Page 1 900100 AcQMap® High Resolution Imaging and Mapping System AcQTrack™ Conduction Pattern Software SuperMap™ Hover Mapping Mode Operator Manual CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician...
Page 3: Table Of Contents
AcQMap High Resolution Imaging and Mapping System Operator Manual Contents Explanation of Symbols...................01 Explanation of Icons ....................03 CHAPTER 1 — Introduction ..................06 1.1. — AcQMap System Description ..............06 CHAPTER 2 — Warnings and Precautions ..............08 CHAPTER 3 — Safety Essentials ................14 3.1.
Page 4 AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 8 — Starting a Study ................53 8.1. — Starting the AcQMap System Software ...........53 8.2. — Starting a New Study ................54 CHAPTER 9 — Setup for Non-contact Mapping ............60 9.1. — Checking Signals ..................61 9.2.
Page 5 AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 14 — SuperMap ...................135 14.1. — Data Acquisition ...................135 14.2. — Waveform Analysis ................137 14.3. — Displaying a SuperMap ...............141 14.4. — Displaying a Propagation History Map with an Amplitude Map ..144 CHAPTER 15 —...
Page 6 AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 19 – Stereotaxis® ................190 19.1. — Non-Contact Mapping .................190 19.2. — Contact Mapping .................191 19.3. — Catheter Setup, Localization and Field Scaling with Ablation Catheter 191 19.4. — Tips on Performing Field Scaling with Navigant ........193 CHAPTER 20 —...
Page 7: Explanation Of Symbols
AcQMap High Resolution Imaging and Mapping System Operator Manual EXPLANATION OF SYMBOLS Consult Instructions Caution for Use Defibrillator Protected Defibrillator Protected Type BF applied part Type CF applied part Manufacturer Catalog number Date of manufacture Serial number Caution: Use only fuse rated at the indicated voltage, current, Alternating current operating speed, and breaking...
Page 8 AcQMap High Resolution Imaging and Mapping System Operator Manual 2000 m Elevation Rating No patient contact Quantity of devices No sitting Ablation Catheter Do not lean No access for forklift trucks and Ablation Generator other industrial vehicles Keep dry MR Unsafe Ingress Protection: Access for forklift trucks and Drip Proof...
Page 9: Explanation Of Icons
AcQMap High Resolution Imaging and Mapping System Operator Manual EXPLANATION OF ICONS Redo Undo Green Undo Revert Arrow Show All Hide All Zoom Smooth Mesh Show/Hide Show/Hide Mesh Mesh Hide Show/Hide Chamber Surface Cut-away Re-mesh Show Surface 2500 Cut-away 2500 Icon Close Holes Re-mesh...
Page 10 AcQMap High Resolution Imaging and Mapping System Operator Manual Ultrasound Ultrasound Save Copy Map Exit Session Close Map Delete Add Map Clear Selection Clear Build Vein Structure Erase Points Grid Overlay Cancel Close Confirm Change Editor Record Button Reset Camera Clear Pause/Resume Waveforms...
Page 11 AcQMap High Resolution Imaging and Mapping System Operator Manual Auto Colorbar (early/late) Trim EGM Move SuperMap New Catheter Shadow Live Signals Segmented Info / Tooltip Anatomy Auto Select Copy Selected Triangles Move to Trash / Delete Cut-Plane Patient Edited Point Records Merged Anatomy Reverse button...
Page 12: Chapter 1 - Introduction
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 1 — INTRODUCTION 1.1. — AcQMap System Description The AcQMap High Resolution Imaging and Mapping System is an advanced imaging, navigation and mapping System capable of displaying: • 3-D cardiac chamber reconstructions – Contact and non-contact (ultrasound) •...
Page 13 AcQMap High Resolution Imaging and Mapping System Operator Manual The AcQMap System also requires the following components: • AcQMap 3D Imaging and Mapping Catheter, Model 900003 / 900009 • AcQMap Catheter Interface Cable Model 800530 • AcQGuide MAX Steerable Sheath - Model 900002 / 900200 •...
Page 14: Chapter 2 - Warnings And Precautions
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 2 — WARNINGS AND PRECAUTIONS AcQMap Console and AcQMap Workstation Placement — Place on a level surface. Do not place other equipment on top of the AcQMap Console or AcQMap Workstation. Do not place AcQMap Console or AcQMap Workstation on top of other equipment.
Page 15 Workstation Power Strip may overload the circuit and interrupt power from the AcQMap Workstation and Display. Acutus Medical installs locking covers on unused outlets of the Workstation power strip to prevent utilization of unauthorized electrical equipment. ™ Conduction Pattern Recognition Software...
Page 16 AcQMap High Resolution Imaging and Mapping System Operator Manual Cybersecurity — The AcQMap System is designed to operate securely in the Windows 10 environment. AcQMap security includes: • Password protection - Microsoft Windows 10 password protection. Auditing enabled by default. •...
Page 17 Handling — All components of the AcQMap System should be handled with care. Installation — Leave shipping containers sealed until trained personnel from Acutus Medical, Inc., arrive to perform AcQMap System installation. Inspection — All AcQMap System components should be inspected for damage prior to use.
Page 18 • Do not place electrodes on skin folds, dry or damaged skin. • Do not modify electrodes prior to use. • MRI compatibility for the electrodes contained in the AcQMap Patient Electrode Kit has not been tested by Acutus Medical. Qualified Users — Only physicians thoroughly trained in electrophysiology procedures should use the AcQMap System.
Page 19 AcQMap High Resolution Imaging and Mapping System Operator Manual Software Warning Messages — Respond to warning messages as soon as possible. Failure to do so may result in an inability to record data or to communicate properly with the AcQMap Console.
Page 20: Chapter 3 - Safety Essentials
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 3 — SAFETY ESSENTIALS 3.1. — Indication for Use The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems...
Page 21: Chapter 4 - Acqmap System Component Descriptions
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 4 — ACQMAP SYSTEM COMPONENT DESCRIPTIONS The AcQMap System has been tested and found to comply with the limits for medical devices to EN 60601-1. The AcQMap System includes the following hardware components: •...
Page 22 Connects Repositionable Monitoring Electrodes to the AcQMap Console. This cable is a Defibrillator Protected Type BF applied part. This defibrillation-protected feature is implemented in the ECG trunk cable. Use only Acutus Medical supplied patient cables. Failure to do so may seriously damage the AcQMap System hardware.
Page 23 AcQMap High Resolution Imaging and Mapping System Operator Manual • AcQMap 2mm Pin Jumper Set Provides the ability to connect the Auxiliary Interface Box outputs (40 total) to the EP Lab pin box or monitoring system. The AcQMap System also requires the following disposable components: •...
Page 24: Chapter 5 - Acqmap System Installation & Setup
Medical arrive to perform AcQMap System installation. 1. Acutus Medical personnel will unpack and install the AcQMap System. 2. Acutus Medical personnel will inspect the AcQMap System for damage and test the AcQMap System prior to clinical use. 5.1.1. — AcQMap System connections...
Page 25 AcQMap High Resolution Imaging and Mapping System Operator Manual 2. Connect the potential equalization terminal on the rear of the console to the potential equalization terminal in the laboratory. 3. Clamp the AcQMap Auxiliary Interface Box to the fluoroscopy table rail in a position where fluids will not be present and that will be acceptable to the physician.
Page 26 AcQMap High Resolution Imaging and Mapping System Operator Manual 8. Power up the AcQMap Workstation computer and display. Launch the Functional Test software application. Wait for Functional Test software to be executed. When you see “Waiting on Clinical”, press Start Functional Test 9.
Page 27 AcQMap High Resolution Imaging and Mapping System Operator Manual AcQMap Electrical Reference Connection A minimum of one electrode that can be placed in the inferior vena cava inferior to the diaphragm from the femoral approach Localization Pt Return ECG Out AcQMap Ablation Generator...
Page 28 AcQMap High Resolution Imaging and Mapping System Operator Manual AcQMap Anatomic Reference Catheter Connection Duodecapolar Catheter with 2-8-2 or 2-10-2 spacing Decapolar Catheter with ≥ 5-5-5 spacing 20-Pole Catheter Extension Cable 10-Pole Catheter Extension Cable AUXILIARY INTERFACE BOX AUXILIARY INTERFACE BOX Aux Cable Aux Cable 9,10...
Page 29 AcQMap High Resolution Imaging and Mapping System Operator Manual This equipment has been tested and found to comply with the limits for medical devices to EN 60601-1-2: 2007. This testing shows the device provides reasonable protection against harmful interference in a typical medical installation. However, there is no guarantee that interference will not occur in a particular installation.
Page 30: Chapter 6 - Acqmap System Patient Preparation
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 6 — ACQMAP SYSTEM PATIENT PREPARATION The following sets of instructions are for identifying the patient electrodes and placing the electrodes on the patient prior to use of the AcQMap System. 6.1.
Page 31 AcQMap High Resolution Imaging and Mapping System Operator Manual 1. Place the Patient Return Electrode (blue) on the lower right back. ( ) Connect Figure 6-1 the Patient Return Electrode to the AcQMap Console front panel. WARNING: The Patient Return Electrode must be the first Patient Electrode connected to the AcQMap System at the beginning of the study, and the last electrode disconnected from the AcQMap System at the end of the study.
Page 32 AcQMap High Resolution Imaging and Mapping System Operator Manual RIGHT SIDE FRONT BACK LEFT SIDE SIDES BACK FRONT PATIENT MONITORING RETURN ConMed® ConMed® Covidien™ 3M Red Dot™ 440-2400 425-2200 E7507 2670-5 BLACK Upper left side torso mid-axillary line at level of 4th intercostal space GRAY Upper right side torso mid-axillary line at level of 4th intercostal space Lower back, opposite 6 –...
Page 33: Electrical Reference Sheath Or Catheter Placement
AcQMap High Resolution Imaging and Mapping System Operator Manual 6.3. — Electrical Reference Sheath or Catheter Placement 1. Insert an Electrical Reference Sheath (AcQRef Introducer Sheath) or Catheter into the right or left femoral vein per standard laboratory procedure. Refer to Chapter 5, Figure 5-2 for recommended sheath/catheter/electrode requirements.
Page 34: Chapter 7 - Navigating The User Interface
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 7 — NAVIGATING THE USER INTERFACE 7.1. — Operating Modes The AcQMap High Resolution Imaging and Mapping System can be operated in two modes: Study View and Study Review. The operating mode determines which features and functions are available.
Page 35: Patient Records And Notes Window
AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function Menu Bar The Menu Bar provides access to system-level controls, tools, and configuration settings Acquisition The Acquisition Tab provides access to the Acquisition Window. Waveforms The Waveforms Tab provides access to the Waveform Window. Maps Tab The Maps Tab provides access to the Maps Window.
Page 36 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 7-2. Full Patient Record List and Notes Window Location Title Function Patient The Patient Records Button accesses the window that displays the Records available sessions, recordings, and maps for each patient data set Button stored on the System hard drive.
Page 37 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 7-3. Session Record and Notes Window Location Title Function Patient ID The Patient ID is the top level in the hierarchy. All patient sessions, recordings and maps associated with the unique identifier will be stored together.
