Technical Publications

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1 GE Healthcare Technical Publications DOC Revision 1 CardioSoft V6.7 for Windows 10 Copyright 2017 by General Electric Co. Do not duplicate

2 GE Healthcare

3 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT

4 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT THIS PAGE LEFT INTENTIONALLY BLANK

5 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT TABLE OF CONTENTS 1. CONFORMANCE STATEMENT OVERVIEW 1.1 CONFORMANCE STATEMENT OVERVIEW INTRODUCTION OVERVIEW OVERALL DOCUMENT STRUCTURE INTENDED AUDIENCE SCOPE AND FIELD OF APPLICATION IMPORTANT REMARKS REFERENCES DEFINITIONS SYMBOLS AND ABBREVIATIONS NETWORK CONFORMANCE STATEMENT INTRODUCTION IMPLEMENTATION MODEL AE SPECIFICATIONS COMMUNICATION PROFILES EXTENSIONS / SPECIALIZATIONS / PRIVATIZATIONS CONFIGURATION SUPPORT OF EXTENDED CHARACTER SETS CODES AND CONTROLLED TERMINOLOGY SECURITY PROFILES MODALITY WORKLIST QUERY IMPLEMENTATION CardioSoft Mapping of DICOM entities Worklist Query MODULE TABLE Worklist Query Module Definitions i

6 CardioSoft V6.7 for Windows MODALITY PERFORMED PROCEDURE STEP IMPLEMENTATION Modality Performed Procedure Step MODULE TABLE Modality Performed Procedure Step Module Definitions Standard Extended and Private Data Attributes Standard Extended and Private CONTEXT Groups STORAGE COMMITMENT PUSH MODEL IMPLEMENTATION Storage Commitment PUSH Model Information Object definition ENCAPSULATED PDF INFORMATION OBJECT IMPLEMENTATION IOD MODULE TABLE INFORMATION MODULE DEFINITIONS Standard Extended and Private Data Attributes Standard Extended and Private CONTEXT Groups LEAD ECG WAVEFORM INFORMATION OBJECT IMPLEMENTATION IOD MODULE TABLE INFORMATION MODULE DEFINITIONS Standard Extended and Private Data Attributes Standard Extended and Private CONTEXT Groups GENERAL ECG WAVEFORM INFORMATION OBJECT IMPLEMENTATION IOD MODULE TABLE INFORMATION MODULE DEFINITIONS Standard Extended and Private Data Attributes Standard Extended and Private CONTEXT Groups ii

7 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT 1. CONFORMANCE STATEMENT OVERVIEW 1.1 CONFORMANCE STATEMENT OVERVIEW The system provides sophisticated image processing and storage functions. It will provide support for DICOM 3.0 to achieve interoperability across equipment produced by different vendors. Table 1.1 provides an overview of the network services supported by the system. Table 1.1 SOP Class Name SOP Class UID SCU SCP Modality Worklist Information Model - FIND Yes No Modality Performed Procedure Step Yes No Storage Commitment Push Model Yes No 12-lead ECG Waveform Storage Yes No General ECG Waveform Storage Yes No Encapsulated PDF Storage Yes No Verification SOP Class Yes Yes 2. INTRODUCTION 2.1 OVERVIEW This DICOM Conformance Statement is divided into Sections as described below: Section 2 (Introduction), which describes the overall structure, intent, and references for this Conformance Statement Section 3 (Network Conformance Statement), which specifies the GE Healthcare equipment compliance to the DICOM requirements for the implementation of Networking features. Section 4 (Modality Worklist Information Model), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of the Modality Worklist service. Section 5 (Modality Performed Procedure Step SOP Class Definition), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of a Modality Performed Procedure Step Service. Section 6 (Storage Commitment Push Model SOP Class Definition), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of a Storage Commitment Push Model Service. Section 7 (Encapsulated PDF Information Object Implementation), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of an Encapsulated PDF Object. Section 8 (12-Lead ECG Waveform Information Object Implementation), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of a 12-Lead ECG Waveform Object. Section 9 (General ECG Waveform Information Object Implementation), which specifies the GE Healthcare equipment compliance to DICOM requirements for the implementation of an General ECG Waveform Object. 1 1

8 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT 2.2 OVERALL DOCUMENT STRUCTURE The Documentation Structure of the GE Healthcare Conformance Statements and their relationship with the DICOM v3.0 Conformance Statements is shown in the Illustration below. APPLICATION ENTITY SPECIFICATION (SERVICE CLASSES, INFORMATION OBJECTS, MESSAGE EXCHANGES, ETC.) Product Implementation: CT Advantage Conformance M R Advantage Statement Conformance CardioSoft Direction: Statement Direction: Conformance Statement Direction: DOC Rev1... Conformance Statement Direction:... DICOM STANDARD Standard Specification: DICOM Part 1 DICOM Part 2 DICOM Part 3 DICOM Part 4 DICOM Part 16 This document specifies the DICOM implementation. It is entitled: CardioSoft V 6.7 for Windows 10 Conformance Statement for DICOM 1 2

