Point-of-Care Device Implementation Guide
0.3.0 - STU 1 Ballot

This page is part of the Point-of-care Device FHIR IG (v0.3.0: STU 1 Ballot 3) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Resource Profile: MDS Device profile

Defining URL:http://hl7.org/fhir/uv/pocd/StructureDefinition/MdsDevice
Version:0.3.0
Name:MdsDevice
Title:MDS Device profile
Status:Draft as of 2021-07-24
Definition:

StructureDefinition for Device resources that represent a Medical Device System (MDS). This is the top-level resource in the hierarchical model of a Point-of-Care device.

Publisher:HL7 International - Devices Work Group
Source Resource:XML / JSON / Turtle

The official URL for this profile is: 

http://hl7.org/fhir/uv/pocd/StructureDefinition/MdsDevice

Scope and Usage

This profile sets minimum expectations for the Device resource that represents a Medical Device System (MDS). It's the top-level resource in the hierarchical model of a Point-of-Care device.

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Device

Summary

The profile defines the following rules:

  • Device.identifier or Device.udiCarrier (or both) shall be present.
  • Device.identifier may include an EUI-64 with either base-16 or hex encoding (octets separated by hyphens). See IEEE Guidelines for Use of EUI, OUI, and CID for details.
  • Device.type shall be present and have a coding from the ISO/IEEE 11073 MDC Device nomenclature if there is an appropriate code available.
  • Device.parent is optional and may refer to another MDS Device resource as a composite MDS.
  • Extensions allow approved jurisdictions, device operator, operating hours, operating cycles, and operating mode to be added.

Mandatory: 1 element (2 nested mandatory elements)
Must-Support: 20 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Device.identifier is sliced based on the value of value:system

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
pocd-dev-1: Must have at least identifier or udiCarrier
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... approved-jurisdictions S0..*CodeableConceptApproved jurisdictions
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region


.... valueCodeableConcept 1..1CodeableConceptApproved Jurisdictions
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... code 0..1codeSymbol in syntax defined by the system
... operator S0..1Reference(Practitioner)Operator of the device
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operator
.... valueUnsignedInt 1..1unsignedIntOperating hours
... operating-cycles S0..1unsignedIntOperating cycles
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
.... valueUnsignedInt 1..1unsignedIntOperating cycles
... operating-mode S0..1codeOperating mode
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode
Binding: Operating Mode (extensible): Operating Mode of the MDS

.... valueCode 1..1codeOperating mode
... Slices for identifier SI0..*IdentifierInstance identifier
Slice: Unordered, Open by value:system
.... identifier:EUI-64 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
..... system 1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
..... value 1..1stringThe value that is unique
... udiCarrier SI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierHRF 0..1stringUDI Human Readable Barcode String
... status S0..1codeactive | inactive | entered-in-error | unknown
... statusReason S0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
... manufacturer S0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName S0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
... modelNumber S0..1stringThe model number for the device
... partNumber S0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: MDC Object infrastructure and Device nomenclature (extensible)
.... coding 0..*CodingCode defined by a terminology system
..... system 0..1uriIdentity of the terminology system
..... version 0..1stringVersion of the system - if relevant
..... code 0..1codeSymbol in syntax defined by the system
... version S0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
... patient S0..1Reference(Patient)Patient to whom Device is affixed
... location S0..1Reference(Location)Where the device is found
... safety S0..*CodeableConceptSafety Characteristics of Device
Binding: Safety (extensible): Safety classification

.... coding 0..*CodingCode defined by a terminology system
..... system 0..1uriIdentity of the terminology system
..... code 0..1codeSymbol in syntax defined by the system
... parent S0..1Reference(MDS Device profile)The parent device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
pocd-dev-1: Must have at least identifier or udiCarrier
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... approved-jurisdictions S0..*CodeableConceptApproved jurisdictions
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"
.... Slices for value[x] 1..1CodeableConceptValue of extension
Slice: Unordered, Closed by type:$this
..... value[x]:valueCodeableConcept 1..1CodeableConceptApproved Jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region

...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1stringUnique id for inter-element referencing
....... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ0..1uriIdentity of the terminology system
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
... operator S0..1Reference(Practitioner)Operator of the device
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operator
... operating-hours S0..1unsignedIntOperating hours
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours"
.... Slices for value[x] 1..1unsignedIntOperating hours
Slice: Unordered, Closed by type:$this
..... value[x]:valueUnsignedInt 1..1unsignedIntOperating hours
... operating-cycles S0..1unsignedIntOperating cycles
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles"
.... Slices for value[x] 1..1unsignedIntOperating cycles
Slice: Unordered, Closed by type:$this
..... value[x]:valueUnsignedInt 1..1unsignedIntOperating cycles
... operating-mode S0..1codeOperating mode
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode
Binding: Operating Mode (extensible): Operating Mode of the MDS


