Administrator Manual
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REF 9515-151-51-ENG Rev B1
X-Scribe DATA EXCHANGE INTERFACES
ADMINISTRATOR MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Copyright © 2010 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. X-Scribe is a trademark of Mortara Instrument, Inc. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. Microsoft and Windows are trademarks or registered trademarks of Microsoft Corporation. Applies to X-Scribe V3.30 and HX-Gate V1.10
TECHNICAL SUPPORT AND SERVICE
Headquarters Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Tel: 800.231.7437 Fax: 414.354.4760 Internet: http://www.mortara.com
European Union Representative Mortara Rangoni Europe, Srl (European Headquarters) Via Cimarosa 103/105 40033 Casalecchio di Reno (BO) Italy Tel: +39.051.298.7811 Fax: +39.051.613.3582
Service/Technical Support Group Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Service: 888.MORTARA (888.667.8272) Fax: 414.354.4760 E-mail: [email protected]
Sales Support/ Supplies & Accessories Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 U.S.A. Tel: 414.354.1600 Fax: 414.354.4760 E-mail: [email protected] Mortara Instrument Germany Kaninenberghöhe 50 45136 Essen Germany Tel: +49.201.18 55 69 70 Fax: +49.201.18 55 69 77 Mortara Instrument Netherlands Postbus 324 5680 AH Best Industrieweg 160b 5683 CG Best Netherlands Tel: +31.499.377310 Fax: +31.499.377908 Mortara Instrument Australia PO Box 7568 Baulkham Hills NSW 2153 Unit 28, 9 Hoyle Avenue Castle Hill NSW 2154 Australia Tel: +61 2 8070 9303 Fax: +61 2 9899 9478
24-hour Technical Support Same-day Shipment of Replacement Parts Biomedical Training Classes Extended Warranties/Service Contracts
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NOTICES Manufacturer’s Responsibility Mortara Instrument, Inc. is responsible for the effects on safety and performance only if: •
Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons authorized by Mortara Instrument, Inc.
•
The electrical installation of the relevant room complies with the requirements of appropriate regulations, and
•
The device is used in accordance with the instructions for use.
Responsibility of the Customer The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards. Equipment Identification Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care should be taken so that these numbers are not defaced. Copyright and Trademark Notices This document contains information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without prior written consent of Mortara Instrument, Inc. Other Important Information The information in this document is subject to change without notice. Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no commitment to update or to keep current the information contained in this document.
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WARRANTY INFORMATION Your Mortara Warranty MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date of shipment from Mortara. Normal use, service, and maintenance means operation and maintenance in accordance with appropriate instructions and/or information guides. This warranty does not apply to damage to the Product/s caused by any or all of the following circumstances or conditions: a)
Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara; c)
Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;
d) Accident; a disaster affecting the Product/s; e)
Alterations and/or modifications to the Product/s not authorized by Mortara;
f)
Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the Product/s when sold. EXCLUDED FROM THE LIMITED WARRANTY SET FORTH ABOVE ARE CONSUMABLE ITEMS SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC STORAGE MEDIUMS. EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
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USER SAFETY INFORMATION
Warning:
Means there is the possibility of personal injury to you or others.
Caution:
Means there is the possibility of damage to the device.
Note:
Provides information to further assist in the use of the device.
Warning(s) •
Reference X-Scribe™ user manual for warnings relating to the stress exercise system.
•
Possible malfunction risks could be associated when installing 3rd party software. Mortara Instrument, Inc. cannot verify the compatibility of all possible hardware/software combinations.
•
Data exchange interfaces are used to exchange data with 3rd party ECG management systems. It is not possible to assure complete compatibility with all possible 3rd party ECG management systems and configurations. It is recommended to contact the 3rd party vendor to ensure device has been verified as compatible with a particular installation of their system.
Caution(s) •
Reference X-Scribe user manual for cautions relating to the stress exercise system.
Note(s) •
Reference X-Scribe user manual for notes relating to the stress exercise system.