9 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT This DICOM Conformance Statement documents the DICOM Conformance Statement and Technical Specification required to interoperate with the GE Healthcare network interface. The GE Healthcare Conformance Statement, contained in this document, also specifies the Lower Layer communications which it supports (e.g., TCP/IP). However, the Technical Specifications are defined in the DICOM Part 8 standard. For more information including Network Architecture and basic DICOM concepts, please refer to the Introduction. For more information regarding DICOM, copies of the Standard may be obtained on the Internet at Comments on the Standard may be addressed to: DICOM Secretariat NEMA 1300 N. 17 th Street, Suite 1752 Rosslyn, VA USA Phone: INTENDED AUDIENCE The reader of this document is concerned with software design and/or system integration issues. It is assumed that the reader of this document is familiar with the DICOM Standard and with the terminology and concepts which are used in that Standard. 2.4 SCOPE AND FIELD OF APPLICATION It is the intent of this documentto provide an unambiguous specification for GE Healthcare implementations. This specification, called a Conformance Statement, includes a DICOM Conformance Statement and is necessary to ensure proper processing and interpretation of GE Healthcare medical data exchanged using DICOM v3.0. The GE Healthcare Conformance Statements are available to the public. 1 3

10 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT The reader of this DICOM Conformance Statement should be aware that different GE Healthcare devices are capable of using different Information Object Definitions. For example, a GE Healthcare CT Scanner may send images using the CT Information Object, MR Information Object, Secondary Capture Object, etc. Included in this DICOM Conformance Statement are the Module Definitions which define all data elements used by this GE Healthcare implementation. If the user encounters unspecified private data elements while parsing a GE Healthcare Data Set, the user is well advised to ignore those data elements (per the DICOM standard). Unspecified private data element information is subject to change without notice. If, however, the device is acting as a "full fidelity storage device", it should retain and re-transmit all of the private data elements which are sent by GE Healthcare devices. 2.5 IMPORTANT REMARKS The use of these DICOM Conformance Statements, in conjunction with the DICOM Standards, is intended to facilitate communication with GE imaging equipment. However, by itself, it is not sufficient to ensure that inter-operation will be successful. The user (or user's agent) needs to proceed with caution and address at least four issues: Integration - The integration of any device into an overall system of interconnected devices goes beyond the scope of standards (DICOM v3.0), and of this introduction and associated DICOM Conformance Statements when interoperability with non-ge equipment is desired. The responsibility to analyze the applications requirements and to design a solution that integrates GE imaging equipment with non GE systems is the user's responsibility and should not be underestimated. The user is strongly advised to ensure that such an integration analysis is correctly performed. Validation - Testing the complete range of possible interactions between any GE device and non GE devices, before the connection is declared operational, should not be overlooked. Therefore, the user should ensure that any non GE provider accepts full responsibility for all validation required for their connection with GE devices. This includes the accuracy of the image data once it has crossed the interface between the GE imaging equipment and the non GE device and the stability of the image data for the intended applications. Such a validation is required before any clinical use (diagnosis and/or treatment) is performed. It applies when images acquired on GE imaging equipment are processed/displayed on a non-ge device, as well as when images acquired on non- GE equipment is processed/displayed on a GE console or workstation. Future Evolution - GE understands that the DICOM Standard will evolve to meet the user's growing requirements. GE is actively involved in the development of the DICOM Standard. DICOM will incorporate new features and technologies and GE may follow the evolution of the Standard. The GE Healthcare protocol is based on DICOM as specified in each DICOM Conformance Statement. Evolution of the Standard may require changes to devices which have implemented DICOM. In addition, GE reserves the right to discontinue or make changes to the support of communications features (on its products) described by these DICOM Conformance Statements. The user should ensure that any non GE provider, which connects with GE devices, also plans evolution of the DICOM Standard. Failure to do so will likely result in the loss of function and/or connectivity as the DICOM Standard changes and GE Products are enhanced to support these changes. 1 4

11 CardioSoft V6.7 for Windows 10 CONFORMANCE STATEMENT Interaction - It is the sole responsibility of the non GE provider to ensure that communication with the interfaced equipment does not cause degradation of GE imaging equipment performance and/or function. 2.6 REFERENCES NEMA PS3: Digital Imaging and Communications in Medicine (DICOM) Standard, available free at DEFINITIONS Informal definitions are provided for the following terms used in this Conformance Statement. The DICOM Standard is the authoritative source for formal definitions of these terms. Abstract Syntax the information agreed to be exchanged between applications, generally equivalent to a Service/Object Pair (SOP) Class. Examples: Verification SOP Class, Modality Worklist Information Model Find SOP Class, Computed Radiography Image Storage SOP Class. Application Entity (AE) an end of a DICOM information exchange, including the DICOM network or media interface software; i.e., the software that sends or receives DICOM information objects or messages. A single device may have multiple Application Entities. Application Entity Title the externally known name of an Application Entity, used to identify a DICOM application to other DICOM applications on the network. Application Context the specification of the type of communication used between Application Entities. Example: DICOM network protocol. Association a network communication channel set up between Application Entities. Attribute a unit of information in an object definition; a data element identified by a tag. The information may be a complex data structure (Sequence), itself composed of lower level data elements. Examples: Patient ID (0010,0020), Accession Number (0008,0050), Photometric Interpretation (0028,0004), Procedure Code Sequence (0008,1032). Information Object Definition (IOD) the specified set of Attributes that comprise a type of data object; does not represent a specific instance of the data object, but rather a class of similar data objects that have the same properties. The Attributes may be specified as Mandatory (Type 1), Required but possibly unknown (Type 2), or Optional (Type 3), and there may be conditions associated with the use of an Attribute (Types 1C and 2C). Examples: MR Image IOD, CT Image IOD, Print Job IOD. Joint Photographic Experts Group (JPEG) a set of standardized image compression techniques, available for use by DICOM applications. Media Application Profile the specification of DICOM information objects and encoding exchanged on removable media (e.g., CDs) Module a set of Attributes within an Information Object Definition that are logically related to each other. Example: Patient Module includes Patient Name, Patient ID, Patient Birth Date, and Patient Sex. Negotiation first phase of Association establishment that allows Application Entities to agree on the types of data to be exchanged and how that data will be encoded. Presentation Context the set of DICOM network services used over an Association, as negotiated between Application Entities; includes Abstract Syntaxes and Transfer Syntaxes. Protocol Data Unit (PDU) a packet (piece) of a DICOM message sent across the network. Devices must specify the maximum size packet they can receive for DICOM messages. Security Profile a set of mechanisms, such as encryption, user authentication, or digital signatures, used by an Application Entity to ensure confidentiality, integrity, and/or availability of exchanged DICOM data 1 5

