CARTO 3 SYSTEM RELEASE NOTES FOR v1.1.2A Sw Ver 1.1.20.214

CARTO® 3 System Release Notes for v1.1.2A

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Incorrect Error Message When Catheter Is in Reduced Accuracy Zone ... 7 QUAD B, and DECA Sockets ... 7 After Reference Change Approved, There is No Indication of Which Points Were Acquired using Which Reference ... 8 Temperature Is Not Displayed in the RF Generator for Some NAVISTAR® Catheters ... 8 Error Message Does Not Appear When Decapolar Catheter Connected to QUAD Socket on the PIU ... 8 No Error Message Appears If Location Pad is Physically Disconnected ... 8 Main Window Not Configured According to Saved Template... 9 Anatomical Structure Is Not Hollow ... 9 Patient Data Cannot Be Modified in Review Mode ... 9 During Ablation, It Is Not Possible to Scroll in the Ablation Table ... 9 Only the Last Ablation Session Data Appears in Remaps ... 9 Unipolar Pacing Reference Channel Cannot Be Changed After Pacing ... 9 Blank Maps Might Appear in Study Backup ... 10 Anonymous Backup Option Combines Multiple Patients into One Anonymous Patient 10 In Random Cases, Communication Cannot Be Established Between Workstation and PIU ... 10 Opening the User-Selected Catheter List During Auto-Identification of an Auto ID Catheter Disables Its Disconnection ... 10 In Extremely Rare, Random Cases, Application Freezes After Clicking on the Screen . 10 Diagnostic non-Auto-ID Catheters Appear Connected When Starting a New Study, Even If They Were Physically Disconnected ... 11 After Selecting the "Draw Scar Area when criteria met" Checkbox, a Map Update Delay Occurs... 11 Recordings Are Not Backed Up When Exiting Study ... 11 Incorrect Error Message Appears If PIU Is Restarted When Location Pad Is Disabled .. 11 Sometimes the Opening Screen Does Not Appear after Application Is Reloaded ... 11 Acquire Button Has No Reduced Accuracy Zone Indication ... 12 In Rare Cases, Setup Tabs Disappear... 12 Switching from Mapping to Verification Is Slow with Multiple Channels or Multiple Maps ... 12 Default Value of Color Threshold Is Incorrect ... 12 Study Rename Field Is Limited to 15 Characters ... 12 Sometimes "Ablation On" Label Appears, Without RF Generator ... 12 Catheter Tip is Projected on the Map Closest to the Catheter ... 13 Incorrect Message Appears When Points with Identical External Reference Are Moved or Copied After a Back Patch Has Moved ... 13 Delayed Display of Auto-ID Catheters in the Monitor Pane ... 13 Some Error Messages Do Not Appear for QUAD A, Ablation Session Time in the Ablation Table Is Not Correct ... 13 Incorrect Error Messages Might Appear when Patch Unit Is Disconnected... 13 Semi-Detached Patch Error Not Issued ... 14 In Rare Instances, Data Synchronization Error Occurs During a Study ... 14 Unclear Options in ICEG Unipolar Configuration Dialog Box ... 14 Stop Button Not Included for Propagation or Playback Toolbars ... 14 Starting Scar Area Tool with New Thresholds or Closing the Tool Deletes Previously Applied Scar Tags ... 14 Selecting "None" for Connected Auto-ID Catheter Disconnects Catheter in Catheter Setup ... 15 Incorrect Image of Distal-to-First Electrode in Catheter Definition Tool ... 15 User-Defined Tag Label Name Is Not Automatically Updated ... 15 © 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Acquiring Points while Applying Point Tags Causes System Freeze ... 15 Splash Screen and Windows® Taskbar Appear while in the Catheter Setup ... 15 Although an Ablation Graph is Hidden, There is No Indication of That ... 16 In Rare Cases, Extremely Large Studies Might Cause the CARTO® 3 System Application to Freeze ... 16 When Clipping Plane is Activated, Hidden-Side Catheters Cannot Be Selected ... 16 In Review Mode, Surface Reconstruction Maps Do Not Appear in the List of Maps in the Study Data Dialog Box ... 16 When Selecting or Unselecting Routing For Reference Annotation Channel, Annotation Viewer Freezes for a Few Seconds ... 16 Sometimes Ablation Tags Disappear from Map (from Point List and Map Reconstruction) When Study Is Opened in Review Mode ... 17 Acquire Button is Disabled Despite System Status "OK" (No Errors or Warnings Appear) ... 17 Incorrect Information for Displayed ECG Channels Appears in Monitor and Annotation Viewer ... 17 Custom Spacing Options Set in Catheter Definition Tool Dialog Box Do Not Reset Correctly ... 17 Design Lines and Anatomical Structures Might Disappear After Restoring a Study ... 18 System Application Sometimes Restarts When Connecting PIU to Workstation ... 18 Magnetic Sensor Error Appears When Disconnecting Magnetic Sensor Catheter ... 18 System Restarts When MAP Catheter Is Moved From Mapping Range During Heavily Loaded Study... 