Boston Scientific RHYTHMIA HDx Manual
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Boston Scientific RHYTHMIA HDx Manual

Boston Scientific RHYTHMIA HDx Manual

Mapping system
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RHYTHMIA HDx
™
Mapping System
Software Instructions for Use ....................... 2
Instrucciones de uso del software ...........106
Mode d'emploi du logiciel ....................... 221
Gebrauchsanweisung der Software ........338
Istruzioni per l'uso del software ..............453
Gebruiksaanwijzing software ..................566
Instruções de Utilização do Software ..... 680

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  • Page 1 RHYTHMIA HDx ™ Mapping System Software Instructions for Use ....... 2 Instrucciones de uso del software ...106 Mode d’emploi du logiciel ....... 221 Gebrauchsanweisung der Software ..338 Istruzioni per l’uso del software ....453 Gebruiksaanwijzing software ....566 Instruções de Utilização do Software ..680...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS DEVICE DESCRIPTION ..............4 Contents.
  • Page 3 ................103 14. SYMBOLS FOUND ON RHYTHMIA HDx DEVICES AND LABELING...

  • Page 4: Device Description

    EP procedures. It amplifies and digitizes these signals and transfers them to the Workstation for real-time processing and display. The SiS also supports catheter localization (tracking) and diagnostic stimulation. Refer to RHYTHMIA HDx Mapping System Hardware Instructions for Use for further information. 1.1.2 System Software Rhythmia software runs on the Workstation.

  • Page 5: Intended Applied Parts

    Only users who meet these criteria should use the system. 2. INTENDED USE The RHYTHMIA HDx Mapping System (the system) is a 3D mapping and navigation system used in EP procedures. The SiS and related accessories provide data connection pathways for external input/output devices (e.g.

  • Page 6: Indications For Use

    There are no known contraindications. 6. WARNINGS The RHYTHMIA HDx Mapping System (the system) is intended for use with other medical devices in an EP laboratory. Carefully read the Instructions for Use (IFU) documents for every medical device that will be used during a study, prior to each study.

  • Page 7: Cautions

    • Diagnosis and treatment of cardiac arrhythmias using the system in conjunction with radio frequency (RF) ablation and other medical devices may pose a risk of adverse events. Adverse events (e.g., cardiac perforation, new arrhythmias, exacerbation of existing arrhythmias) may require additional intervention.

  • Page 8: Potential Adverse Events

    Instructions for Use documents associated with the catheters and ablation generators that will be employed during a mapping session. As with other mapping systems, the RHYTHMIA HDx Mapping System can be incidentally associated with minor or major clinical complications intrinsic to intracardiac procedures. Potential adverse events associated with the use of the system include, but are not limited to, the following: 8.1 Arrhythmias...

  • Page 9: How Supplied

    9. HOW SUPPLIED The software is pre-loaded on Workstations and can only be updated thereafter by authorized Do not use if package is opened or damaged. Do not use if labeling is incomplete or illegible. 10. MAJOR OPERATING MODES 10.1 Study Log In After turning on the Workstation, the Startup screen appears (Figure 1).

  • Page 10: Live Mode

    • Review Mode – Use to review, analyze, manipulate, and edit maps and study data. This mode is used after an active mapping study and should not be used during a study. • Configure Mode – Use to configure, add, or select different catheters, physicians, or study templates.

  • Page 11: Setup Screen

    10.3.1 Setup Screen The Live Mode setup screen (Figure 3) is used to prepare the system for a mapping study. For example, it is used to define, add, or configure catheters, electrodes, stimulator signals, SiS connections, and graphs. From any Live Mode screen, click on Setup to access setup choices. iii &...
  • Page 12 B. Signal Station Status and Connections The system employs a hardware auto-detect feature to display the status of the major SiS connection ports to identify connected peripherals and to identify warning conditions should they exist. The SiS front panel is represented in a diagram on the Live Mode setup tab. The center circle of idle ports is dark.
  • Page 13 • Filters Users can select low-pass and high-pass filters for unipolar and bipolar channels, as well toggle on or off line noise rejection (60 Hz or 50 Hz). • Defining Catheter Channels By clicking on a catheter name, that catheter’s unipolar and bipolar channels are displayed.

  • Page 14: Multiple Monitor Configuration

    • The patch quality indicators (Figure 6) display the quality for the electrodes used for impedance tracking (Back Patch, RA, LA, LL, V1, V3, and V6). Figure 6. Patient Alignment and Reference User Interface • The patch quality indicators have 4 separate severity levels – GREEN, YELLOW, ORANGE, and RED.
  • Page 15 The Multiple Monitor feature supports HDMI, DVI and DisplayPort cables. Each cable and monitor may be connected prior to or during a study. Refer to RHYTHMIA HDx Mapping System Hardware Instructions for Use for further information regarding the Workstation.

  • Page 16: Preparing Intellamap Orion Family Of Catheters For Use

    10.3.3 Preparing IntellaMap Orion Family of Catheters for Use An IntellaMap Orion mapping catheter must be conditioned before it is used with the RHYTHMIA HDx Mapping System. 1. Connect an IntellaMap Orion mapping catheter to either end of the umbilical cable.

