Arthrex AR-3200-1020 Synergy HD3 DICOM Key Instruction Manual

Arthrex AR-3200-1020 Synergy HD3 DICOM Key

The Arthrex SynergyHD3™ DICOM Set Up and Use Instructions provides important information for the Set Up and Use of the SynergyHD3™ DICOM License. Read this User’s Guide thoroughly prior to Installation and Use, and keep it in an easily accessible place for use by all operating personnel. Read and follow all safety warnings, cautions and precautions.

Proprietary Information

• This manual contains information deemed proprietary to Arthrex. The information contained herein, including all of the designs and related materials, is the sole property of Arthrex, and/or its licensors. Arthrex and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction.
• This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of Arthrex.
• Arthrex reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.
• This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

Introduction

• DICOM stands for “Digital Imaging and Communication in Medicine.” DICOM is a standard which defines a method of communication for digital medical imaging devices and software. The DICOM standard is used by the majority of medical imaging hardware manufacturers. The DICOM standard makes it possible for equipment to communicate remotely through a network or media by ensuring the compatibility of the equipment and by eliminating proprietary formats.
• It is recommended that personnel study this manual before attempting to install and use the SynergyHD3™ DICOM License Key. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual.

Intended Use

• The intended use is to obtain the images of the patient and all epidemiological information associated with the patient images, in an identical format allowing the interconnection and the interaction (” interoperability “) of the equipments and the transfer of the data.
• SynergyHD3™ currently supports DICOM (Digital Imaging and Communications in Medicine) image creation and exporting.

Intended User

• Intended user of this IFU is the hospital’s PACS administrator with knowledge of DICOM requirements.
• User must have administrative rights to the SynergyHD3™ system.

Licensing

DICOM is an optional feature on the SynergyHD3™ and requires the purchase and activation of a DICOM license (part number AR- 3200-1020). When a site purchases a DICOM license they will be provided with a license key that is unique to each individual SynergyHD3™ (i.e., this license cannot be used on another SynergyHD3™ unit). Licenses are issued on a per SynergyHD3™ basis and are not transferrable to another device. In the event that a DICOMlicensed SynergyHD3™ is replaced by another SynergyHD3™ due to a failure covered under warranty, the new SynergyHD3™ would be also be licensed for DICOM. A single DICOM license covers not only DICOM export but also DICOM modality worklist. A facility may choose to use only DICOM export or DICOM modality worklist; however, there is not an option to purchase a license for only one of these functions.

Warnings and Precautions
The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be read carefully.

WARNING:The safety and/or health of the patient, user, or a third party is at risk. Comply with this warning to avoid injury to the patient, user, or third party.

NOTE:A note is added to provide additional, focused, information.

WARNINGS
Prior to use, read the entire Arthrex California Technology SynergyHD3™ System Instruction Manual [950-0027-XX] before use during surgical procedures.

Symbol Definitions

| Precaution of Warning Notice
**| Caution: Federal Law Restricts this device to sale by or on the**

order of a Physician.

---|---
**| Manufacturer**

Requirements

To utilize the SynergyHD3™ DICOM export functionality, the facility is required to implement the following requirements.

• Have a DICOM enabled PACS, archive, etc. on their network
• Configure their PACS, archive, etc. to receive DICOM images from each individual SynergyHD3™
• In some cases, configuration may require purchase of additional PACS or third-party licenses (i.e., some PACS charge a license fee for each device connected to their PACS or charge a volume based license fee for each DICOM study sent to the PACS)
• In some cases, purchase of additional storage is necessary to accommodate SynergyHD3™ DICOM studies on their PACS, archive, etc.

SynergyHD3™ DICOM Scope of Use

• Synergy DICOM capability is available on Software Versions 1.3.0 and greater.
• To Verify SynergyHD3™ Software Version for DICOM Use.
• Login and access the About screen on the tablet by pressing and holding the Date string at the top right of the app, and selecting “About” from the list presented. Verify that “Version 1.3.0” or greater appears at the top of the page.

