: Public Class
Created: 11/8/2007 3:31:01 PM
Modified: 3/21/2015 1:47:00 AM
Project:
Advanced:
DEFINITION:<br /></p><p>An object intended for use whether alone or in combination for diagnostic, prevention, monitoring, therapeutic, scientific, and/or experimental purposes.  <br /></p><p><br /></p><p>EXAMPLE(S): <br /></p><p>tongue depressor, pacemaker, insulin pump, EKG machine, x-ray machine, mass spectrometer, polymerase chain reaction (PCR) machine, microscope, pH meter<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p>Equipment<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  handlingCode
Details:
Map:CTRv1.0=Device.handlingCode
Map:ICSRr2=Product.handlingCode (in R_Product)
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying special handling requirements for the device.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;keep at room temperature, store upright#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  riskCode
Details:
Map:CTRv1.0=Device.riskCode
Map:ICSRr2=Product.riskCode (in R_Product)
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the type of hazard or threat associated with the device.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;flammable, explosive#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  reprocessedDeviceCode
Details:
Map:AE=Device.reprocessedDeviceCode
Map:CTRPv1.0=Device.reprocessedDeviceCode
Map:CTRv1.0=Device.reprocessedDeviceCode
Map:LSDAM=Equipment.reprocessedDeviceCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying whether a device is reconditioned.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;initial use of device, reuse, unknown#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public PQ.TIME
  age
Details:
Map:AE=Device.deviceAge
Map:CTRPv1.0=Device.deviceAge
Map:CTRv1.0=Device.age
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  manufactureDate
Details:
Map:AE=Device.manufactureDate
Map:CTRPv1.0=Device.manufactureDate
Map:CTRv1.0=Device.manufactureDate
Map:LSDAM=Equipment.manufactureDate
Map:LSDAM=Software.buildDate
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the device is made.  #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public TS.DATETIME
  returnedToReprocessorDate
Details:
Map:caAERSv2.2=MedicalDevice.returnedDate
Map:CTRv1.0=Device.returnedToReprocessorDate
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the device was returned to the manufacturer or reprocessor.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  singleUseDeviceIndicator
Details:
Map:AE=Device.singleUseDeviceIndicator
Map:CTRPv1.0=Device.singleUseDeviceIndicator
Map:CTRv1.0=Device.singleUseDeviceIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether a device is intended to be used only one time.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  availableForEvaluationIndicator
Details:
Map:AE=Device.availableForEvaluationIndicator
Map:CTRPv1.0=Device.availableForEvaluationIndicator
Map:CTRv1.0=Device.availableForEvaluationIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether or not the device is accessible for assessment by the manufacturer. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  overTheCounterProductIndicator
Details:
Map:AE=Device.overTheCounterProductIndicator
Map:CTRPv1.0=Device.overTheCounterProductIndicator
Map:CTRv1.0=Device.overTheCounterProductIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether a device is available over-the-counter.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  ceMarkIndicator
Details:
Map:CTRRr3=Device.ceMarkIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this device bears a CE (Conformite Europeenne) mark.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
Software
Class   		Name: specifyingDevice
  		Name: specifiedSoftware
 
Details:
DESCRIPTION:<br /></p><p>Each Device might specify the use of one or more Software.  Each Software might be specified by one or more Device.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Element Source Role Target Role
Assessor
Class   		Name: performedAssessor
  		Name: performingDevice
 
Details:
DESCRIPTION:<br /></p><p>Each Assessor might be a function performed by one Device.  Each Device might function as one or more Assessor.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
ReferenceResult
Class   		Name: performedReferenceResult
  		Name: performingDevice
 
Details:
DESCRIPTION:<br /></p><p>Each ReferenceResult might apply to results produced by one Device. Each Device might produce one or more ReferenceResult.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Performer
Class   		Name: performedPerformer
  		Name: performingDevice
 
Details:
DESCRIPTION:<br /></p><p>Each Performer might be a function performed by one Device. Each Device might function as one or more Performer.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DeviceParameter
Class   		Name: definingDeviceParameter
  		Name: definedDevice
 
Details:
DESCRIPTION:<br /></p><p>Each DeviceParameter always defines the use of one Device. Each Device might have use defined by one or more DeviceParameter.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:AE Device
Details:
 
Map:caAERSv2.2 MedicalDevice
Details:
 
Map:CTRPv1.0 Device
Details:
 
Map:CTRRr3 Device
Details:
 
Map:CTRv1.0 Device
Details:
 
Map:ICSRr2 DeviceInstance (in R_Product)
Details:
 
Map:LSDAM Equipment
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".
Object Type Connection Direction Notes
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):
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):
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):