18 Incorrect System Notification Regarding BCS Change When Opening New Map During PIU Initialization ... 19 Reduced Catheter Visualization for Catheters Connected to Yellow Sockets on PIU ... 19 Catheter Visualization Issues When Reference Annotation Is Invalid ... 19 When Template is Saved, Changes to Connector Labels Are Only Saved for Recorded Channels ... 19 QUAD Catheter Visualization Is Unstable during Ablation ... 19 10-POLE LASSO® NAV Catheter Visualization Is Distorted or Disappears after Rapid, Rotating Movement ... 20 Random Point Acquisition by System ... 20 Orientation and Movement of Catheter Visualization Is Randomly Inverted ... 20 When Fifth Catheter Is Connected During a Study, Unrelated EEPROM Errors Might Appear ... 20 Raw Data Export Utility Graph and Ablation Graph Viewer Appear Different from One Another ... 20 In Random Cases, Incorrect Dialog Box Appears If RF Energy Is Detected When Initialization Starts ... 21 Restoring Studies from Dual-Layer DVD Sometimes Fails ... 21 Selection of User-Defined Template Distorts the View (21" Monitor) ... 21 In Random Cases, Catheter Visualization Displays Excessive Movement ... 21 In Rare, Random Cases, Points Do Not Contribute Data to Map After Location Only Tag Is Removed ... 21 Points with Voltage Values Equal to the Scar Threshold Are Marked as Scar ... 22 In Rare Cases, Point Acquisition Is Disabled when Ablation Session Is Longer Than 600 Seconds ... 22 Change to Pace Routing During Initialization Might Cause Delay of Pacing ... 22 Repeater Monitor Activation from Tools Menu Changes Current Layout ... 22 After Returning to Repeater Monitor Mode, the Full Layout is Not Displayed ... 23 Random Application Failure during Vessel Editing ... 23 © 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Random Application Failure when Unipolar Pacing Is Routed to None ... 23 Total Mapping Time in Print Report Might Include Days ... 23 Scar Type and Scar Area Are Not Applied to Points with Tags ... 23 Unipolar Pacing Is Disabled After PIU Restart ... 23 CARTO® XP Review Mode Initializes Incorrectly After Image Installation or Upgrade Procedure Performed on Dell T3500 ... 24 System Freezes in New Studies After Dark Red is Selected as Catheter Shaft Color ... 24 Troubleshooting the FAM Application ... 24 Dialog Box with Notice Regarding Cycle Length Difference Erroneously Opens ... 24 Creating FAM Maps in Gated Mode is Possible, Although It Should Be Only Possible in Stable Mode... 24 Names of Maps Acquired in Stable Mode Do Not Appear in 2D Ultrasound Window .. 24 All FAM Map Intersections Appear in a Single Color in 2D Ultrasound Window ... 25 Ultrasound Connectivity Status Icon Not Updated ... 25 "Show Fan" Option Missing From Map Viewer Shortcut Menu ... 25 Sometimes Ultrasound Catheter and Fan Do Not Appear When Starting New Study ... 25 Cannot Specify FAM Catheter After LASSO® NAV Catheters Are Reconnected to Another Socket ... 25 Extracted Surface Does Not Appear If More Than Three Unconnected Areas Exist ... 25 Incorrect FAM Recording if Mapping Catheter Is Disconnected ... 26 Random System Failure during FAM-EA Study ... 26 FAM Reconstruction Might Appear Distorted If Study Is Continued After a Sudden Failure of the Application ... 26 Map and Point Menus Disabled when FAM-Advanced Mode Dialog Box Is Opened during Recording ... 26 Troubleshooting the CARTOSOUND™ Add-On Module ... 26 CARTO® 3 System Recognizes Change in Ultrasound System Settings with Delay ... 26 Marking Line Measurements on Contours Does Not Function Correctly ... 27 Wrong Communication Error Message Appears during CARTOSOUND™ Study ... 27 Auto Draw Mode Disabled while Ultrasound Video is in Split, Dual, or 4D Mode ... 27 Segment Image Names Do Not Appear in the 2D Viewer Drop-Down List while Using Map Intersection... 27 Incorrect Error Message for Unsupported Video Mode... 27 Catheter Disconnection Error Message Appears Instead of Correct "No Communication with PIU" Error Message ... 28 Default View Does Not Return After Entering Pan Mode... 28 Incorrect Error Message Appears If There Is a SOUNDSTAR® Catheter Calibration Error ... 28 2D Ultrasound Window Is Not Displayed Automatically During CARTOSOUND™ Study ... 28 2D Map List Appears Empty ... 28 Incorrect Error Message Regarding Metal Interference when Ultrasound Catheter is in Reduced Accuracy Zone ... 29 Contour Tags Cannot Be Defined Until the First Contour Is Assigned ... 29 Communication Initialization Frozen in 2D Ultrasound Window If Ethernet Cable Disconnected During Study ... 29 "Severe Distortion" or "Ultrasound Catheter Out Of Mapping Range" Error Appears In 2D Ultrasound Window Together With Warning 6150 ... 