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ARTEN600035010 A
2018-06
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
2 ARTEN600035010 A
Bedrail Clamp
Catheter Input Module Cable Connector
Display Workstation
Catheter Interface Module cable
connection for catheter inputs 57-120
Display Workstation Kit
Do not reuse
Consult Instructions for Use
DWS Kit
Data Network Connection
DWS Velocity v. 2.0
Date of Manufacture
DWS Velocity v. 2.1
Includes
Equipotential jack
HN Keep Dry
On carton: Transport/storage
temperature limitation
Medical Electrical Equipment
On CathLink™ or RecordConnect
MODEL Model Number
cable: CathLink™ or RecordConnect
catheter channels 1 to 64 cable
connector
Module
Multi-electrode Diagnostic Catheter Multi-electrode Diagnostic Catheter On the EnSiteTM Amplifier: ECG or
RecordConnect ECG cable connector
Non Sterile
On the EnSiteTM Amplifier: Fiber optic
Cable Connector
Link
Software
Power Plug
Software Installation
Power Switch
Software Upgrade Kit Software Upgrade Kit
Printer Printer
Status
Universal RecordConnect
RecordConnect
Catalog number
US Rail Clamp US Rail Clamp
Symbol Description
Weight
Workstation Workstation
Table of Contents
Appendix E. EnSite™ Verismo™ Segmentation Tool Appendix F. EnSite™ Fusion™ Registration Module
Module 261 289
Indications for Use 261 Indications for Use 289
Description 261 Warnings, Cautions, and Disclaimers 289
Contraindications 262 Introduction 289
Warnings and Precautions 262 Performing Registration 290
Operator Requirements 262 Importing a DIF Model 290
System Requirements and Considerations 262 Scaling the EnSite™ NavX™ Navigation and Visualization
Overview of Segmentation 262 Technology Navigation Field 291
Optimal Characteristics for the EnSite™ Verismo™ Placing Fiducial Point Pairs 292
Segmentation Tool Image Files 263 Display Options 295
Loading Files for Segmentation 264 The EnSite™ Fusion™ Registration Module Control Panel
Starting the EnSite™ Verismo™ Segmentation Tool 264 Display Options 295
Verismo Cleanup 264 Map Settings Menu 296
Loading DICOM Files 264
Using DICOM Files from Saved Data 264 Appendix G. Glossary 299
Using the Wizard 265
Introduction to the Patient Screen 265
Selecting a Series for Segmentation 265 Appendix H. Index 309
Viewing Options 266
Subregioning the Series 266
Loading the Series for Segmentation 266
Using the Segmentation Interface 267
Introduction to the Segmentation Screen 267
Menu Bar Summary 268
Using Basic Interface Controls 268
Navigating in Slice Views 269
Using the Zoom Control 269
Using the Pan Control 269
Using the Intensity (W/L) Controls 270
Rotating the 3D Model 270
Using Templates 270
Performing Segmentation 271
Overview of Segmentation Tools 271
Additional Controls: Delete, Undo, Cancel 271
Using the Structure List 272
Structure Attributes 272
Modifying Structures 272
Using the Region Grow Tool 273
Using the Chamber Tool 275
Using the Vessel Tool 276
Using the Separator Tool 277
Using the Trace Tool 278
Using Trace in a Slice View 278
Using Trace in the 3D View 278
Using the Barrier Tool 279
Using the Reassign Tool 280
Reassigning a Structure 280
Placing Labels 281
Using the Measurement Tools 281
Measuring Distances 282
Measuring Volumes 282
Saving and Exporting 283
Key Points About Saving Models 283
Saving the Model to the Hard Drive 283
Exporting Models to CD or DVD 283
Saving Work in Progress 284
Reviewing the Final Model 284
Using the DIF Viewer 284
Viewing Segmentation Contours 285
Printing Images 286
Troubleshooting 286
Contacting Technical Support 286
Troubleshooting Tools 286
Troubleshooting Common Problems 287
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 13
Introduction CHAPTER 1
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have
been indicated.
■ When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the
right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
■ When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to
display the position of conventional electrophysiology (EP) catheters in the heart.
System Description
The EnSite™ Velocity™ Cardiac Mapping System (Figure 1 on page 13) is a catheter navigation and mapping system capable of
displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical
activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-
dimensional maps are based on the anatomy of the patient’s own cardiac chamber.
Figure 1. The EnSite™ Amplifier and Cart (left), DWS and Cart (right).
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
14 Key System Features ARTEN600035010 A
Catheter Catalog – Catheter-specific information, including catheter diameter, tip electrode size, body electrode size, type, and
interelectrode spacing, can be saved to a searchable catalog.
Clipping Plane . The clipping plane helps to increase the understanding and relationship of the model to other related features while
reducing visualization obstructions.
Contact Mapping. Maps can be created from conventional EP catheters. Maps can display various information, including: activation
timing, peak-to-peak voltage, peak-negative voltage, or complex fractionated electrograms.
■ MultiPoint Mapping Technology – Map points can be added from the active electrode, all electrodes on a specified catheter, or all
electrodes in use.
■ Low -V ID – An adjustable Low Voltage Identification (Low -V ID) option allows low-voltage potentials to appear in gray instead
of affecting the color pattern. Low - V ID is available for Local Activation Time (LAT) isochronal maps and Complex Fractionated
Electrogram (CFE) maps.
Data Storage and Export Capabilities. During an EP study, the monitors display the data and that data can be stored on the DWS
hard drive. Once the study is complete, a prompt is displayed to remind the user to back up the study data.
■ Patient records are stored in a database searchable by patient name, patient weight, physician name, date, diagnosis, and study
type.
■ Records are copied to CD/DVD, USB, and network drive.
■ Still images, animations, and study data can be exported to a CD/DVD, USB, and network drive, which can then be displayed and
reviewed using a non-EnSite™ Velocity™ Cardiac Mapping System computer.
■ The study images can be printed using a color printer.
Delayed Enhancement Magnetic Resonance Imaging. – (DEMRI) See “DEMRI (Delayed Enhancement MRI) Image Integration”
on page 137.
Digital Image Fusion (DIF). Digital images processed by segmentation tools such as the EnSite™ Verismo™ Segmentation Tool can
be imported into the EnSite™ Velocity™ Cardiac Mapping System for display.
Field Scaling. – Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates
distance measurements.
■ EnSite™ NavX™ Navigation and Visualization Technology (NavX): Known interelectrode spacing used to create the model is
used to adjust the dimensions of the navigation field.
First Deflection – Searches for the first spot in the signal (from left to right) where the signal deviates from isoelectric baseline by at
least the sensitivity amount.
Fractionation Map – Displays the area of the map where there are clusters of Fractionation and is useful in identifying noisy points
or points that require more attention.Indicates the number of CFE detections.
Image and Animation Export (Offline Review only) – Several options allow images and animations to be captured from the system:
■ Image sequences can be exported as either a series of JPEGs or as an mpeg (.mpg) movie.
Last Deflection – Searches for the last spot in the signal (the first spot when scanning from right to left to right) where the signal
deviates from isoelectric baseline by at least the sensitivity amount.
Models of Cardiac Chambers. The EnSite™ Velocity™ Cardiac Mapping System can generate a model of one or more of the
patient’s cardiac chambers by tracking conventional EP catheter electrodes at various locations on the surface of the endocardium.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600035010 A Key System Features
15
Noncontact Mapping. (EnSite™ Array™ Catheter studies only) When the EnSite™ Velocity™ Cardiac Mapping System is used
along with the EnSite™ Array™ Multi-Electrode Catheter, the system can collect, store, and display more than 3000 intracardiac
electrograms. Several tools are available to facilitate interpretation:
■ AutoFocus Color Controls allow the system to automatically adjust the color levels of isopotential maps to quickly and clearly
identify activation patterns.
■ Isopotential Mapping displays voltages sensed by the EnSite™ Array™ Catheter as three-dimensional maps, which use color to
represent a range of electrical potentials across the surface of the heart chamber’s endocardium. These maps contain the electrical
potentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform display, the
same information is animated in the display of the isopotential map.
■ Single-Beat Isochronal Maps of activation time can be projected onto the surface of the anatomic model in review mode.
■ Substrate Mapping (SM) Tool allows voltage patterns from noncontact mapping to be displayed as maps and labeled on the map.
■ Virtual Waveforms are based on simulated electrodes placed on the map display.
Non-fluoroscopic Catheter Navigation. The EnGuide navigation system allows 3D navigation of conventional EP catheters.
Notebook. The notebook allows recorded data and study information to be filed and annotated for future access.
■ Bookmarks can be added to the Notebook to allow the system to return to a specific time in review mode.
■ Events can be added to the Notebook to mark specific times in a study, such as the time of a drug administration.
OneMap. This feature is used to simultaneously create a cardiac chamber model and a contact map.
Point Count Map – Provides a method to visualize areas of high map point density versus low map point density.
Presets. Presets store setting preferences for catheters, models, maps, and layouts.
Propagation Maps. This feature facilitates the playing back of the activation sequence of recorded reentrant maps.
■ Provides controls to turn this feature on/off and features to control the playing through the activation sequence.
■ Loops over the cycle length.
■ Export of propagation sequences are available only in Offline Review.
Reentrant Maps. These maps facilitate the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps.
Respiration Compensation. (EnSite™ NavX™ Navigation and Visualization Technology studies only.) Respiration Compensation
can be configured to dynamically adjust to the motion artifact from patient respiration during an EnSite™ NavX™ Navigation and
Visualization Technology study. Respiration Compensation can also be manually recomputed during a study.
■ Respiration Meter – A respiration meter displays the relative level of patient respiration in the map display, based on EnSite™
NavX™ Navigation and Visualization Technology transthoracic impedance. The range is based on the lowest and highest
impedance values sampled during Respiration Compensation collection.
■ Respiration Rejection – If a patient’s respiration exceeds the set limits of the respiration levels collected during Data Collection,
the system will stop collecting points and stop placing labels and lesions at the Active EnGuide.
Saturation Recovery. Saturation Recovery allows the system to quickly recover signals following defibrillation or RF energy
ablation. Rapid system recovery allows assessment of post-defibrillation or post-ablation complexes.
Screen Views. The interface can be configured to display different types of information. Various options are available to display
waveforms, one or two maps, and split screen.
Sheath Filter – Determines if an electrode is within the sheath (Sheathed) or outside the sheath (Unsheathed).
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
16 Key System Features ARTEN600035010 A
Signal Recording and Display. The EnSite™ Velocity™ Cardiac Mapping System is designed to collect, record, and display surface
ECG and intracardiac electrogram signals provided by ECG electrodes, conventional EP catheters, other EP laboratory equipment, and
the EnSite™ Array™ Catheter.
Sort Options – The user can sort the collected map points by the following criteria:
■ Order of Collection
■ LAT
■ Peak to Peak
■ Peak Negative
■ CFE Mean
■ CFE Std. Dev.
■ Fractionation
■ Annotation
■ Cycle Length
■ Point Count
■ Point Status
■ Wave Name
■ Force
Sparkle Map – Live activation map overlaid on the voltage map for easy visualization of voltage pathways on a single map.
Stabilize ABL – The Stabilize ABL feature adjusts the location of the distal electrode, based on the properties of the catheter.
Tape Measures. Tape measures allow measurement between points on the anatomic model of the endocardial surface.Tools to
Provide Map Orientation. Several tools are available to enhance map orientation.
TurboMap – Once original mapping has occurred, the user may change mapping criteria and play back through the original dataset at
maximum speed to generate a new map at the DWS’s maximum speed. This may be useful if the physician is mapping Sinus Rhythm
and intermittent, multiple PVC or VT morphology beats are occurring. This may also be useful if the physician is trying to map
multiple, distinct Cycle Length atrial tachycardias.
Waveform Traces. The EnSite™ Velocity™ Cardiac Mapping System has capabilities similar to traditional EP recording systems,
including the ability to collect, store, and display surface ECG and intracardiac electrograms as waveform traces.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600035010 A System Components
17
System Components
The EnSite™ Velocity™ Cardiac Mapping System is comprised of two subsystems: the EnSite™ Amplifier and the Display
Workstation (DWS).
EnSite™ Amplifier
The EnSite™ Amplifier subsystem consists of the EnSite™ Amplifier, NavLink™ Module, ArrayLink™ Module, CathLink™
Module, SJM™ ECG Cable, RecordConnect, and GenConnect. The devices accept signals from electrodes attached to the patient and
pass these signals to the EnSite™ Amplifier. The EnSite™ Amplifier converts these signals to a digital format and sends them to the
DWS for processing.
EnSite™ Amplifier. Accepts signals from the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM™ ECG
Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the DWS for processing. The
Amplifier is connected to the DWS through a fiber-optic cable.
NavLink™ Module. Connects the EnSite™ surface electrodes and the system reference surface electrode to the EnSite™ Amplifier.
It also has a connection for an auxiliary unipolar reference electrode.
ArrayLink™ Module. Connects the EnSite™ Array™ catheter to the EnSite™ Amplifier.
SJM™ ECG cable. Connects standard ECG electrodes to the EnSite™ Amplifier.
RecordConnect. Connects a recording system to the EnSite™ Amplifier without the need for jumpers. A different RecordConnect
model is required for each make of recording system.
GenConnect. Connects the ablation catheter and dispersive surface electrodes to the EnSite™ Amplifier. It isolates the EnSite™
Velocity™ Cardiac Mapping System location signal from being loaded by the ablation generator, thereby eliminating the need for
separate dispersive electrode filters. A different GenConnect model is required for each make of ablation generator.
Workstation. The workstation contains the system software displaying data from the EnSite™ Amplifier. Attached to the workstation
are a keyboard and mouse for user input.
Monitors. Monitors are used to display patient information. One monitor is placed near the workstation and keyboard for system
operation, and an optional second monitor can be placed near the patient table for use by the physician. The monitors display identical
information from the same source.
Medical Grade Isolation Transformer. All system components on the DWS cart are connected to line power through the isolation
transformer. Only components of the DWS should be connected to this isolation transformer.
Video Extender. This device splits the video signal so that the same information appears on both of the EnSite™ Velocity™ Cardiac
Mapping System monitors.
Media Converter. The Media Converter converts optical signals to digital signals. It connects to the hardware via a Fiber Optic Cable
and connects to the DWS via an Ethernet cable and a USB cable, which is used for power only.
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
18 System Components ARTEN600035010 A
Ethernet Switch. The Ethernet Switch allows users to use multiple modules that require Ethernet connections in conjunction with the
EnSite™ Velocity™ Cardiac Mapping System.
EnSite™ Array™ Catheter. This noncontact multi-electrode catheter collects cardiac electrical information.
Conventional EP Catheters . These catheters are introduced into the cardiac chamber of interest and placed in contact with the
chamber wall.
Surface Electrodes – Six surface electrodes are used for the EnSite™ Cardiac Mapping System.
ECG Electrodes. These industry-standard surface electrodes are placed in a standard 12-lead configuration.
System Reference Surface Electrode. A system reference surface electrode is required for all EnSite™ ArrayLink™ Module and
EnSite™ NavX™ Navigation and Visualization Technology studies. This surface electrode should be suitable for defibrillation or
electrosurgery, such as the Covidien™ Valleylab™ Non-REM Polyhesive™ Patient Return Electrodes (see below).
A system reference surface electrode is included in the EnSite™ Velocity™ Surface Electrode Kit.
Remote Monitor. The Remote Monitor can be purchased separately. This monitor is typically used in the Patient area of the lab, where
the DWS may only be available in the control room.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600035010 A EnSite™ Cardiac Mapping System Diagram
19
Figure 3. EnSite™ Velocity™ System fixed installation (preferred installation for new labs).
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
20 EnSite™ Cardiac Mapping System Diagram ARTEN600035010 A
Figure 4. Signal and power connections for an EnSite™ Velocity™ Cardiac Mapping System configuration.
CAUTION: Non-Patient environment system components are not suitable for use within the patient environment where intentional
or unintentional contact can occur between a patient and these components or between a patient and other persons
touching parts of these components.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600035010 A Warnings and Cautions
21
WARNING: A warning contains information for avoiding hazards that represent a significant hazard to the patient or operator.
Warnings are also used for hazards that could significantly harm the EnSite™ Velocity™ Cardiac Mapping System.
CAUTION: A caution contains information for avoiding hazards to the system components or improper system performance.
Operator Requirements. The EnSite™ Velocity™ Cardiac Mapping System must be operated by, or under the supervision of, an
electrophysiologist trained in the operation of the EnSite™ Velocity™ Cardiac Mapping System and supported by other qualified
personnel trained in the field of cardiac EP. It must be used in conjunction with other equipment required for electrophysiology studies
such as suggested by the North American Society of Pacing and Electrophysiology1 (a.k.a. Heart Rhythm Society) and the American
Heart Association2.
Support Equipment. The EnSite™ Velocity™ Cardiac Mapping System is not intended for use as a primary ECG monitor. During
EnSite™ Velocity™ Cardiac Mapping System studies, an ECG monitor that conforms to safety requirements defined in IEC 60601,
designated as the primary ECG monitor, must be present.
Connections to non-EnSite™ Velocity™ Cardiac Mapping System equipment. Observe the following:
CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator,
defibrillator, and other devices) may create a location shift.
■ Do not modify or make any additional connections to the EnSite™ Velocity™ Cardiac Mapping System, other than those
described in this manual.
■ Do not connect the system to multiple portable socket outlets or extension cords.
WARNING: Installing an un-approved operating system or software on the EnSite™ system DWS hard drive may severely affect
system performance and device safety.
WARNING: The EnSite™ Velocity™ Cardiac Mapping System should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, this product should be observed to verify normal operation in the configuration in
which it will be used.
WARNING: For patient safety, any connections that directly connect the patient to the EnSite™ Velocity™ Cardiac Mapping System
must be routed through the appropriate module: NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM™
ECG Cable, RecordConnect, or GenConnect.
CAUTION: The EnSite™ Array™ Catheter is intended for single use only. Device integrity will be compromised by any reuse, which
may compromise patient safety and system performance.
CAUTION: The EnSite™ Velocity™ Surface Electrode Kit is intended for single use only. Device integrity will be compromised by
any reuse, which may compromise patient safety and system performance.
■ Do not touch non-medical equipment and the patient at the same time.
Damaged Cables. Between studies, inspect cables for insulation or connector damage. Replace damaged cables immediately.
Validating the EnSite™ Array™ Catheter. Always have the EnSite™ Array™ Catheter inserted into the patient before validating the
catheter in the software.
1. Waldo, AL, et. al, “NASPE Policy Statement: The Minimally Appropriate Electrophysiologic Study for the Initial Assessment of Patients with Documented Sustained Monomorphic
Ventricular Tachycardia,” PACE, v. 8, pp 918-922, 1985.
2. Gettes, LS, et. al., “AHA Committee Report: Personnel and Equipment Required for Electrophysiologic Testing,” Circulation, v. 69, pp 1219A-1221A, 1984.
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
22 Warnings and Cautions ARTEN600035010 A
Validating EnSite™ NavX™ Navigation and Visualization Technology. Before validating EnSite™ NavX™ Navigation and
Visualization Technology, make sure that all connections have been made between the EnSite Amplifier and DWS. Ensure that the
EnSite™ NavLink™ Module is connected to the EnSite™ Amplifier and that all EnSite™ Velocity™ surface electrodes have been
connected as described. In particular, make sure that the left leg surface electrode is connected to the EnSite™ NavLink™ Module.
Validation should be performed as close as possible to creating the first model, map or 3D point.
External Stimulation. When using stimulus inputs on multiple EP systems, use care not to deliver stimulus through multiple paths.
Software Warning Messages. Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an
inability to record data or to communicate properly with the EnSite™ Amplifier.
CAUTION: Make all connections between systems before validating EnSite™ NavX™ Navigation and Visualization Technology.
Adding or removing connections after validation may affect navigation quality. Additionally, all patient connections to
ancillary equipment (e.g. external defibrillators) should be made prior to validation. Connections between systems refers
only to SJM-supplied or approved devices.
CAUTION: When the EnSite™ Amplifier is turned off, it can affect ECG signals viewed on the recording system. When the EnSite™
Amplifier is turned off and a recording system is in use, it is recommended that the cables to the EnSite™ Cardiac
Mapping System be disconnected from the EnSite™ Amplifier.
WARNING: Do not use Stabilize ABL in situations where the proximal electrodes on the ablation catheter may be covered by a sheath.
CAUTION: (EnSite™ Array™ Catheter studies) If the EnSite™ Array™ Catheter is repositioned or unintentionally moved, a new
model must be created. If a new EnSite™ Array™ Catheter is introduced, a new study must be started.
■ For EnSite™ NavX™ Navigation and Visualization Technology studies, a new study must be started if any of the EnSite™
Velocity™ surface electrodes are repositioned.
■ EnSite™ NavX™ Navigation and Visualization Technology studies intending to use Field Scaling must not have electrodes in a
sheath during point collection.
NOTE: Using location information from non-functional electrodes may yield unexpected Field Scaling results. This cannot be
reversed. However, the use of Field scaling is optional and can be unapplied if unexpected results are seen.
■ Check for and disable non-functional electrodes or electrodes in a sheath before creating a model. Collecting points from non-
functioning electrodes or electrodes in a sheath can result in unexpected field scaling results. See “Field Scaling” on page 134 for
details.
WARNING: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator,
defibrillator, and other devices), poor patch adhesion or patient movement may create a location shift. Use conventional
EP techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location.
WARNING: Overlap of cardioversion patches and surface electrode patches may result in patient skin burns.
Noncontact Mapping. Use appropriate techniques when interpreting data from noncontact maps:
CAUTION: When placing bipolar virtual electrodes near the poles of the map, select latitudinal orientations. Failure to do so may
cause the electrograms to be computed improperly, resulting in inaccurate traces.
CAUTION: If the high pass filter is set to low frequencies (< 2Hz), signals may be subject to low-frequency baseline drift.
CAUTION: In the caliper measurements for noncontact isochronal maps and Substrate Mapping, do not use portions of the waveform
display that have purple waveforms.
CAUTION: If the EP catheter electrode is not in contact with the endocardium, the comparison between the EnGuide virtual
electrogram and the EP catheter electrode may not accurately reflect the relationship between these signals.
CAUTION: Do not disconnect the Array Module from the EnSite™ ArrayLink™ Module or the EnSite™ ArrayLink™ Module from
the EnSite™ Amplifier during a study.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600035010 A Warnings and Cautions
23
Shutting Down the Workstation. To shut down the workstation, always follow the instructions in “Ending a Study” on page 209.
WARNING: If the workstation is powered off by the user, rather than shutdown by the operating system, data on the hard drive may
become corrupted and the EnSite™ Velocity™ Cardiac Mapping System may cease to be operational.
Removable CD/DVD Handling. CD/DVDs must be handled with care. Do not allow CD/DVDs to fall onto a hard surface. Do not
place paper labels on the CD/DVD, write directly on the CD/DVD.
Surface Electrodes. Use care in applying and removing surface electrodes (ECG, system reference, EnSite™ Velocity™ surface
electrodes):
CAUTION: Ensure that surface electrodes and associated connectors do not contact one another, electrical ground, or metallic
objects.
CAUTION: Do not attempt to connect the system reference surface electrode for the EnSite™ Velocity™ Cardiac Mapping System
to other equipment, such as ablation systems.
CAUTION: The system reference surface electrode must be the first patient electrode connected to the EnSite™ Amplifier at the
beginning of a study, and the last patient electrode to be disconnected at the end of the study.
CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient
before disconnecting its jack from the EnSite™ NavLink™ Module.
CAUTION: Do not warm the ECG surface electrodes before they are positioned on the patient.
CAUTION: Do not warm the EnSite™ Velocity™ surface electrodes before they are positioned on the patient.
CAUTION: Do not warm the system reference surface electrode before it is positioned on the patient.
WARNING: Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, or the “use by” date has
passed.
WARNING: Before applying the EnSite™ Velocity™ surface electrodes, ensure that the application sites are hair-free, clean, and dry.
Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.
WARNING: Before applying the System Reference surface electrode, ensure that the application site is hair-free, clean, and dry.
Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.
Liquids . System components are susceptible to damage from liquids. Keep liquids away from this equipment.
CAUTION: Do not apply cleaners while the system is warm to the touch.
CAUTION: Do not sterilize EnSite™ Velocity™ Cardiac Mapping System interconnect cables.
CAUTION: Do not use aerosol sprays near the equipment as these sprays can damage circuitry.
CAUTION: Do not leave cable connectors where they can be damaged, particularly on the floor, where they can easily be stepped on
and damaged.
CAUTION: Pull connections apart by gripping the connector. Do not pull them apart by tugging on the cable as this can damage the
connecting cable. Never force a connection or a disconnection.
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
24 Best Practices and Recommendations ARTEN600035010 A
Hardware Disposal. The EnSite™ Velocity™ Cardiac Mapping System contains electronic printed circuit board assemblies that may
contain lead-based solder. Disposal of the equipment must be in accordance with local laws.
NOTE: Refer to “Technical Specifications” on page 247 for specific environmental electromagnetic specifications and
recommendations.
NOTE: Activate security settings, individual user logins, and passwords per the Administrators Guide For the EnSite™ Cardiac
Mapping System.
Compatible Components. The EnSite™ Velocity™ Cardiac Mapping System has been tested to meet the safety requirements of IEC
60601-1 (refer to Table 35 on page 248). Use of components, accessories and cables other than those specified by St. Jude Medical
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper
operation. These components have been tested to meet safety requirements:
■ EnSite™ Velocity™ system Display WorkStation (DWS)
■ EnSite™ Amplifier
■ Hospital grade power cord
■ RecordConnect
■ GenConnect
■ CathLink™ Module
■ ArrayLink™ Module
■ NavLink™ Module
■ SJM™ ECG Cable
■ EnSite™ Array™ Catheter
■ Fiber optic cable
■ EP WorkMate™ System 4.3.x
■ WorkMate Claris™ System 1.x
■ GE CardioLab™ Recording System
■ LABSYSTEM™ PRO EP Recording System with ClearSign™ Amplifier
■ Siemens AXIOM™ Sensis™ XP Recording System
■ EnSite™ Velocity™ Surface Electrode Kit
Compatible Modules. The EnSite™ Velocity™ Cardiac Mapping System is compatible with the following software modules:
■ AutoMark Module
■ EnSite™ AutoMap Module
■ EnSite™ Contact Force Module
Chapter 1. Introduction EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
26 Best Practices and Recommendations ARTEN600035010 A
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 27
Operating Modes
The EnSite™ Velocity™ Cardiac Mapping System can operate in two modes: Realtime and Offline Review. The operating mode
determines which system functions are available.
■ Realtime mode allows data to be gathered, displayed, and recorded simultaneously while a patient is being studied. Patient
connections to the EnSite™ Amplifier are required, and the EnSite™ Amplifier must be powered on.
■ Offline Review mode allows data from a previous study to be viewed and edited. The EnSite™ Amplifier does not need to be
connected or powered on.
The functions available in Offline Review mode are more limited than those available in Realtime mode. Table 1 on page 27 describes
the functions that are available in Realtime mode and Offline Review mode.
Mapping Primary & Secondary View: Left Primary pane shows the • Open maps.
realtime study. Right Secondary pane shows either Realtime or • Review map points.
Review. (When Split Screen is active.)
• Collect points from the recorded catheter signal.
Real • In Realtime mode, the Real Review task allows recorded data • In Offline Review mode, the Review task allows recorded data
Review from the study to be viewed. from a past study to be viewed and edited.
• Primary & Secondary View: Left Primary pane shows the • Primary & Secondary View: Left pane shows recorded data
realtime study. Right Secondary pane also shows the realtime from the past study selected in the Title screen. Right pane
study. You can switch between realtime and recorded shows a different view of the recorded data from the same past
information. study.
Main Workspace
G Q
A F B
C
D E
H
I
K
J
L
N
O P
Figure 5. The main workspace (the EnSite™ NavX™ Navigation and Visualization Technology Model workflow is shown here).
A Menu Bar Provides access to system-level controls. For more information, refer to “Menu Bar” on page 29.
B Task Bar Provides access to the five workflow tasks: Setup, Model, Mapping, Therapy, and RealReview (Note, when
in Offline Review mode, the RealReview task button reads just Review). When selecting a task, the right-hand
control panel changes to provide controls and settings relevant to the task. Each task may have sub-tasks.
C Subtask Bar Most workflow tasks have subtasks. For example, the Setup task has ECG, Catheter, and either EnSite™ NavX™
Navigation and Visualization Technology or EnSite™ Array™ Catheter subtasks. In Figure 5 the Model subtasks
shown are Model, DIF and Fusion (with EnSite™ NavX™ Navigation and Visualization Technology). When a
subtask icon is selected, the control panel changes.
G Split Screen View Switches between single and split screen views. Display two maps, each generated with a different set of mapping
points. The primary display contains the live map, while the secondary can display the same map, a second live map
generated with different mapping points, or a Review map. See “Split Screen” on page 39 for more information.
H Single/Dual View Toggles between single and dual map views. Refer to “Dual View” on page 38 for more information.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 2. Using the Graphical User Interface
ARTEN600035010 A Common Controls
29
K Control Panel Each task or subtask has its own control panel that displays the controls applicable to the task.
L Tool Palette The tools that are available depend on the task that is enabled and the state of the procedure. Only one tool can be
selected at a time from the palette. For more information, refer to “Tool Palette” on page 32.
M Model/Map Display The area where catheters, three-dimensional models, and/or maps are displayed.
O Status Bar The status bar contains icons that indicate the status of various system components, as well as system information.
P Bedside View Depending on the system setup, this control adjusts the bedside monitor display, so that different parts of the
workspace may be brought into view. This control will be present only if a remote monitor with a display of 1600 x
1200 (21inch) or less is part of the system setup.
An abbreviated view of the EnSite™ Velocity™ Cardiac Mapping System displays because the lower resolution of
the 21-inch bedside monitor can display only a portion of the higher resolution primary monitor.
• By default, the left portion of the primary monitor containing the model/mapping workspace displays on the bedside
monitor.
• The Bedside View button enables you to toggle the bedside monitor to display the left side (model/mapping) or the
right side (control panel) of the primary monitor screen.
• The Bedside View button can only be controlled in the lab or control room where the lab technician has access to
the mouse.
NOTE: Primary Monitor: a 24-inch wide-screen monitor (1920x1028 resolution) should always be used as the primary monitor.
The DWS will automatically configure this monitor to display the system’s full screen view.
Remote Monitor. The remote monitor is available as either a 21-inch monitor (1600x1200, 4:3 aspect ratio), 24-inch wide-screen
monitor (1920x1200, 16:10 aspect ratio), or 23-inch monitor (1920x1080, 16:9 aspect ratio).
The EnSite™ Velocity™ Cardiac Mapping System uses a video extender to transmit a video signal from the DWS to the remote
monitor over a fiber-optic cable. Refer to “Connecting the Remote Monitor to the DWS” on page 54 about how to connect the remote
monitor to the DWS.
Common Controls
Menu Bar
The menu bar provides access to system-level controls. All active menu bar and menu
options for the current operating mode are displayed in white lettering. Options not
available for the current operating mode are shown in gray lettering. Selecting a menu will Figure 6. The menu bar.
display a column of additional options. Menu options followed by three periods “...” will
display a window when selected.
The menu bar can also be accessed using the keyboard. Notice that each of the menu names in the menu bar has one letter underlined.
Hold the <Alt> key and press the key that corresponds to the underlined letter. For example, hold <Alt> and press <F> to access the
File menu.
NOTE: The underlined letters in the menu bar will be different, dependent on the translated language.
Chapter 2. Using the Graphical User Interface EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
30 Common Controls ARTEN600035010 A
File Study/Patient Information Displays the Study and Patient Information screen.
Save Bookmark... <Ctrl> + <B> Create and save a bookmark to the notebook. (Review mode only.)
Save Event... <Ctrl> + <E> Create and save a timestamped comment to the Notebook.
Save Animation... Capture and save either MPEG movies or a series of JPEG images
Load DIF Import a three-dimensional model created from digital images collected from Spiral CT or
MRI for display in the EnSite™ Velocity™ Cardiac Mapping System for display. See
“Digital Image Fusion (DIF)” on page 135 for more details.
Resume Study Initiates the continuation of a previous study. Available in Offline review mode only.
End Study <Ctrl> + <Q> End the current study and Logout.
Reconnect Initiate communication between the DWS and EnSite™ Amplifier. (Realtime mode only.)
Validate... Initiate the use of the EnSite™ Array™ Catheter or EnSite™ surface electrodes. (Realtime
mode only.)
HotKeys Synchronize Split Screen <F3> Synchronizes the two screens so that both models pan, zoom, rotate, spin, and change
perspective together.
EnGuide Enabled <Shift> + <F5> Turn on/off the EnGuide navigation system.
Add 3D Lesion at EnGuide <Shift> + <F6> Add a 3D lesion at the Active Electrode.
Step Forward <right arrow> Moves the cursor to the right (forward)
Step Backward <left arrow> Moves the cursor to the left (backward)
About Display hardware and software version information, copyright information, notable
features, and known issues.
Chapter 2. Using the Graphical User Interface EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
32 Common Controls ARTEN600035010 A
Tool Palette
The tool palette is shown in Figure 7. The available tools depends on the active task. The properties for a selected
tool display in the toolbar.
Table 4. Tool Palette
B Auto Correct Centers the model back into view, if it is beyond the borders of the screen. B
Model
Visibility C
C Rotate/Pan The Rotate/Pan (hand) tool is used to rotate the model or map.
D
D Arrow Used for selection.
E
E Label Used to annotate a model or map. For more information, refer to “Labels” on page 153.
NOTE: The labels have no intrinsic meaning to the EnSite™ Velocity™ Cardiac Mapping System. F
Users can assign their own meaning to labels.
F Anatomic Used to create anatomic markers. For more information, refer to “Anatomic Markers” on page 155. G
Marker
H
G Tape Measure Used to create tape measures. For more information, refer to “Tape Measures” on page 162.
H Lesion Used to create lesions. For more information, refer to “Lesion Markers” on page 196. I
I Virtuals (EnSite™ Array™ Catheter studies only) Used to place virtual electrodes on noncontact maps. For
more information, refer to “Virtuals” on page 167.
J
J EnGuide Used to place a shadow on the selected EnGuide. For more information, refer to “EnGuide K
Shadow Shadows” on page 158.
L
K Add a Caliper Add a timing caliper.
L Cleanup Toggle: Show/Hide meters and controls in the Model/Map display area. M
Display
M Meter Clicking this icon displays a list of checkboxes that control the display of: N
Displays • Velocity Meter (EnSite™ NavX™ Navigation and Visualization Technology only)
• Velocity Filter (EnSite™ NavX™ Navigation and Visualization Technology only) O
• Respiration Meter (EnSite™ NavX™ Navigation and Visualization Technology)
• Voltage Caliper
P
• Tracking Virtual (ArrayLink™ Module only, RealReview)
• Electrode Spacing (EnSite™ NavX™ Navigation and Visualization Technology only)
• Proximity to Surface (realtime only) Q
• Velocity Lockout Slider (EnSite™ NavX™ Navigation and Visualization Technology only)
• Collect Respiration Data (EnSite™ NavX™ Navigation and Visualization Technology only). Figure 7. Tool
For more information, refer to “Information Display Settings” on page 149. palette.
NOTE: In an EnSite™ Array™ Catheter study, Velocity Filters, Meter Threshold, and Lockout
Settings are not available.
N EnGuide Displays a list of checkboxes that control the EnGuide Display options, including Show EnGuides,
Displays Electrode Numbers, Active EnGuide Silhouette, Stabilize ABL, and a slider control for EnGuide
Responsiveness. For more information, refer to “EnGuide Display Settings” on page 148.
O Display Map Settings Properties (see “Map Settings Properties” on page 147)
Settings
P Waveform Filters/Waves properties used to control the filter settings for the waveforms and the settings used
Display for manipulating the displayed waveforms.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 2. Using the Graphical User Interface
ARTEN600035010 A Common Controls
33
Q Detection Configure signal detection settings (see “Signals Collection” on page 179).
Settings
NOTE: When a Map Tag is selected, the color of its name changes to white or red in the model/map display area.
