HEALTHCARE DICOM Conformance Statement

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MED/PL/000406 Page 1 of 15 HEALTHCARE DICOM Conformance Statement IMPAX Web1000 (Release 2.0) Status: Released

Page 2 of 15 MED/PL/000406 26 September, 2002 HealthCare Document Information Author Patricia Lang tel: 1 (800) 581-2432 x3598 email: patricia.lang.b@us.agfa.com Editing & Layout Allan Morris With the assistance of Lauren Wasserman email: lauren.wasserman.lw@us.agfa.com For questions regarding the technical content of this document, please contact: Patricia Lang tel: 1 (800) 581-2432 x3598 email: patricia.lang.b@us.agfa.com Issued by: HealthCare Glasgow Business Community P.O. Box 6020 640 Technology Drive Newark, DE 19714-6020 USA tel: 1 (302) 631-3494 fax: 1 (302) 631-3145 email: jim-m.morgan.b@us.agfa.com Agfa shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this publication. Agfa reserves the right to revise this publication and to make changes to its content at any time, without obligation to notify any person or entity of such revisions and changes. This publication may only be used in connection with the promotion, sales, installation and use of Agfa equipment by Agfa personnel. The information presented herein is sensitive and is classified Company Confidential. Without written authority from the proprietor, further distribution outside the company is not allowed. Copyright September, 02 HealthCare All rights reserved

MED/PL/000406 Page 3 of 15 Table of Contents 1 Introduction... 6 1.1 Intended Audience... 6 1.1.1 Integration... 6 1.1.2 Validation... 6 1.1.3 Future Evolution... 6 1.2 Purpose of this Document... 6 1.3 Source for this Document... 6 2 IMPLEMENTATION MODEL... 7 2.1 Application Data Flow Diagram... 7 2.2 Functional Definition of Application Entities... 8 2.2.1 Receive Images... 8 2.2.2 Query to Other Devices... 8 2.2.3 Retrieve from Other Devices... 8 3 AE Specifications... 8 3.1 Web1000 Specifications... 8 3.1.1 Verification as an SCU and SCP... 8 3.1.2 Extended Transfer Syntaxes... 9 3.1.3 Storage as an SCP... 9 3.1.4 Query/Retrieve as an SCU and SCP... 10 4 Association Establishment Policies... 10 4.1 General... 10 4.1.1 Number of Associations... 10 4.1.2 Asynchronous Nature... 10 4.1.3 Implementation Identifying Information... 10 4.1.4 Called/Calling Titles... 10 4.1.5 Association Acceptance Policy... 11 4.1.5.1 Real World Activity - Verification... 11 4.1.5.1.1 Associated Real World Activity - Verification...11 4.1.5.1.2 Presentation Context Table - Verification...11 4.1.5.1.3 SOP Specific Conformance - Verification...11 4.1.5.1.4 Presentation Context Acceptance Criterion - Verification...11 4.1.5.1.5 Transfer Syntax Selection Policies - Verification...11 4.1.5.2 Real World Activity - Storage... 11 4.1.5.2.1 Associated Real World Activity - Storage...11 4.1.5.2.2 Presentation Context Table - Storage...12

Page 4 of 15 MED/PL/000406 26 September, 2002 HealthCare 4.1.5.2.3 SOP Specific Conformance - Storage...12 4.1.5.2.4 Presentation Context Acceptance Criterion - Storage...12 4.1.5.2.5 Transfer Syntax Selection Policies - Storage...13 4.1.5.3 Real World Activity - Find... 13 4.1.5.3.1 Associated Real World Activity - Find...13 4.1.5.3.2 Presentation Context Table - Find...13 4.1.5.3.3 SOP Specific Conformance - Find...13 4.1.5.3.4 Presentation Context Acceptance Criterion - Find...13 4.1.5.3.5 Transfer Syntax Selection Policies - Find...13 4.1.5.4 Real World Activity - Move... 13 4.1.5.4.1 Associated Real World Activity - Move...13 4.1.5.4.2 Presentation Context Table - Move...14 4.1.5.4.3 SOP Specific Conformance - Move...14 4.1.5.4.4 Presentation Context Acceptance Criterion - Move...14 4.1.5.4.5 Transfer Syntax Selection Policies - Move...14 5 Communications Profiles... 14 5.1 TCP/IP Stack... 14 5.1.1 Physical Media Support... 14 6 Extensions/Specializations / Privatizations... 14 7 Configuration... 14 8 Support for Extended Character Sets... 15 9 Acronyms and Abbreviations... 15