Definitions

Definitions

Term| Definition
DICOM| Digital Imaging and Communication in Medicine – standard detailing the exchange of medical imaging data
PACS| Picture Archiving and Communication System – system for

acquisition, storage, distribution, and manipulation of digital images

AE Title| Application Entity Title – unique name assigned to each DICOM application
OT Modality| A device specified as other by the DICOM standard
ES Modality| A device specified as endoscopy by the DICOM standard
JPEG| Joint Photographic Experts Group – compressed image file format
DICOM Modality Worklist| A list of imaging orders provided from one system to another via the DICOM standard
OT [default Search Modality field]| A device specified as other by the DICOM standard
Modality Type [ES, OT]| An imaging device type as specified by the DICOM standard

SynergyHD3™ DICOM Set Up and Configuration

Set up and Configuration Requirements
To configure the SynergyHD3™ for DICOM export, there are several pieces of information the facility must provide to Arthrex about their PACS, archive, etc. To facilitate the collection of this information, Arthrex has created a DICOM data collection form that should be utilized to collect data for DICOM License submittal. Arthrex recommends that this data be collected as soon as possible to facilitate the obtaining of the DICOM License in an expeditious manner. This will allow the DICOM installation to proceed efficiently. A copy of this form appears in Appendix 2.0. If the facility does not provide the information on this form to Arthrex, the SynergyHD3™ cannot be configured for DICOM export. Ideally, the facility’s PACS administrator should be present for the DICOM configuration to confirm settings, ensure that the PACS is configured correctly, assist in troubleshooting if needed, etc.

Set Up the DICOM Export Function
To set up the DICOM export function log in as an Administrator on the SynergyHD3™ tablet. Enter System Set-Up by pressing the Maintenance Icon located in the upper left corner of SynergyHD3™ tablet (Figure 2-SynergyHD3™ Tablet Maintenance Icon) and then select Advanced Settings.

Select the DICOM Menu Item as shown below
NOTE: Until the DICOM License Key is input into the SynergyHD3™ Camera Controller, the screen below will appear when you select the DICOM Menu Item.

Obtaining the SynergyHD3™ DICOM Key from Arthrex

• Get the device ID at the top of the screen [Figure 3-Select DICOM Menu Item] and call Marie Gillmore at Arthrex Inc, 800-933-7001 Ext. 1245 [Hours 8am to 5pm USA Eastern Time Zone]. Prior to call, make sure to have the following information available:
  • Bill-to #
  • PO#
  • Mac ID#
  • CCU serial number (located on bottom of CCU)
• Marie will take the device ID you provide and generate a license key for the unit. (License keys are not case sensitive and have this format XXXX:XXXX)
• Input the license key and click on the Enable DICOM button [Top Right Corner of Figure 3-Select DICOM Menu Item].
• If the license key is accepted, then you will see the DICOM configuration screen [Figure 4-Setting Up Initial DICOM Data]. If you do not see the DICOM configuration screen, then the license key you entered is incorrect.