NOTE: Multiple Map Tags can only be selected if they are of the same type (such as labels, anatomic markers, tape measures
lesion markers, and EnGuide shadows).
NOTE: When a Map Tag is selected, the color of its name changes to white in the model/map display area.
A. Button. Click a button to initiate the action described by the button’s label. B C
Buttons are referred to in the text with the button’s label in brackets, such as “Click
[OK] to continue.” Some labels on buttons will change to reflect the buttons role in a
process. For example, in the Mapping control panel, clicking the propagation map
[Play] button changes the button to [Stop]. When the [Stop] button is clicked, it E
changes to [Play]. The following buttons commonly appear at the bottom of
D
windows:
■ [OK] – When clicked, all the settings in the window are accepted, the required E
actions are performed, and the window closes.
■ [Apply] – When clicked, all the settings in the window are accepted, the required
actions are performed, and the window remains open.
E
■ [Cancel] – When clicked, settings that have not been applied are ignored, and
the window closes, without implementing changes.
■ [Close] – This button appears in windows with controls that take effect as soon E
as they are selected. When clicked, the window closes.
F
B. Checkbox. The item is selected when either a white check mark ✓
or ✕ is shown in the box. When the box is empty, the item is not selected. Click the
checkbox to select or unselect the item.
E. Slider. Click and drag the bar to change the value. In some cases, the value is
displayed to the right of the slider.
Interface Text. Interface text is shown in this document as a bold sans-serif font.
Lists. Lists display information that can be selected by clicking with the mouse. If a
list contains more information than will fit in the list, scrollbars appear on the right
or bottom edge of the list. Click and drag the scrollbars to move the information in
the list.
■ Select contiguous multiple items from a list by clicking and dragging in the list
or by clicking one item, pressing <Shift>, and then clicking another item to
select all items in between.
■ Select multiple individual items from a list by hold down <Shift> while clicking
on items in the list.
Figure 8. Common Controls.
Text areas. Text areas are for typing text using the keyboard. To use a text area, click
on the text area to display a cursor. Then, use the keyboard to type information into the text area.
NOTE: In the Toolbar area only, when typing in new names (e.g., labels, markers, shadows), the area behind the text turns a pale
yellow color. This is a reminder that the text entry is not complete until <Enter> has been pressed.
Keyboard keys. Keys on the keyboard are represented by the text that appears on the key in angled brackets, such as <Shift>.
Chapter 2. Using the Graphical User Interface EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
36 Common Controls ARTEN600035010 A
When the Mapping task is selected, the Mapping Settings appear in the control panel on
the right side of the main workspace. You can save these settings as “Presets” when you
anticipate using a particular setting often for future setups. A
B
When Split Screen is active, the settings apply to the display that has focus, which is
highlighted with a yellow border.
A. Active map name: Name of the map that has focus (yellow border). Double-click the C
name to rename the map.
NOTE: At least one LAT point must be mapped and saved in order for Peak-to-Peak,
Peak-Negative, and CFE Mean options to become available.
C. Settings
– Low-V ID slider
– Map Display (Standard LAT, Reentrant Map, Propagation Map, [Play])
■ Map Display (Standard LAT, Reentrant Map, Propagation Map)
Dual View
Dual View allows you to display two views of the same map. Using Dual View with Split Screen mode you can display two views of
the same map in either the primary or secondary display, or in both displays.
In Dual View, the active view is highlighted by green corners. To make the other view active, click once on the black background of
the non-highlighted view.
The following features are available only for the highlighted, active view:
■ Using the mouse to rotate the model
■ Adjusting the clipping plane
■ Adjusting the view scale
■ Saving or loading a Map View
Using the mouse to delete surface points or place map labels, lesion markers, anatomic markers, tape measures, or virtual electrodes
can only be done in the highlighted view; however, the result of these actions appear in both views.
C
A B
Callout Description
A Primary View
B Secondary View
Split Screen
(Available in all tasks except Setup.)
Split Screen mode allows you to display combinations of Realtime and Review maps, generated with the same or different mapping
points. You can:
■ Display the same map side-by-side in Realtime and Review workflows
■ Display two different maps, each generated with the same or different mapping points
■ Display one Realtime map (primary display) and one Realtime or Review map (secondary display)
NOTE: To visualize different screen arrangements, try a different screen layout preset (see “Screen Layout Presets” on page 42).
F
I E
G
A B
Window Elements
Table 6. Horizontal Split Screen Mode Elements
Callout Description
D Yellow highlight around the active display. The Control Panel works with the active display and shows the active map name (E).
G Toggle on or off unipolar map. Available only for Peak-to-Peak and Peak-Negative.
Hotkey Hotkey F3 Synchronizes the two screens so that both models rotate and zoom together
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 2. Using the Graphical User Interface
ARTEN600035010 A Common Controls
41
NOTE: You can only have one Realtime Waveforms display at a time, even when in Split Screen mode. The second Waveforms
display will revert to a blank window showing that the Waveforms content has been selected, and it will fill the window
when it can (if the display group is changed to show review data, or the Waveforms display from the other realtime
display group is closed).
B C
B C
B C
NOTE: A Layout Preset contains the configuration for a single display group. When saving a Layout Preset in Split Screen mode,
the preset will contain only the information for the focused display group (outlined with the yellow focus box). When
loading a Layout Preset, it will load only into the focused display group.
C
D
E F
Display Options
The following options are available from the right-click menu in the respective window:
■ Size, location, and content type of each window
■ Waveform Display (Figure 13 E)
– Font Size
– Sweep Speed
– Wave Thickness
■ Acquisition Waveform Display (Figure 13 F)
– Font Size
– High/Low Lines setting (“Show All”, “Show Distal”, or “Hide All”)
– Sweep Speed
– Wave Thickness
■ Map Display
– Active EnGuide Silhouette (Off, Normal, Enhanced)
– CL/Metric display
– Visibility
– Flash for new points on/off
– Electrode spacing visibility
– Font Size
– Proximity Indicator
– Visibility
– Fixed on/off
– Proximity to Surface visibility (text display)
– Respiration Meter visibility
– Tracking Virtual visibility
– Velocity Meter visibility
– Voltage Caliper visibility
System Messages
System messages appear near the status tray or on the desktop. The appearance and behavior of each message depends on the severity
of the situation. System messages are logged to the system for troubleshooting purposes. There are four types of messages, as shown
below.
Information Message
Information messages are non-critical messages that appear temporarily in a blue window
above the status tray. They persist for 3 seconds and then fade away. (Figure 15).
NOTE: Access a list of Information and Advisory messages displayed during the study
by clicking on the Message Log icon in the status tray in the lower right portion
of the screen of Realtime and live studies only.
Figure 15. Information message.
Advisory Message
Advisory messages appear above the status tray and persist until the user closes the message
(Figure 16).
NOTE: Access a list of Information and Advisory messages displayed during the study by
clicking on the Message Log icon in the status tray in the lower right portion of
the screen of Realtime and live studies only.
Figure 16. Advisory message.
Warning Message
Warning messages alert the user of an action that is going to occur and asks the user to verify
the action. The message must be acted upon before any other action can be taken on the system.
Figure 18. Warning message.
NOTE: Some warning messages can be disabled by checking the “Do not show this
message again” box; once this box is checked and the user clicks OK, the message
will no longer display for the remainder of the study session.
Chapter 2. Using the Graphical User Interface EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
46 Notebook ARTEN600035010 A
Notebook
The section labeled “A” shows study information stored in the Notebook, which can
be presented in Order by Type or Order by Time. The section labeled “B” shows A
labels names and visibility status.
The Notebook contains study information that was saved during a study. This
information includes the following:
NOTE: Click on Order by Type / Order by Time to switch from one to the other.
▼ Order by Type
■ Animation
■ Bookmark
■ Mapping
■ Image Sequence
■ Segment
■ Stop Time
■ Auto Segment (System automatically adds)
■ Comment
■ Image
■ Model
■ StartTime
Order by Time
For example:
– Autosegments (#)
– Events (#)
– Segments (#)
B
– Images (#)
– Bookmarks (#)
– Mapping (#)
– and others....
The Notebook is used to review segments and other events saved during a study.
Events are designated under Description and are logged along with the associated
Time that the event took place.
Saving an Event
(Realtime mode and RealReview mode only)
An event can be added to the Notebook to mark important activities (e.g. drug
administration). An event is always stamped with the current Realtime clock (not the time
cursor, in RealReview mode.)
NOTE: The key sequence for saving an event is <Ctrl> + <E>. The time is stamped
when the key sequence is executed.
1. From the menu bar, select File > Save Event. The Save Event window will appear
(Figure 20 on page 47).
2. Type the text of the annotation in the text area, and then click [Save].
Figure 20. The Save Event window.
Saving a Bookmark
(RealReview mode and Offline Review mode only)
Bookmarks create Notebook entries that allow the system to return to a specific time.
NOTE: The key sequence for saving a bookmark is <Ctrl> + <B>. The time is stamped when the key sequence is executed.
1. If the segment is playing, pause it by clicking [ll].
2. From the menu bar, select File > Save Bookmark. The Save Bookmark window will appear.
3. Type the annotation for the bookmark in the text area, and then click [Save].
Chapter 2. Using the Graphical User Interface EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
48 Presets ARTEN600035010 A
Presets
Load a preset
Open the Preset menu and select a preset from the list. The menu
lists all of the available presets, which include not only the active
physician but all physicians.
Save a preset
To save the current settings as a preset, open the Preset menu in
the upper-right corner of the control panel, select Save Preset,
type a name for the preset, in the Name text area then click [OK].
WARNING: For patient safety, any connections that directly connect the patient to the EnSite™ Velocity™ Cardiac Mapping System
must go through the NavLink™ Module, the ArrayLink™ Module, the CathLink™ Module, SJM™ ECG Cable,
RecordConnect, and GenConnect.
The connections shown in this chapter should only be made after a successful
EnSite™ Velocity™ Cardiac Mapping System installation by qualified SJM
personnel.
Description
The EnSite™ Amplifier accepts signals from the NavLink™ Module, the
ArrayLink™ Module, the CathLink™ Module, SJM™ ECG Cable,
RecordConnect, and GenConnect, converts these signals to digital format,
• See Note: and sends them to the workstation for processing. The EnSite™ Amplifier is
for letter “H” connected to the workstation through a fiber-optic cable.
A. Status lights.
B. GenConnect connector.
I. Power switch.
K. Equipotential ground.
Description
Description
Description
A. Catheter connectors.
Description
RecordConnect Connections
Description
GenConnect Connections
Description
Use the fiber optic cable to connect the DWS to the EnSite™ Amplifier. Take one end of the fiber-optic cable and align the tabbed
edge of the connector on the cable to the slotted edge of the connector on either port of the EnSite™ Amplifier, and press it into place.
Take the other end of the fiber optic cable and connect it to the Media Converter in the same manner.
If, for any reason, the DWS and EnSite™ Amplifier must be disconnected, be sure to disconnect the fiber optic cable from the EnSite™
Amplifier and the Media Converter and store it in a safe place.
The local monitor is connected to the DWS using a digital video connector cable Connect one end of the cable to the digital video
connector on the back of the DWS, and connect the other end to the connector on the rear of the monitor. Hand-tighten the connector
thumb screws at each end.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
54 Connecting the Remote Monitor to the DWS ARTEN600035010 A
The remote monitor is connected to the DWS by means of a video extender. Two type of video extenders available: Opticis and
Avenview. The procedure used to connect the remote monitor to the DWS depends on the video extender being used. Refer to one of
these procedures:
■ “Opticis Video Extender” on page 54.
■ “Avenview Video Extender” on page 56.
A B
C
D
F
Figure 30. Opticis Video Extender and Workstation Remote Monitor Connection.
Table 8.
A 5V DC Power Cable
C Blue LED
F Display Port
3. Start the workstation. The same video should display on both the Primary Monitor and on the Remote Monitor.
4. Follow the steps in “Using the Remote Monitor Configuration Tool” on page 58 to configure the remote monitor.
NOTE: Avoid wear and tear on the fiber optic video cable connections by only handling the (Opticis) video extenders by the
black chassis. Avoid repeatedly disconnecting and re-connecting the fiber optic video cable connectors.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
56 Connecting the Remote Monitor to the DWS ARTEN600035010 A
The Avenview COMPUTER video extender must be configured for use with the remote monitor before first use. Whenever the model
of the remote monitor is changed, the Avenview COMPUTER video extender must be reconfigured.
C Red LED
D 5V DC Power Cable
2. Connect the MONITOR video extender to the remote monitor (see Figure 32):
a. Plug the 5VDC Power Adapter into a power source and then into the video extender.
b. Connect the video extender to the remote monitor’s DVI input connector.
Table 10.
A DVI Input
C Red LED
D 5V DC Power Cable
3. Connect the DVI converter cable to the COMPUTER video extender, then connect the
DVI converter cable (D) to the workstation display port (E). (See Figure 33 on page 57.) Figure 32. Remote Monitor
Connections.
4. Connect one end of the fiber optic cable to the MONITOR video extender, and the other
end to the COMPUTER video extender.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Connecting the Remote Monitor to the DWS
57
5. Be sure to connect the same color to each connection (either both black or both red).
A B
C E
Figure 33. Avenview Video Extender and Workstation Remote Monitor Connection.
Table 11.
A 5V DC Power Cable
E Display Port
6. Restart the Workstation. The same video should display on both the Primary Monitor and on the Remote Monitor.
NOTE: If the Remote monitor fails to display properly after the reboot, refer to “Using the Remote Monitor Configuration Tool”
on page 58.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
58 Using the Remote Monitor Configuration Tool ARTEN600035010 A
NOTE: Click [Reset to Default (Auto-select)] to return the system to the state where it will attempt to function with whichever
monitor is connected.
5. Click [Reboot Now] to complete the setup.
NOTE: All changes will be discarded if the user does not select [OK] before exiting. Changes will not take effect until the DWS
is rebooted.
NOTE: All monitors and video extenders should be connected prior to booting or re-booting the DWS.
NOTE: The DWS detects monitors and video extenders that are connected to it during the boot process. Any monitors or video
extenders that are not connected during the boot process will not have their video signals enabled by the DWS (i.e. you
will not see anything on the monitor.)
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Connecting Cables to the EnSite™ Amplifier
59
The NavLink™ Module, ArrayLink™ Module, CathLink™ Module, SJM™ ECG Cable, RecordConnect, and GenConnect are
connected to the EnSite™ Amplifier using locking ring connectors.
Figure 34. Connecting a cable to and disconnecting a cable from the EnSite™ Amplifier.
■ To connect a cable to the EnSite™ Amplifier (Figure 34 above), align the dot on the cable connector with the arrow on the
EnSite™ Amplifier connector and push the cable connector onto the EnSite™ Amplifier connector until a click is heard.
■ To disconnect a cable from the EnSite™ Amplifier (Figure 34 above), turn the locking ring on the cable connector
counterclockwise and pull the cable connector off of the EnSite™ Amplifier connector.
Color-Coded Connections
The cable connectors and the EnSite™ Amplifier connections are color coded and labeled with identical icons on each, for easy
identification. The icons and color codes are described in Table 12 below.
Black GenConnect
A system reference surface electrode is required for proper system operation for EnSite™ Array™ Catheter and EnSite™ NavX™
Navigation and Visualization Technology studies. The system reference surface electrode connects to the NavLink™ Module.
Therefore, EnSite™ Array™ Catheter studies require both the ArrayLink™ Module and the NavLink™ Module.
NOTE: The EnSite™ Velocity™ Surface Electrode Kit contains a system reference surface electrode.
CAUTION: Do not warm the system reference surface electrode prior to application to the patient.
CAUTION: The system reference surface electrode must be the first patient electrode connected to the EnSite™ Amplifier at the
beginning of a study, and the last patient electrode to be disconnected at the end of the study.
CAUTION: Do not attempt to connect the system reference surface electrode for the EnSite™ Velocity™ Cardiac Mapping System
to other equipment, such as ablation systems.
WARNING: Do not use surface electrodes if the package seal is broken, the conductive adhesive is dry, or the “use by” date has
passed.
WARNING: Before applying the system reference surface electrode, ensure that the application site is hair-free, clean, and dry.
Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.
The numbered steps in the following procedure correspond to the numbered callouts in Figure 36 on page 60.
1. Place the system reference surface electrode on the patient’s abdomen (Figure 36 on page 60).
2. Connect the system reference surface electrode lead to the Sys-Ref connector on the NavLink™ Module.
3. Connect the NavLink™ Module cable to the green NavLink™ Module connector on the EnSite™ Amplifier.
Placement Considerations
When placing the EnSite™ surface electrodes on the patient, it is important to place them in the correct position, not only in
relationship to each other, but also in relationship to other surface electrodes placed for other purposes (see Figure 37).
It is recommended to avoid removing the liner until the surface electrode is ready to be placed on the patient. Once the liner has been
removed, do not attempt to stick the liner back on the adhesive side of the surface electrode. Doing so may result in the liner becoming
stuck to the surface electrode.
Skin preparation
Good skin preparation is essential to all electrophysiology studies. Adhering to the steps below helps minimize the noise related to
surface patch placement during EnSite™ Velocity™ System procedures.
1. Trim excess hair from all locations where surface electrodes and patches will be used.
2. Prepare the skin surface where ECG and surface electrodes will be placed using the following technique:
a. Gently abrade the skin using a gauze pad or like material, or using a gel prep (such as Omni Prep) that contains small particles
of gritty material. Make sure that all the gel material is removed from the skin.
b. Clean the surface with soap and water after the skin has been abraded.
NOTE: Avoid cleaning with isopropyl alcohol unless the skin is excessively oily or covered with lotion.
c. Ensure that the skin is completely dry and that all alcohol has evaporated before placing any surface patches.
NOTE: Press firmly on the center of the surface electrodes with a circular motion to ensure proper contact.
NOTE: None of the surface electrodes should overlap each other or overlap any other surface electrodes used for other purposes.
Edge-to-edge contact with ECG surface electrodes should not create interference. Avoid direct contact of any surface
electrode with an RF return patch.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
62 Connecting EnSite™ Surface Electrodes ARTEN600035010 A
NOTE: The rectangular version front surface electrode has cutouts to allow ECG surface electrode positioning. The V2 ECG
surface electrode should be placed before the front surface electrode is placed. Refer to “Connecting ECG Surface
Electrodes” on page 65 for more information.
NOTE: The left leg surface electrode contains an integrated Data Module chip.
WARNING: Before applying the surface electrodes, ensure that the application sites are hair-free, clean, and dry. Dryness is
particularly important if the preparation agent is flammable or a potential skin irritant.
CAUTION: Ensure that surface electrodes and associated connectors do not contact one another, electrical ground, or metallic
objects.
CAUTION: Do not warm the surface electrodes before they are positioned on the patient.
Correct Placement
Incorrect Placement
NOTE: Do not add or remove any surface patches of any type after validating the data module.
Figure 38. surface electrode placement order. The dashed lines indicate electrode fields.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
64 Connecting EnSite™ Surface Electrodes ARTEN600035010 A
Figure 39. Use a low removal angle (left) while holding the skin taut (right)
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Connecting ECG Surface Electrodes
65
(EnSite™ Array™ Catheter and EnSite™ NavX™ Navigation and Visualization Technology studies)
When a RecordConnect is used, ECG surface electrodes are connected to the recording system manufacturer’s ECG cable and the ECG
cable is connected to the RecordConnect. When a RecordConnect is not used, ECG surface electrodes are normally connected to the
SJM™ ECG Cable and the SJM™ ECG Cable is connected to the EnSite™ Amplifier.
NOTE: For EnSite™ NavX™ Navigation and Visualization Technology studies, a set of ten ECG surface electrodes is included
in the EnSite™ Velocity™ Surface Electrode Kit. Place ECG surface electrodes within the front EnSite™ Velocity™
surface electrode (Figure 40 on page 65). Placing the ECG surface electrodes on the patient in the following order may
prove to be the most efficient:
1. Place the V2 ECG surface electrode at the 4th intercostal space, left sternal edge.3
2. Place the front surface electrode.
3. Place the remaining ECG surface electrodes.
CAUTION: Ensure that surface electrodes and associated connectors do not contact one another, electrical ground, or metallic
objects.
CAUTION: Do not warm the ECG surface electrodes before they are positioned on the patient.
3. “Guidelines For Recording A 12 Lead Electrocardiogram (ECG),” South Durham Health Care NHS Trust.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
66 Connecting ECG Surface Electrodes ARTEN600035010 A
Connect the SJM™ ECG Cable to the blue ECG connector on the EnSite™ Amplifier.
Figure 42. ECG surface electrode connections when not using a RecordConnect.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
68 Connecting an RF Ablation Catheter and Generator ARTEN600035010 A
For optimal navigation, RF ablation should be routed through the EnSite™ Amplifier using a GenConnect specifically designed for
the model of ablation generator being used. Contact St. Jude Medical for a list of available GenConnect models.
CAUTION: Do not sterilize the EnSite™ Velocity™ Cardiac Mapping System interconnect cables.
NOTE: The extension cable must be designed for use with both the ablation catheter and the ablation generator. Extension cables
often contain thermistor/thermocouple wiring that allow catheters to be compatible with RF generators.
NOTE: The procedure described here and the accompanying diagram (Figure 43) are generic. The specific connections required
to connect an ablation system depend on the brand of ablation system being used.
The numbered steps in the following procedure correspond to the numbered callouts in Figure 43.
1. Connect the ablation catheter extension cable to the Ablation Catheter cable connector IN on the GenConnect.
2. Connect the dispersive patches cable to the Dispersive Patches cable connector IN on the GenConnect.
3. Connect one end of the SJM™ catheter interconnect cable to the Ablation Catheter cable OUT connector on the GenConnect and
the other end to the RF ablation generator.
4. Connect one end of the SJM™ dispersive interconnect cable to the GenConnect Dispersive cable OUT connector on the
GenConnect and the other end to the RF ablation generator.
5. Connect one end of the SJM™ interconnect cable to the EnSite™ Amplifier connection on the GenConnect module and the
other end to the EnSite™ Amplifier.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Connecting Diagnostic Catheters
69
When a RecordConnect is used, diagnostic catheters are connected to the recording system manufacturer’s catheter input module
(CIM) and the CIM is connected to the RecordConnect. When a RecordConnect is not used, diagnostic catheters are connected using
a CathLink™ Module.
CAUTION: Make all connections between systems before validating EnSite™ NavX™ Navigation and Visualization Technology.
Adding or removing connections after validation may affect navigation quality.
CAUTION: When the EnSite™ Amplifier is turned off, it can affect ECG signals viewed on the recording system. When the EnSite™
Amplifier is turned off and a recording system is in use, it is recommended that the cables to the EnSite™ Cardiac
Mapping System be disconnected from the EnSite™ Amplifier.
NOTE: Catheter polarity and waveform display are controlled in the software. See “EP Catheter Setup” on page 101.”
NOTE: An EnSite™ NavX™ Navigation and Visualization Technology study will support up to 128 diagnostic catheter
electrodes through either a RecordConnect or up to two CathLink™ Modules.
NOTE: An EnSite™ Array™ Catheter study will support up to 64 diagnostic catheter electrodes through either a RecordConnect
or a CathLink™ Module. However, only the first 28 channels are available for locating electrodes.
Figure 44. CathLink™ Module - In an EnSite™ Array™ Catheter Study only the first 28 channels can
be used for locating electrodes.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
70 Connecting the EnSite™ Array™ Catheter ARTEN600035010 A
NOTE: The ArrayLink™ Module must be clamped to the table rail and facing the patient.
CAUTION: Do not disconnect the Data Module from the ArrayLink™ Module or the EnSite™ Amplifier during a study.
NOTE: Prepare and introduce the EnSite™ Array™ Catheter as per the product literature provided with the EnSite™ Array™
catheter.
The numbered steps in the following procedure correspond to the numbered callouts in Figure 46 on page 70.
1. Align the EnSite™ Array™ Catheter connector so that the plastic chain connecting the Data Module is facing to the left and
gently press the connector into the EnSite™ ArrayLink™ Module connector on the ArrayLink™ Module. The latch on the
ArrayLink™ Module will lock the connection in place.
2. Connect the Data Module to the Data Module connector on the ArrayLink™ Module. The Data Module is tethered to the
EnSite™ ArrayLink™ Module connector.
3. Connect the large yellow connector on the ArrayLink™ Module to the yellow ArrayLink™ Module connection on the far right
side of EnSite™ Amplifier.
4. Connect the small white connector on the ArrayLink™ Module cable to the white Data Module connection on the EnSite™
Amplifier.
Figure 46. An EnSite™ Array™ Catheter connector and Data Module connected to the ArrayLink™ Module.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Connecting an Auxiliary Unipolar Reference
71
The unipolar reference is the zero potential reference for unipolar diagnostic catheters and EnSite™ Array™ Catheter signals.
■ For EnSite™ Array™ Catheter studies, the default unipolar reference is the most proximal ring electrode (E3) on the EnSite™
Array™ Catheter.
■ For EnSite™ NavX™ Navigation and Visualization Technology studies, the default unipolar reference is the System Reference.
NOTE: The Auxiliary Unipolar Reference electrode needs to be stationary throughout the study.
1. Place the electrode of the diagnostic catheter to be used as the unipolar reference within the blood pool, but outside of all
chambers of interest. If using an Auxiliary Unipolar Reference, connect the lead of this electrode to the Aux Ref connector on the
NavLink™ Module.
2. From the menu bar, select Amplifier > Settings > References, and select Auxiliary or the desired electrode as the unipolar
reference.
Figure 47. Connecting a diagnostic catheter electrode being used as a unipolar reference.
Chapter 3. External Connections EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
72 Using a Recording System ARTEN600035010 A
There are two methods of using the EnSite™ Velocity™ Cardiac Mapping System with a conventional recording system. The first
method offers a convenient means of making patient connections, but is dependent on the type of recording system. The second method
offers a universal means of using any recording system, but requires more manual connections. These methods are described here and
illustrated in Figure 50 on page 75.
Method 1 uses a recording system RecordConnect, which routes the ECG and EP catheter signals from the patient to both the EnSite™
Amplifier and the recording system, thereby eliminating the need for a second set of ECG surface electrodes and the use of jumper
cables to share intracardiac signals.
■ The ECG surface electrode leads are connected to the recording system ECG cable, and the ECG cable is normally connected to
the RecordConnect. The RecordConnect routes the ECG signals from the patient to the EnSite™ Amplifier and the recording
system.
■ The EP catheters are connected to the recording system CIM, and the CIM is connected to the RecordConnect. The
RecordConnect routes the EP catheter signals from the patient to the EnSite™ Amplifier and the recording system.
Method 2 uses a CathLink™ Module catheter input module, an SJM™ ECG Cable, a second set of ECG surface electrodes, and jumper
cables.
■ One set of ECG surface electrode leads is connected to the SJM™ ECG Cable, and the SJM™ ECG Cable is connected to the
EnSite™ Amplifier. The second set of ECG surface electrode leads is connected to the recording system.
■ The EP catheters are connected to the recording system and jumpered to a CathLink™ Module. The CathLink™ Module routes
the EP catheter signals from the recording system to the EnSite™ Amplifier.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600035010 A Using a Recording System
73
The numbered steps in the following procedure correspond to the numbered callouts in Figure 48 on page 73.
1. Connect the diagnostic catheter electrode leads to the recording system manufacturer’s CIM.
2. Connect the recording system manufacturer’s CIMs to the CIM input connectors on the RecordConnect.
3. Connect the CIM interconnect cables on the RecordConnect to the recording system.
4. Connect the CIM cables on the RecordConnect to the yellow RecordConnect connectors on the EnSite™ Amplifier.
Connect electrodes to sequentially numbered channels, (1 through 64) on the CIM of the conventional recording system.
Figure 51 on page 78 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology study that uses RecordConnect.
Table 13 on page 79 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.
Chapter 4. Preparing for a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
78 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600035010 A
Figure 51. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when
* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600035010 A Preparing for an EnSite™ NavX™ Navigation and Visualization
79
Table 13. EnSite™ NavX™ Navigation and Visualization Technology study with RecordConnect.
1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 89
study.
2. Connect the EnSite™ Velocity™ Cardiac Mapping System component cables to the “Using the Remote Monitor Configuration
EnSite™ Amplifier. Tool” on page 58
3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 60
4. Place the V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 65
5. Place the EnSite™ Velocity™surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 61
6. Place the remaining ECG surface electrodes on the patient, and then connect all electrode “Connecting ECG Surface Electrodes” on
leads to the recording system’s ECG cable. page 65
7. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When
Using a RecordConnect” on page 66
8. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the “Connecting Diagnostic Catheters When
RecordConnect. Using a RecordConnect” on page 73
9. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite™ Velocity™ Cardiac Mapping Generator” on page 68
System.
11. Log in to the EnSite™ Velocity™ Cardiac Mapping System. “Logging In” on page 91
12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 95
14. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 99
16. Add EP catheters to the study. “EP Catheter Setup” on page 101
17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and
Visualization Technology Setup” on page 114
Figure 52 on page 81 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology study that does not use RecordConnect.
Table 14 on page 82 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600035010 A Preparing for an EnSite™ NavX™ Navigation and Visualization
81
Figure 52. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when
a RecordConnect is not used.
* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
Chapter 4. Preparing for a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
82 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600035010 A
Table 14. EnSite™ NavX™ Navigation and Visualization Technology study without RecordConnect.
1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 89
study.
2. Connect the EnSite™ Velocity™ Cardiac Mapping System component cables to the “Using the Remote Monitor Configuration
EnSite™ Amplifier. Tool” on page 58
3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 60
Note: Two sets of ECG surface electrodes are required. They are referred to here as Set 1
and Set 2.
4. Place the Set 1 V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 65
5. Place the EnSite™ Velocity™surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 61
6. Place the remaining Set 1 ECG surface electrodes on the patient, and then connect all “Connecting ECG Surface Electrodes When
electrode leads to the SJM™ ECG Cable. Not Using a RecordConnect” on page 67
7. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads “Connecting ECG Surface Electrodes When
to the recording system’s ECG cable. Not Using a RecordConnect” on page 67
8. Connect EP catheters to the recording system’s CIMs, as per the recording system’s “Connecting Diagnostic Catheters When Not
instructions, and then jumper the EP catheters from the recording system’s CIMs to the Using a RecordConnect” on page 74
CathLink™ Module.
9. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite™ Velocity™ Cardiac Mapping Generator” on page 68
System.
11. Log in to the EnSite™ Velocity™ Cardiac Mapping System. “Logging In” on page 91
12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 95
14. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 99
16. Add EP catheters to the study. “EP Catheter Setup” on page 101
17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and
Visualization Technology Setup” on page 114
Figure 53 on page 84 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that uses
RecordConnect.
Table 15 on page 85 describes the basic tasks required in an EnSite™ Array™ Catheter study.
Chapter 4. Preparing for a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
84 Preparing for an EnSite™ Array™ Catheter Study ARTEN600035010 A
Figure 53. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is used.
* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600035010 A Preparing for an EnSite™ Array™ Catheter Study
85
1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 89
study.
2. Connect the EnSite™ Velocity™ Cardiac Mapping System component cables to the “Using the Remote Monitor Configuration
EnSite™ Amplifier. Tool” on page 58
3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 60
4. Place the ECG surface electrodes on the patient, and then connect the electrode leads to “Connecting ECG Surface Electrodes” on
the recording system ECG cable. page 65
5. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When
Using a RecordConnect” on page 66
6. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the “Connecting Diagnostic Catheters When
RecordConnect. Using a RecordConnect” on page 73
7. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite™ Velocity™ Cardiac Mapping Generator” on page 68
System.
8. Connect the EnSite™ Array™ Catheter cable and Data Module to the EnSite™ Array™ “ArrayLink™ Module Connections” on page
Catheter. 50
10. Log in to the EnSite™ Velocity™ Cardiac Mapping System. “Logging In” on page 91
11. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 95
13. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 99
14. Deploy the EnSite™ Array™ Catheter in the patient. EnSite™ Array™ Catheter Instructions for
Use.
16. Add EP catheters to the study. “EP Catheter Setup” on page 101
17. Perform EnSite™ Array™ Catheter setup. “Catheter Presets” on page 107
Figure 54 on page 87 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that does not
use RecordConnect.
Table 16 on page 88 describes the basic tasks required in an EnSite™ Array™ Catheter study.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600035010 A Preparing for an EnSite™ Array™ Catheter Study
87
Figure 54. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is not used.
* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
Chapter 4. Preparing for a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
88 Preparing for an EnSite™ Array™ Catheter Study ARTEN600035010 A
1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 89
study.
2. Connect the EnSite™ Velocity™ Cardiac Mapping System component cables to the “Using the Remote Monitor Configuration
EnSite™ Amplifier. Tool” on page 58
3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
lead to the NavLink™ Module. Electrode” on page 60
4. Place the Set 1 ECG surface electrodes on the patient, and then connect the electrode leads “Connecting ECG Surface Electrodes” on
to the SJM™ ECG Cable. page 65
5. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads “Connecting ECG Surface Electrodes When
to the recording system, as per the recording system’s instructions. Not Using a RecordConnect” on page 67
6. Connect EP catheters to the recording system’s CIMs, as per the recording system’s “Connecting Diagnostic Catheters When Not
instructions, and then jumper the EP catheters from the recording system’s CIMs to the Using a RecordConnect” on page 74
CathLink™ Module.
7. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite™ Velocity™ Cardiac Mapping Generator” on page 68
System.
9. Log in to the EnSite™ Velocity™ Cardiac Mapping System. “Logging In” on page 91
10. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 95
12. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 99
13. Deploy the EnSite™ Array™ Catheter in the patient. EnSite™ Array™ Catheter Instructions for
Use.
14. Connect the EnSite™ Array™ Catheter cable and Data Module to the ArrayLink™ Module. “ArrayLink™ Module Connections” on page
50
Note: Two sets of ECG surface electrodes are required. They are referred to here as Set 1
and Set 2.
16. Add EP catheters to the study. “EP Catheter Setup” on page 101
17. Perform the EnSite™ Array™ Catheter setup. “Catheter Presets” on page 107
NOTE: If the system will only be used to review previously recorded data in Offline Review mode, the EnSite™ Amplifier does
not need to be powered on.
NOTE: If the EnSite™ Amplifier is already powered on when setting up the system for a new study, power cycle the EnSite™
Amplifier before starting a new study. The EnSite™ Amplifier self-test provides important information about the status
of the EnSite™ Amplifier components that may not be available unless the EnSite™ Amplifier is power cycled.
1. Press the EnSite™ Amplifier power switch to the ON position.
2. When the system is powered on, the status lights may change state for approximately two minutes while the system performs
self-testing. After two minutes, check the EnSite™ Amplifier status lights. The green light should illuminate and remain lit. If
the amber light flashes or is steadily illuminated, there is a problem. To resolve the problem, refer to “Troubleshooting” on page
221 or contact EnSite™ Velocity™ Cardiac Mapping System Technical Support before proceeding.
3. Power on the power conditioner.
4. Press and release the workstation power switch (located on the front of the workstation) to power on the workstation. When
powered on, the workstation begins automated self-testing. When self-testing is complete, the system login screen appears on the
monitor.
Chapter 5. Starting a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
90 Keyboard and Screen Languages ARTEN600035010 A
Languages can be selected for the keyboard and the screens. The default keyboard language and screen language is U.S. English. If a
different keyboard language is to be used, follow the steps in “Selecting a Keyboard Language” on page 90 to select the keyboard
language. If a different screen language is to be used, follow the steps in “Selecting a Screen Language” on page 90 to select the screen
language.
NOTE: The keyboard language selected must match the language of the keyboard.
To select a keyboard language, click the keyboard icon in the upper-right corner of the Login screen, and select the language from the
displayed list that matches the keyboard to be used.
NOTE: If the screen language selected is Chinese or Japanese, the user can toggle between English characters and Chinese
characters, or between English characters and Japanese characters, by holding down the Ctrl key and pressing the space
bar.
1. Log in to the system (see “Logging In” on page 91).
2. Click on the Language icon in the lower right corner of the screen.
3. Select a language from the displayed list, and then click the [Change Language] button. During login, the system will ask if the
screen language selection is to be used for only the current session or for all sessions.
