XML
| phg-device (Device) | I | Device | There are no (further) constraints on this element Element idDevice Item used in healthcare DefinitionThis resource identifies an instance or a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.
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| id | Σ | 0..1 | id | There are no (further) constraints on this element Element idDevice.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
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| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idDevice.meta Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idDevice.implicitRules A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.language Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human language. Common Languages (extensible)Constraints
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| text | I | 0..1 | Narrative | There are no (further) constraints on this element Element idDevice.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idDevice.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| identifier | 0..0 | Identifier | There are no (further) constraints on this element Element idDevice.identifier Instance identifier Alternate namesSerial Number DefinitionUnique instance identifiers assigned to a device by manufacturers other organizations or owners. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
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| udi | Σ | 0..1 | BackboneElement | There are no (further) constraints on this element Element idDevice.udi Unique Device Identifier (UDI) Barcode string DefinitionUnique device identifier (UDI) assigned to device label or package. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.udi.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udi.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udi.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
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| deviceIdentifier | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.udi.deviceIdentifier Mandatory fixed portion of UDI Alternate namesDI DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Note that FHIR strings may not exceed 1MB in size
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| name | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.udi.name Device Name as appears on UDI label Alternate namesBrand Name DefinitionName of device as used in labeling or catalog. Use the
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| jurisdiction | 0..1 | uri | There are no (further) constraints on this element Element idDevice.udi.jurisdiction Regional UDI authority DefinitionThe identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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| carrierHRF | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.udi.carrierHRF UDI Human Readable Barcode String Alternate namesHuman Readable Form DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
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| carrierAIDC | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element idDevice.udi.carrierAIDC UDI Machine Readable Barcode String Alternate namesAutomatic Identification and Data Capture DefinitionThe full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
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| issuer | 0..1 | uri | There are no (further) constraints on this element Element idDevice.udi.issuer UDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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| entryType | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.udi.entryType barcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered. Supports a way to distinguish hand entered from machine read data. Note that FHIR strings may not exceed 1MB in size Codes to identify how UDI data was entered UDIEntryType (required)Constraints
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| status | Σ ?! | 1..1 | codeBindingFixed Value | Element idDevice.status active | inactive | entered-in-error | unknown DefinitionStatus of the Device availability. This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. The availability status of the device. FHIRDeviceStatus (required)Constraints
active
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| type | 1..1 | CodeableConceptBinding | Element idDevice.type What kind of device this is DefinitionCode or identifier to identify a kind of device. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes to identify medical devices ?? (required)Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.type.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.type.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| coding | Σ | 1..1 | Coding | There are no (further) constraints on this element Element idDevice.type.coding Code defined by a terminology system DefinitionA reference to a code defined by a terminology system. Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.type.coding.id xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idDevice.type.coding.extension Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| system | Σ | 0..1 | uri | Element idDevice.type.coding.system Identity of the terminology system DefinitionThe identification of the code system that defines the meaning of the symbol in the code. Need to be unambiguous about the source of the definition of the symbol. The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.
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| version | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.type.coding.version Version of the system - if relevant DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
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| code | Σ | 1..1 | code | Element idDevice.type.coding.code Symbol in syntax defined by the system DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Need to refer to a particular code in the system. Note that FHIR strings may not exceed 1MB in size
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| display | Σ | 0..1 | string | Element idDevice.type.coding.display Representation defined by the system DefinitionA representation of the meaning of the code in the system, following the rules of the system. Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Note that FHIR strings may not exceed 1MB in size
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| userSelected | Σ | 0..1 | boolean | There are no (further) constraints on this element Element idDevice.type.coding.userSelected If this coding was chosen directly by the user DefinitionIndicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
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| text | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.type.text Plain text representation of the concept DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Very often the text is the same as a displayName of one of the codings.
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| lotNumber | 0..0 | string | There are no (further) constraints on this element Element idDevice.lotNumber Lot number of manufacture DefinitionLot number assigned by the manufacturer. Note that FHIR strings may not exceed 1MB in size
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| manufacturer | 1..1 | string | Element idDevice.manufacturer Actual options: "Roche" and "mySugr" DefinitionActual options: "Roche" and "mySugr" Actual options: "Roche" and "mySugr"
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| manufactureDate | 0..0 | dateTime | There are no (further) constraints on this element Element idDevice.manufactureDate Date when the device was made DefinitionThe date and time when the device was manufactured.
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| expirationDate | 0..0 | dateTime | There are no (further) constraints on this element Element idDevice.expirationDate Date and time of expiry of this device (if applicable) DefinitionThe date and time beyond which this device is no longer valid or should not be used (if applicable).
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| model | 1..1 | string | Element idDevice.model Model id assigned by the manufacturer DefinitionThe "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type. Note that FHIR strings may not exceed 1MB in size
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| version | 1..1 | string | Element idDevice.version Version number (i.e. software) DefinitionThe version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware. Note that FHIR strings may not exceed 1MB in size
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| patient | I | 0..0 | Reference(Patient) | There are no (further) constraints on this element Element idDevice.patient Patient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person. If the device is implanted in a patient, then need to associate the device to the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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| owner | I | 0..0 | Reference(Organization) | There are no (further) constraints on this element Element idDevice.owner Organization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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| contact | I | 0..0 | ContactPoint | There are no (further) constraints on this element Element idDevice.contact Details for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc.
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| location | I | 0..0 | Reference(Location) | There are no (further) constraints on this element Element idDevice.location Where the resource is found DefinitionThe place where the device can be found. Device.location can be used to track device location. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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| url | 0..0 | uri | There are no (further) constraints on this element Element idDevice.url Network address to contact device DefinitionA network address on which the device may be contacted directly. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
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| note | 0..* | Annotation | There are no (further) constraints on this element Element idDevice.note Device notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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| safety | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idDevice.safety Safety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes used to identify medical devices safety characterics. These codes are derived in part from the [United States Food and Drug Administration recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. DeviceSafety (example)Constraints
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