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EQUIPMENT SYMBOLS Symbol Delineation
Attention, consult accompanying documents
Do not dispose as unsorted municipal waste. Per EC Directive 2002/96, requires separate handling for waste disposal according to national requirements
Indicates compliance to applicable EEC directives
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TABLE OF CONTENTS INTRODUCTION SECTION 1 Purpose ...1 Architecture ...1 HL7...3 DICOM...3 DICOM Storage Events...3 DICOM MPPS Events...3
CONFIGURATION OF INTERFACES SECTION 2 Filenames...5 XML Orders ...6 Configuration of HL7 ...6 Configuration of DICOM ...6
INSTALLATION SECTION 3 Install HXGate...9 Open Ports in Firewall...9
TROUBLESHOOTING SECTION 4 Log Files...11 DICOM Echo ...11
MORTARA STRESS REPORT XML APPENDIX A XML Description...13
STRESS REQUEST (ORDER) XML APPENDIX B Stress Request (Order) XML Description ...25
ALTERNATE 1 XML APPENDIX C Alternate 1 XML Description...29
DICOM ERROR MESSAGES APPENDIX D DICOM Error Codes ...33
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TABLE OF CONTENTS
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INTRODUCTION SECTION 1
Purpose The X-Scribe stress system offers several ways to exchange information with 3rd party ECG management systems. This manual covers the technical aspects of installing and configuring the various interface options. • • • • • • • • • • • •
Stress report as PDF file Stress report as TIFF file Stress report statistics as Mortara XML file Stress report statistics as Alternate XML file Stress report statistics sent in HL7 message Stress report as PDF encapsulated in HL7 message Stress report as DICOM®-encapsulated PDF storage Stress orders as DICOM Modality Worklist (MWL) request Stress orders received in HL7 messages Stress orders receives as XML files Stress report DICOM storage commitment Stress study status reported as DICOM Modality Performed Procedure Step (MPPS)
Architecture Figure 1-1 shows the overall architecture of the X-Scribe data exchange interfaces. X-Scribe can be configured to export PDF, TIFF, and XML files into folders monitored by other systems for import. The exported files can also be used by Mortara’s HL7 Gateway for generating HL7 results messages. The Microsoft® Windows™ service “HXGate for X-Scribe” is used to generate DICOM messages; the Windows service “HXGateWaitForEvent” listens for confirmations from DICOM storage commitment requests. The HL7 Gateway is centralized per enterprise and typically runs on its own server; however, the Windows’ HXGate and HXGateWaitForEvent services are installed on each X-Scribe system.
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SECTION 1
Figure 1-1
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SECTION 1
HL7 HL7 implementations vary widely between products, versions, and installations. As such, Mortara offers its HL7 Gateway which includes a commercial HL7 messaging broker that is configured for each installation. Mortara representatives work directly with the site’s IT representatives to configure and test the interface. The HL7 Gateway uses the Mortara XML files to generate results messages. These messages can include discrete data found in the XML file as well as the displayable PDF or TIFF report.
DICOM HXGate is used to communicate with 3rd party systems that use the DICOM protocol. It supports Modality Worklist (MWL) queries, PDF storage, storage commitment, and Modality Performed Procedure Step (MPPS) status messages.
DICOM Storage Events DICOM-encapsulated PDF messages are sent whenever a report is exported from the archive, or when the report is saved and “Export on Save” option is enabled. If Storage Commitment is enabled, a commitment request will be sent at the same time.
DICOM MPPS Events Events in X-Scribe cause MPPS messages to be sent if MPPS is enabled in HXGate: •
An “In Progress” message is sent when a procedure is started. X-Scribe considers the procedure started when a new exam is selected and the “OK” button is clicked after entering the patient demographics.
•
A “Discontinued” message is sent when a procedure is stopped before entering into the exercise phase. X-Scribe considers the procedure discontinued when the “Abort” button is clicked before “Start Exercise” is selected.
•
A “Completed” message is sent when a procedure is completed. X-Scribe considers a procedure completed when the “End” button is clicked in the recovery phase.
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SECTION 1
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CONFIGURATION OF INTERFACES SECTION 2
X-Scribe can export several kinds of files. The file types and locations are configured in the Miscellaneous tab of the User Profile Settings. Option
Description
Export Directory
The full path where the files will be exported. The default is C:XS2REPORTS.
Request Directory
The full path where order XML files are placed. The default is C:XS2Requests.
Sub Directories
Check if exported files should be placed into a separate sub directory per test. The sub directories will have the following format: X<PatientID>[<ExamDate><ExamTime>]<FirstName>_<MI>_<LastName>.
Export On Save
Check if files should be automatically exported when the report is saved.
Export Formats
Description
Check if a PDF of the report should be exported.