29 Error Message Appearance while There is No Video Signal Sometimes Indicates Video Cable Disconnection ... 30 Depth Greater than “11 cm” in ACUSON X300™ Ultrasound System Causes CARTO® 3 System Auto-Draw Feature to Fail ... 30 © 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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CARTO® 3 System Freezes after Attempting To Remove Map from Map Viewer While "Maps Intersection" Option Active with Many Maps in Map Viewer ... 30 Floating Contour on Map without Reconstruction Cannot Be Selected in Map Viewer . 30 Large Studies Cannot Be Restored from PACS ... 30 Troubleshooting the CARTOMERGE® PLUS Image Integration Module ... 31 Some CT or MRI Images in the Additional View Might Appear Red ... 31 Statistics Are Not Updated If Landmarks Are Added and Matched While Match Statistics Table Is Open ... 31 Registration Is Lost If a CARTOMERGE® Study with a Registered CARTO® 3 Study Is Restored to a Different Workstation with a Study of the Same Name ... 31 Match Statistics Data for Multi-Cavity Surface Registration Is Not Displayed in Review Mode ... 31 Standard Deviation Is Not Calculated Correctly If Some Landmark Pairs Are Hidden .. 32 Cannot Load Images If Image Studies Used Have the Same Name ... 32 Landmark Remains on Image After Its Paired Point Is Moved ... 32 Maps with Different Reference Channels Can Be Matched to Single Image ... 32 Rename Image Option Is Missing ... 32 System Freezes When Performing X-Y Move on FAM Maps ... 32 Notification That Study is Not the Most Recent Does Not Appear ... 33 Image List Not Displayed in Open Study Dialog Box ... 33 Image Studies from CARTO® XP Backups Can Be Restored to the CARTO® 3 System ... 33 Reloading Image Study Before Registration Removes Landmarks ... 33 System Appears Frozen When Color Is Projected on Image during FAM Recording ... 33 Troubleshooting the CFAE Software ... 34 CFAE Tags Are Not Projected on Images ... 34 Threshold Lines and Peaks Are Not Displayed When Acquiring Points in CFAE ... 34 System Speed Slows in CFAE Studies with More Than 300 Points ... 34 CFAE Map Data Cannot Be Reviewed in the CARTO® XP System Mode ... 34 Troubleshooting the CARTO® RMT Module ... 35 Points Not Acquired in CARTO® 3 System When Choosing Auto Map Option in Navigant™... 35 CARTO® 3 RMT Module and Navigant™ System Incorrectly Appear Registered When Body Coordinate System Movement Occurs ... 35 CARTO® 3 System Might Freeze after Selection of Point from Restored CARTO® RMT Studies ... 35 Incorrect Error Event Appears in Navigant™ Software when Patch Unit Is Disconnected ... 35 "Reference Patch out of Range" Event Does Not Appear in Navigant™ Software ... 36 Deleted Design Lines Are Displayed in Review Mode ... 36 Vertical Caliper on Location Setup Guide Is Not Accurate for CARTO® RMT Module .. 36 After Closing Study in CARTO® 3 System, Data Continues to Transfer to Navigant® System ... 36 Click & Go Mode Remains Active After Releasing Alt Key ... 36 Incorrect Error Message Appears When Connecting Ultrasound Catheter with Navigant™ System Magnets Not Stowed ... 37 No Message Appears in Navigant™ System Notifying When CARTO® 3 Study is Closed and New One Started... 37 In Some Extremely Large CARTO® 3 RMT Studies, Communication with Navigant™ System is Terminated ... 37 Navigant™ Maps Not Updated During Large Studies ... 37 Navigant™ Does Not Display Tags on Remap of FAM Map Until Refreshed ... 37 Troubleshooting the EP Recording System ... 38 © 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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CARTO® 3 System and Sensis AXIOM XP EP Recorder Remain in Stand-By State after Creating a New Study ... 38 Clock Synchronization Between CardioLab® and CARTO® 3 Systems Is Delayed ... 38 Importing Patient Data with Non-Supported Characters Erases Existing Data ... 38 Interfaced Points Are Still Linked After Map Is Renamed ... 38 System Displays a Disconnected State when CardioLab® Is on and the Cable is Connected ... 39 No Change in Signals Appears in AXIOM Sensis XP System Review Window After Ref. Annotation of Interfaced Point Is Edited in Interfaced State of CARTO® 3 System . 39 ECG Signals and Point Time of CARTO® 3 System Event Do Not Change in Sensis when Beat of Interfaced Point Is Changed in CARTO® 3 System ... 39 Point Data in AXIOM Sensis XP System is Not Same As in CARTO® 3 System when Creating Remap ... 39 Acquired Interfaced Points Beyond 500 in CARTO® 3 System Do Not Create Shared Events in AXIOM Sensis XP System ... 39 Impossible to Import Patient Data during CARTO® 3 Study if Patient Data in AXIOM Sensis XP System Contains Non-Supported Character in Any Field ... 40 If Gender Field Is Blank in CardioLab®, Gender in CARTO® 3 System Is Set to Female 40