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode"
.... Slices for value[x] 1..1codeOperating mode
Slice: Unordered, Closed by type:$this
Binding: Operating Mode (extensible): Operating Mode of the MDS

..... value[x]:valueCode 1..1codeOperating mode
Binding: Operating Mode (extensible): Operating Mode of the MDS

... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SI0..*IdentifierInstance identifier
Slice: Unordered, Open by value:system
.... identifier:EUI-64 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
..... value Σ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!SΣ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason S0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer S0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName S0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber S0..1stringThe model number for the device
... partNumber S0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: MDC Object infrastructure and Device nomenclature (extensible)
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version S0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
... patient S0..1Reference(Patient)Patient to whom Device is affixed
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location S0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety SΣ0..*CodeableConceptSafety Characteristics of Device
Binding: Safety (extensible): Safety classification


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... parent S0..1Reference(MDS Device profile)The parent device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
pocd-dev-1: Must have at least identifier or udiCarrier
... approved-jurisdictions 0..*CodeableConceptApproved jurisdictions
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region


... operator 0..1Reference(Practitioner)Operator of the device
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operator
... operating-hours 0..1unsignedIntOperating hours
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours
... operating-mode 0..1codeOperating mode
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode
Binding: Operating Mode (extensible): Operating Mode of the MDS


... Slices for identifier I0..*IdentifierInstance identifier
Slice: Unordered, Open by value:system
... udiCarrier ΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... manufacturer 0..1stringName of device manufacturer
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 1..1CodeableConceptThe kind or type of device
Binding: MDC Object infrastructure and Device nomenclature (extensible)
... version 0..*BackboneElementThe actual design of the device or software version running on the device
... patient 0..1Reference(Patient)Patient to whom Device is affixed
... location 0..1Reference(Location)Where the device is found
... safety Σ0..*CodeableConceptSafety Characteristics of Device
Binding: Safety (extensible): Safety classification


... parent 0..1Reference(MDS Device profile)The parent device

doco Documentation for this format

This structure is derived from Device

Summary

The profile defines the following rules:

  • Device.identifier or Device.udiCarrier (or both) shall be present.
  • Device.identifier may include an EUI-64 with either base-16 or hex encoding (octets separated by hyphens). See IEEE Guidelines for Use of EUI, OUI, and CID for details.
  • Device.type shall be present and have a coding from the ISO/IEEE 11073 MDC Device nomenclature if there is an appropriate code available.
  • Device.parent is optional and may refer to another MDS Device resource as a composite MDS.
  • Extensions allow approved jurisdictions, device operator, operating hours, operating cycles, and operating mode to be added.

Mandatory: 1 element (2 nested mandatory elements)
Must-Support: 20 elements
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Device.identifier is sliced based on the value of value:system

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
pocd-dev-1: Must have at least identifier or udiCarrier
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... approved-jurisdictions S0..*CodeableConceptApproved jurisdictions
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region


.... valueCodeableConcept 1..1CodeableConceptApproved Jurisdictions
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... code 0..1codeSymbol in syntax defined by the system
... operator S0..1Reference(Practitioner)Operator of the device
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operator
.... valueUnsignedInt 1..1unsignedIntOperating hours
... operating-cycles S0..1unsignedIntOperating cycles
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
.... valueUnsignedInt 1..1unsignedIntOperating cycles
... operating-mode S0..1codeOperating mode
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode
Binding: Operating Mode (extensible): Operating Mode of the MDS

.... valueCode 1..1codeOperating mode
... Slices for identifier SI0..*IdentifierInstance identifier
Slice: Unordered, Open by value:system
.... identifier:EUI-64 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
..... system 1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
..... value 1..1stringThe value that is unique
... udiCarrier SI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierHRF 0..1stringUDI Human Readable Barcode String
... status S0..1codeactive | inactive | entered-in-error | unknown
... statusReason S0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
... manufacturer S0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName S0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
... modelNumber S0..1stringThe model number for the device
... partNumber S0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: MDC Object infrastructure and Device nomenclature (extensible)
.... coding 0..*CodingCode defined by a terminology system
..... system 0..1uriIdentity of the terminology system
..... version 0..1stringVersion of the system - if relevant
..... code 0..1codeSymbol in syntax defined by the system
... version S0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
..... coding 0..*CodingCode defined by a terminology system
...... system 0..1uriIdentity of the terminology system
...... version 0..1stringVersion of the system - if relevant
...... code 0..1codeSymbol in syntax defined by the system
... patient S0..1Reference(Patient)Patient to whom Device is affixed
... location S0..1Reference(Location)Where the device is found
... safety S0..*CodeableConceptSafety Characteristics of Device
Binding: Safety (extensible): Safety classification

.... coding 0..*CodingCode defined by a terminology system
..... system 0..1uriIdentity of the terminology system
..... code 0..1codeSymbol in syntax defined by the system
... parent S0..1Reference(MDS Device profile)The parent device

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*DeviceItem used in healthcare
pocd-dev-1: Must have at least identifier or udiCarrier
... id Σ0..1stringLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages: A human language.

... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... approved-jurisdictions S0..*CodeableConceptApproved jurisdictions
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"
.... Slices for value[x] 1..1CodeableConceptValue of extension
Slice: Unordered, Closed by type:$this
..... value[x]:valueCodeableConcept 1..1CodeableConceptApproved Jurisdictions
Binding: Jurisdiction ValueSet (extensible): Codes for country, country subdivision and region

...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ0..*CodingCode defined by a terminology system
....... id 0..1stringUnique id for inter-element referencing
....... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ0..1uriIdentity of the terminology system
....... version Σ0..1stringVersion of the system - if relevant
....... code Σ0..1codeSymbol in syntax defined by the system
....... display Σ0..1stringRepresentation defined by the system
....... userSelected Σ0..1booleanIf this coding was chosen directly by the user
...... text Σ0..1stringPlain text representation of the concept
... operator S0..1Reference(Practitioner)Operator of the device
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operator
... operating-hours S0..1unsignedIntOperating hours
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-hours"
.... Slices for value[x] 1..1unsignedIntOperating hours
Slice: Unordered, Closed by type:$this
..... value[x]:valueUnsignedInt 1..1unsignedIntOperating hours
... operating-cycles S0..1unsignedIntOperating cycles
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-cycles"
.... Slices for value[x] 1..1unsignedIntOperating cycles
Slice: Unordered, Closed by type:$this
..... value[x]:valueUnsignedInt 1..1unsignedIntOperating cycles
... operating-mode S0..1codeOperating mode
URL: http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode
Binding: Operating Mode (extensible): Operating Mode of the MDS


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..0
.... url 1..1uri"http://hl7.org/fhir/uv/pocd/StructureDefinition/operating-mode"
.... Slices for value[x] 1..1codeOperating mode
Slice: Unordered, Closed by type:$this
Binding: Operating Mode (extensible): Operating Mode of the MDS

..... value[x]:valueCode 1..1codeOperating mode
Binding: Operating Mode (extensible): Operating Mode of the MDS

... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... Slices for identifier SI0..*IdentifierInstance identifier
Slice: Unordered, Open by value:system
.... identifier:EUI-64 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
..... value Σ1..1stringThe value that is unique
Example General: 123456
..... period Σ0..1PeriodTime period when id is/was valid for use
..... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!SΣ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason S0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer S0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName S0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber S0..1stringThe model number for the device
... partNumber S0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: MDC Object infrastructure and Device nomenclature (extensible)
.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version S0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ0..*CodingCode defined by a terminology system
...... id 0..1stringUnique id for inter-element referencing
...... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ0..1uriIdentity of the terminology system
...... version Σ0..1stringVersion of the system - if relevant
...... code Σ0..1codeSymbol in syntax defined by the system
...... display Σ0..1stringRepresentation defined by the system
...... userSelected Σ0..1booleanIf this coding was chosen directly by the user
..... text Σ0..1stringPlain text representation of the concept
... patient S0..1Reference(Patient)Patient to whom Device is affixed
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location S0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety SΣ0..*CodeableConceptSafety Characteristics of Device
Binding: Safety (extensible): Safety classification


.... id 0..1stringUnique id for inter-element referencing
.... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... Slices for extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... parent S0..1Reference(MDS Device profile)The parent device

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Max Binding: AllLanguages
Device.extension:approvedJurisdictions.value[x]:valueCodeableConceptextensibleJurisdiction ValueSet
Device.extension:operatingMode.value[x]extensibleOperatingMode
Device.extension:operatingMode.value[x]:valueCodeextensibleOperatingMode
Device.identifier:EUI-64.userequiredIdentifierUse
Device.identifier:EUI-64.typeextensibleIdentifier Type Codes
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typeextensibleMdcObject
Device.safetyextensibleSafety

Constraints

IdPathDetailsRequirements
pocd-dev-1DeviceMust have at least identifier or udiCarrier
: identifier.exists() or udiCarrier.exists()