  • Page 17: Map Tab

    7. Conditioning process completion is indicated when the blue circle is no longer illuminated and a confirmation message is shown on the Workstation. Do not condition an IntellaMap Orion mapping catheter when it is in contact with the patient, either external or indwelling. Conditioning when in contact with a patient may lead to patient injury, including new arrhythmias or exacerbation of existing arrhythmias.
  • Page 18 Annotating and Editing Maps Toolbar The annotation and editing toolbar on the Map tab may be used to configure mapping settings and to start mapping (Figure 10). Figure 10. Live screen tools include: A. Mapping Catheter Selection B. New Map Button C.
  • Page 19 The values of Cycle Length (CL) and Respiration (Resp) metrics are also plotted over time on a graph (Figure 11). The green area indicates the acceptance threshold and can be manually adjusted in case of drift over time. Figure 11. Cycle Length (CL) and Respiration (Resp) display Proper beat metrics setting is necessary for the creation of high quality electroanatomical maps.
  • Page 20 Do not begin a study if any of the system messages or status indicators indicates a problem. There are three levels of system messages (Table 1). Refer to the software troubleshooting guide (Section 11, Software troubleshooting guide) or contact Boston Scientific Support for further assistance. Table 1. System Messages Block Require immediate user action.
  • Page 21 The following electrode pairs can be selected for stimulation routing: • An IntellaMap Orion mapping catheter, any electrode pair; • Ablation catheter, any electrode pair; and Any electrode pair on any catheters connected to the system through breakout boxes on input ports M, A or B. Users must be in Live Mode to use the Stimulation function.
  • Page 22 Figure 13. Sample 3D view Color Bar The color bar is used as a legend for the relationship between the map color and electrogram values (based on the electroanatomical map type). The user can drag the color bar handles to set the desired range of colors for the displayed map.
  • Page 23 3D Orientation Manipulation Use the 3D orientation toolbar to visualize the current map orientation relative to the patient and to rotate it to the desired orientation (Figure 15). Users can select from 8 predefined orientations (INF, SUP, RL, LL, RAO, LAO, PA, or AP) or adjust the torso icon with the mouse to the desired orientation.
  • Page 24 Note: If a map is deleted and it is the only visible map in a 3D View or the only existing map in a study, Lock Map Visibility will automatically disable for the 3D View. Note: Multiple 3D Views can be locked simultaneously. If the current active map is not being visualized in any 3D View on the primary monitor, an error message will be displayed in the 3D View and the Active Map Selection will turn red (Figure 16 B).
  • Page 25 clipping plane, drag the yellow frame to the desired depth and dimensions (i.e., drag corners to adjust depth; drag sides to rotate the plane along its center axis) or use the clipping plane pop-up menu to invert the clipping plane. For example, the clipped and viewed map portions reverse such that the clipped object(s) become viewed and the viewed object(s) become clipped.
  • Page 26 10.3.4.5 ECG and Intracardiac Signal Display Functions The system collects ECG signals from 10 body-surface electrodes and up to 200 intracardiac electrograms from electrodes on connected intracardiac catheters. The system monitor displays ECG and intracardiac signals on both a Sweep Graph and Beat Graph.
  • Page 27 Figure 19. Sweep Graph (example) Beat Graph The Beat Graph (Figure 20) shows multiple surface ECG and intracardiac electrograms, typically of one or two beats. It enables users to examine individual beats and compare different beats. The Beat Graph signals are aligned to the selected timing reference channel (Section 10.3.8, Map Tagging and Editing).
  • Page 28 Figure 21. Beat Review Graph during review of Activation Time Map (example) Study Log Use the study log to search for, view, edit, add to, or remove recorded events and tags. Users can scroll to find a specific event or tag and then select it for viewing or editing.
  • Page 29 The Slow Graph (left side of Figure 20) can display data best viewed at a slow sweep speed (for example, the respiration trace). Each signal can be toggled on or off by its associated icon in the upper left corner of the Slow Graph. Multiple signals can be displayed simultaneously.
  • Page 30 10.3.4.6 AutoTag Parameter Panes AutoTag Parameters Live Pane The live AutoTag parameter pane (Figure 23) displays the tag drop progress bars and tag coloring parameters associated with the active AutoTag group per the user-defined AutoTag preset. When ablation is occurring, the tag drop progress bars and tag coloring parameters update in real-time to display the data being accumulated for the current tag.

  • Page 31: Ablation Tab

    Figure 24. AutoTag Parameters Review Pane 10.3.5 Ablation Tab The Ablation tab is a Live Mode tab available on the Primary monitor. This tab allows the user to configure a layout specific for managing and reviewing RF ablation sessions. Like the Map tab, the Ablation tab is configurable and allows the user to perform all the same functions (i.e.
  • Page 32 10.3.6.1 Map Setup Clicking on the New Map button expands the Map Initiation Tool, as shown in Figure 25 and in Figure 26. The user starts by selecting a mapping catheter. Once the catheter is selected, use the panel to the right within the Map Initiation Tool to: 1.
  • Page 33 Map Type The user is then prompted to select from one of the following map types: • Anatomy Only – If the Anatomy Only map type is selected, the user is able to click create map and begin mapping. The map will default to beat gated and respiration gated.
  • Page 34 10.3.6.2 Mapping Window The mapping window (Figure 28) displays the portion of the cardiac cycle that is analyzed to determine activation time and voltage. Signal activity outside the mapping window is ignored. The purpose of the mapping window is to define the window of interest relative to the timing reference and to exclude artifacts that may influence the mapping algorithms.
  • Page 35 Beats are detected on peaks in the timing reference channel that are beyond a user-determined threshold. The user can select the polarity (Min, Max or Absolute) and level of the threshold as needed. The threshold prevents detection of beats on inappropriate signal components such as secondary parts of QRS complex (e.g., T-Wave), ventricular far field, or noise (Figure 29).
  • Page 36 To ensure correct clinical decisions, use fluoroscopy, ultrasound, pace mapping or other visualization techniques to verify mapping results and catheter position. Always compare the anatomical map to the patient’s expected anatomy. Incorrect catheter localization may lead to incorrect clinical conclusion or patient injury. Figure 30.
  • Page 37 Figure 31. Activation Time Map with Beat Review Graph color bar (example) The Beat Review Graph displays a color bar to aid the user in interpreting difficult-to-understand maps. The colors on the color bar synchronize with the activation time map, making it easier to see relationships between the map colors and the activation times on the Beat Graph.
  • Page 38 Voltage Maps Voltage Maps (Figure 32) are typically used to identify areas with low voltage (due to scar, for example). The map displays, in different colors, the peak-to- peak voltage (within the mapping window) in each included electrogram. Areas in which low voltage is observed are typically red. Voltage amplitude is determined by either the bipolar or unipolar signals of the electrogram, based on user preference.
  • Page 39 10.3.6.6 Electroanatomical Mapping Modes Data for Activation Time and Voltage Maps can either be acquired manually (by manually accepting beats into the map) or continuously (by using the system’s continuous mapping feature). Manual Beat Acquisition (beat-by-beat) Mapping During an active study, individual beats may be added manually to a map. To do this, the user freezes the Beat Graph by clicking the Freeze button to review single beat electrograms.
  • Page 40 Continuous Mapping The continuous mapping mode allows users to rapidly complete a map by continuously acquiring beats as the catheter is moved around the chamber. Before mapping, the user determines the beat acceptance criteria by which the algorithm evaluates each beat for inclusion in the map. Beat acceptance criteria include the following options: •...

