Common Sub-Domain::Device

: Public Class

Created:	11/8/2007 3:31:01 PM
Modified:	8/14/2018 1:58:57 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{962A7C33-ABED-42fe-BA81-4A89A437BCD9}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View BSP: Biospecimen, View EX: Experiment, View CM: Common, View SC: Study Conduct, View IM: Imaging, Product, Performer, Imaging Acquisition, DICOM SR TID 1500 BRIDG Class Diagram, Oncology & Imaging View, Anatomic Pathology Structured Report (APSR), Specimen Containers & Storage Equipment

DEFINITION: An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes. EXAMPLE(S): tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter OTHER NAME(S): Equipment NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
handlingCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=Device.handlingCode
Map:ICSRr2=Product.handlingCode (in R_Product)

Notes:

DEFINITION: A coded value specifying special handling requirements for the device. EXAMPLE(S): keep at room temperature, store upright OTHER NAME(S): NOTE(S):

Public CD
riskCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=Device.riskCode
Map:ICSRr2=Product.riskCode (in R_Product)

Notes:

DEFINITION: A coded value specifying the type of hazard or threat associated with the device. EXAMPLE(S): flammable, explosive OTHER NAME(S): NOTE(S):

Public CD
reprocessedDeviceCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Device.reprocessedDeviceCode
Map:CTRPv1.0=Device.reprocessedDeviceCode
Map:CTRv1.0=Device.reprocessedDeviceCode
Map:LSDAMv2.2.3Plus=Equipment.reprocessedDeviceCode

Notes:

DEFINITION: A coded value specifying whether a device is reconditioned. EXAMPLE(S): initial use of device, reuse, unknown OTHER NAME(S): NOTE(S):

Public PQ.TIME
age

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	True
IsID:	False

Map:AE=Device.deviceAge
Map:CTRPv1.0=Device.deviceAge
Map:CTRv1.0=Device.age

Notes:

DEFINITION: A measure (or best estimate) of the length of time during which a device existed, measured from manufacture date (and time) to a given date (and time) of use. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from the difference between the manufacture date and the date of the activity in which it is used. This is not really a characteristic of the device since the device could be used in multiple activities.

Public TS.DATETIME
manufactureDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Device.manufactureDate
Map:CTRPv1.0=Device.manufactureDate
Map:CTRv1.0=Device.manufactureDate
Map:LSDAMv2.2.3Plus=Equipment.manufactureDate
Map:LSDAMv2.2.3Plus=Software.buildDate

Notes:

DEFINITION: The date (and time) on which the device is made. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public TS.DATETIME
returnedToReprocessorDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:caAERSv2.2=MedicalDevice.returnedDate
Map:CTRv1.0=Device.returnedToReprocessorDate

Notes:

DEFINITION: The date (and time) on which the device was returned to the manufacturer or reprocessor. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
singleUseDeviceIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Device.singleUseDeviceIndicator
Map:CTRPv1.0=Device.singleUseDeviceIndicator
Map:CTRv1.0=Device.singleUseDeviceIndicator

Notes:

DEFINITION: Specifies whether a device is intended to be used only one time. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
availableForEvaluationIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Device.availableForEvaluationIndicator
Map:CTRPv1.0=Device.availableForEvaluationIndicator
Map:CTRv1.0=Device.availableForEvaluationIndicator

Notes:

DEFINITION: Specifies whether or not the device is accessible for assessment by the manufacturer. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
overTheCounterProductIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=Device.overTheCounterProductIndicator
Map:CTRPv1.0=Device.overTheCounterProductIndicator
Map:CTRv1.0=Device.overTheCounterProductIndicator

Notes:

DEFINITION: Specifies whether a device is available over-the-counter. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
ceMarkIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=Device.ceMarkIndicator

Notes:

DEFINITION: Specifies whether this device bears a CE (Conformite Europeenne) mark. EXAMPLE(S): OTHER NAME(S): NOTE(S): CE is a mark for device products placed on the market in the European Economic Area (EEA). By placing the CE marking on a product, the manufacturer affirms that the product conforms with the requirements of the applicable European Community directives.

Element	Source Role	Target Role
Organization Class	Name: locatedDevice	Name: locatingOrganization
Details: DESCRIPTION:<br/>Each Device might be located at one Organization. Each Organization might be the location for one or more Device.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Software Class	Name: specifyingDevice	Name: specifiedSoftware
Details: DESCRIPTION:<br/>Each Device might specify the use of one or more Software. Each Software might be specified by one or more Device.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>

Element	Source Role	Target Role
DeviceParameter Class	Name: definingDeviceParameter	Name: definedDevice
Details: DESCRIPTION:<br/>Each DeviceParameter always defines the use of one Device. Each Device might have use defined by one or more DeviceParameter.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
AuthoringDevice Class	Name: performedAuthoringDevice	Name: performingDevice
Details: DESCRIPTION:<br/>Each AuthoringDevice might be a function performed by one Device. Each Device might function as one or more AuthoringDevice.<br/><br/>DEFNITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
ReferenceResult Class	Name: performedReferenceResult	Name: performingDevice
Details: DESCRIPTION:<br/>Each ReferenceResult might apply to results produced by one Device. Each Device might produce one or more ReferenceResult.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Performer Class	Name: performedPerformer	Name: performingDevice
Details: DESCRIPTION:<br/>Each Performer might be a function performed by one Device. Each Device might function as one or more Performer.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:AE	Device
Details:
Map:AIM v4 rv48	Equipment
Details:
Map:APSRv2.1	[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:component [Any kind of AP observation] > hl7:observation > hl7:participant > CHOICE OF PLAYING DEVICE OR PLAYING ENTITY > hl7:playingDevice
Details:
Map:APSRv2.1	[Problem] hl7:organizer - [Problem] hl7:organizer > hl7:participant > CHOICE OF PLAYING DEVICE OR PLAYING ENTITY > hl7:playingDevice
Details:
Map:APSRv2.1	hl7:author - hl7:author > hl7:assignedAuthor > CHOICE OF ASSIGNED PERSON OR DEVICE > hl7:assignedAuthoringDevice
Details:
Map:caAERSv2.2	MedicalDevice
Details:
Map:CDMHv1.0	Device
Details:
Map:CTRPv1.0	Device
Details:
Map:CTRRr3	Device
Details:
Map:CTRv1.0	Device
Details:
Map:DICOM	TID 1004 DeviceObserverIdentifyingAttributes
Details:
Map:DICOM	Equipment Specification Module
Details:
Map:DICOM	General Equipment Module
Details:
Map:ICSRr2	DeviceInstance (in R_Product)
Details:
Map:LSDAMv2.2.3Plus	Equipment
Details:

Constraint	Type	Status
Attribute Set actualIndicator Qualifier	Invariant	Approved
Details: effectiveDateRange, codeModifiedText, lotNumberText, expirationDate, manufactureDate, returnedToReprocessorDate are valid only when actualIndicator = "true".<br/>

Object	Type	Connection	Direction	Notes
Product	Class	Generalization	To	DESCRIPTION: Each Device always is specialized by one Product. Each Product might be specialized by one Device. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
Software	Class	Generalization	From	DESCRIPTION: Each Software always specializes one Device. Each Device might be specialized by one Software. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
StorageEquipment	Class	Generalization	From	DESCRIPTION: Each StorageEquipment always specializes one Device. Each Device might be specialized by one StorageEquipment. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):