Page 38 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function Anatomy Anatomy Recordings hold the raw data that was collected during the Recordings patient session. Double-clicking on an Anatomy Recording will bring the dataset into the appropriate window for review and processing. Map Recordings Map Recordings hold the raw data that was collected during the patient session.
Page 39: Common Controls
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.4. — Common Controls 7.4.1. — Menu Bar The menu bar provides access to system-level controls, tools, and configuration settings. Menu bar options are shown on the upper left corner of the Main Workspace. Selecting a menu item will reveal a set of sub-menu options.
Page 40: Using The Mouse
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.5. — Using the Mouse 7.5.1. — Basic Mouse Actions The following terms are used to describe ways to use the mouse. • Click — Move the mouse pointer over the desired element and press the left mouse button once and release.
Page 41 AcQMap High Resolution Imaging and Mapping System Operator Manual Task Keyboard Shortcut Results Rotating ↑ Rotate the image upward ↓ Rotate the image downward ← Rotate the image to the left → Rotate the image to the right Panning Q or Shift + ↑ Move the image up on the screen Z or Shift + ↓...
Page 42 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 7-4. Common Interface Elements Location Title Function Drop-down Click on the arrow to display a list of choices. menu Slide-out menu Click on the arrow to show/hide a panel or a list of choices. Click the tab to display a panel.
Page 43: Live Signals Window - Non-Contact And Contact Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.6. — Live Signals Window – Non-contact and Contact Mapping The Live Signals Window is accessed via the Live Signals icon in the upper left corner of the screen. The Live Signals Window allows the user to view the Surface ECG, AcQMap and Auxiliary Catheter electrograms, AcQMap and Surface and Auxiliary Live Localization signals, and Ultrasound.
Page 44 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function Signal View The Signal View Title Bar provides access to the six (6) signal views: Surface Title Bar Lead Biopotentials (Sur ECG), AcQMap Catheter Biopotentials (QMap EGM) Auxiliary Biopotentials (Aux EGM), AcQMap Catheter Localization (QMap Loc), Surface and Auxiliary Localization (Aux Loc), and Ultrasound (US).
Page 45: Acquisition Window
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.7. — Acquisition Window The Acquisition Window appears when the Acquisition Tab is selected. The Acquisition Window is available in both Non-contact and Contact mapping modes. 7.7.1. — Acquisition Window in Non-contact Mapping Mode Figure 7-6.
Page 46 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function 3D Displays The 3D Displays will show localized catheters, cardiac surface reconstructions, markers, and labels in 3-dimensional space Trace Display The Trace Display shows the real-time waveforms of measured surface ECG leads and internal EGMs.
Page 47 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function Pause Live 3D Allows the Live 3D Display to be paused to evaluate the on-screen view. Display Aux 4 Input Box The Aux 4 Input Box provides display and user-editable entry of auxiliary channels used for the display of Auxiliary Catheter 4.
Page 48 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function Menu Bar The Menu Bar provides access to system-level controls, tools, and configuration settings Acquisition Tab The Acquisition Tab provides access to the Acquisition Window. Patient Records The Patient Records Icon accesses the window that displays the Icon available sessions, recordings, and maps for each patient data set stored on the System hard drive.
Page 49 AcQMap High Resolution Imaging and Mapping System Operator Manual Waveforms Window The Waveforms Window appears when the Waveforms tab is selected. The Waveforms Window is only available in non-contact mapping mode. ( Figure 7-8 Figure 7-8. Waveforms Window.
Page 50 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function 3D Display The 3D Display shows three-dimensional anatomy and localization information at the time marked by the Time Cursor. The displayed view is selected in the 3D Display Selection Panel. Localization view shows the position of the AcQMap Catheter and auxiliary catheters as well as the reconstructed cardiac surface.
Page 51: Maps Window
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.8. — Maps Window The Maps Window appears when the Maps tab is selected. The Maps Window is only available in Non-contacting mapping mode. ( Figure 7-9 Figure 7-9. Maps Window...
Page 52 AcQMap High Resolution Imaging and Mapping System Operator Manual Location Title Function 3D Display 1 The 3D Display 1 shows the three-dimensional surface map at the time marked by the Time Cursor. 3D Display 2 The 3D Display 2 shows the three-dimensional surface map at the time marked by the Time Cursor in a second reference view.
Page 53: Configure 3-D Display
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 7-10. Configure 3-D Display. A. View options available in the Waveforms/Maps Window. B. Lighting options. C. Curve Fitting options. D. Camera options. 7.9. — Configure 3-D Display 3-D Display Controls are configured via the 3D Settings. The 3D Settings contains settings for the 3-D Display.
Page 54 AcQMap High Resolution Imaging and Mapping System Operator Manual AcQMap Catheter The following controls are used to adjust the appearance of the AcQMap Catheter in the 3-D display. The AcQMap Catheter icon is only available in Non-contact mapping mode. • Show AcQMap Splines –...
Page 55 AcQMap High Resolution Imaging and Mapping System Operator Manual • Show Aux 2 – Enables or disables the display of the fitted Auxiliary Catheter 2 as configured in the auxiliary catheter connections. (Chapter 9, Aux Catheter Channel Mapping). – Clicking on the Show Aux 2 shortcut icon will enable or disable the display. –...
Page 56 AcQMap High Resolution Imaging and Mapping System Operator Manual 7.9.2. — 3D Settings – Curve Fitting Auxiliary Catheter Control The following controls are used to vary the parameters of the auxiliary catheter curve-fitting algorithm. • Show Aux 1 Labels, Aux 2 Labels, Aux 4 Labels, Aux 5 Labels Select the Aux 1, Aux 2, Aux 4 or Aux 5 catheter.
Page 57: Electrode Highlighting
AcQMap High Resolution Imaging and Mapping System Operator Manual 7.9.4. — 3D Settings – Lighting The following controls are used to adjust the Lighting in the 3-D display. • Surface Transparency Adjust the level of transparency of the Surface Anatomy. Shortcut icon: Hover over the Show/Hide Chamber Surface icon and use the mouse scroll wheel Show/Hide to change the level of transparency.
Page 58: 3D Settings - View Catheter Silhouette
AcQMap High Resolution Imaging and Mapping System Operator Manual 4. To adjust the plane of the surface cut, right click on the blue frame. The frame will turn green allowing the plane of the surface cut to be adjusted in the selected view. 5.
Page 59: Chapter 8 - Starting A Study
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 8 — STARTING A STUDY Refer to Chapters 5 and 6 for AcQMap System set up and connections 8.1. — Starting the AcQMap System Software 1. Wait for the AcQMap Console start-up as indicated by the presence of the AcQMap logo screen.
Page 60: Starting A New Study
AcQMap High Resolution Imaging and Mapping System Operator Manual 8.2. — Starting a New Study In the Patient Records Window ( ) select the active Console as denoted by the blue Figure 8-3 console. Use the search window to locate previous studies for a returning patient or right click on the AcQMap Console name to access the window that will allow you to create a new patient.
Page 61 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 8-4. New Patient. A. Window to create new patient in the System. B. Secondary window to calculate patient BMI from height/weight. 3. Complete all required fields. Required fields are shown in red. 4.
Page 62 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 8-5. Select Mapping Mode: Contact or AcQMap.
Page 63 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 8-6. Right click on the patient and select Create New Session to create a new patient session within the patient record. 8.2.2. — Starting a New Session for an Existing Patient 1.
Page 64 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 8-7. Confirm New Session and make the new session the default session. 4. A new Session will be created with an automatically generated number based on the number of Sessions that already exist for the patient. The new Session is identified by the current date and time.
Page 65 AcQMap High Resolution Imaging and Mapping System Operator Manual 8.2.3. — Resuming a Study 1. Navigate to and double-click on the existing session for the patient to resume the session. 2. The screen will now show the Acquisition Window with the selected Patient ID and Session number in the Session Label at the top of the screen.
Page 66: Chapter 9 - Setup For Non-Contact Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 9 — SETUP FOR NON-CONTACT MAPPING This chapter describes the steps for setting up the AcQMap System for non-contact data acquisition, biopotentials display, anatomy reconstruction, and map creation. Refer to Chapter 16 for the steps to set up the AcQMap System for contact mapping.
Page 67: Checking Signals
AcQMap High Resolution Imaging and Mapping System Operator Manual 9.1. — Checking Signals The Live Signals window is used to verify input connectivity and signal quality of the AcQMap System. Navigate to the Live Signals Window by clicking the Live Signals button. The Live Signals Window consists of six (6) signal views: Live •...
Page 68 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-1. High pass, Low pass and Notch filters can be activated using the selection boxes at the bottom of the screen. NOTE: The AcQMap Catheter localization (QMap Loc), and Surface and Auxiliary Catheter localization (Aux Loc) screens contain a Localization View Sub-Menu which will enable the display of localization magnitude or phase for each of the three localization frequencies.
Page 69 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-2. Phase and Magnitude sub-menu located on the QMap Loc and Aux Loc screens. For better viewing, double clicking on any signal grid will bring up an expanded view of the selected signal.
Page 70 AcQMap High Resolution Imaging and Mapping System Operator Manual 9.1.1. — Surface ECG Biopotentials – Surface ECG The Surface ECG Screen displays surface ECG leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6. Signal gain can be adjusted using the Gain slider on the left side of the screen. Signals can be refreshed using the Refresh button.
Page 71 AcQMap High Resolution Imaging and Mapping System Operator Manual 9.1.2. — AcQMap Catheter Setup Biopotentials – QMap EGM The QMap EGM screen displays the 48 measured electrograms from the AcQMap Catheter. Click [QMap EGM] to access the AcQMap EGM screen. ( Figure 9-5 Figure 9-5.
Page 72 AcQMap High Resolution Imaging and Mapping System Operator Manual Localization – QMap Loc The AcQMap Loc Screen displays the localization signal selected in the Localization View Sub- Menu for all 48 electrodes of the AcQMap Catheter. The phase of localization signal should be near constant for in vivo connections.
Page 73 AcQMap High Resolution Imaging and Mapping System Operator Manual 9.1.3. — EP Auxiliary Catheter Setup Biopotentials – Aux EGM The Aux EGM Screen displays the measured electrograms from the Auxiliary Catheter channels as well as the surface electrode signals. Click [Aux EGM] to access to the Aux EGM screen. ( Figure Figure 9-7.
Page 74 AcQMap High Resolution Imaging and Mapping System Operator Manual Localization – Surface and Aux Loc The Surface and Aux Loc screen displays the localization signal selected in the Localization View Sub-Menu for the Surface electrode channels (e.g. ECG) and for all auxiliary catheter channels. Click [Aux Loc] to access the Aux Loc screen.
