value="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"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.root"/>
      </mapping>
    </element>
    <element id="Device.udi.entryType">
      <path value="Device.udi.entryType"/>
      <short value="barcode | rfid | manual +"/>
      <definition value="A coded entry to indicate how the data was entered."/>
      <requirements
                    value="Supports a way to distinguish hand entered from machine read data."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udi.entryType"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="UDIEntryType"/>
        </extension>
        <strength value="required"/>
        <description value="Codes to identify how UDI data was entered"/>
        <valueSetReference>
          <reference value="http://hl7.org/fhir/ValueSet/udi-entry-type"/>
        </valueSetReference>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="NA"/>
      </mapping>
    </element>
    <element id="Device.status">
      <path value="Device.status"/>
      <short value="active | inactive | entered-in-error | unknown"/>
      <definition value="Status of the Device availability."/>
      <comment
               value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.status"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <isModifier value="true"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="FHIRDeviceStatus"/>
        </extension>
        <strength value="required"/>
        <description value="The availability status of the device."/>
        <valueSetReference>
          <reference value="http://hl7.org/fhir/ValueSet/device-status"/>
        </valueSetReference>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value=".statusCode"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="status"/>
      </mapping>
    </element>
    <element id="Device.type">
      <path value="Device.type"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="coding.system"/>
        </discriminator>
        <description value="Discriminated by code system"/>
        <rules value="open"/>
      </slicing>
      <short
             value="Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set."/>
      <definition
                  value="A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text."/>
      <comment
               value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"/>
      </type>
      <mustSupport value="true"/>
      <binding>
        <strength value="preferred"/>
        <description value="The type of device"/>
        <valueSetReference>
          <reference
                     value="http://hl7.org/fhir/uv/ips/ValueSet/medical-devices-uv-ips"/>
        </valueSetReference>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="CE/CNE/CWE"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CD"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="normative"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
        <valueCode value="4.0.0"/>
      </extension>
      <path value="Device.type"/>
      <sliceName value="absentOrUnknownDevice"/>
      <short value="Concept - reference to a terminology or just  text"/>
      <definition
                  value="Slice to be valued in case of no information or known absence of relevant devices for the purpose of this IPS"/>
      <comment
               value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="absentOrUnknownDevice"/>
        </extension>
        <strength value="required"/>
        <description value="Absent problem or unknown device"/>
        <valueSetReference>
          <reference
                     value="http://hl7.org/fhir/uv/ips/ValueSet/absent-or-unknown-devices-uv-ips"/>
        </valueSetReference>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="CE/CNE/CWE"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CD"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept rdfs:subClassOf dt:CD"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.id">
      <path value="Device.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.extension">
      <path value="Device.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding">
      <path value="Device.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition value="A reference to a code defined by a terminology system."/>
      <comment
               value="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."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
        <profile
                 value="http://hl7.org/fhir/uv/ips/StructureDefinition/Coding-uv-ips"/>
      </type>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.id">
      <path value="Device.type.coding.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.extension">
      <path value="Device.type.coding.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.system">
      <path value="Device.type.coding.system"/>
      <short value="Identity of the terminology system"/>
      <definition
                  value="The identification of the code system that defines the meaning of the symbol in the code."/>
      <comment
               value="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&#39;s list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously."/>
      <requirements
                    value="Need to be unambiguous about the source of the definition of the symbol."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Coding.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <fixedUri
                value="http://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips"/>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.3"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="./codeSystem"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.version">
      <path value="Device.type.coding.version"/>
      <short value="Version of the system - if relevant"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Coding.version"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.7"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="./codeSystemVersion"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.code">
      <path value="Device.type.coding.code"/>
      <short value="Symbol in syntax defined by the system"/>
      <definition
                  value="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 value="Need to refer to a particular code in the system."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Coding.code"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="./code"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.display">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="Device.type.coding.display"/>
      <short value="Representation defined by the system"/>
      <definition
                  value="A representation of the meaning of the code in the system, following the rules of the system."/>
      <requirements
                    value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Coding.display"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.2 - but note this is not well followed"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CV.displayName"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.display.id">
      <path value="Device.type.coding.display.id"/>
      <representation value="xmlAttr"/>
      <short value="xml:id (or equivalent in JSON)"/>
      <definition
                  value="unique id for the element within a resource (for internal references)"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.display.extension">
      <path value="Device.type.coding.display.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element
             id="Device.type:absentOrUnknownDevice.coding.display.extension:translation">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="normative"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version">
        <valueCode value="4.0.0"/>
      </extension>
      <path value="Device.type.coding.display.extension"/>
      <sliceName value="translation"/>