NOTE: The user must log out and log back in to the system for the change to take effect.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 5. Starting a Study
ARTEN600035010 A Logging In
91
Logging In
Title Screen
The Title Screen allows you to access the Clinical and Services menus of the EnSite™ Cardiac Mapping System, as well as other
functions (depending on the DWS license configuration, not all functions may be available).
■ Click an icon to access that function or menu item.
■ Select system language , view system information , and access SJM™ Connect from the tool bar at the
bottom of the screen.
■ Click the Back button to return to the previous menu.
■ Click to log out of the session.
Chapter 5. Starting a Study EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
92 Getting Started ARTEN600035010 A
Getting Started
Clinical Menu
Services Menu
■ [About the System] to display a variety of system information, including the software release notes, controls for setting the
system clock, controls for establishing the hospital name, utilities for advanced technical support, and notices. See
“Troubleshooting” on page 221 and “Setting Environmental Information” on page 234 for further information.
New Patient
To begin a new study for a new patient:
1. Click [New Study] from the Clinical Menu (Figure 57 on page
93) to display the Study Setup screen.
2. Click [New Patient]. (Default)
3. Fill in the patient information: Last Name, First Name, M.I., 2
Patient ID, Date of Birth, Gender, Weight.
Existing Patient
To begin a new study for an existing patient:
1. Click [New Study] from the Title Screen to display the New
Study Patient Information screen.
2. Click [Existing Patient].
3. Select a patient from the list. A summary of patient
2
information and a list of past studies are displayed on the 3
screen.
4. Click [Next] to display the Study Setup screen.
5. Select a study type: EnSite NavX or EnSite Array.
6. Enter the study information: Diagnosis, Procedure, and
Physician.
4
7. Click [Begin Study] to begin the study.
Past Studies
Resuming a Study
NOTE: Studies may only be continued using the same data module.
NOTE: When a study is resumed, all settings will be loaded from the cursor position in the segment being reviewed.
NOTE: A study can be resumed even after a system has been shut down, either intentionally or unintentionally.
Setup CHAPTER 6
D E
Validation
(All studies)
The Data Module must be validated before catheter navigation can begin. Validation should be performed as close as possible to
creating the first model, map or 3D point.
NOTE: It is recommended to validate again just prior to model or map creation. Validation can be performed more than once.
CAUTION: The EnSite™ Array™ Catheter and the EnSite™ Velocity™ Surface Electrode Kits are intended for single use only.
Device integrity will be compromised by any reuse, which may compromise patient safety and system performance.
Once the above actions have been completed, validate the Data Module as follows:
1. Insert the Data Module into the Data Module connection on either the ArrayLink™ or NavLink™ modules, as appropriate.
Note: The Data Module cable connectors and their corresponding connections for the ArrayLink™ or NavLink™ module look
completely different from one another.
2. Click on the Catheter Setup subtask in order to see the yellow Validation window. The yellow Validation window will appear in
the upper left corner of the screen.
3. Click on [Validate], in the yellow message window, to begin the validation process. When validation is complete, a message
appears in the lower right side of the screen. Set up the catheters.
Note: Because the default position for located catheters may be outside the model display, right-click in the model display
background, select Center Model At:, and then select one of the following from the submenu:
■ Center of Surface(s)
■ Surface Point
■ Active Electrode
■ Catheter Tip (brings up submenu of the chosen catheters from list)
4. If validation fails, check that the ArrayLink™ or NavLink™ Module connections are correct. To attempt to revalidate, from the
menu bar, select Amplifier > Validate (re-validation can be done as many times as necessary, within the 18-hour Data Module
time frame).
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600035010 A EP Catheter Setup
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EP Catheter Setup
(All studies)
1 3456
7 8
16
9
10 11
12
13 14 15
1. CIM – Graphic representation of the catheter input modules (CIMs) used to connect catheters to the EnSite™ Velocity™ Cardiac
Mapping System. Shown is the CathLink, which is connected directly to the EnSite™ Amplifier. Also available are CIMS that match
some recording systems, and are connected to the EnSite™ Velocity™ Cardiac Mapping System with specific RecordConnects.
2. Catheter List – List of the catheters included in this study. Click on a line item in the catheter list to select that catheter. The selected
catheter’s properties will be displayed below the list.
4. Catheter Color – Click the colored box to change the color of the catheter.
5. Sheath Filer – Detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to
be within the sheath, both visibility and data collection from the electrode will suspend. See “Sheath Filter Setup” on page 109.
6. Electrode Numbers Checkbox – Requires Show Electrode Numbers to be selected from the Display Settings menu.
7. Electrode Spacing – The electrode spacing of the selected catheter is displayed here. Electrode spacing is calculated from the edges
of the electrodes, not the center.
Chapter 6. Setup EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
102 EP Catheter Setup ARTEN600035010 A
8. Catheter Representation – This is a representation of the selected catheter. It shows the electrodes and how they map to the input
channels.
■ To show/hide the mapping lines, right-click and turn the Show Lines checkbox On or Off.
■ To show/hide the catheter representation, right-click and turn the Show Catheter checkbox On or Off.
9. Filter Controls – The Noise Filter can be turned on or off and the High Pass and Low Pass filters can be adjusted as needed for
bipolar and unipolar signals. Separate controls are available for ECG, and the EnSite™ Array™ Catheter under the model workflow.
In addition, the EnSite™ Array™ Catheter has a Spatial filter.
10. Waveforms – The waveforms of the selected catheter are displayed here.
11. Catheter Properties – Catheter properties are Name, Brand Name, Type, Manufacturer, Model Number, Number of Electrodes,
Diameter, Distal Length, Electrode Length, Type, and Electrode Spacing.
12. Signal Order – These checkboxes dictate the order in which the waveforms are displayed.
(Distal to Proximal or Proximal to Distal).
13. Polarity – This drop-down menu is used to set the selected catheter’s polarity: Paired Bipolar, All Bipolar, or All Unipolar.
14. Add a Trace – Clicking the [+] button will add a trace. By default, it will be a unipolar electrogram configured with the Distal
electrode set as positive (left column), with the reference set as the System Reference (or Aux Ref, if chosen) (right column).
■ You can also configure this trace as a bipole by changing the electrode configuration to any combination of electrodes on the same
catheter.
■ To remove a trace, left-click and drag the trace to the left of the window.
NOTE: Cryo Ablation connections can be made through the CIM or RecordConnect.
15. GenConnect Panel – This panel serves as the software connection for the ablation catheter. When adding an RF catheter, this
panel must be used rather than the CIM representation shown above it. Note that the ablation catheter should only be visualized using
these inputs. If the EGM output from the generator is input to the CIM to see cardiac signals on the recording system, those channels
should not be used to visualize a catheter in the EnSite™ System.
16. Add and Delete Catheter buttons – To add a catheter to the Catheter List, click the [+] button. To delete a catheter, select it in the
Catheter List and click the [-] button.
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Defining a Catheter
1. Click the + button beneath the Catheter List.
2. Enter a catheter name (up to four alphanumeric characters) or choose a system default name from the drop-down menu.
NOTE: When typing in the text area for Name, Manufacturer, Model Number, Brand Name, and Electrode Spacing, the text
area turns yellow. Text entry is not complete and accepted until the <Enter> key has been pressed and the text area returns
to blue. To return to the previously accepted data, press the <ESC> key.
3. Select a color for the catheter body. The color of the waveforms for the catheter defaults to the color selected for the catheter
body.
4. Specify the catheter properties: number of electrodes, catheter diameter, distal length, electrode length, electrode spacing.
When specifying the number of electrodes, the electrodes will be assigned to consecutive Input Channels starting with the distal
electrode assigned to the first available channel.
NOTE: Electrode spacing is calculated from the edges of the electrodes, not the centers of the electrodes.
NOTE: If the catheter is to be used as an ablation catheter, move it to the GenConnect panel by right-clicking on the first
GenConnect input channel and then selecting Set Distal.
NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.
5. From the Polarity drop-down menu, specify whether signals should be collected from paired bipoles, all possible bipoles, or all
possible unipoles.
6. Set the filters using the filter controls.
7. (Optional) To add the catheter to the Catheter Catalog, click [Add to Catalog]..
To redefine a catheter already in the Catheter List using the Catheter Catalog:
1. Highlight the catheter to be redefined in the Catheter List.
2. Click the [Catheter Catalog] button. The catalog window opens.
3. Select the desired catheter in the catalog list.
4. Click [Apply to Current] at the lower right corner of the catalog window.
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5. Choose more catheters or close the catalog window with the [Close] button at the lower right corner of the catalog window.
– The selected catheter's attributes will populate the applicable property setting fields, and the catheter's distal electrode will be
automatically assigned to the first available input. Subsequent electrodes will be placed in consecutive inputs, if available.
■ The catheter name can be modified by double clicking on the name in the Catheter List or in the Name field (four character limit).
The name can also be modified by selecting a system default name from the drop down list in the Name field.
■ Modify any editable properties, if necessary. (Note: only diagnostic catheters added via the catalog can be modified.)
■ Reassign any input channels, if necessary.
For more information about using the Catheter Catalog, refer to “Catheter Catalog” on page 106.
To load a preset belonging to another physician, open the Preset menu in the upper-right corner of the control panel and select Load
Preset... The Load Preset window lists the presets for all physicians on the system. Select the desired preset and then click [OK].
For more information about using catheter presets, refer to “Catheter Presets” on page 107.
One or more waveforms can be selected for trace height adjustment. Traces should be smooth lines that are free of excessive noise. If
traces contain excessive noise, check all electrode and cable connections between the patient and the EnSite™ Amplifier. Also, try the
Noise Filter (see “Signal Filters” on page 122 and “Patient Signal Problems” on page 228).
NOTE: Saturated waveforms appear purple in the waveform display. Should this occur, it is advisable to initiate Saturation
Recovery. Refer to “Saturation Recovery” on page 121 for instruction.
Chapter 6. Setup EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
106 Catheter Catalog ARTEN600035010 A
Right click on an electrode input channel in the CIM to display the options for the catheter representation:
■ The Visible checkbox shows/hides the selected electrode.
NOTE: Making an electrode not visible will cause the system to not use the electrode's location
information for EnGuide related functions such as collecting model points, making map Figure 66. Catheter
tags, or 3D mapping information. Electrograms from the electrode will be available for settings right-click menu.
viewing and measurement with calipers, but the electrograms will have “No Location” if
displayed in Mapping Waveforms. Mapping points will not be taken from electrodes with
“no Location.”
NOTE: The visibility of non-functional electrodes on any catheter should be turned off.
■ The Connected checkbox connects/disconnects the selected electrode. When an electrode is disconnected, its channel becomes
available. To reconnect a disconnected electrode, click on the electrode on the catheter image in the CIM.
■ The Set Distal checkbox moves all electrodes on a selected catheter to new input channels. To move the electrodes, select the
catheter in the Catheter List, position the mouse over the new distal input channel of choice, right-click and check the Set Distal
checkbox. The input channel positions can also be manually moved by clicking and dragging the displayed electrode lines.
■ The Show Lines checkbox shows the mapping lines between the input channels and the electrodes on the catheter representation.
■ The Show Catheter checkbox shows/hides the display representation of the catheter in the CIM.
■ By right-clicking on an electrode in the CIM, it can be checked/unchecked to be Visible or not. An electrode can also be chosen
(checkbox) to be Connected (available) or not.
Catheter Catalog
The Catheter Catalog contains the most commonly-used SJM catheters. These catheters can be selected from the catalog, or additional
catheters can be added to the Catheter Catalog, for use in a study. See “Selecting a Catheter from the Catheter Catalog” on page 104.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
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107
Catheter Presets
Catheter presets allow for the quick recall of routinely used catheter definition and setups. Certain types of studies may consistently
use the same catheter setup, or defined catheters of the same type. Catheter presets allow for a one time setup of these parameters for
use in multiple studies.
A catheter preset stores all the information needed for each catheter defined in the setup. This information includes:
■ Catheter List
■ Input and Channel Configuration
■ Catheter Signal Settings
The Catheter Presets include catalog or user definitions for each catheter in the list including:
■ Name ■ Type
■ Color ■ Diameter (display in either mm or french size)
■ Number of Electrodes ■ Distal Length
■ Manufacturer ■ Electrode Length
■ Model Number ■ Electrode Spacing
■ Brand Name
The preset input channel configuration includes corresponding channel numbers to catheter electrodes. A message is displayed if a
preset is loaded after Catheter Setup.
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108 Catheter Presets ARTEN600035010 A
To load a preset, open the Preset menu in the upper-right corner of the control panel
and select a preset from the list. The menu lists all of the presets in the system.
After the preset is loaded the Catheter List is populated with the catheter names. To
modify a catheter in the list, select the catheter.
Description
The Sheath Filter detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to
be within the sheath, both visibility and data collection from the electrode will suspend.
A sheath graphic is drawn around the proximal catheter shaft to indicate that the sheath filter is active. The Sheath Filter has three
states:
Inactive. Amber colored sheath graphic. A baseline Blue colored sheath graphic. Sheath Filter is
procedure for the selected catheter is active; both enabled and baselined.
required.
NOTE: When the Sheath Filter is active, both the distal electrode (D) and electrode 2 must be out of the sheath for the catheter
to be displayed (Figure 71 A). If electrode 2 is in the sheath, the entire catheter will be shown as sheathed (Figure 71 B).
D
2
A B
Figure 71. A: Electrode 2 is out of the sheath - catheter is displayed
B: Electrode 2 is in the sheath - catheter is not displayed
OR
■ Selecting the catheter from the Sheath Filter option in the Display Settings right-click menu (Figure 72).
Figure 72. Enable Sheath Filter: from right-click Display menu (left) or Catheter Setup (right)
NOTE: This procedure does not require a contact vs. non-contact position as when using a TactiCath™ Quartz ablation catheter,
but rather requires that all electrodes be out of the sheath.
2. Perform the baseline procedure by first positioning the catheter with all electrodes out of the sheath.
3. Begin the baselining procedure by:
■ Selecting Set Baseline from the right-click Display Menu (Figure 73)
OR
■ Right-clicking on the Sheath Filter icon in the catheter list item and selecting Set Baseline (Figure 73).
Figure 73. Set Baseline: from right-click Display menu (left) or Catheter Setup (right)
– During the baselining process, a progress bar display in the lower-right area of the window.
NOTE: The baselining procedure may fail if the system determines that electrodes
are in the sheath. This automatic determination can be overridden by
clicking Ignore if it is confirmed by other means that all of the electrodes
are out of the sheath during the baselining process (Figure 74).
Figure 74. Baseline Fail Message
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600035010 A Sheath Filter Setup
111
NOTE: The baselining procedure may also fail if there is an impedance error
condition in the incoming data (Figure 75). There is no user override for
this condition.
NOTE: If the Sheath Filter is falsely triggering, a new baseline may be required.
Fly-Eye
Bar Chart
CAUTION: The EnSite™ Array™ Catheter is intended for single use only. Device integrity will be compromised by any reuse, which
may compromise patient safety and system performance.
NOTE: A connected EnSite™ Array™ Catheter must be deployed in the chamber of interest and validated before it can be used
to gather data. Refer to “Validation” on page 100.
1. Use the Amplitude slider to adjust trace height as desired. Evaluate the signals in the fly-eye display. Traces should be smooth
lines that are free of excessive noise. If traces contain excessive noise, check the EnSite™ Array™ Catheter and system
reference patch connections between the patient and the EnSite™ Amplifier.
The Fly-Eye is divided into 64 labeled frames containing EnSite™ Array™ Catheter traces. The A1-A8 column on the left side
of the display has electrodes that progress from the proximal to the distal end of the electrode array. Each of the other columns, B
through H, are arranged in the same manner.
Note: For EnSite™ Array™ Catheter signals, saturated data is also indicated by magenta traces for those signals which are
saturated. Should this occur, it is advisable to initiate Saturation Recovery.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600035010 A EnSite™ Array™ Catheter Setup
113
2. In the fly-eye, evaluate the electrode status and deselect any noisy electrodes. Click on a frame in the fly-eye display to manually
activate or inactivate electrodes. The catheter may have a maximum of eight inactive electrodes. Signals that are either
excessively noisy or display an excessively low signal should typically be turned off. The frame border and label color in each
frame indicates the electrode status:
■ Blue indicates an active electrode.
■ Pink indicates an inactive electrode that was automatically disabled by the system. The EnSite™ Velocity™ Cardiac
Mapping System employs an automatic detection scheme for determining when an electrode on the EnSite™ Array™
Catheter is not functioning properly. The automatic detection scheme can inactivate or activate EnSite™ Array™ Catheter
electrodes as the signal quality changes. If a number of electrodes are automatically disabled, verify that the system
reference electrode is properly connected to the patient’s abdomen and to the NavLink™ Module. Also verify that the
EnSite™ Array™ Catheter is properly connected to the ArrayLink™ Module.
■ Red indicates an inactive electrode that has been manually disabled.
■ Magenta indicates an electrode that has been disabled during the manufacturing process. Up to three electrodes may be
disabled during the manufacturing of a valid catheter. These electrodes cannot be activated.
The values (displayed with the mean subtracted) start at a high positive value, for the proximal electrodes,
and progress to lower resistances until they become high negative values for the distal electrodes (Figure 77
on page 113).
Each column of electrodes on the EnSite™ Array™ Catheter should form a smooth step-like pattern.
1. Visualize a line that intersects the value of each column, similar to the green line shown in Figure 78 on
page 113. Adjust the Amplitude slider as necessary to visualize the pattern.
2. Identify inappropriate values. Typically, an inappropriate value is represented by any column that
deviates from the expected pattern by over 2 Ohms or over 50% of the column height, whichever is
greater.
3. Use the EnSite™ Array™ Catheter fly-eye display to inactivate electrodes with inappropriate values.
CAUTION: The EnSite™ Velocity™ Surface Electrode Kit is intended for single use only. Device integrity will be compromised by
any reuse, which may compromise patient safety and system performance.
1. Click [Collect Respiration Data] to collect Respiration Compensation
data. When respiration data has been collected, Apply Respiration
Compensation and Apply Respiration Rejection are automatically
turned on. Refer to “Respiration Compensation” on page 119 for more
information.
2. During EnSite™ NavX™ Navigation and Visualization Technology 1
studies, the displayed position of all electrodes is relative to the location of
the positional reference.
This feature requires that the positional reference catheter be located in a stable location throughout the procedure. It is recommended
that the coronary sinus (CS) catheter be used for this purpose. The Positional Reference Tool is intended to be used with a multi-
electrode positional reference catheter, and requires that the positional reference catheter consist of at least 4 electrodes. The Positional
Reference Tool detects positional reference catheter movement by comparing the current position of the positional reference electrode
to its past position. The Positional Reference Tool examines all the electrodes on the positional reference catheter to confirm that the
detected movement is due to actual physical catheter dislodgement.
By default, this feature is not enabled; however, the user can enable or disable this feature at any time during the procedure. If
positional reference catheter movement is detected, the user is provided with several methods to manage the repositioning of the
catheter.
NOTE: The Positional Reference Tool can only be enabled if the positional reference catheter has at least 4 electrodes. If fewer
than 4 visible electrodes are defined, the Positional Reference Tool will not activate, even if the user attempts to set up
and enable the feature.
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116 Positional Reference Tool ARTEN600035010 A
NOTE: The Positional Reference Tool requires that the positional reference
catheter be located in a stable location. It is recommended that the A
coronary sinus (CS) catheter be used for this purpose.
the Positional Reference Tool is being enabled, and another message when the
Positional Reference Tool is enabled (Figure 82, below). The catheter must be
kept in a stable position and not disturbed for the duration of the Positional
Reference Tool’s initialization.
Figure 82. The message on the left appears when Positional Reference
Tool is being enabled. The message on the right appears after the
Positional Reference Tool is enabled.
CAUTION: If the [Adjust Later] button is selected, the user must be aware that any tasks that rely on the positional reference
catheter’s location may be affected. These tasks include collecting model points, collecting mapping points, placing
labels, placing lesions, etc.
CAUTION: The Positional Reference Tool will not monitor positional reference catheter dislodgements if [Adjust Later] is selected.
To re-enable the Positional Reference Tool and accept the new location of the positional reference electrode after a
dislodgement has been detected, click on [Accept] (see Figure 80 on page 116).
NOTE: If the user wants to reset the Positional Reference Tool and not accept the new location, they should uncheck then recheck
the Positional Reference Tool enabled checkbox shown in Figure 80 on page 116.
CAUTION: In the event that the system notifies the user of both an EnSite™ Velocity™ surface electrode error and a Positional
Reference Tool dislodgement message, the EnSite™ Velocity™ surface electrode error should be addressed first.
CAUTION: In the event that the system notifies the user of both an EnSite™ Velocity™ surface electrode error and a Positional
Reference Tool dislodgement message, the user should verify that the positional reference catheter has physically moved.
CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator,
defibrillator, and other devices) may trigger the Positional Reference Tool. The user should verify the movement before
accepting the adjustment.
The steps below discuss how to assess the validity of the dislodgement prior to accepting the new positional reference electrode
location. With the Positional Reference Tool window open:
1. Assess the position of all the catheters within the EnSite™ NavX™ Navigation and Visualization Technology field relative to
the created geometry and other known landmarks.
2. Validate against fluoro (if needed).
3. If the catheters are shown in appropriate positions, the user should click [Accept] and the Positional Reference Tool will adjust
and re-initialize. If the user does not think the catheters are shown in the appropriate locations, the user can disable and then re-
enable the Positional Reference Tool by using the check box shown in Figure 80 on page 116. This will disregard the notification
and will not update the position of the catheters.
NOTE: Whenever the user clicks [Accept] the positional reference must be kept in a stable position and not be disturbed for the
duration of the Positional Reference Tool’s re-initialization.
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118 Positional Reference Tool ARTEN600035010 A
The user can choose to manually reposition the positional reference electrode using the yellow sphere and dashed line as a guide
(catheter movement will appear damped). To return the positional reference electrode to its previous position, move the positional
reference catheter until the positional reference electrode moves into the yellow sphere and the sphere turns green (see Figure 84
below). The yellow sphere will turn green once the selected electrode is within 4mm of the previous location. When satisfied with the
readjusted position, click [Accept]. This will reset the Positional Reference Tool with the new coordinates of the selected electrode.
When the user selects [Accept] the new location of the positional reference catheter is set. All other catheters will be displayed relative
to this new position.
The user can also choose to click [Accept] without manually repositioning the positional reference catheter. This will also reset the
Positional Reference Tool with the new coordinates of the selected electrode. When the user selects [Accept] the new location of the
positional reference catheter is set. All other catheters will be displayed relative to this new position. The user should ensure that the
positional reference catheter is in a clinically appropriate, stable location before clicking [Accept].
C B E
Figure 84. A and B show the previous position of the positional reference catheter and electrode. C and D show the current position
of the positional reference catheter and electrode.To return the positional reference electrode to its previous position, move catheter
C until electrode D is within the yellow sphere, in which case the yellow sphere will turn green. E shows the positional reference
electrode properly adjusted.
A progress bar (beneath the control panel) can be seen while the re-
initialization is in progress (see Figure 85, right). When complete, the
system will be ready for continued operation. During that time, some
catheters may temporarily appear to have shifted. Figure 85. Progress bar monitors percent completion of
catheter repositioning
Re-initializing the Positional Reference Tool takes approximately 10
seconds from the time that the [Accept] button is selected.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600035010 A Respiration Compensation
119
Respiration Compensation
(All studies)
The Respiration Compensation feature is used to compensate for catheter movement caused by a patient’s breathing. It may facilitate
more consistent model creation and lesion marking, and improve navigation stability while placing lesions.
Before Respiration Compensation can be used, the system needs to briefly monitor the patient’s respiration in order to collect
respiration data and calculate a respiration range.
During respiration data collection, all catheters must be in stable positions; then, over a period of 12 seconds, the system collects the
x-y-z coordinate of all located electrodes and the impedance values of all EnSite™ Velocity™surface electrodes. The system identifies
respiration by a gradual rise in intrathoracic impedance of the EnSite™ Velocity™surface electrodes. The lowest and highest
impedance values sampled during data collection define the respiration range. This range is referred to as the Respiration
Compensation range.
When respiration data collection is complete, an automatic segment is recorded and Respiration Compensation monitors the EnSite™
Velocity™surface electrodes for the impedance pattern of respiration; when respiration occurs, navigation on each electrode is
gradually compensated in correlation with the degree of the impedance change.
When respiration compensation is applied, the system will continually monitor the respiration motion of the catheters and gradually
update the compensation values throughout the study when the individual catheters are in a stable position.
NOTE: If a new electrode or catheter is defined after respiration data collection completes, the user should manually recollect
respiration compensation data.
NOTE: Visibility of bad electrodes on a catheter should be turned off in order to have Respiration Compensation applied to a
catheter. Refer to “Catheter Input Settings” on page 106 for instruction).
NOTE: Respiration Compensation can be turned on and off. If it is turned off and then turned on, it uses the previously collected
respiration data.
NOTE: Respiration Compensation data can be manually collected at any time during a study.
The [Collect Respiration Data] button appears on the NavX Utilities subtask on the Setup Task or in the Meters Display in the Tool Bar.
To cancel Respiration Compensation Data collection. click the Cancel button on the progress box (see Figure 86, right). When
Respiration Compensation Data collection is canceled, Apply Respiration Compensation and Apply Respiration Rejection are
turned off.
NOTE: If desired, a respiratory waveform computed from surface electrode impedances can be displayed in the Waveform
Display.
Respiration data can be re-collected at any time during a study. To do so, click on the Meter Displays icon on the tool palette and then
click the Collect Respiration Compensation button, or click the Collect Respiration Compensation button on the control panel in
the EnSite™ NavX™ Navigation and Visualization Technology Setup task. The re-computed Respiration Compensation values
replace all previous Respiration Compensation values.
Adaptive Respiration compensation is best used when a controlled and regular respiration pattern is expected such as when general
anesthesia is used for patient sedation.
Adaptive Respiration should be disabled when there is the potential for irregular respiration such as coughing or sleep apnea such as
when conscious sedation is used.
Respiration Rejection
(All studies)
NOTE: Respiration data must be collected to use the Respiration Rejection feature.
The Respiration Rejection feature is used to suspend model point collection and labeling functions when the patient’s respiration falls
outside of a percentage of the Respiration Compensation range.
When the Respiration Rejection criteria is met, the Respiration Meter outline flashes red, and all displayed electrodes flash yellow,
and the following functions are suspended:
■ Model point collection
■ Map labels at the Active Electrode
■ Lesion markers at the Active Electrode
■ Shadow at selected EnGuide
■ Map points
When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Meter outline and displayed electrodes
return to their normal color and the suspended functions resume.
To set the Respiration Rejection threshold, drag the purple bar in the Respiration Meter up or down.
To turn off Respiration Rejection, uncheck the Apply Respiration Rejection checkbox.
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121
Respiration Meter
(EnSite™ NavX™ Navigation and Visualization Technology studies, Realtime only)
The Respiration Meter (Figure 87, right) shows the current level of respiration, as computed by the relative
impedance on the EnSite™ surface electrodes. The data in this display is identical to the respiration
waveform available in the Waveform Display. The units on the meter are a percentage of the Respiration
Compensation range based on the Respiration Rejection sensitivity setting. The Respiration Meter is turned
on by selecting the Meter Displays icon on the Tool Palette and checking the Respiration Meter checkbox.
The Respiration Meter will display by default when Respiration Data has been collected.
If Respiration Rejection is turned on, when the Respiration Rejection criteria is met, the Respiration Meter
outline flashes red, all displayed electrodes flash yellow, model point collection stops, and labeling is
disabled. When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Figure 87. Respiration
Meter outline and displayed electrode return to their normal color and the suspended functions resume. Meter.
EnGuide Alignment
In the control panel, click [Show EnGuide Alignment] to initiate EnGuide Alignment. If there are changes in catheter location that
cannot be adapted by navigating the positional reference electrode, EnGuide Alignment allows for visually realigning the catheter to
the model along the x-y-z- axes.
EnGuide Alignment is used to visually adjust the alignment of EnGuides relative to the model. To align the EnGuides in the workspace,
hold down the <Shift> key and the middle mouse button, and drag the mouse. While dragging the mouse, the EnGuides will move,
but the model remains stationary. Use the middle mouse button to rotate the model. Use the [Apply] checkbox to switch between the
aligned (checkbox on) and unaligned (checkbox off) states. When satisfied with the alignment, click [Accept].
Saturation Recovery
(All studies)
NOTE: Signals in the Waveforms Display turn purple during Saturation Recovery.
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122 Signal Filters ARTEN600035010 A
Signal Filters
Noise Noise filters are 50 - 60 Hz notch filters that reduce OFF, ON OFF OFF OFF OFF OFF
powerline noise. Available settings are On/Off. To
adjust the powerline frequency and filter, see
“Setting the Powerline Frequency” on page 234.
Highpass Highpass filters reduce low-frequency signals (i.e., 0.05, 0.5, 0.5 Hz 30 Hz 2 Hz 2 Hz 2 Hz
repolarization signals) and baseline drift. 1, 2, 5, 10,
20, 30, 40
Hz
Lowpass Lowpass filters reduce high-frequency signals 500, 400, 50 Hz 300 Hz 300 Hz 100 Hz 100 Hz
commonly caused by electronic interference. 300, 200,
100, 60,
50, 40, 30,
20, 10 Hz
Model CHAPTER 7
The EnGuide navigation system is used to display catheters and electrodes. The display of an EP catheter in the model window display
is called an EnGuide.
NOTE: The maximum catheter Navigation Accuracy error is 2.0mm in an EnSite™ NavX™ field scaled model.
The EnGuide navigation system is turned on and off with the Active EnGuide control. See Figure 89 on page 123.
■ To turn the EnGuide navigation system on, set the Active EnGuide control to any catheter.
■ To turn the EnGuide navigation system off, set the Active EnGuide to None. When the EnGuide navigation system is off, no
EnGuides are displayed. Turning off the EnGuide navigation system can remove the appearance of the EnGuide signal on
recording systems. The EnGuide signal may appear on the other recording systems on the located catheter during an EnSite™
Array™ Catheter study and on the surface ECG during an EnSite™ NavX™ Navigation and Visualization Technology study.
Hot key: <Shift>+<F5> switches the EnGuide signal between off and the most recently used active catheter. In an EnSite™
NavX™ Navigation and Visualization Technology study, using this Hot key toggles all located and visible catheters.
The EnGuide navigation system can be used to locate one or more conventional EP catheters. The maximum number of electrodes that
can be located varies by study type. For EnSite™ NavX™ Navigation and Visualization Technology studies, the maximum number
of electrodes that can be located is 132, and the maximum number of electrodes per catheter is 32. For EnSite™ Array™ Catheter
studies, the maximum number of electrodes that can be located is 4, and the maximum number of electrodes per catheter is 32. See
“Connecting Diagnostic Catheters” on page 69 for information about which catheter inputs can be located in EnSite™ Array™
Catheter studies. EnGuide setup is typically done as a part of the Setup task at the beginning of a study. Refer to “EP Catheter Setup”
on page 101 for more information.
If an EnGuide is displaying fewer electrodes than expected (based on catheter settings), the electrodes may be too close to one another
for the EnGuide to display different electrodes, or there may be a problem with an electrode, such as a short.
The controls for selecting the Active EnGuide and Active Electrode are Figure 89. The Active EnGuide and Active Electrode
located at the left side of the Tool Bar. Use the drop-down menus to controls. The Active Electrode is green.
change these values. The Active Electrode is green; all other electrodes
are silver (Figure 89 on page 123).
Chapter 7. Model EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
124 The EnGuide Navigation System ARTEN600035010 A
EnGuide Responsiveness
The response speed between catheter motion and the EnGuide navigation display
is adjustable using the EnGuide Responsiveness slider on the EnGuide Displays
on the Tool Palette, as shown in Figure 90 on page 124.
Faster response settings show all catheter motion, while more stable settings may
reduce the influence of respiration and cardiac motion. The default setting for
EnSite™ NavX™ Navigation and Visualization Technology is mid-range. For
EnSite™ Array™ Catheter studies, the default setting is “Fast”.
Surface Proximity
The surface proximity distance is the distance from the Active Electrode to the model or DIF surface (Fusion must be applied). To
display this measurement on an EnSite™ NavX™ Navigation and Visualization Technology model, field scaling must be applied. The
proximity distance is displayed at the bottom of the map display in the following fashion: the current value, followed by the average
calculated value over 12 seconds, shown in parentheses. A negative value indicates that the electrode is inside the model surface, while
a positive value indicates the electrode is outside the model surface. The surface distance can be disabled by unchecking the Proximity
to Surface checkbox, located under the Meter Displays menu on the Tool Palette.
NOTE: The surface distance is displayed even if the EnGuide proximity indicator is not displayed.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600035010 A The EnGuide Navigation System
125
When the EnGuide navigation system is on, R values and Z values appear at the bottom of the
map display. (Refer to labels A and B in Figure 92 on page 125).
■ R Value (label A) - is the distance in millimeters from the center of the electrode array on
the EnSite™ Array™ Catheter to the Active Electrode.
NOTE: For the most accurate electrogram reconstruction, the R Value should be within 40 A
mm.
■ Z Value (label B) - is the distance in millimeters of the Active Electrode above or below the B
equator of the electrode array on the EnSite™ Array™ Catheter. When the Active Electrode
is nearer to the distal end of the EnSite™ Array™ Catheter, the Z value is negative. When
the Active Electrode is nearer to the proximal end of the electrode array, the Z value is
Figure 92. A: R value; B: Z value.
positive.
The Velocity Filter prevents model point collection during rapid catheter
movements. When the velocity of any electrode used to collect model points
exceeds a user-specified percentage of the electrode’s velocity (the velocity
threshold), model point collection is suspended only for those electrodes exceeding
the threshold for a user-specified period of time.
Model point collection resumes after the lockout period only if the velocity of all
electrodes has returned to a value below the velocity threshold. Velocity Filter
settings are active only during model creation.
The Velocity Meter shows the relative velocity of the Active Electrode (green bar)
and the velocity threshold (purple bar). The meter’s border, normally white, flashes
red if the velocity exceeds the velocity threshold during model edit or OneMap.
To display the Velocity Filter controls, click on the Meter Display icon in the Tool
Palette. Put a check in the Velocity Filter checkbox to turn the Velocity Filter on.
Uncheck the box to turn the filter off. Use the Filter Lockout in Seconds slider to
set the collection lockout period. The Velocity threshold value can be set by
dragging the purple threshold line, in the Velocity meter, to the desired location.
Modeling
The EnSite™ Velocity™ Cardiac Mapping System displays contoured, three-dimensional surface models of the patient’s cardiac
anatomy. The purpose of creating a model is to collect and label the anatomic locations within the chamber. The software does not
assume a specific chamber shape; therefore, it is important to collect enough points to provide sufficient chamber definition. A single
model may consist of multiple surfaces.
A surface is created by dragging a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected
at and between all electrodes on the catheter. A surface is wrapped around the outermost points. This process can be repeated to create
multiple surfaces. If surfaces in the same group overlap, the surfaces combine and the overlapping section is clipped away.
WARNING: The EnSite™ Velocity™ Cardiac Mapping System model display should be used in conjunction with conventional EP
techniques to confirm catheter location.
NOTE: A model is not required for EnSite™ NavX™ Navigation and Visualization Technology studies, but is required in order
to use Field Scaling. Field Scaling is based on model points collected and requires that model points collected include
representations of all 3 axes in all areas of the model. Known interelectrode spacing used to create the model is used to
adjust the dimensions of the navigation field.
CAUTION: (EnSite™ Array™ Catheter studies) If the EnSite™ Array™ Catheter is repositioned or unintentionally moved, a new
model must be created. If a new EnSite™ Array™ Catheter is introduced, the new catheter must be validated and a new
study started.
Respiration Gating
The Respiration Compensation algorithm (“Respiration Compensation” on page 119) is used to
compensate for the changes in the impedance field.
Model Presets
Model presets are used to initialize a model using a predefined list of surfaces. When a model preset
is loaded, the surfaces don't exist, but they have properties such as names and colors. This list can
serve as a starting point for which surfaces to collect points. Model presets tend to fall into two
categories. A study-type model preset is for surfaces that are appropriate for a specific study type.
An anatomy study-type model preset is for surfaces that refer to a specific anatomical group.