Page 75 AcQMap High Resolution Imaging and Mapping System Operator Manual 9.1.4. — Ultrasound The Ultrasound view shows histograms of range data from each of the 48 AcQMap Catheter transducers. Click [US] to access the Ultrasound screen. ( Figure 9-9 Figure 9-9. Ultrasound. 9.1.5.
Page 76 AcQMap High Resolution Imaging and Mapping System Operator Manual Calibrating the Localization Phase using AcQMap catheter connections 1. Ensure that localization electrodes have been properly applied and the AcQMap Catheter is connected and in the chamber of interest outside the sheath. 2.
Page 77: Acquisition Setup
AcQMap High Resolution Imaging and Mapping System Operator Manual 9.2. — Acquisition Setup Localization, 3D Display, and Trace Display settings must be configured prior to acquiring data. Navigate to the Acquisition window by clicking on the Acquisition tab. 9.2.1. — Localization Configuration Localization with the AcQMap System can be configured with the following steps: (1) AcQMap catheter setup, (2) auxiliary (or AUX) catheter setup, (3) Initialization, (4) Respiratory Compensation, and (5) Field Scaling.
Page 78 AcQMap High Resolution Imaging and Mapping System Operator Manual Catheters (Auxiliary) Setup Click on Configure Catheters to select and configure the Auxiliary (AUX) catheters connected to the system for the given case. These typically include Coronary Sinus (CS) catheter, circular loop or other linear catheters.
Page 79 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: Setup may be canceled at any time, doing so will cause the System to revert to previously saved values. If setup has not been previously performed, no correction will be applied and motion due to respiration will be unchanged. NOTE: If excessive residual respiration motion (catheters appears to move >5 mm due to respiration) is observed, setup can be repeated except during a recording.
Page 80 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-12 Respiratory compensation training window. Figure 9-13 Partial Respiration Compensation Complete. Figure 9-14 Respiration Compensation Training Complete. Each segment in the respiration compensation algorithm adds additional data to train the algorithm to compensate for respiration so as to minimize respiration induced catheter movement.
Page 81 AcQMap High Resolution Imaging and Mapping System Operator Manual - Yellow: respiration compensation data collected, calculated and rejected due to catheter instability. - White border: active segment indicating ongoing compensation data collection and application. A Stability Warning may appear if the system detects unusual catheter movement during training. Stability warnings will appear as a yellow warning message.
Page 82 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-15 Respiration compensation training window indicating rejected (yellow) segment due to catheter instability. Figure 9-16 Completion of respiration compensation with 2 unstable segments (yellow). User has the option to Restart Training, or Ignore Stability Warnings or Proceed with Partial Compensation. Figure 9-17 RAdvanced View of the Respiration Compensation Training Window showing the amount of compensation and respiration peak to peak amplitude.
Page 83: Configure Trace Display
AcQMap High Resolution Imaging and Mapping System Operator Manual Field Scaling Initial Field Scaling is collected instantly when the AcQMap catheter is inside the chamber. Rescale the localization sub-system by clicking on the Redo Scaling button. This will re-calculate the scaling transform applied to the voltage data to calculate electrode positions in position-space. As errant electrodes are excluded, rescaling of the localization sub-system will produce a more accurately localized AcQMap Catheter electrode spacing.
Page 84 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-18. Configure Trace Channels Window (Maps Channels shown). A. AcQMap Catheter. B. Surface ECG. C. Auxiliary Catheters. D. Chamber Prefixes. E. Number of Visible Sensors. F. Save Configuration. 9.3.2. — Trace Display Control Panel The Trace Display Control Panel provides access to trace display and gain settings.
Page 85 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 9-19. Trace Menu. • Group Menu Quickly adjust the gain for an entire Group designation. ( Figure 9-20 Figure 9-20. The Group Menu allows quick adjustment of the gain for an entire Group designation.
Page 86: Chapter 10 - Building A Surface Anatomy Using Ultrasound
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 10 — BUILDING A SURFACE ANATOMY USING ULTRASOUND This chapter describes the process by which a Surface Anatomy is created for non-contact mapping. NOTE: If initial setup has not yet been completed, refer to Chapter 9 – Setup to complete the AcQMap System setup.
Page 87: Step 2: Configure And Enable Ultrasound
AcQMap High Resolution Imaging and Mapping System Operator Manual 10.1.2. — Oriented The relative orientation of the AcQMap Catheter and Auxiliary Catheters should be correct and the standard Left-Posterior-Superior (LPS) orientation should match the fluoroscopy. Clicking [AP], [LAO], [RAO], etc. should display the AcQMap Catheter and Auxiliary Catheters with the same orientation as the fluoroscopy display.
Page 88 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 10-2. A. Green vectors indicate that ultrasound is active, the length of the vector represents the distance from the selected targets. B. A green line appears next to the Ultrasound On/Off icon to indicate that ultrasound is active.
Page 89: Step 3: Surface Build Menu
AcQMap High Resolution Imaging and Mapping System Operator Manual 10.3. — Step 3: Surface Build Menu From the Acquisition Menu, click on the [Build] selection button under the Surface in Use heading on the upper right corner of the 3-D Display to open the Surface Build menu. The Surface Build menu provides controls and options for setup and acquisition of a Surface Anatomy.
Page 90 AcQMap High Resolution Imaging and Mapping System Operator Manual 10.4.2. — Initial Position of the AcQMap Catheter For best results in building a Surface Anatomy, the AcQMap Catheter should be positioned at or near the center of the chamber of interest. Once the AcQMap Catheter is initially positioned in this location, click the [Clear Current Surface] button to center the Catheter on the screen.
Page 91 AcQMap High Resolution Imaging and Mapping System Operator Manual — TIPS AND TRICKS — Tips for Successful Surface Anatomy Reconstruction Rotation of the AcQMap Catheter is the primary motion recommended for scanning large regions of the anatomy. Rotations of the AcQMap Catheter need only be through a quarter- or half-turn to cover the circumferential area of the chamber.
Page 92 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: Effort should be taken to fill in holes to the point where a flat “patch” will span the omitted parts of the surface and smoothly align with the surrounding surface. This “patch” will contain larger triangles than the rest of the constructed anatomy.
Page 93 AcQMap High Resolution Imaging and Mapping System Operator Manual 10.4.4. — Filters Four data filtering settings may be applied for data quality assessment. The surface data filters allow visualization and assessment of the distribution of surface points in each pyramidal bin of the PointCloud data structure in terms of the following statistics: •...
Page 94: Pausing Or Resuming An Anatomy Acquisition
AcQMap High Resolution Imaging and Mapping System Operator Manual • Colors Color definitions for above-threshold and below-threshold regions are set in the Color Control panel. Click on the color sample bar to open a color selection palette. ( Figure 10-4, B The colorized surface should appear above threshold across the displayed surface when the Number of Points and Number of Points in one (1) Standard Deviation are chosen.
Page 95 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 10-5. Saving and processing an anatomy. A. Save Raw Surface. B. Preprocess. C. Edit Surface. NOTE: Right-clicking on the current Session provides access to the Anatomy Browser, which locates the raw and final anatomies associated with the patient session.
Page 96 AcQMap High Resolution Imaging and Mapping System Operator Manual 10.5.3. — Editing a Surface Reconstruction Click on the [Edit Surface] button to open the Anatomy Editor Window. ( Figure 10-6 Figure 10-6. Surface Edit Controls – Edit tab. A. Edit Correction Icons. B. Auto Select. C. Manual Select. Verify that the displayed surface is the surface reconstruction to be edited.
Page 97 AcQMap High Resolution Imaging and Mapping System Operator Manual Edit Tool tab • Selection tools Selection tools are used to select faces or regions of the anatomy for editing. • Individual selection Individual faces of the surface mesh may be selected by right-clicking on faces, one at a time. To de-select a face, repeat the right-click.
Page 98 AcQMap High Resolution Imaging and Mapping System Operator Manual • Sharp Triangles ( Figure 10-7, A Checking the Sharp Triangles box will automatically select triangles forming a sharp outward “spike”. • Angle Limit ( Figure 10-7, B Angle Limit defines the angular threshold of the raw surface triangle normal that will be automatically selected by the inward and sharp triangle detection tools.
Page 99 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 10-9. Ellipse Selection Tool. • Ellipse Under Manual Select, select the Ellipse tool. Click on the [Select Region] button to activate the Ellipse selection tool. (Keyboard shortcut Alt + E). The Select Region button will change to “OK”...
Page 100 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 10-10. Rectangle selection tool. • Rectangle Under Manual Select, select the Rectangle tool. Click on the [Select Region] button to activate. (Keyboard shortcut Alt + R). Faces and vertices of the surface can now be selected in bulk.
Page 101 AcQMap High Resolution Imaging and Mapping System Operator Manual 10.5.4. — Enhance Controls tab The Enhance Controls tab contains tools to prepare a Surface Anatomy reconstruction for mapping and analysis. ( Figure 10-11, A Figure 10-11. Surface Edit Controls. Enhance Tools. A. Enhance. B. Enhancement options. C. Execute button. To execute any or all of these processes, enable the desired tools by checking the check box next to the tool label.
Page 102: Exit The Anatomy Editor
AcQMap High Resolution Imaging and Mapping System Operator Manual • Close Holes Identifies and automatically closes holes in the surface. • Re-mesh Surface Close Holes Re-distributes the mesh triangulation to make the surface triangles more uniform in size. The # Samples indicates the minimum number of vertices of the re-meshed surface. •...
Page 103 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: Once a point-cloud has been created, it can be cleared by clicking on the Clear button Click the Collect Points icon to stop the data collection. An erasure tool is available to trim points off the point-cloud.
Page 104 AcQMap High Resolution Imaging and Mapping System Operator Manual Click the right mouse button and drag to define an ellipse on the vein ostium. The dimensions or position of the ellipse can be adjusted by clicking and dragging with the right mouse button. The orientation of the structure can be changed by adjusting the orientation of the anatomy.
Page 105: Surface Processing Of The Modified Anatomy
AcQMap High Resolution Imaging and Mapping System Operator Manual 10.8. — Surface Processing of the Modified Anatomy 10.8.1. — Merging the anatomy into a single mesh 1. Open the Anatomy Browser from the Sessions window Segmented 2. Find the modified anatomy to process. Modified anatomies will be denoted in Anatomy the Anatomy Browser with the Segmented Anatomy designator.
Page 106: Resume An Existing Surface Reconstruction