MED/PL/000406 Page 5 of 15 Revision Record Revision No. Date Author Reason for Change 1.0 16 September 1998 Dan A. First version, based on 1.0 Conformance Statement 1.1 09 October 1998 Dan A. Minor editorial changes. 1.2 27 November 1998 Dan A. Added LEE transfer syntax. 1.3 07 December 1998 Dan A. Added Query/Retrieve support. 1.4 31 January 1999 Dan A. Removed some SOP classes and added some transfer syntaxes. 1.5 30 March 1999 Dan A. Removed BEE and BEI transfer syntaxes. 1.6 27 December 1999 Amorris New style implemented 1.7 02 February 2000 Amorris Returned to old style 1.8 16 February 2000 Amorris Draft overlay added, prior to updates being incorporated. 1.9 08 March 2000 Amorris Released 16.2.00 2.0 08 September 2000 Amorris New conventions to be implemented 2.1 08 September 2000 Amorris New conventions implemented 2.2 15 November 2001 Lauren Wasserman Formatting updated 2.3 20 November 2001 Patricia Lang Released

Page 6 of 15 MED/PL/000406 26 September, 2002 HealthCare 1 INTRODUCTION 1.1 Intended Audience The user of this document is involved with system integration and/or software design. We assume that the reader is familiar with the terminology and concepts that are used in the DICOM 3.0 standard. Readers not familiar with DICOM 3.0 terminology should first read the appropriate parts of the DICOM standard itself, prior to reading this conformance statement. Although the use of this conformance statement in conjunction with the DICOM 3.0 standard is intended to facilitate communication with other medical imaging equipment, it is not sufficient to guarantee, by itself, the inter-operation of the connection. The following issues need to be considered: 1.1.1 Integration The integration of any device into a system of interconnected devices goes beyond the scope of the DICOM 3.0 standard and this conformance statement when interoperability is desired. The responsibility for analyzing the applications requirements and developing a solution that integrates the Agfa equipment with other vendors systems is the user s responsibility and should not be underestimated. 1.1.2 Validation Testing the complete range of possibilities between the Agfa equipment and non-agfa devices, before the connection is declared operational, is deemed to be a necessity. The user should ensure that any non- Agfa provider accepts full responsibility for all validation required for their connection with the Agfa equipment. The accuracy of image data once it has crossed the interface between the Agfa equipment and the non-agfa device as well as the stability of the image data for the intended applications is the responsibility of the non-agfa provider. 1.1.3 Future Evolution As the DICOM 3.0 standard evolves to meet the user s growing requirements and to incorporate new features and technologies, Agfa will follow the evolution of the standard. This evolution of the standard may require changes to devices that have implemented DICOM 3.0. The user should ensure that any non-agfa provider who connects with Agfa devices also plans future evolution of the DICOM standard. A refusal to do so may reflect in the loss of functionality and/or connectivity between the different products. 1.2 Purpose of this Document This document is a DICOM Conformance Statement for the storage services of Web1000. Web1000 is a service class provider for services for the storage and retrieval of images. 1.3 Source for this Document > ACR-NEMA Digital Imaging and Communications in Medicine (DICOM) V3.0. Current. > Web1000 2.0 Software Design Description.

MED/PL/000406 Page 7 of 15 2 IMPLEMENTATION MODEL Web1000 is a web server that allows web users access to medical images. Web1000 is a single application entity that stores images sent to it by service class users, and simplifies the images into a format that can be viewed in a web browser. It also is able to query service class providers based on several standard query models, and retrieve requested images from a service class provider to the local database, either by an automated mechanism, or manually by user interaction. 2.1 Application Data Flow Diagram Figure 2.1 Implementation model.