  • Page 41: Mapping With Catheters Other Than Intellamap Orion Family Of Catheters

    10.3.7 Mapping with Catheters other than IntellaMap Orion Family of Catheters Non-Orion Map Data Interpolation Maps created with catheters that have electrodes which are distributed in a non- basket configuration may be sparse and have spatial gaps in anatomical data acquisition compared to maps created with an IntellaMap Orion mapping catheter.

  • Page 42: Map Tagging And Editing

    10.3.8 Map Tagging and Editing 10.3.8.1 Map Cloning Users can clone a map by selecting the Clone Map option from the map’s settings menu (Figure 35). Activation Time Maps, Voltage Maps, and Anatomical Maps can be cloned (Fractionation Maps do not support cloning). When a map is cloned, an exact duplicate map will be created and set as the active map.
  • Page 43 Table 4. Tools for Annotating and Editing Maps Click the tagging window tool to create and manage manual and AutoTag groups. In this window, a tag group can be marked active, organized into a folder, and modified to preference (e.g., renamed, colored, resized, and projected onto the closest surface).
  • Page 44 Section 10.3.8.5 Editing Anatomy for information about editing tools used during live study review and post-study review 10.3.8.4 Tagging There are four tagging options within the Rhythmia HDx Mapping System Software: 1. Manual tagging 2. Anatomy tagging 3.
  • Page 45 To mark a tag group as active, select the “M” or “A” icon next to the group name. These icons will be highlighted when the group is active. There can be one active manual tag group and one active AutoTag group at any time.
  • Page 46 Figure 38. Tagging Window The Tagging Window includes the following functionality: a. “New tag group…” edit field for creating a new tag group. b. “New folder…” edit field for creating a new tag group folder. c. Tagging location button. d. Tag preview button. e.
  • Page 47 Tagging Tools Tagging Location Either the center or the end of the tip of the distal electrode can be selected for tagging for manual and trace tag types. Defining the tagging location is important for tag location accuracy. This is especially true for catheters with large distal electrodes.
  • Page 48 Note: A projected tag (disc) will not be projected onto the anatomy if the distance to the anatomy is greater than the user-defined upper limit or if there is no visible surface. Instead, an unprojected tag (i.e., sphere) will be made at the location where it was acquired.
  • Page 49 Tag Visibility Tag groups can be hidden by toggling the eye icon next to the tag group’s name in the Tagging Window (Figure 38). An individual tag can be hidden by right-clicking the tag in the 3D view and selecting “Hide in All Views,” or by toggling the eye icon in the study log entry associated with that tag.
  • Page 50 Manual Tags To facilitate manual tagging of catheter location in relation to a patient’s respiration, the software provides respiration feedback in the tagging window. The catheter listed in the drop-down menu at the top of the tagging window represents the catheter from which manual tagging will be performed (Figure 38).
  • Page 51 all data saved and associated with the tags and provides the ability to retrospectively change the user-defined criteria to assess the impact of different parameters on the tags. The AutoTag type is supported for magnetically tracked ablation catheters that are set as the active ablation catheter. Impedance tracked catheters are not supported by this tagging type.
  • Page 52 To create a new preset, the user can click the “New” button in the lower left of the window (Figure 41a). By first selecting an existing preset, the user can create a new preset using the selected preset’s settings as a starting point by clicking the “Duplicate”...
  • Page 53 To assign a preset to a tag group, open the tag group sub-menu from the gear icon next to the group name (Figure 43). The preset can be selected from the dropdown list. Refer to the AutoTag Preset section for information on how to create a preset.
  • Page 54 Data accumulation to an AutoTag resets if catheter stability is considered lost, or if any tag drop criteria cannot be calculated due to an error (refer to the AutoTag Error States section). Figure 44. AutoTag Live Parameter Pane showing drop criteria progress bar and active coloring parameter There are four drop parameters than can be configured by the user during preset creation.
  • Page 55 Like manual tags, the color palette for an AutoTag is user-selectable from the tagging window, the tag ribbon drop-down, and the study log. The group color can be changed at any time. An AutoTag is colored in one of three shades, depending on the coloring parameter thresholds.
  • Page 56 Reprocessing an AutoTag Group An AutoTag group that was active during RF ablation sessions can be reprocessed. Reprocessing involves assigning a different preset to an AutoTag group, which recalculates the tag group as if that preset had been originally used. Refer to section AutoTag Presets for details on how to assign an AutoTag preset.
  • Page 57 Note: Multiple tags can be selected from the study log or in the 3D view for simultaneous viewing. This can be performed by holding the CTRL key and clicking on the tags or study log entries. All data associated with a manual, trace or AutoTag individual tag is stored as a snapshot.
  • Page 58 Editing the Anatomical Shell The software allows two types of anatomy editing: • Surface editing • Volume editing Note: Voxel-based editing affects only the anatomical shell (not data). No beats are rejected when anatomy is deleted with voxel-based editing. The surface editing and volume editing tools have different applications (Table 6): Surface Editing Use surface editing tools to select and explicitly remove all of the selected...
  • Page 59 The name of the map that is selected for editing appears at the top of the anatomy editing user interface (Figure 47). Prior to editing, it is advisable to confirm that the correct map is the target. If it is not, click on the currently named map in the anatomy editing user interface and use the drop down menu to select an alternate map.