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 10-14. Existing Surface. The yellow arrow indicates selection of the Existing Surface in the Acquisition Window. 4. If the registration appears to be improperly registered, re-load the saved registration information. a.
Page 107: Chapter 11 - Acquiring Recordings
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 11 — ACQUIRING RECORDINGS Recordings are periods of data that are saved to the hard drive and may be used for analysis or mapping. These recordings are recorded in the Acquisition Window and are made available in the Waveforms and Maps Windows for analysis and mapping.
Page 108 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 11-1. A. Recordings are acquired using the recording controls at the bottom of the screen. B. Toggle SuperMap icon to N for Single Position data recording. C. Toggle to activate the Centering visual guidance (green sphere) in the 3D Display.
Page 109: Chapter 12 - Reviewing Recordings
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 12 — REVIEWING RECORDINGS Current and past records may be reviewed in the Waveforms window. The Waveforms window is accessed by clicking on the Waveforms Tab. Figure 12-1. Waveforms Window. A. 3D Display. B. Trace Display. C. Filtering Controls. D. Create Mapping. E. 3D Settings and Shortcut Icons.
Page 110: Signal View And Filter Settings
AcQMap High Resolution Imaging and Mapping System Operator Manual 12.1. — Signal View and Filter Settings 12.1.1. — Single-Channel View In the Single-Channel view, one channel is selected for review. The channel may be selected in the Channel Selection panel. ( Figure 12-1, F Multiple calculated waveforms may be displayed concurrently in the Trace Display.
Page 111 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 12-2. Selected Displayed Signals in the Trace Display Window. 12.1.2. — Signal Filters Filtering of the electrograms in the Waveforms window is an important precursor to mapping. Filters are applied via the Filtering area. ( Figure 12-1, C •...
Page 112: Full-Screen Multi-Channel Visualization
AcQMap High Resolution Imaging and Mapping System Operator Manual • Smoothing The Smoothing Filter is an adaptive Low-Pass Filter that is used to reduce baseline noise on the electrograms. • Segment Zeroing Please refer to section 12.5, below, for additional information related to removal of the V-wave.
Page 113 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 12-3. All-Channel AcQMap Grid View. A. Excluded channels. B. Cursor and Gain sliders. C. Return to Waveforms Window. – Channels deemed to be performing poorly will be excluded by selecting the small checkbox in the upper right corner of each individual plot.
Page 114 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 12-4. Alignment of all channels in Overlay view. A. Channel alignment. B. Cursor and Gain Sliders. C. View Excluded Channels. D. View All Channels. – All channels may be aligned by clicking on the Align Channels button located on the bottom left of the display.
Page 115: Select A Time Window For Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual 12.3. — Select a Time Window for Mapping From the Signal Overlay view locate a segment that represents the arrhythmia to be mapped and has the most consistent baseline. Use the calipers to select the segment. •...
Page 116: Exclusion Of Signal Traces For Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 12-6. Zoomed view of electrograms in Overlay Window. Click the Zoom arrow to return to default time scale. Return to the default time scale by clicking the Zoom arrow icon in the lower right corner of the Overlay Display.
Page 117 AcQMap High Resolution Imaging and Mapping System Operator Manual Traces can be excluded by right clicking on the Trace to be excluded. A pop-up box will appear that identifies the Trace and options to Exclude Sensor, Make Invisible or Cancel. ( Figure 12-7 Figure 12-7.
Page 118 AcQMap High Resolution Imaging and Mapping System Operator Manual When all appropriate Traces have been excluded from the selected segment, click on the cursor label to record the data segment in the Create Mapping fields in the Waveform Window. ( Figure ) Click on the X to return to the Waveform Window.
Page 119: Vwave Removal And Zeroing In Atrial Fibrillation
AcQMap High Resolution Imaging and Mapping System Operator Manual 12.5. — VWave Removal and Zeroing in Atrial Fibrillation VWave Removal and VWave Zeroing tools are filters that remove or zero the V-wave from the biopotential recordings. For best results, identify the most consistent V-wave morphology in the data segment using the filtered electrogram.
Page 120: Export Data For Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual • Optionally adding VWave Zeroing Clicking on the Zero VWave checkbox will use the same time calipers placed above to identify VWave segments across the recording. Rather than calculating a per-channel subtraction template, by selecting Zero VWave the waveform at each identified VWave segment will be interpolated across the identified segment between the first and last samples of the segment, applied on the raw waveform data prior to all other filters.
Page 121: Chapter 13 - Mapping, Labels And Markers
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 13 — MAPPING, LABELS AND MARKERS The AcQMap System can produce different static and dynamic, three dimensional (3D) maps of electrical activation across the ultrasound acquired cardiac chamber surface. These maps can be either charge density-based or voltage-based.
Page 122: The Maps Screen
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 13-2. Maps Screen. A. Dual 3D Display. B. Trace Display. C. Playback Controls. D. Map Types Drop Down. E. Labels/Markers. F. Map Controls 13.1. — The Maps Screen The 3D Maps Mode is used to generate 3D Maps of the data selected and exported from the Waveforms window.
Page 123 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 13-3. Independent 3D Displays. The orange border on the left-hand display indicates the active display. 13.1.2. — Trace Display The Trace Display shows the exported data used to generate the 3D Maps. Signals displayed are selected by navigating to Configure Maps Channels from the Menu Bar.
Page 124: Creating Maps
AcQMap High Resolution Imaging and Mapping System Operator Manual The left and right arrow keys on the keyboard serve as hot keys for the same functions as the step- buttons. Enter the sample number in the “Current Sample” text box to move the Time Cursor to a specified sample number.
Page 125 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 13-4. Charge Calculation Configuration Window..
Page 126 AcQMap High Resolution Imaging and Mapping System Operator Manual 13.2.2. — Execute the CDA Inverse Solution Surface Charge, Surface Voltage, Propagation History Charge and Propagation History Voltage are computed from the output of the Charge Density Algorithm. After the calculations are complete, the Propagation History Charge map will be displayed.
Page 127 AcQMap High Resolution Imaging and Mapping System Operator Manual 13.2.3. — Adjustment of the Surface Charge or Surface Voltage Display (Figure 13-5, B) • Color Bar The Color Bar is used to adjust the limits of the Map color-gradient used to color-code the magnitude of the displayed electrical data upon the surface anatomy.
Page 128 AcQMap High Resolution Imaging and Mapping System Operator Manual • Propagation History The Propagation History Map is an animated version of an Isochrone Map. Color is used to show where the activation wave front was located over a series of time-increments. The Propagation History Map requires calculation of an Activation Matrix based on the upper limit of the Color Bar for Surface Charge or Surface Voltage, respectively.
Page 129 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 13-6. Map Controls menu highlights the options available to adjust the Propagation History Map in the 3D Display.
Page 130: Placing Labels
AcQMap High Resolution Imaging and Mapping System Operator Manual 13.3. — Placing Labels The Label control panel is used to organize, define and edit Labels used in the 3D Displays. Figure 13-8 Figure 13-8. Labels. A. List of Default Labels. B. List of Current Labels. C. Labels placed on the display. D. View or Hide Labels icons.
Page 131: Placing Markers
AcQMap High Resolution Imaging and Mapping System Operator Manual • Deleting Labels Labels can be deleted in two ways: (1) Select the Label in the Current Label list to highlight it and then click delete or (2) Right click on the Label in the Current Label list and select delete. Figure 13-8, B 13.4.
Page 132 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: When using [F3] or [Space] and the user-selected active electrode is within 4mm of the reconstructed Surface Model, the marker will be placed at the nearest location on the reconstructed Surface Model. NOTE: Holding [Shift + F3] while placing the marker will optionally place the marker at the location of the user-selected active electrode.
Page 133 AcQMap High Resolution Imaging and Mapping System Operator Manual 13.4.4. — Deleting Markers Markers can be deleted from the surface in multiple ways. • Right click on the Marker to be deleted. This will bring up details related to the Marker. Right click on delete to remove the Marker.
Page 134: Acqtrack™ Conduction Pattern Software
AcQMap High Resolution Imaging and Mapping System Operator Manual 13.5. — AcQTrack™ Conduction Pattern Software 13.5.1. — Conduction Pattern Recognition AcQTrack™ is an optional feature that systematically quantifies and classifies conduction patterns on the propagation history maps. These conduction patterns have not been confirmed to be sources of arrhythmia.
Page 135 AcQMap High Resolution Imaging and Mapping System Operator Manual Conduction Pattern Recognition is calculated in the background once the Propagation History map has been calculated. Analysis and quantification of various conduction patterns may aid the user in interpreting or offer the user an expanded perspective of regional conduction behavior. AcQTrack should be used in conjunction with physician discretion and other available data or tools when assessing maps –...
Page 136 AcQMap High Resolution Imaging and Mapping System Operator Manual 13.5.3. — Conduction Pattern Controls Controls to adjust the visualization of conduction patterns can be accessed by clicking on AcQTrack button above the 3D Display window. Controls to adjust the display of conduction patterns include: •...
Page 137: Complex Fractionated Atrial Electrograms (Cfae) Tool
AcQMap High Resolution Imaging and Mapping System Operator Manual 13.6. — Complex Fractionated Atrial Electrograms (CFAE) Tool CFAE enables the visualization of regions of the map that contain fractionated electrograms. These are electrograms with a rate of occurrence (count per second) of short intervals (the time difference between two consecutive activation times in ms) that exceed a user defined threshold within the Time Window for Mapping segment.
Page 138: Composite Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual Because the CFAE algorithm is predicated on local activation time detections, it is recommended that the user ensure that the LAT maps are free of artifacts and are of high quality. Figure 13-13 Check “Show CFAE”...
Page 139 AcQMap High Resolution Imaging and Mapping System Operator Manual substrate. The composite mapping tool should be used in conjunction with physician discretion especially in sites of low amplitude, conduction block, focal activation and wave collision. Composite Mapping is recommended to be used with data comprising at least three wavefronts. When possible, the module is also recommended to be used with data collected using the SuperMap mode.
Page 140 AcQMap High Resolution Imaging and Mapping System Operator Manual The 3D display shows the composite map derived from the user selected list of maps. The color bar defaults to a range from 0 to the maximum number of concurrences at a given node on the 3D ultrasound anatomy where conduction velocity is less than the user specified threshold (here, 0.3 mm/ms).