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

Biosense Webster (Israel), Ltd. 4 Hatnufa Street P.O. Box 275 Yokneam 20692 ISRAEL Tel: +972 (4) 813-1111 E-mail: [email protected]

ABOUT THIS RELEASE This Release Notes document includes troubleshooting sections relating to known issues. The third-party trademarks used herein are trademarks of their respective owners.

IMPORTANT SYSTEM INFORMATION ABOUT THIS RELEASE This version was created for the use of the DELL PRECISION™ T3500MT-G3 Xeon® workstation and its image (V 4.2.4). There are no changes, other than for that purpose, to the software. Therefore, there are no new troubleshooting topics for new defects, because no new defects are known. This version of the workstation replaces the DELL PRECISION™ T3500 that was released in version 1.1.2.

Information from the Previous Release WARNING: When a progress bar is indicating that the system is processing a large number of points, a message might appear, requesting that you "Please wait." Any additional action performed before the message disappears will cause the system to freeze. When entering data, only letters or numbers are supported in the CARTO® 3 System. When switching from one external system to another, always physically disconnect the system before connecting the next system. Otherwise, the CARTO® 3 System will freeze. Before beginning a backup, take into consideration that the estimated time needed is 30 minutes per GB of data. This is true whether using a CD or DVD as the backup media. Online help for the CARTO® 3 System does not appear in this version of the software. It is, however, available for viewing from the Documentation CD that is supplied with the system. RF energy delivery through the CARTO® 3 System is not enabled in any of the following situations: 

After clicking Initialize



When the PIU is OFF



Up to 40 seconds after clicking Continue Study



Up to 40 seconds after the approval of a BCS (body coordinate system) move



During the ~40-second recovery after a loss of communication with the PIU



Up to 40 seconds after clicking Reset Visualization



Up to 40 seconds after the approval of "Patch Detached" or a disconnection

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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If a Patch Detached error message appears and a gray-striped patch appears in the Location Setup Guide, verify that all the patches are firmly attached to the patient and properly connected. If the message does not disappear, perform the following until the patch is correctly displayed: 1. When the "Patch Detached" message appears, click Learn New. 2. Click Reset Visualization. When using the CARTO® 3 RMT Software Module, physicians should rely only on the CARTO® 3 System maps when ablating. Navigant™ system maps are not yet aligned with CARTO® 3 System maps. Whenever the PIU resets (for whatever reason) during a Study, close the Study and continue it in Review Mode. Do not use a NAVISTAR® Catheter with the Thermistor temperature sensor for ablation. Use a NAVISTAR® Catheter with the ThermoCouple temperature sensor instead. WARNING: The clinical significance of utilizing the CFAE Module to help identify areas with complex fractionated atrial electrograms for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

TROUBLESHOOTING Sometimes Ablation Tags Are Not Displayed on Map In rare, random cases, ablation tags are not displayed on the map when points are acquired during ablation. Refer to the Point List to identify points acquired during ablation and tag them manually. BR#2633

Windows® Explorer Can Be Opened Access to the Microsoft® Windows® Explorer should be disabled, but is not. To prevent undesired damage to the study or the system, do not attempt to open the Windows® Explorer. If it somehow opens, close it immediately. BR#2636

Extracted Surface of a FAM Reconstruction Randomly Disappears In rare, random cases, the extracted surface of a FAM reconstruction disappears. This might be related to having changed the Global Resolution. Change the Global Resolution to a different value. BR#2645

Template List Might Disappear When Arrow Keys Are Used for Selection The Template list in the Study Setup might temporarily disappear when the keyboard arrow keys are used to scroll between templates. © 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Use the mouse to select a template. BR#2776

System Freezes When Editing Reference Annotation and Deleting the Only Point in the Point List Occasionally, if a map contains only one point and it is deleted while the Edit Reference Annotation option is used, if the reference annotation is moved, the CARTO® 3 System application might freeze. Open the study in the Review mode and continue the study. BR#2796

User-Selected Catheters Do Not Appear after PIU is Reset During a Study If the PIU is reset during a study, the user-selected catheters do not appear as connected. Re-select the required catheters in the Catheter Setup. BR#3384