  • Page 60: Catheter Location Tracking

    Note: Only Boston Scientific catheters equipped with a magnetic sensor can be tracked using magnetic location technology. 10.3.9.2 Impedance Location Technology Impedance location technology is used to track catheters that are not equipped with a magnetic location sensor.
  • Page 61 Figure 48. Tracking Quality Indicator appears in the 3D view (in this case indicating good tracking quality) Table 7. Visual Indicators of Tracking Quality Vertical bar The vertical bar is a visual representation of the real time error of tracking quality. It measures the difference between impedance location of all electrodes and the actual magnetic position.
  • Page 62 Drift Adjustment Impedance measurements from a stationary catheter may degrade due to normal study conditions (e.g., respiratory impact, reference catheter motion or saline irrigation). An accumulation of impedance tracking errors over time is called drift. The Rhythmia software automatically adjusts for the effects of drift if the drift adjustment feature is enabled in the Live Mode setup screen (Figure 3).
  • Page 63 Observing Trends in Tracking Quality Observing visual trends in tracking quality can help target and troubleshoot the source of low-quality signals. For example, a gradual decline in tracking quality over time could be attributed to normal drift. However, a sudden or dramatic change might indicate patient movement or an abrupt shift in the impedance reference electrode or a magnetic field disturbance (such as significant movement of the fluoroscopy image intensifier).
  • Page 64 Catheter Proximity Visualization Catheter proximity visualization provides a qualitative way to understand the location of a tracked catheter relative to a 3D anatomical shell within a 2D view (i.e., close or far, or inside or outside). The proximity visualization is based on the following factors: •...
  • Page 65 anatomy facing towards the user and black on the part of the anatomy facing away from the user. In addition, a 3D dot is displayed on the anatomical shell at the center of the ablation catheter proximity ring. The dot always corresponds to the closest ablation catheter point to the anatomical surface.

  • Page 66: Directsense

    10.3.10 DirectSense The DirectSense software provides a display of local bipolar impedance that measures the dielectric properties closest to the catheter distal electrode. This diagnostic metric can be used in conjunction with other diagnostic elements (e.g., electrogram amplitude, fluoroscopy, intracardiac echocardiography, magnetic and impedance navigation, and tactile feedback) to inform the user on catheter impedance stability and proximity of the catheter electrodes to the endocardial surface.
  • Page 67 impedance of that location, and allows the user to visualize a relative change in local impedance. The user is able to define the minimum or maximum value at any time during a study. Figure 51. DirectSense graph (Graph Toolbar is in the upper left corner) The DirectSense graph also has an option for setting the fast and slow sweep speeds of the x-axis in the graph toolbar.
  • Page 68 Figure 53. Catheter tip visualization. To display the catheter tip visualization, use the Setup icon next to the relevant catheter in the catheter dropdown menu and check Show DirectSense Tip Visualization. Local Impedance Value Widget (DirectSense value widget) The DirectSense value widget provides the filtered value in one of three user- This widget can be turned ON by right clicking in the 3D view and selecting Show DirectSense –...
  • Page 69 10.3.10.2 Local Impedance During Ablation Please refer to the Instructions for Use for the compatible catheter prior to enabling the display of DirectSense during RF energy application. Avoid increasing power or duration of RF application beyond your standard of care to target a specific change in local impedance. Doing so may result in damage to adjacent structures, perforation caused by steam pop, arrhythmias, and/or embolism.

  • Page 70: Ablation Generator Data Display

    Figure 55. DirectSense (a) catheter tip visualization (b) graph and (c) value widget when RF energy is being delivered 10.3.11 Ablation Generator Data Display If the ablation generator is so configured, the system can display impedance, power, temperature and time data received from the ablation generator during ablation (Figure 56).

  • Page 71: Force Sensing

    StablePoint Instructions for Use and RHYTHMIA HDx Ablation Connection Box- IntellaNav StablePoint Instructions for Use . 10.3.12.1 Force Preconditioning When an IntellaNav StablePoint catheter is connected to the RHYTHMIA HDx Mapping System, it must be warmed up inside the patient’s body and zeroed before force values can be displayed.
  • Page 72 Figure 57. Warm-up window (top) before warm-up is initiated and (bottom) while warm-up is in process. When a force-enabled catheter is connected, the Force value widget will display a message (Figure 57– top) notifying the user that the catheter must be placed inside the patient with the electrodes outside of the sheath.
  • Page 73 ensuring it is out of the sheath, and pressing the Zero button, which can be accessed from the gear icon on both the Force Graph and Force Value widgets (Figure 60 and Figure 62). Refer to Section 10.3.12.2 Force User Interface Elements, for more details.
  • Page 74 Figure 60. Force graph (Graph Toolbar is in the upper left corner) Clicking the gear icon in the upper left corner of the graph accesses the Graph Toolbar. From the Toolbar, the user can set the sweep speed of the compressed history (“Slow”) and the real-time (“Fast”) sections of the Force graph.
  • Page 75 The center of the arc represents low force and the bars fill toward the outer edges of the arc as force magnitude increases beyond the user-defined thresholds. The color of the arc corresponds to the value of the filtered force signal.
  • Page 76 Figure 62. Force value widget and angle indicator Note: If the raw force value exceeds the high force threshold, the background of the 3D view, the catheter tip, and the force values in the widget will turn red. Note: When the force value is above measurable range, the tip indicator and 3D view background will turn red, the angle indicator will be hidden, and the force value and force graph will read “High.”...