12 CardioSoft V6.7 for Windows 10 Service Class Provider (SCP) role of an Application Entity that provides a DICOM network service; typically, a server that performs operations requested by another Application Entity (Service Class User). Examples: Picture Archiving and Communication System (image storage SCP, and image query/retrieve SCP), Radiology Information System (modality worklist SCP). Service Class User (SCU) role of an Application Entity that uses a DICOM network service; typically, a client. Examples: imaging modality (image storage SCU, and modality worklist SCU), imaging workstation (image query/retrieve SCU) Service/Object Pair (SOP) Class the specification of the network or media transfer (service) of a data (object); the fundamental unit of DICOM interoperability specification. Examples: Ultrasound Image Storage Service, Basic Grayscale Print Management. Service/Object Pair (SOP) Instance an information object; a specific occurrence of information exchanged in a SOP Class. Examples: a specific x-ray image. Tag a 32-bit identifier for a data element, represented as a pair of four digit hexadecimal numbers, the group and the element. If the group number is odd, the tag is for a private (manufacturer-specific) data element. Examples: (0010,0020) [Patient ID], (07FE,0010) [Pixel Data], (0019,0210) [private data element] Transfer Syntax the encoding used for exchange of DICOM information objects and messages. Examples: JPEG compressed (images), little endian explicit value representation. Unique Identifier (UID) a globally unique dotted decimal string that identifies a specific object or a class of objects; an ISO-8824 Object Identifier. Examples: Study Instance UID, SOP Class UID, SOP Instance UID. Value Representation (VR) the format type of an individual DICOM data element, such as text, an integer, a person s name, or a code. DICOM information objects can be transmitted with either explicit identification of the type of each data element (Explicit VR), or without explicit identification (Implicit VR); with Implicit VR, the receiving application must use a DICOM data dictionary to look up the format of each data element. 2.8 SYMBOLS AND ABBREVIATIONS AE Application Entity AET Application Entity Title CR Computed Radiography CT Computed Tomography DICOM Digital Imaging and Communications in Medicine HIS Hospital Information System HL7 Health Level 7 Standard IHE Integrating the Healthcare Enterprise IOD Information Object Definition ISO International Organization for Standards JPEG Joint Photographic Experts Group LUT Look-up Table MPPS Modality Performed Procedure Step MSPS Modality Scheduled Procedure Step MTU Maximum Transmission Unit (IP) MWL Modality Worklist O Optional (Key Attribute) OSI Open Systems Interconnection PACS Picture Archiving and Communication System PET Positron Emission Tomography PDU Protocol Data Unit R Required (Key Attribute) SCP Service Class Provider SCU Service Class User SOP Service-Object Pair SPS Scheduled Procedure Step SR Structured Reporting TCP/IP Transmission Control Protocol/Internet Protocol U Unique (Key Attribute) UL Upper Layer VR Value Representation 1 6

13 3. NETWORK CONFORMANCE STATEMENT 3.1 INTRODUCTION This section of the DICOM Conformance Statement specifies the CardioSoft compliance to DICOM requirements for Networking features. Note that the format of this section strictly follows the format defined in DICOM Standard PS 3.2 (Conformance). Please refer to that part of the standard while reading this section. CardioSoft is a PC based diagnostic workstation for Exercise tests, Resting ECG, Ambulatory Blood Pressure (ABP), Spirometry and Ergospirometry tests. All 3 products CardioSoft include the identical software application. It provides the following DICOM functionality: Querying and retrieving a DICOM Modality Worklist from a Worklist SCP. Sending start and end of a test (MPPS in progress, MPPS completed/ discontinued) to a DICOM Modality Performed Procedure Step SCP. Sending storage commitment requests (and receiving replies) to a DICOM Storage Commitment SCP. Exporting DICOM Composite Instances (as Storage SCU) o o ECG Waveforms for Exercise- or Ergospirometry tests Final report as DICOM Encapsulated PDF for all types of tests DICOM Verification (as SCP and SCU) 3.2 IMPLEMENTATION MODEL Application Data Flow Diagram The network application model for the CardioSoft is shown in the following Illustration: 2 1

14 ILLUSTRATION 2 1 NETWORK APPLICATION MODEL AND DATA FLOW DIAGRAM Association Initiation DICOM Standard Interface Worklist Query Modality Worklist SCP Start/ End Test Save Test CASE CardioSoft CS Modality PPS SCP Storage SCP Save Test completed Storage commitment received Association Acceptance Storage Commitment SCP Echo Remote Verification SCP/SCU Association Initiation 2 2