System Supports Only Four Electrodes and Four ECG Channels (Unipolar and Bipolar) Despite Connecting a Hexa Unipolar Catheter The CARTO® 3 System supports only four of the five electrodes on the 1086259RT Hexa unipolar catheter. The electrode furthest from the tip of the catheter (the fifth electrode) is not supported. However, unipolar pacing with those four electrodes is still supported. Be aware that the fifth electrode is not enabled on the CARTO® 3 System. BR#3684

Changes to Socket Color Do Not Appear When Study Is Continued Changes made to the socket color do not appear when a study is continued from Review mode. Be aware that changes to the socket color are not saved in Review mode. BR#3702

If Back Patch Is Detached More Than Five Minutes, Error Message Does Not Disappear When Patch Is Reattached If a back patch is detached for more than five minutes before it is reattached, the "patch detached" error message does not disappear. Click Initialize to perform catheter visualization initialization again. BR#3719

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Disconnecting LASSO® NAV Catheter Before Recognition Causes Incorrect Visualization of Next Catheter Connected to Same Socket When a LASSO® NAV Catheter is connected to a socket and disconnected before it is identified by the system, it will cause the next catheter that is connected to the same socket to appear constantly moving, even when it is not actually moving. Always wait at least six seconds (for recognition and identification) after connecting a LASSO® NAV Catheter to a socket before disconnecting it. If it is disconnected before it is identified, wait six seconds and reconnect the same catheter to complete identification. Only after that, connect another catheter to the same socket. BR#3752

Ablation Data Is Incorrect If the EP I/O Box Is Disconnected from the RF Generator during Ablation If the EP I/O box is disconnected from the RF Generator during ablation and then reconnected, the Ablation Graph Viewer should show a gap indicating the time the systems were disconnected. However, no gap is displayed. In addition, in this case, the times displayed in the Ablation Label, Ablation Table, and Ablation Graph do not match. This does not occur if the EP I/O box is disconnected from the Workstation. Be aware that if the EP I/O box is disconnected and reconnected during ablation from the RF Generator side, the data displayed in the CARTO® 3 System might be incorrect. BR#3760

Early Meets Late Remains Inactive After Surface Reconstruction Deactivated Is Ended and Reactivated The Early Meets Late option should be deactivated when Surface Reconstruction is activated. Furthermore, Early Meets Late should return to Active state after Surface Reconstruction is deactivated. However, Early Meets Late remains inactive. Be aware of this when deactivating Surface Reconstruction. BR#3770

DVD Tray Opens Before Verification Phase When Backing Up to DVD Between the copying and verifying phases of backup, the DVD-ROM tray opens momentarily and then shuts again. Wait for the system to confirm that the backup is complete before removing the disk. BR#3773

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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If Point List Is Displayed While Printing, Printed Data Is Covered by Unrelated Text When printing, if the Point List is displayed, a message box with unrelated text might cover printed data. Before printing, display a map in the Map Viewer or select a point in the Point List. This will ensure that all relevant information is printed and visible. BR#3781

Cannot Cancel "Save Template As" If There Are NonSupported Characters If there are non-supported characters in the Save Template As dialog box, the Cancel and Close (X) buttons are disabled. Delete the non-supported characters, and then click Cancel. BR#3843

Free Space Amount on CD-R/DVD-R Does Not Update When Recording Data Is Introduced in Backup Study If the Include Recording Data checkbox is selected when you back up a study, the amount of free space on the CD-R or DVD-R should be updated, but it is not. If the amount of data selected is greater than the space available, a message appears notifying you of that. If this message appears, data will not be backed up. Replace the DVD (if possible with one that has a larger capacity) and retry the backup. BR#3907

Blank Screen Appears When <ALT>+<TAB> is Pressed If users press <ALT>+<TAB> on the workstation keyboard, the screen turns gray and blank. If users then click the blue circle in the top left corner of the screen, the system fails. Do not press <ALT>+<TAB>. If <ALT>+<TAB> is mistakenly pressed, press <ALT>+<ESC>. Do not click the blue circle at the top left corner of the screen before pressing <ALT>+<ESC>. BR#3911

Unipolar Reference Is Not Saved With Template The unipolar reference is not saved when you save a template. Therefore, after saving a template set the unipolar reference again. BR#3918

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Connection of Auto-ID Catheter Is Not Recognized When Connected to a Socket in Which Non-Auto-ID Diagnostic Catheter Was Connected When you connect an Auto-ID catheter to a socket that previously had a non-Auto-ID diagnostic catheter connected to it, the Auto-ID catheter is not recognized by the system. Physically disconnect the catheter and disconnect it in the Catheter Setup. After this, reconnect the catheter for recognition. BR#4020

Slow System Recognition of LASSO® NAV Catheters When a LASSO® NAV Catheter is connected to the PIU, the CARTO® 3 System takes at least five seconds to recognize that it is connected. Do not proceed until the catheter is recognized. BR#4033