  • Page 77: Lumipoint Module

    10.3.12.4 Force During Ablation Force user interface elements change to inform the user when RF energy is being delivered from the ablation generator. During RF energy delivery, the force graph has an orange overlay to indicate that ablation is occurring or has occurred, and the Force catheter rendered in the 3D view will appear to glow orange (Figure 63).
  • Page 78 Figure 64. LUMIPOINT control panel LUMIPOINT control panel items include: Split Activation LUMIPOINT Control Panel Preset Options (Star) Strictness Criteria Slider Settings Activation Group Re-annotation Complex Activation 10.3.13.1 LUMIPOINT Tools The LUMIPOINT module consists of the following tools, which are accessible in the control panel or directly from the Beat Review Graph: •...
  • Page 79 ACTIVATION The Activation category is used to highlight regions of the map that activate at a certain time within the mapping window. To use, click the ACTIVATION icon in the LUMIPOINT control panel, position the green zone over the time period of interest within the mapping window, and adjust the activation strictness criteria as desired.
  • Page 80 SKYLINE The SKYLINE feature plots a histogram of the normalized surface area of the map which is active at different times across the mapping window (a higher value indicates more of the map surface activated at this time). The SKYLINE histogram is calculated only for the duration of the mapping window.
  • Page 81 Figure 66. Group Re-annotation rendering A. A Circle represents a Manually Re-annotated electrogram B. A Square represents a Group Re-annotated electrogram C. A Plus represents a detected electrogram of interest Group Re-annotation is only available for the Activation and Complex Activation categories.
  • Page 82 Figure 67. The Green Zone depicted in the Beat Review Graph Figure 68. Linear Bar (Left), Donut Bar (Right) The time period of interest is interactive. It can be resized and positioned anywhere within the mapping window. To do so, manipulate the edges and location of the green zone in the Beat Review Graph or adjust accordingly using the LUMIPOINT bar.

  • Page 83: Image Import

    Import a study onto a LUMIPOINT-enabled Workstation. Select the relevant studies from the Review Mode menu and select reprocess. A progress bar will display that gives the status of the reprocessing for all selected studies. Note: It is recommended that you back up the study prior to reprocessing. 10.3.14 Image Import Image Import is available to import geometries created by another application (such as CT or MRI) and align it to the already created maps, such that maps can be...

  • Page 84: Review Mode

    Prior to using the image import mechanism within the software, verify that the pre- segmented VTK files are supported. The software supports triangle mesh Dataset types of (1) Unstructured grid and (2) Polydata in the following formats: (1) legacy - ASCII and (2) XML.

  • Page 85: Dynamic Review

    10.4.1 Dynamic Review Dynamic review facilitates the review of map data and map editing. Dynamic review can be performed when the study is in either Live Mode or Review Mode. 10.4.2 Display of Live or Recorded Catheter Locations in 3D View The display of live or recorded catheter locations is selected by clicking on the corresponding button located in the upper left corner of the 3D View.

  • Page 86: Showing Earliest Point(S) Of Activation

    10.4.4 Showing Earliest Point(s) of Activation The Roving Probe can assist in finding the earliest point(s) of activation on unipolar and bipolar Activation Time Maps (Figure 71). Note that this feature does not work with other types of maps (i.e., Voltage or Fractionation). To identify the earliest point of activation on the unipolar or bipolar Activation Map in either Live Mode or Review Mode, place the roving probe onto the map in the area of interest and either:...

  • Page 87: Study Archiving And Export

    • Reject the entire beat (Recordings are not deleted permanently from the system; they are removed from the map and are not used while rejected. The user can accept the beat and it will be added back into the map). •...

  • Page 88: Matlab Export

    • MATLAB – Ablation Data Basic: Exports data on RF sessions, AutoTag summary values, and manual tags. This export is only compatible with studies created in Rhythmia HDx Mapping System Software Version 4.0.1 and later that contain ablation data. • MATLAB – Ablation Data Advanced: Includes all data from the Ablation Data Basic export and includes additional data such as trace data for DirectSense, force, ablation catheter tip position, and EGM reference signals.

  • Page 89: Configure Mode

    10.6 Configure Mode Access the Configure screen (Figure 74) to add or select catheters, study templates, or physician names. From the startup screen, click on Configure to access the configure screen and functions. Figure 74. Configure screen items include: • Catheter Catalog - Use to view, add, remove, or edit a catheter listed in the catalog •...
  • Page 90 To begin using the network storage point, a new file share must be configured in the Rhythmia Software. Under the Configure tab, select FILE SHARES. The resulting dialog window contains the following information: • NAME - This is a user-defined name to label the file share. Upon saving, the name of the file share will appear in the left hand column in the list of file shares.
  • Page 91 Note: This capability works with or without connection to the Signal Station or any other system components CAUTION: RHYTHMIA HDx Mapping System should only be connected to a secure network.

  • Page 92: System Settings

    Access to this mode is restricted to authorized users with a password. Advanced settings are solely used by Boston Scientific Support personnel. Figure 76. System settings screen System settings screen items include: A.