Page 141: Chapter 14 - Supermap
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 14 — SUPERMAP This chapter describes the steps for acquiring and processing data to create SuperMaps on an ultrasound anatomy reconstruction. SuperMap is an efficient way to collect data throughout the chamber of interest, which is aligned to a timing reference and processed through the charge density inverse solution to create both dynamic and static non-contact maps of simple and complex repetitive rhythms.
Page 142 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 14-1. Data Acquisition. A. SuperMap Icon. B. Record Button. C. Surface Illumination. D. New Recording. E. Clear Surface & Progress Bar 4. As the catheter is being roved around the chamber and data is being collected, a progress bar will update in real time to display the proportion of the chamber that has been covered.
Page 143: Waveform Analysis
AcQMap High Resolution Imaging and Mapping System Operator Manual 14.2. — Waveform Analysis Waveform analysis will initially process the acquired data using default settings. The data is processed to determine unique beat groups and their cycle lengths using all available reference unipoles.
Page 144 AcQMap High Resolution Imaging and Mapping System Operator Manual 14.2.2. — Adjusting SuperMap Parameters NOTE: The user can update any of the default settings or calculated values prior to producing a SuperMap. Filters can be selected or deselected by expanding the Signal Processing window. Filters include Respiration, Low Pass, High Pass, Notch and Smoothing.
Page 145 AcQMap High Resolution Imaging and Mapping System Operator Manual The plot in the Detected Cycle Length window shows the time alignment of the ECG and Intracavitary signals to the reference signals. The window can be adjusted to minimize the influence of the QRS and T-waves on the segmented signals used for beat-grouping. Default value is 50/50 of the cycle length around the primary reference channel.
Page 146 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 14-5. Preparing Data for Mapping. A. Trim EGM window B. Create Map button Figure 14-6. View Map. A. View Map button B. New Map...
Page 147: Displaying A Supermap
AcQMap High Resolution Imaging and Mapping System Operator Manual 14.3. — Displaying a SuperMap Two types of SuperMaps are produced: Activation (Propagation History) and Amplitude. • Propagation History – The propagation history map is an animated version of an isochrone map.
Page 148 AcQMap High Resolution Imaging and Mapping System Operator Manual SuperMap Sensitivity Defines the sensitivity setting for SuperMap. Default is Standard. High sensitivity setting is chosen when a when atrial EGMs are very small or if there may be conduction in very low amplitude regions. (Figure 14-7, C) Color Mode defines the type of map to be displayed.
Page 149 AcQMap High Resolution Imaging and Mapping System Operator Manual 14.3.3. — Playback settings (Figure 14-7, H) Timing data can be displayed as a progression played back over time. The user can adjust the playback speed, direction and mode. Playback speed: Allows the rate at which the data is played to be adjusted. Playback direction: Allows the data to be played either forward or backward.
Page 150: Displaying A Propagation History Map With An Amplitude Map
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 14-8. Displaying and Adjusting Amplitude Map Parameters. A. Amplitude map selected from dropdown menu. B. Maximum Voltage color. C. Color Depth. D. Illumination Setting. E. Playback Settings. 14.4. — Displaying a Propagation History Map with an Amplitude Map The Dual 3D Displays allow simultaneous visualization of the generated SuperMaps.
Page 151 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 14-9. Independent 3D Displays. A. Link Icon disconnected. B. Propagation History Map. C. Amplitude Map.
Page 152: Chapter 15 - Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 15 — EXPERT MODE Enabling Expert Mode provides the user with a variety of additional user selectable parameters to enhance and refine the data and presentation by the AcQMap System. When enabled, Expert Mode activates all of the features and functions described in this chapter.
Page 153: Acquisition Window Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 15-1. Ultrasound Window in Expert Mode provides access to a plotting sub-menu. (Blue box) Additional parameters now available in the Ultrasound Live Signals Window provide access to a plotting sub-menu that allows selection of histogram parameters including the length of the time window over which the displayed histogram data encompasses as well as the vertical scaling mode for the histograms: •...
Page 154 AcQMap High Resolution Imaging and Mapping System Operator Manual • View voltage View voltage bypasses the localization scaling from voltage to position and displays all localized electrodes in voltage space. Surface reconstructions and AcQMap System rendered Auxiliary Catheters will not be scaled correctly with this setting enabled. This setting is not recommended for general use.
Page 155 AcQMap High Resolution Imaging and Mapping System Operator Manual 3D Settings – View Tab ( Figure 15-2, A • Inner Chamber Surface - Select the desired color for the Inner Chamber Surface • Viewport Settings - The following function is used to adjust the display appearance –...
Page 156 AcQMap High Resolution Imaging and Mapping System Operator Manual Trace Display Control Panel • Calipers - The Caliper tab displays information related to the user-specified calipers placed in the Trace Display. Caliper name and color may be changed within the tab. Start and end points for the calipers are adjusted by dragging the caliper markers on the Trace Display.
Page 157: Ultrasound Surface Anatomy In Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 15-4. The Others tab provides access to settings for the Trace Sweep Speed. (yellow box) For additional information related to all aspects of Set Up refer to Chapter 9 Set up. 15.4.
Page 158: Reviewing Recordings In Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual 15.4.2. — Editing a Surface Anatomy Surface Edit Controls • Enhance Tab – Smooth Mesh - The smooth mesh function reduces the surface variation and adjusts positions of surface vertices to reduce the variation in surface normals between neighboring nodes.
Page 159 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 15-5. Expert Mode functions available in Mode 1 in the Waveforms Window. A. Reference signal display. B. Displayed signal types. • Filtering is available in both Mode 1 and Mode 2 –...
Page 160 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 15-6. Expert Mode functions in the Waveforms Window available in Mode 2. A. Mode 2 button. B. Filtering options. 15.5.1. — Configure XYZ Provides easy access to update the localization configuration. 15.5.2.
Page 161 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 15-7. Waveforms Window. A. GridMap. B. ColorScale. C. Signal To Plot. D. GridMap/AcQMap Options. The GridMap is an “opened-planar” representation of the AcQMap Catheter, which displays the filtered voltage amplitude at each electrode as a color-mapped color. The GridMap maintains the relative orientation of electrodes on the AcQMap Catheter.
Page 162: Mapping, Labels And Markers In Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual BMP button – captures a sequence of BitMap image files and places them the C:\Temp\BMPFiles\<GUID> folder. The input box is used to configure the number of samples to skip between BitMaps. Subtract BCT checkbox removes the BCT Display Signal.
Page 163 AcQMap High Resolution Imaging and Mapping System Operator Manual 15.6.2. — Additional Mapping Tools Figure 15-9. Maps Window in Expert Mode. A. Electrode Voltage. B. Electrode Voltage Grid. C. Coulombian Map. D. Image Capture Controls. • Electrode Voltage The voltage at the AcQMap Catheter electrodes may be displayed as a comparative reference for the Surface Voltage-based or Surface Charge-based maps.
Page 164: Supermap In Expert Mode
AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: The Coulombian activation threshold is set by the upper Color Bar setting. – The Coulombian data will be calculated for both Charge and Voltage. Upon completion, the Charge version of the Coulombian Map will be displayed. •...
Page 165 AcQMap High Resolution Imaging and Mapping System Operator Manual 15.7.2. — Waveform Analysis Signal Processing when used in Expert Mode allows the user to adjust the filter settings for the ACMCatheter, 12-Lead, Raw-ECG and Auxiliary Catheters (AUX). ( , A) To adjust Figure 15-10 the filter settings, left click on the text to access the filters for those signals.
Page 166 AcQMap High Resolution Imaging and Mapping System Operator Manual 15.7.3. — Displaying a SuperMap in Expert Mode SuperMap, when used in Expert Mode, can display two additional types of maps: Surface Charge and Surface Voltage. Surface Charge Surface Charge Density is derived by an inverse solution applied on the voltages measured from the AcQMap Catheter electrodes.
Page 167: Chapter 16 - Setup Contact Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 16 — SETUP CONTACT MAPPING This chapter describes the steps for setting up the AcQMap System for data acquisition, contact electrograms, geometry construction and contact map creation. Before starting data acquisition, ensure that the following steps have already been completed: System set up –...
Page 168 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 16-1. Contact mapping setup – Defining catheters. A. Devices panel. B. Define catheter function. C. Assign unipolar and bipolar channels. D. Configure filter and detection parameters. Defining Devices and Selecting Signals 1.
Page 169 AcQMap High Resolution Imaging and Mapping System Operator Manual 5. Click on a catheter to define the Unipoles. Unipoles are defined by the catheter electrode number (CH), Pin, label and function. The Pin should match the electrode (CH) connection to the Auxiliary Catheter cable. The unipoles can be auto-pinned by entering the first catheter electrode number and then hovering over the entry.
Page 170 AcQMap High Resolution Imaging and Mapping System Operator Manual Set Contact Mapping Filters The Filters screen is used to define the filter settings for the unipoles and bipoles. ( Figure 16-2 Figure 16-2. Contact mapping setup – Setting Filters. A. Filters panel. B. Unipolar filter settings. C. Bipolar filter settings.
Page 171 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 16-3. Contact mapping setup – Setting Activation Detection for Reference and Mapping Channels. A. Activation Detection Parameters. B. Ref Channels. C. Mapping channels. Activation Detection for Reference Channels The Reference Channel is used to identify a consistent time during the cardiac cycle that is used by the system to identify and align beats, set the Mapping Window for each beat, and as a zero time for activation time measurement.
Page 172 AcQMap High Resolution Imaging and Mapping System Operator Manual Rhythm Type The user can also select the Rhythm Type from a pull down combo box that includes: Sinus, Paced or Tachycardia. The Max Cycle Length Variance changes based on the select Rhythm Type. It defaults to 200 ms for Sinus and 20 ms for Paced.
Page 173 AcQMap High Resolution Imaging and Mapping System Operator Manual • Distance from Geometry defines the electrode distance from the reconstructed chamber geometry for acquiring points. Saving and Loading Configuration Template • The user can save and load the Catheter Setup configuration into a template file for future use.
Page 174: Select Catheter To Establish Localization And Field Scaling