15 There are 6 local real-world activities that occur in CardioSoft: Worklist Query Start/End Test Save Test Save Test completed Test Status change Echo Worklist Query initiates a connection to the Modality Worklist SCP, performs a query and retrieves the matching entries to the product. Start/ End Test initiates a connection to the Modality PPS SCP. N-CREATE/ N-SET messages are sent. Save Test initiates a connection to the Storage SCP (Image Archive) and transmits configured Composite Instances to the Storage SCP (C-STORE). After successful transmission the transfer status of the test in the database is set to Transferred (DCM). Save Test completed initiates a commitment request (N-ACTION-RQ) message that is sent to the Storage Commitment SCP for the images of the test (if Storage Commitment is enabled (default) in the System Configuration). Storage commitment received: Receiving the corresponding commitment responses (N- EVENT-REPORT) from the Storage Commitment SCP at any time the system runs, initiates the system to set the transfer status of the test in the database to Committed (DCM). If Storage Commitment is disabled, the transfer status is directly set to Committed (DCM). A committed test cannot be modified (default, see Service Manual). Echo: Initiates a connection to the DICOM SCP, sends a verification request and closes the connection. It also responds to incoming Verification requests (for service use) Functional Definition of AE's Application Entity CardioSoft supports the following functions: Initiates a DICOM association to query a DICOM worklist Receives DICOM modality worklist information. Initiates a DICOM association to notify start of test. Initiates a DICOM association to notify end of test. Initiates a DICOM association to send Composite Instances. Transmits DICOM Composite Instances to the DICOM Storage SCP. Initiates a DICOM association to request storage commitment of Composite Instances. Responds to replies for storage commitment requests of Composite Instances. Initiates verification (as SCU) to assist in network diagnostics. Responds to verification requests (as SCP) from other devices. 2 3

16 3.2.3 Sequencing of Real-World Activities In case of a scheduled test the following sequence takes place: Modality Worklist query Start test with Modality Performed Procedure Step In Progress End test with Modality Performed Procedure Step Completed or Discontinued. Save test with storage of Composite Instances Save test completed with Storage Commitment request (if enabled in system configuration) Test status change with reception of Storage Commitment replies For an unscheduled test the sequence is identical except that the Modality Worklist query is not applicable. 3.3 AE SPECIFICATIONS CardioSoft AE Specification The CardioSoft Application Entity provides Standard Conformance to the following DICOM SOP Classes as an SCU: SOP Class Name SOP Class UID Modality Worklist Information Model - FIND Modality Performed Procedure Step Storage Commitment Push Model lead ECG Waveform Storage General ECG Waveform Storage Encapsulated PDF Storage Verification SOP Class The CardioSoft Application Entity provides Standard Conformance to the following DICOM SOP Classes as an SCP: SOP Class Name SOP Class UID Verification SOP Class

17 Association Establishment Policies General The DICOM Application Context Name (ACN), which is always proposed, is: Application Context Name The maximum length PDU receive size (not configurable) for the CardioSoft is: Maximum Length PDU Number of Associations The CardioSoft will initiate a maximum of 1 simultaneous associations to remote nodes. The CardioSoft will support a maximum of 1 simultaneous associations initiated by remote nodes Asynchronous Nature Asynchronous mode is not supported. All operations will be performed synchronously Implementation Identifying Information The Implementation UID for this DICOM Implementation is: CardioSoft Implementation UID The Implementation Version Name for this DICOM Implementation is: CardioSoft Implementation Version Name CSOFT_V11 2 5

18 Association Initiation Policy When the CardioSoft Application Entity initiates an Association for any Real- World Activity, it will propose the Presentation Context for only this Real-World Activity. CardioSoft proposes a set of Transfer Syntaxes per Presentation Context and Abstract Syntax Real-World Activity A (Worklist Query) Associated Real-World Activity The user may initiate a DICOM Worklist Query when entering the Order List screen or when clicking the Find button in the Order List screen. The query sends a C-FIND- RQ to the Worklist SCP. The association is closed upon the receipt of C-FIND-RSP confirmation Proposed Presentation Context Table Presentation Context Table Proposed by AE CardioSoft for Activity A (Worklist Query) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Modality Worklist Implicit VR Little Endian SCU None Information Model - FIND Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for the Modality Worklist Information Model - FIND SOP Class The CardioSoft includes matching keys in the Modality Worklist queries as described in Section 3. The Scheduled Procedure Steps and it s corresponding response information are displayed in the DICOM Worklist, accessible through the Patient List (button Order List ). In System Configuration (DICOM tab) the displayable fields of the worklist can be configured. Further information see Service Manual. A C-FIND CANCEL is not supported. However, the number of displayed worklist items is limited to 200. If more are available, the user is informed to modify the filter criteria for the query (see Operators Manual). 2 6

19 Following are the status codes that are more specifically processed when receiving messages from a Modality Worklist SCP equipment : Service Status Status Code Further Meaning Application Behavior When Receiving Status Code Failure A700 Refused: Out of resources Received items of the worklist are displayed and the user is informed, that there may be more items. The association is closed. A900 Error: Identifier does not match SOP Class The user is informed in the status bar of the worklist screen that the worklist could not be received. The worklist is cleared. The error is logged. The association is closed. Cxxx Error: Unable to process The user is informed in the status bar of the worklist screen that the worklist could not be received. The worklist is cleared. The error is logged. The association is closed. Cancel FE00 Matching terminated due to cancel The user is informed in the status bar of the worklist screen that the worklist could not be received. The worklist is cleared. The error is logged. The association is closed. Success 0000 Matching is complete - No final identifier is supplied Pending FF00 Matches are continuing - Current Match is supplied and any Optional Keys were supported in the same manner as Required Keys. FF01 Matches are continuing - Warning that one or more Optional Keys were not supported for existence for this The worklist is displayed. The association is closed. Continue receiving keys. Continue receiving keys. 2 7