  • Page 93: Software Troubleshooting Guide

    2. Verify the two LED lights near the optical connector on the back of the Workstation are on and blinking. 3. If the error persists, “power cycle” the SiS. 4. If the error persists, contact Boston Scientific Support. 1004-2 Mapping...
  • Page 94 10 minutes while monitoring for unusual detected. operation. 2. If the error persists, restart the SiS. 3. If the error persists, contact Boston Scientific Support and continue using the system as usual until instructed otherwise by Boston Scientific Support. 1109...
  • Page 95 HDx Mapping`System hardware IFU. 2. Disconnect and then reconnect the proper cables to each port. 3. If error persists replace cable(s) or contact Boston Scientific Support 1208-02 Channels 33-40 CardioLab direct-connect cable Pin A IN catheter to channels other than 33-40 on A IN are not is connected to A OUT.
  • Page 96 Table 9. Software Troubleshooting Guide (continued) Code Blocked Data Error Message Meaning Resolution 1302 IntellaMap Unable to detect deployment 1. Verify deployment state using fluoroscopy or Orion catheter state of an IntellaMap Orion other imaging modality. deployment mapping catheter 2. If mapping in a vein, pull catheter back detection failed.
  • Page 97 Table 9. Software Troubleshooting Guide (continued) Code Blocked Data Error Message Meaning Resolution 1313-2 Magnetic Magnetic tracking is not 1. Verify placement and connections of the positions are functional for the named localization generator, SiS and Localization not available for catheter(s) components.
  • Page 98 1. Reconfigure stimulation routing on the detected between switching does not match the Workstation. hardware hardware stimulation switching 2. If error reappears, restart SiS. and software 3. If error persists, contact Boston Scientific stimulation Support. routing configuration 1403 The selected The unipolar reference selected 1.
  • Page 99 Table 9. Software Troubleshooting Guide (continued) Code Blocked Data Error Message Meaning Resolution 1407 Mapping Location The Location Reference Back 1. Verify the Localization Generator has not Reference Back Patch has moved relative to the moved. Patch has moved. magnetic field 2.
  • Page 100 Code Blocked Data Error Message Meaning Resolution 0001 System Error The system has encountered an 1. Restart the SiS and Workstation. internal error. 2. If error persists, contact Boston Scientific 1001 Support 1006 1103 1104 1311 1402 1701-2 Force Force connection...
  • Page 101 1707-2 Force No force The System has encountered an Restart the Signal Station and Workstation. computation error with the force computation If error persists, contact Boston Scientific software module software module. Support. detected. 1708-2 Force Force catheter is...
  • Page 102 If the error persists: either a) Replace the force catheter to display force values; or b) Continue the procedure without force data. 1713-2 Force Internal error Incorrect Signal Station FPGA Contact Boston Scientific Support. detected. version for compatibility with the force computation software module. 1714-2 Force catheter Force value accuracy may be Navigate force catheter to blood pool.

  • Page 103: Warranty

    CETechSupportEMEA@bsci.com japantsc@bsci.com SOFTWARE LICENSE You have acquired the RHYTHMIA HDx Mapping System which includes software developed and owned licensors. The RHYTHMIA HDx Mapping System ships with an unmodified copy of ITK-SNAP 3.6. ITK-SNAP is free software, provided under the GNU General Public License (http://www.gnu.org/licenses/ gpl-3.0.txt).

  • Page 104: Symbols Found On Rhythmia Hdx Devices And Labeling

    14. SYMBOLS FOUND ON RHYTHMIA HDx DEVICES AND LABELING Breakout box input Electrophysiological signal input Australian Sponsor Address Dirección del patrocinador australiano Entrée de boîte de dérivation Adresse du promoteur australien Adresse des australischen Sponsors Eingang Elektrophysiologiesignal Indirizzo sponsor australiano...
  • Page 105 Serial Number Seriennummer Serienummer Lot Number Número de lote Numéro de lot Chargennummer Numero lotto Partijnummer Número do Lote Recyclable Package Envase reciclable Emballage recyclable Wiederverwertbare Verpackung Recyclebare verpakking Embalagem Reciclável Do not use if package is damaged. Bei beschädigter Verpackung nicht danneggiata.
  • Page 106 Local Contact Para obtener información de Argentina SA, por favor, acceda al Para informações de contato da www.bostonscientific.com Do not use if package is damaged. Recyclable Package 2797 © 2020 Boston Scientific Corporation or its affiliates. All rights reserved. 51193436-01...
  • Page 107 RHYTHMIA HDx ™ Mapping System Hardware Directions for Use Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...
  • Page 108 Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...
  • Page 109 TABLE OF CONTENTS DEVICE DESCRIPTION ..............1 Operating principle .
  • Page 110 OPERATING INSTRUCTIONS ............11 Setup and installation .
  • Page 111 ................37 19. SYMBOLS FOUND ON RHYTHMIA HDx™ DEVICES AND LABELING .
  • Page 112 Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...

  • Page 113: Device Description

    DEVICE DESCRIPTION 1.1 Operating principle The RHYTHMIA HDx™ Mapping System (the system) is a 3D mapping and navigation system used in electrophysiological (EP) procedures. The system employs two mechanisms to perform 3D mapping and navigation: (a.) continuous mapping based on patient cardiac signals acquired from intracardiac catheters and surface ECG electrodes, and (b.)

  • Page 114: System Software

    • ECG and intracardiac signal display • Catheter localization and tracking • 3D mapping and visualization • Diagnostic stimulation routing Refer to RHYTHMIA HDx™ Mapping System Software Directions for Use for further information. 1.2.3 Workstation The workstation comprises both computer hardware (e.g. computer, monitor, keyboard, mouse, and power cords) and system software.

  • Page 115: User Information

    There are no known contraindications. WARNINGS The RHYTHMIA HDx Mapping System (the system) is intended for use with other medical devices in an EP laboratory. Carefully read the directions for use (DFU) documents for every medical device that will be used during a study, prior to each study. Observe all contraindications, warnings, and cautions.
  • Page 116 • Do not condition an IntellaMap Orion™ mapping catheter when it is in contact with the patient, either external or indwelling. • Do not operate the system near flammable anesthetics. • All devices that are connected to system hardware must independently meet IEC 60601-1 requirements as well as any other relevant safety standards.

  • Page 117: Cautions

    CAUTIONS 3.1 General • Carefully inspect all system components prior to using system hardware. Do not use any component that shows evidence of being damaged or defective. • Do not drop system components or subject them to extreme shock. Dropping components or forcefully hitting them against hard objects may damage components and cause system malfunction.