Image Processing Tool Freezes When Attempting to Close the Import Window during Scanning If the Import window of the Image Processing Tool is closed during the importing of a CT or MRI study, the Image Processing Tool freezes. Reopen the Image Processing Tool and keep the Import window open until image importing is completed. BR#4096

Large Backup to CD or DVD Takes Considerable Time Backing up a large amount of data to a CD or DVD takes considerable time during which the system is unresponsive. Before beginning a backup, take into consideration that the estimated time needed is 30 minutes per GB of data. This is true whether using a CD or DVD as the backup media. BR#4111

Error Message Regarding Disconnected Patch Disappears If Patch Moves In the rare occasion that a Back Patch becomes disconnected and afterwards moves, there should be two error messages: one regarding the disconnected patch and one regarding the movement. On the movement-related message dialog box, if you click Continue to relearn the Body Coordinate System (BCS), the error regarding the detached patch disappears, even though it is still disconnected. In the Location Setup Guide, the patch is correctly displayed as disconnected (gray). When relearning the BCS, disregard the fact that the messages disappears and refer to the Location Setup Guide for actual Back Patch status. BR#4126

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Automatic Gain Cannot Be Deactivated Via the ECG Viewer Drop-Down Menu After applying automatic gain to a channel in any ECG viewer (using the Perform Auto Gain option), the option cannot be deactivated via the viewer's drop-down menu. To deactivate automatic gain, adjust the gain manually. BR#4128

Design Line Is Disabled in Review Mode The Design Line option is disabled in Review mode. It is also disabled in Acquisition Mode if there are errors. In Review mode, continue the study to enable the Design Line option. In Acquisition mode, resolve the errors. BR#4163

Backing Up Studies with More 700 MB to CDs Is Not Stopped by System Message When backing up a Study with more than 700 MB of data to CD, the system should display a message warning that this action is impossible. Therefore, the process continues without end. The number that appears in the space slider of the Backup dialog box, as a negative number, indicates the amount of data that will not fit on the CD. Do not start the backup process, unless the extra data has been deleted and the number on the slider is a positive number. BR#4166

New User-Defined Tags Cannot Be Added If No Points Are Selected When attempting to create a new user-defined tag, but no points are selected in the Point List or Map Viewer, the "+" button appears disabled. Select a point to add a new tag. BR#4169

Incorrect Error Message When Catheter Is in Reduced Accuracy Zone If a catheter enters the reduced accuracy zone, the error message notifying this does not appear. Instead, there is an incorrect message regarding metal interference. If a metal interference message appears, the catheter might be in the Reduced Accuracy Zone. BR#4179, BR#4516

QUAD B, and DECA Sockets When catheters with Auto-ID are used, error messages do not appear in the System Status panel for errors relating to invalid catheter ID, EEPROM reading errors, EEPROM

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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checksum errors, or invalid EEPROM format. The catheter is not recognized by the system. Replace the catheter. BR#4197, BR#3835, BR#4195

After Reference Change Approved, There is No Indication of Which Points Were Acquired using Which Reference During a Study, if a change in BCS (Body Coordinate System) occurred and was approved, the system should indicate which points were acquired using the previous reference and which were acquired using the new reference. However, no such indication appears. For differentiation purposes, create comments for points that will indicate which points were acquired with which reference. BR#4201

Temperature Is Not Displayed in the RF Generator for Some NAVISTAR® Catheters When a NAVISTAR® Catheter with the Thermistor temperature sensor is used, the RF Generator does not display the temperature. Do not use a NAVISTAR® Catheter with the Thermistor temperature sensor for ablation. Use a NAVISTAR® Catheter with the ThermoCouple temperature sensor instead. BR#4211

Error Message Does Not Appear When Decapolar Catheter Connected to QUAD Socket on the PIU If users incorrectly connect a decapolar catheter to the QUAD A or QUAD B socket on the PIU, the catheter is not visualized in the Map Viewer. However, an error message does not appear stating that fact. Connect catheters only to the appropriate socket. BR#4249

No Error Message Appears If Location Pad is Physically Disconnected In the unlikely event that the Location Pad is physically disconnected, no error will appear, despite the fact that the system cannot provide relevant data (ACL and magnetic) without being connected to the Location Pad. Shut down the system, reconnect the Location Pad, and restart the system. BR#4280

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

Page 9 of 40

Main Window Not Configured According to Saved Template If users make changes in the configuration of the main window, select the Save Template option, and then open a new study with the saved template, the configuration of the main window of the new study might not match the template. The following features are not saved in a new template: showing grid, hiding Patient Icon, hiding Color Bar, Sweep Speed changes, and adding or removing signals in ECG Viewers. Manually configure the main window of the new study for any change not derived from the template. BR#4332