AcQMap High Resolution Imaging and Mapping System Operator Manual 16.2. — Select Catheter to Establish Localization and Field Scaling Initial localization configuration and setup is completed via the following steps: (1) Catheter configuration, (2) Initialization, (3) Respiratory Compensation and (4) Field Scaling. ( Figure 16- Catheter Configuration Click on Configure Catheters to configure and setup the linear, ablation and circular catheters...
Page 175: Field Scaling
AcQMap High Resolution Imaging and Mapping System Operator Manual 16.3. — Field Scaling To establish the localization field, the system needs to recognize catheter movement in two planes. Ensure the catheter being used to establish the localization field matches the catheter shown under Anatomy Settings in the Aux Catheter box.
Page 176: Chapter 17 - Creating A Contact Anatomy
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 17 — CREATING A CONTACT ANATOMY The AcQMap System can display three-dimensional renderings of cardiac chambers. The purpose of constructing the cardiac anatomy is to define the anatomic structures within the chamber. It is important to collect enough points within the chamber to provide enough chamber definition.
Page 177 AcQMap High Resolution Imaging and Mapping System Operator Manual During anatomy point collection an eraser tool is available to delete unwanted points. Select the Erase Points icon to access the eraser toolkit. Erase Points Figure 17-2. Eraser toolkit. The anatomy point cloud will be visible, and all the points will be yellow indicating edit mode. The mouse pointer becomes a circular eraser.
Page 178: Editing An Anatomy
AcQMap High Resolution Imaging and Mapping System Operator Manual Redo icon: Clicking on the Redo icon will redo the most recent editing step that was undone using the undo icon. NOTE: New points can be added at any time during the procedure using the selected catheter and clicking the Collect Point Cloud icon.
Page 179 AcQMap High Resolution Imaging and Mapping System Operator Manual To cut out the valve plane, under Manual Select click on the Ellipse icon. Additionally, check the Front Surface Only and Move and Resize checkboxes. Click on the [Select Region] button to activate the Ellipse selection tool.
Page 180: Add A New Structure
AcQMap High Resolution Imaging and Mapping System Operator Manual It is also possible to add Catheter Shadows. From the drop down menu, select the desired catheter you’ d like to shadow. This can include All Catheters or individual ones. Click on the “+” sign to capture the shadow. The shadowed catheters will appear in the table below together with the associated timestamp.
Page 181: Chapter 18 - Contact Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 18 — CONTACT MAPPING The AcQMap System can display conventional electrophysiology mapping data as three- dimensional maps. Data is collected from various locations within the chamber of interest in a stable rhythm using localized electrophysiology catheters.
Page 182 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 18-1. Trace Display Control Panel – Annotation Window. A. Access Trace Display Control Panel. B. Trace visibility. C. Trace color. To add or delete ECG or EGM traces check the checkbox next to the trace to be displayed in the Live Annotation window.
Page 183 AcQMap High Resolution Imaging and Mapping System Operator Manual Alternatively, the display gain for multiple tracings can be set to match that of a single tracing. This is achieved by first selecting multiple tracings that include the tracing with the desired gain setting.
Page 184: Creating A Contact Electroanatomic Map
AcQMap High Resolution Imaging and Mapping System Operator Manual To use the mouse, hover over the white border of the window of interest to be adjusted. When the mouse cursor changes to a double arrow, left click and hold, then move the white border to increase or decrease the time before or after time zero.
Page 185 AcQMap High Resolution Imaging and Mapping System Operator Manual Use the dropdown menu above the left side display window to select the map type that will be displayed as points are acquired. ( ) Move the mapping catheter to desired area in the Figure 18-3 chamber.
Page 186 AcQMap High Resolution Imaging and Mapping System Operator Manual The user can manually adjust the threshold for each criterion by hovering over the criterion and scrolling the mouse wheel up or down. Additionally, the user can disable and enable the criterion by clicking on the corresponding box.
Page 187 AcQMap High Resolution Imaging and Mapping System Operator Manual LAT and voltage amplitude map. Whereas a dashed vertical line indicates that the associated point will be included in the voltage amplitude map but not the LAT map. The user can move any point into the Points List by right clicking on the EGM and selecting “Move to Points List”.
Page 188: Displaying Maps
AcQMap High Resolution Imaging and Mapping System Operator Manual 18.3. — Displaying Maps Map types display the core information of the map. Other types of information can be simultaneously displayed from the same set of data. e.g. Voltage amplitude can be displayed where color indicates the amplitude and timing data can also be displayed using a secondary visual representation.
Page 189 AcQMap High Resolution Imaging and Mapping System Operator Manual Amplitude-based maps Voltage amplitude maps are used to identify areas with low voltage. (e.g. possible areas of scar) Voltage amplitude maps display color-coded voltage values for each collected point. Voltage amplitude measurement is user selectable (Peak-to-Peak, Peak Positive and Peak Negative). Figure 18-6 Similar to LAT maps, it is possible to display low amplitude regions that are below a user selected threshold.
Page 190 AcQMap High Resolution Imaging and Mapping System Operator Manual Color Bar Color Bar settings adjust the parameters used to display the timing or voltage amplitude data. Figure 18-7 Figure 18-7. Color Bar settings. A. Color Modes (Isochronal, Amplitude). B. Color Depth. C. Propagation Mode (Reentrant or Linear).
Page 191 AcQMap High Resolution Imaging and Mapping System Operator Manual Playback settings – Timing data can be displayed as a progression played back over time. The user can adjust the playback speed, direction and mode. • Playback speed: Allows the rate at which the data is played to be adjusted. •...
Page 192 AcQMap High Resolution Imaging and Mapping System Operator Manual Color order - Allows the user to select the order of colors represented in the Color Bar. Standard isochrone: Shows a progression of color with Linear Color Bar Mode red designating ‘earlier’ and purple designating ‘later’ . When the linear Color Bar mode is selected, times ear- lier than the first Color Bar slider will be designated as red, times later than the second Color Bar slider will be...
Page 193: Reviewing Maps
AcQMap High Resolution Imaging and Mapping System Operator Manual 18.4. — Reviewing Maps Points are managed in the Points List management window ( ). Accepted points Figure 18-14, B appear in the Points List and those that fail certain detection criteria or are manually rejected appear in the Recycle Bin.
Page 194: Adding/Deleting A Map
AcQMap High Resolution Imaging and Mapping System Operator Manual Removing points from the map To remove a point from the map, right click on the point in the 3D display and select Recycle. Alternatively, with the point selected, hitting the <Delete> key will also remove the point. Restoring points to the map To restore a point to the map, access the Recycle Bin and right click on the point to be added.
Page 195: Copying A Map
AcQMap High Resolution Imaging and Mapping System Operator Manual To delete the active data set, select the Delete icon at the top of the 3D Display window. This will remove all the acquired data from the surface reconstruction. Selecting the Close Map icon will return to the anatomy window. The current anatomy can now be edited, or a new anatomy or structure can be built.
Page 196: Chapter 19 - Stereotaxis
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 19 – STEREOTAXIS® The AcQMap 3D Imaging and Mapping System is compatible with the Stereotaxis Niobe® and Genesis RMN® systems. Integration with the Stereotaxis system occurs in two ways: 1. Non-Contact Mapping: it is possible to stream the ultrasound anatomy acquired with the AcQMap catheter onto the Navigant system.
Page 197: Contact Mapping
AcQMap High Resolution Imaging and Mapping System Operator Manual 19.2. — Contact Mapping In this mode, the electroanatomic map collected using the AcQMap system can be visualized on the Navigant screen of the Stereotaxis system. Figure 19-2 Sample screen showing the 3D display window (Panel A) on the AcQMap System screen with the Navigant (Panel B) For a detailed description on how to setup a session for Contact Mapping and perform respiratory compensation as well as field scaling for localization, refer to Chapter 16 –...
Page 198 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure 19-3 Setup ablation catheter for mapping and ablation. 2. Using a Coronary Sinus (CS) catheter is recommended to configure the timing reference. Figure 19-4 Configuring the timing reference on the CS catheter. 3.
Page 199: Tips On Performing Field Scaling With Navigant
AcQMap High Resolution Imaging and Mapping System Operator Manual 4. Choose the Virtual Reference radio button under Anatomical Reference Channels for respiratory compensation. 5. Click Start Compensation. The Respiration Compensation Training Window will pop up to show the initiation and progress of respiration compensation. NOTE: If Respiration Compensation does not produce the desired results, then click on Calibration Reference Catheter to change the calibration device to the Auxiliary Catheter and select the desired CS catheter electrode as the calibration reference...
Page 200: Chapter 20 - Acqmap System Power Down
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 20 — ACQMAP SYSTEM POWER DOWN 20.1. — Exporting Session Files At the end of a study, the entire session can be exported for off-line review. 1. Prior to export, plug an external drive into the USB port at the rear of the workstation computer.
Page 201: Shutting Down The Acqmap System
AcQMap High Resolution Imaging and Mapping System Operator Manual 20.2. — Shutting Down the AcQMap System AcQMap Workstation Shutdown To safely shut down the AcQMap Workstation, first exit the current session. To exit the session, click on the [Exit Session] icon at the top of the screen. This will close out the current session.
Page 202: Maintenance
AcQMap High Resolution Imaging and Mapping System Operator Manual 20.4. — Maintenance • Only trained and certified service personnel will perform AcQMap System maintenance. • Local standards and regulations should be followed with respect to periodic performance verification. • Any AcQMap System component exposed to excessive shock, vibration, or any mishandling should be returned to the manufacturer for evaluation.
Page 203: Chapter 21 - Technical Description
AcQMap High Resolution Imaging and Mapping System Operator Manual CHAPTER 21 — TECHNICAL DESCRIPTION 20.1 System Specifications Operating Environment Operating temperature and 15° to 30°C, 15% to 75% relative humidity, non- humidity condensing Shipping temperature and humidity 0° to 60°C, 15% to 95% relative humidity, non- condensing Storage temperature and humidity 5°...
Page 204 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: Operation of the AcQMap System with signals smaller than 10uV peak may result in inaccurate results. Front panel connections AcQMap Catheter Custom, black, Defibrillator Protected Type CF ECG Input 12-pin, latching, red, Defibrillator Protected Type BF ECG Output 14-pin, latching, blue Auxiliary Interface Box...
Page 205 AcQMap High Resolution Imaging and Mapping System Operator Manual 20.3 AcQMap Auxiliary Interface Box Physical characteristics Dimensions 13 H x 36 W x 11 D (cm) Weight 3 kg Connections AcQMap Console Custom, green Catheter Input 40, 2mm female, green, Defibrillator Protected Type CF Catheter Output 40, 2mm female, black, Defibrillator Protected Type CF 20.4 AcQMap Workstation...