Setting up DICOM Export

1. Input the AE title for the SynergyHD3™ unit in the Local AE Title field. The AE title must be unique. If the facility provided an AE title for use with the device, then use this AE title. If the facility did not provide an AE title, then use the default AE title— SYNERGY. If the facility has multiple SynergyHD3™ devices, then it is recommended that you use the host name of the unit as the AE title. (Note: If the AE title is not unique on the facility’s network, then DICOM functionality may not work. Also, an AE title is case sensitive. Thus, if a facility needs to input the AE title of the SynergyHD3™ into their PACS, DICOM archive, etc., then you must provide the facility the AE title using the same case as it was input in this field.)
2. Scroll down to the Send section of the DICOM setup as shown in Figure 4-Setting Up Initial DICOM Data above.
3. Enable DICOM exporting by setting the Send Enable slider to On at the top of the Send section.
4. Select the option for when DICOM images would be exported via the Default Send Method. This is a facility setting that applies to all surgeons. The options are to export images automatically on an image-by-image basis immediately as they are captured, automatically when the case ends, or manually. The automatic export of images as they are captured is useful for sites that have slow network connections as it limits the amount of data sent at one time; however, choosing this option means that if an image is accidentally captured it will be automatically sent as soon as it is captured. The automatic export of images at the end of a case is a better option for facilities that have sufficient network bandwidth as it allows for removal of accidentally captured images before the images are sent. The manual option only allows for manual sending of images when the case ends. Even if one of the automatic options is selected a user can manually send images after the case ends in the event that the images do not successfully send.
5. Choose the number of retries for DICOM exports via the Send Retry Count field. This setting dictates the number of times the system will automatically try to resend a failed export. A facility can choose to set this value between one and ten retries based on their experience with exporting from other DICOM devices. If the facility has no experience, then leave this setting at its default—three—and only adjust this if there are a lot of failed export attempts from the device.
6. Choose the timeout for exporting images via the Send Timeout field. This option allows the site to choose how long an export will wait for a response before failing a DICOM send job. This can be set between 5 seconds and 60 seconds in 5 second increments. The facility should select this option based on their experience with their PACS, DICOM archive, etc. as well as their network speed. If the facility is unsure, then leave this setting at its default. If the facility finds that a lot of DICOM exports fail, then this setting should be adjusted to lengthen the timeout.
7. Select the DICOM modality type (OT or ES) to be used when exporting DICOM images from the SynergyHD3™ via the Send Modality field. You should ask the facility what modality type – OT (other) or ES (endoscopy) – their PACS, DICOM archive, etc. supports. If they are unsure, then leave the setting set to OT, which is the default as this is more commonly supported by third party systems. (Note: OT is equivalent to secondary capture and some facilities will refer to it via this terminology.)
8. Select the Send Image Format to be used for the DICOM send. There are two options, JPEG Lossy and Raw. JPEG lossy images have lossy JPEG image compression applied to them. These images are equivalent to the JPEG images that have been historically exported from SynergyHD3™. These images are smaller in size and therefore transfer faster than raw images. Thus, it is recommended to set this to JPEG lossy unless a facility does not utilize compressed images in its PACS, DICOM archive, etc. Raw images are uncompressed images and are substantially larger in size than JPEG images. Raw images were not previously available from the SynergyHD3™.
9. Input the AE Title of the PACS, DICOM archive, etc. provided by the facility. (Note: Again, this is case sensitive so you must input the AE title using the exact case specified by the facility.)
10. Input the IP address of the PACS, DICOM archive, etc. provided by the facility.
11. Input the network port of the PACS, DICOM archive, etc. provided by the facility.
12. Click on the Test Settings button to verify that the SynergyHD3™ unit can successfully connect to the DICOM export location. If everything is set up correctly on the SynergyHD3™ and on the facility’s DICOM export location, then you will see the following message—DICOM Test Succeeded: OK. If the test is not successful you will see the following error message – DICOM test failed—followed by additional details on why the test failed. In this case verify all the settings on this screen are correct as even a single error will prevent connection. If all the settings are confirmed to be correct, then there may be an issue with the network connection or with the settings on the PACS, DICOM archive, etc.
13. Click on the Save button in the lower right corner of the screen to save all the settings.

SynergyHD3™ DICOM Export Use Instructions

Assuming that the facility has opted to configure the SynergyHD3™ to automatically export DICOM images then as long as the SynergyHD3™ is connected to the facility’s network when the export takes place there is no additional user interaction needed for the DICOM export. In the event that the SynergyHD3™ is not connected to the network or the PACS, DICOM archive, etc. is not available, then the SynergyHD3™ will try to resend images up to the number of times specified in the DICOM send configuration. If these retry attempts also fail, then the user will need to manually export the DICOM images. Please note that the device will not indicate whether or not a DICOM export was successful. It is the responsibility of the facility to confirm that the case successfully and completely exported to their PACS, DICOM archive, etc. To manually export DICOM images when the case has ended, the user can choose the Export button in the lower right corner of SynergyHD3™ tablet as shown in the figure below. Selecting the Export button will provide a DICOM export option as shown in the figure (Note: The DICOM export icon has been called out in this figure to show additional icon detail). Selecting the DICOM export button will initiate the manual DICOM export.

SynergyHD3™ DICOM Modality Worklist

SynergyHD3™ currently supports DICOM (Digital Imaging and Communications in Medicine) modality worklist. This feature allows automatic population of patient and study demographics on the SynergyHD3™ from any system that can send DICOM based order messages.