Anatomical Structure Is Not Hollow If the marked area is sparsely mapped (too few points), three dimensions cannot be created, leaving a solid appearance to the structure. Acquire more points until the structure assumes three dimensions. BR#4358

Patient Data Cannot Be Modified in Review Mode When a Study is opened in Review Mode, the Edit Patient Details option is disabled. To modify patient details, continue the study and then edit the details. BR#4397

During Ablation, It Is Not Possible to Scroll in the Ablation Table When there are multiple ablation sessions, the motion of the scroll bar in the ablation table freezes during ablation. Resize the Ablation Graphs pane after each ablation session, or refer to the recording system for ablation data. BR#4428

Only the Last Ablation Session Data Appears in Remaps If a remap is created of a map with multiple ablation sessions, only the data from the last session appears in the Ablation Graph Viewer. Refer to the recording system for remap ablation data. BR#4440

Unipolar Pacing Reference Channel Cannot Be Changed After Pacing If a unipolar pacing reference channel is set (through ECG > IECG Unipolar Configuration) and then pacing is activated, the unipolar pacing reference channel cannot be changed. For example, if you activate pacing through REF 11 and then change the unipolar pacing reference channel to QUAD 6, the change appears to be accepted. However, pacing is not routed to the new channel. To change the reference channel, do one of the following: 

Set the unipolar pacing reference channel to None and then select the new routing channel.

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

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Page 10 of 40

Disable Unipolar Pacing and then enable it with the new setting (ECG > IECG Unipolar Configuration). BR#4445

Blank Maps Might Appear in Study Backup In random cases, a map icon appears next to a blank map in the Restore dialog box. Ignore the blank maps when restoring the patient's data. BR#4446

Anonymous Backup Option Combines Multiple Patients into One Anonymous Patient The anonymous backup option (Backup as Anonymous) combines all patients on a disk into one anonymous patient. Back up only one patient per disk (CD/DVD). After restoring an anonymous patient, rename the patient before restoring another anonymous patient. BR#4449

In Random Cases, Communication Cannot Be Established Between Workstation and PIU In random cases, communication was not established after the PIU was restarted. If this occurs, reload the CARTO® 3 Application. BR#4450

Opening the User-Selected Catheter List During Auto-Identification of an Auto ID Catheter Disables Its Disconnection When an Auto-ID catheter is connected to a socket and auto-identification is in progress, if the User-Selected Catheter List is opened on that socket before the auto-identification is completed, it renders the disconnection of the catheter impossible. Do not open the User-Selected Catheter List while auto-identification is in progress. If the list has been opened, connect to another socket or reload the application. BR#4457

In Extremely Rare, Random Cases, Application Freezes After Clicking on the Screen In extremely rare cases, the CARTO® 3 System application becomes unresponsive after clicking on anywhere on the screen. If this occurs, press <Alt>+<Tab> to restore system response. BR#4459

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

Page 11 of 40

Diagnostic non-Auto-ID Catheters Appear Connected When Starting a New Study, Even If They Were Physically Disconnected If a diagnostic non-Auto-ID catheter is disconnected after a study is closed, it will still appear as connected when the next Study is started, even if a different catheter is connected to the same socket. Preferably, disconnect diagnostic non-Auto-ID catheters-both physically and in the application-before closing a study. If a diagnostic non-Auto-ID catheter was left connected after closing a study, disconnect it and reload the CARTO® 3 System application. BR#4461

After Selecting the "Draw Scar Area when criteria met" Checkbox, a Map Update Delay Occurs When the Auto Scar Settings dialog box is opened and the Draw Scar Area when criteria met check box is selected on an existing map, the check mark in the check box does not appear immediately. In addition, a delay occurs in the update process of the map. During this delay, the system becomes unresponsive. Wait at least 10 seconds after selecting the Draw Scar Area when criteria met check box before continuing. BR#4463

Recordings Are Not Backed Up When Exiting Study If you choose to back up data when you exit a study, recordings are not included in the backup, even if you select the Include Recording Data option. To include recordings when backing up the data, click Backup from the System Tools dialog box in the opening screen. BR#4473

Incorrect Error Message Appears If PIU Is Restarted When Location Pad Is Disabled When disabling the Location Pad in the GUI, restarting the PIU causes the Location Pad icon to appear connected. In addition, a communication error appears. However, the Location Pad icon gives the impression that the Location Pad continues to be connected. At this point, a Location Pad disconnection error message should appear. Click the Location Pad Icon twice. When the Location Pad is reconnected, the communication error message disappears. BR#4481

Sometimes the Opening Screen Does Not Appear after Application Is Reloaded In random cases, the Opening Screen does not appear after the system is reloaded. If the Opening Screen does not appear after a moment, press <ALT>+<TAB>. This designates the CARTO® 3 System as the active application and the Opening Screen appears. BR#4488