      <short value="Language Translation (Localization)"/>
      <definition
                  value="Language translation from base language of resource to another language."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile value="http://hl7.org/fhir/StructureDefinition/translation"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &#39;value&#39;)])"/>
        <source value="Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="ST.translation"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.display.value">
      <path value="Device.type.coding.display.value"/>
      <representation value="xmlAttr"/>
      <short value="Primitive value for string"/>
      <definition value="The actual value"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="string.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/regex">
          <valueString value="[ \r\n\t\S]+"/>
        </extension>
        <code>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type">
            <valueString value="string"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type">
            <valueString value="xsd:string"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type">
            <valueString value="xsd:string"/>
          </extension>
        </code>
      </type>
      <maxLength value="1048576"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.userSelected">
      <path value="Device.type.coding.userSelected"/>
      <short value="If this coding was chosen directly by the user"/>
      <definition
                  value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/>
      <comment
               value="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 &#39;directly chosen&#39; implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/>
      <requirements
                    value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Coding.userSelected"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="boolean"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="Sometimes implied by being first"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="CD.codingRationale"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="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 &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]"/>
      </mapping>
    </element>
    <element id="Device.type:absentOrUnknownDevice.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="Device.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="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."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="Device.lotNumber">
      <path value="Device.lotNumber"/>
      <short value="Lot number of manufacture"/>
      <definition value="Lot number assigned by the manufacturer."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.lotNumber"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="udi"/>
        <map
             value="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."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".lotNumberText"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.manufacturer">
      <path value="Device.manufacturer"/>
      <short value="Name of device manufacturer"/>
      <definition value="A name of the manufacturer."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.manufacturer"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="udi"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].scoper.name"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.manufactureDate">
      <path value="Device.manufactureDate"/>
      <short value="Date when the device was made"/>
      <definition value="The date and time when the device was manufactured."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.manufactureDate"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="dateTime"/>
      </type>
      <mapping>
        <identity value="udi"/>
        <map
             value="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”."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".existenceTime.low"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.expirationDate">
      <path value="Device.expirationDate"/>
      <short value="Date and time of expiry of this device (if applicable)"/>
      <definition
                  value="The date and time beyond which this device is no longer valid or should not be used (if applicable)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.expirationDate"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="dateTime"/>
      </type>
      <mapping>
        <identity value="udi"/>
        <map
             value="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”."/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".expirationTime"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.model">
      <path value="Device.model"/>
      <short value="Model id assigned by the manufacturer"/>
      <definition
                  value="The &quot;model&quot; 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."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.model"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].code"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.version">
      <path value="Device.version"/>
      <short value="Version number (i.e. software)"/>
      <definition
                  value="The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.version"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".softwareName (included as part)"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="what"/>
      </mapping>
    </element>
    <element id="Device.patient">
      <path value="Device.patient"/>
      <short value="Patient to whom Device is affixed"/>
      <definition
                  value="Patient information, If the device is affixed to a person."/>
      <requirements
                    value="If the device is implanted in a patient, then need to associate the device to the patient."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.patient"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.eu/fhir/trillium2/StructureDefinition/Patient-uv-ips"/>
      </type>
      <mustSupport value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="who.focus"/>
      </mapping>
    </element>
    <element id="Device.patient.id">
      <path value="Device.patient.id"/>
      <representation value="xmlAttr"/>
      <short value="xml:id (or equivalent in JSON)"/>
      <definition
                  value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.patient.extension">
      <path value="Device.patient.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional Content defined by implementations"/>
      <definition
                  value="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."/>
      <comment
               value="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."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.patient.reference">
      <path value="Device.patient.reference"/>
      <short value="Literal reference, Relative, internal or absolute URL"/>
      <definition
                  value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with &#39;#&#39;) refer to contained resources."/>
      <comment
               value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries.   Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure &quot;/[type]/[id]&quot; then it should be assumed that the reference is to a FHIR RESTful server."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Reference.reference"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ref-1"/>
      <mustSupport value="true"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.patient.identifier">
      <path value="Device.patient.identifier"/>
      <short value="Logical reference, when literal reference is not known"/>
      <definition
                  value="An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference."/>
      <comment
               value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. 