The following attributes are included in model preset: color, name, grid type, show, detail level
(surface type), fill level, group.
To load a Model Preset, open the Preset menu in the upper-right corner of the control panel and
select a preset from the list.
After the preset is loaded, the Surface List is populated with surface names saved in the model
Figure 95. Model Preset
preset. To modify a surface in the list, select the surface.
Menu.
Chapter 7. Model EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
128 Modeling ARTEN600035010 A
Collect Points. Clicking on this button allows the user to continually collect points to create
a surface model.
Name. The name of the surface. Select a name from the drop-down menu, or type a name.
Group. The Group drop-down menu allows a surface to be associated, generally in terms of
blood pool. Selections are Left, Right, and Other. Overlapping surfaces from the same group
are automatically cut away. Overlapping surfaces from different groups are not cut away.
Type. These radio buttons control the level of surface detail. Select High or Low when not
creating the model with the OneModel tool. Select OneModel when using the OneModel tool
to create the model.
Center. (For Type set to High or Low only) Controls how the center of the model is defined.
■ Auto – The center of the model is based on the average location of the points collected.
Auto is the default setting.
■ EnGuide – The center of a model is at the Active Electrode.
■ Fixed – In EnSite™ Array™ Catheter studies, the first surface uses the Fixed setting and
cannot be changed. The surface uses the EnSite™ Array™ Catheter as the center point.
Fill. Controls the level of surface detail. As the slider is dragged to the right, the surface detail
smooths.
Points. This dropdown menu shows/hides the collected points. Hiding points is useful if they
begin to obscure navigation. Showing points is useful for evaluating areas requiring further
collection.
Edit Surface – When selected, the currently selected surface can be edited.
Edit Points – When selected, point editing is active. To select points in the
selected surface, click and drag to create a closed loop around the desired points.
Once the loop is closed the selected points will be highlighted. These points can
then be deleted, assigned to another surface, or copied to another surface.
[Delete Points]. When enabled, the [Delete Points] function allows the user to use the
mouse to erase selected points from the model.
[Discard Changes]. Discards model point editing on the selected surface except for a reassigned or copied point.
CAUTION: Discard Changes will delete all surfaces if the model has not been finished at least once.
Show/Hide Field Scaling. Field Scaling can be computed and applied if point collection is not in progress and catheter electrode
spacing has been specified.
Chapter 7. Model EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
130 Collecting Surface Points ARTEN600035010 A
B. Color Chart. Use the color chart to select a color for the item. Click on the colored square
to open the color chart, and then click on the desired color.
C. Grid. The number of clicks (1, 2, or 3) on cylinder will determine where a surface grid is
placed on the model. Clicking once, places the grid on the interior of the model, clicking twice,
places the grid on the exterior of the surface. Clicking a third time turns the grid off.
E. Show/Hide. Use the visibility icon to show or hide the item. When the icon is showing, the
item is visible. To hide the item, click on the icon. Hiding an item does not delete the item. Figure 99. Color Chart & Visibility
Selector.
(Realtime mode only and requires that the EnGuide navigation system be enabled.)
NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any
catheter that is used for collecting points.
NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.
NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the
model.
Collect Points
1. Set the Active EnGuide that is to be used to collect points.
2. Click the [+] button in the control panel to create a new surface.
3. Use the Name drop-down to select an existing surface name, or type the name of the new surface.
4. Use the Group drop-down to associate the surface with a group: Left, Right, or Other.
5. Click [Collect Points] to begin collecting points on and between electrodes of the Active EnGuide. Drag the catheter along the
chamber walls and throughout the interior to create a surface.
A surface appears:
■ For an EnSite™ Array™ Catheter study, the first surface appears around the wireframe of the EnSite™ Array™ Catheter.
■ For subsequent surfaces of EnSite™ Array™ Catheter and all EnSite™ NavX™ Navigation and Visualization Technology
studies, the surface begins at the center of the Active EnGuide. This does not apply to surfaces created with the OneModel
tool.
6. Click [Stop Collecting Points] to stop collecting points.
7. Click [Finish Model] when model creation is complete. Otherwise, repeat steps 1-6 for all additional surfaces.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600035010 A Collecting Surface Points
131
Edit Points
As the model is created, use the following controls in the control panel to inspect and adjust the model.
■ To delete points, click the [Delete Points] button (which then changes to [Stop Deleting]). The mouse pointer becomes a square
eraser. Move the eraser over the points to be deleted, and click the left-mouse button to delete. Clicking and holding the mouse
button erases points by dragging. To return recently deleted points to the surface, click [Undo Delete]. To stop deleting points,
click the [Stop Deleting] button; once this is done, [Undo Delete] is not possible.
■ Use the Edit Points tool to move or copy points from the current
surface to another surface, or to delete a large group of points. Click
the Edit Points icon, and then click on the map display to form a
closed shape around the group of points to be reassigned. The
points on the interior of the closed shape turn red. The map can then
be rotated to confirm appropriate selection. Use the Assign to
drop-down menu to move the points, or the Copy to drop-down
menu to copy the points, to one of the available options:
– New assigns the points to a new surface.
– Delete removes the points.
– Existing surface. Selecting the name of an existing surface
assigns the points to that surface.
OneModel Tool
(All studies)
The OneModel tool is a cardiac model creation tool that wraps the model surface tightly around collected points without tying it back
to a center point. It provides enhanced anatomic detail of the cardiac model when creating a single surface model, and reduces the time
required to create a finished model without requiring the user to change the point collection techniques.
Type. These checkboxes determine the method used by the system to create a model with the
collected points. Select the OneModel checkbox to use the OneModel Tool to create the
model.
NOTE: When creating the model, the user can switch back and forth between definition
Types: High, Low, and OneModel. Items projected onto the surface may adjust
their positions based on the surface generated by each type.
Fill. (with OneModel) When using the OneModel Tool, a higher Fill value (shown in the box
to the right of the slider) results in more space between collected points being filled in, but
with less detail. A lower Fill value has less space filled in, but with finer detail. More points
may need to be collected to fill in the gaps.
NOTE: When OneModel is selected, the Center options are grayed out because they are
not applicable to the OneModel Tool.
NOTE: Moving surfaces to separate surface groups can help in situations where visible
separation between surfaces is desired.
After creating a model and/or importing a DIF model, the name of each available structure appears in the control panel surface list.
The list can contain one model with up to 16 created surfaces and one DIF model with up to 16 surfaces.
NOTE: See EnSite™ Verismo™ Segmentation Tool Instructions For Use for further information on creating multiple-structure DIF
models. Structures from DIF models are identified with “DIF.” If the DIF icon is selected, only the DIF control displays.
You can adjust and edit surfaces independently of one another. To adjust a surface attribute, follow these actions:
A B
D A B CE
Figure 102. A: The LSPV is included and shown; B: The LSPV is included, but not shown. The result is a hole in the left atrial body
at the points of intersection.
B Surface Color Double-click the color and select a color from the color picker.
C Grid (Created surfaces only) Click the grid icon to toggle through the display states:
1. Grid off (default)
2. Display the Grid on the inside of the surface
3. Display the Grid on the outside of the surface
F + Add a surface.
Field Scaling
(EnSite™ NavX™ Navigation and Visualization Technology only and requires a model.)
Field Scaling can be configured to automatically scale model, map, and EnGuide catheter locations and facilitates distance
measurements.
Average measured interelectrode spacing is collected for all locations within the
Figure 103. NavX Field Scaling controls.
model. Adjustments to the dimensions of the navigation field are made to match the
known interelectrode spacing of the catheters used to create the model.
As the catheter is moved during model creation, the system records the location of the electrodes on the active catheter, as well as the
relative change in displayed interelectrode locations.
Field Scaling allows for straight line and surface tape measures in EnSite™ NavX™ Navigation and Visualization Technology. If Field
Scaling is not applied, the EnSite™ NavX™ Navigation and Visualization Technology tape measure length is not displayed in the
marker area.
NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any
catheter that is used for collecting points.
NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.
NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the
model.
Model points are not used for Field Scaling under the following conditions:
■ Electrodes having spacing greater than 11.25 mm (center to center)
■ Collecting with a single electrode
■ Catheters without defined interelectrode spacing or electrode length
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600035010 A Digital Image Fusion (DIF)
135
Three-dimensional models created from digital images collected from Spiral CT, MRI, and DEMRI (Delayed Enhancement MRI) can
be imported into the EnSite™ Velocity™ Cardiac Mapping System for display.
In addition to the DIF file format, the EnSite™ Velocity™ Cardiac Mapping System also supports CardEP file format for digital
images, as well as Siemens, Phillips, Toshiba (Vital Images), and Terra Recon formats; however, formats other than DIF may not be
able to use all DIF-related functions, such as the ability to show or hide individual chamber surfaces.
NOTE: For loading DIF files before validation, select File > Load DIF...
3. From the Load DIF window, select a DIF file for import. Select
a source, either HardDrive or DVD/CD, for import from the
drop-down menu at the top left corner of the window.
■ HardDrive – DIF files created by the EnSite™ Verismo™
Segmentation Tool on the same EnSite™ Velocity™
Cardiac Mapping System DWS are stored on the
workstation’s hard drive. As additional models are added,
the oldest models are deleted first. Models can also be
manually deleted by selecting a model from the list and
clicking [Delete]. (Figure 105 ).
NOTE: The colors applied to the DIF model are the EnSite™
Velocity™ Cardiac Mapping System software model
colors, not the colors that were used during
segmentation. Figure 106. The Import Digital Images window, DVD/CD.
Patient information. In the Import Digital Image window, models are displayed with information from the patient, scan, and saved
model name. Clicking on the category name at the top of a column sorts the data by that column.
DIF viewer – A viewer is available for previewing DIF models. Select [View] to display the selected DIF model. The following
controls are available in the viewer:
■ Rotate – Hold down the middle mouse button and drag.
■ Zoom – Use the roller wheel on the mouse.
■ Wireframe – Options > Wireframe.
■ Bounding box display – Options > Bounding Box.
■ Default views – Views > AP/PA/LL/RL/CRA/CAU.
Digital images are saved with rotational information included. The orientation reference will automatically appear for the digital
image.
■ In an EnSite™ Array™ Catheter study, the EnSite™ Velocity™ Cardiac Mapping System model and DIF model rotate together
when an AP view is saved for the map display.
■ In an EnSite™ NavX™ Navigation and Visualization Technology study, the EnSite™ Velocity™ Cardiac Mapping System model
and DIF model rotate together when EnSite™ NavX™ Navigation and Visualization Technology is validated.
NOTE: Clipping, Map Scale, rotation, spin, Edge Enhancement, and panning can be used to change the appearance of the model.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600035010 A Digital Image Fusion (DIF)
137
Once imported, interaction is similar to a DIF file, with options to view or use
with the EnSite™ Fusion™ Registration module. The DIF list (Figure 108 - 1)
shows both surfaces and associated maps as defined in the third party
application. The color spectrum bar on the left (Figure 108 - 2) is displayed just
as it is for timing and voltage maps within the system. One map tool data set
(Figure 108 - 3) can be displayed on the surface at a time.
In Split Screen mode, you can display an EnSite model in one screen and the DEMRI in the other.
3
Figure 108. Imported DEMRI Image
Waveforms CHAPTER 8
The two types of waveform display windows in the GUI are shown in Figure 109 below:
1. Waveform Display
2. Acquisition Waveform Display.
D
2
C
A
B D
A. Waveforms – Signals can be simultaneously displayed as waveforms. Each waveform consists of a label and a trace. The label
identifies the source of the signal, and includes whether the signal is unfiltered, whether contact catheters are unipolar, the signal label,
and the signal amplitude. If the traces turn purple, then the data should not be used. Purple signal traces are also used to indicate a
blanking period and saturation recovery.
Chapter 8. Waveforms EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
140 Selecting and Adjusting Waveforms ARTEN600035010 A
B. Time cursor – (Waveform Display only) The time cursor is a vertical yellow line in the waveform display that indicates the time
represented by the map display. The specific time represented by the time cursor appears in the lower right corner of the waveform
display. The following controls are available for the time cursor in review mode:
■ Left-clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.
■ Dragging the time cursor moves the cursor across the waveform display.
NOTE: In Realtime, the cursor is not shown when one or more waves are visible.
C. Time scale – The time scale (in milliseconds) appears at the top edge of the waveform display. Right-click between waveforms in
the window to display a menu for setting the sweep speed, font size, and waveform thickness.
D. Calipers – Calipers are used to measure timing between signal features in the waveform display during review mode. See “Using
Calipers” on page 142 for information about using calipers.
Waveforms can be selected and adjusted by clicking on the waveform in the waveform display.
Removing waveforms – To remove a waveform from the Waveform Display, click on the
Waveform Display icon in the Tools Palette and turn off the waveform’s checkbox in the
Waves tab, or left-click on the waveform and drag it off the left edge of the screen.
Adjusting amplitude – To adjust the waveform amplitude, middle-click the waveform and
drag up or down to increase or decrease the amplitude for all waveforms of that signal type.
To adjust the amplitude for a single waveform, hold <Ctrl> + middle-click and drag up or
down.
Sweep Speed – Adjusts the number of mm/sec. in the waveform display (time scale).
Figure 111. Adding/Removing signals
Reset Offsets – Evenly spaces all visible waveforms vertically in the waveform display,
from the Acquisition Waveform
without changing the order of the display.
Display
Reorder Waveforms – Rearranges the waveforms according to the trace number and types
as defined by the order in the Waves tab (Figure 112 on page 141).
Font Size – Used to select a font size for the label text in the waveform display.
Thickness – Used to adjust the thickness of all waveforms in the waveform display.
Hi/Lo Lines – During non-contact mapping, doing a shift-left-click on a selected virtual waveform causes the waveform to bold and
for color calipers to display. The color calipers are horizontal rail lines that indicate the current Color High and the current Color Low
values of the selected waveform. Doing a shift-left-click again will remove them.
NOTE: Hi/Lo Color lines also appear for the roving catheter in the Acquisition Waveform Display and display the p-p value of
the electrogram.
A B
Figure 112. A: Waves Control Tab; B: Filters Control Tab
Chapter 8. Waveforms EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
142 Calipers ARTEN600035010 A
(EnSite™ Array™ Catheter studies only) Use the Virtuals control panel to set the properties for virtual electrodes. (For more
information refer to “Virtuals” on page 167).
For additional functionality of the waveforms in the Acquisition Waveform Display, refer to “Signals Collection” on page 179.
Calipers
Using Calipers
Calipers are used to measure timing between signal features in the waveform display during review mode.
■ The caliper is a set of two vertical lines with a horizontal line between them. The time between the vertical lines is displayed above
the horizontal line in milliseconds. The frequency is displayed beneath the caliper measurement is greater than 1m Sec.
■ Ten calipers can be placed in a recorded segment, and ten per mapping point in the Mapping Task. The calipers in the Mapping
points are saved with the points. Calipers placed in a recorded segment are not saved.
■ To move vertical caliper lines, click on the lines to move that side of the caliper.
■ To move the entire caliper without changing the distance between the vertical lines, middle-click the caliper and drag left or right.
■ To move a horizontal caliper line, left-click and drag the horizontal line up or down.
■ To add a caliper, click the caliper button, next to the [Show/Hide Wave Controls] button.
■ To remove a caliper, left-click and drag the horizontal line past the top or the bottom of the waveform display.
■ Calipers move with the waveform display. When a vertical line or caliper moves outside of the display area, a small arrow appears
at the edge of the screen. This arrow can be left-clicked to select the vertical caliper line then dragged to bring the caliper back
into the waveform display. The relative caliper position also appears in the segment overview.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 143
Recording Segments
Segment recording is used to save a segment of information to the Notebook for future review. The recording controls are available in
Realtime mode and RealReview mode.
1. From the control bar, click the green [Record] button to begin recording. The [Record] button will change to a orange [Stop]
button. The recorded segment begins approximately 10 seconds before the [Record] button was clicked. The length of the
segment being recorded and the number of segments recorded during the study appear at the top of the Notebook.
Hot key: <F4> key can be used in place of [Record] and [Stop].
2. Click [Stop] to stop recording.
3. An annotation can be added to the segment by typing in the text area on the control bar. Annotations can be added or modified at
a later time from the Notebook.
The system automatically records segments. These automatically recorded segments are added to the Notebook where they are
identified as Auto Segments. Automatic recording occurs under the following circumstances:
■ After validating
■ When the positional reference is changed
■ When positional reference dislodgement is detected
■ When positional reference dislodgement is adjusted and accepted
■ When the user collects Respiration Compensation data
■ Right-click and select Sheath Filter Baseline
■ When the model is finished
■ Before and after EnGuide Alignment
■ Every 15 minutes
■ At the end of a study
NOTE: Auto segments do not appear in the segment drop down menu.
Chapter 9. Recording and Playing Segments EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
144 Accessing Recorded Segments ARTEN600035010 A
The purpose of the RealReview task and Offline Review mode is to review data recorded during Realtime mode.
To access a recorded segment (RealReview or Offline Review modes) from the same study, use the notebook:
1. From the list, select a recorded segment or bookmark.
2. Select [Load] or double click on the segment or bookmark name, if doing it from the Notebook in Realtime.
A recorded segment can also be accessed from the Segment drop-down menu in the control bar.
[] / []. By default, when RealReview mode is first entered, the system waits for the user to select a segment in that study.
■[] starts the time cursor moving to the right. When the cursor reaches the right edge of the waveform display, segment
playback starts over again. After clicking [], the label on the button changes to [].
■[] pauses playback. After clicking [], the label on the button changes to [].
Time cursor. The time cursor is a vertical yellow line in the waveform display that indicates the time represented by the map display.
The specific time represented by the time cursor appears in the lower right corner of the waveform display.
■ Clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.
■ Dragging the time cursor moves the cursor across the waveform display.
■ Moving the time cursor in the waveform display also affects the time represented by the map display.
Arrow buttons. While the waveform display is frozen, the left and right arrow buttons move the time cursor one sample to the left or
right, respectively. Holding down an arrow button causes the time cursor to scroll. To set a sample (in 1, 10, or 100ms), right click on
the right or left arrow keys and make a selection from the windows.
Hot key: The arrow keys on the keyboard can be used to scroll the time cursor left or right.
Review Speed. In Review modes, the Review Speed drop-down menu controls the speed of the time cursor as it moves to the right,
which controls how fast the waveforms scroll across the screen. To choose a speed, click on the drop-down menu button and select a
speed from the available list: 1:1 (real time speed), 1:2 (half speed), 1:4 (quarter speed), 1:10, 1:25, 1:50, 1:100, 1:200, 1:500, 1:1000,
2:1 (double speed), TurboMap (maximum speed).
Overview – The segment overview shows the length of the entire recorded segment in black. The portion of the entire recorded
segment that is shown in the waveform display appears in gray in the Overview.
■ Click and drag the gray area of the Overview to display that area in the waveform display.
■ The time cursor and any placed calipers also appear in the Overview.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 145
A B D
C
E
F H
I
G
J
K
L M
Figure 114. A Noncontact Isopotential map (left) and (right). Refer to chapters 11 & 12.
A Active EnGuide and The catheter and electrode to use for creating a model, placing labels, and placing lesions.
Active Electrode
B Map Selection (Applies to contact maps only, not shown above) Click button to display the list of map names created during a
study.
C Dual Views/Single Click on this button to select a dual view map/model display or a single view map/model display. The default
View setting is a single view display.
D Map Settings Click to display a list of checkboxes that control how information is displayed in the map display area.
E Orientation Reference This torso-shaped icon indicates the current orientation of the model by rotating as the model rotates. Select
different map views by right-clicking the torso, then selecting from a menu. Refer to “Views and the Orientation
Reference” on page 150.
F Color Controls The color bar depicts how the map display translates numerical data into color. The data varies by map type.
Refer to “Mapping – Noncontact” on page 165 and “Mapping – Contact” on page 177.
• Color High and Color Low handles allow adjustment of current color bar settings.
• Double-click numeric values to directly enter values.
By right-clicking on the color controls the user is able to change to a Grey Scale.
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146 ARTEN600035010 A
G Model The model is the representation of the patient’s cardiac chamber. There are several options for adjusting the
features of the model. A map can be displayed on the model surface.
H Translucency Slider Adjust the translucency of the image for optimal visualization of objects behind other surfaces.
I Edge Enhancement When enabled, provides a rendering of the model where the body can be translucent but the edge remains
distinctly defined.
J Clipping Plane Clipping planes allow for a view of the interior and rear of the closed model by cutting a plane away from the
viewing space. The slider provides a smooth, controlled way of adjusting the clipping plane. Unlocking the
Clipping Plane deletes it.
K Plane Lock Clipping planes can be locked in the model/map display window. When locked, the orientation remains fixed
relative to the model. When unlocked, the orientation is parallel to the screen. To change the orientation of a
locked clipping plane, unlock it, rotate, and lock it again.
L Tracking Virtual (EnSite™ Array™ Catheter studies only) The Tracking Virtual indicates the Peak-Negative location on an
isopotential map. The tracking virtual waveform displays 100 milliseconds of data, based on the location of the
Tracking Virtual. The waveform display can be adjusted by middle-clicking the waveform and dragging up or
down.
M Voltage Caliper The Voltage Caliper displays the measured potential at the selected signal of the Active Electrode. To select the
signal displayed, right click on the Voltage Caliper and select Select Signal.
Select Auto Adjust and the caliper automatically adjusts to the peak to peak value of the waveform.
N Map Highlight When Split Screen is activated, the active view is outlined with a yellow border. To make the other view active,
click once on the black background of the non-highlighted view. The following features are available only for the
highlighted, active view:
• Using the mouse to rotate the model
• Hold <Shift> and rotate the mouse wheel to zoom at the pointer position
• Adjusting the clipping plane
• Adjusting the view scale
• Edge Enhancement
• Saving or loading a Map View
• Using the mouse to delete surface points or place map labels, lesion markers, anatomic markers, tape
measures, or virtual electrodes can only be done in the highlighted view; however, the result of these actions
appear in both views.
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147
Label Text On. This checkbox shows/hides the label text for all map labels, anatomic markers,
tape measures, lesions, virtuals, and EnGuide Shadows.
Label Show Through. This checkbox allows or prevents label text for all map labels, anatomic
markers, tape measures, lesion markers, virtuals, and EnGuide Shadows from showing through
other objects.
Show EnSite Model. This checkbox enables/disables the display of the contoured, three-
dimensional surface model(s) of a patient’s cardiac anatomy.
Show DIF Model. This checkbox allows the DIF model (i.e., CT scan or MRI) to either be
hidden or displayed.
Project on DIF. (After registration has been performed using the EnSite™ Fusion™
Registration Module) Enabling this checkbox allows the user to project or unproject 3D Labels
and/or Lesions (referred to as 3DP), and map data onto the DIF surface rather than onto the
EnSite™ Velocity™ Cardiac Mapping System model surface.
Show Mapping. Causes surfaces to be colored using the current map color.
Hide Non-Map Surface Groups – Hide surfaces that have no maps projected on them.
Map Transparency On – Check this box to display map colors with values greater than Color
Figure 115. Map settings menu.
High as transparent instead of purple, or (in EnSite™ Array™ Catheter only) charcoal gray in
the gray scale scheme. Areas of the contact map that are not colored will be hidden.
NOTE: Do not check the Map Transparency On box unless a map is currently displayed.
Confidence Region – (EnSite™ Array™ Catheter studies only) This checkbox enables or disables a red highlight on areas of the grid
that are more than 4cm from the center of the EnSite™ Array™ Catheter. Signal and tape measure accuracy can be decreased in these
areas.
Show Proximity Indicator – (EnSite™ NavX™ Navigation and Visualization Technology studies only) This checkbox enables the
proximity indicator.
Fixed Proximity Indicator – Enabling this checkbox allows the diameter of the proximity indicator to be set to a maximum of 10mm,
regardless of the current lesion size.
Show EnSite Array – (EnSite™ Array™ Catheter studies only) This checkbox shows the EnSite™ Array™ Catheter.
Zoom – Increases/decreases the size of the model in the display window. The middle mouse / scroll wheel can also be used to zoom.
Color Contour – This slider adjusts the gradation between colors on the map. At low Color Contour values, colors appear as distinct
bands. At high Color Contour values, there is a smooth transition between colors.
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Show EnGuides – Select this checkbox to show EnGuides in the map display. It does
not disable the EnGuide navigation system. To disable the EnGuide navigation system,
set the Active EnGuide to None, or use the <Ctrl>+<F5> Hot Key. The EnGuide
navigation system must be enabled in order to display EnGuides.
Electrode Numbers – Select this checkbox to show catheter electrode numbers on the
map display to facilitate navigating the ablation catheter to specific electrodes. You can
show electrode numbers on all or none. In Dual View, Split Screen, and RealReview,
this checkbox affects each view independently.
Stabilize ABL – Select this checkbox to enable Stabilize ABL; default setting is off, or
unselected. Stabilize ABL is applied to Ablation catheters or catheters placed in
GenConnect.
NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be
collected.
Stabilize ABL corrects the location of the distal electrode based on the properties of the
catheter. ABL electrodes 2, 3, and 4 need to be displayed for Stabilize ABL to be
enabled.
NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each
catheter independently and only when appropriate.
Active EnGuide Silhouette – Select this checkbox to produce an outline of the Active
EnGuide, which displays over the model, showing where it resides inside the chamber. Figure 116. Active EnGuide silhouette
The silhouette is displayed in the color selected for the Active EnGuide. Select “Off”, feature.
“Normal”, or “Enhanced”.
EnGuide Responsiveness – This slider controls the response speed between catheter motion and EnGuide navigation.
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149
Velocity Meter. Displays a meter that shows the relative velocity of catheter movement
as calculated by the Velocity Filter during model creation.
Filter Lockout in Seconds. Adjusts the time in which point collection is suspended
(collection lockout period), in the event that the velocity of the catheter exceeds the
velocity threshold and point collection is disabled. Once the Filter Lockout time is met,
point collection will resume.
Velocity Filter. Calculates the velocity of a catheter as it collects points during model
creation.
Respiration Meter. Displays a meter that shows the current level of respiration, as
computed by the relative impedance on the EnSite™ surface electrodes.
Voltage Caliper. This checkbox enables/disables the display of the waveform from the
Active Electrode, located in a window within the lower right corner of the map display.
Proximity to Surface. This checkbox enables/disables the display of the distance from
the Active Electrode to the closest surface. The distance information is displayed in text at the bottom of the Map Display. A positive
number expresses locations outside the chamber, and a negative number expresses locations inside the chamber.
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150 Views and the Orientation Reference ARTEN600035010 A
(Any mode)
A view is a saved orientation of a model or map (rotation and panning) that is accessible by
clicking a button. The current rotation of the display is indicated by the orientation reference icon
in the upper right of the model or map display (Figure 118 on page 150).
Four predefined views and up to three custom views are available. The predefined views are AP,
LAO, RAO, and PA. The three custom views are user-named.
To access the view controls and the orientation reference settings, right-click on the orientation
reference icon (see Figure 119).
NOTE: In an EnSite™ Array™ Catheter study, the orientation reference icon is gray, until
the AP view is defined.
Figure 118. The orientation
reference icon.
Orientation Toolbar
The Orientation Toolbar provides one-click access to several model/map views:
Icon Name
AP view.
LOA view.
RAO view.
PA view.
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To save the current view and settings as the AP view, select Save New AP View from the right-
click menu. Saving the AP view automatically saves the LAO, RAO, and PA views. In the default
settings, LAO is set at -45 degrees from AP, and RAO is set at 30 degrees from AP. These angles
can be adjusted using the LAO Angle Setting and RAO Angle Setting slider bars under the “View
Angles” tab, or the up and down arrows on the keyboard or my manual text entry.
■ For EnSite™ Array™ Catheter studies, saving an AP, LAO, RAO, or PA map view
automatically establishes the other three views and enables the orientation reference.
■ For EnSite™ NavX™ Navigation and Visualization Technology studies, the orientation
reference and AP view are automatically established at the time of system validation. If a
model is created, and LAO and RAO are undefined, the LAO and RAO views are
automatically established when the model is completed. Saving AP, LAO, RAO, or PA views
also adjusts the orientation reference. The system does not overwrite custom views.
To access a view, select AP, LAO, RAO, PA, or a custom view from the right-click menu.
Synchronize Dualviews. When in Dual View, turn this checkbox on to synchronize the orientation of the two views and allow both
models or maps to be rotated at the same time.
Centering – A view can be established by centering. Right click on the main display space (on the model). A menu will come up that
includes Center Model At. Selecting this option will display a submenu with 4 options for recentering.
■ Center of Surface(s) – Centers the model within the view. In Dual View,
it works independently for each model.
■ Surface Point – Centers the model at a selected point. When Surface
Point is selected, the cursor changes to a red box with a dot in the center.
With a left mouse click, select the point of interest on the model. The
view is recentered to this point, and a small marker appears at this point.
Exit this mode by selecting off the model surface.
■ Active Electrode – Centers the map display to the active electrode. Figure 121. Center Model menu.
■ Catheter Tip – Centers the model on the desired EnGuide.
Translucence – To support the image integration of co-located models, surface translucency can be applied independently to each
surface. Translucency is applied to All Surfaces as the default setting.
Select the Translucence menu item, then select one or more options:
■ All Surfaces
■ Per EnSite Surface
■ Per EnSite Group
■ All EnSite Surfaces
■ Per DIF Surface
■ All DIF Surfaces
Labels
Labels (Figure 123 on page 153) are used to identify points on the model. Up to 1024 labels
can be placed during a study.
NOTE: The labels have no intrinsic meaning to the EnSite™ Velocity™ Cardiac
Mapping System. Users can assign their own meaning to labels.
A
B C D
Figure 124. Label controls. A: Label Name; B: Projection Slider and Spin Box; C: Label at EnGuide button; D: 3D Label at
EnGuide buttonE: Right-click in black background for menu.
NOTE: The list in the drop down is cleared at the end of each study.
3. Use the Projection slider (or spin box) to set the projection distance if the label is to be projected.
4. Place the label using one of the following methods:
■ Click on the map or DIF surface to place the label at the pointer location. Clicking repeatedly places multiple labels.
Note: When placing labels with the mouse, labels can be placed on either the DIF model or the created model surface. For
multiple-surface models, the label appears on the surface beneath the pointer.
■ Click [Label at EnGuide] to place a label at a point on the surface nearest to the Active Electrode. For multiple-surface
models, the label appears on the nearest included surface. Label location is projected from the 3D center of the Active
Electrode to the nearest surface. If the surface is edited and the projection distance is exceeded, the label re-projects from the
original 3D catheter location, because the original 3D catheter location is preserved.
■ Click [3D Label at EnGuide] to place a label at the Active Electrode location. This label is not connected to the surface of
the map, but rotates with the model. This function is useful for labeling the location of catheters outside of the chamber.
Note: When a label is placed, it is also added to the Label List in the RealReview task.
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NOTE: Labels can only be modified once they have been created.
■ To select a single Label, click on the Label tool in the Tool Palette, hold down
<Shift>, and then click on the item’s name.
■ To select multiple Labels, click the Label tool in the Tool Palette, hold down <Ctrl>,
and then click on each item. Alternatively, click on the Label tool in the Tool Palette,
hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box
around the Labels.
■ To deselect a Label, hold down <Shift> and click away from the Label’s name.
NOTE: When Label is selected, the color of its name changes to white in the
model/map display area.
Figure 125. The Label List is available in
■ To select Labels in a list: the Review task. Use it to modify labels.
– To select a single Label in the list, click on the Label in the list. Use the Tool Palette and Tool Bar controls
– To select multiple Labels in the list, hold down <Ctrl> and click on each label to create labels.
– To select multiple consecutive Labels in the list, hod down <Shift>, click on a
Label, and then click on another Label. Alternatively, click on a Label and drag
to select additional consecutive Labels.
NOTE: When a Label is selected, the color of its name changes to white in the model/map display area.
■ To modify a label using the Tool Palette and Tool Bar, select the Label tool on the Tool Palette, select the label, and then use the
Tool Bar controls to change the label’s name and projection.
■ To modify a label using the Label List and control panel in the Review task, select the Label icon in the control panel, select the
label in the Label List, and then use the control panel controls to modify the label’s visibility, or click [Delete] to delete the label
from the map and the Label List.
■ To show/hide, delete, move, or project a label using the Label right-click menu, select the Label tool on the Tool Palette, select
the label, right-click in the display area to display the Label menu, and then select one of the following:
– Show All Labels shows all labels.
– Hide Selected Labels hides/shows the selected labels. The labels are only hidden, not deleted.
– Delete Selected Labels deletes the selected labels from the map and the Label List.
– Move Selected Label moves the selected mouse placed label only. To move a label, select the label, click Move Selected
Label, and then click on the map at the desired location. Only mouse placed labels can be moved.
– Project Selected Labels changes a label’s projection. A label placed with [Label at EnGuide] is already projected. To move
the label to the original 3D location where the label was placed, turn off Project Selected Labels. A label placed with [3D
Label at EnGuide] is placed at the Active Electrode. To project the label onto the closest surface, turn on Project Selected
Labels.
– Show Labels Through Map makes labels visible regardless of the map orientation.
NOTE: Displayed 3D (D3D) labels can be renamed, deleted, and hidden, but the changes are not saved when the study is ended.
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155
Label Colors
The color of a label indicates the label’s relationship to the surface (Figure 126 on page 155).
■ Green indicates that the label is on the nearest surface.
■ Amber indicates that the label is on the surface, but something is obstructing the label. This could
indicate that the label is on the far side of the model or behind an object such as an EnGuide
electrode.
■ Blue indicates that the label is not tied to the surface (such as 3D labels and EnGuide Shadows).
■ White indicates that the label is selected.
Figure 126. Map label
colors.
Anatomic Markers
Anatomic markers connect points on the surface of the model with lines. Closed anatomic markers are useful for drawing valve or
vessel openings on the model; these circular markers can be cut out of the map to show these openings. Up to 256 anatomic markers
can be placed on the map.
The method of calculating the area differs depending on whether or not the marker is cut out.
■ For markers that have not been cut out, the area is calculated for the entire surface encompassed by the marker.
■ For markers that have been cut out, the area is calculated for an averaged plane across the open marker.
NOTE: Field Scaling must be applied for values to be displayed (EnSite™ NavX™ Navigation and Visualization Technology
only).
The Marker List in the RealReview and Review tasks includes the name of every anatomic marker in use.
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156 Anatomic Markers ARTEN600035010 A
A B C D
Figure 127. Anatomic marker controls. A: color control; B: thickness control; C: marker name; D: cutout checkbox; E: right-click
menu.
NOTE: When Anatomic Marker is selected, the color of its name changes to white in the model/map display area.
■ To select Anatomic Markers in a list:
– To select a single Anatomic Marker in the list, click on the Anatomic Marker in the list.
– To select multiple Anatomic Markers in the list, hold down <Ctrl> and click on each Anatomic Marker.
– To select multiple consecutive Anatomic Markers in the list, hold down <Shift>, click on an Anatomic Marker, and then click
on another Anatomic Marker, Alternatively, click on an Anatomic Marker and drag to select additional consecutive Anatomic
Markers.
NOTE: When an Anatomic Marker is selected, the color of its name changes to white in the model/map display area.
■ To modify a marker using the Tool Palette and Tool Bar: select the Anatomic Marker tool on the Tool Palette, select the marker,
and then use the Tool Bar controls to modify the marker’s color, thickness, name, and cutout.
■ To modify a marker using the Marker List and control panel in the RealReview task: select the Marker icon in the control panel,
select the marker in the Marker List, and then use the control panel controls to modify the marker’s visibility, or click [Delete] to
delete the marker.
■ To modify a marker using the right-click menu, select the Marker tool on the Tool Palette, select the marker, right-click in the
display area to display the Marker menu, and then select one of the following:
– Show All Markers shows/hides all markers. The markers are only hidden, not deleted.
– Hide Selected Markers hides/shows the selected markers. The markers are only hidden, not deleted.
– Delete Selected Markers deletes the selected markers from the map and the Marker List.
– Move Selected Marker moves the selected marker. Click on one of the displayed marker points to select the marker point to
move, then click the location on the map where the selected marker point is to be moved.
– Complete Open Marker completes the open marker being created.