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

Page 12 of 40

Acquire Button Has No Reduced Accuracy Zone Indication There is no indication on the Acquire button if the catheter is in a Reduced Accuracy Zone. However, there is an alert message. Regard alert messages as an indication of reduced accuracy. BR#4489

In Rare Cases, Setup Tabs Disappear In rare and random cases, the Study, Catheter, and Map setup tabs disappear when starting a new study. Exit the study and begin a new one. BR#4497

Switching from Mapping to Verification Is Slow with Multiple Channels or Multiple Maps If you are using a study with several channels (approximately 15) in the Monitor Pane, switching between Mapping and Verification Layouts might be slow. Each new map in the study also adds to the delay. Delete the Monitor Pane from the current layout, move to the required layout, and then add the Monitor Pane again. BR#4506

Default Value of Color Threshold Is Incorrect During a study with points acquired before and during ablation, the first time the Color check box in the Fill and Color Threshold dialog box is checked, the coloring of the existing map should not change. The value displayed in the dialog box should be the default value. However, the map color changes. The default Color Threshold value of the map is 23, but the default value in the Fill and Color Threshold dialog box is 15. BR#4511

Study Rename Field Is Limited to 15 Characters When renaming a study, enter no more than 15 characters in the Study Name or Study Rename field. BR#4520

Sometimes "Ablation On" Label Appears, Without RF Generator Sometimes the "Ablation On" label appears, even if the RF Generator is not connected. Ignore this message and continue with the Study. BR#4522

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

Page 13 of 40

Catheter Tip is Projected on the Map Closest to the Catheter When there is more than one map in the Map Viewer, the catheter tip is projected on the map closest to the catheter. Be aware that the catheter tip projection might not appear on the active map. BR#4525

Incorrect Message Appears When Points with Identical External Reference Are Moved or Copied After a Back Patch Has Moved When moving or copying points with identical Body Coordinate System (BCS) location between two maps, if one or more of the back patches moved more than 1 cm during point acquisition for the second map, a system message might appear, stating that moving or copying the points is impossible. Ignore the message and click OK. BR#4528

Delayed Display of Auto-ID Catheters in the Monitor Pane After connecting an Auto-ID catheter, the catheter image appears after approximately 6 seconds in the Catheter Setup Guide, but the ECG signal does not appear for approximately 16 seconds in the Monitor pane and other ECG viewers. Be aware that the signal will appear after a delay. BR#4538

Some Error Messages Do Not Appear for QUAD A, Ablation Session Time in the Ablation Table Is Not Correct The ablation time counter of ablation sessions starts from the time when a previous session is ended, instead of starting from zero. The data displayed in the Ablation Graph Viewer (graph and sessions) might be inaccurate. Use the ablation data displayed on the RF generator or recording system. BR# 4541

Incorrect Error Messages Might Appear when Patch Unit Is Disconnected During a study, when the patch unit is disconnected from the PIU, Error 1003 ("The Patch Unit appears disconnected") appears. Several other error messages might appear. Address Error 1003 first, by verifying that the patch unit is connected to the PIU. BR#4546

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)

CARTO® 3 System Release Notes for v1.1.2A

Page 14 of 40

Semi-Detached Patch Error Not Issued When starting a new study, the system does not give notification that a chest or back patch is partially detached and it is possible to proceed in the study. If the patch becomes fully attached in the course of the study, the system then issues an error message stating, falsely, that a patch is detached. Verify that patches are connected properly before starting a study. BR#4548

In Rare Instances, Data Synchronization Error Occurs During a Study During a CARTO® 3 Study, an error in data synchronization might occur for no apparent reason. Error message 260 will appear and the Acquire button will become disabled. To resolve this problem, restart the PIU. BR#4555

Unclear Options in ICEG Unipolar Configuration Dialog Box The IVC Electrode options in the ICEG Unipolar Configuration dialog box are not named in an intuitive manner. The Reference 11 option button is used for the REF, electrode 11. The QUAD A 6 option button is used for the QUAD A, electrode 6. BR#4556

Stop Button Not Included for Propagation or Playback Toolbars A Stop button does not exist for the Propagation or Playback toolbars. Instead, once the Play button has been clicked, it becomes a Pause button for this purpose. After pausing, it will return to its Play capacity. Click Pause to stop playback or propagation. BR#4559

Starting Scar Area Tool with New Thresholds or Closing the Tool Deletes Previously Applied Scar Tags When the Scar Area tool is started and a new threshold is set, or when the tool is closed, all previously applied Scar tags are deleted. Similarly, closing the tool also deletes Scar tags. To prevent Scar tags from being deleted, create a user-defined Point Tag with a Scar type. BR#4564

© 2011 BY BIOSENSE WEBSTER (ISRAEL), LTD. ALL RIGHTS RESERVED.

P.N.: UG-5400-02 (11B)