Mortara XML
Check if Mortara XML should be exported.
Alternate XML
Check is Alternate XML should be exported.
TIFF
Check if a TIFF of the report should be exported.
HL7
Check if orders will be coming from an HL7 interface or from another external source of XML-format orders. If unchecked, the clinician can pre-enter demographics and orders using the X-Scribe interface.
DICOM
Check if a DICOM interface is being used.
Filenames Configure filename formats in the “XS2.ini” file. The file is located in the folder “C:Mortara Instrument IncXScribeIISystem”. Add a line specifying “ExportFileNameFormat=” in the [Behavior] section. An appropriate file extension will be added automatically, e.g., .xml or .pdf. EXAMPLE: [Behavior] ExportFileNameFormat=<PatientID>[<TestDateTime>]<PatientFirstName>_<PatientLa stName> The following variables can be used to specify the filename format: Variable
Description
<PatientID>
Patient’s ID.
<PatientLastName>
Patient’s last name.
<PatientFirstName>
Patient’s first name.
<PatientMiddleName>
Patient’s middle name.
<PatientSex>
Patient’s gender: M = male F = female U = Unknown
<TestDateTime>
Start date/time of the test in HL7 yyyyMMddHHmmss format.
<TestDate>
Start date of the recording in HL7 yyyyMMdd format.
<ReportDateTime>
The current (local) date/time when the report is exported, in HL7 yyyyMMddHHmmss format.
<ReportDate>
The current (local) date when the report is exported, in HL7 yyyyMMdd format.
<PatientDOB>
Patient’s date of birth, in HL7 yyyyMMdd format.
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X-Scribe will not replace incompatible characters used as part of the filename format. For example, if the Patient ID field is used and it contains a / (slash), the resulting filename will be incompatible with the Windows file system and the file export will fail. X-Scribe overwrites files with the same name. If exported files will remain in the destination folder, verify the filename formats include variables to ensure each filename is unique. For example, use <TestDateTime> so multiple tests for the same patient are named uniquely. Or, if each revision (export) of the same test will be kept, use <ReportDateTime> so each revision is named uniquely.
XML Orders When X-Scribe is configured for HL7 mode, orders in XML files can be dropped into its Request Directory from the Mortara HL7 Gateway, or from other systems that drop the XML files directly. The XML files must be in the format described in Appendix B. Filenames do not matter; however, filenames starting with the reserved words “Dicom” and “Request” will be ignored. File extensions must be .xml. Orders in the Request Directory can be seen when X-Scribe displays the Worklist. X-Scribe will delete the corresponding XML file when the exam is completed. If the exam is aborted before entering the exercise phase, the XML file will remain in the directory. If an order is canceled before it is used, the corresponding XML file must be removed by the source system generating the XML files. The source system is also responsible for replacing XML files with updated versions whenever an order is updated (e.g., patient demographics change).
Configuration of HL7 HL7 implementations vary widely between products, versions, and installations. As such, Mortara offers its Mortara HL7 Gateway which includes a commercial HL7 messaging broker that is configured for each installation. Mortara representatives work directly with the site’s IT representatives to configure and test the interface. If HL7 order messages will be received, check the HL7 option in the Miscellaneous tab of the User Profile Settings.
Configuration of DICOM HXGate is used to communicate with 3rd party systems that use the DICOM protocol. All DICOM communications settings and Modality Worklist (MWL) filters are configured by running HXConfig.exe. This configuration utility is found in the HXGate folder where the service was installed, typically at:
C:Mortara Instrument IncHXGateHXConfig.exe. The left side of the configuration table shows settings for the four DICOM services: C-STORE, C-FIND/MWL, MPPS, and Storage Commitment. It is assumed that C-STORE and Storage Commitment SCPs share the same host and port. Setting
Description
C-STORE
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Host
The network name or TCP/IP address of the Storage SCP server. This is the same SCP for Storage Commitment requests.
Port
The TCP/IP port number used by the Storage SCP.
AE Title
Application Entity Title of the Storage SCP.
Retry (days)
When the Storage SCP is unavailable, the number of days to continue trying to reach the Storage SCP before giving up.
SECTION 2
Setting
Description
New Series Instance UID
Check if each version of a report should be stored in a new DICOM Series. If unchecked, each version is stored in the same Series.
MWL (Modality Worklist) Host
The network name or TCP/IP address of the MWL SCP server.