  • Page 118: Workstation

    3.4 Workstation • Do not place containers of water or other liquids directly on or near the workstation or other system components. This reduces the risk of electric shock and/or damage to the workstation. • Use only a flat, stable surface to hold or transport the workstation and workstation- related accessories.

  • Page 119: Magnetic Localization System

    • Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may damage connectors, which may cause system malfunction. • Always follow guidelines for equipment storage and transport. Storage or transport in extreme environmental conditions can damage system components. For specific storage and handling guidelines, see section 15.

  • Page 120: Repair Or Replacement

    As with other mapping systems, the RHYTHMIA HDx™ Mapping System can be incidentally associated with minor or major clinical complications intrinsic to intracardiac procedures. Potential adverse events associated with the use of the system include, but are not limited to, the following: 4.1 Arrhythmias...

  • Page 121: Conformance To Standards

    CONFORMANCE TO STANDARDS The system hardware components meet the following standards • IEC 60601-1:2005+A1:2012 • IEC 60601-1-2:2014 • IEC 60601-1-6:2010+A1:2013 • IEC 60601-2-27:2011 CORR 1:2012 • IEC 62366:2007+A1:2014 • EN 55011:2009+A1:2010, Group 1, Class A • CISPR 11:2009+A1:2010, Group 1, Class A HOW SUPPLIED The system is packaged and supplied in a series of shipping cartons handled by common carrier.
  • Page 122 Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...

  • Page 123: Operating Instructions

    OPERATING INSTRUCTIONS 7.1 Setup and installation Setup and installation of the RHYTHMIA HDx™ Mapping System (the system) hardware must be performed by an authorized Boston Scientific representative. Only such authorized personnel should open the sealed product packaging. 7.2 Major hardware components The system is comprised of two major hardware groups: •...

  • Page 124: Sis Front Panel Description

    7.4 SiS front panel description Specific input and output cables connect to dedicated ports on the front panel of the SiS (Figure 2 and Table 1). Ports 1 through 5 in Figure 2 are inputs. Ports 6, 7, 8, and 9 are outputs. The three ports labeled M, A, and B in the upper row are intracardiac signal inputs.
  • Page 125 Connects to external stimulator signal output Stimulator input WARNING: Only IEC 60601 compliance-certified stimulators should be used with the RHYTHMIA HDx™ Mapping System. Reserved for future use Not currently used Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...

  • Page 126: Sis Front Panel Inputs

    1. Connect the fiber optic data cable to the SiS and Hardware initialization complete, SiS ready workstation to communicate with workstation 2. Start a LIVE mapping session on the workstation FLASHING RHYTHMIA HDx™ Mapping System fully None operational SOLID Do not use the SiS. Error identified Contact Boston Scientific Support.

  • Page 127: Ecg Input Cables

    connected to the system and an external stimulator is connected to the external stimulator direct input ports associated with the particular M, A, or B port in use. These connections can be used to manually connect an intracardiac catheter to the stimulation signal, if desired.

  • Page 128: Ablation Connection Box

    7.5.4 Ablation connection box The system itself does not provide RF ablation energy; external RF generators are used for this purpose. WARNING: Use only Maestro™, IBI™, Ampere™, SmartAblate™ or EP-Shuttle RF ablation generators with the system. Do not use the system with other RF ablation generators.

  • Page 129: Stimulator Jumper Cables

    Maestro™ EP-Shuttle IBI/Ampere™ SmartAblate™ Figure 5. Ablation connection box variants IntellaTip MiFi™ IntellaNav™ Standard Catheter Figure 6. Ablation connection box connectors 7.5.5 Stimulator jumper cables The stimulator jumper cables (Figure 7) are used to connect an external stimulator to either the standard stimulator input ports (item 13 in both Figure 2 and Table 1) or to the direct stimulator input ports (indicated by the symbol in both Figure 2 and Table 1).

  • Page 130: Location Reference Back Patch

    Figure 7. Stimulator input jumper cables 7.5.6 Location reference back patch The location reference back patch (back patch) is applied in a medial, stable position on the patient’s back and serves as a location reference for the tracking system. The back patch has a cable and connector that connect to the patch cable (Figure 8).

  • Page 131: Direct Connect Ecg Cables

    connected to the OUT-A+ port, ablation data is carried on output ports 65-72. • CardioLab recording system—The Direct Connect CardioLab™ IC cable may be used at any of the three output ports. Note that whenever this cable is used at port OUT-A+ , any data input on breakout box ports 33- 40 is supplanted by ablation data on output ports 33-40.

  • Page 132: Ecg Output Box

    Figure 11. Rhythmia IC Out 72 cable 7.6.4 ECG output box The ECG output box (Figure 12) routes ECG signals from the SiS to a recording system. The ECG output box cable connects to the OUT-ECG port on the SiS front panel (item 9 in both Figure 2 and Table 1).

  • Page 133: Sis Rear Panel Description

    7.7 SiS rear panel description SiS rear panel connectors Figure 13 attach to the SiS’s dedicated power supply, the workstation, and several SiS accessories. Rear panel items are described in Table 3. Rear panel connections are diagrammed in Figure 14. Figure 13.

  • Page 134: Sis Rear Panel Connections

    LAB MONITOR FOOT SWITCH SIGNAL STATION AC POWER CORDS VIDEO CABLE CABLE POWER INPUT WORKSTATION FIBER OPTIC LOCALIZATION AC MAINS PERIPHERALS DATA CABLE GENERATOR CABLE CONNECTION LOCALIZATION SIGNAL STATION FOOT SWITCH POWER SUPPLY GENERATOR Drawings not to scale – for illustration purposes only Figure 14.

  • Page 135: Workstation Data Connection

    Note: The potential exists for localization generator interference with other medical equipment. See the following cautions for important information on mitigating potential localization generator interference. CAUTION: The localization generator may interfere with other systems that use magnetic-field-based technology. Consult the supplier of these systems before using them in the presence of the magnetic localization system.