20 Identifier Real-World Activity B (Start/ End Test) Associated Real-World Activity The Modality Performed Procedure Step In Progress (N-CREATE) is sent when the test is started: Exercise test: when entering the Pre-Test phase Resting ECG test: after the first 10 second ECG has been acquired Spirometry test: when initiating the first trial ABP test: when initiating the download from the BP Monitor Ergospirometry test: when entering the Pre-Test phase The Modality Performed Procedure Step Completed or Discontinued (N-SET) is sent when the test is finished: Exercise test: Confirmation of the Test end status dialog (when stepping to the Post Test Review or Initial screen) Resting ECG test: Confirmation of the Test end status dialog (when stepping to the Post Test Review screen) Spirometry test: Confirmation of the Test end status dialog (when stepping to the Post Test Review screen) ABP: Confirmation of the Test end status dialog (after downloading data from the BP Monitor) Ergospirometry: Confirmation of the Test end status dialog (when stepping to the Post Test Review or Initial screen) The Test end status dialog provides the following selections: Test successfully finished : leads to MPPS Completed Test cancelled/ unsuccessfully terminated : leads to MPPS Discontinued with one of the following selectable reasons: o Procedure was cancelled o Equipment failure o Incorrect procedure ordered o Patient allergic to media o Patient refused to continue o Patient did not arrive o Duplicate order o Equipment change o Unspecified reason o Incorrect worklist entry selected o Patient condition prevented continuing The association is opened before the transaction and closed after the transaction. 2 8

21 Proposed Presentation Context Table Presentation Context Table Proposed by AE CardioSoft for Activity B (Start/ End Test) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Modality Performed Implicit VR Little Endian SCU None Procedure Step SOP Class Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for Modality Performed Procedure Step SOP Class The CardioSoft includes attributes in the Modality Performed Procedure Step N- CREATE as described in Section 4.2 If the response to an N-CREATE-RSP fails, the user is informed by an error message, that the connection to the PPS-Manager failed. The AE includes attributes in the Modality Performed Procedure Step N-SET as described in Section 4.2 If the response to an N-SET-RSP fails, the user is informed by an error message, that the connection to the PPS-Manager failed Real-World Activity C (Save Test) Associated Real- World Activity The Image Stored (C-STORE) message is sent to the Storage SCP when the test is stored: Exercise test: When stepping to the Post Test Review or Initial screen. Resting ECG test: When stepping to the Post Test Review screen. Spirometry test: When stepping to the Post Test Review screen. ABP test: After downloading data from the BP Monitor. Ergospirometry: When stepping to the Post Test Review or Initial screen. After successful transmission of all C-STORE messages per test the transfer status for this test is set to Transferred (DCM), which is displayed in the overall test list of CardioSoft. If the response to a C-STORE fails, the user is informed by an error message, that the connection to the Image Archive failed. In case of an error CardioSoft does not send further C-STORES for this corresponding test. Encapsulated PDF: 2 9

22 The Encapsulated PDF is created as one final report, depending on the test specific configuration. ECG Waveforms: Note: DICOM Encapsulated PDF is provided by the following test types: Exercise test Resting ECG Spirometry test ABP test Ergospirometry test The association is opened before the transaction and closed after the transaction. DICOM ECG Waveforms are only provided by the Exercise- and Ergospirometry test. The following ECG Waveforms objects are sent per test: The first 12SL ECG strip in Pre-Test phase (as "Resting ECG"), if available. Last ECG strip in Pre-Test phase (as "Baseline ECG"), if available. Last ECG strip per stage in Exercise Phase (as "Exercise ECG"), if available. Last ECG strip in Recovery Phase (as "Post Exercise ECG"), if available. Per ECG Waveform object one C-STORE message is sent. The association is opened before the first ECG Waveform object is sent and closed after the last ECG Waveform object was sent. Storage of ECG Waveforms either uses the General ECG Waveform SOP Class or the 12-Lead ECG Waveform SOP Class, which is the default value (Product Service Manual). The General ECG Waveform SOP Class also supports 15-Lead ECG acquisition. Alternatively, CardioSoft provides DICOM Part 10 File Export (using all listed Storage SOP Classes) to a configurable folder. File name customization can be done in the Export-Configuration dialog of the System Configuration. This fits into the CardioSoft export concept. CardioSoft does not use the DICOM File Services and therefore does not play the role of an FSC (DICOMDIR is not used) Proposed Presentation Context Table 2 10