Page 8 of 15 MED/PL/000406 26 September, 2002 HealthCare 2.2 Functional Definition of Application Entities 2.2.1 Receive Images Web1000 stores a received image in its entirety, without change, in its internal data store. Web1000 stores each image with the File Meta Information attached to it. Web1000 extracts the query information with respect to the patient, study, series and image, and stores this information within its internal database. 2.2.2 Query to Other Devices Web1000 acts as a Service Class User of C-Find to query for studies based on a number of criteria: > Patient name > Patient ID or MRN > Study accession number > Referring physician > Modality > Date > Time This type of query is initiated by the user. See the Web1000 User Manual for more details. Web1000 can also automatically query a remote HIS device periodically for studies based on the following criteria: > Study Date > Study Time Results returned by this query can be used to retrieve studies from a remote PACS device using C-Move. See the Web1000 Software Design Description for more details. 2.2.3 Retrieve from Other Devices Web1000 acts as a Service Class User and Provider of C-Move to retrieve images from a remote device. It does so by using the results obtained from a C-Find to request that the images be moved to Web1000 via C-Move. 3 AE SPECIFICATIONS 3.1 Web1000 Specifications 3.1.1 Verification as an SCU and SCP Web1000 provides standard conformance to the following DICOM V3.0 SOP Class as an SCU and SCP. SOP Class Verification 1.2.840.10008.1.1 Table 3.1 Verification SOP class. SOP Class UID

MED/PL/000406 Page 9 of 15 Web1000 supports the default transfer syntaxes displayed in Table 3.2. Transfer Syntax DICOM Implicit VR Little Endian 1.2.840.10008.1.2 Table 3.2 Transfer syntax. UID 3.1.2 Extended Transfer Syntaxes Web1000 supports the extended transfer syntaxes displayed in Table 3.3 for the purpose of storage. Transfer Syntax DICOM Implicit VR Little Endian 1.2.840.10008.1.2 DICOM Explicit VR Little Endian 1.2.840.10008.1.2.1 DICOM Little Endian Lossy JPEG1 1.2.124.113532.1.2.4.50 DICOM Little Endian Lossy JPEG4 1.2.124.113532.1.2.4.51 DICOM Lossy Lossless JPEG 14-1 1.2.840.10008.1.2.4.70 DICOM RLE Lossless 1.2.840.10008.1.2.5 Table 3.3 Extended transfer syntaxes. UID 3.1.3 Storage as an SCP Table 3.4 lists the SOP classes that are supported by Web1000 for storage services. In general, Web1000 supports all image SOP classes recognized by DICOM, with the following exceptions: > Multi-frame images (US and XA Biplane) > Standalone overlays or curves > Standalone LUTs Multi-frame X-Ray Angiographic images (SOP class 1.2.840.10008.5.1.4.1.1.12.1) will be stored but cannot be displayed in the web browser interface. SOP Class Name Table 3.4 Storage SOP classes. SOP Class UID Computed Radiography Image Storage 1.2.840.10008.5.1.4.1.1.1 CT Image Storage 1.2.840.10008.5.1.4.1.1.2 MR Image Storage 1.2.840.10008.5.1.4.1.1.4 Nuclear Medicine Image Storage 1.2.840.10008.5.1.4.1.1.5 Ultrasound Image Storage (retired) 1.2.840.10008.5.1.4.1.1.6 Ultrasound Image Storage 1.2.840.10008.5.1.4.1.1.6.1 Secondary Capture Image Storage 1.2.840.10008.5.1.4.1.1.7 X-ray Angiographic Image Storage 1.2.840.10008.5.1.4.1.1.12.1 X-ray RadioFluoroscopic Image Storage 1.2.840.10008.5.1.4.1.1.12.2 Nuclear Medicine Image Storage 1.2.840.10008.5.1.4.1.1.20

Page 10 of 15 MED/PL/000406 26 September, 2002 HealthCare 3.1.4 Query/Retrieve as an SCU and SCP Web1000 provides Standard Conformance to the following DICOM 3.0 Query/Retrieve SOP classes as an SCU and SCP. SOP Class Name Study Root Query/Retrieve IM Find 1.2.840.10008.5.1.4.1.2.2.1 Study Root Query/Retrieve IM Move 1.2.840.10008.5.1.4.1.2.2.2 Table 3.5 Query/Retrieve SOP classes. SOP Class UID 4 ASSOCIATION ESTABLISHMENT POLICIES 4.1 General The following Application Context Name will be proposed and recognized by Web1000: > DICOM 3.0 Application Context: 1.2.840.10008.4.1.1.1 Web1000 contains no limitations for maximum PDU size. The default size is 100.000 bytes. 4.1.1 Number of Associations The maximum number of simultaneous associations accepted by Web1000 is configurable at run time, based on the system resources available. By default, the maximum number of associations is set at 32. There is no inherent limit to the number of associations other than limits imposed by the computer operating system. 4.1.2 Asynchronous Nature Web1000 allows a single outstanding operation on any association. Therefore, Web1000 does not support asynchronous operations window negotiation, other than the default as specified by the DICOM specification. 4.1.3 Implementation Identifying Information Web1000 will respond with the following implementation identifying parameters: > Implementation Class UID: 1.2.124.113532.3520 > Implementation Version Name: Web1000_2.0 The implementation version name policies are the following: product name Web1000 followed by the version of the product, _2.0. 4.1.4 Called/Calling Titles The default calling title that Web1000 will use is the host name of the computer. This parameter can be configured via the GUI. Web1000 can be configured to validate the Called Title of the requesting SCU during association negotiation.