  • Page 136: Electric Power Input

    Initial workstation setup and cable connections are performed by an authorized Boston Scientific representative. CAUTION: Use only the equipment, supplies, and accessories supplied or recommended by Boston Scientific for use with the RHYTHMIA HDx™ Mapping System. The use of other equipment, supplies, and accessories may cause equipment damage or system malfunction.

  • Page 137: Preparing For A Mapping Study

    PREPARING FOR A MAPPING STUDY 8.1 Prior to patient arrival 8.1.1 Setup the hardware and make the cable connections Place the SiS on a dedicated table or cart that is alongside and slightly higher than the patient table. The SiS front panel should face the table and be positioned so that the cables can be attached without pulling, bending, kinking or otherwise straining them.

  • Page 138: Prepare The Workstation

    8.1.2 Prepare the workstation Verify that the workstation fiber optic cable is properly connected and secure. If display of ablation information on the Rhythmia software is desired, verify cable connectivity between the workstation and the data connection port on the ablation generator. 8.2 Upon patient arrival 8.2.1 Make required cable and catheter connections Apply the back patch to the patient’s back according to its directions for use.

  • Page 139: Important Considerations During A Study

    8.3 Important considerations during a study During a study, all system operation is controlled by the workstation software and catheter manipulation. In case of electrical power interruption or system lock-up, restart the SiS and workstation and use the software ‘resume’ option to resume the same procedure. Verify that all catheters, signals and references are configured appropriately before continuing the procedure.

  • Page 140: Individual Cables Associated With System

    INDIVIDUAL CABLES ASSOCIATED WITH SYSTEM Cable Type/ Connection Scheme Device Description Label Name INTRACARDIAC INPUTS IntellaMap Orion mapping Umbilical cable is used to connect an IntellaMap Orion mapping Umbilical cable catheter to SiS front panel catheter to the SiS and carry signals for 64 intracardiac electrodes, port IN-M magnetic tracking sensors and memory chip.
  • Page 141 REAR PANEL CABLES Power supply is used to convert mains AC voltage to low level DC Input: AC mains RHYTHMIA HDx™ voltage for the SiS. It includes the power converter itself as well as a power supply Output: SiS rear panel connection cable to the SiS.

  • Page 142: Direct Connect Channel Mapping

    10. DIRECT CONNECT CHANNEL MAPPING Clearsign™ IC Clearsign™ IC CardioLab™ cable Orion™ cable A/B cable (3 end connectors) (Gray) (Black) OUT-M OUT-A+ OUT-M and OUT-B OUT-M OUT-A+ OUT-B Orion Output Input Output Input Output Input Output Input Output Input Output spline channels channels...

  • Page 143: Preparing Intellamap Orion™ Family Of Catheters For Use

    11. PREPARING INTELLAMAP ORION™ FAMILY OF CATHETERS FOR USE When used with the RHYTHMIA HDx™ Mapping System, an IntellaMap Orion mapping catheter must be conditioned before use. Connect an IntellaMap Orion mapping catheter to either end of the umbilical cable.

  • Page 144: Sis Troubleshooting

    1. Connect the fiber optic data cable to the SiS and Hardware initialization complete, SiS ready workstation to communicate with workstation 2. Start a LIVE mapping session on the workstation FLASHING RHYTHMIA HDx™ Mapping System fully None operational SOLID Do not use the SiS. Error identified Contact Boston Scientific Support.

  • Page 145: Electromagnetic Emissions And Immunity

    Table 5: Guidance and manufacturer's declaration – electromagnetic emissions The RHYTHMIA HDx™ Mapping System is intended for use in the electromagnetic environment specified below. The customer or the user of the RHYTHMIA HDx Mapping System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 146 Table 6: Guidance and manufacturer's declaration – electromagnetic immunity The RHYTHMIA HDx™ Mapping System is intended for use in the electromagnetic environment specified below. The customer or the user of the RHYTHMIA HDx Mapping System should assure that it is used in such an environment.
  • Page 147 Table 6: Guidance and manufacturer's declaration – electromagnetic immunity (continued) Radiated RF 3v/m Pass Recommended separation distance: IEC 61000-4-3 80 MHz to 2.7 GHz: 1.17 √ 150 KHz to 80 MHz 27 V/m 380 - 390 MHz: 1.17 √ 80 MHz to 800 MHz 28 V/m 430 - 470 MHz: 2.33...

  • Page 148: Technical Specifications

    15. TECHNICAL SPECIFICATIONS Device Category Position The SiS should be placed on a dedicated table or cart that is adjacent to the foot of the patient table or on the foot of the patient table. Patient Inputs 12 lead ECG 64 intracardiac channels of an IntellaMap Orion mapping catheter 128 additional diagnostic channels plus eight dedicated ablation signal channels...

  • Page 149: Service Information

    16. SERVICE INFORMATION Equipment Service and Maintenance The RHYTHMIA HDx™ Mapping System does not have any parts that require periodic service from users. In case of malfunction, contact Boston Scientific Support. 17. WARRANTY Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument.

  • Page 150: Symbols Found On Rhythmia Hdx™ Devices And Labeling

    19. SYMBOLS FOUND ON RHYTHMIA HDx™ DEVICES AND LABELING Breakout box input Electrophysiological signal input IntellaMap™ Orion Mapping Catheter input Electrophysiological signal output Location reference patch input Direct stimulation input Surface ECG Ablation Catheter [black and red safety sign] No Pacemakers Ethernet Defibrillation-Proof Type CF Applied Part...
  • Page 151 Target Pantone 541 CVC ΔE ≤2.0 / Pantone 2925 CVC ΔE ≤2.0 / Pantone 300 CVC ΔE ≤2.0 / Black (K) ΔE ≤5.0 / CMYK Image...
  • Page 152 Brazil Local Contact Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra EU Authorized Representative Boston Scientific Limited Ballybrit Business Park Galway IRELAND Australian Sponsor Address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia...

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