23 Presentation Context Table Proposed by AE CardioSoft for Activity C (Save Test) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation 12-lead ECG Waveform Implicit VR Little Endian SCU None Storage Explicit VR Little Endian Explicit VR Big Endian General ECG Waveform Implicit VR Little Endian SCU None Storage Explicit VR Little Endian Explicit VR Big Endian Encapsulated PDF Implicit VR Little Endian SCU None Storage Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for All Storage SOP Classes The CardioSoft includes optional data elements in the SOP Instances as described in Sections 6.2 (Encapsulated PDF IOD), 7.2 (12-Lead ECG Waveform IOD) and 8.2 (General ECG Waveform IOD) Real-World Activity D (Save Test completed) Associated Real-World Activity When the test is stored (Real-World Activity C Save Test ), CardioSoft initiates an association and sends an N-ACTION-RQ to the SCP, if this is enabled in the System Configuration (which is the default value). N-EVENT-REPORT messages shall use a different association as the one used to transfer N-ACTION-RQ messages. All status codes of the N-ACTION-RSP with status Failure or Warning are treated as failures and terminate the association and operation. The user is informed by an error message, that the connection to the Image Manager failed. After reception of the N-ACTION-RSP the association is closed. The number of SOP Instances per individual request depends on the duration of the test: For Resting ECG, Spirometry and ABP only 1 SOP Instance is sent (final report sent as encapsulated PDF). For the Exercise- and Ergospirometry test the number depends on how many 12SL-ECGs were executed and how many stages have passed. Typically, about 10 SOP Instances may be sent to the SCP. Maximum is

24 Proposed Presentation Context Table Presentation Context Table Proposed by AE CardioSoft for Activity D (Save Test completed) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Storage Commitment Implicit VR Little Endian SCU None Push Model Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for the Storage Commitment Push Model SOP Class SCU CardioSoft uses DICOM network storage services to transfer SOP Instances which are to be committed. It does not support the optional Storage Media File-Set ID and UID Attributes in the Storage Commitment N-ACTION for transfer of SOP Instances by media for Storage Commitment. CardioSoft may request Storage Commitment for Instances of any of the SOP Classes it supports as an SCU (see Section ) The Storage Commitment Information Object is described in Section Real-World Activity F (Echo) Associated Real-World Activity The user may initiate a DICOM Verification Request in the System Configuration screen. Associations will be released upon the receipt of each C-ECHO confirmation. In the event that the SCP does not respond, the operation will time out, close the association and inform the user Proposed Presentation Context Table Presentation Context Table Proposed by AE CardioSoft for Activity F (Echo) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Verification SOP Class Implicit VR Little Endian SCU None Explicit VR Little Endian Explicit VR Big Endian

25 Association Acceptance Policy Real-World Activity E (Storage commitment received) Associated Real-World Activity CardioSoft waits for an SCP association request for the N-EVENT-REPORT messages on the configured port (see System Configuration). When the requested association is accepted by CardioSoft, all messages are read, processed and the corresponding N-EVENT-RSP messages are sent. The CardioSoft receives N-EVENT-REPORT messages at any time CardioSoft is running. N-EVENT-REPORT messages shall use a different association as the one used to transfer N-ACTION-RQ messages. There is no time limit for the duration of applicability of the Transaction UID Accepted Presentation Context Table Presentation Context Table - Accepted by AE CardioSoft for Activity E (Storage commitment received) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Storage Commitment Implicit VR Little Endian SCU None Push Model Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for the Storage Commitment Push Model SOP Class SCU CardioSoft will only accept the SCU role (which must be proposed via SCP/SCU Role Selection Negotiation) within a Presentation Context for the Storage Commitment Push Model SOP Class. Upon receiving a Storage Commitment N-EVENT-REPORT (Storage Commitment Result), CardioSoft will validate the Transaction UID against its list of outstanding Storage Commitment Request Transaction UIDs. If it matches an outstanding Request and if all SOP Instances for this test indicate a success status, the AE will mark the test in it s test list with Committed (DCM). If at least one of them don t have success status, the test keeps its status Transferred (DCM). The transfer status Committed (DCM) does not allow to modify this test anymore (default, can be changed in System Configuration). If the Storage Commitment Result indicates any failure status, the error will be written to the error log. 2 13

26 Any retry of the Storage Commitment Request must be manually reinitiated by resending the test to the Image Archive (test list, button Send to Image Archive ). In this case also the C-STORE is resent. The AE always returns a Success Status 0000 to a Storage Commitment N-EVENT- REPORT Presentation Context Acceptance Criterion CardioSoft evaluates each Presentation Context independently, and accepts any Presentation Context that matches an Abstract Syntax for any Real-World Activity Transfer Syntax Selection Policies Within each Presentation Context, CardioSoft will accept the first proposed transfer syntax that it also supports for that Abstract Syntax Real-World Activity F (Echo) Associated Real-World Activity An incoming Verification Request will cause the AE to accept the association and respond with a Verification Response Accepted Presentation Context Table Presentation Context Table - Accepted by AE CardioSoft for Activity F (Echo) Abstract Syntax Transfer Syntax Role Extended Name UID Name List UID List Negotiation Verification SOP Class Implicit VR Little Endian SCP None Explicit VR Little Endian Explicit VR Big Endian SOP Specific DICOM Conformance Statement for Verification SOP Class The AE provides standard conformance to the Verification SOP Class as an SCP. The default port number is 108. No criterion Presentation Context Acceptance Criterion 2 14