Page 206 AcQMap High Resolution Imaging and Mapping System Operator Manual AcQMap Workstation connections AcQMap Console Dual LC fiber optic (isolated) Power inlet IEC type 320 Color display output 1 DVI, connected to desktop computer Color display output 2 (optional) Display port Keyboard Mouse AcQMap Workstation Power Consumption...
Page 207 AcQMap High Resolution Imaging and Mapping System Operator Manual Acoustic Output Reporting Table Non-Auto Scanning Mode 10 MHz Operating Mode: M-Mode Applications: Transducer Model TI Type TI Value SPTA.3 PPA.3 (mW/cm (W/cm 900003 0.08 3.62E-05 5.61E-02 1.03 non-scan SYMBOLS DESCRIPTION Derated Spatial-Peak Temporal-Average Intensity (milliwatts per SPTA.3 square centimeter)
Page 208 APPENDICES...
Page 209: Appendix A - Connecting Acqmap With Adjunct Equipment
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX A — CONNECTING ACQMAP WITH ADJUNCT EQUIPMENT Connecting Ablation Generators The AcQMap System has been tested with the following Ablation Generator Systems: Ampere, SmartAblate, Stockert 70 and Maestro 4000. The diagrams below show the connections required for ablation catheter localization and RF energy delivery.
Page 210 AcQMap High Resolution Imaging and Mapping System Operator Manual A-1. Ablation Configuration: Ampere/TactiCath Generator Adapter AcQMap to Ampere AcQMap Console 800431 Front Panel Interface – Ablation 1641 IBI RF AcQMap to Ampere Interface Cable Ampere Adapter Cable Irrigation Pump Ablation Generator Ampere ‡...
Page 211 AcQMap High Resolution Imaging and Mapping System Operator Manual A-2 Ablation Configuration: SMARTABLATE Generator Adapter AcQMap to SmartAblate AcQMap Console Front Panel Interface – Ablation Catheter to SMARTABLATE Cable Model D130302 Irrigation Pump Ablation Generator SMARTABLATE ® ‡ Unused Generator AcQMapSmartAblate Catheter Catheter...
Page 212 AcQMap High Resolution Imaging and Mapping System Operator Manual A-3. Ablation Configuration: Stockert 70 AcQMap Console Front Panel Interface – Ablation Ablation Catheter Connection Cable Irrigation Pump Ablation Model C10-MR10/MSTK Generator Stockert 70 RF Generator Catheter Catheter Pacing Input Reference 2D Recording Ablation Return Electrode Ablation Electrogram Interface Cable 800508...
Page 213 AcQMap High Resolution Imaging and Mapping System Operator Manual A-4. Ablation Configuration: MAESTRO 4000 w/ INTELLATIP MIFI XP Generator Adapter AcQMap to Maestro AcQMap Console Front Panel Interface – Ablation MAESTRO 4000™ Ablation Generator Generator ‡ Unused 800745 AcQMap Catheter Catheter AcQMapMaestro to MAESTRO...
Page 214 AcQMap High Resolution Imaging and Mapping System Operator Manual A-5. SMARTABLATE with Carto Force Adapter Cable Configuration Generator Adapter AcQMap to SmartAblate 800696 Console Carto 800500/800500-001 SMARTABLATE SMARTABLATE ® Cable D129707 Irrigation Pump Ablation CARTO 3 Generator SMARTABLATE ® Mapping ‡...
Page 215: Appendix B - Manual Configuration Of Orientation Reference
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX B — MANUAL CONFIGURATION OF ORIENTATION REFERENCE In the event that the automatic phase calibration fails to generate the correct Left/Posterior/ Superior (LPS) orientation (X-axis = Left, Y-axis = Posterior, Z-axis = Superior), a manual configuration may be used to orient the axes.
Page 216 AcQMap High Resolution Imaging and Mapping System Operator Manual VIII APPENDIX C — CHOOSING ANATOMIC REFERENCE ELECTRODES – AUXILIARY CATHETER The Anatomic Reference Channels are used to establish a common-mode motion signal with the AcQMap Catheter for respiratory and cardiac motion rejection. Adequate common-mode motion rejection is critical to minimizing error in surface reconstruction.
Page 217 AcQMap High Resolution Imaging and Mapping System Operator Manual 7. With the Anatomic Reference mode set to “Translation Only”, repeat steps 4-6 above, editing the selected list of electrodes with each attempt. a. Observing the motion of both AcQMap Catheters and Auxiliary Catheters under “Translation Only”...
Page 218: Appendix D - Troubleshooting Ultrasound
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX D — TROUBLESHOOTING ULTRASOUND The AcQMap System is configured to best balance the sensitive detection of reflected acoustic signals from the chamber surface with the rejection of noise that would compromise the accuracy of the measured range to the surface.
Page 219 AcQMap High Resolution Imaging and Mapping System Operator Manual Figure D-2. Ultrasound transducers reporting no range data. NOTE: Acoustic detection of the chamber surface is dependent on many factors, including range, angle of incidence, target reflectivity, motion, etc. In an in vivo state, not all areas of the chamber’s surface reflect equally.
Page 220 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: The range signals in each histogram are distributed about a mean within a range consistent with cardiac wall motion or AcQMap Catheter motion during the cardiac cycle. There is also noticeable structure down the length of several splines (columns).
Page 221 AcQMap High Resolution Imaging and Mapping System Operator Manual XIII Figure D-5. Example of several nodes with detected range distributions extending beyond a reasonable excursion distance. 6. The Ultrasound detection gain and threshold are configured for typical operation. On occasion, the gain or threshold settings may be overly sensitive and noise will be detected immediately after the end of the minimum reject interval.
Page 222 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: The hard limit on the left is consistent from channel to channel in the plot in Figure D-6 . This is a clear indication of a high level of noise being detected. Detection gain and threshold should be adjusted to reduce this behavior.
Page 223: Appendix E - Manual Catheter Registration
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX E — MANUAL CATHETER REGISTRATION The AcQMap System uses impedance, electric field and ultrasound measurements to establish and maintain accurate registration of the AcQMap, Auxiliary and Ablation catheters in the chamber anatomy.
Page 224 AcQMap High Resolution Imaging and Mapping System Operator Manual NOTE: If the Start Recording button is pressed before exiting the Manual Registration Editor all changes will be canceled. Changes must be confirmed and the Manual Registration Editor exited before the changes are committed.
Page 225: Appendix F - Acqmap System Keyboard Shortcuts
AcQMap High Resolution Imaging and Mapping System Operator Manual XVII APPENDIX F — ACQMAP SYSTEM KEYBOARD SHORTCUTS Task Keyboard Shortcut Results Panning Q or Shift + ↑ Move the image up on the screen Z or Shift + ↓ Move the image down on the screen A or Shift + ←...
Page 226: Appendix G - Post And Functional Test Status Indicators
AcQMap High Resolution Imaging and Mapping System Operator Manual XVIII APPENDIX G — POST AND FUNCTIONAL TEST STATUS INDICATORS Status Indicators during Console POST Status Indicator Description Controller Board Power Up and Self Test Daughter Board Power Up and Self Test Daughter Board Verification and Super Cap Charging Troubleshooting POST Description...
Page 227 AcQMap High Resolution Imaging and Mapping System Operator Manual Status Indicator States Status Indicator Description POST Console Indicators Power up failure Daughter Board POST failure Daughter Board configuration failure Backup Power Failure Functional Test System communication failure Functional Test ECG Cable failure Functional Test Bio/Source Board failure Functional Test Ultrasound Board failure Clinical Operation...
Page 228: Appendix H - Declaration Of Electromagnetic Emissions
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX H — DECLARATION OF ELECTROMAGNETIC EMISSIONS Guidance and Manufacturer’s Declaration of Electromagnetic Emissions The AcQMap System is intended for use in the electromagnetic environment specified below. The customer or end user of the AcQMap System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment...
Page 229 AcQMap High Resolution Imaging and Mapping System Operator Manual Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (continued) NOTE: UT is the AC mains voltage prior to application of the test level. Immunity Test IEC60601 Compliance Electromagnetic Environment Test Level Level Power Frequency 30 A/m 30 A/m...
Page 230 AcQMap High Resolution Imaging and Mapping System Operator Manual XXII Guidance and Manufacturer’s Declaration of Electromagnetic Immunity (continued) NOTE: At 80MHz and 800MHz, the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Page 231: Appendix I - On Demand Ecg Test
Approximately 1 minute later the status indicators will turn off indicating the internal auxiliary power supply is empty. Power should remain available for ~3 minutes, if this is not the case contact Acutus Medical. Testing the functionality when the System is turned OFF: 1.
Page 232 Approximately 1 minute later the status indicators will turn off indicating the internal auxiliary power supply is empty. Power should remain available for ~3 minutes, if this is not the case contact Acutus Medical. NOTE: The internal auxiliary power supply will be re-charged during normal AcQMap System operation.
Page 233: Appendix J - Ecg System Test
AcQMap High Resolution Imaging and Mapping System Operator Manual APPENDIX J — ECG SYSTEM TEST The AcQMap Console includes functionality to test the ECG cable integrity. This helps to ensure that the connector, leads, yoke, and clip connections are all still functional. Note: ECG System test should be used when it is observed that the ECG signals are noisy or not present.
Page 234 AcQMap High Resolution Imaging and Mapping System Operator Manual XXVI Figure J-1. ECG Cable test connections. (A) ECG Input Cable. (B) ECG POST Cable 800524 is connected to the AcQMap Catheter receptacle on the console front panel. (C) Connect each ECG connector to the corresponding name of ECG lead.
Page 235: Appendix K - Setup Acqmap System With Stereotaxis
AcQMap High Resolution Imaging and Mapping System Operator Manual XXVII APPENDIX K – SETUP ACQMAP SYSTEM WITH STEREOTAXIS® Required Tools and Items for Stereotaxis Setup 1. USB A to USB B cable (3m) 2. Ethernet Cat5 Cable (3m or longer), unless supplied by Stereotaxis 3.
Page 236 AcQMap High Resolution Imaging and Mapping System Operator Manual XXVIII 2. Move the Navigant mouse cursor to the AcQMap display on the Odyssey screen and verify the workstation can be controlled remotely. Data sharing connection 1. Locate the configured network adaptor connection on the rear of the AcQMap workstation PC 2.
Page 237 AcQMap High Resolution Imaging and Mapping System Operator Manual XXIX Setup Communication between AcQMap and Stereotaxis Navigant Network configuration 1. Open Network and Sharing Center. 2. Click on [Change Adapter Settings] from the lefthand pane. 3. Right click the appropriate adapter and go to Properties. 4.
Page 238: Appendix L - Compatible Catheters List
APPENDIX L – COMPATIBLE CATHETERS LIST A list of mapping and ablation catheters available in the dropdown list of Devices in the AcQMap system is provided below: Detailed Description Software String 2.5 mm tip - 4 pole - Ablation - 8F - [Legacy Abl 2.5] Abl 2.5 8 mm tip - 4 pole - Ablation - 8F - [Legacy IntellaTip] IntellaTip...
Page 239: Appendix M - Limited Warranties And Disclaimers
APPENDIX M — LIMITED WARRANTIES AND DISCLAIMERS AcQMap System ACUTUS MEDICAL, INC. WARRANTS THAT REASONABLE CARE HAS BEEN USED IN THE DESIGN AND MANUFACTURE OF ITS PRODUCTS. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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Page 244 FAX: +1 442-232-6081 acutus.com Acutus Medical , the Acutus Medical logo, AcQGuide , AcQRef and AcQMap are registered trademarks of ® ® ® ® Acutus Medical, Inc. Copyright © 2021 Acutus Medical, Inc. All rights reserved. acutus.com/patents OM-009us Rev L (12/2021)

