Материал: part03

C.34.15 Protocol Approval​

The Protocol Approval Module records approvals of the content of one or more SOP Instances containing protocols by a person or​ device.​

AnapprovalismodeledasaformofAssertion.ThenatureoftheapprovalisdefinedbytheAssertionCodeintheembeddedAssertion​

Macro.​

Neither the Protocol Approval Module nor the underlying Assertion Macro address securing the approved instance against tampering​ (e.g., via a digital hash) or authenticating the identity of the source of the Assertion.​

Table C.34.15-1. Protocol Approval Module Attributes​

Note​

For experimental use this Attribute is used to identify the​ experiment.​

Required if Assertion Code Sequence (0044,0101) is (128604, DCM,​ "Approved for use in the clinical trial") or (128624, DCM, "Disapproved​ foruseintheclinicaltrial")or(128611,DCM,"Approvedforexperimental​ use") or (128612, DCM, "Disapproved for experimental use").​

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Note​

The institution for which use of the protocol is approved (recorded in the Approval Sequence (0044,0100) Item) may or may​ not differ from the institution that is currently responsible for managing the protocol instance (recorded in the Custodial Or-​ ganization Sequence (0040,A07C) of the Defined Protocol instance). Similarly, the clinical trial for which use of the protocol​ is approved (recorded in the Approval Sequence (0044,0100) Item) may or may not differ from the clinical trial, if any, for​ which the protocol instance was originally designed (recorded in the Clinical Trial Context of the Defined Protocol instance).​

A number of the Assertion codes in CID 800 “Protocol Assertion Codes” affirm details related to Attributes in a Protocol object. The​ ProtocolAttributesassociatedwitheachAssertioncodeareshowninTableC.34.15-2.Areceivingsystemmightdisplaytheassociated​ Attribute contents together with the Assertion code to convey the full meaning of the Assertion.​

Table C.34.15-2. Associated Attributes for Protocol Assertion Codes​

An instance may contain multiple approvals. Receiving systems will determine which approvals apply and what may be​ useful to display to the system operator.​

C.35 Manufacturing 3D Model Modules​

C.35.1 Manufacturing 3D Model Module​

Table C.35.1-1 defines Attributes specific to models used in medical 3D manufacturing.​

Table C.35.1-1. Manufacturing 3D Model Module Attributes​

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This would typically be used to visually distinguish between models​ that are part of the same assembly and/or provide best analog to​ real world appearance.​

The units are specified in PCS-Values, and the value is encoded as​

CIELab.​

This value may be superseded by individual colors that have been​ specified inside the encapsulated model (when the encapsulated​ format allows this).​

See Section C.10.7.1.1.​

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A non-opaque value would typically be specified when either (a)​ another model grouped in the same assembly needs to be visible​ behind or inside this model, or (b) the model represents anatomy​ that is not fully opaque.​

If not present, then it is assumed the model should be presented​ and manufactured as opaque.​

See Section C.27.1.1.3.​

C.36 RT Second Generation Modules​

The following Attribute Macros and Modules are used by the RT Second Generation IODs.​

C.36.1 RT Second Generation Concepts​

This section dicusses general concepts used in RT Second Generation Modules.​

Note​

See also explanations in Section 7.14 “Extension of The DICOM Model of The Real-world for Radiotherapy Second Gener-​ ation Information Objects” and in the IOD definitions in Section A.86.1.​

C.36.1.1 RT Second Generation Radiation Concepts​

C.36.1.1.1 Control Points​

A Control Point represents the state of a delivery device in a sequence of states defined at a given Cumulative Meterset (300A,063C)​ value.​

AControlPointcontainsgeometricandradiologicalparameters.ControlPointsareusedbythedeliverydevicetoimplementaplanned​ delivery and to record the actual delivery.​

C.36.1.1.2 Nominal Energy​

Nominal energy characterizes the penetration of the beam into a material. The values are defined by the manufacturer to label a​ specific beam spectrum. For photon beam delivery, the maximum energy of the delivered photon spectrum is typically used. For​ electron beam delivery, the most probable energy of the spectrum is typically used.​

C.36.1.1.3 Meterset​

A Meterset is a single parameter from which the absorbed dose delivered can be calculated through a calibration procedure with ad-​ ditional information. The Meterset is used to measure the progress of radiation delivery during treatment, or report on progress after​ treatment.​

See [IEC 60601-2-64] for more information on using monitor units as the unit for the Meterset.​

C.36.1.1.4 Radiation Dose Point​

A point chosen in space, or in the patient treatment volume, to measure or plan for a specific amount of radiation. The point usually​ is placed at a significant location, such as within a tumor (where radiation will be delivered), or within healthy tissue (where radiation​ will be minimized) or where a measurement device can be positioned.​

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C.36.1.1.5 Continuous Rotation Angle​

A Continuous Rotation Angle is an angle in the range (-∞,+∞).​

ContinuousRotationAnglerepresentarotationdirectionandmagnitude.Themagnitudeisnotlimitedtobebetween0and360degrees.​

Allrotationsaredefinedinaright-handedcoordinatesystem,thusthedirectionofapositiverotationisseenasclockwisewhenviewed​ in the positive direction of the axis of rotation.​

C.36.1.1.6 External Contour​

The External Contour is the spatial extent that is taken into account for dose calculation. The External Contour includes the Patient​ Anatomy Model, Bolus, Patient Positioning Devices, Patient Immobilization Devices or other devices in the path of the radiation.​

C.36.1.1.7 C-Arm LINAC​

A C-Arm LINAC is a linear accelerator that follows the coordinate definitions of [IEC 61217]. Any hardware belonging to this category​ may or may not represent an actual C-Arm gantry.​

C.36.1.1.8 Virtual Simulation​

Virtual Simulation is a form of Radiotherapy treatment simulation that uses volumetric imaging studies in a computer to model the​ geometry of a radiation beam with respect to a patients anatomy. The spatial relationship between beam and anatomy is verified in​ Digitally Reconstructed Radiograph (DRR) images that conceptually represent actual beam portal images.​

C.36.1.1.9 Beam Modifier Coordinate System​

Beam modifiers, e.g., beam limiting devices, compensators and blocks, are specified by geometric coordinates.​

A Base Beam Modifier Coordinate System is defined with respect to the Equipment Coordinate System (see Section 10.39.1.1). The​ x/y plane of the Base Beam Modifier Coordinate System is referred to as the Base Beam Modifier Definition Plane. The orientation​ of the Base Beam Modifier Coordinate System is such that the Base Beam Modifier Definition Plane is parallel to the x/y plane of the​ Equipment Coordinate System. The origin of the Base Beam Modifier Coordinate System is offset from the RT Device Distance Ref-​ erence Location by the RT Beam Modifier Definition Distance (300A,0688) as shown in Figure C.36.1-1.​

Plane

Figure C.36.1-1. Base Beam Modifier Coordinate System​

Each beam modifier is defined in its own Beam Modifier Coordinate System with the following characteristics:​

•​Defined with respect to the Base Beam Modifier Coordinate System.​

•​Right-handed Cartesian coordinate system, with the positive z-axis pointing towards the nominal Radiation Source location.​

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