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158 EnGuide Shadows ARTEN600035010 A
EnGuide Shadows
(Any mode)
3. Right-click in the display area to display the EnGuide Shadows menu, and then select Add Shadow to place an EnGuide
Shadow at the location of the selected catheter, or select Add Shadow At All EnGuides to place an EnGuide Shadow at the
locations of all catheters.
4. Type a name for the EnGuide shadow in the Name text area or select a name from the drop-down menu. Names appear at the
middle of the EnGuide Shadow display.
Note: When a shadow is placed on the map, it also appears in the EnGuide Shadow List in the RealReview task.
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160 EnGuide Shadows ARTEN600035010 A
For information about selecting EnGuide shadows, refer to “Common Interface Elements” on page 35.
■ To select a single EnGuide Shadow, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift>, and then click on
the EnGuide Shadow’s name.
■ To select multiple EnGuide Shadows, click on the EnGuide Shadow tool in the Tool Palette, hold down <Ctrl>, and then click on
the EnGuide Shadow. Alternatively, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold
down the left mouse button, and then drag a box around the EnGuide Shadows.
■ To deselect an EnGuide Shadow, hold down <Shift> and click away from the EnGuide Shadow’s name.
NOTE: When EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.
■ To select EnGuide Shadows in a list:
– To select a single EnGuide Shadow in the list, click on the Anatomic Marker in the list.
– To select multiple EnGuide Shadows in the list, hold down <Ctrl> and click on each EnGuide Shadow.
– To select multiple consecutive EnGuide Shadows in the list, hold down <Shift>, click on an EnGuide Shadow, and then click
on another EnGuide Shadow, Alternatively, click on an EnGuide Shadow and drag to select additional consecutive EnGuide
Shadows.
■ When an EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.To modify an
EnGuide Shadow using the Tool Palette and Tool Bar: select the EnGuide Shadow tool on the Tool Palette, select the EnGuide
Shadow, and then use the Name text area on the Tool Bar to change the name.
■ To modify an EnGuide Shadow using the EnGuide Shadow List and control panel in the Review task: select the EnGuide Shadow
in the EnGuide Shadow List, and then use the checkbox to control visibility or the Delete button to delete the EnGuide Shadow.
■ To show, hide, and delete a shadow using the EnGuide Shadow right-click menu, select the EnGuide Shadow tool on the Tool
Palette, select the shadow, right-click in the display area to display the EnGuide Shadow menu, and then select one of the
following:
– Show All Shadows shows/hides all shadows.
– Hide Selected Shadows hides/shows the selected shadows. The shadows are only hidden, not deleted.
– Delete Selected Shadows deletes the selected shadows from the map and the EnGuide Shadow List.
Tape Measures
(EnSite™ Array™ Catheter, EnSite™ NavX™ Navigation and Visualization Technology with field scaling applied, DIF surfaces)
Tape measures are used to measure the distance (in mm) between points
on the model of the endocardial surface (Figure 133 on page 162). Up
to 12 tape measures can be placed on the map.
Figure 133. This map shows two tape measure lines across
the endocardial surface.
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ARTEN600035010 A Tape Measures
163
A B
Figure 134. Tape measure controls. A: color control; B: type buttons; C: right-click menu.
The tape measure appears on the map as a colored line. The tape measure’s type and the distance between the points in mm, appear at
the beginning of the tape measure. Up to 12 tape measures (yellow, green, cyan, orange, red, and magenta) can be used.
NOTE: In an EnSite™ NavX™ Navigation and Visualization Technology study, measurements will not be shown if Field
Scaling is not enabled (the line will still show through).
Chapter 10. Adjusting and Labeling Maps EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
164 Tape Measures ARTEN600035010 A
NOTE: When Tape Measure is selected, the color of its name changes to white in the model/map display area.
■ To select Tape Measures in a list:
– To select a single Tape Measure in the list, click on the Tape Measure in the list.
– To select multiple Tape Measures in the list, hold down <Ctrl> and click on each Tape Measure.
– To select multiple consecutive Tape Measures in the list, hold down <Shift>, click on a Tape Measure, and then click on
another Tape Measure, Alternatively, click on a Tape Measure and drag to select additional consecutive Tape Measures.
NOTE: When a Tape Measure is selected, the color of its name changes to white in the model/map display area.
■ To modify a tape measure using the Tool Palette and Tool Bar: select the Tape Measure tool on the Tool Palette, select the tape
measure, and then use the Tool Bar controls to modify the tape measure’s color and type.
■ To modify a tape measure using the Tape Measure control panel in the RealReview task: select the Tape Measure icon in the
control panel, select the tape measure in the Tape Measure List, and then use the control panel controls to modify the tape
measure’s visibility, or click [Delete] to delete the tape measure
■ To modify a tape measure using the Tape Measure right-click menu, select the Tape Measure tool on the Tool Palette, select the
tape measure, right-click in the display area to display the Tape Measure menu, and then select one of the following:
– Show All Tape Measures shows/hides all tape measures. The tape measures are only hidden, not deleted.
– Hide Selected Tape Measures hides/shows the selected tape measures.
– Delete Selected Tape Measures deletes the selected tape measures from the map and the Tape Measure List.
– Move Selected Tape Measure moves the selected tape measure. To move a tape measure, select the tape measure, click Move
Selected Tape Measure, and then click on the map at the desired location.
The EnSite™ Array™ Catheter study Mapping task is used to create noncontact maps. Three types of noncontact maps are available:
isopotential, substrate, and isochronal.
■ An Isopotential map shows voltages sensed by the EnSite™ Array™ Catheter as a three-dimensional map that uses color to
represent a range of electrical potentials across the surface of the heart chamber’s endocardium. This type of map contains the
electrical potentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform
display, the same information is animated in the display of the isopotential map.
■ A Substrate map shows relative peak-negative unipolar voltage over a user-specified beat, throughout the chamber. Color in a
substrate map represents relative unipolar voltage levels at each location on the first surface.
■ An Isochronal map shows the progression of activation through the first surface. This type of map is especially useful in locating
functional block or lines of block created by ablation. Color in an isochronal map represents activation time (in milliseconds)
rather than voltage measurements.
Chapter 11. Mapping – Noncontact EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
166 Interpreting Isopotential Maps ARTEN600035010 A
The EnSite™ Array™ Catheter study uses the dynamic isopotential map and the unipolar electrogram interpretation, in combination,
to identify the earliest activation sites. Map color is used to identify the areas of interest; virtual waveforms are used for confirmation.
NOTE: For multiple surface models, non-contact mapping can only be performed on the first surface.
1. Place virtual electrodes across an area of interest.
2. Locate a beat of interest in the waveform display. Reposition the virtual electrodes on the map if necessary.
3. Place the time cursor within the beat of interest.
4. Use the left arrow button to step the time cursor backward one frame at a time.
5. Adjust the High Pass filter (if necessary) to reduce baseline drift and low-frequency repolarization. Raise the filter as little as
possible, to preserve slow conduction sensitivity.
6. Adjust the color controls to identify isopotential color in the map display and reposition virtual electrodes within the color.
Review the virtual waveform traces to confirm activation.
7. Follow activation through the beat of interest, using color to identify general areas of interest and unipolar electrograms for
diagnosis. Label sites of interest.
8. Use conventional methodologies to confirm diagnosis.
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ARTEN600035010 A Virtuals
167
Virtuals
By using the mouse to select a pattern of virtual electrodes on the map, virtual waveforms can be displayed based on signals from the
EnSite™ Array™ Catheter. Virtual waveforms are analogous to contact electrograms from conventional EP catheter electrodes.
Virtual waveform parameters can be adjusted as described below. Two sets of parameters for virtual electrograms are available,
Virtuals 1 and Virtuals 2.
A single virtual waveform, called the EnGuide Virtual, can be created from the site on the map surface where a vector going from the
center of the model through the distal tip of the Active EnGuide intersects the first map surface. As the EP catheter moves, so does the
signal location.
Placing Virtuals
1. Set the virtual parameters as described in “Setting Virtual Waveform Parameters” on page 167.
2. Select the Virtuals tool on the Tool Palette.
3. Select Virtuals 1 or Virtuals 2 on the Tool Bar.
4. Use the mouse to place the virtual electrodes on the first surface. Each virtual electrode on the map is labeled with a number.
This number corresponds to the trace number in the waveform display.
■ To place a line of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where
virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed
along the entire path between the start and end points.
■ To place a block of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where
virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed in a
rectangle with the corners determined by the start and end points.
■ To distribute the virtual electrodes over the entire chamber surface (Global Virtuals - see below), click on the map to place
the first virtual electrode. Virtual electrodes are distributed across the first surface.
CAUTION: When placing bipolar virtual electrodes near the poles of the map, select latitudinal orientations. Failure to do so may
cause the electrograms to be computed improperly, resulting in inaccurate traces.
The global virtuals technique offers an approach to localizing areas of electrical interest, by creating virtual electrograms throughout
the first surface, simulating numerous multipolar catheters.
1. After recording a segment of focal arrhythmia, set up Global Virtuals.
2. Use global virtuals to identify a region of focal activation on the map.
a. Select Pattern: Global.
b. Adjust the number of virtual waveforms to be displayed.
c. Click on the first surface to distribute the global virtuals.
3. After identifying several points that display unipolar activation, use block virtuals to locate early activation.
a. Select Pattern: Block and swipe a block of virtual electrodes to encompass the area of interest.
b. Evaluate virtual traces to locate the earliest activation.
4. Confirm the early activation site using isopotential analysis.
5. Use conventional methodologies to confirm diagnosis.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600035010 A Interpreting Isopotential Color
169
Isopotential maps use color to represent voltage. Color on the surface of the map is interpreted by
using the color bar to the left of the main workspace, or the Color High and Color Low controls on
top of the workspace.
The color bar (Figure 138 on page 169) appears as a scale, ranging from +5 mV to
Higher than
-5 mV. Color in the color bar represents the progression of color values in the map
Color High
display. In the default color scheme, colors on an isopotential map’s surface and in
the color bar indicate the following:
■ The Color High value appears on the Color Bar and is represented on the color
bar by the purple caliper.
Color High
■ The Color Low value appears on the Color Bar and is represented on the color
bar by the white caliper.
■ Other colors represent the range of voltages between the Color High and Color
Low values. Color Low
See Figure 139 on page 169, for the color bar representations (1-3, in yellow) 1 2 3
described below (from left to right):
1. Color bar representing data collected for either an isopotential Local
Activation Time (LAT) or a Voltage Map.
A - Purple caliper - indicates color high
B - White caliper - indicates color low
C - Green caliper - midpoint between high and low
D - Shows the unit of measure (millivolts in this case) A
2. Color bar showing an isochronal LAT based color scale (in milliseconds)
3. Color bar shows a color scale, using a Low-V ID, P-P setting where gray C
shows the areas where voltage is below the set value.
B
Color bar calipers – The color bar calipers are used to adjust the map
color. Use the mouse to drag the calipers:
■ The top caliper (purple) adjusts the Color High value.
■ The bottom caliper (white) adjusts the Color Low value.
■ The middle caliper (green) adjusts both the Color High and Color Low
values while preserving the difference between these values.
Color bar scale – The scale of the color bar can be adjusted by selecting
the gray triangular arrows above and below the color bar (Figure 140 on
page 170).
Figure 141. This diagram shows how the AutoFocus algorithm adjusts
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Enabling AutoFocus color controls – In the control panel, select a sensitivity level from the AutoFocus drop-down menu:
■ Off – AutoFocus is disabled and manual controls are active.
■ Discrete – The discrete setting may be useful for fine localization of early activation sites or highlighting a gap in a line of block.
■ Nominal – The nominal setting provides a balance between finding sites of earliest activation and tracking activation through the
cycle.
■ Broad – The broad setting may be useful for tracking chamber activation through the entire cardiac cycle.
NOTE: The AutoFocus color controls adjust the color bar pointers; however, AutoFocus does not adjust the High Pass Filter.
Adjusting the Upper Limit – The Upper Limit is the highest voltage that the AutoFocus algorithm will consider. The range is 1.00 to
-0.20 mV (default -0.03). Use the Upper Limit slider in the control panel to make fine adjustments to the AutoFocus algorithm.
Adjusting the high pass filter – During isopotential analysis, the high pass filter can be useful for reducing low-frequency signals
(such as repolarization signals) and baseline drift in waveform traces based on EnSite™ Array™ Catheter signals (such as virtual
waveforms). Use the High Pass Filter drop-down menu in the control panel to adjust the highpass filter settings.
CAUTION: If the high pass filter is set to low frequencies (< 2Hz), signals may be subject to low-frequency baseline drift.
To disable AutoFocus and use the manual controls, select [Off] from the AutoFocus drop-down menu in the control panel.
Chapter 11. Mapping – Noncontact EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
172 Using the Tracking Virtual ARTEN600035010 A
(EnSite™ Array™ Catheter studies, RealReview, and Offline Review modes only)
The Tracking Virtual tool is used to locate and interpret the Peak-Negative
location in the chamber of interest. The Tracking Virtual appears on the map as
a small red icon comprised of eight short lines converging at the Peak-Negative
position. The unipolar virtual waveform from this location appears in a window
in the lower right side of the map display. The window is sized to display 100
milliseconds of data, and the amplitude can be adjusted by middle-clicking the
waveform and dragging up or down.
NOTE: In Review mode, the Tracking Virtual and Voltage calipers can be
displayed simultaneously.
Substrate Mapping
A substrate ratiometric map is a single color map that displays relative peak-negative
unipolar voltage over a user-specified beat, throughout the chamber. Color in a
substrate map represents relative unipolar voltage levels at each first surface location.
To understand the substrate mapping algorithm, it is important to remember that every point on the surface represents a virtual
electrogram, each of which could be represented by a waveform trace. For each noncontact electrogram, the substrate mapping
algorithm locates the most negative signal within a user-defined caliper range. The system displays the relative voltages as a
ratiometric map of voltage in one of two ways (Figure 145 on page 173):
■ Global – In a Global substrate map, the system displays
relative color, from 0% (0mV) to 100% of the peak-
negative map value, throughout the first surface.
■ Absolute – In an Absolute substrate map, the system
displays relative color, from 0% (0mV) to 100% of a
user-defined threshold, throughout the first surface.
NOTE: Click Apply after adjusting the calipers to update the map.
■ To add a substrate map marker:
a. Adjust the Peak Negative% slider to a percentage of interest.
b. Click [+]. A marker appears at all map locations that match the selected voltage.
Markers appear as a double line. Identifying the high-voltage side of the marker
is a thick line in the selected color. Identifying the low-voltage side of the marker
is a thinner darker line.
c. (Optional) Adjust the marker’s visibility, color, and name using the controls in
the marker list. Adjust the marker’s thickness using the Thickness slider. Names
for substrate map markers only appear in the marker list, not in the map display.
Note: The model surface must be stable before adding a substrate map marker. If the
model is modified after a substrate map marker is added, the marker keeps its 3-
dimensional position, which may not be on the revised model surface.
6. Use conventional methodologies to confirm diagnosis from substrate mapping.
Isochronal Mapping
(EnSite™ Array™ Catheter studies only; RealReview and Offline modes only)
Figure 148. Example of a virtual waveform trace used in an isochrone algorithm. Events 1 and 2 are defined by the
points where the trace crosses the baseline. Event 1 is used to display activation, because it is the first event that crosses
the multiple event sensitivity level.
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176 Isochronal Mapping ARTEN600035010 A
The map can be modified by adjusting the caliper range, or the Multiple Event
Sensitivity slider. Adjusting either the caliper range or the Multiple Event Sensitivity
slider requires that the [Apply] button be clicked again.
NOTE: When reviewing maps or virtuals created using the EnSite™ Array™
Catheter, be sure that the distance between the catheter and the location of
interest is within the desired distances. Figure 149. The isochronal map control
panel.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 177
The mapping tool organizes data collected during conventional electrophysiology procedures and displays the data in three-
dimensional maps. During mapping, the clinician samples various heart locations (points) in a stable rhythm using EnGuide-located
conventional catheters. The 3D location of each sampled location (point) is saved along with voltage and activation data, which can
be displayed on the nearest surface as color. A single set of collected data can be used to display several types of maps.
NOTE: For Peak-to-Peak and Peak Negative, the user can select the Unipole box to display unipole maps. Unipole waveforms
display on the right. Deselect the Unipole box to display bipole maps.
NOTE: At least one LAT point must be mapped and saved in order for Peak-to-Peak and Peak-Negative, and CFE Mean options
to become available. Prior to this action, these options are grayed out.
Signals Collection
Non-cardiac triggered maps do not use any part of the cardiac signal as a reference. Instead, the
waveform window refreshes once each second.
The reference signal is highlighted with a box around the waveform’s label in the Acquisition
Waveform Display, as shown in Figure 152.
Detection Algorithm
Both reference signals and roving signals require a detection algorithm. Detection algorithms locate the best point on the waveform
signal to use to identify activation. The detection algorithm first uses a P-P sensitivity to identify activation complexes in the signal.
A detection marker is then placed on the activation complex according to the Detection Marker Placement.
P-P Sensitivity – (Applies to the map that has focus when in Split Screen mode.) The minimum peak-to-peak voltage required for the
detection algorithm to operate. Incoming signal complexes must be larger in amplitude than the P-P Sensitivity in order to be
considered activations by the system. While changing the P-P Sensitivity, red amplitude lines will appear on the related signal in the
acquisition panel to indicate the current setting. Set this sensitivity to just above the noise floor. If 1.5 seconds has elapsed since the
last reference signal detection, the algorithm will identify an optimal activation complex, even if it does not meet the P-P Sensitivity.
NOTE: For the Reference signal, the default sensitivity setting is Automatic, but Fixed sensitivity is an option unless Multiple
ECGs is selected as the reference source. For Roving, Auto Sensitivity is only available when using First Deflection or
Last Deflection.
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180 Signals Collection ARTEN600035010 A
NOTE: The user can drag the green Reference Offset line to the desired position, and the system calculates the timing
automatically from that position. The aqua-colored line is the reference line placed by the detection algorithm and cannot
be moved.
NOTE: Do not change the reference offset after saving the first beat when using Score Map. Changing of the reference offset
after the first beat may lead to an incorrect mapping display.
NOTE: Cardiac triggered CFE maps use the same detection algorithm as LAT, P-P, and P-Neg. Non-cardiac CFE maps use the
one second window refresh signal as a trigger. The detection algorithm is not selectable.
NOTE: Detection on the roving waveform takes place within the Roving Activation Interval (“Roving Activation Interval (RAI)”
on page 186).
Additional Signals
Additional ECG or intracardiac signals can be selected to facilitate confirmation of rhythm
stability. These signals are only for visualization and are not involved in detection.
Considerations
Reentrant Maps
■ Reentrant maps present the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps. The color
displayed within the map is linked to the cardiac cycle length (CL) and allows the adjacent display of “early” (white) and “late”
(purple) activation times.
■ The CL of a Reentrant LAT map is determined by the spacing between the curtains. Adjustment of the CL can be made by clicking
and dragging the edge of the curtains to the desired location. The CL will not take effect until the Reentrant checkbox is turned on.
NOTE: Adjusting the CL and then collecting points may invalidate the map.
Propagation Maps
■ These maps display areas of activation times that fall within a specific time interval. The interval, represented by a white band on
a purple background, can be moved forward through one heart cycle either automatically or by user control.
■ A button beneath the Propagation checkbox controls automatic motion of the activation interval with [Play] and [Freeze] options.
These options are available in Review mode only.
■ [Play] loops over the user-selected cycle length.
■ Propagation maps can be played in Realtime or RealReview but recordings can only be exported in Offline Review.
■ When Propagation is enabled, the colors of the map change to purple and white only. The leading edge of the white stripe is
brighter than the trailing edge of the stripe to indicate the direction of travel activation.
■ Using the side color bar, the stripe can be widened (increasing the interval in milliseconds [ms]), by clicking and dragging above
the white stripe. This action can also be accomplished by clicking to the right of the stripe in the color bar at the top of the window.
SparkleMap
■ The SparkleMap feature allows you to view the activation sequence on top of another map (ex. Voltage map) which allows the
physician to simultaneously view multiple datasets on the same anatomic model. The SparkleMap shows the propagation
sequence via a series of circular flashes.
■ Click the SparkleMap button in the Mapping Control Panel (“Mapping Control Panel” on page 182) to activate.
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182 Mapping Control Panel ARTEN600035010 A
C Current Map Checkboxes control the type of data displayed on the map that E
Type has focus. When the checkbox is changed, the scale, values,
and colors on the color bar will change in the map display. The
F
numeric display type for the waveforms under the Points tab will
also change to the current map type. The following display types G
are available:
• LAT: Local Activation Time isochrone
• Peak-to-Peak: Peak-to-Peak voltage
• Peak-Negative: Peak-negative voltage
• CFE Mean: Complex Fractionated Electrogram Mean
activation between complexes H
CFE Std. Dev.: Complex Fractionated Electrogram Standard
Deviation between complexes. (Available only if Cardiac
Triggered Reference is unchecked).
D Project Map to Project the map to the desired surface group in the list. Closest
projects the map to the surface closest to the point(s).
E Low-V ID (Applies to the map that has focus when in Split Screen mode.)
Identifies low-voltage zones in LAT or CFE maps (see Figure 155
A for an example of a map with a Low-V ID filter applied). If a I
collected point’s P-P value is lower than the specified Low-V ID
value, then that point will display a gray area instead of the color-
coded scale for the current map type. Grey points do not
interpolate with color points.
H Map Appearance: Includes slider controls that modify various features of the map.
Interior Projection
(Applies to both maps when Split Screen mode is active.) This slider controls the
maximum distance that an interior 3D Point (represented as a triangle) can project to
a location on the surface (represented by a square). For multiple-surface models,
points will project to the nearest surface.
Exterior Projection
(Applies to both maps when Split Screen mode is active.) This slider controls the
maximum distance that an exterior 3D Point (represented as a triangle) can project
to a location on the surface (represented by a square). For multiple-surface models,
points will project to the nearest surface.
Interpolation
(Applies to the map that has focus when in Split Screen mode.) This slider controls
the minimum distance between surface points necessary for the system to
interpolate color. For multiple surface models, points will interpolate between
surfaces in the same group.
3D Points
(Applies to the map that has focus when in Split Screen mode.) Enables/disables the
display of collected points as triangular markers. The triangular markers are placed
on the positive electrode of the roving signal channel (Figure 155 on page 184).
3D Labels
(Applies to the map that has focus when in Split Screen mode.) Allows data to be
numerically displayed adjacent to the triangular 3D points. 3D Points must be
enabled in order to show 3D labels (Figure 155 on page 184).
3D Annotation
(Applies to the map that has focus when in Split Screen mode.) Displays or hides the
user-defined annotations associated with 3D points.
Surface Points
(Applies to the map that has focus when in Split Screen mode.) Enables/disables the
display of small square points on the surface. These squares represent the point on
the surface closest to a collected 3D point (Figure 155 on page 184).
J Appearance
Auto Color
• (Applies to the map that has focus when in Split Screen mode.) Controls whether
the system automatically controls the pointers on the color bar during mapping. If
Auto Color is enabled, the pointers will adjust to the minimum and maximum data
values for all points in the current map. Auto Color applies separately for each
display type. Auto Color will be disabled if any color is manually adjusted.
A B
Figure 155. A: An LAT isochrone with Low-V ID; B:A collected point displayed as A: surface point; B: 3D point; C: 3D label.
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ARTEN600035010 A Mapping Control Panel
185
Collecting Points
N
G E
D
O PQ RS
C
I
H
F
J
A
M L K
A Time scale The time scale (in milliseconds) at the top edge of the waveform display. The detected timing reference appears at 0
msec. Right-click on the Time Scale to display a menu to set the sweep speed, font size, and waveform thickness.
B Color bar (LAT maps only) When collecting or displaying LAT isochronal data, the color bar displays above the waveform
display. The function of the color bar duplicates the color bar in the map display. Dragging the pointers on the color
bar will adjust the range.
C Roving Activation The Roving Activation Interval is a timing parameter that is used in the detection of roving catheter activation. The
Interval (RAI) RAI is defined by the black area between the curtains. The curtains appear as shaded areas on either side of the
RAI. Roving catheter activation will not be reliably detected unless the beat falls within the black-background portion
of the waveform display. To adjust the RAI, click and drag the edge of the shaded background. The current RAI value
appears in the lower right of the waveform display. For non-cardiac CFE maps, the RAI is equivalent to the segment
length, and appears as a left curtain only. For cardiac triggered CFE maps, the RAI is set independently for CFE
maps and other contact map types.
D RAI Curtain Click and drag the curtain to adjust the RAI.
E Reference Reference catheter activation as defined by the selected reference detection algorithm. The reference caliper will
Activation Tic Mark always appear at 0 msec on the time scale.
NOTE: If the current rhythm does not meet the reference detection settings, this caliper will be magenta.
Points can still be collected and adjusted.
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ARTEN600035010 A Collecting Points
187
F Reference Offset Drag to place the Reference Offset Caliper to the desired point in the waveform. Waveform timing calculations will be
Caliper (Green) based upon the offset location.
G Roving Activation Roving catheter activation as defined by the selected roving detection algorithm, within the Roving Activation
Tic Mark Interval. When adjusting this caliper, the associated location in the map display will move to reflect the roving
position at the time of the caliper measurement.
NOTE: If the current rhythm does not meet the roving detection settings, this caliper will be magenta. Points
can still be collected and adjusted. If a time is adjusted and there are error conditions in the signal and
the reference caliper is not purple, the caliper will turn yellow.
NOTE: For CFE maps, multiple tick marks may appear on the roving waveform. Activation tick marks for CFE
maps are not adjustable.
H Voltage Low Roving catheter low voltage. This voltage caliper is set to the lowest voltage within 100 msec of detected roving
Caliper activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage and peak-negative voltage.
I Voltage High Roving catheter high voltage. This voltage caliper is set to the highest voltage within 100 msec of detected roving
Caliper activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage.
K [Freeze]/[Save] When data is being collected (gated to detection of the timing reference), click the [Freeze] button to stop the
display and review data.
• After pressing [Freeze], the label on the button changes to [Save]. Clicking [Save] allows you to save the
current point and point display to the current map, a different map, or a new map using the pulldown menu.
• The following data is saved with each collected beat: electrode position, current waveforms (reference, roving,
signal1, signal2, signal3), buffered waveforms and related roving electrode locations, timing, and voltage.
Performance may begin to slow after 1000 points.
• When mapping is used in Review mode, [Freeze] will also freeze the waveform display and [Save] will cause the
waveform display to play.
Hot key: <F11> duplicates the function of the [Freeze] and [Save] buttons.
L [Cancel]/[Resume] When the waveform display is frozen, [Cancel] will remove the currently displayed beat and resume gated data
collection without adding information to the map. [Resume] will resume gated data collection.
Hot key: <F12> duplicates the function of the [Cancel] button.
M Collected point As data is collected, each detected beat is temporarily saved in a buffer. When the waveform display is frozen,
buffer buffered data can be accessed using the buffer controls below the waveform display (Figure 157 on page 186). The
beat that was present at the time that [Freeze] was selected is represented by [0]. Previous beats can be accessed
by selecting the buttons for [-1], [-2], etc. When reviewing beats in the buffer, the associated location in the map
display will change to reflect the roving location at each selected beat.
Hot key: The left and right arrow buttons in the beat buffer are duplicated by the left and right arrow keys on the
keyboard.
N Points list This is a list of the points that have been collected for the map.
See the Help Menu for the Points List keyboard shortcut list.
O Timing Caliper Click the icon to place a Timing Caliper on the waveform. Up to ten calipers can be placed for each collected point.
Waveform Shadows
Shadows behind the waveform indicate morphology of previous beats.
NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.
Item Description
Reference Shadows The first point saved in a map will store the displayed Reference and “extra” waveforms as gray shadows, and will be
displayed in the RAI behind subsequent detected beats. If the first saved point is deleted, the next point saved will
generate the shadows.
NOTE: Changing the reference signal of the waveform will remove the shadow.
NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.
Roving Shadows A dark red shadow appears behind the current waveform for the roving catheter. This waveform indicates the morphology
of the previous beat for this catheter. This shadow is used to confirm beat-to-beat stability.
NOTE: If data does not exist for the previous beat (earliest beat in the buffer, etc.), then the dark red shadow will
not appear.
Unipole Waves Select to display unipolar waves (this selection must be made to display unipolar electrograms in the Waveform Display).
Amplitude – The amplitude for ganged waveforms can be adjusted by middle-clicking the waveform and dragging up or down. To
adjust the amplitude of an individual waveform, Shift + middle-click on the waveform.
Sweep Speed – To adjust the sweep speed for waveforms, right-click in the waveform area and then select the sweep speed from the
pop-up menu.
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ARTEN600035010 A Points Display
189
Points Display
Click the Points tab to display the collected points. The display is a combined
waveform segment, synchronized in time, of every roving catheter waveform
incorporated into the map. Each waveform includes a tick mark indicating the
activation point and a numeric metric that is determined by the current map type.
Selecting a waveform in the Points display shows the original data for that heartbeat
in the waveform display including all saved waveforms, up to ten timing calipers per
point (timing calipers can be adjusted), voltage calipers, and all buffered data. The A B C
beat of interest and voltage caliper settings can be adjusted. All changes are saved
automatically. The point in the map display that is related to the highlighted D
waveform will flash red.
F
NOTE: The first point(s) in the map are highlighted green to indicate that they
are the template beat for the map. These points, while first E
chronologically, may appear at different places in the list with other
sort orders. These template beats are colored green so they are not
inadvertently deleted, as doing so would change the map.
Table 25. Points Display
I
CALLOUT ITEM Description
C Sort Sort waveforms by order of collection, current map type, and cycle
length.(After making timing adjustments, the user must select sort
by LAT again.)
G
D Time scale • The time scale, in milliseconds (msec), displays at the top edge
of the waveform display. The timing reference of all waveforms is
synchronized to 0 msec. H
• Adjust the Sweep Speed by right-clicking in the black K
background and selecting Sweep Speed. The available options
are 40, 50, 100, 200, and 400 mm/sec. J
G Hide point When checked, this checkbox indicates that this point on the map
checkbox may show. Clear the check mark to hide this point. When
unchecked, the point is hidden, and a red circle displays.
H Duplicate A star above the check box indicates a duplicate point. There are L
M N
Points 3 types of duplicate points:
• Blue outline star - duplicate point, but not used
• Solid blue star - point has duplicates, but this point is used by the O
system
• Solid gold start - point has duplicates, but the user chose to use Figure 159. The Points display.
this point
Dashed line A dashed waveform line indicates that a point is not used to color
the map (not shown). The following types of points are drawn as
dashed: hidden points, duplicate points, points outside the
projection distances, and points with no locations.
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190 Points Display ARTEN600035010 A
Solid line Indicates a point that is used in the map (not shown).
I Blue Indicates the selected waveform. The data for the waveform is
background shown in the waveform display. If the corresponding point is used
in the map, the 3D point, its projection on the map surface, and its
text, flash red.
K Map point The Timing (in ms) or Voltage (in mV) of the map point.
measurement
L Number of The number of points that have been used/collected. The list may
points have to be scrolled to see all of the waveforms.
Amplitude – Waveform amplitude can be adjusted by middle-clicking the waveform and dragging up or down. For the Points display,
amplitudes are ganged for all waveforms.
Panning – The Points display will default to centering on the timing reference. The display can be panned by <Shift> + middle-
clicking in the background and dragging left or right.
Waveform indicators – The type of line used in the waveform indicates the effect of the waveform on the map.
■ Solid, bold with blue background – The waveform is selected. The original data for this waveform is currently displayed in the
waveform display. If displayed in the map display, the 3D point, 3D text, and surface point for this waveform flash red.
■ Solid – The waveform is used by the map.
■ Dashed – The point is a duplicate or is degraded.
Delete Hidden Points – To delete points that were hidden using the Show checkbox, right-click in the waveform display or Points
display and select Delete Hidden Points.
Delete Unused Points – To delete all points that are not displayed due to the current projection settings, right-click in the waveform
display or Points display and select Delete Unused Points.
NOTE: Due to the potential collection of duplicate points, the action to “Delete Unused Points” may cause more unused points
to appear. To delete duplicates, sort by point status, then select and delete all of the unused duplicates.
Scroll bar – Use this control to scroll through all activation points.
Hot key: When the Points display is open, the up and down arrow keys select the previous or next point, respectively.
When the Points display is open, [Delete] will remove the current beat in the waveform display.
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ARTEN600035010 A The OneMap Tool
191
The OneMap Tool is used to simultaneously create a model and a map. By default,
the OneMap Tool is disabled. To use the OneMap Tool, click the [OneMap] button at
the top of the Mapping control panel.
If no model surfaces have been created, a default surface will be created. If model
surfaces have already been created, the currently selected surface is chosen by
default.
To create a new map, click on the drop-down menu in the top right of the control panel
or choose No Map Selected in the Mapping Window. Click on [New Map]. Enter a
name for the new map and click [OK]. Refer to “Creating a Map” on page 192.
There are three tabs located above the catheter selections (Settings, Points, and
Model). The Model tab is only available when [One Map] is selected. The Model tab
displays the entire menu that is available under the Model task, including Show/Hide
Field Scaling. This permits the user to easily edit the model without the need to return
to the Model task.
There is no need to click on the [Finish Model] button. When exiting the OneMap
Tool, the model finishes automatically.
Creating a Map
Collecting Points
In the OneMap Tool mode, the Active EnGuide is automatically changed to be the same as the Roving catheter. The Active EnGuide
control is not selectable in the OneMap Tool mode.
1. With the patient in the clinical rhythm, place the roving catheter to collect data. When a beat of interest appears in the RAI, select
[Freeze].
NOTE: (OneMap Tool only) Selecting [Freeze] will automatically enable [Collect Points] when model type is set to OneModel.
2. In the frozen mapping window, review the morphology of the beat and placement of the caliper lines. If necessary, select an
optimal beat from the collected point buffer and/or adjust calipers.
3. Click [Save] or select a New Map or an existing map from the pulldown menu to save the point; otherwise, select [Cancel]. The
waveform display will return to acquisition mode.
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ARTEN600035010 A Creating a Map
193
NOTE: You will need to switch the secondary screen from Live to Review mode (see Table 6 on page 40 for details).
2. Select the appropriate segment from the drop-down list at the bottom of the right display.
3. If necessary, use the Waveform control panel in the right display to set the roving catheter and electrode.
4. Reference K through N under “Collecting Points” on page 186. (Refer to Figure 157 on page 186).
NOTE: Points can be added to either the left or right display and will be applied to both displays. Offline Review only.
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194 Managing Maps ARTEN600035010 A
Managing Maps
New Map – New Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel. Select New
Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click [OK].
Copy Open Map - Copy Open Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel.
Select Copy Open Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click
[OK].
NOTE: You can rename a map by double-clicking in the Map Name field at the top of the Control Panel and typing in the new
name.
Mapping Controls
Access these Mapping controls by clicking on the eye ball icon in the upper right of the map
workspace.
Label Show Through – Projects the labels through surfaces that may be obscuring them.
Show EnSite Model – Turns the entire model on and off during mapping.
Show DIF Model – This checkbox allows the DIF model (i.e., CT scan or MRI) to either be
hidden or displayed.
Project on DIF – (After registration has been performed using the EnSite™ Fusion™
Registration Module) Enabling this checkbox allows the user to project or unproject 3D Labels
and/or Lesions (referred to as 3DP), and map data onto the DIF surface rather than onto the
EnSite model surface.
Show Mapping – Causes surfaces to be colored using the current map color.
Hide Non-Map Surfaces – When turned on, hides surfaces that are not assigned to a map.
Figure 162. Map Displays.
Map Transparency On – Turn the map Transparency on and off.
Fixed Proximity Indicator – Turning this checkbox on sets the diameter of the Proximity Indicator to a maximum of 10mm, regardless
of the current lesion size.
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ARTEN600035010 A 195
Therapy CHAPTER 13
The Therapy task is used to place lesion markers on the map and perform ablation therapy. The Therapy control panel contains a list
of lesion markers and controls for modifying their appearance. When using the Lesion Marker tool, you can place lesion markers with
the mouse or use the tool bar to place surface and 3D lesions at the Active Electrode.