27 Transfer Syntax Selection Policies The selected transfer syntax is based on the proposed transfer syntax list. The priority order is Explicit VR Little Endian, Explicit VR Big Endian and Implicit VR Little Endian. 3.4 COMMUNICATION PROFILES Supported Communication Stacks The DICOM Upper Layer Protocol is supported using TCP/IP, as specified in DICOM PS3.8. The TCP/IP stack is inherited from the Windows Operating System Physical Media Support The product is provided with a 10/100 Mb/s auto-sensing Ethernet interface. Additional or alternate network interfaces may be available. Note: For more information about the Physical Media available on CardioSoft, please refer to the Product Data Sheet DHCP DHCP can be used to obtain TCP/IP network configuration information. The network parameters obtainable via DHCP are shown in the Table below. The Default Value column of the table shows the default used if the DHCP server does not provide a value. Values for network parameters set in the Service/Installation tool take precedence over values obtained from the DHCP server. Support for DHCP is pre-configured on the system. If DHCP is not in use, TCP/IP network configuration information must be manually configured via the service interface IPv4 and IPv6 Support This product supports only IPv EXTENSIONS / SPECIALIZATIONS / PRIVATIZATIONS Standard Extended / Specialized / Private SOP Classes Standard Extended SOP Classes There are no Standard Extended SOP Class supported by this product Private SOP Class There are no Private SOP Classes supported by the product Private Transfer Syntaxes There are no private Transfer Syntaxes supported by the product. 2 15

28 3.6 CONFIGURATION AE Title/Presentation Address Mapping The Local AE title is configurable in the System Configuration, see below Configurable Parameters The following fields are configurable for this AE (local): Local AE Title: through System Configuration, DICOM screen Local IP Address: through Operating System (static IP Address configuration) Local Listening Port Number (for Storage Commitment SCU): through System Configuration, DICOM screen Local IP Netmask: through Operating System (static IP Address configuration) The following SCP DICOM AE s are configurable: SCP DSS/ Order Filler (DMWL Query) SCP PPS Manager (MPPS) SCP Image Archive/ Storage (Image Stored) SCP Image Manager (Storage Commitment) The following fields are configurable for the listed SCP DICOM AE s (also used for Verification): SCP AE Title: through System Configuration, DICOM screen SCP IP Address: through System Configuration, DICOM screen SCP TCP/IP Port Number: through System Configuration, DICOM screen The following field is configurable as Storage Commitment SCU (also used for Verification): SCU TCP/IP Port Number: through System Configuration, DICOM screen DICOM Verification: Max retries, retry interval, timeout (see product Service Manual) General: Timeout for reading messages, e.g. response messages (default value: 5 seconds) Further information about the DICOM Configuration please see the Service Manual of the Product. Note: All configurations must be performed by a GE Field Engineer. 2 16

29 3.7 SUPPORT OF EXTENDED CHARACTER SETS CardioSoft will support the following single-byte extended character sets: ISO_IR 6 (ASCII): Default ISO_IR 100 (ISO : Latin 1: Western Europe) ISO_IR 101 (ISO : Latin 2: Central/Eastern Europe) ISO_IR 144 (ISO : Cyrillic) ISO_IR 148 (ISO : Latin 5: Turkish) as extended character set. As a Query SCU, the product will accept response items with any value of Specific Character Set (0008,0005). However, it will display in the user interface only characters specified as within ISO_IR 6 (ASCII) or the configured extended character set. The product user interface will allow the user to enter characters that are within ASCII or the configured extended character set. If any such extended characters are included in SOP Instances or in query identifier matching fields, the product will appropriately specify the extended character set in Specific Character Set (0008,0005). The product will accept, as a Modality Worklist SCU, Scheduled Procedure Step Identifiers with any value of Specific Character Set (0008,0005). Text attributes of the Scheduled Procedure Step Identifier, including Patient and Physician names, that include extended characters will be displayed as described above. Please see the Service Manual for the extended character set configuration. 3.8 CODES AND CONTROLLED TERMINOLOGY Fixed Coded Terminology Not applicable Mapped Coded Terminology Not applicable Configurable Coded Terminology The product allows configuration of the following sets of coded terminology: Context Group Default Value Set Use Stress Protocol CID 3261, CSO_STRESS, CSO_ESPIRO, CSO_ECG, Value of Scheduled Protocol Code Sequence (0040,0008) from selected Modality Worklist Scheduled Procedure Step is matched to this group for selection of the test type (one of Exercise test, Resting ECG, Spirometry, ABP test, 2 17