Licensing: DICOM modality worklist is included along with DICOM exporting as part of the DICOM license. For additional information on the DICOM license please review the Licensing section for DICOM image distribution above.
Requirements: To utilize the DICOM modality worklist functionality a facility needs to:

• Have an information system capable of providing DICOM orders
• Schedule orders in the DICOM worklist provider for all surgeries performed on each SynergyHD3™
• Configure their DICOM worklist provider to send orders to each individual SynergyHD3™ (note: some vendors charge fees to do this if the facility does have knowledge in house to be able to do this)
• In some cases, configuration may require purchase of additional licenses for the DICOM worklist provider.

SynergyHD3™ DICOM Modality Worklist Set Up and Configuration
To configure the SynergyHD3™ for DICOM modality worklist, there are several pieces of information the facility must provide about their DICOM modality worklist provider. To facilitate the collection of this information, Arthrex has created a DICOM data collection form that should be utilized to collect data for DICOM License submittal. Arthrex recommends that this data be collected as soon as possible to facilitate the obtaining of the DICOM License in an expeditious manner. This will allow the DICOM installation to proceed efficiently. A copy of this form appears in Appendix 2.0. If the facility does not provide the information on this form the SynergyHD3™ cannot be configured for DICOM modality worklist. Ideally, the facility’s PACS administrator should be present for the DICOM configuration to confirm settings, ensure that the modality worklist provider is configured correctly, assist in troubleshooting if needed, etc. To set up the DICOM modality worklist function, log in as an Administrator on the SynergyHD3™ tablet. Enter System Set-Up by pressing the Maintenance Icon located in the upper left corner of SynergyHD3™ tablet (as shown in Figure 6-Setting Up DICOM Modality Worklist below) and then select Advanced Settings.

1. Select the DICOM tab as shown Figure 7-Configuring the SynergyHD3™ Modality Worklist Use the following procedure to configure the SynergyHD3™ for DICOM modality worklist use (Note: you must activate the DICOM license following the procedure in the DICOM export section above before completing the steps below). If the local AE title was already set up for DICOM export, then skip to step 2.
2. Input the AE title for the SynergyHD3™ unit in the Local AE Title field. The AE title must be unique. If the facility provided an AE title for use with the device, then use this AE title. If the facility did not provide an AE title, then use the default AE title—SYNERGY. If the facility has multiple SynergyHD3™ devices, then it is recommended that you use the host name of the unit as the AE title. (Note: If the AE title is not unique on the facility’s network, then DICOM functionality may not work. Also, an AE title is case sensitive. Thus, if a facility needs to input the AE title of the SynergyHD3™ into their PACS, DICOM archive, etc., then you must provide the facility the AE title using the same case as it was input in this field.)
3. Scroll down to the Modality Worklist section of the DICOM setup as shown in the figure above.
4. Enable DICOM Modality Work list by setting the Enable slider to On at the top of the Modality Worklist section.
5. Choose the default date range for issuing worklist queries in the Default Search Date Range field. The date range includes the date of the procedure ± some number of days. Unless the facility specifies a different default date range to accommodate their scheduling practices, leave this set to the default of ± 1 day. (Note: SynergyHD3™ only displays a maximum of 200 returned worklist records. For a facility that performs a lot of procedures, setting the default date range too large may consistently return too many records and may lead to additional manual steps for the staff to locate a particular record in the worklist.)
6. Choose the default modality type to use with modality worklist in the Default Search Modality field. If the facility does not indicate a preference, leave this set to the default (OT). (Note: One of the options is All. In most instances if this option is selected, then a significant amount of extraneous orders will be returned and the user will often not find the needed order. Only select the All option in the case where the facility’s worklist provider doesn’t support any of the other options or in cases where the facility’s worklist provider will be performing the filtering of the data before returning it.)
7. Input the AE Title of the worklist provider as provided by the facility. (Note: Again, this is case sensitive so you must input the AE title using the exact case specified by the facility.)
8. Input the IP address of the worklist provider as provided by the facility.
9. Input the network port of the worklist provider as provided by the facility.
10. Click on the Test Settings button to verify that the SynergyHD3™ unit can successfully connect to the DICOM modality worklist provider. If everything is set up correctly on the SynergyHD3™ and on the facility’s DICOM modality worklist provider, then you will see the following message—DICOM Test Succeeded: OK. If the test is not successful you will see the following error message – MWL test failed – followed by additional details on why the test failed. In this case verify all the settings on this screen are correct as even a single error will prevent connection. If all the settings are confirmed to be correct, then there may be an issue with the network connection or with the settings on the modality worklist provider.
11. Click on the Save button in the lower right corner of the screen to save all the settings.