Acutus Medical AcQMap 900100 Operator's Manual

CHAPTER 1 - Introduction

CHAPTER 2 - Warnings and Precautions

CHAPTER 3 - Safety Essentials

CHAPTER 4 - Acqmap System Component Descriptions

CHAPTER 5 - Acqmap System Installation & Setup

CHAPTER 6 - Acqmap System Patient Preparation

CHAPTER 7 - Navigating the User Interface

CHAPTER 8 - Starting a Study

CHAPTER 9 - Setup for Non-Contact Mapping

CHAPTER 10 - Building a Surface Anatomy Using Ultrasound

CHAPTER 11 - Acquiring Recordings

CHAPTER 12 - Reviewing Recordings

CHAPTER 13 - Mapping, Labels and Markers

CHAPTER 14 - Supermap

CHAPTER 15 - Expert Mode

CHAPTER 16 - Setup Contact Mapping

CHAPTER 17 - Creating a Contact Anatomy

CHAPTER 18 - Contact Mapping

CHAPTER 19 - Stereotaxis

CHAPTER 20 - Acqmap System Power down

CHAPTER 21 - Technical Description

Appendix A - Connecting Acqmap with Adjunct Equipment

Appendix B - Manual Configuration of Orientation Reference

Appendix D - Troubleshooting Ultrasound

Appendix E - Manual Catheter Registration

Appendix F - Acqmap System Keyboard Shortcuts

Appendix G - POST and Functional Test Status Indicators

Appendix H - Declaration of Electromagnetic Emissions

Appendix I - on Demand ECG Test

Appendix J - ECG System Test

Appendix K - Setup Acqmap System with Stereotaxis

Appendix L - Compatible Catheters List

Appendix M - Limited Warranties and Disclaimers

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