: Public Class
Created: 11/8/2007 3:31:01 PM
Modified: 8/14/2018 1:58:57 PM
Project:
Advanced:
DEFINITION:<br/>An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes.  <br/><br/>EXAMPLE(S): <br/>tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter<br/><br/>OTHER NAME(S):<br/>Equipment<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  handlingCode
Details:
Map:CTRv1.0=Device.handlingCode
Map:ICSRr2=Product.handlingCode (in R_Product)
Notes: DEFINITION:<br/>A coded value specifying special handling requirements for the device.<br/><br/>EXAMPLE(S):<br/>keep at room temperature, store upright<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  riskCode
Details:
Map:CTRv1.0=Device.riskCode
Map:ICSRr2=Product.riskCode (in R_Product)
Notes: DEFINITION:<br/>A coded value specifying the type of hazard or threat associated with the device.<br/><br/>EXAMPLE(S):<br/>flammable, explosive<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  reprocessedDeviceCode
Details:
Map:AE=Device.reprocessedDeviceCode
Map:CTRPv1.0=Device.reprocessedDeviceCode
Map:CTRv1.0=Device.reprocessedDeviceCode
Map:LSDAMv2.2.3Plus=Equipment.reprocessedDeviceCode
Notes: DEFINITION:<br/>A coded value specifying whether a device is reconditioned.<br/><br/>EXAMPLE(S):<br/>initial use of device, reuse, unknown<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public PQ.TIME
  age
Details:
Map:AE=Device.deviceAge
Map:CTRPv1.0=Device.deviceAge
Map:CTRv1.0=Device.age
Notes: DEFINITION:<br/>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. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>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.<br/>
Public TS.DATETIME
  manufactureDate
Details:
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:<br/>The date (and time) on which the device is made.  <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public TS.DATETIME
  returnedToReprocessorDate
Details:
Map:caAERSv2.2=MedicalDevice.returnedDate
Map:CTRv1.0=Device.returnedToReprocessorDate
Notes: DEFINITION:<br/>The date (and time) on which the device was returned to the manufacturer or reprocessor.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  singleUseDeviceIndicator
Details:
Map:AE=Device.singleUseDeviceIndicator
Map:CTRPv1.0=Device.singleUseDeviceIndicator
Map:CTRv1.0=Device.singleUseDeviceIndicator
Notes: DEFINITION:<br/>Specifies whether a device is intended to be used only one time.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  availableForEvaluationIndicator
Details:
Map:AE=Device.availableForEvaluationIndicator
Map:CTRPv1.0=Device.availableForEvaluationIndicator
Map:CTRv1.0=Device.availableForEvaluationIndicator
Notes: DEFINITION:<br/>Specifies whether or not the device is accessible for assessment by the manufacturer. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  overTheCounterProductIndicator
Details:
Map:AE=Device.overTheCounterProductIndicator
Map:CTRPv1.0=Device.overTheCounterProductIndicator
Map:CTRv1.0=Device.overTheCounterProductIndicator
Notes: DEFINITION:<br/>Specifies whether a device is available over-the-counter.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  ceMarkIndicator
Details:
Map:CTRRr3=Device.ceMarkIndicator
Notes: DEFINITION:<br/>Specifies whether this device bears a CE (Conformite Europeenne) mark.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>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.<br/>
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):