B C D E F
G
A
A. Lesion Marker Tool – Use this tool to place lesion markers on the model.
E. Lesion at EnGuide – Click this button to place a lesion marker on the surface at the Active Electrode.
F. 3D Lesion Marker at EnGuide – Click this button to place a 3D lesion marker at the Active Electrode.
G. Lesion List – This is a list of all the lesion markers that have been placed.
H. Properties – Use these controls to modify a lesion marker’s color, diameter, 3D projection, or to show/hide lesion markers.
Lesion Markers
(Any mode)
Lesion markers (Figure 164 on page 196) are used to identify ablation lesion
marker sites. Up to 1024 lesions can be placed in the map display.
Lesion markers are projected from the 3D center of the Active Electrode to
the nearest surface. The original 3D catheter location is preserved. If the
surface is edited, the lesion is re-projected from the original 3D catheter
location.
An adjustable distance control allows you to edit the distance allowed for
projection. Lesion markers that are present and do not meet the 3D distance
requirement are displayed as 3D objects (without being tied to a surface).
You have the option to project, or not to project the lesion.
Each lesion marker has a numeric name that is displayed in a list. This
number increments each time a lesion marker is placed on the map. If a
lesion marker is deleted, the numeric list is updated to keep numbers
consecutive.
A B C D E E
Figure 165. Lesion marker controls. A: lesion tool; B: color control; C: size control; D: projection control; E: placement buttons;
F: right-click menu.
NOTE: The diameter control also adjusts the maximum diameter of the proximity indicator on the EnGuide electrode (refer to
“EnGuide Proximity Indicator” on page 124 for more information).
3. Place the lesion marker using one of the following methods:
■ Click on the map to place the lesion marker at the mouse pointer. Clicking repeatedly places multiple lesion markers. For
multiple-surface models, the lesion marker appears on the surface beneath the pointer.
■ Click [Lesion at EnGuide] to place the lesion marker on the point on the endocardial surface that is highlighted by the
EnGuide proximity indicator. For multiple-surface models, the lesion marker appears on the nearest included surface. A
lesion marker placed with [Lesion at EnGuide] is already projected. To move the lesion marker to the Active Electrode,
turn off the Project Selected Lesions checkbox from the right-click menu.
Hot key: <F6> places a lesion marker at the Active Electrode.
■ Click [3D Lesion at EnGuide] to place the lesion marker at the Active Electrode. This lesion marker appears as a sphere and
is not connected to the surface of the map, but rotates with the model. To project the lesion marker onto the closest surface,
turn on the Project Selected Lesions checkbox from the right-click menu.
Hot key: <Shift>+<F6> places a 3D lesion marker at the Active Electrode.
NOTE: The last lesion marker placed is outlined in yellow. If this lesion marker is deleted, the next to last lesion marker is
outlined.
NOTE: When a lesion marker is placed on the map, it is added to the Lesion List.
Chapter 13. Therapy EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
198 Lesion Markers ARTEN600035010 A
For information about selecting lesion markers, refer to “Common Interface Elements”
on page 35.
■ To select a single Lesion Marker, click on the Lesion Marker tool in the Tool
Palette, hold down <Shift>, and then click on the Lesion Marker’s label.
■ To select multiple Lesion Markers, click on the Lesion Marker tool in the Tool
Palette, hold down <Ctrl>, and then click on the each Lesion Marker.
Alternatively, click on the Lesion Marker tool in the Tool Palette, hold down
<Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around
the Lesion Markers.
Figure 166. Lesion Marker list control panel.
■ To deselect a Lesion Marker, hold down <Shift> and click away from the Lesion
Use this control panel to modify lesion
Marker's label.
markers.
To select Lesion Markers in a list:
■ To select a single Lesion Marker in the list, click on the Lesion Marker in the list.
■ To select multiple Lesion Markers in the list, hold down <Ctrl> and click on each Lesion Marker.
■ To select multiple consecutive Lesion Markers in the list, hold down <Shift>, click on a Lesion Marker and then click on another
Lesion Marker. Alternatively, click on a Lesion Marker and drag to select additional consecutive Lesion Markers.
NOTE: When a Lesion Marker is selected, the color of its label changes to white in the model/map display area.
■ To modify a lesion using the Tool Palette and Tool Bar: select the Lesion Marker tool on the Tool Palette, shift and click on the
lesion marker’s label, and then use the Tool Bar controls to modify the lesion marker’s color and size.
■ To modify a lesion marker using the Lesion Marker control panel in the RealReview task: select the lesion in the Lesion Marker
List, and then use the control panel controls to modify the lesion’s color, size, and projection.
■ To modify a lesion marker using the right-click menu, click on the lesion marker, right-click in the display area to display the
Lesion Marker menu, and then select one of the following:
– Show All Lesions shows all lesion markers.
– Hide Selected Lesions hides the selected lesion markers. The lesion markers are only hidden, not deleted.
– Delete Selected Lesions deletes the selected lesion markers from the map and the Lesion Markers List.
– Move Selected Lesion moves the selected lesion marker. To move a lesion marker, select the lesion marker, click Move
Selected Lesion, and then click on the map at the desired location. Moving a lesion marker changes it to a mouse-placed
lesion.
– Project Selected Lesions A lesion marker placed with [Lesion at EnGuide] is already projected. Project Selected Lesions
moves the lesion to the Active Electrode. A lesion marker placed with [3D Lesion at EnGuide] is placed at the Active
Electrode. Project Selected Lesions projects the lesion marker onto the closest surface.
– Show Lesion Text shows/hides the name of all lesion markers.
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ARTEN600035010 A Lesion Markers
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B. Color – Clicking on this icon allows you to select a color for the lesion marker.
E. 3D Lesion Marker – Clicking on the box icon changes the lesion from projected to 3D.
RealReview CHAPTER 14
RealReview is the task that allows the user to review study notebook recorded in the current study.
The RealReview screen can be divided into two display areas via the Split Screen icon (Figure 168 on page 201). The control panel
displays a Notebook (A) that contains recorded data that can be listed by Time or Type (Segments, Bookmarks, Images, Animations,
and Events).
Below the saved study content is a collection of annotation lists (B). While direct manipulation of annotations on the model will be
the most common way of interacting with annotations, these lists provide redundant access to labels, markers, measurements, lesion
markers, and shadows. To display the list for labels, tape measure, lesion markers or shadow for the specific display, select the
corresponding icon in the tool palette.
B. Annotation Listings – Displays a list of map tags corresponding to the selected icon on the tool palette. Refer to “Tool Palette” on
page 32.
Chapter 14. RealReview EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
202 ARTEN600035010 A
Reviewing Segments
Selecting a segment from the notebook (by double clicking it
with the left mouse button) will display it in the right pane.
Playback controls become enabled beneath the view.
Reviewing Bookmarks
Selecting a bookmark from the control panel list (by double
clicking it with the left mouse button) opens the recorded
segment with the time cursor frozen at the bookmarked location.
This point is marked by a yellow line in the waveform display
and segment overview.
Reviewing Images Figure 169. Reviewing a segment in the right pane of dual view.
Reviewing Annotations
The annotation list area can be used to view and modify the
annotations (labels, anatomic markers, tape measures, lesion
markers, and EnGuide shadows). Select a type icon from the
Tool Palette. Annotations created in Offline Review will have a
brown background in the control panel. To modify an
annotation, select the annotation in the list (it will be selected in
the model) then use the controls to show/hide, delete, and change
the appearance of the annotation.
Figure 171 on page 202 shows the individual lists and controls.
Figure 171. Annotation lists and controls. A: labels; B: anatomic markers; C: tape measures; D: lesion annotations; E: EnGuide
shadows.
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ARTEN600035010 A 203
Past Studies
5 6 3
Offline Review
Opening a study from the Past Studies screen opens the study in the Model task. The last recorded segment will automatically be
played. The brown status bars indicate Offline Review mode (Figure 174 on page 205).
Figure 174. Offline Review screen. Note the brown status bars.
NOTE: Lesion markers added in offline review will be given a brown background in the list.
NOTE: If the patient has more than one study and the user wants the change to apply to only the selected study, check the Apply
Changes box for the selected study only.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Chapter 15. Reviewing and Editing Past Studies
ARTEN600035010 A Managing Patient and Study Records
207
Deleting Studies
Removing study information from the DWS hard drive will make more drive space available for future studies.
NOTE: If the hard drive becomes full during a study, the system will delete the oldest backed up studies first.
NOTE: Studies that have been removed from the hard drive can still be loaded from removable media for future reference.
Ending a Study
WARNING: If the DWS is powered off by the user, rather than shutdown by the operating system, data on the hard drive may become
corrupted and the EnSite™ Velocity™ Cardiac Mapping System may cease to be operational.
CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient
before disconnecting its connection from the NavLink™ Module.
NOTE:
5. The system will return to the Login screen.
Images and study data can be stored to a USB device, a network drive, or CD/DVD for reuse on PC or Macintosh computers with a
compatible CD or DVD drive. Compatible CD/DVD formats are: CD-R, CD+R, CD-RW, CD+RW, DVD-R, DVD+R, DVD+RW, and
DVD-R Dual Layer.
NOTE: CD/DVDs must be handled with care. Do not allow a CD/DVD to fall on a hard surface. To label a CD/DVD, never use
a paper label, always write directly onto the CD/DVD using a permanent marker.
NOTE: A CD/DVD may contain multiple images, but only one study.
NOTE: If export to a USB device fails, try an alternate external storage device, a network location, or CD/DVD.
NOTE: Network File System (NFS) versions prior to NFSv3 may experience limitations to the addressable file system size to
less than 4.2GB. (This is a protocol limitation.)
NOTE: File system access errors may be experienced when using Server Message Block (SMB) versions prior to 2.0. Some files
may become inaccessible.
NOTE: USB devices having FAT32 file systems may be unable to store Velocity studies, due to the number of files, file name
length, or file size limitations of FAT32. NTFS or ext3 file systems are recommended to be used.
When images are stored to external media, they are listed by their annotation and an index number to differentiate duplicate
annotations. Images are stored as JPEG files.
When capturing images or creating animations, the entire screen or a selected area of the screen can be captured. In addition, the images
and animations can be captured with a white background. The user specifies what is to be captured in the Capture Image, Record
Movie, and Capture Images windows.
■ To capture the entire screen, select Full Screen.
■ To define the area of the screen to be captured, select Selected Area. To define the area to be captured, Click and hold down the
left mouse button and drag a box around the desired area of the screen. Adjust the box if necessary.
■ To capture the entire screen or selected area with a white background, select White Background. A white background is beneficial
if the images are going to be printed on a printer.
When the desired area has been selected, click [Capture Image] to capture an individual image, or click [Start] to capture an animation.
The captured image or animation is stored in the Notebook.
Chapter 17. Capturing, Exporting, and Importing Information EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
212 Saving and Accessing Individual Images ARTEN600035010 A
NOTE: MPEG and JPEG animations can only be captured in Offline Review.
Images of entire screens can be saved. These images can also be viewed.
Saving an Image
To save an individual image:
1. Select File > Save Image to display the Capture Image window.
2. Type a description of the image in the text area.
3. Indicate the screen area to be captured:
■ Select Full Screen to capture the entire screen.
■ Select Selected Area to manually select the screen area to
capture. Refer to “Selecting an Area for Capture” on page 211 Figure 176. The Capture Image dialog is used to capture
for more information about selecting the screen area. individual JPEG images.
4. Select White Background if a white background is desired.
5. Click [Capture Image]. The image is captured and saved as a part of the patient study, and is added to the Notebook.
Accessing an Image
NOTE: Images are saved with their appropriate study. If a study containing images created in Offline Review mode is removed
from the workstation hard drive, the images are removed as well. Be sure to backup studies so the images are saved.
1. Access the Notebook in RealReview.
2. Select an annotation from the list. Use the buttons described below to view or manage image files:
■ [Load] displays the image.
Creating Animations
A series of continuous images of the entire screen can be exported from the system as either an mpeg movie file or a sequence of jpeg
images.
Data Export
(Offline Review only)
To begin Data Export, select File > Export to bring up the Data
Export window (Figure 179 on page 214).
A
Waveform Data
Near the top of the window is a list of the types of data that can
be exported (A). Any or all of them can be selected using the
check boxes, and each will be written to its own file. When the B
user selects any type of data that changes over time (e.g.
Waveforms, or Electrode Locations), the Export Interval options
become available (C) to choose the time interval for the export. C
The Displayed Waveforms option is a special shortcut selection
that exports only those waveforms (of any type) that are
currently displayed, over the current span of the waveform
window. The Export Data and Export Interval options do not D
apply to this selection.
Directory Name
A directory prefix is assigned in the Directory Name field of the Data Export window (see Figure 179, B). Each time the Export button
is clicked, a folder is created using this name and the current date and time of the button click, and the exported data files are saved
into this folder.
Caliper. Select this option to use the green calipers in the waveform display to capture the time interval desired.
Displayed Window. Selecting this option captures the visible time interval in the waveform display.
Cursor Location . Selecting this option exports the segment beginning at the cursor. This option requires that one of two sub-options
also be selected:
■ Export until segment end, which will continue exporting data until the segment ends.
■ Duration (in seconds), in which the exact segment interval is determined by the user and is manually entered in the field supplied.
NOTE: Selecting [Clear Selections], at the top of the Data Export window, will clear all Export Option check marks. De-
selecting items can be done anytime prior to Export.
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ARTEN600035010 A Data Export
215
Exporting
When [Export] is clicked, a progress bar is displayed for each option selected. If Export Data: All is selected (see Figure 179, A), all
available data for the selected type(s) will be exported from the study (e.g., all EP Catheter Unipole Waveform channels). In contrast,
when Export Data: Displayed is selected, only those channels currently displayed in the waveform window will be exported.
NOTE: When the progress bar(s) is displayed, [Cancel] can be selected to stop the Export. The Export may not stop immediately;
a slight delay can be expected.
When exporting EnSite™ NavX™ Navigation and Visualization Technology data, the segment playback speed is automatically set to
1:4. This ratio allows for internal processing and the Export of data. When exporting non-contact data, if the Virtuals Grid option is
chosen, the playback speed is automatically set to 1:10; this ratio allows for the additional processing requirements.
Presets
The user can choose to save a Preset for application configurations that will be used in more than one
Export.
Once all the desired parameters are set, click on the Preset icon located in the upper right of the Data Save Preset…
Export window. Click on Save Preset to bring up the Save Preset window. Type in a name for the
Manage Presets...
preset and click [OK].
To reapply a Preset, click on the Preset icon and click on the appropriate Preset name. Figure 180. Preset icon
and Preset menu selections
NOTE: Export Presets can be applied to any segment in the study in which they are defined.
However, Export Presets cannot be applied to a different study.
Chapter 17. Capturing, Exporting, and Importing Information EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
216 Archiving Studies ARTEN600035010 A
Archiving Studies
2
3
4 5
7
6
8. The system prompts the user to anonymize the archived patient data. Click Yes or No.
■ A progress bar displays “Store in Progress.”
■ The study is archived on the selected media when the progress bar finishes.
Archiving Media
2. Select the Archive Media tab (2). Figure 183. Clinical Menu.
2
3 4
4b
5 6
6. Select the Identifier (name of the USB device or enter the name of the CD/DVD) (6),
7. Click [Archive] (7).
8. The system prompts the user to anonymize the archived patient data. Click Yes or No.
■ A progress bar displays “Store in Progress.”
■ The images and animations are archived on the selected media when the progress bar finishes.
Importing Studies
The user can import studies to the DWS from a USB device, a
network drive, or CD/DVD.
1. Click Import from the Clinical Menu (1).
2
3
Troubleshooting APPENDIX A
The following troubleshooting guide is intended to help resolve problems with the system. If problems cannot be resolved by using
the suggestions presented here, contact your EnSite™ Velocity™ Cardiac Mapping System field representative or distributor.
651-756-6985
Toll Free: 800-374-8038, Option 1
Troubleshooting Tools
Technical Support may ask that the user access one or more of the following software resources:
SJM™ Connect – Technical Support is able to electronically access your EnSite™ Velocity™ Cardiac Mapping System to perform
troubleshooting. See “Using SJM™ Connect” on page 222.
About the EnSite™ Velocity™ Cardiac Mapping System – This information provides your EnSite™ Velocity™ Cardiac Mapping
System Technical Support representative with general information about your DWS and EnSite™ Amplifier. There are two ways to
access this information:
■ During a study, from the menu bar, select Help > About.
■ From the title screen, Select [About EnSite Velocity].
Amplifier Logs – This function displays messages from the EnSite™ Amplifier during a study. From the menu bar, select Amplifier >
Log. A window appears that displays all of the collected logs.
Collect Log Files – This function collects all the log files from the DWS and exports them to external media. From the title screen,
select [Services], then [Collect Logs] from the Services menu. [Follow the on-screen prompts to complete the process. This operation
can take several minutes to complete.
Viewing recorded settings – Some settings used in Realtime mode can be viewed (but not changed) in Offline Review mode.
■ Hardware settings can be viewed by selecting Amplifier > Settings from the menu bar.
■ Catheter settings can be viewed in the Setup task.
■ EnSite™ NavX™ Navigation and Visualization Technology settings can be viewed in the Setup task.
Run external program – This function allows utilities to be accessed. From the title screen, select [About EnSite Velocity] > Utilities
> [Run External Program]. Follow the on-screen prompts to complete the process.
Study Files – Record a segment that shows relevant information (if possible) and save the study using the anonymize option to
extrenal media.
Troubleshooting EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
222 Using SJM™ Connect ARTEN600035010 A
SJM™ Connect is a feature that is available on the EnSite™ Velocity™ Cardiac Mapping System. It allows an EnSite™ Velocity™
Cardiac Mapping System Technical Support representative to connect to your DWS through a broadband Internet connection. When
connected to your DWS, the EnSite™ Velocity™ Cardiac Mapping System Technical Support representative is able to see the
interface. You will also be able to chat with the Technical Support Representative through a chat window.
NOTE: SJM™ Connect is intended for troubleshooting purposes. SJM™ Connect is not intended to be used in lieu of an on-site
system operator.
NOTE: Personal patient information is automatically deleted from uploaded studies. The Technical Support representative uses
these anonymous studies to research any technical issues. When possible, record and annotate segments of any unusual
behavior for analysis.
NOTE: An Ethernet cable with Internet access must be plugged into the hospital network port on the back of the DWS. This is
an encrypted, secure connection used by SJM Technical Support.
NOTE: SJM™ Connect will be enabled for the selected amount of time, ranging from 0.1 hour (6 minutes), 1 hour, 2 hours, 24
hours, and 48 hours. The default timeout is 0.1 hour (6 minutes). The timeout determines how long the session can remain
idle before being terminated. The session will not timeout at any time during a study.
5. If Technical Support initiates a remote connection to the DWS, a prompt displays requesting to view and control your computer
(Figure 190).
NOTE: The default status of SJM™ Connect on system startup is disabled. SJM™ Connect should only be enabled when a
Technical Support session is necessary.
If not disabled manually, SJM™ Connect will stay enabled until the specified timeout irrespective of user logouts or system shutdown.
It will disable automatically after the specified timeout if no Technical Support is connected at that time. If a Technical Support is
connected and the timeout expires, the SJM™ Connect session will stay enabled until Technical Support terminates the connection.
Whenever SJM™ Connect window is not active window on the screen, it will close itself. It can always be launched by clicking the
SJM™ Connect icon on the EnSite™ Cardiac Mapping System’s tool bar.
NOTE: Do not click [Close] (Red X) button from the chat window, it will terminate the ongoing session with Tech Support. Do
not click any buttons from the chat window until Technical Support instructs you to.
NOTE: The logs will not be uploaded automatically. They will remain on the DWS until SJM Technical Support connects to the
DWS to collect them.
Uploading Studies
If SJM Technical Support requests that you upload patient studies:
1. Click the [Clinical] button, then the [Archive] button from the EnSite™ Cardiac Mapping System main page.
2. Select the study or studies to upload.
3. Select the [SJM Connect] checkbox and click [Archive].
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Troubleshooting
ARTEN600035010 A Using SJM™ Connect
225
4. Click [Close].
NOTE: The studies will not be uploaded automatically. They will remain on the DWS until SJM Technical Support connects to
the DWS to collect them.
Proxy Configuration
SJM Technical Support may request that you configure the proxy server in order to establish a connection to the DWS:
1. Click [Configure Proxy] in the SJM™ Connect window (Figure 189).
NOTE: The [Configure Proxy] button will be inactive if SJM™ Connect is enabled.
NOTE: Do not configure a proxy if the hospital network does not require a proxy for Internet access. By default, no proxy is
configured and all the fields from the Proxy Configuration window will be inactive.
Notifying SJM
When system logs or patient studies have been prepared for uploading, contact SJM by telephone or e-mail.
In Europe: 32-2-774-68-11
■ To contact SJM by email: USDTechSupport@sjm.com
Troubleshooting EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
226 Troubleshooting Common Problems ARTEN600035010 A
Power Failures: A power If there is reason to believe that some type of power failure has occurred, turn the EnSite™ Amplifier power switch to
blackout will cause a total OFF immediately. Try to end the study and shutdown the workstation, as described in “Ending a Study” on page 209. If
system shutdown. In the the normal shutdown procedure is unsuccessful:
case of a brownout, the • Try Ctrl-Alt-Delete
system may totally
• Try Alt-F10 > [Exit EnSite Velocity] > [Exit]
shutdown or may show
signs of abnormal system • Try momentarily pressing the power button on the front of the DWS
behavior. • As a last resort, press and hold the power button on the front of the DWS.
When the power resumes and appears to be stable, power up the system as described in “Starting the System” on page
89. Monitor the automated system check during the power-up procedure. If any system problems occur, contact SJM
Technical Support immediately. To continue the study, see “Past Studies” on page 97.
There is a problem with • A solid amber LED indicates a self-test problem in the EnSite™ Amplifier.
the EnSite™ amplifier, • A flashing amber LED indicates an error in the EnSite™ Amplifier.
indicated by an amber
• Contact EnSite™ System Tech Support.
LED on the amplifier front
panel after the two-
minute power on self-test.
The EnSite™ Amplifier The EnSite™ Amplifier is unresponsive or is not collecting data in Realtime mode or RealReview mode. Try to re-
is not communicating with establish communication with the EnSite™ Amplifier by selecting Amplifier > Reconnect. If communication is not
the workstation. reestablished, do the following:
• Check the fiber-optic cable connection at the EnSite™ Amplifier and at the workstation.
• Power on the EnSite™ Amplifier and all peripherals.
• Power on the workstation.
• Check the 3 indicator lights on the Media Converter (inside the back door of the DWS).
- Fiber - green - Media Converter is receiving the signal from the EnSite™ Amplifier
- via the Fiber- Optic cable.
- Power (Pwr) - green - Media Converter is receiving power from the Workstation.
- Copper - green - Media converter is receiving the signal from the DWS
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Troubleshooting
ARTEN600035010 A Troubleshooting Common Problems
227
There is a problem with The workstation displays a yellow warning dialog: “Amplifier Error.”
the EnSite™ Amplifier The user should Contact EnSite™ System Technical Support.
indicated by the
workstation.
The workstation will not • Verify that the power conditioner switch is on.
turn on, will not boot, or • Verify that the power cable is properly connected between the workstation and the power conditioner.
turns off unexpectedly.
• If the system should cease to function due to a power outage or other failure, turn off all power switches. Then restart
the system as described in “Starting the System” on page 89. System recovery may take up to 6 minutes.
• Try momentarily pressing the power button on the front of the DWS
• As a last resort, press and hold the power button on the front of the DWS.
• To continue the study, refer to “Past Studies” on page 97.
Hard drive has run out of If there is insufficient space on the hard drive to load a study from the external media, delete studies from the hard drive,
space. then load the study.
The printer does not • Ensure the printer is enabled. To do this, go to the Services menu and select [Select Printer]. Select the desired printer
print images. and click “Apply.”
• Ensure that printer ink cartridges are not depleted; replace depleted cartridges. Ensure that there is paper in the
printer.
Troubleshooting EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
228 Troubleshooting Common Problems ARTEN600035010 A
There is a need to validate If the validity of a virtual electrogram signal or a map is in question, compare the EnGuide virtual electrogram to the
virtual electrogram EP catheter electrode in contact with the endocardium at the same site. Similarity between these signals suggests
morphology to contact validity of the virtual electrogram or map at the same site. This can be done in any mode. However, in review mode
electrograms the EnGuide locator must have been enabled before the segment was recorded.
• Set an electrode on an EP catheter to Active EnGuide.
• Under model controls, display the EnGuide locator as a vector with a single electrode.
• Under catheter setup / waveform controls, set EnGuide virtual polarity to Unipolar.
• In Waveform, set up two traces. Set one trace source to EP catheter and set the second trace source as EnGuide.
Use the electrode that is selected for EnGuide on both traces.The d/dt checkbox and Amplitude filtering should be
identical between the EP catheter and EnGuide traces.
• Verify that the EP catheter electrode is in contact with the chamber wall. Use the EnGuide locator to determine the
location of the EP catheter electrode.
Caution: If the EP catheter electrode is not in contact with the endocardium, the comparison between the
EnGuide virtual electrogram and the EP catheter electrode may not accurately reflect the relationship between
these signals.
• Compare the traces in the waveform display. Similarity between the signals indicates validity of the virtual
electrogram.
Interference between This equipment has been tested and found to comply with the limits for medical devices to EN 60601-1-2: 2015. This
devices is evident. 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. If this
equipment does cause harmful interference to other devices or is negatively impacted by other devices, try to
correct the interference by one or more of the following measures:
• Reorient or relocate the devices.
• Increase the separation between the devices.
• Connect the equipment to an outlet on a different circuit.
• Contact Technical Support for further assistance (“Contacting Technical Support” on page 221).
There is excessive If noise levels are excessive in general, check the following:
waveform noise. • Under catheter setup / waveform controls, evaluate signals with noise filters enabled and disabled.
• Ideally, the power source for the EnSite™ Amplifier should be a properly grounded, dedicated 15 amp circuit.
Avoid using hospital emergency power for either the workstation or EnSite™ Amplifier.
An EnSite™ NavX™ • Verify that all cable connections between the surface electrodes and the NavLink™ Module are secure.
Navigation and • Verify that none of the surface electrodes have come loose. If a surface electrode has come loose from the patient,
Visualization Technology re-apply the electrode in the same location and verify that navigation is accurate, compared to fluoroscopy and
surface electrode has signals. It may be necessary to re-validate.
become disconnected or
loose, indicated by a warning
message.
ECG signals are not • Verify that the system reference patch is connected to the patient.
functioning properly. • Verify that the ECG cables are connected properly.
• If not using a RecordConnect, verify that the ECG cable was labeled by St. Jude Medical.
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An EnGuide locator • In an EnSite™ NavX™ Navigation and Visualization Technology study, if EnGuide locators appear kinked, there
appears kinked or displays may be a problem with the catheter. A new catheter or extension cable may display better results.
fewer electrodes than • If EnGuide is displaying fewer electrodes than expected (based on EnGuide settings) the electrodes may be
expected. spaced too close to one another for EnGuide to display different electrodes, or there may be a problem with the
roving catheter, such as a weak electrode or short.
Patient Rate or Rhythm change • Heart rate or rhythm changes have the potential to change the physical anatomical
volume of the heart chamber. If the rate or rhythm changes occur after a model has been
created, new model may need to be created for the new rate or rhythm.
Patient Isoproterenol bolus • Wait for the respiration pattern to stabilize. The EnGuide may return to its original
expected location.
Patient Heart Motion • If the heart has physically moved from its original position, create a new model if
necessary.
Device Interaction Introduction of a Guide Wire • Remove the guidewire if it is not in use.
Device Interaction Pacing – connection of a • If there is no active pacing on the electrode pair, remove the connection of the stimulation
stimulation channel to channels.
electrodes
Troubleshooting EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
230 Troubleshooting Common Problems ARTEN600035010 A
Surface Electrode Adding or removing patient • Avoid moving bedding materials such as a pillow that have the potential to disturb the
Changes bedding materials surface electrode
Unable to access controls to • Verify that Offline Review mode is selected; the external media is not intended to be used to export data or
export information to the animations during a study.
external media.
The study screen display If the system appears to be running but does not respond to keyboard or mouse input, press and hold the <Alt> key
freezes. on your keyboard, then press the <Tab> key. The system should then return to normal operation.
The study screen freezes after a manual reset of the EnSite™ Amplifier or an inadvertent reset following a
defibrillation. Possible messages include: Data rate is out of range or No data is being received from the
EnSite™ Amplifier. When one or both of these messages appear, click [OK]. If the screen remains frozen, perform
the following steps:
• Power cycle the EnSite™ Amplifier by turning the EnSite™ Amplifier power switch off and (after five seconds) then
on.
• Select Amplifier > Reconnect and wait up to 2 minutes for the EnSite™ Amplifier to complete its self-test
routines.
• Select <Alt> + <Tab> to see if the study screen starts responding.
• To force the system to shut down, select <Alt> + <F10> YES, REALLY EXIT VELOCITY.
• To end the current session, or to force the system to shutdown or restart, select <Ctrl> + <Alt> + <Del>, and
choose the desired option.
If the problem still persists, contact EnSite™ Velocity™ Cardiac Mapping System Technical Support.
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An on-screen warning A number of problems are reported by displaying a message in a window. One or more buttons are available, which
message has appeared. specify the action to take to remedy the identified problem.
A desktop manager window may also pop up on-screen when an application is not responding. It will have two
options - “Terminate” or “Keep Running.” Select the desired option.
Note: Further details on problems related to the current version of the software can be viewed by selecting Release
Notes under the Help menu.
Other information may be displayed along with these messages indicating what caused the problem. Note this
information for future reference should you wish to contact support personnel.
Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an inability to
record data or to communicate properly with the EnSite™ Amplifier.
Different buttons may appear based upon the severity of the identified problem. Some examples of these button
options are:
• [Reconnect] reconnects to the EnSite™ Amplifier.
Troubleshooting EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
232 Troubleshooting Common Problems ARTEN600035010 A
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 233
Due to the complexity of this system, service may be performed only by trained personnel. Contact your EnSite™ Velocity™ Cardiac
Mapping System representative or distributor for service and technical support.
Australian Sponsor:
St. Jude Medical Australia Pty Limited
17 Orion Rd.,
Lane Cove NSW 2066
AUSTRALIA
+61 (02) 9936 1200
Care and Service EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
234 Setting Environmental Information ARTEN600035010 A
NOTE: This is a 24 hour clock. The clock can only be set to a time that is at least 18 hours later than the time that the last study
ended.
NOTE: After the user sets the system clock, the system prompts the user to confirm system shutdown.
Customer-Performed Maintenance
EnSite™ Amplifier
Cleaning
WARNING: Cleaning is recommended after each use. All surfaces should be cleaned with a dry, lint free cloth, gently applied. Where
necessary, alcohol can be applied on such a cloth to remove grease and stains. The monitor screens can be cleaned with
an appropriate solution.
CAUTION: Do not clean the system components with disinfectants that contain surfactants.
CAUTION: Do not apply cleaners while the system is warm to the touch.
Periodic Inspection
The system components should be inspected by the customer on a monthly basis:
■ Ensure that the fans on system components are operating when power is on. Periodic fan filter cleaning or replacement is
recommended.
■ Check the components, cables, and connections for mechanical damage.
■ Check cables and connectors for damaged pins.
■ Verify that inscriptions and labels on the system components are properly and completely fixed.
■ Visually inspect that this Instructions for Use document is undamaged and complete.
c. Mount a new filter in the handle using the two screws. The
gestated side of the filter should be oriented as shown.
4. Slide the filter into the channels in the EnSite™ Amplifier until the handle
is flush with the side of the EnSite™ Amplifier.
5. Fasten the handle to EnSite™ Amplifier using the Phillips screw.
Replacing Fuses
The EnSite™ Amplifier power supply is protected by two replaceable fuses
located near the power cord connection.
Use only 5x20mm type, 5 amp, 250 VAC fuses (T5AL250V). Always replace
both fuses.
To remove the fuses, remove the power cord, flip up the fuse cover, and pull out Figure 198. Removing the filter.
the red fuse holder. The fuses are located on opposite sides of the fuse holder.
Replace both fuses, reinsert the red fuse holder, flip down the fuse cover, and
reattach the power cord.
The EnSite™ Amplifier should be tested annually. These tests require specialized equipment and training. Contact an EnSite™
Velocity™ Cardiac Mapping System-trained field service representative to schedule testing.
Replacement Parts
Table 26. EnSite™ Velocity™ Replacement Parts
RecordConnect • GE - 1000005745
• WorkMate - 100005746
• Siemens - 100005747
• Bard-Stamp - 100013362
• Bard Clear Sign - 100018069
• Universal 100010720
Monitor - DWS and remote, 24” or 21” 100022163 (24”) or 100017757 (21”)
Do not disconnect any cables other than those mentioned below. These are not user-serviceable connections.
NOTE: When reconnecting the fiber-optic cable to the EnSite™ Amplifier, be sure to align the tabbed edge of the cable
connector to the slotted edge of the jack.
8. Power ON the system. Monitor the startup procedure as described in “Starting the System” on page 89.
EnSite™ products are activated by installing appropriate licenses. A base license must be installed before installing any optional
module such as EnSite™ Fusion™ or EnSite™ Verismo™ module.
NOTE: Attempts to install optional EnSite™ modules on a system without a base license for the EnSite™ Cardiac Mapping
System will fail.
Preparing to Install
Required equipment:
■ A computer with Internet connection
■ Software Upgrade Kit
■ USB Flash Drive
or
■ CD Writer, needed in order to burn the license(s) to CD
These processes have been validated using Internet Explorer 6.0 through Internet Explorer 9.0.
NOTE: Retrieve licenses before the site visit, if Internet access could pose an issue. The hostname from the DWS or LRS will
be required for the license.
Requirements
A Software Upgrade Kit, which includes:
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600035010 A Installing EnSite™ Cardiac Mapping System Software Licenses
239
Table 27.
Name Description
Installation Installation Report is used to document the installation and maybe returned to
Report St Jude Medical
The following steps must be performed on a computer with an Internet connection and CD writer or USB flash drive to acquire the
licenses.
1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/
NOTE: The Activation ID for the base license is the same as the hostname. Use the hostname from the DWS as the activation
ID and not what is on the box.
2. Enter the Activation ID in the Activation ID text box.
3. Click validate.
Figure 201.
■ Start Date: the intended date of install.
■ PIU/Amplifier Serial #: The serial number on the rear of the Patient Interface Unit (PIU). Enter ‘unknown’ or ‘none’ if the
PIU/Amplifier Serial # is unknown, or if it is for a LRS.
■ Installer Name: Full Name
■ Installer Email: SJM email address
■ Email License? choose how to deliver the license.
– Yes, Download and Email, to have the license downloaded immediately and emailed
– No, Just Download, to have the license downloaded immediately
b. Click Yes, Download and Email License when finished.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600035010 A Installing EnSite™ Cardiac Mapping System Software Licenses
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NOTE: For an optional module license, fill in license information as follows. It is recommended that a copy of the license is
emailed to you for future reference.
Figure 205.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600035010 A Installing EnSite™ Cardiac Mapping System Software Licenses
243
Install Licenses
For EnSite™ Velocity™ software v.5.x or Newer:
1. Take the license media created in “Retrieve License(s) and Create Media” on page 239 to the Display Workstation
2. Login as user service
3. Click Service > Install License From Media
4. Follow the prompts
The status of all currently licensed features for this system is displayed. The system example, above, has a permanent base EnSite™
System license. This section will also display:
■ Status of any optional modules
■ Demo software
■ Demo days remaining
Re-Creating Licenses
If a license was created earlier and another copy of the existing needs to download use the same page to retrieve another copy.
1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/lserv/
2. Enter the old Activation ID and hostname of the DWS or LRS for the license created earlier
NOTE: This will not work if the Activation ID and hostname combination do not match any existing licenses.
■ The Web page will download the old license file and then it can be emailed.
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ARTEN600035010 A Installing EnSite™ Cardiac Mapping System Software Licenses
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Manage Licenses
For EnSite™ Velocity™ software v.5.x or Newer:
1. Log in as service
2. Click Services > Manage Licenses, from the title screen. The Manage Licenses window displays the licenses on the system.