30 CSO_ABP, CSO_SPI Ergospirometry test) and protocol type (e.g. BRUCE) Selected value from this group is used in the Performed Protocol Code Sequence (0040,0260) Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) CSO_STRESS CSO_WHO Exercise Test, WHO Ergometer Protocol CSO_STRESS CSO_WHO50 Exercise Test, WHO50 Ergometer Protocol CSO_STRESS CSO_WHO75 Exercise Test, WHO75 Ergometer Protocol CSO_STRESS CSO_HOLLMANN Exercise Test, HOLLMANN Ergometer Protocol CSO_STRESS CSO_BAL Exercise Test, BAL Ergometer Protocol CSO_STRESS CSO_STD.FRANCE Exercise Test, STD.FRANCE Ergometer Protocol CSO_STRESS CSO_MODWHO Exercise Test, MODWHO Ergometer Protocol CSO_STRESS CSO_CONCONI Exercise Test, CONCONI Ergometer Protocol CSO_STRESS CSO_BRUCE Exercise Test, BRUCE Treadmill Protocol CSO_STRESS CSO_MODBRUCE Exercise Test, MODBRUCE Treadmill Protocol CSO_STRESS CSO_NAUGHTON Exercise Test, NAUGHTON Treadmill Protocol CSO_STRESS CSO_ELLESTAD Exercise Test, ELLESTAD Treadmill Protocol CSO_STRESS CSO_MODBALKE Exercise Test, MODBALKE Treadmill Protocol CSO_STRESS CSO_USAFSAM Exercise Test, USAFSAM Treadmill Protocol CSO_STRESS CSO_SLOWUSAFSAM Exercise Test, SLOWUSAFSAM Treadmill Protocol CSO_STRESS CSO_CORNELL Exercise Test, CORNELL Treadmill Protocol CSO_STRESS CSO_BALKE Exercise Test, BALKE Treadmill Protocol CSO_STRESS CSO_MODBALKEWARE Exercise Test, MODBALKEWARE Treadmill Protocol CSO_STRESS CSO_ADENOSINE Exercise Test, ADENOSINE Pharma Protocol CSO_STRESS CSO_DOBUTAMINE Exercise Test, DOBUTAMINE Pharma Protocol CSO_STRESS CSO_PERSANTINE Exercise Test, PERSANTINE Pharma Protocol CSO_STRESS CSO_ERG_UNKNOWN Exercise Test, Unknown Ergometer Protocol CSO_STRESS CSO_TRM_UNKNOWN Exercise Test, Unknown Treadmill Protocol CSO_ESPIRO CSO_E_WHO Ergospirometry, WHO Ergometer Protocol CSO_ESPIRO CSO_E_WHO50 Ergospirometry, WHO50 Ergometer Protocol CSO_ESPIRO CSO_E_WHO75 Ergospirometry, WHO75 Ergometer Protocol CSO_ESPIRO CSO_E_HOLLMANN Ergospirometry, HOLLMANN Ergometer Protocol CSO_ESPIRO CSO_E_BAL Ergospirometry, BAL Ergometer Protocol CSO_ESPIRO CSO_E_STD.FRANCE Ergospirometry, STD.FRANCE Ergometer Protocol CSO_ESPIRO CSO_E_MODWHO Ergospirometry, MODWHO Ergometer Protocol CSO_ESPIRO CSO_E_CONCONI Ergospirometry, CONCONI Ergometer Protocol CSO_ESPIRO CSO_E_BRUCE Ergospirometry, BRUCE Treadmill Protocol CSO_ESPIRO CSO_E_MODBRUCE Ergospirometry, MODBRUCE Treadmill Protocol CSO_ESPIRO CSO_E_NAUGHTON Ergospirometry, NAUGHTON Treadmill Protocol CSO_ESPIRO CSO_E_ELLESTAD Ergospirometry, ELLESTAD Treadmill Protocol CSO_ESPIRO CSO_E_MODBALKE Ergospirometry, MODBALKE Treadmill Protocol CSO_ESPIRO CSO_E_USAFSAM Ergospirometry, USAFSAM Treadmill Protocol CSO_ESPIRO CSO_E_SLOWUSAFSAM Ergospirometry, SLOWUSAFSAM Treadmill Protocol CSO_ESPIRO CSO_E_CORNELL Ergospirometry, CORNELL Treadmill Protocol CSO_ESPIRO CSO_E_BALKE Ergospirometry, BALKE Treadmill Protocol 2 18

31 CSO_ESPIRO CSO_E_MODBALKEWARE Ergospirometry, MODBALKEWARE Treadmill Protocol CSO_ESPIRO CSO_E_ADENOSINE Ergospirometry, ADENOSINE Pharma Protocol CSO_ESPIRO CSO_E_DOBUTAMINE Ergospirometry, DOBUTAMINE Pharma Protocol CSO_ESPIRO CSO_E_PERSANTINE Ergospirometry, PERSANTINE Pharma Protocol CSO_ESPIRO CSO_ERG_UNKNOWN Ergospirometry, Unknown Ergometer Protocol CSO_ESPIRO CSO_TRM_UNKNOWN Ergospirometry, Unknown Treadmill Protocol CSO_ECG CSO_ECG Resting ECG test (EKG), Protocol not applicable CSO_ABP CSO_ABP Ambulatory Blood Pressure test, Protocol not applicable CSO_SPI CSO_SPI Spirometry test, Protocol not applicable Procedures for configuring these Context Groups are found in the product Service Manual. 3.9 SECURITY PROFILES The product does not conform to any defined DICOM Security Profiles. It is assumed that the product is used within a secured environment. It is assumed that a secured environment includes at a minimum: 1. Firewall or router protections to ensure that only approved external hosts have network access to the product. 2. Firewall or router protections to ensure that the product only has network access to approved external hosts and services. 3. Any communications with external hosts and services outside the locally secured environment use appropriate secure network channels (such as a Virtual Private Network (VPN)) 2 19

32 4. MODALITY WORKLIST QUERY IMPLEMENTATION 4.1 MAPPING OF DICOM ENTITIES The CardioSoft maps DICOM Information Entities to local Information Entities in the product s database and user interface. TABLE MAPPING OF DICOM ENTITIES TO ENTITIES DICOM CardioSoft Entity Scheduled Procedure Step Requested Procedure Imaging Service Request Visit Patient Test Test Test Not applicable Patient 4.2 WORKLIST QUERY MODULE TABLE See DICOM PS 3.3 and PS 3.4 for a complete definition of the entities, modules, and attributes. TABLE MODALITY WORKLIST INFORMATION MODEL MODULES Entity Name Module Name Reference Scheduled Procedure Step SOP Common Scheduled Procedure Step Requested Procedure Requested Procedure Imaging Service Request Imaging Service Request Visit Visit Identification Visit Status Visit Relationship Visit Admission Patient Patient Relationship Patient Identification Patient Demographic Patient Medical