SynergyHD3™ Modality Worklist Use Instructions

• Once DICOM modality worklist has been configured, a user will see the Cases screen shown on the top of the next page when he or she logs on to the SynergyHD3™ tablet.

• The top portion of the screen (Cases) behaves as it had with previous releases. Any manually created and saved cases will appear in the top portion of the list. The Add New Case button still exists in the upper right corner of the screen to allow a facility to manually create a new case if necessary. And the folder button in the upper right corner of the screen will display a list of completed cases as in previous versions of SynergyHD3™.
• The bottom portion of the screen (Worklist) will automatically populate based on a DICOM modality worklist query initiated using the system defaults when a user logs on to the system. If there are a lot of Cases in the Case list at the top of the screen, then the user may need to drag the screen upward to view the items on the worklist. The system will display a message indicating the last time the worklist was updated. If no results are returned, then a message alerts the user to this fact as shown in Figure 8- SynergyHD3™ DICOM Cases Screen. A user can manually issue a DICOM modality worklist query and regenerate the worklist at any time by tapping the refresh button identified in Figure 8-SynergyHD3™ DICOM Cases Screen (Note: other than when a user logs into the system the worklist will not automatically update). The items on the worklist are not cases but are merely orders returned from the query. The results in the list can be sorted by tapping any of the column headers. If the list is longer than what can appear on the screen the user can drag the screen up and down to scroll through the list of orders. The list itself is limited to 200 orders. If more than 200 orders are returned, then the list will display the first 200 orders it received and will display a message indicating that the maximum number of orders has been exceeded and that only the first 200 are displayed.
• In the event that the maximum numbers of orders has exceeded 200 and the needed order was not returned or in the event that the needed order was not returned because it was excluded by the default filters, the user can tap the filter button, which is identified in Figure 8-SynergyHD3™ DICOM Cases Screen, to modify the DICOM modality worklist query filter. When tapping the filter button the user will see in Figure 9-SynergyHD3™ Modify Search Window.

• The user can then select any combination of parameters and initiate a DICOM modality worklist query based on those parameters by tapping the Save button. The patient name and patient ID fields allow for wild card searching. To perform a wild card search the user should type at the end of their search string to query for any items that match the beginning portion of the text entered before the (e.g., typing 12345* in the patient ID field would return possible patient ID results ranging from 123450 to 123459 assuming the facility used a six-digit patient ID). If the user selects a surgeon or procedure these will only return results in the event that surgeons and procedures created on the SynergyHD3™ exactly match those used in the system providing the worklistorders.Touching outside of the Modify Search window will close the window if it was accessed accidentally. The Clear button in the lower left will clear all the fields on the search screen. When the user initiates the search via the Save button, the user is returned to the Cases screen and the returned results matching the search criteria appear in the Worklist section of the Cases screen.
• Please note that modifying the search criteria does so only for the current query. Changing the search criteria does not modify the default search criteria set up as part of the DICOM modality worklist configuration.
• Once a user locates the particular order in the Work list section of the Cases screen that matches the study to be performed, the user can highlight that order by tapping it in the list. When an order is highlighted, an Add Patient button appears to the right of the order in the list as is shown in the Figure 10- SynergyHD3™ DICOM Add Patient Button.

• The user should tap the Add Patient button and they will be see the Add New Case Figure 11- SynergyHD3™ DICOM Add New Cases.