MED/PL/000406 Page 11 of 15 4.1.5 Association Acceptance Policy 4.1.5.1 Real World Activity - Verification 4.1.5.1.1 Associated Real World Activity - Verification Web1000 will respond to Verification requests to provide an SCU with the ability to determine if Web1000 is receiving DICOM requests. 4.1.5.1.2 Presentation Context Table - Verification Web1000 will accept any of the Presentation Contexts listed in Table 4.1 for Verification. SOP Class Transfer Syntax Role Extended Negotiation All Table 3.1 All Table 3.2 SCU None Table 4.1 Presentation contexts. 4.1.5.1.3 SOP Specific Conformance - Verification Web1000 provides standard conformance to the DICOM Verification Service Class. Web1000 returns one of the following status codes. Service Status Further Meaning Protocol Codes Related Fields Description Success Success 0000 - Operation performed properly Table 4.2 Verification status codes. 4.1.5.1.4 Presentation Context Acceptance Criterion - Verification Web1000 will always accept a Presentation Context for the Verification SOP Class with the default DICOM transfer syntax listed in Table 3.2. 4.1.5.1.5 Transfer Syntax Selection Policies - Verification Since no DICOM data object is associated with a Verification command, only the default DICOM transfer syntax is required/supported. 4.1.5.2 Real World Activity - Storage 4.1.5.2.1 Associated Real World Activity - Storage Web1000 will store images that are sent to it from an SCU. Images are stored temporarily in the local cache. Image data in Web1000 is considered inherently transient.

Page 12 of 15 MED/PL/000406 26 September, 2002 HealthCare 4.1.5.2.2 Presentation Context Table - Storage Web1000 will accept any of the Presentation Contexts listed in Table 4.3 for Storage. SOP Class Transfer Syntax Role Extended Negotiation All from Table 3.4 All from Table 3.3 SCU See Note below Table 4.3 Presentation contexts. Note: Storage Extended Negotiation will be supported. Web1000 will respond with the information in Table 4.4. Field Name Value Description of Field Level of Support 2 Level 2 (FULL) SCP Element Coercion 0 Does not coerce any element Table 4.4 Storage extended negotiation. 4.1.5.2.3 SOP Specific Conformance - Storage Web1000 conforms to the DICOM Storage Service Class at Level 2 (Full). No elements are discarded or coerced by Web1000. In the event of a successful C-STORE operation, the image has been written to internal storage. Web1000 returns one of the following status codes: Service Status Further Meaning Protocol Codes Related Fields Description Refused Out of resources A700 Indicates that there was not enough storage space to store the image. Recovery from this condition is left to the administrative functions. SOP Class not supported A800 Indicates that the SOP Class of the Image in the C- STORE operation did not match the Abstract Syntax negotiated for the Presentation Context. Error Data set does not match SOP Class A900 Indicates that the Data Set does not encode an instance of the SOP Class specified. Failed C000 The operation was not successful. Cannot understand C005 Indicates that the Data Set cannot be parsed into elements. Warning Data set does not match SOP Class B007 Indicates that the Data Set does not match the SOP Class, but that the image was stored anyway. Duplicate SOP Instance UID D000 Indicates that the SOP Instance UID of the specified image is already stored in the database. Success Success 0000 Operation performed properly. Table 4.5 Verification status codes. 4.1.5.2.4 Presentation Context Acceptance Criterion - Storage Web1000 will accept any number of Storage Presentation Contexts per association request. Any one Abstract Syntax may be specified more than once in an association request, if the Transfer Syntaxes differ between the Presentation Contexts.