Installation Report
Fill out the installation report supplied with the kit once the installation is complete.
1. Confirm that the system base license is installed as shown in the Verify Installed Licenses section.
2. Contact SJM Tech support, if the proper version of the base license is not installed
SJM Tech support numbers:
Toll Free: 800.374.8038
Phone Number: 651.523.6985
For a new EnSite™ System or DWS replacement, use the system hostname as the Activation ID when logging into the SJM licensing
web site at: https://ensite-license.sjm.com/lserv/
Warranty Policy
For warranty information, contact your EnSite™ Velocity™ Cardiac Mapping System representative or distributor for a description
of warranty coverage, service agreements, and replacement/upgrade component costs.
General Notices
EnSite™ products are returnable only with prior authorization from St. Jude Medical.
St. Jude Medical reserves the right to change or discontinue products without notice.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 247
Specifications
Table 28. EnSite™ Amplifier Specifications Table 29. Signal Processing Specifications
Gain accuracy ± 2%
Leakage Conforms with IEC 60601-1 Input signal DC ± 1500 mV
offset
Defibrillator Conforms to IEC 60601-1
Protection Type CF, Type BF Input amplitude Absolute 10%; channel to channel 5%
Defibrillator-proof applied parts accuracy
Isolation > 4000 volts; > 5000 volts surge EnGuide signal 8.138 kHz signal to up to four EP catheter
electrodes
Protection IPX0
against the
ingress of water Table 30. Display Workstation (DWS) Specifications
Input from patient Workstation Multi core CPU PC, PCI Express graphics,
and DVD/CD writer
ECG 12 lead
Display monitor Refer to the product literature provided with
Catheter 2 mm patient-safe jacks the monitor for connector characteristics.
EnSite™ Custom assembly
Array™ Catheter
Table 31. Software Specifications
EnSite™ Custom assembly
Velocity™ Operating Linux
Surface system
Electrodes
Mapping St. Jude Medical proprietary software
Recording Custom assembly system
System
Mode of Continuous
operation
Technical Specifications EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
248 Specifications ARTEN600035010 A
Table 33. Environmental Conditions Table 34. System Component Physical Characteristics
EnSite™ Amplifier +18 to +27 °C to 90% relative humidity, Component Dimension in cm Weight in kg (lb)
Operating non-condensing (nominal)
EnSite™ Amplifier -25 to +55 °C to 90% relative humidity, EnSite™ Amplifier 49 H, 46 W, 51 D 31 (68)
Transport/ non-condensing
storage EnSite™ Amplifier 94 H, 62 W, 58 D 42 (92)
cart
EnSite™ Velocity™
Surface Electrode Kit – EnSite™ Velocity™
Storage Conditions -10°C to 40°C Cardiac Mapping DWS6 & DWS7 DWS6: 15.5 (34.2)
System Workstation 44.45 cm H
computer
17.15 cm W DWS7: 15 (33.1)
46.48 cm D
The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.
RF emissions Group 1 The EnSite™ Amplifier / Workstation uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class A The EnSite™ Amplifier / Workstation is suitable for use in all establishments other
CISPR 11 than domestic and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.
Electrical fast ±2 kV for power supply lines ±2 kV Mains power quality should be that of a typical
transient/burst commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/output lines ±1 kV
Voltage dips, short 0% UT; 0.5 cycle 100% dropout in VNOM for Mains power quality should be that of a typical
interruptions and voltage At 0º, 45º, 90º, 135º, 180º, 0.5 cycle at listed phase commercial or hospital environment. If the user of
variations on power supply 225º, 270º and 315º angles the EnSite™ Amplifier / Workstation requires
input lines. continued operation during power mains
IEC 61000-4-11 interruptions, it is recommended that the EnSite™
0% UT; 1 cycle 100% dropout in VNOM for
Amplifier / Workstation be powered from an
1 cycle at 0º
and uninterruptible power supply or a battery.
30% dropout in VNOM for
70% UT; 25/30 cycles
25/30 cycles at 0º
Single phase: at 0º
Power frequency 30 A/m 30 A/m Power frequency magnetic fields should be at levels
(50/60 Hz) characteristic of a typical location in a typical
commercial or hospital environment.
magnetic field
IEC 61000-4-8
Note UT is the a.c. mains voltage prior to application of the test level.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use Technical Specifications
ARTEN600035010 A Electromagnetic Emissions – Declaration
251
The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.
d = 1.2 P
7 800 MHz to 2.7 GHz
d = ------- P
E1
d = 2.3 P
Immunity to Proximity 385-5785 MHz 9-28 V/m Per IEC 60601-1-2 (Per Table 9 of Standard)
Fields from RF wireless
communications
equipment IEC 60601-1-2
(Clause 8.10)
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EnSite™ Amplifier /
Workstation is used exceeds the applicable RF compliance level above, the EnSite™ Amplifier / Workstation should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EnSite™ Amplifier /
Workstation.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.
Technical Specifications EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
252 Electromagnetic Emissions – Declaration ARTEN600035010 A
The EnSite™ Amplifier / Workstation are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the EnSite™ Amplifier / Workstation can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the EnSite™ Amplifier / Workstation as recommended
below, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacture.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
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Refer to the EnSite™ Cardiac Mapping System Instructions for Use for Indications for Use.
Introduction
The EnSite™ Derexi™ Module consists of software features that uniquely integrate the EP-WorkMate™ Recording System with the
EnSite™ Cardiac Mapping System. This integration was introduced to consolidate patient and clinical information and to reduce the
duplication of work effort. The interface between the two systems allows for the sharing of information, which promotes ease of use
and a clearer representation of the case events.
NOTE: Refer to the EnSite™ Cardiac Mapping System IFU and the EP-WorkMate™ Recording System IFU for additional
information and regulatory considerations.
A RecordConnect is required to route the ECG and EP Catheter signals from the patient to both the EnSite™ Amplifier and the EP-
WorkMate™ Recording System Signal Conditioning Unit (SCU). The EP catheters are connected to the EP-WorkMate™ Recording
System’s Catheter Input Module (CIM), and the CIM is connected to the RecordConnect. The RecordConnect routes EP catheter
signals from the CIM to the EnSite™ Amplifier and to the EP-WorkMate™ Recording System SCU.
Figure 210. EnSite™ Cardiac Mapping System to the EP-WorkMate™ Recording System basic signal connections.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
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EnSite™ Derexi™ Module
Connecting to the EnSite™ Cardiac Mapping System
255
A hardware connection must be made between the EP-WorkMate™ Recording System and the EnSite™ Cardiac Mapping System,
using an Ethernet cable and an Ethernet Isolator.
1. Connect the Ethernet cable to the EP- EP-Workmate ™ Recording System CPU
WorkMate™ Recording System CPU
(either an HP xw6400 or HP xw6600), HP xw6400 HP xw6400 or HP Z600
using the port shown at right:
Optional switch
3. Connect the 1’ Ethernet cable (B) into EnSite ™ Cardiac Mapping System Workstation
the 2nd Ethernet port from the right
(C) on the back of the EnSite™ Cardiac
Mapping System Workstation:
4. Connect the Ethernet cable from the
EP-Workmate™ Recording System A
CPU or switch (optional) to the
Ethernet Isolator (A).
C
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
256 EnSite™ Derexi™ Module
Connecting to the EnSite™ Cardiac Mapping System ARTEN600035010 A
Connection States
On the EnSite™ Cardiac Mapping System, there are three possible connection states for the communication between the EnSite™
Cardiac Mapping System and EP-WorkMate™ Recording System (Disabled, Ready, and Connected). The following table shows and
describes the icons that display at the bottom of the EnSite™ Cardiac Mapping System screen during each of the following states.
NOTE: The EnSite™ Derexi™ Module license must be installed on the EnSite™ Cardiac Mapping System before the icons will
display.
Table 40.
State Description
NOTE: This is an active icon that the user can use to disable or enable the connection at any time.
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EnSite™ Derexi™ Module
Maps and Integration
257
Signals are defined by the EnSite™ Cardiac Mapping System and are provided to the EP-WorkMate™ Recording System along with
the map point data.
Mapping Constraints
■ Map names can only be Edited, Renamed, or Deleted via the EnSite™ Cardiac Mapping System Notebook in the RealReview task.
■ The EnSite™ Cardiac Mapping System will only accept a Point-Save request from the EP-WorkMate™ Recording System if both
systems are in Realtime mode.
■ When creating a new map, it is required that the EnSite™ Cardiac Mapping System take the first mapping point. Any Point-Save
requests from the EP-WorkMate™ Recording System, prior to the EnSite™ Cardiac Mapping System taking the first point, will
be rejected.
■ The EP-WorkMate™ Recording System is only allowed to change the annotation string of an EnSite™ Cardiac Mapping System
mapping point.
■ Only the EnSite™ Cardiac Mapping System can create a new map or change the active map.
Patient Connections
The connections between the patient and the two systems consist of a 12 lead ECG and intra-cardiac catheter connections. Connecting
the catheters and the 12 lead ECG cable is the same process for the standalone or integrated systems and has not been changed by the
data integration. For detailed patient connections, consult the Instructions for Use (IFU) for the EnSite™ Cardiac Mapping System and
the EP-WorkMate™ Recording System IFU.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
258 EnSite™ Derexi™ Module
Dual System Start-up Procedure using the EnSite Derexi Module
™ ™ ARTEN600035010 A
The following procedure shows the steps required to setup a case study with the integration of the EP-WorkMate™ Recording System
and the EnSite™ Cardiac Mapping System, via the EnSite™ Derexi™ Module.
1. Ensure that both the EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System are powered up.
2. Install license on the EnSite™ Cardiac Mapping System and configure the EP-WorkMate™ Recording System.
3. In the EnSite™ Cardiac Mapping System, fill in at least the patient weight from the Patient Information screen.
4. In the EnSite™ Cardiac Mapping System, select the EP-WorkMate™ Recording System from the RecordConnect drop-down
menu.
5. Begin a study from the EnSite™ Cardiac Mapping System:
a. Check that the EP-WorkMate™ Recording System heart icon (in the bottom right of the EnSite™ Cardiac Mapping System
Mapping window) is yellow.
b. As long as the EnSite checkbox in the EP-WorkMate™ Recording System is checked, the icon will turn green, meaning that
a connection between EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System has been made (see
Figure 211 on page 260).
c. A pop-up message is generated: “Accept the Connection to EP-WorkMate™ for patient “First” “Middle Initial” “Last Name,”
“Patient ID”? [ACCEPT] [REJECT].”
6. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the connection:
a. Demographic data is sent from the EP-WorkMate™ Recording System to the EnSite™ Cardiac Mapping System.
b. A pop-up message is generated: “Updated Demographics Received from EP-WorkMate™: “First” “Middle Initial” “Last
Name,” “Patient ID” “Birthdate” “Gender” Physician” Diagnosis” “Procedure” [ACCEPT] [REJECT].
Note: If both the Patient Information and the Diagnostic Information received from the EP-WorkMate™ Recording System
is an exact match to the EnSite™ Cardiac Mapping System data, no pop-up message is generated.
7. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the demographic data.
NOTE: All data fields are updated in the EnSite™ Cardiac Mapping System database except the patient’s weight.
8. Create a model (if needed) in EnSite™ Cardiac Mapping System, either within the Model Workflow or from the One Map tool in
the Mapping Workflow.
9. Depending on which workflow was used in the EnSite™ Cardiac Mapping System, follow step (9.a.[Model task] or
9.b.[Mapping task]) to proceed with the case study:
a. If a model was created while in the Model task, the user must then select the Mapping task and access the Mapping Workflow
of the EnSite™ Cardiac Mapping System to take the first point. (The [Freeze]/[Save] feature is required to capture points.)
After a first point is taken by the EnSite™ Cardiac Mapping System, it will begin accepting mapping point requests from the
EP-WorkMate™ Recording System for the current active map.
b. If the points or the model were created using the One Map tool, the system is already in the Mapping task and is using the
Mapping Workflow. (The [Freeze]/[Save] feature is required to capture points.) After a first point is taken by the EnSite™
Cardiac Mapping System, it will begin accepting mapping point requests from the EP-WorkMate™ Recording System for
the current active map.
10. Proceed with the case in the EnSite™ Cardiac Mapping System.
11. Exit Study from the EnSite™ Cardiac Mapping System (if the demographic data and/or diagnostic data for the patient profile has
not been completed, a message will pop-up requesting that the patient demographic be updated. The user will not be allowed to
exit the study until all Patient Information and Diagnostic Information is complete).
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EnSite™ Derexi™ Module
Interface Features & Descriptions
259
NOTE: For instructions on how these features are enabled from the EP-WorkMate™ Recording System, refer to the EP-
WorkMate™ Recording System IFU.
Active Map Change – This feature can only be executed from the EnSite™ Cardiac Mapping System. When a new map is created, the
active map name/ID is automatically sent to the EP-WorkMate™ Recording System. If the EP-WorkMate™ Recording System does
not already possess this map, one is created. The same process takes place when changing to a different map.
Add/Edit Annotation – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™
Recording System. In the EnSite™ Cardiac Mapping System, mapping points are automatically labeled with the Tag and Type, but
additionally comments/annotations may be added by right-clicking on the trace point of interest and selecting Edit Annotation. This
new text will be added to the Points list. The annotation will also be sent to the EP-WorkMate™ Recording System, where it is saved
as a Procedure Log entry and in the Mapping Window as Notes.
Delete Map – This can only be done in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task. Click on
the map name to delete (this map cannot be open at this time) and click on the [Delete] button on the bottom right below the Notebook
entries. The map will also be deleted from the EP-WorkMate™ Recording System Mapping Window and the Procedure Log.
Delete Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™ Recording
System. To delete a point in the EnSite™ Cardiac Mapping System, go to the Points tab in the Control Panel and select a point. Click
on the [Delete] button located at the bottom of the Control Panel. Points can also be deleted by right clicking in the black background
of the trace display and selecting Delete Point from the menu. The system that issues this request, sends the identifier of the selected
map point to delete to the other system.
NOTE: The same process can be used to Delete Hidden Points, and to Delete Unused Points, which are also in the menu.
Edit Mapping Points – In the EnSite™ Cardiac Mapping System only, the calipers and voltage levels can be edited in the waveform
display below the map by simply clicking and dragging the calipers and/or the voltage levels. As explained below, the annotation may
also be edited.
Reload Map – This request can only be issued from the EP-WorkMate™ Recording System. With the appropriate map identifier
present in the Map field of the Mapping Control Bar (EP-WorkMate™ Recording System), click on the [Reload Map] button. The
map is sent to the EnSite™ Cardiac Mapping System and the EnSite™ Cardiac Mapping System returns the map to the EP-WorkMate™
Recording System with all previous points plus any new points that have been added.
Rename Map – This change can only be made in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task.
Click on the map name to be changed and click on the [Edit] button. The Edit Event window is displayed. Here the map name can
be changed. The updated name is then sent to the EP-WorkMate™ Recording System.
Save Image – When requested by the EP-WorkMate™ Recording System, an image will be captured by the EnSite™ Cardiac Mapping
System. The image is then saved to the Notebook, on the EnSite™ Cardiac Mapping System, and then sends the single image (in jpeg
format) to the EP-WorkMate™ Recording System where it is stored in the Mapping window. Images requested by the EnSite™ Cardiac
Mapping System alone, are saved to the EnSite™ Cardiac Mapping System only. These images are not sent to the EP-WorkMate™
Recording System.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
260 EnSite™ Derexi™ Module
EP-WorkMate™ Recording System Mapping Controls ARTEN600035010 A
Save Mapping Points – The first point of a map must be defined by the EnSite™ Cardiac Mapping System. Points are captured by
clicking on the [Freeze] then [Save] buttons at the bottom of the EnSite™ Cardiac Mapping System Mapping window. Once the first
point is saved, the point is also sent to the EP-WorkMate™ Recording System where it is stored in the procedure Log file and
displayed. After the initial point is created in the EnSite™ Cardiac Mapping System, the EP-WorkMate™ Recording System can also
request that points be taken. (Refer to the EP-WorkMate™ Mapping System Interface for EnSite™ Derexi™ Module IFU for more
information).
NOTE: When creating a new map, the EnSite™ Cardiac Mapping System must take the first mapping point. Any Point-Save
requests made by the EP-WorkMate™ Recording System will be rejected prior to the first point taken by the EnSite™
Cardiac Mapping System.
Select Mapping Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™
Recording System. In the EnSite™ Cardiac Mapping System, selecting a point can be accomplished by clicking on the trace of interest
under the Points tab. Clicking on the trace will highlight the trace and, if shown on the model, will cause the surface points/3D points
to flash on the anatomic model. The checkbox feature will toggle on/off the model points. The system that issues this request, sends
the identifier of the selected map point to the other system.
Sort Map – Mapping points can be sorted by either system. In the EnSite™ Cardiac Mapping System, select the Points tab in the
Control Panel and click on the down arrow of the drop-down Sort menu. Here the mapping points can be sorted according to Order
of Collection, Cycle length, or map type (e.g., LAT, Peak to Peak, Peak Negative, CFE Mean, CFE Std. Dev.).
Start Recording of Electrograms – In the EnSite™ Cardiac Mapping System, click the [Record] button below the Realtime data pane
on the left side of the screen to start recording segment data. The EnSite™ Cardiac Mapping System also sends a Start Recording
request to the EP-WorkMate™ Recording System, which also starts recording. If the EP-WorkMate™ Recording System is not already
recording, a new recording will begin.
Stop Recording – In the EnSite™ Cardiac Mapping System, click the [Stop] button below the Realtime data pane on the left side of
the screen to stop recording segment data. The EnSite™ Cardiac Mapping System also sends the Stop Recording request to the EP-
WorkMate™ Recording System.
Updating Demographics – To share patient demographics between the systems, the updates must be made on the EP-WorkMate™
Recording System. When patient demographics are changed on the EP-WorkMate™ Recording System, the updated information is
automatically sent to the EnSite™ Cardiac Mapping System. The EnSite™ Cardiac Mapping System user will be prompted to
[Accept] or [Reject] the updated patient demographics.
Patient demographics can also be updated on the EnSite™ Cardiac Mapping System, but these changes are not sent to the EP-
WorkMate™ Recording System. In the EnSite™ Cardiac Mapping System, click File and click Study/Patient Information. This
displays a patient demographics window, which can then be completed as needed. The case cannot be exited on the EnSite™ Cardiac
Mapping System until all required demographic information has been completed. Once all the fields are filled in, the [OK] button
becomes active. Clicking on the [OK] button will end the case.
The EP-WorkMate™ Recording System Mapping Control Bar has features that coincide with the EnSite™ Cardiac Mapping System
controls. These features are functional when the EnSite™ Derexi™ Module is connected and the EnSite box is checked (see Figure
211. below).
NOTE: Refer to The EP-WorkMate™ Mapping System Interface for the EnSite™ Derexi™ Module for descriptions of these
controls and how they are used in conjunction with the controls in the EnSite™ Cardiac Mapping System.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
ARTEN600035010 A 261
The EnSite™ Verismo™ Segmentation Tool (H702504) is indicated for use in generating 3D models from CT, MR, or rotational
angiography DICOM image data. Generated models are intended to be displayed on the EnSite™ Velocity™ Cardiac Mapping
System.
Description
The EnSite™ Verismo™ Segmentation Tool is a software utility used to convert large volumes of sliced-based images into a
manageable 3D model of cardiac structures.
The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from most CT and MRI scanners, including enhanced CT/MR
images. Once image data are imported into the EnSite™ Verismo™ Segmentation Tool, a 3D model can be extracted from the images
in a process called segmentation. Segmentation is the process of isolating an object of interest from a digital image using the greyscale
intensity of slice-based data. This model (see Figure 212) can be easily viewed and manipulated during an electrophysiology procedure
using the EnSite™ Velocity™ Cardiac Mapping System software. See the EnSite™ Velocity™ Cardiac Mapping System Instructions
for Use for information about viewing models.
Contraindications
There are no known warnings or precautions specific to this product. Refer to the EnSite™ Velocity™ Cardiac Mapping System
Instructions for Use for warnings and precautions pertaining to the EnSite™ Velocity™ Cardiac Mapping System.
Operator Requirements
The EnSite™ Verismo™ Segmentation Tool must be operated by, or under the supervision of, an electrophysiologist trained in the
operation of the EnSite™ Verismo™ Segmentation Tool and supported by other qualified personnel trained in the field of cardiac EP.
EnSite™ Velocity™ Cardiac Mapping System requirements – the EnSite™ Verismo™ Segmentation Tool v.2.0.1 can only be
installed on an EnSite™ Velocity™ Cardiac Mapping System workstation with EnSite™ Velocity™ Cardiac Mapping System v.3.0.1
Software or higher.
Verification – To ensure model accuracy, segmentation results should be compared to the original slice data by (or under the
supervision of) a physician.
DICOM conformance – the EnSite™ Verismo™ Segmentation Tool allows importation of slice-based images in DICOM 3.0 (2009)
data sets from CD/DVD or a PACS network.
■ The EnSite™ Verismo™ Segmentation Tool does not support direct connection to a PACS network. DICOM data sets located on
a PACS network are retrieved by the EnSite™ Courier™ Module and written to the EnSite™ Velocity™ Cardiac Mapping System
Display Workstation (DWS) hard drive.
■ The EnSite™ Verismo™ Segmentation Tool does not support image export.
■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal enhanced CT/MR images.
■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal cine images with missing or inconsistent timing
information within each volume.
Refer to the EnSite™ Verismo™ Segmentation Tool v.2.0.1 DICOM Conformance Statement for details.
Overview of Segmentation
1. Power on the DWS and start the EnSite ™ Verismo ™ Segmentation Tool. “Indications for Use” on page 261
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool
263
The following minimum requirements are provided to optimize the quality of the cardiac model generated through the EnSite™
Verismo™ Segmentation Tool segmentation process:
■ Missing Slices The EnSite™ Verismo™ Segmentation Tool cannot segment images
with missing slices
■ Slice Orientation Do not use oblique slice orientations
■ Slice Spacing Must be uniform, .5mm increments, such as .5mm, 1.0mm, and
1.5mm.
■ DICOM Header Use only standard letters and numbers in the DICOM header. Do not
use special characters, such as: ^ " & % $ # @ !
EnSite™ Verismo™ Segmentation Tool Module EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
264 Loading Files for Segmentation ARTEN600035010 A
Verismo Cleanup
Upon launching Verismo, the system allows you to perform a cleanup procedure before Verismo launches. Click the [Clean Verismo]
button. This procedure removes all temporary files. Perform a Cleanup procedure if Verismo fails to launch. See “Troubleshooting
Common Problems” on page 287 for more information.
NOTE: Performing a Cleanup will remove any data currently in the Verismo workspace, such as work in progress files. DIF files
will not be deleted.
The Wizard is intended to guide the clinician through the segmentation process (see
Figure 214). The Wizard will describe how to load files and provides an overview of
the segmentation tools.
■ Follow the suggested task at the top of the Wizard.
■ Below the task are several options. Selecting the option will provide additional
details and describe how to access the controls.
■ When a step is complete, click [Next].
Note: Clicking [Back] will access the previous step.
Note: The Wizard may be closed by clicking [Close] or [Finish]. To access the
Wizard again, select File > Resume Wizard.
A DICOM data disk may contain multiple patients, multiple radiology studies for each patient, and multiple series per study. Use the
panels on the lower half of the screen to select a series for segmentation.
1. From the Patient panel, select a patient name.
2. From the Study panel, click on the study of interest.
EnSite™ Verismo™ Segmentation Tool Module EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
266 Subregioning the Series ARTEN600035010 A
Viewing Options
The following options are available for sorting patient data:
■ To add or remove columns of information from the patient, study, or series panels, click [List Options]. A window will appear with
display options. Select display options and click [Close].
■ Clicking on the heading at the top of a column will sort the data by that column.
Subregioning is a process of identifying a region of interest within the scan for segmentation. Subregioning can improve the
performance of the segmentation tool by processing only the regions of interest. The goal of subregioning is to minimize the volume
to maximize processing speed.
1. A green bounding box appears in the image display.
Left-click on any handle of the bounding box and drag to
outline the region of interest (see Figure 216).
Note: During subregioning, the Zoom, Pan, and W/L
controls may help visualize the slice data. See “Using
Basic Interface Controls” on page 268.
After subregioning the series, the data may need to be preprocessed, filtered, and loaded into the segmentation interface.
Filtering removes grainy artifacts and non-uniformities that may affect thresholding operations. By default, filters are applied to CT,
but not to MR images. To adjust filter defaults, select Advanced > Settings and select the desired filter settings before loading the series
for segmentation.
Loading a subregioned series – To load the subregioned data series, click [Segment Series]. A progress bar is shown while the
subregioned volume is preprocessed, filtered, and then loaded.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Using the Segmentation Interface
267
Note: If the size of the subregioned series is larger than 60Mb, a message will
appear providing the following options (see Figure 217):
■ Subregion – Return to the subregioning tools and identify a smaller region
of interest.
■ Resample – Resampling will reduce the size of the data by adjusting the
resolution of the images until the subregioned series is less than 60MB.
Resampling may decrease accuracy of measurement tools. See “Using the
Measurement Tools” on page 281.
■ Continue – Use the identified data set without further subregioning or
resampling. Processing speed may not be optimal.
Import DICOM Files Import currently saved DICOM files into the EnSite ™ Verismo ™ Segmentation Tool.
Save As Save the displayed 3D model to the hard drive as a DIF file.
Save Work in Progress Save the segmentation results during a segmentation session, without creating a DIF
file.
Load Work in Progress Reload a segmentation session from a previous Save Work in Progress.
Print Print the full segmentation screen, 3D heart model, or any of the slice views.
Exit Exit the EnSite ™ Verismo ™ Segmentation Tool and return to the EnSite ™ Velocity ™
Cardiac Mapping System title screen.
Load Default Threshold Restore the default threshold after manual adjustments have been made.
Display Info Select preferences for displaying patient, study, and series information on the Slice
views. Allows access to information from the DICOM header.
Options Set options for crosshairs display and the number of undo levels.
Settings Set preferences for filters and the Growth Limit for the Vessel tool.
Release Notes Display information about the software not contained in the IFU.
The EnSite™ Verismo™ Segmentation Tool interface provides controls for navigating in slice views, zooming, panning, and adjusting
the intensity of the image. These controls are located in the lower left and lower right corners of the slice and 3D panels.
Note: After segmentation, if the Slice control is active, moving the mouse over the Zoom, Pan, or W/L controls will deactivate the Slice
control. If the Zoom, Pan, or W/L controls is active, moving the mouse over the Slice control will deactivate the Zoom, Pan, or W/L
controls.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Using Basic Interface Controls
269
Note: W/L adjustments do not affect the result of automated segmentation tools. To adjust intensities for automated segmentation, use
the thresholding and boundary emphasis controls under the related tools.
Using Templates
Interface preferences may be saved in templates. The following attributes can be saved in templates:
■ Structure names and colors
■ Default structure
■ Information displayed in the upper left corner of slice and 3D views.
■ Show crosshairs on/off
■ Growth limit for vessel tool
■ Font size for labels and tape measure
■ Number of undo levels
To create a template – Modify the above attributes, and select File > Save Template.
Note: Templates can only be saved or loaded from the segmentation screen, not the patient screen.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Performing Segmentation
271
Performing Segmentation
Each segmentation tool is represented by an icon in the control panel. Clicking the icon will display the tool.
Region Grow – Segment a region that consists of many connected structures, such as the
blood pool.
Barrier – Enhance boundaries between structures to improve the use of the Region Grow,
Chamber, Vessel, and Separator tools.
The Structure list manages the display of up to 16 structures (see Figure 221). It features
a drop-down menu of 16 structures and an ***Undefined*** option. One structure may
be selected from this list to be used by segmentation tools.
The ***Undefined*** option is used to remove information from the segmented model. Figure 221. The structure list.
All other structures add information to the segmented model. Undefined cannot be
locked, displayed, colored, or renamed.
Structure Attributes
Each structure has the following attributes (see Figure 221):
■ Lock – Locking a structure prevents modifications. To lock or unlock a structure, click on the lock icon. The icon for an unlocked
and modifiable structure appears in green (default), and the icon for a locked structure appears in red.
■ Display – Display controls whether the structure will be displayed in the 3D view. If the display is enabled (default), the display
icon appears as a small monitor, and the structure is shown in 3D view. If the display is disabled, the icon appears as a monitor
with a red slash, and the structure is hidden from 3D view. If a structure is not displayed, no part of that structure can be removed
or assigned to a different structure; however, a structure that is not displayed can still have additional information added to it by
other segmentation tools.
Note: Structures that are not displayed when a model is saved will not be available when the model is displayed on the EnSite™
Velocity™ Cardiac Mapping System software.
■ Color – The color controls the display color for the structure in the slice and 3D views.
Modifying Structures
Structure attributes may be modified.
1. Select a structure from the list to modify.
2. Select the [Modify] button adjacent to the structure list (see Figure 222), or
select Edit > Modify Structure. The Modify Structure window will appear.
3. Modify the structure attributes.
■ Name – Type a name using up to 16 characters, or select a name
from the list.
■ Color – Type a color name (“red”) or select [...] to display a color
selection tool.
Figure 222. The structure list and Modify Structure
■ Lock – Lock or unlock the structure. window.
■ Display – Display or hide the structure.
4. Select [OK].
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Using the Region Grow Tool
273
The Region Grow tool (see Figure 223) is used to quickly isolate a larger region of the
scanned volume such as the blood pool. Other segmentation tools can then be used to separate
individual structures from the blood pool. Region Grow requires the placement of one or more
seed points and manual adjustment of the threshold range.
6. Click [Apply] to segment the defined structure. The segmented structure is shown
in the 3D view (Figure 226).
Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo
the last change to the 3D model. See “Additional Controls: Delete, Undo, Cancel”
on page 271.
The Chamber tool (Figure 227) is used to quickly isolate a heart chamber from the scanned
volume. This tool requires the placement of a seed point in the middle of the chamber of
interest and manual adjustment of the threshold range. The Chamber tool emphasizes the
segmentation of a single chamber using an erosion algorithm. The erosion algorithm uses
thresholding and boundary emphasis values to automatically break thin connections to other
structures. The Chamber tool is often faster than Region Grow for segmenting a single
chamber, but generally has slightly less resolution.
The Vessel tool (see Figure 229) is used to quickly isolate a vessel from the scanned volume.
This tool grows a vessel on adjacent slices, using a seed point and a threshold range.
1. Select a structure from the list.
2. In the desired slice view, left-click to place a seed point in a vessel. The seed point
should generally be placed in a plane perpendicular to the vessel, such as the sagittal
view for pulmonary veins.
Note: The growth of structures using the Vessel tool is controlled by the Growth Limit.
The Growth Limit, available under Advanced > Settings, is user adjustable, but defaults to
1.5 times the size of the original slice.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 271.
3. Adjust the Min. Threshold and Max. Threshold sliders:
■ Adjust the Min. Threshold until a dotted line appears around the structure of
interest. If the dotted line surrounds multiple structures, the Min. Threshold
may be too low.
■ The Max. Threshold generally does not need to be adjusted unless a hard
structure (bone, implanted metal) is present.
Figure 229. The Vessel tool.
Note: If thresholding does not identify separations that can be visually
identified, consider using the Barrier tool before proceeding. See “Using the
Barrier Tool” on page 279.
4. Select one of the following directions to grow the vessel:
■ (Superior/Anterior/Left) to grow the vessel in the specified direction.
■ Both directions to grow the vessel in both directions.
■ (Inferior/Posterior/Right) to grow the vessel in the specified direction.
5. Click [Apply] to segment the vessel (see Figure 230).
Note: If the effect of the segmentation is undesirable, use the [Undo] button to
undo the last change to the 3D model. See “Additional Controls: Delete, Undo,
Cancel” on page 271.
The Separator tool (see Figure 231) is used to separate structures for individual visualization,
for example, separating the left ventricle from the left atrium. This tool can also be used to
remove a portion of the 3D model if too much detail was segmented. Structures are separated
between two or more seed points placed on the surrounding structures.
1. Select the Separator icon.
2. Select a structure to separate (e.g. Left Atrium).
Note: Selecting “Undefined” from the structure list allows the separator tool to delete
portions of the segmented model.
3. In the desired Slice or 3D view, left-click to place one or more seed points on the
appropriate structure (e.g. left atrium).
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 271.
4. Repeat steps 2 and 3 as needed to continue identifying surrounding structures.
Note: To preserve the original structure, be sure to place at least one point in the original
Figure 231. The Separator tool.
structure. For example, if the “Left Atrium” structure also contains portions of the left
ventricle and aorta, place points not only in the left ventricle and aorta, but also in the left
atrium.
5. Drag the Boundary Emphasis slider to emphasize the boundaries between structures.
6. Click [Apply] to separate the defined structures (see Figure 232).
Note: If separations do not occur at locations that can be visually identified, consider using the barrier tool before proceeding. See
“Using the Barrier Tool” on page 279.
Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo the last change to the 3D model. See
“Additional Controls: Delete, Undo, Cancel” on page 271.
EnSite™ Verismo™ Segmentation Tool Module EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
278 Using the Trace Tool ARTEN600035010 A
The Trace tool (see Figure 233) is used to manually outline a structure. It can be used to
create structures from slice views or reassign portions of the segmented model to a different
structure.
The Barrier tool (see Figure 235) is used to place divisions between structures that can be
visually identified, but may be difficult to automatically identify for a variety of reasons.
The Barrier tool improves the use of the Region Grow, Chamber, Vessel, and Separator
tools.
To create a barrier:
1. Select the Barrier icon.
2. In the desired Slice view, left-click and drag to draw a line (see Figure 236).
3. Advance to another slice in the same view and draw another line. Repeat this
process until the barrier has progressed from one side of the structures to the other.
■ When drawing barriers, always draw in the same general direction (left-
to-right, top-to-bottom, etc.)
■ Slices do not need to be consecutive.
■ The barrier tool will create an estimated line on all of the slices between
user-drawn lines. These estimated lines are displayed in purple; drawing
a new line on this slice will remove the estimated line.
■ Drawing a new line on a slice that already contains a line will replace
the previous line.
4. Click [Create Barrier] to grow the barrier through adjacent slices (see Figure 235).
The Reassign tool (see Figure 238) is used to reassign a structure that has already been defined. It is an efficient way to segment the
remaining structures from the slice or 3D views.
Reassigning a Structure
1. Select the Reassign icon.
2. Select the structure to be reassigned.
3. Select from the following assignment methods:
■ Entire Structure reassigns all components of one structure to a different
structure. For example, if a model of the left atrium was inadvertently
assigned to the Left Ventricle structure, use Entire Structure to reassign the
entire model to the Left Atrium structure.
■ Contiguous 3D reassigns all connected 3D regions to the defined structure.
For example, if a model in the Blood Pool structure contained the anatomy
of the descending aorta and the rest of the heart, and the aortic anatomy
was not connected to the posterior wall of the heart, this option would
allow the descending aorta to be reassigned to the Aorta structure.
■ Components less than 125 mm3 reassigns connected 3D regions less than 125
mm3. A new number can be typed if desired. For example, if the Left Figure 238. The Reassign tool.
Atrium structure includes many small disconnected and undesirable pieces,
this option can be used to reassign the small pieces to the Unassigned structure.
4. In the desired slice or 3D view, left-click to place a seed point on the structure to reassign.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo,
Cancel” on page 271.
5. Click [Apply] to reassign the defined structure.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Placing Labels
281
Placing Labels
The Label tool (see Figure 239) is used to label the 3D heart model. All labels are saved with the 3D model and will be included on
models imported into an EnSite™ Velocity™ Cardiac Mapping System study.
The Measure tool (see Figure 241) is used to measure linear and screen distances between two user-selected points. Measurement
accuracy is based on the original scan data +/- one slice space.
Note: Resampling may decrease the accuracy of measurement tools. See “Loading the Series for Segmentation” on page 266.
EnSite™ Verismo™ Segmentation Tool Module EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
282 Using the Measurement Tools ARTEN600035010 A
Figure 241. The Measurement Tool. Figure 242. Using the Measurement Tool
Measuring Distances
1. Select the Measure icon.
2. Select a font size for displaying the measured distance.
■ Small – 10 point
■ Medium – 12 point (default)
■ Large – 14 point
3. In any slice view or the 3D view, left-click and drag on the area to be measured.
■ Straight (slice or 3D views) is the shortest distance across the structure.