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.identifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="Device.patient.display">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="Device.patient.display"/>
      <short value="Text alternative for the resource"/>
      <definition
                  value="Plain text narrative that identifies the resource in addition to the resource reference."/>
      <comment
               value="This is generally not the same as the Resource.text of the referenced resource.  The purpose is to identify what&#39;s being referenced, not to fully describe it."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.display"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.owner">
      <path value="Device.owner"/>
      <short value="Organization responsible for device"/>
      <definition
                  value="An organization that is responsible for the provision and ongoing maintenance of the device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.owner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=OWN].scoper"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="who.source"/>
      </mapping>
    </element>
    <element id="Device.contact">
      <path value="Device.contact"/>
      <short value="Details for human/organization for support"/>
      <definition
                  value="Contact details for an organization or a particular human that is responsible for the device."/>
      <comment value="used for troubleshooting etc."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.contact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="ContactPoint"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".scopedRole[typeCode=CON].player"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="who.source"/>
      </mapping>
    </element>
    <element id="Device.location">
      <path value="Device.location"/>
      <short value="Where the resource is found"/>
      <definition value="The place where the device can be found."/>
      <requirements
                    value="Device.location can be used to track device location."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.location"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=LOCE].scoper"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="where"/>
      </mapping>
    </element>
    <element id="Device.url">
      <path value="Device.url"/>
      <short value="Network address to contact device"/>
      <definition
                  value="A network address on which the device may be contacted directly."/>
      <comment
               value="If the device is running a FHIR server, the network address should  be the Base URL from which a conformance statement may be retrieved."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.url"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".telecom"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="where"/>
      </mapping>
    </element>
    <element id="Device.note">
      <path value="Device.note"/>
      <short value="Device notes and comments"/>
      <definition
                  value="Descriptive information, usage information or implantation information that is not captured in an existing element."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.note"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Annotation"/>
      </type>
      <mapping>
        <identity value="rim"/>
        <map value=".text"/>
      </mapping>
    </element>
    <element id="Device.safety">
      <path value="Device.safety"/>
      <short value="Safety Characteristics of Device"/>
      <definition
                  value="Provides additional safety characteristics about a medical device.  For example devices containing latex."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.safety"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="DeviceSafety"/>
        </extension>
        <strength value="example"/>
        <description
                     value="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."/>
        <valueSetReference>
          <reference value="http://hl7.org/fhir/ValueSet/device-safety"/>
        </valueSetReference>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="NA"/>
      </mapping>
    </element>
  </snapshot>
  <differential>
    <element id="Device">
      <path value="Device"/>
      <comment
               value="This profile applies the rules defined by HL7 International for representing the UDI in the FHIR standard, by the document &quot;Medical Devices and Unique Device Identification (UDI) Pattern, Release 1&quot;"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.id">
      <path value="Device.id"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.meta">
      <path value="Device.meta"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.identifier">
      <path value="Device.identifier"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.type">
      <path value="Device.type"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="coding.system"/>
        </discriminator>
        <description value="Discriminated by code system"/>
        <rules value="open"/>
      </slicing>
      <short
             value="Type of device.
Preferably valued by using SNOMED CT.
The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"/>
      </type>
      <mustSupport value="true"/>
      <binding>
        <strength value="preferred"/>
        <description value="The type of device"/>
        <valueSetReference>
          <reference
                     value="http://hl7.org/fhir/uv/ips/ValueSet/medical-devices-uv-ips"/>
        </valueSetReference>
      </binding>
    </element>
    <element id="Device.type:absentOrUnknownDevice">
      <path value="Device.type"/>
      <sliceName value="absentOrUnknownDevice"/>
      <definition
                  value="Slice to be valued in case of no information or known absence of relevant devices for the purpose of this IPS"/>
      <max value="1"/>
      <type>
        <code value="CodeableConcept"/>
        <profile
                 value="http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"/>
      </type>
      <mustSupport value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="absentOrUnknownDevice"/>
        </extension>
        <strength value="required"/>
        <description value="Absent problem or unknown device"/>
        <valueSetReference>
          <reference
                     value="http://hl7.org/fhir/uv/ips/ValueSet/absent-or-unknown-devices-uv-ips"/>
        </valueSetReference>
      </binding>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding">
      <path value="Device.type.coding"/>
      <min value="1"/>
      <max value="1"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.type:absentOrUnknownDevice.coding.system">
      <path value="Device.type.coding.system"/>
      <min value="1"/>
      <max value="1"/>
      <fixedUri
                value="http://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.patient">
      <path value="Device.patient"/>
      <min value="1"/>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.eu/fhir/trillium2/StructureDefinition/Patient-uv-ips"/>
      </type>
      <mustSupport value="true"/>
    </element>
    <element id="Device.patient.reference">
      <path value="Device.patient.reference"/>
      <min value="1"/>
      <mustSupport value="true"/>
    </element>
  </differential>
</StructureDefinition>