CertiScan Device Registry Implementation Guide (FHIR R4B)
0.1.0 - ci-build

CertiScan Device Registry Implementation Guide (FHIR R4B) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: CertiScan Device

Official URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device Version: 0.1.0
Draft as of 2025-06-05 Computable Name: CertiScanDevice

Defines the structure and metadata for CertiScan-connected devices like smart caps and blister packs.

Usages:

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 1..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier S 1..* Identifier Instance identifier
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type SΣ 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
... manufacturer S 1..1 string Name of device manufacturer
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name that identifies the device
.... type 1..1 code udi-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.
... type S 1..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.3.0
From the FHIR Standard
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.3.0
From the FHIR Standard
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnosticextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-statusextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.3.0
From the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
From the FHIR Standard
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device Device
... id 1..1 id Logical id of this artifact
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
.... type S 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
..... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
..... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
... manufacturer S 1..1 string Name of device manufacturer
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
.... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... type
...... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: firmware
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... type
...... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: hardware

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 1..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible)
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example)
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): IETF language tag
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
Constraints: dom-r4b
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier S 1..* Identifier Instance identifier
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type SΣ 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
.... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value Σ 0..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 0..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 0..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer S 1..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name that identifies the device
.... type 1..1 code udi-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 0..1 string The manufacturer's model number for the device
... partNumber 0..1 string The part number or catalog number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
.... text Σ 0..1 string Plain text representation of the concept
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: firmware
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: hardware
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The device that this device is attached to or is part of

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
From the FHIR Standard
Device.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
From the FHIR Standard
Device.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
From the FHIR Standard
Additional Bindings Purpose
AllLanguages Max Binding
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.3.0
From the FHIR Standard
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.3.0
From the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.3.0
From the FHIR Standard
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnosticextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-statusextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.3.0
From the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
From the FHIR Standard
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
dom-r4bwarningDevice.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 14 elements(3 nested mandatory elements)
Must-Support: 8 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Device.statusReason
  • The element 1 is sliced based on the value of Device.version

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 1..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier S 1..* Identifier Instance identifier
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type SΣ 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
... manufacturer S 1..1 string Name of device manufacturer
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name that identifies the device
.... type 1..1 code udi-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.
... type S 1..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... value 1..1 string The version text

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.3.0
From the FHIR Standard
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.3.0
From the FHIR Standard
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnosticextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-statusextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.3.0
From the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
From the FHIR Standard
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device Device
... id 1..1 id Logical id of this artifact
... meta
.... profile S 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
.... type S 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
..... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
..... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
... manufacturer S 1..1 string Name of device manufacturer
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
.... coding 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... type
...... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: firmware
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... type
...... coding 0..* Coding Code defined by a terminology system
Required Pattern: At least the following
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: hardware

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 1..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..1 canonical(StructureDefinition) Profiles this resource claims to conform to

Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible)
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example)
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): IETF language tag
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
Constraints: dom-r4b
... Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:label 0..1 string CertiScan Device Label
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-label
.... extension:max-use 1..1 integer CertiScan Device Maximum Use
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-max-use
.... extension:use-count 1..1 integer CertiScan Device Use Count
URL: https://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-device-use-count
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier S 1..* Identifier Instance identifier
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type SΣ 1..1 CodeableConcept Description of identifier
Binding: CertiScan Device Identifier ValueSet (required)
.... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value Σ 0..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... Slices for statusReason 2..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Slice: Unordered, Open by pattern:coding.system
Binding: CertiScan Device Status Reason ValueSet (required)
.... statusReason:diagnostic 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Diagnostic ValueSet (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-diagnostic-cs
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 0..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... statusReason:rec-status 1..1 CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Recording Status ValueSet (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-status-reason-rec-cs
...... version Σ 0..1 string Version of the system - if relevant
...... code Σ 0..1 code Symbol in syntax defined by the system
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer S 1..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 1..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber S 1..1 string Serial number assigned by the manufacturer
... deviceName S 1..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name that identifies the device
.... type 1..1 code udi-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 0..1 string The manufacturer's model number for the device
... partNumber 0..1 string The part number or catalog number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
Binding: CertiScan Device Type ValueSet (required)
.... text Σ 0..1 string Plain text representation of the concept
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... Slices for version 2..2 BackboneElement The actual design of the device or software version running on the device
Slice: Unordered, Open by pattern:type.coding
.... version:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
.... version:firmware 1..1 BackboneElement Firmware version currently running on the device
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: firmware
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
.... version:hardware 1..1 BackboneElement Hardware version of this product type
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system

Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-device-version-cs
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: hardware
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... component 0..1 Identifier A single component of the device version
..... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The device that this device is attached to or is part of

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.meta.securityextensibleAll Security Labels
http://hl7.org/fhir/ValueSet/security-labels
From the FHIR Standard
Device.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
From the FHIR Standard
Device.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
From the FHIR Standard
Additional Bindings Purpose
AllLanguages Max Binding
Device.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|4.3.0
From the FHIR Standard
Device.identifier.typerequiredCertiScanDeviceIdentifierVS(a valid code from CertiScan Device Identifier Types)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-identifier-vs
From this IG
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.3.0
From the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.3.0
From the FHIR Standard
Device.statusReasonrequiredCertiScanDeviceStatusReasonVS
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-vs
From this IG
Device.statusReason:diagnosticextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:diagnostic.codingrequiredCertiScanDeviceStatusReasonDiagnosticVS(a valid code from CertiScan Device Status Reason)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-diagnostic-vs
From this IG
Device.statusReason:rec-statusextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
From the FHIR Standard
Device.statusReason:rec-status.codingrequiredCertiScanDeviceStatusReasonRecVS(a valid code from CertiScan Device Recording Status Code System)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-status-reason-rec-vs
From this IG
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.3.0
From the FHIR Standard
Device.typeexampleDeviceType
http://hl7.org/fhir/ValueSet/device-type
From the FHIR Standard
Device.type.codingrequiredCertiScanDeviceTypeVS(a valid code from CertiScan Device Type)
https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-device-type-vs
From this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
dom-r4bwarningDevice.containedContaining new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
: ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 14 elements(3 nested mandatory elements)
Must-Support: 8 elements

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Device.statusReason
  • The element 1 is sliced based on the value of Device.version

 

Other representations of profile: CSV, Excel, Schematron