Port
The TCP/IP port number used by the MWL SCP.
AE Title
Application Entity Title of the MWL SCP.
MPPS (Modality Performed Procedure Step) Enable MPPS
Check to enable MPPS messages.
Host
The network name or TCP/IP address of the MPPS SCP server.
Port
The TCP/IP port number used by the MPPS SCP.
AE Title
Application Entity Title of the MPPS SCP.
Storage Commitment Enable Storage Commitment
Check to enable Storage Commitment messages. Messages will be sent to the C-STORE SCP after report is stored.
Receive Event Port
TCP/IP port where HXGateWaitForEvent Windows service listens for results messages.
Wait For Response (days)
Number of days to wait for a result message before giving up.
Station Settings
Description
SCU AE Title
The SCU AE Title used by HXGate in all DICOM transactions.
Institution Name
(0008,0080)
This is the name of the institution and/or department where the Holter exam was performed. This will be stored in the DICOM object.
Station Name
(0008,1010)
DICOM Station Name assigned to this X-Scribe system. This will be stored in the DICOM object.
Modality
(0008,0060)
Typically “ECG”.
Scheduled Station Name
(0040,0010)
Scheduled Procedure Step Location
(0040,0011)
Current Patient Location
(0038,0300)
Requested Procedure Location
(0040,1005)
Scheduled Procedure Step ID
(0040,0009)
Requested Procedure ID
(0040,1001)
Accession Number
(0008,0050)
Scheduled Station AE Title
(0040,0002)
User Tag
This can be used to define one additional DICOM tag for filtering the MWL.
User Tag Value Requested Procedure Description List
(0032,1060)
List of procedure descriptions accepted. These values are not sent to the MWL SCP for filtering, but are used by HXGate to filter the results from the MWL SCP.
Use Institution
(0008,0080)
When checked, the Institution Name will be used to filter the Modality Worklist query.
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INSTALLATION SECTION 3
Installation of HXGate includes installation of the HXGate and HXGateWaitForEvent Windows services. This is necessary to support DICOM. HXGate must be installed on every X-Scribe stress system and Review Station when DICOM is used. If PDF and XML file export, or HL7 will be used without DICOM, HXGate is not necessary.
Install HXGate 1. 2. 3. 4. 5. 6.
Install X-Scribe first. If X-Scribe is not installed, do not install HXGate. Insert the “HXGate for X-Scribe” installation CD. If the installer does not automatically launch, use Windows Explorer to view the files on the CD and launch HXGate (X-Scribe).msi Follow the prompts to complete the installation. When possible, keep the default folder: C:Mortara Instrument IncHXGate Reboot Windows after installation is complete.
In X-Scribe, check the DICOM box in the Miscellaneous tab under User Profiles in Settings.
Open Ports in Firewall If the system where HXGate was installed has firewall software, it must be configured to allow connections to the computer on the TCP/IP port it listens on. The default port for HXGateWaitForEvent is 104, but it can be changed in the HXGate configuration dialog.
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SECTION 3
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TROUBLESHOOTING SECTION 4
Log Files HXGate creates a log file for each day of the month. Log files are kept for one month and are overwritten on the same day of the next month. The log files are saved in the “logfiles” folder where HXGate is installed, typically C:Mortara Instrument IncHXGateLogFiles. Examine the log files when troubleshooting communication problems. HXGate uses a DICOM library from Merge and has its own log. Modify the file C:Mortara Instrument IncHXGatebinMerge.ini to turn logging on. Remove the comment symbol, #, in front of the last lines of the file to turn on the various levels of logging. There are comments in the file to indicate what is logged at each level. Messages will be logged into the file C:Mortara Instrument IncHXGatebinmerge.log. When changes are made to the merge.ini file, the HXGate service must be restarted for the changes to take effect. The Merge library uses an environment variable called MERGE_INI. If there is some question where Merge is looking for its ini and DLL files, check this variable. If it is not set, Merge will use a default search path (e.g., current working folder, system32, etc.).
DICOM Echo A DICOM Echo should be performed whenever you need to test the connection to the DICOM SCPs. Open a cmd window, or use Windows Explorer and go to the HXGate installation folder (default is C:Mortara Instrument IncHXGate). There are 3 BAT files starting with “Echo”, one each for CSTORE, MPPS, and MWL. Execute the appropriate file. A command window will display the result of the DICOM Echo.
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