• Any items returned via the DICOM modality worklist order will automatically populate the Add New Case screen. The user should review all the items automatically populated to ensure that they are correct and should add any items that are missing in the event that the DICOM modality worklist order did not include those items. As in previous versions of the system certain fields (i.e., surgeon, procedure, and patient name) are required to allow a user to start a case. Once these fields are completed, then the Start button activates and the user can tap the Start button to begin the case. As with previous versions of the system, if the user does not want to start the case but wants to save the case information, then he or she can click on the Save button and will be returned to the main Cases screen. The case that was just added will now appear in the Cases list at the top of the screen.
• Please note that a new field, Accession #, was added to the Add New Case screen with this release. Accession number is a unique study identifier assigned by a facility. Often a PACS, DICOM archive, etc. will either not accept a study that is missing an accession number or will accept the study but flag it as missing a required piece of data. Thus, while it is not a mandatory field to start a case it may be a mandatory field for successful exporting of the DICOM images.
• While a user can modify fields automatically populated via DICOM modality worklist, in general this is not a good practice because a PACS, DICOM archive, etc. often utilizes the same order information provided to SynergyHD3™ via modality worklist for matching incoming studies. If users modify patient or study demographics, then the demographics sent with the DICOM images may not match those expected on the PACS, DICOM archive, etc.
• To successfully populate the Surgeon and Procedure fields via modality worklist, the list of surgeons and procedures set up in SynergyHD3™ must match exactly to those utilized by the facility in their orders. If there is not an exact match for the surgeon name or procedure, then the fields will appear blank. If a facility is planning on using modality worklist, then they should provide an exact listing of surgeons and procedures as they appear in their ordering system and these should be input into the surgeon and procedure lists in SynergyHD3™ exactly as they are provided.
• If a facility is adding modality worklist capabilities to an existing SynergyHD3™, then they will most likely need to modify their surgeons and procedures to match those used in the facility’s ordering system.

Troubleshooting

• In the event of problems and issues with your installation and operation, please feel free to call Arthrex Troubleshooting staff for Technical Support 1-888-420-9393.

Appendix 1.0 Synergy HD3™ DICOM LICENSE Label

It is important to keep the License key number in a convenient place and Identify each SynergyHD3™ Console that is DICOM enabled. Enter the License Key number and the SynergyHD3™ console serial number with a “Sharpie” on this Sticker that is provided, shown above. Place the sticker on the top cover of the SynergyHD3™ console as shown in Figure 13-SynergyHD3™ with DICOM License Label.

Appendix 2.0 Arthrex SynergyHD3™ DICOM Data Collection Form
The following pages contain a DICOM data collection form that should be provided to a facility in advance of the SynergyHD3™ arriving on site. The information on this form is required to set up DICOM functionality on the SynergyHD3™.

Arthrex SynergyHD3™ DICOM Data Collection Form
Please complete the following and provide the completed form back to your Arthrex contact in advance of device configuration. The device cannot be set up without this information.

Site Information

Site Name|
---|---
IT Contact Name|
IT Contact Phone|
IT Contact Email|
PACS Contact Name|
PACS Contact Phone|
PACS Contact Email|

SynergyHD3™ Device Information
(Note: if host name or AE title not provided, then will utilize unique default names)

Host Name|
---|---
AE Title|
Port| 11112 (fixed in device; provided here for reference)
Modality Type| □ ES (endoscopy)       □ OT (other)     (default is OT if no selection

made)

Network Information

Physical IP Address or DHCP|
---|---
Subnet Mask|
Gateway|
Restrictions|

PACS (DICOM Send) Information

PACS Vendor, System, & Version|
---|---
Host Name|
IP Address|
AE Title|
Port|

DICOM Modality Worklist Information

Worklist Vendor, System, & Version|
---|---
Host Name|
IP Address|
AE Title|
Port|

1370 Creekside Blvd.

• Naples, FL 34108, USA
• Customer Service
• 866-267-9138

Arthrex, Inc.

• 1370 Creekside Blvd.
• Naples, FL 34108, USA
• 1 +800-934-4404

Arthrex GmbH

• Erwin-Hielscher-Strasse 9
• 81249 München, Germany
• +49 89 9095005-0

References

• Arthrex - Helping Surgeons Treat Their Patients Better®
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