MED/PL/000406 Page 13 of 15 4.1.5.2.5 Transfer Syntax Selection Policies - Storage Web1000 supports all transfer syntaxes listed in Table 3.3. 4.1.5.3 Real World Activity - Find 4.1.5.3.1 Associated Real World Activity - Find Web1000 will negotiate requests to an SCP. Web1000 negotiates the Study Root query model only. 4.1.5.3.2 Presentation Context Table - Find Web1000 will initiate any of the Presentation Contexts listed in Table 4.6 for Query. SOP Class Transfer Syntax Role Extended Negotiation All Table 3.4 Find All Table 3.2 SCU See Note below Table 4.6 Presentation contexts. Note: C-Find Extended Negotiation will be supported. Web1000 will respond with the information in Table 4.7. Field Name Value Description of Field Relational queries 1 Relational queries supported Table 4.7 Find extended negotiation. 4.1.5.3.3 SOP Specific Conformance - Find SOP classes of the Query/Retrieve Service Class are implemented via the DIMSE C-FIND and C-MOVE services as defined in Part 7 of the DICOM standard. 4.1.5.3.4 Presentation Context Acceptance Criterion - Find Web1000 will initiate one Find Presentation Context per association request. Any one Abstract Syntax may be specified more than once in an association request, if the Transfer Syntaxes differ between the Presentation Contexts. 4.1.5.3.5 Transfer Syntax Selection Policies - Find Web1000 currently only supports the default transfer syntax of Implicit Little Endian. 4.1.5.4 Real World Activity - Move 4.1.5.4.1 Associated Real World Activity - Move Web1000 will initiate retrieve requests to an SCP. Web1000 negotiates only the Study Root query model.

Page 14 of 15 MED/PL/000406 26 September, 2002 HealthCare 4.1.5.4.2 Presentation Context Table - Move Web1000 will initiate any of the Presentation Contexts listed in Table 4.8 for Query. SOP Class Transfer Syntax Role Extended Negotiation All Table 3.4 Find All Table 3.2 SCU None Table 4.8 Presentation contexts. 4.1.5.4.3 SOP Specific Conformance - Move Web1000 will try to establish an association with the move destination specified in the Move request. One or more of the Presentation Contexts listed in the Store section of this document may be negotiated in this association. 4.1.5.4.4 Presentation Context Acceptance Criterion - Move Web1000 will accept any number of Move Presentation Contexts per association request. Any one Abstract Syntax may be specified more than once in an association request, if the Transfer Syntaxes differ between the Presentation Contexts. 4.1.5.4.5 Transfer Syntax Selection Policies - Move Web1000 currently supports the transfer syntax that was used originally when the image was stored. Web1000 will soon be enhanced to also support conversion to Implicit Little Endian. 5 COMMUNICATIONS PROFILES Web1000 provides DICOM 3.0 TCP/IP Network Communication Support as defined in Part 8 of the DICOM Standard. 5.1 TCP/IP Stack Web1000 inherits its TCP/IP stack from the computer system upon which it executes. 5.1.1 Physical Media Support Web1000 is indifferent to the physical medium over which TCP/IP executes; it inherits the medium from the computer system upon which it executes. 6 EXTENSIONS/SPECIALIZATIONS / PRIVATIZATIONS Not applicable. 7 CONFIGURATION Web1000 obtains configuration information from the following source: > Mapping from Application Entity Title to Presentation Address is provided by the database. Along with this mapping, the database stores those AE titles that are allowed to communicate with Web1000.

MED/PL/000406 Page 15 of 15 8 SUPPORT FOR EXTENDED CHARACTER SETS Web1000 is known to support the following character sets: ISO-IR 6 (default): Basic G0 Set ISO-IR 100: Latin Alphabet No. 1 9 ACRONYMS AND ABBREVIATIONS The following acronyms and abbreviations are used in this document: ACR AE DICOM NEMA PDU SCP SCU SCP SOP TCP/IP UID American College of Radiology Application Entity Digital Imaging and Communications in Medicine National Electrical Manufacturers Association Protocol Data Unit Service Class Provider Service Class User Service Class Provider Service-Object Pair Transmission Control Protocol/Internet Protocol Unique Identifier