Class TDeviceDefinition

Unit

Declaration

type TDeviceDefinition = class(TDomainResource)

Description

The characteristics, operational status and capabilities of a medical-related component of a medical device. If the element is present, it must have either a @value, an @id, or extensions

Hierarchy

Overview

Methods

Public constructor Create; override;

Properties

Public property description : string read Getdescription write Setdescription;
Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
Public property identifier : TIdentifierArray read GetidentifierArray;
Public property udiDeviceIdentifier : TDeviceDefinitionUdiDeviceIdentifierArray read GetudiDeviceIdentifierArray;
Public property regulatoryIdentifier : TDeviceDefinitionRegulatoryIdentifierArray read GetregulatoryIdentifierArray;
Public property partNumber : string read GetpartNumber write SetpartNumber;
Public property partNumberElement : Tstring read GetpartNumberElement write SetpartNumberElement;
Public property manufacturer : TReference read Getmanufacturer write Setmanufacturer;
Public property deviceName : TDeviceDefinitionDeviceNameArray read GetdeviceNameArray;
Public property modelNumber : string read GetmodelNumber write SetmodelNumber;
Public property modelNumberElement : Tstring read GetmodelNumberElement write SetmodelNumberElement;
Public property classification : TDeviceDefinitionClassificationArray read GetclassificationArray;
Public property conformsTo : TDeviceDefinitionConformsToArray read GetconformsToArray;
Public property hasPart : TDeviceDefinitionHasPartArray read GethasPartArray;
Public property packaging : TDeviceDefinitionPackagingArray read GetpackagingArray;
Public property version : TDeviceDefinitionVersionArray read GetversionArray;
Public property safety : TCodeableConceptArray read GetsafetyArray;
Public property shelfLifeStorage : TProductShelfLifeArray read GetshelfLifeStorageArray;
Public property languageCode : TCodeableConceptArray read GetlanguageCodeArray;
Public property property_ : TDeviceDefinitionPropertyArray read Getproperty_Array;
Public property owner : TReference read Getowner write Setowner;
Public property contact : TContactPointArray read GetcontactArray;
Public property link : TDeviceDefinitionLinkArray read GetlinkArray;
Public property note : TAnnotationArray read GetnoteArray;
Public property material : TDeviceDefinitionMaterialArray read GetmaterialArray;
Public property productionIdentifierInUDI : TBSFHIRPrimitiveStringArray read GetproductionIdentifierInUDIArray;
Public property guideline : TDeviceDefinitionGuideline read Getguideline write Setguideline;
Public property correctiveAction : TDeviceDefinitionCorrectiveAction read GetcorrectiveAction write SetcorrectiveAction;
Public property chargeItem : TDeviceDefinitionChargeItemArray read GetchargeItemArray;

Description

Methods

Public constructor Create; override;
 

Properties

Public property description : string read Getdescription write Setdescription;

Additional information to describe the device.

Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
 
Public property identifier : TIdentifierArray read GetidentifierArray;

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

Public property udiDeviceIdentifier : TDeviceDefinitionUdiDeviceIdentifierArray read GetudiDeviceIdentifierArray;

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Public property regulatoryIdentifier : TDeviceDefinitionRegulatoryIdentifierArray read GetregulatoryIdentifierArray;

Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.

Public property partNumber : string read GetpartNumber write SetpartNumber;

The part number or catalog number of the device.

Public property partNumberElement : Tstring read GetpartNumberElement write SetpartNumberElement;
 
Public property manufacturer : TReference read Getmanufacturer write Setmanufacturer;

A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.

Public property deviceName : TDeviceDefinitionDeviceNameArray read GetdeviceNameArray;

The name or names of the device as given by the manufacturer.

Public property modelNumber : string read GetmodelNumber write SetmodelNumber;

The model number for the device for example as defined by the manufacturer or labeler, or other agency.

Public property modelNumberElement : Tstring read GetmodelNumberElement write SetmodelNumberElement;
 
Public property classification : TDeviceDefinitionClassificationArray read GetclassificationArray;

What kind of device or device system this is.

Public property conformsTo : TDeviceDefinitionConformsToArray read GetconformsToArray;

Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

Public property hasPart : TDeviceDefinitionHasPartArray read GethasPartArray;

A device that is part (for example a component) of the present device.

Public property packaging : TDeviceDefinitionPackagingArray read GetpackagingArray;

Information about the packaging of the device, i.e. how the device is packaged.

Public property version : TDeviceDefinitionVersionArray read GetversionArray;

The version of the device or software.

Public property safety : TCodeableConceptArray read GetsafetyArray;

Safety characteristics of the device.

Public property shelfLifeStorage : TProductShelfLifeArray read GetshelfLifeStorageArray;

Shelf Life and storage information.

Public property languageCode : TCodeableConceptArray read GetlanguageCodeArray;

Language code for the human-readable text strings produced by the device (all supported).

Public property property_ : TDeviceDefinitionPropertyArray read Getproperty_Array;

Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.

Public property owner : TReference read Getowner write Setowner;

An organization that is responsible for the provision and ongoing maintenance of the device.

Public property contact : TContactPointArray read GetcontactArray;

Contact details for an organization or a particular human that is responsible for the device.

Public property link : TDeviceDefinitionLinkArray read GetlinkArray;

An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.

Public property note : TAnnotationArray read GetnoteArray;

Descriptive information, usage information or implantation information that is not captured in an existing element.

Public property material : TDeviceDefinitionMaterialArray read GetmaterialArray;

A substance used to create the material(s) of which the device is made.

Public property productionIdentifierInUDI : TBSFHIRPrimitiveStringArray read GetproductionIdentifierInUDIArray;

Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.

Public property guideline : TDeviceDefinitionGuideline read Getguideline write Setguideline;

Information aimed at providing directions for the usage of this model of device.

Public property correctiveAction : TDeviceDefinitionCorrectiveAction read GetcorrectiveAction write SetcorrectiveAction;

Tracking of latest field safety corrective action.

Public property chargeItem : TDeviceDefinitionChargeItemArray read GetchargeItemArray;

Billing code or reference associated with the device.


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