■ Screen (3D view only) is the projected screen distance, which changes as the 3D model is rotated. The screen measurement may
be useful for analyzing a distance at various angles.
Note: Measurements are shown on a model only when the Measure tool is selected. Measurements are not saved with the final DIF file.
Note: To delete tape measures, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 271.
When using the delete tool with tape measures, click on the red ends of a tape measure.
Measuring Volumes
Click [Measure Volume] to display the calculated volumes for all structures.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Saving and Exporting
283
Saving work in progress will help preserve the model in various stages of segmentation by returning to a previous point in the
segmentation process.
Note: Barriers, labels, and tape measures are not saved with work-in-progress files.
1. Select File > Save Work in Progress.
2. To recover this saved model at any time, select File > Load Work in Progress.
To access the segmentation contour viewer, select Display > View Segmentation Contour.
■ The rendered model from the 3D view appears as shaded solid areas.
■ The surface of the DIF model appears as thick opaque lines.
■ The slice images appear in a single view, which may be navigated using the same controls as the other slice views.
Printing Images
1. Select File > Print.
2. Select from the following options:
■ Full Screen prints the entire Segmentation screen
■ 3D Rendering prints the 3D heart model
■ Transverse (CAU) prints the transverse Slice view
■ Coronal (AP) prints the coronal Slice view
■ Sagittal (LL) prints the sagittal Slice view
Troubleshooting
651-756-6985
Toll Free: 800-374-8038, Option 1
www.sjm.com
Troubleshooting Tools
Technical Support may ask you to access one or more of the following software resources:
About EnSite Verismo – This information will provide technical support with general information about your software version. From
the EnSite™ Verismo™ Segmentation Tool menu bar, select Help > About EnSite Verismo.
Collect Log Files – This function collects all the log files from the system and exports them to a disk. Place a blank disk in the
DVD/CD writable drive. From the EnSite™ Velocity™ Cardiac Mapping System title screen, click on the [About EnSite ...] button.
Click on the Utilities tab then click on the [Collect Log Files] button. Follow the on-screen prompts to complete the process. This
operation can take several minutes to complete.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600035010 A Troubleshooting
287
Series will not load – Verify that the data was created in accordance with the “Optimal Characteristics for the EnSite™ Verismo™
Segmentation Tool Image Files” on page 263. If the series information displays but the series will not load, check the usability
indicator.
■ OK – No problems were detected.
■ Bad Dircos – Coordinate information is missing, or vectors are not at right angles.
■ Rot### – Volume is not orthogonal - direction cosines are reported.
■ NOT_3D – Only one section, or no slice locations, missing coordinate information, or all slices are at the same location.
■ Unsupported orientation – Volume is not a standard orthogonal.
■ GantryTilt – Gantry tilt field is nonzero.
■ IRREGULAR_SPACING – Spacing conflicts cannot be resolved.
EnSite™ Verismo™ Segmentation Tool is not responding – If the EnSite™ Verismo™ Segmentation Tool is not responding, press
<Alt> + <F10>.
Registration Module
The EnSite™ Fusion™ Registration Module is indicated for registering the EnSite™ NavX™ Navigation and Visualization
Technology system to anatomic models of any of the four individual cardiac chambers.
Introduction
The EnSite™ Fusion™ Registration Module is a software expansion module for the EnSite™ Cardiac Mapping System that provides
non-fluoroscopic navigation registered to a model of patient anatomy generated by CT or MR scanners. The EnSite™ Fusion™
Registration Module is intended for use with the EnSite™ Velocity Surface Electrode Kit and cardiac models from CT or MR scans
segmented into a compatible file format.
Once the registration is applied, EnSite™ NavX™ Navigation and Visualization Technology mapping and labeling functions can be
applied to the Digital Image Fusion (DIF) surface, including Contact Mapping, Map Labels, Lesion Markers, and Anatomic Markers.
NOTE: For information on the indications for EnSite™ NavX™ Navigation and Visualization Technology and compatible file
formats, see the EnSite™ Cardiac Mapping System Instructions for Use.
NOTE: The features associated with the EnSite™ Fusion™ Registration Module are available for EnSite™ NavX™ Navigation
and Visualization Technology studies only. The EnSite™ Fusion™ Registration Module is not available for EnSite™
Array™ Catheter studies.
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Performing Registration
The EnSite™ Fusion™ Registration Module provides non-fluoroscopic navigation, mapping, and labeling on a DIF model. The
dynamic registration process involves the following steps:
■ Importing a DIF model
■ Scaling the EnSite™ NavX™ Navigation and Visualization Technology navigation field
■ Placing fiducial point pairs
NOTE: Registration should be performed for one cardiac chamber at a time. A high quality scan is necessary for the creation of
an accurate registration. The quality of the scan is fundamental to the user’s ability to create a highly detailed model
during the segmentation process. In turn, a detailed segmentation is essential to the user’s ability to identify precise
fiducial points during the registration process.
EnSite™ Velocity™ Cardiac Mapping System Instructions for Use EnSite™ Fusion™ Registration Module
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291
Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field
Field Scaling, available in EnSite™ Cardiac Mapping System software, compensates for local changes in impedance fields (Figure
247). For further information on Field Scaling, see the EnSite™ Cardiac Mapping System Instructions for Use.
NOTE: Field Scaling the EnSite™ NavX™ Navigation and Visualization Technology field is optional, but recommended.
Figure 247. An EnSite™ NavX™ Navigation and Visualization Technology model before (left) and after field scaling.
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A
Callout Item Description
A EnSite™ Fusion™ Display the EnSite™ Fusion™ Registration Module control panel.
B C
Registration Module
C Used A check mark in this column indicates that the fiducial is being used.
No check mark indicates that the fiducial is not being used.
D Add At Surface Select to place a fiducial point at the mouse location on the EnSite™
NavX™ Navigation and Visualization Technology model and DIF
model.
E Add At EnGuide Select to place a fiducial point at the Active EnGuide on the EnSite™
NavX™ Navigation and Visualization Technology model and mouse
location on the DIF model.
F
G Select Select to select individual fiducial points.
G
H [Compute] Click to compute registration. The Apply button must also be selected H
to see the registration.
I
K
J [Delete Fiducials] Click to delete the selected fiducial point.
L
M
K Use Fiducials Select to use the selected fiducial point. Deselect to not use the
selected fiducial point.
Figure 249. The EnSite™ Fusion™
L Show Fiducials Select to show all fiducial points; deselect to hide all fiducial points.
Registration Module control panel
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293
M Show Points Select to show the EnSite™ NavX™ Navigation and Visualization
Technology model point cloud; deselect to hide.
Figure 250. A scaled EnSite™ NavX™ Navigation and Visualization Technology model adjacent to a DIF model of the same patient.
2. Click the EnSite™ Fusion™ Registration Module icon in the Model control panel to display the EnSite™ Fusion™ Registration
Module control panel (Figure 249 on page 292).
3. Place fiducial points to link common locations between the EnSite™ NavX™ Navigation and Visualization Technology and DIF
model.
■ To place a fiducial point at the mouse:
a. Select the Add at Surface button. While this button is selected, the left mouse button is used to place fiducial points on
both the EnSite™ NavX™ Navigation and Visualization Technology and DIF surfaces. When the cursor is over the
EnSite™ NavX™ Navigation and Visualization Technology map display, it will be cross-hair shaped.
b. On the EnSite™ NavX™ Navigation and Visualization Technology model surface, left-click on a model location that is
also recognizable on the DIF surface. After placing a fiducial point on the EnSite™ NavX™ Navigation and
Visualization Technology side of the screen, the cursor will change to a cross-hair inside a square.
NOTE: When a fiducial point is placed on the EnSite™ NavX™ Navigation and Visualization Technology model surface, the
fiducial point will link to the nearest model point, not the model surface. This ensures that the location is tied to a previous
catheter position.
c. Left-click on the matching anatomic location on the DIF model. A spring-shaped icon will appear to connect the paired
fiducial points (Figure 251).
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NOTE: After any change to fiducial point pairs, click [Compute] to apply
the change.
NOTE: Select the Apply button to see the results of any changes.
Deleting a point – To delete a fiducial point, select the point in the fiducial list, and then click [Delete Fiducials].
Removing a registration – Select the Apply button to remove a registration. When registration is removed, navigation and labeling
at EnGuide will apply to the EnSite™ NavX™ Navigation and Visualization Technology model.
Display Options
Several controls are available to manage the display of the DIF and EnSite™ NavX™ Navigation and Visualization Technology
models. These controls are located on “The EnSite™ Fusion™ Registration Module control panel,” Figure 249. on page 292, the “Map
Settings menu,” Figure 255. on page 296, and the “Map Display Sliders,” Figure 256. on page 297.
Selection Description
Label Text On Shows/hides the label text for all map labels, anatomic markers, tape
measures, lesions, virtuals, and EnGuide Shadows.
Label Show Allows or prevents label text for all map labels, anatomic markers, tape
Through measures, lesion markers, virtuals, and EnGuide Shadows from showing
through other objects.
Show DIF Allows the DIF model (i.e., CT scan or MRI) to either be hidden or
Model displayed.
Project on DIF (After registration has been performed) Project or unproject 3D Labels
and/or Lesions (referred to as 3DP), and map data onto the DIF surface
rather than onto the EnSite™ Cardiac Mapping System model surface.
NOTE: Before registration, the Surface Distance is the distance from the
Active Electrode to the EnSite™ NavX™ Navigation and Visualization
Technology model surface. After registration, the Surface Distance is the
distance from the Active Electrode to the DIF model surface.
Show Mapping Causes surfaces to be colored using the current map color.
Low Accuracy (EnSite™ Array™ Catheter studies only) Enables or disables a red
Grid On highlight on areas of the grid that are more than 4cm from the center of the
EnSite™ Array™ Catheter. Signal and Tape Measure accuracy may be
decreased in these areas.
Show Proximity (EnSite™ NavX™ Navigation and Visualization Technology studies only)
Indicator Enables the proximity indicator.
Fixed Proximity Allows the diameter of the proximity indicator to be set to a maximum of
Indicator 10mm, regardless of the current lesion size.
Show EnSite (EnSite™ Array™ Catheter studies only) Shows the EnSite™ Array™
Array Catheter.
Zoom Increases/decreases the size of the model in the display window. The
middle mouse/scroll wheel can also be used to zoom.
Color Contour Adjusts the gradation between colors on the map. At low Color Contour
values, colors appear as distinct bands. At high Color Contour values, there
is a smooth transition between colors.
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A Translucency Adjusts the density of the surface model between translucent and
Slider opaque. This control works independently for each view in dual map
displays. A
Refer to the EnSite™ Cardiac Mapping System Instructions for Use
for more information. B
B Edge When enabled, provides a rendering of the model where the body
Enhancement can be translucent but the edge remains distinctly defined. C
C Clipping Plane Clipping planes allow for a view of the interior and rear of the closed D
Slider model by cutting a plane away from the viewing space. The slider
provides a smooth, controlled way of adjusting the clipping plane.
Unlocking the Clipping Plane deletes it.
D Plane Lock Clipping planes can be locked in the model/map display window.
When locked, the orientation remains fixed
relative to the model. When unlocked, the orientation is parallel to Figure 256. Map Display Sliders
the screen. To change the orientation of a
locked clipping plane, unlock it, rotate, and lock it again.
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Glossary APPENDIX G
3D – Three-dimensional.
ABL – Ablation.
Abstract Syntax – the information agreed to be exchanged between applications, generally equivalent to a Service/Object Pair (SOP)
Class. Examples: Verification SOP Class, Modality Worklist Information Model Find SOP Class, Computed Radiography Image
Storage SOP Class.
Accession Number – Sequential numbers assigned by imaging vendors as unique identifiers of an examination.
Application Entity (AE) – an end point of a DICOM information exchange, including the DICOM network or media interface
software; i.e., the software that sends or receives DICOM information objects or messages. A single device may have multiple
Application Entities.
Active Electrode – The electrode on the active EnGuide that is used for creating surfaces, placing labels, placing lesions, and
collecting points for maps.
Active EnGuide – The the catheter that is used for creating surfaces, placing labels, placing lesions, and collecting points for maps.
Active EnGuide Silhouette – A silhouette outline of the Active EnGuide where it resides inside the chamber of interest. The outline
takes on the color of the assigned Active EnGuide color.
Anatomic marker – A tool that is used to connect points on the surface of the model with lines.
Application Context – the specification of the type of communication used between Application Entities. Example: DICOM network
protocol.
Application Entity Title (AE Title) – the externally known name of an Application Entity, used to identify a DICOM application to
other DICOM applications on the network.
AP – Anterior Posterior.
ArrayLink™ Module – Used to connect the EnSite™ Array™ Catheter and Data Module to the EnSite™ Amplifier.
Asynchronous – Asynchronous Storage Commitment is returned to the requestor in a different DICOM association than the one by
which the request was sent (see Synchronous).
Auto Segment – The system automatically records segments to periodically store study information. These automatically recorded
segments are added to the Notebook where they are identified as type Auto Segment.
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AutoFocus – A tool that automates the dithering of the Color High and Color Low values to highlight early focal activation or small
diastolic or pre-systolic potentials.
Bio Impedance Scaling – A feature that corrects for the slow drift of the EnSite™ NavX™ Navigation and Visualization Technology
positions caused by a change in the saline concentration within body fluids over the course of a study.
Bookmark – A feature that allows the system to return to a specific time in review mode.
Boundary emphasis – Segmentation technique used to sharpen the edges of a structure so that the computer can identify what the
user sees as boundaries.
Calipers – A tool that is used to measure and adjust timing between signal features in the waveform display.
Cardiac Triggered Maps – Maps that use a surface electrocardiogram or an intra-cardiac electrogram as the reference to which
collected points are measured.
CFE Mean maps – Maps that provide a fractionation index based on the cycle length between multiple, discrete, local activations in
an electrogram.
CFE Standard Deviation map – A map that provides a fractionation index based on the cycle length between multiple, discrete, local
activations in an electrogram.
Clipping Plane – Clipping planes allow for a view of the interior and rear of the closed map by cutting a plane away from the viewing
space.
Coronal plane – Image plane that divides the body vertically into a front and back. Also called the frontal plane.
CT – Computed Tomography.
CT scan – Imaging technique that provides a 3D computer model of a patient’s anatomy. CT (computed tomography) scanners use
detectors rather than film to collect and digitize x-ray images. CT images are used to examine cross-sections (slices) of the heart from
all angles.
Data Module – The Data Module is included in the EnSite™ Array™ Catheter Kit and the EnSite™ Surface Electrode Kit. It contains
an EEPROM that must be validated prior to the start of a study.
DICOM Header – a text based portion of a DICOM file that describes the image dimensions and other information about the scan.
Digital Imaging and Communications in Medicine (DICOM) – an industry standard that facilitates interoperability of medical
imaging equipment.
Digital Image Fusion – A three-dimensional model created from digital images collected from Spiral CT or MRI scans.
Distal Length – The length of the distal electrode, which is located at the tip of the catheter.
Dynamic Host Configuration Protocol (DHCP) – used to automatically assign IP addresses, deliver TCP/IP configuration
parameters (such as the subnet mask and default router) and provide other configuration information such as the addresses of time
servers. DICOM requires fixed IP addresses and the configuration of AE Titles at each individual device.
ECG – Electrocardiogram.
ECG electrodes – Patch electrodes on the patient's skin, used to collect extra-thoracic cardiac signals.
EEPROM – Electrically Erasable Programmable Read-Only Memory. Also referred to as a Data Module.
Electrode Spacing – The distance from the edges of the electrodes on a catheter (not the distance from the centers of the electrodes).
EnGuide Alignment – A tool used to manually adjust the alignment of EnGuides relative to the model.
Enhanced CT and MR images – This refers to the multi-frame image objects defined by the DICOM standard for CT and MR. The
new multi-frame image objects collect frames into a single file with a standard structured header. This reduces the data size and file
transfer overhead.
Enhanced DICOM Object – the new enhanced objects for MR, CT, XA and RF (radiography/fluoroscopy) accommodate new
developments and acquisition techniques. As an example, for MR, the image data will be exchanged not only as individual images,
but as multiframe objects. Multiframe objects are a convenient way to package all the pixel data of a complete acquisition in one
message (or envelope). The differences between the individual frames of the multiframe object, such as the frame-rate, are described
in the multiframe header.
EnSite™ Array™ Catheter – The entire catheter from the proximal handle to the distal tip. The stainless steel braid, with the 64
electrodes, which is supported by the inflated balloon in the cardiac chamber.
EnSite™ Amplifier – The EnSite™ Amplifier accepts signals from the NavLink™ Module, ArrayLink™ Module, CathLink™
Module, SJM™ ECG Cable, RecordConnect, and GenConnect, converts these signals to digital format, and sends them to the DWS
for processing. The EnSite™ Amplifier is connected to the DWS through a fiber optic cable.
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EnSite™ Courier™ Module – The EnSite™ Courier™ Module is a software expansion module to the EnSite™ Velocity™ Cardiac
Mapping System Software. It enables the EnSite™ Velocity™ Cardiac Mapping System user to communicate with the hospital PACS
server for the purposes of storing and retrieving patient data in DICOM format.
EnSite™ NavX™ Navigation and Visualization Technology – The EnSite™ NavX™ Navigation and Visualization Technology
feature supports the tracking of EP Catheter locations from sensed potential on each axis of an orthogonal electric field generated by
body surface patches.
EnSite™ Verismo™ Segmentation Tool – a software utility used to convert large volumes of slice-based images into a manageable
3D model of cardiac structures.
EP – Electrophysiology.
EP catheter electrodes – The tip or ring electrodes on the shaft of an EP catheter which must be in contact with the endocardial wall
to collect good signals.
EPS – a DICOM modality type for basic cardiac electrophysiology, the specification for digitalized electrical signals from the patient
cardiac conduction system collected in the heart. EPS is the modality type used to store EnSite™ Velocity™ Cardiac Mapping System
studies.
Field Scaling – A feature that provides patient-specific scaling of EnSite™ NavX™ Navigation and Visualization Technology
dimensions to allow for distance measurements in EnSite™ NavX™ Navigation and Visualization Technology studies.
Fly-Eye – In an EnSite™ Array™ Catheter study, the display is divided into 64 labeled frames containing EnSite™ Array™ Catheter
traces.
F.O. cable – Fiber optic cable. The fiber optic cable provides the data connection between the The EnSite™ Amplifier and the DWS.
Ganged Signals – A group of signals in which a specific function is performed on all of them at once (e.g., a high pass filter setting
is set for all of the ECG signals simultaneously).
GenConnect – GenConnect is used to connect the ablation catheter and dispersive surface electrodes to the The EnSite™ Amplifier.
Highpass Filter – A filter that reduces low-frequency signals (i.e., repolarization signals) and baseline drift.
HR – Heart Rate.
Information Object Definition (IOD) – the specified set of Attributes that comprise a type of data object; does not represent a specific
instance of the data object, but rather a class of similar data objects that have the same properties. The Attributes may be specified as
Mandatory (Type 1), Required but possibly unknown (Type 2), or Optional (Type 3), and there may be conditions associated with the
use of an Attribute (Types 1C and 2C). Examples: MR Image IOD, CT Image IOD, Print Job IOD.
Intra-Cardiac Electrogram – An electrogram produced using catheters placed within the heart.
IP Address – a numerical label that is assigned to devices participating in a computer network that uses the Internet Protocol for
communication between its nodes. An IP address serves two principal functions: host or network interface identification and location
addressing. An IP Address can either be fixed or dynamic (see DHCP).
Isochronal Map – A map that shows the progression of activation through the first surface.
Isopotential Map – A map of voltages on the endocardial surface where similar voltages are represented by similar colors.
Lesion – Markers that are used to identify ablation points on the model.
Local Activation Time (LAT) Isochronal Map – A map that shows color-coded activation times for each collected location (or nearest
surface).
Local Activation Time – The difference in milliseconds between detected activation on the roving waveform and the reference
waveform.
Lowpass Filter – A filter that reduces high-frequency signals commonly caused by electronic interference.
Low-V ID – An adjustable low voltage identification option (Low -V ID) allows low-voltage potentials to appear in gray instead of
affecting the color pattern. Low-V ID is available for Local Activation Time (LAT) isochronal maps and Complex Fractionated
Electrogram (CFE) maps.
Model – The geometric surface model which describes the size, shape, and orientation of a heart chamber in relation to the EnSite™
Array™ Catheter and including the location of the EnSite™ Array™ Catheter or EnSite™ Velocity™ surface electrodes and any EP
catheter electrodes with location signals.
MRI Scan – Imaging technique that uses magnetic signals rather than x-rays to provide a 3D model of the patient’s anatomy. MRI
(magnetic resonance imaging) is based on the absorption and emission of radiowave pulses of energy. MRI images are used to examine
cross-sections (slices) of the heart from all angles.
NavLink™ Module – Used to connect EnSite™ surface electrodes and the system reference surface electrode to the The EnSite™
Amplifier.
Negotiation – first phase of Association establishment that allows Application Entities to agree on the types of data to be exchanged
and how that data will be encoded.
Non-Cardiac Triggered Maps – Maps that are created by collecting points at one second intervals.
Non-Contact Map – A map that is created with the EnSite™ Array™ Catheter.
Notebook – A feature that allows recorded data and study information to be filed and annotated for future access.
Offline Review – An operating mode in which data from a previous study is viewed and edited. The EnSite™ Amplifier does not need
to be connected or powered on.
Omnidirectional Polarity – The voltage is an arithmetic combination of unipolar measurements between the source of interest, a
specific electrode, and 4 or more other sources from equally spaced directions surrounding this electrode.
OneMap Tool – A tool that is used to simultaneously create a model and a map.
OneModel Tool – Default type for model creation. The OneModel tool wraps the model surface tightly around collected points
without tying back to a center point and may provide enhanced anatomic detail of the cardiac model.
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Orientation Reference – A torso-shaped icon in the upper right of a map that indicates the current orientation of the map by rotating
as the map rotates.
Orthogonal – Intersecting or lying at right angles. The axes of scanned orthogonal images are perpendicular to each other and to the
coronal (frontal), transverse (horizontal), and sagittal (medial) planes of the body.
Picture Archiving and Communication System (PACS) – an electronic and ideally filmless information system for acquiring,
sorting, transporting, storing, and electronically displaying medical images.
P-P – Peak-to-Peak.
Peak-Negative (P-Neg) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest
surface).
Peak-to-Peak (P-P) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest surface).
Perspective View – A feature that allows the field of view, or perspective of the model, to be changed to increase the understanding
of the model, the position of the catheters and/or the identification of points of interest.
Polarity – A voltage is the difference between positive and negative poles. The polarity defines these poles.
Port Number – a numerical identifier for the data structures of the endpoints for host-to-host communications.
Positional Reference – An electrode that will remain stable during an EnSite™ NavX™ Navigation and Visualization Technology
study. The displayed position of all electrodes is relative to the location of the positional reference.
Presentation Context – the set of DICOM network services used over an Association, as negotiated between Application Entities;
includes Abstract Syntaxes and Transfer Syntaxes.
Protocol Data Unit (PDU) – a packet (piece) of a DICOM message sent across the network. Devices must specify the maximum size
packet they can receive for DICOM messages.
Proximal Electrode – Any catheter electrode other than the distal electrode.
Proximity Indicator – Represents the position of the Active Electrode. The position of the indicator is size scaled based upon the
distance from the Active Electrode to the closest surface. The proximity indicator is drawn on the surface as a colored translucent spot,
matching the color of the Active Electrode.
Query / Retrieve – DICOM Query/Retrieve allows for querying a database from an archive, workstation, or other device for the
information it has available. It also allows for the retrieval (“pull”) of those objects, such as images.
R Value – The distance in millimeters from the center of the electrode array on the EnSite™ Array™ Catheter to the Active Electrode.
Realtime mode – An operating mode in which data is gathered, displayed, and recorded simultaneously while a patient is being
studied. Patient connections to the EnSite™ Amplifier are required, and the EnSite™ Amplifier must be powered on.
RecordConnect – RecordConnect is used to connect a recording system to the The EnSite™ Amplifier. A different RecordConnect
model is required for each make of recording system.
Reference Signal – The reference signal monitors a specific voltage point, based on the detection algorithm, of a specific waveform
to aid in the collection of activation data.
Render – To translate and regenerate an image. In the EnSite™ Verismo™ Segmentation Tool, heart structures are isolated from a
volume of scanned images and rendered for 3D visualization.
Resolution – Minimum distance at which two adjacent objects can be distinguished as separate.
Respiration Compensation – A feature that is used to compensate for catheter movement caused by a patient's breathing.
Respiration Meter – A meter that shows the current level of respiration, as computed by the relative impedance on the EnSite™
surface electrodes.
Respiration Rejection – A feature that is used to suspend model point collection and labeling functions when the patient's respiration
falls outside of a percentage of the Respiration Compensation range.
RF – Radio Frequency.
Rotational Angiography (RA) – A type of X-ray angiography where a series of images is acquired while the RA modality C-arm
performs a continuous rotation around the region of interest.
Roving Activation Interval – A timing parameter that is used in the detection of roving catheter activation.
Roving Signal – The roving signal is used for sampling local activation times (relative to the timing reference signal) and voltages
from various locations in the heart.
Sagittal plane – Image plane that divides the body into a right and left half. Also called medial plane.
Saturated Waveform – When a signal amplitude has reached its maximum value.
Saturation Recovery – A feature that allows for the quick recovery of signals to facilitate identification of post-therapy complexes.
Seed point – Reference point used by the EnSite™ Verismo™ Segmentation Tool to identify the heart structure of interest.
Segmentation – In digital image analysis, segmentation is the process of isolating the object of interest (foreground) from the rest of
the objects in the image (background).
Service Class Provider (SCP) – role of an Application Entity that provides a DICOM network service; typically, a server that
performs operations requested by another Application Entity (Service Class User). Examples: Picture Archiving and Communication
System (image storage SCP, and image query/retrieve SCP), Radiology Information System (modality worklist SCP).
Service Class User (SCU) – role of an Application Entity that uses a DICOM network service; typically, a client. Examples: imaging
modality (image storage SCU, and modality worklist SCU), imaging workstation (image query/retrieve SCU).
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Service/Object Pair (SOP) Class – the specification of the network or media transfer (service) of a particular type of data (object);
the fundamental unit of DICOM interoperability specification. Examples: Ultrasound Image Storage Service, Basic Grayscale Print
Management.
Service/Object Pair (SOP) Instance – an information object; a specific occurrence of information exchanged in a SOP Class.
Examples: a specific x-ray image.
Setup task – The task used to define the catheters used in a study.
SJM™ Connect – A feature that enables an SJM Technical Support representative to connect to the DWS through a broadband
Internet connection to perform remote technical support.
SM – Substrate Map.
SOP – see Service/Object Pair (SOP) Class and Service/Object Pair (SOP) Instance.
Spatial Filter – A filter that optimizes signals based on the placement of the EnSite™ Array™ Catheter.
Stabilize ABL – Stabilize ABL corrects the location of the distal electrode based on the properties of the catheter. ABL electrodes 2,
3, and 4 need to be displayed for Stabilize ABL to be enabled.
WARNING: Do not use Stabilize ABL in situations where electrodes 2, 3, or 4, on the ablation catheter, are covered by a sheath.
NOTE: If Stabilize ABL is enabled and the display of electrodes 2, 3, or 4 is turned off, Stabilize ABL is disabled and a message
displays to alert the user.
NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each catheter independently and only when
appropriate.
NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be collected.
Static Map – A map which is created by performing computations on a number of isopotential maps (e.g., an isochronal map).
Storage Commitment – The DICOM storage commitment service is used by the modality or workstation to confirm that an image
has been permanently stored by a device, usually a server and/or archive station, and it is safe to delete the images locally.
Study – A medical session occurring in a single day, where EP procedures are performed on a patient.
Substrate map – A map that shows relative peak-negative unipolar voltage over a user-specified beat throughout the chamber.
Surface Proximity Distance – The distance from the Active Electrode to the model or DIF surface.
Sweep Speed – The number of mm/sec in the waveform display (time scale).
Synchronous – Synchronous Storage Commitment is returned using the same DICOM association (a DICOM communication
session) as the one by which the Storage Commitment request was sent (see Asynchronous).
System Reference Surface Electrode – A surface electrode that is required for proper system operation for both EnSite™ Array™
and EnSite™ NavX™ Navigation and Visualization Technology studies. The system reference surface electrode connects to the
NavLink™ Module.
Tape Measure – A tool that is used to measure the distance between points on the model of the endocardial surface.
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Thresholding – Segmentation technique that uses intensity values to distinguish between the foreground and background objects of
a digital image. The intensity threshold is chosen from a histogram of intensity values for the image.
Time Cursor – A vertical yellow line in the waveform display that indicates the time represented by the map display.
Traces – Waveforms.
Tracking Virtual – A tool that is used to locate and interpret the Peak-Negative location in the chamber of interest.
Transfer Syntax – the encoding used for exchange of DICOM information objects and messages. Examples: JPEG compressed
(images), Little Endian explicit value representation.
Transverse Plane – Image plane that divides the body into upper and lower portions. The transverse plane is perpendicular to the
coronal and sagittal planes. Also called horizontal plane, axial plane, or transaxial plane.
Trigger Event – The detection event plus a user selectable time offset.
Triggering – To 'phase lock' both the waveform and the map displays, providing a view of the data which is synchronized with each
triggering event. Thus, when the triggering event is a heartbeat the waveforms and maps shall be repeatedly displayed, frozen at the
same point in time of each heart cycle.
Unipolar Reference – The signal return path for unipolar diagnostic catheter and EnSite™ Array™ Catheter signals.
Unique Identifier (UID) – a globally unique “dotted decimal” string that identifies a specific object or a class of objects; an ISO-8824
Object Identifier. Examples: Study Instance UID, SOP Class UID, SOP Instance UID.
Velocity Filter – A feature that prevents model point collection during rapid catheter movements.
Velocity meter – A meter that shows the relative velocity of the Active Electrode (blue bar) and the velocity threshold (purple bar).
Verismo – A software utility used to convert large volumes of sliced-based images into a manageable 3D model of anatomic
structures.
Virtual Electrogram – An electrogram from a selected site on the endocardium computed from map potentials over the specified
timeframe
Virtual Waveform – A waveform based on simulated electrodes placed on the map display.
Voltage Caliper – A tool that displays the measured potential at the distal signal of the Active Electrode.
Volume – Set of cross sectional images obtained when scanned slices are stacked in computer memory. A volume or volumetric data
set is based on inter-pixel and inter-slice distances that represent a real-world volume.
Voxel – Short for volume and pixel. A voxel is a pixel with depth, thus it is the smallest distinguishable volume element of a digital
image. See also pixel.
Waveform – A representation on the screen of all the data from a signal within a defined timeframe where time moves from left to
right and the height of the waveform represents the amplitude of the signal.
Waveform Display – The area on the screen in which waveforms are displayed.
Glossary EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
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Z Value – The distance in millimeters of the Active Electrode above or below the equator of the electrode array on the EnSite™
Array™ Catheter.
Index APPENDIX H
powering on 89 Head
EnSite Array Interpreting Isopotential Color 169
fly-eye display 112 Hide point checkbox 189
EnSite Array Catheter highpass filter
connecting to ArrayLink 70 description 122
EnSite Array Kit Home 187, 189
description 18 Hot key
EnSite Surface Electrodes 190
connecting to NavLink 63
positioning on patient 61
EnSite™ Amplifier 17 I
EnSite™ Array™ Catheter Setup 112 images
EnSite™ Cardiac Mapping System saving and accessing 212
Diagram 19 Imported DEMRI Image 137
EnSite™ NavX™ Navigation and Visualization Technology Study without Importing Studies 218
RecordConnect 80 Indications for Use
EnSite™ NavX™ Navigation and Visualization Technology, Sensor En- EnSite Cardiac Mapping System 13
abled™ Setup 114 EnSite Derexi 253
Environmental conditions 248 EnSite Fusion 289
EP catheter setup 101 EnSite Verismo 261
export information display settings 149
data 14 Interior Projection
Verismo models to DVD/CD 283 Mapping Control Panel 183
Export Interval Options 214 Interpolation
Export to USB fails 211 Mapping Control Panel 183
Exporting 215 Interpreting Isopotential Color 169
Exporting Data to External Devices 211 IRREGULAR_SPACING 287
Isochronal Mapping 175
Isochronal maps
F creating 176
fiber-optic cable description 165
connecting to the EnSite Amplifier 53 LAT 178
Field Scaling 14, 134 methodology 175
field scaling Single-Beat 15
applying 134 Isopotential maps
filtering 266 description 165
filters interpreting 166
highpass 122
lowpass 122
noise 122 L
spatial 122 Label 32
First Deflection 14 Label - segmentation tool 271
Flash New Points Label Colors 155
Mapping Control Panel 183 labels
fly-eye display description 153
description 112 placing 153
font size 281, 282 LAO view 150
Fractionation Threshold Laplacian 167
Mapping Control Panel 182 Laplacian bipole
Freeze polarity type 167
display button 187 Last Deflection 14
Last Duplicate 36
LAT maps 178
G Lesion 32
GantryTilt 287 Lesion at EnGuide 196
GenConnect Lesion control panel 199
connecting an ablation catheter 68 Lesion List 196
description 53 Lesion list 198
global virtuals Lesion Marker Tool 195
using to locate focal activation 168 Lesion Markers 196
Gray Scale 145 lesions
growth limit 276 control panel 199
description 196
list 198
H placing 197
hard drive selecting and modifying 198
out of space, troubleshooting 227 Licenses
Index EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
312 ARTEN600035010 A
P Realtime mode 27
Reassign - segmentation tool 271
pan 269
Reassign Tool, Verismo 280
Panning 190
panning maps 34 reassigning points on a model 131
RecordConnect
password 91
description 52
Past Studies 97
past study recording
feature description 16
reviewing 204
recording segments 143
patient records
creating 95 Recording System 72
recording system
managing 206
using 72
modifying 206
removing 207 Redo
Verismo 271
searching for 206
reentrant maps 181
patient safety requirements 21
pattern Reference Activation Caliper 186
Reference Offset Caliper 187
types for virtual electrodes 167
Reference Shadows 188
perspective view 152
playing recorded segments 144 reference signal
detection algorithm 179
P-Neg voltage maps 178
setting 179
Points 187
Points display 189 Refractory 181
Refractory slider (CFE maps only) 185
Points list 187
region grow 273
Points/Labels
Region Grow - segmentation tool 271
Mapping Control Panel 183
polarity remote monitor
connecting to the workstation 54
types for virtual waveforms 167
Remote Monitor Configuration Tool 58
Positional Reference Catheter Dislodgement 117
Positional Reference Tool 114 Replacement Parts 237
Respiration Compensation 119
power source
respiration compensation
recommendations 24
specifications 247 collecting 119
definition 119
powerline frequency
feature description 15
setting 234
P-P voltage maps 178 respiration meter 121
respiration rejection 120
Preparing for a Study 77
Respiration Gating 127
Preparing for an EnSite™ Array™ Catheter Study 83
Presets respiration meter 15
description 121
Export 215
respiration rejection 15
Export configuration 215
Load, Save 48 description 120
resuming a study 97
presets
review speed
model 127
print adjusting 144
reviewing past studies 204
Verismo menu bar 268
RF filtering
Verismo options 286
progress bar 265, 267 description 15
Rot### 287
Project Map to
Rotate/Pan 32
Mapping Control Panel 182
propagate 278 rotating 270
roving activation interval
propagation maps 181
description 186
Properties 196
proximity indicator 124 Roving Activation Tic Mark 187
Roving Shadows 188
proximity to surface 149
roving signal
detection algorithm 179
R setting 179
R value 125 run external program 221
RAI Curtain 186
RAO view 150
RealReview task
S
Saturation Recovery 121
annotations 202
saturation recovery
bookmark 202
images 202 description 15, 121
setting the controls 121
lists and controls 202
Save
screen 201
data after freeze 187
Index EnSite™ Velocity™ Cardiac Mapping System Instructions for Use
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